bioihbjkbjnl/mcl2 huggingface dataset:
Cefazolin Subcutaneous Microdialysis in Morbidly Obese Patients
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Observational

Summary: 
      The investigators hypothesize that cefazolin perfusion to subcutaneous adipose tissue is
      reduced in morbidly obese patients. The primary objective of this exploratory pilot study is
      therefore to investigate target site (subcutaneous adipose tissue) penetration of cefazolin
      in morbidly obese patients and non-obese patients. The investigators aim to examine whether
      and how cefazolin plasma concentrations are predictive of subcutaneous (target) cefazolin
      concentrations. Possible factors of influence on the distribution of cefazolin (tissue
      perfusion, body weight, distribution of adipose tissue, other) will be identified.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        8 morbidly obese patients undergoing weight reducing surgery And 8 non-obese patients
        undergoing surgery which will require an arterial line, nadroparin and cefazolin
        administration perioperatively and postoperative stay at the Post-Anesthesia Care Unit.
      
Biospecimen description: 
      serum and microdialysis filtrate of subcutenous tissue
    
Keywords: cefazolin; microdialysis; morbid obesity; pharmacokinetics
Donafenib Monotherapy for Previously Treated Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators do the clinical trial (patients with metastatic colorectal cancer treated
      with donafenib after failure of standard therapy) to assess safety and efficacy of donafenib
      in patients with metastatic colorectal cancer, progressing after all approved standard
      therapies.
    

Detailed description: 
      The study is a multicentre, phase 1B study recruiting 47 patients in 6 sites. Patients were
      eligible to participate when they have histological or cytological documentation of
      adenocarcinoma of the colon or rectum. They must have received locally and currently approved
      standard therapies and to have disease progression during or within 3 months after the last
      administration of the last standard therapy or to have stopped standard therapy because of
      unacceptable toxic effects. The available standard therapies have to include as many of the
      following as were licensed: a fluoropyrimidine,oxaliplatin, irinotecan, and bevacizumab;and
      cetuximab or panitumumab for patients who had KRAS wild-type tumours.

      Patients have to be aged 18 years or older and have an Eastern Cooperative Oncology Group
      (ECOG) performance status of 0 or 1; life expectancy of at least 3 months;and adequate
      bone-marrow, liver, and renal function at the start of the trial. Patients could not
      participate if they had previously received sorafenib or had uncontrolled medical disorders.

      All patients receive best supportive care, excluding other investigational antitumour agents
      or antineoplastic chemotherapy, hormonal therapy, or immunotherapy. Patients receive oral
      donafenib 300mg (CM4307) of each 4 week cycle until disease progression,death, unacceptable
      toxic effects, withdrawal of consent by the patient, or decision by the treating physician
      that discontinuation would be in the patient's best interest.The primary endpoint is
      safety.The second endpoint is progression-free survival.
    

Intervention name(s): CM4307
Intervention type(s): Drug
Intervention description(s): CM4307 300mg bid, each 4 week cycle
Other intervention name(s): Donafenib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic Colorectal Cancer; CM4307; Previously treated metastatic colorectal cancer
The Effects of 12 Weeks Pilates-inspired Exercise Training on Functional Performance in Older Women
Condition: Aging
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      The purpose of the present study was to investigate the effects of 12-week Pilates-inspired
      exercise on functional performance in community-dwelling older women.
    

Detailed description: 
      Pilates is an exercise system developed over 70 years ago that has been recently received
      attention due to its beneficial effects on postural stability, coordination, muscle strength
      and flexibility. The studies published involving Pilates were very different among them
      regarding intervention period (5, 8, 12 and 24 weeks), frequency (2 and 3 sessions/week) and
      exercises (mat, mat with accessories, apparatus and others combinations), making meaningful
      comparison difficult. Furthermore, other important physical features to maintain an
      independent life at older age, such as cardiorespiratory fitness, were accessed in few
      studies. So, the effective benefits of Pilates method on physical fitness of
      community-dwelling older people remain unclear.
    

Intervention name(s): Pilates; Control
Intervention type(s): Other; Other
Intervention description(s): The Pilates program was conducted twice weekly, 60 minutes/session, for twelve consecutive weeks by a certified Pilates Instructor.; The control group did not receive the Pilates training program and were instructed to maintain their currently activities during the twelve-week follow-up period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pilates method; elderly; postural balance
The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis
Condition: ESRD; Fatigue; Hemodialysis-Induced Symptom
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      A majority of patients with end-stage renal disease (ESRD) on in-center hemodialysis (HD)
      require several hours to recover from fatigue after an HD session. Evidence for practical
      interventions to improve this recovery time from conventional in-center HD is lacking. This
      study investigates the effects of reducing HD blood flow rates on patients' self-reported
      post-dialysis fatigue.
    

