bioihbjkbjnl/mcl2 huggingface dataset:
Point-Of-Care TBI Detection System For Head Injured Patients In The Emergency Department
Condition: Brain Injuries
MeSH terms: Brain Injuries; Emergencies
Study type: Observational

Summary: 
      A prospective, non-randomized trial for the extension and replication of the development
      database of brain electrical activity recordings and clinical information collected from
      patients who present to the ED following closed head injury.
    

Detailed description: 
      The objective of this study is to test the clinical utility of the BrainScope technology for
      the acute identification of traumatic structural brain injury in the TBI population,
      following closed head injury. The data generated will serve to validate and/or refine the
      current algorithms to detect acute, traumatic, structural brain injury.
    

Intervention name(s): BrainScope Ahead 200
Intervention type(s): Device
Intervention description(s): A single-use, proprietary headset containing pre-gelled electrodes will be placed on the subject's forehead according to the standard locations of the modified International 10/20 system. Subjects will undergo approximately 5 minutes of eyes closed brain electrical activity recording.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who are suspected of a traumatic, closed head injury within 24 hours will be
        recruited from patients who enter the Emergency Department at hospitals that are
        participating as clinical sites for this study.
Study of Danicopan in Participants With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK)
      of ACH-0144471 (danicopan) in participants with hepatic impairment (HI) as compared to
      healthy matched participants.
    


Intervention name(s): Danicopan
Intervention type(s): Drug
Intervention description(s): Oral tablet.
Other intervention name(s): ALXN2040; ACH-0144471 (formerly); ACH-4471; ACH4471; 4471
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was to be conducted sequentially in 2 parts.
Part 1: Participants with moderate HI (based on Child-Pugh scores) were compared to demographically matched participants with normal hepatic function.
Following a review of PK and safety data from Part 1, a decision was to be made by the principle investigators and the sponsor whether to conduct Part 2 of this study, which was planned to enroll participants with severe and mild HI.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hepatic Impairment; Danicopan; ALXN2040; ACH-0144471; Pharmacokinetics; Factor D Inhibitor; Safety
A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if the study drug, PF-06252616 is safe and well
      tolerated when given to adult healthy volunteers.
    


Intervention name(s): PF-06252616; Placebo; PF-06252616; Placebo; PF-06252161; Placebo; PF-06252616; Placebo; PF-06252616; Placebo; PF-06252616; Placebo; PF-06252616; Placebo
Intervention type(s): Biological; Drug; Biological; Drug; Biological; Drug; Biological; Drug; Biological; Drug; Biological; Drug; Biological; Drug
Intervention description(s): 1.0 milligram per kilogram of PF-06252616, IV infusion, single dose; Placebo for PF-06252616, IV infusion, single dose; 3.0 milligram per kilogram of PF-06252616, IV infusion, single dose; Placebo for PF-06252616, IV infusion, single dose; 10.0 milligram per kilogram of PF-06252616, IV infusion, single dose; Placebo for PF-06252616, IV infusion, single dose; 3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose; Placebo for PF-06252616, Subcutaneous injection, single dose; 10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose; Placebo for PF-06252616, IV infusion, repeat dose; 20.0 milligram per kilogram of PF-06252616, IV infusion, single dose; Placebo for PF-06252616, IV infusion, single dose; 40.0 milligram per kilogram of PF-06252616, IV infusion, single dose; Placebo for PF-06252616, IV infusion, single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Pseudoexfoliation and Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      Background: Pseudoexfoliation (PEX) is characterised by the deposition of fibrillar material
      in an eye structures and many other parts of the body including kidneys and blood vessels. As
      both PEX and chronic kidney disease (CKD) are associated with oxidative stress and
      endothelial dysfunction we studied if the risk of PEX was increased in patients with CKD.