Detailed description: 
      Post-dialysis fatigue reduces patients' quality of life and is also associated with
      cardiovascular events and mortality. Dialysis recovery time (DRT) is a measure of
      post-dialysis fatigue. Internationally, it has been found that more than a quarter of
      maintenance HD patients report >6 hours of DRT. The interventions showing the most
      improvement in DRT involve increases in treatment time, suggesting that post-dialysis fatigue
      may be in part related to the rate of solute clearance. Solute clearance rate is just one
      part of extending dialysis time, and its effect on DRT in patients undergoing typical-length
      dialysis sessions is not known. There is scant evidence to guide blood flow rate
      prescriptions aside from meeting clearance targets. Blood flow rate reductions are
      easily-implementable interventions that would slow solute clearance rates and may have an
      effect on post-dialysis fatigue.
    

Intervention name(s): Blood Flow Rate Reduction; Control
Intervention type(s): Other; Other
Intervention description(s): Hemodialysis blood flow rate will be reduced by 100 mL/min, or to a minimum of 300 mL/min, whichever is higher. Patients will be surveyed regarding their dialysis recovery time and other symptoms weekly.; No changes will be made to the dialysis prescription. Patients will be surveyed regarding their dialysis recovery time and other symptoms weekly.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel-Group, Randomized Controlled Trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Patient-Reported Outcomes; Post-dialysis Fatigue; Dialysis Recovery Time
Seroquel in Bipolar Depression Versus Lithium
Condition: Bipolar Disorder; Bipolar Depression; Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in
      treating bipolar depression during an 8-week acute phase compared with placebo and lithium,
      followed by continuation treatment for 26 up to 52 with quetiapine fumarate (Seroquel)
      compared to placebo.
    


Intervention name(s): Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bipolar disorder; bipolar depression; depression
The Influence of Whole-body Vibration Training on Postural Stability in People With Generalized Joint Hypermobility
Condition: Hypermobility, Joint
MeSH terms: Joint Instability
Study type: Interventional

Summary: 
      The aim of this study was the assessment of muscle flexibility after 2-weeks of whole-body
      vibration (WBV) training in people with generalized joint hypermobility (GJH). The study
      included 33 participants aged 22-25 years. 12 participants were classified into the GJH group
      and 21 into the control group (CG). The study included the Beighton score and muscle
      flexibility tests: straight leg raise test (SLR), popliteal angle test (PA), and the modified
      Thomas test. These tests were performed before and after the short-term WBV program, which
      consisted of six sessions (frequency: 15 Hz and 30 Hz, amplitude 3 mm, 3 trials x 3 min.).
    


Intervention name(s): Galileo Med35
Intervention type(s): Device
Intervention description(s): whole-body vibration training on the platform
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Chlorpheniramine Nasal Spray to Accelerate COVID-19 Clinical Recovery in an Outpatient Setting: ACCROS-III
Condition: COVID-19; Symptoms and Signs; COVID-19 Pandemic; Coronavirus Disease 2019; Coronavirus Infections
MeSH terms: COVID-19; Coronavirus Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The goal of this clinical trial is to examine the effectiveness of intranasal-administered
      Chlorpheniramine Maleate in COVID-19-positive participants as part of early treatment for
      COVID-19. The main questions it aims to answer are:

        -  To assess the efficacy of nasal spray with Chlorpheniramine (0.4%) for improving
           clinical recovery in COVID-19 patients.

        -  To assess the efficacy, safety, and tolerability of nasal spray with Chlorpheniramine
           (0.4%) as an adjunct to the standard of care in reducing hospitalizations and improving
           clinical recovery in adult patients with mild COVID-19.
    

Detailed description: 
      The main goal of the present study is to examine the effectiveness of CPM intranasal spray as
      part of early treatment for COVID-19. The study will test the hypothesis that intranasal CPM
      would accelerate clinical recovery, particularly the alleviation of sensory symptoms and URS,
      in patients with COVID-19.
    

Intervention name(s): Chlorpheniramine Maleate 0.4% Nasal Spray; Placebo
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Chlorpheniramine Maleate 0.4% Nasal Spray; Placebo nasal spray
Other intervention name(s): ClorNasal; ClorNovir
Intervention MeSH terms: Chlorpheniramine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multi-center, Phase 2/3 Study to evaluate the efficacy and safety of nasally administered CPM in subjects with symptomatic COVID-19 with a positive PCR test.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent Influenza Virus Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate the safety and immunogenicity of Fluzone® Quadrivalent
      vaccine in participants aged 6 months to < 9 years at enrollment, divided into 2 age strata
      (6 months to < 36 months and 3 years to < 9 years)

      Primary Objective:

        -  To describe the safety of the 2013-2014 formulation of Fluzone Quadrivalent vaccine,
           administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on
           Immunization Practices (ACIP) recommendations, in children 6 months to < 9 years of age.

      Observational Objectives:

        -  To describe the immunogenicity of the 2013-2014 formulation of Fluzone Quadrivalent
           vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP
           recommendations, in children 6 months to < 9 years of age.

        -  To submit sera from subjects to the Center for Biologics Evaluation and Research (CBER)
           for further analysis by the World Health Organization (WHO), the Centers for Disease
           Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support
           formulation recommendations for subsequent influenza vaccines.
    

Detailed description: 
      Participants will be assigned to the appropriate age group (6 months to < 36 months of age or
      3 years to < 9 years of age) based on the subject's age at the time of enrollment.

      Solicited adverse event (AE) information will be collected for 7 days after each vaccination,
      unsolicited AE information will be collected from Visit 1 to Visit 2, or to Visit 3 for those
      subjects receiving 2 doses. Serious adverse event information will be collected from Visit 1
      to Visit 2, or Visit 3 for those subjects receiving 2 doses.

      Immunogenicity will be evaluated in all subjects prior to vaccination on Day 0 (Visit 1) and
      at Day 28 after the final vaccination using the hemagglutination inhibition technique. For
      each influenza vaccine strain, pre- and post-vaccination geometric mean titers will be
      calculated.
    

Intervention name(s): Fluzone® Quadrivalent Influenza Virus Vaccine, No Preservative; Fluzone® Quadrivalent Influenza Virus Vaccine, No Preservative
Intervention type(s): Biological; Biological
Intervention description(s): 0.25 mL, Intramuscular (Pediatric Dose, 2013-2014 formulation); 0.5 mL, Intramuscular (2013-2014 formulation)
Other intervention name(s): Fluzone® Quadrivalent, No Preservative; Fluzone® Quadrivalent, No Preservative
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Influenza virus vaccine; Fluzone® Quadrivalent Influenza Vaccine (No Preservative)
The Early Integrated Intervention for Child Brain-developmental Disorders in China
Condition: Brain Developmental Diseases; Autism Spectrum Disorder; Global Developmental Delay; Attention Deficit-Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Developmental Disabilities
Study type: Interventional

Summary: 
      This study is focused on developing the early integrated intervention for child
      brain-developmental disorders, including globe developmental delay (GDD), autism spectrum
      disorder (ASD), and attention deficit-hyperactivity disorder (ADHD), in China.
    

Detailed description: 
      The early integrated intervention of GDD and ASD is developed by Children's Hospital of Fudan
      University.

      The early integrated intervention of ADHD is developed by Nanjing Brain Hospital.
    

Intervention name(s): The early integrated intervention for GDD; The early integrated intervention for ASD; The early integrated intervention for ADHD; community intervention for ASD; Community intervention for GDD; community intervention for ADHD
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): The early integrated intervention for GDD integrates developmental approaches with strategies of applied behavior analysis.; The theoretical underpinnings of the early integrated intervention for ASD originate from Early Start Denver Model.; The methods of the early integrated intervention for ADHD includes behavior training, sensory integration training and psychological counseling; TEACCH (Treatment and Education of Autistic and related Communication- handicapped Children) intervention or ABA(applied behavior analysis) intervention; community intervention based on developmental approaches; School and family education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Drug-Drug Interaction (DDI) Study in Healthy Volunteers
Condition: Drug Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Open Label, Fixed Sequence Study to Evaluate the Effect of BLD-0409 on the Single
      Dose Pharmacokinetics of a Cocktail of Probe Substrates for CYP450 Enzymes in Healthy
      Volunteers
    

Detailed description: 
      This is a single center, open label study designed to determine the effect of BLD-0409 on the
      PK of probe substrates and to evaluate the safety and tolerability of BLD-0409 administered
      alone and co-administered with a cocktail of probe substrates (i.e., Geneva cocktail less
      fexofenadine) in healthy adult volunteers.

      Geneva Cocktail (Less Fexofenadine):

        -  CYP1A2 Caffeine 50 mg

        -  CYP2C Flurbiprofen 10 mg

        -  CYP2C19 Omeprazole 10 mg

        -  CYP2D6 Dextromethorphan 10 mg

        -  CYP3A4 Midazolam 1 mg

        -  CYP2B6 Bupropion 20 mg
    

Intervention name(s): Geneva Cocktail; BLD-0409
Intervention type(s): Drug; Drug
Intervention description(s): Fixed sequence use of drug cocktail; Fixed sequence use of active product
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Uninvasive Cardiac Output Monitoring (USCOM) in Critically Ill Children: Validation and Prediction of Hemodynamic Instability
Condition: Hemodynamic Instability
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      Hemodynamically unstable ventilated PICU & PCICU patients, which a decision for commencement
      in inotropic therapy or fluid bolus has been made, will be recruited. Hemodynamic
      measurements will be carried out before and after therapy have been made, including customary
      hemodynamic parameters, echocardiography and USCOM studies.

      All parameters will be analyzed for fluid responsiveness or inotropic therapy prediction.
      Trend in USCOM parameters will be compared to echocardiography CO parameters.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric critically ill ventilated patients addmited to PICU & PCICU
      
Keywords: pediatric; cardiac output; fluid responsiveness; critically ill; hemodynamic monitoring
Neural Links Between OCD and Anorexia
Condition: Anorexia Nervosa; Obsessive-compulsive Disorder
MeSH terms: Anorexia; Obsessive-Compulsive Disorder; Anorexia Nervosa
Study type: Observational

Summary: 
      Individuals with anorexia nervosa (AN) have long been observed to demonstrate symptoms in
      common with obsessive-compulsive disorder (OCD), in particular, an obsessive fear of normal
      weight leading to dangerous food restriction, as well as many compulsive rituals about food.
      Both AN and OCD are seriously handicapping and often resistant to conventional therapies.
      Given that the two conditions often co-occur and are associated with still unknown genetic
      risk factors, the aim of this project is to identify their shared and distinct patterns of
      brain activity.

      The investigators propose to use functional magnetic resonance imaging to compare brain
      response among adolescents with AN, OCD, and age-matched healthy individuals. Specifically,
      this study will investigate function of distinct brain circuits related to core aspects of
      these related disorders. The investigators use three tasks related to set shifting, global
      vs. local processing, and reward. Based on evidence of deficits in cognitive flexibility and
      ability to change behavior, the investigators hypothesize that adolescents with AN and with
      OCD will show hypoactivity of frontostriatal circuitry during cognitive tasks, and
      adolescents with AN will show hyperactivity in limbic regions in a reward task.

      This study is the first to directly compare brain activation patterns using functional
      neuroimaging in AN and OCD. The goal is to determine how abnormal brain activity relates to
      symptom formation, what accounts for shared characteristics amongst these disorders, and
      whether deficits in specific circuitry underlie their unique defining features. The study of
      shared and unique elements of functional brain circuitry reflects a new, emerging approach to
      the classification of psychiatric illness, one based on identifying unique combinations of
      biological risk factors that link related conditions. This approach is widely believed to be
      a critical step forward in developing more brain-relevant targeted strategies for
      preventative interventions.
    


Intervention name(s): Functional Magnetic Resonance Imaging
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adolescent females ages 12-19 drawn from clinic and community populations. With diagnosis
        of anorexia nervosa or obsessive-compulsive disorder or no psychiatric diagnosis.
A Study Designed to See How [14C]-CORT125134 is Taken up, Broken Down and Removed From the Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was designed to evaluate how CORT125134 is taken up, broken down and removed from
      the body when given as an oral capsule to healthy subjects.
    

Detailed description: 
      The study was conducted to determine the recovery of [14C]-CORT125134 after the
      administration of a single oral dose of [14C]-CORT125134, to determine the routes and rate of
      elimination of [14C]-CORT125134 and associated radioactivity from the body, and to measure
      concentrations of radioactivity in the blood. Additional objectives of the study were to
      determine the chemical structure of each significant metabolite in plasma, urine and feces.
      Safety and tolerability were assessed.
    

Intervention name(s): [14C]-CORT125134
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Absorption, distribution, metabolism, and excretion (ADME); Metabolism; Metabolite Profiling; Excretion