      Methods: Patients over age 40 with the diagnosis of CKD were included in the study. Chronic
      kidney disease was diagnosed as decreased glomerular filtration rate (GFR) of less than 60
      mL/min/1.73 m². Study groups were arranged as group 1 consisting of HD receiving patients,
      group 2 consisting of stage 1-4 CKD patients and group 3 consisting of patients with normal
      kidney functions (control group). Demographic properties and the rate of PEX were evaluated
      and compaired between the groups.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients from nephrology clinic
      
Keywords: Pseudoexfoliation, chronic kidney disease
Effects of Two Techniques of Mobilization in the Dorsiflexion on Patients With Chronic Ankle Instability
Condition: Chronic Instability of Joint
MeSH terms: Joint Instability
Study type: Interventional

Summary: 
      Restrictions on ankle dorsiflexion are common in subjects with chronic ankle instability
      (CAI). In fact, this is one factor that can contribute to the recurrence of such injuries.
      Passive mobilization techniques to improve ankle dorsiflexion are commonly used in
      physiotherapy treatments. However, no studies have compared manipulative techniques of
      mobilization techniques in subjects with chronic ankle instability.

      The aim of this study is to compare the effects of two mobilization techniques on ankle
      dorsiflexion in patients with chronic ankle instability.
    


Intervention name(s): HVLA; MWM; placebo
Intervention type(s): Other; Other; Other
Intervention description(s): High velocity and low amplitude manipulation in traction of subtalar jonit; Mobilization with movement as Mulligan for increase dorsiflexion of the ankle in weight bearing; Manual contact during a period of time similar of teh other interventions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Surufatinib DDI With a PPI and a CYP3A Inducer
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this is to evaluate the effect of proton pump inhibitor (rabeprazole) and the
      effect of a CYP3A inducer (rifampin) on the pharmacokinetics of Surufatinib.
    

Detailed description: 
      This study will be a single center, open-label, 2 part, 2 period fixed-sequence crossover
      study to be conducted with 28 healthy male and female subjects (part A and part B). Subjects
      will be enrolled in either part A or part B.

      In Part A, subjects will be administered surufatinib alone in treatment Period 1 and
      co-administered with rabeprazole in treatment Period 2.

      In Part B, subjects will be administered surufatinib alone in treatment Period 1 and
      co-administered with rifampin in treatment Period 2.

      PK samples will be collected through out both study periods.Subjects will be confined in the
      clinic from check-in on Day -1 through the end-of study visit on Day 15 (part A) and Day 16
      (part B).
    

Intervention name(s): Part A; Part B
Intervention type(s): Drug; Drug
Intervention description(s): in Part A, all subjects will receive Surufatinib 300 mg in a single dose on study days 1 and 11 and receive Rabeprazole 30 mg single dose on study days 5 through 11; in Part B, all subjects will receive Surufatinib 300 mg in a single dose on study days 1 and 12 and receive Rifampin 600 mg single dose on study days 5 through 16
Other intervention name(s): Rabeprazole 30 mg; Rifampin 600 mg
Intervention MeSH terms: Rifampin; Rabeprazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder
Condition: Bipolar Disorder; Affective Disorders, Psychotic; Mood Disorders; Mental Disorders
MeSH terms: Bipolar Disorder; Mental Disorders; Psychotic Disorders; Mood Disorders; Affective Disorders, Psychotic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of topiramate in
      adolescents with manic or mixed episodes of Bipolar I Disorder.
    

Detailed description: 
      This is a 4-week study to evaluate the safety and effectiveness of topiramate compared to
      placebo in the treatment of Bipolar I Disorder with an optional 6-month open-label (OL)
      extension for qualified patients following completion of the study. On Days 1-28 patients
      will receive placebo or topiramate 2x/day by mouth except for the 1st and last doses which
      will be a single evening dose and a single morning dose, respectively. Study drug will be
      titrated in 100-mg increments to 400 mg/day and patients maintained on a stable dose through
      Day 28. During the OL extension phase, topiramate will be titrated over 5 days to 200 mg/day.
      After Day 7, topiramate may be tapered down to 100 mg/day or up to 600 mg/day, as clinically
      indicated.
    

Intervention name(s): Topiramate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Double-blind period: Up to 400 mg/day (two 100-mg tablets twice a day) for 28 days.
OL period: Up to 600 mg/day (three 100-mg tablets twice a day) for at least 6 months.; Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days.
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar; Mania; Pediatric; Children; Adolescent; Topiramate; Anticonvulsants; Central Nervous System Agents; Protective Agents; Neuroprotectiive Agents
Impact of Air Pollution on the Autonomic Nervous System Activity and the Presence of Sleep Apnea in Older Subjects
Condition: Healthy
MeSH terms: Sleep Apnea Syndromes
Study type: Observational

Summary: 
      Impact of air pollution on the autonomic nervous system activity and presence of sleep apnea
      in older subjects.
    

Detailed description: 
      The relation between the air pollution and morbidity, cardiovascular mortality was increasing
      interest. Analyses show an increase of respiratory difficulty, but also cardiac deaths in the
      daytime when the atmospheric pollution was increased. It was demonstrated that health effects
      of ambient air pollution in subjects presenting cardiac or lung difficulty were important.
      Mechanisms show a possible relation to autonomic nervous system (ANS) deactivation and
      mortality. Particularly, the ageing and ANS reach would be more predictive of cardiovascular
      events. Thus, we suggest estimating in 60 healthy volunteers from 60 to 80 years old, the
      impact of the air pollution on the autonomic nervous system activity and sleep apnea
      consequences.
    

Intervention name(s): Air pollution study on healthy volunteers.
Intervention type(s): Other
Intervention description(s): The subjects are examined three times:
First the volunteers get used to equipments.
Second and third the volunteers sleep in a pollution or purified air.
Other intervention name(s): physiopathologic study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The subjects will have to live in districts where important atmospheric pollution is
        established
      
Keywords: air pollution; autonomic nervous system; sleep apnea; Heart rate variability; Healthy volunteers
Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Who Have Not Received Prior Treatment
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the safety, tolerability, and pharmacokinetics of five
      ISIS 113715 intravenous dose cohorts in drug-naïve type 2 diabetics.
    


Intervention name(s): ISIS 113715
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Fasting plasma glucose; HbA1c
Safety and Immunogenicity of a Live-attenuated Vaccine Against Respiratory Syncytial Virus in Elderly Volunteers
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I trial will enroll 36 healthy adult volunteers. The study will enroll a sentinel
      group of 6 younger adults aged 18 to 49 years followed by approximately 30 healthy older
      adults aged 50 to 75 years. All participants will receive two doses, 28 days apart. The
      vaccine will be administered as nose drops to both the low and high dose cohorts.
    


Intervention name(s): CodaVax-RSV; Normal saline
Intervention type(s): Biological; Biological
Intervention description(s): Codon deoptimized, live-attenuated vaccine against RSV delivered intranasally via dropper; Saline (0.9%) administered via dropper
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: RSV; live-attenuated vaccine; codon deoptimized; respiratory infection
Muscle Fatigue and Carbonic Anhydrase Inhibitors
Condition: Hypoxia
MeSH terms: Fatigue; Hypoxia
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this research is to assess the effects of acetazolamide and methazolamide on
      respiratory and limb muscle fatigue development. A fatiguing protocol will be conducted for
      the respiratory and plantar flexor muscles and the difference in pressure/torque produced by
      supramaximal nerve stimulation used to assess muscle fatigue between conditions.
    


Intervention name(s): Acetazolamide; Methazolamide; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): 250 mg, taken orally three times per day; 100mg, taken orally two times per day. A placebo pill will be taken between each dose of methazolamide to match the timing of doses and the number of pills between study arms.; A placebo will be taken three times per day
Intervention MeSH terms: Acetazolamide; Methazolamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Muscle Fatigue; Acetazolamide; Methazolamide
Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Valve Surgery
Condition: Heart Valve Diseases
MeSH terms: Heart Valve Diseases
Study type: Interventional

Summary: 
      The aim of our study was to evaluate the effect of different temperature regimens of
      cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during surgical
      correction of acquired heart diseases.
    

Detailed description: 
      Our aim was to evaluate the effect of hypothermic and normothermic regimens of
      cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during valve
      surgery
    

Intervention name(s): hypothermic CPB; normothermic CPB
Intervention type(s): Device; Device
Intervention description(s): maintenance of mild hypothermia during cardiopulmonary bypass; maintenance of normal body temperature during cardiopulmonary bypass
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: perfusion; cardiopulmonary bypass; hypothermia; cerebral oxygenation
Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair
Condition: Peripheral Nerve Discontinuities
Study type: Interventional
Phase: Phase 3

Summary: 
      Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety and
      functional outcomes for the repair of nerve injuries in the hand.
    


Intervention name(s): Processed Nerve Allograft (human); Collagen Nerve Cuff
Intervention type(s): Biological; Device
Intervention description(s): Bovine collagen based nerve cuff
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy Study of Lactobacillus Administered Vaginally in Women With Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase IIa clinical trial in women with bacterial vaginosis. This study will
      determine whether treatment with vaginal lactobacillus in combination with antibiotic therapy
      (metronidazole) is effective in colonizing the vagina with the lactobacillus bacteria found
      in normal vaginal flora.
    

Detailed description: 
      Phase IIa randomized, double blind, placebo-controlled, clinical trial of LACTIN-V at 2 x
      10^9 cfu/dose versus placebo, administered vaginally with a pre-filled applicator once daily
      for five consecutive days followed by a weekly dose over 2 additional weeks after an initial
      standardized antibiotic treatment with 0.75% topical metronidazole (MetroGel). A single site
      will enroll 40 participants (30 randomized to LACTIN-V and 10 to placebo).

      Colonization rate of Lactobacillus crispatus CTV 05 will be assessed with culture and
      rep-PCR.

      Safety will be determined by comparing the incidence of adverse events and serious adverse
      events in the LACTIN-V and placebo groups as determined by clinical symptoms, physical
      examination, pelvic examination with colposcopy and laboratory measurements. Tolerability
      will be measured by percentage of subjects who discontinue study product use due to overt
      adverse events and percentage of subjects who adhere to complete dosing schedule.
      Acceptability will be assessed via a standardized questionnaire and focus group discussions.
    

Intervention name(s): LACTIN-V; Placebo control substance
Intervention type(s): Drug; Drug
Intervention description(s): Vaginal application of single-use applicators pre-filled with LACTIN-V (Formulation 1) at 2 x 10^9 cfu/dose or placebo control substance. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.; Vaginal application of single-use applicators pre-filled with placebo control substance. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Bacterial Vaginosis; BV; UCSF; SFGH
An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of EQ143
Condition: Severe Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Participants aged 18 to 75 years with severe hepatic impairment (Child-Pugh class C) who meet
      the full study eligibility criteria will be enrolled into the study. For each participant
      with severe hepatic impairment, a corresponding healthy participant will be enrolled who
      matches with regard to age, sex, and BMI. A single dose of 55-mg EQ143 tablet will be
      administered in the morning on Day 1, and participants will remain for 5 days (4 nights) in
      the study center for collection of blood samples and safety monitoring. Participants will
      attend outpatient follow-up visits on Days 5, 6, 8, and 9 for additional blood sampling and
      safety assessments. The study will measure and describe the concentrations of EQ143 and its
      metabolite (HAS-719) in plasma over the course of 9 days (including calculation of PK
      parameters), the degree of EQ143 and metabolite HAS-719 (and other metabolites, if
      applicable) binding to proteins in plasma, and the safety of administering a single dose of
      EQ143 in severely hepatically impaired and matched healthy participants
    


Intervention name(s): aumolertinib
Intervention type(s): Drug
Intervention description(s): A single dose of 55-mg EQ143 tablet will be administered in the morning on Day 1, and participants will remain for 5 days (4 nights) in the study center for collection of blood samples and safety monitoring. Participants will attend outpatient follow-up visits on Days 5, 6, 8, and 9 for additional blood sampling and safety assessments.
Other intervention name(s): HS-10296
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment