bioihbjkbjnl/mcl2 huggingface dataset:
Macrophage Markers, Soluble CD163 (sCD163) and Soluble CD206 (sCD206) in Paracetamol Overdose
Condition: Drug-Induced Acute Liver Injury
MeSH terms: Chemical and Drug Induced Liver Injury
Study type: Interventional
Phase: Phase 1

Summary: 
      Paracetamol (PCM) is a widely used over-the-counter analgesic, and overdose with PCM is a
      condition regularly seen in everyday clinical practice. Identification of the patients with
      early signs of liver injury that may develop into acute liver failure is important. Previous
      research has shown that macrophages play a role in the development of liver damage in
      PCM-induced acute liver failure, making macrophage markers interesting possible biomarkers of
      this condition. In the present study, the investigators aimed to investigate the extent and
      timing of macrophage activation in PCM-induced liver injury by measuring levels of macrophage
      markers sCD163 and sCD206 in patients admitted with PCM overdose. The investigators also
      hoped to find out whether these markers are valuable as prognostic markers of severe outcome
      in these patients.

      Furthermore the investigators examined the possible effect of antidote treatment with
      N-acetylcysteine on activation and function of macrophages by administering NAC to healthy
      subjects and measuring levels of sCD163 and sCD206 prior to and after completion of
      treatment.
    

Detailed description: 
      The part of the study concerning the patients with PCM overdose was strictly observational
      with measurement of macrophage markers and no other intervention than the NAC treatment
      administered in the setting of management of the participants PCM overdose according to best
      clinical practice.

      The interventional part of the study which is submitted for registration here concerns only
      healthy controls who were exposed to NAC treatment in order to assess the direct effects of
      NAC on macrophages. The participants received NAC treatment according to the same protocol as
      the PCM overdosed patients, and macrophage activation markers were measured prior to and
      after 16 hours of NAC treatment. Thus, the involvement of the participants in the study was
      limited to the 16 hours of NAC treatment.
    

Intervention name(s): N-acetylcysteine
Intervention type(s): Drug
Intervention description(s): Non-randomized exposure to N-acetylcysteine (NAC) of healthy individuals corresponding to the clinical treatment guidelines for paracetamol-overdosed patients
Other intervention name(s): NAC; Paracetamol antidote; Acetylcysteine
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine; Antidotes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: macrophage activation, N-acetylcysteine, acetaminophen
Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids and Benzodiazepines.
Condition: Elective Spine Surgery Receiving Pre and/or Postoperative Pain Control With Opioids
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of this study is to examine the safety, acceptability, and feasibility of a
      controlled taper off of opioids and/or benzodiazepines, with the use of behavioral health
      tele-health based therapy services, in the perioperative patient.
    


Intervention name(s): Opioid and Benzodiazepine Naive-patients; Opioid and Benzodiazepine Tolerant-patients
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Duration of treatment : 1 month Lucid Lane is a service that will be used by patients scheduled for elective orthopedic or neurosurgical spine surgery that will incorporate continuous MEASUREMENT & MONITORING, PERSONALIZED TREATMENT PLANNING and REAL-TIME INTERVENTIONS (MPI) as the patient is tapering off of opioids and/or benzodiazepines. Patients will participate in the Lucid Lane program.Daily support will include 1 or more from the following: Therapist chat, and/or audio psychotherapy sessions, and/or group therapy sessions, Cognitive behavioral therapy(CBT), Mindfulness, and/or peer support. Patients will submit a weekly survey and the therapist will submit weekly reports to the physician.; Duration of treatment : 6 months Lucid Lane is a service that will be used by patients scheduled for elective orthopedic or neurosurgical spine surgery that will incorporate continuous MEASUREMENT & MONITORING, PERSONALIZED TREATMENT PLANNING and REAL-TIME INTERVENTIONS (MPI) as the patient is tapering off of opioids and/or benzodiazepines. Patients will participate in the Lucid Lane program.Daily support will include 1 or more from the following: Therapist chat, and/or audio psychotherapy sessions, and/or group therapy sessions, CBT, Mindfulness, and/or peer support. Patients will submit a weekly survey and the therapist will submit weekly reports to the physician.
Intervention MeSH terms: Analgesics, Opioid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opioid taper; post-surgery; behavioral tele-health
A PD/Safety Study of RDEA3170 in Combination With Febuxostat for Treating Gout or Asymptomatic Hyperuricemia Patients
Condition: Gout and Asymptomatic Hyperuricemia
MeSH terms: Gout; Hyperuricemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to explore the pharmacodynamics (PD), pharmacokinetics (PK),
      safety, and tolerability of multiple doses of RDEA3170 administered in combination with
      febuxostat compared to RDEA3170 administered alone and febuxostat administered alone in
      Japanese adult male subjects with gout or asymptomatic hyperuricemia.
    


Intervention name(s): RDEA3170; Febuxostat; Benzbromarone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral Treatment; Oral Treatment; Oral Treatment
Intervention MeSH terms: Febuxostat; Verinurad; Benzbromarone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study of Myocardial Interstitial Fibrosis in Hyperaldosteronism
Condition: Primary Hyperaldosteronism; Secondary Hyperaldosteronism; Essential Hypertension; Healthy
MeSH terms: Hypertension; Essential Hypertension; Hyperaldosteronism; Fibrosis
Study type: Observational

Summary: 
      Animal models have demonstrated the role of aldosterone in left ventricular remodeling
      involving fibrosis, apoptosis and hypertrophy. Myocardial fibrosis is a risk factor for
      serious arrhythmia and sudden death in ischemic and idiopathic hypertrophic heart disease. It
      is accepted that patients with primary aldosteronism have a higher prevalence of LV
      hypertrophy , arterial involvement and increased cardiovascular risk. In humans, a link has
      been demonstrated between aldosterone and heart failure as well as the benefit of the
      administration of an anti -aldosterone drug to lower mortality in this population ,
      regardless of blood pressure level . The administration of spironolactone ( aldosterone ) in
      hypertensive rats has prevented the occurrence of aortic fibrosis . Plasma aldosteronism in
      humans has been associated with inflammation, fibrosis and aortic stiffness . However,
      primary aldosteronism is generally associated with so-called secondary hypertension . Chronic
      hypertension alone is a recognized etiological factor of myocardial hypertrophy ( myocardial
      fibrosis very advanced ) . The purpose of this study is to investigate the effects of MRI
      hyperaldosteronism on the heart.
    

Detailed description: 
      Cross-sectional study with double analysis (A and B) with 2 x 2 sub-groups (ratio
      control/case 1/1)

        -  clinical situation: subjects are hypertensive. 20 subjects with primary aldosteronism
           will be compared to 20 patients with essential arterial hypertension

        -  clinical situation are normotensive subjects, 20 subjects with secondary aldosteronism
           loss in congenital salt (Bartter's syndrome / Gitelman) will be compared to 20 healthy
           volunteers. Controls (essential hypertension and healthy volunteers) are matched for
           age, sex and body size in two experimental groups (HAP and Gitelman). All subjects were
           recruited by the CIC of the European Georges Pompidou Hospital (Paris).
    

Intervention name(s): non interventional study
Intervention type(s): Other
Intervention description(s): Non invasive imaging study without interventional procedures
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with primary or secondary hyperaldosteronism compared to hypertensive or
        normotensive controls
      
Biospecimen description: 
      Urines and plasma
    
Keywords: Primary hyperaldosteronism; Secondary hyperaldosteronism; Cardiac fibrosis; magnetic resonance imaging
Manual Lymphatic Drainage for Pain, Muscle Strength, and Sensation
Condition: Manual Lymphatic Drainage Effects
Study type: Interventional

Summary: 
      To evaluate the acute effect of MLD on pressure pain threshold (PPT), pain tolerance, tactile
      sensation, and muscle strength in healthy young adults.

      healthy young adults were included in the study. Before and after MLD and plasebo touchs, the
      same physiotherapist performed PPT and pain tolerance measurements, muscle strength
      measurements with a hand dynamometer (Jamar®) and pinchmeter (Baseline®), and two-point
      discrimination (2PD) evaluation with an esthesiometer.
    


Intervention name(s): Manual Lymphatic Drainage; Plasebo Group
Intervention type(s): Other; Other
Intervention description(s): Manual lymphatic drainage (MLD), one of the components of complex decongestive physiotherapy, is a gentle massage technique with proven positive effects on lymphatic circulation. MLD can be applied to different parts of the body (e.g., arms, legs, neck, abdomen, and trunk), with a different technique for each region (stationary circle, scoop, pump, and rotary); random superficial touches not involved in any manual technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Manual lymphatic drainage; pain threshold; pain tolerance; two-point discrimination; muscle strength
Multi-Center, Clinical Evaluation of the Cutera Secret RF Device
Condition: Skin Quality
Study type: Interventional

Summary: 
      The objectives of this study are to evaluate the efficacy and safety of the Cutera Secret RF
      device.
    

Detailed description: 
      This is a multi-center, study in approximately 40 subjects, ages 18 and older. Subjects will
      receive treatments and will be followed at 4 and 12 weeks post the final treatment.
    

Intervention name(s): Secret RF
Intervention type(s): Device
Intervention description(s): Subjects will receive treatment with the Secret RF device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Efficacy and Safety Study in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The efficacy and safety study of saxagliptin 5mg, once daily for 24 weeks in patients with
      type 2 diabetes mellitus.
    

Detailed description: 
      A multicenter, single arm, cohort study to evaluate the Efficacy and Safety of saxagliptin
      5mg, once daily for 24 weeks, in patients with type 2 diabetes mellitus who are treatment
      naive or who have inadequate glycaemic control on metformin alone
    

Intervention name(s): Saxagliptin
Intervention type(s): Drug
Intervention description(s): oral, 5 mg once a day (Q.D.)
Other intervention name(s): Onglyza
Intervention MeSH terms: Saxagliptin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 DM
A Phase I Trial to Investigate the Safety and Tolerability of PF-06412562
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the safety and tolerability of PF-06412562 given orally to healthy
      volunteers. To determine the optimal dose for future studies, the concentration of the drug
      over time will be determined by periodic blood samples. The rate of eye blinks will be
      measured as an indicator of PF-06412562 action on the receptors of interest in the brain.
    


Intervention name(s): PF-06412562; PF-06412562
Intervention type(s): Drug; Drug
Intervention description(s): Single doses, given by oral solution, starting at 0.5 mg up to a possible maximum of 150 mg. The subject will have been fasted for 10 hours prior to the single dose. Two doses, 120 mg and 150 mg, will be split into 3 doses such that the total dose is given over 8 hours (i.e. t = 0, 4, and 8 hours). For each dosing period, 2 subjects will be given a placebo as a comparator. One dose will be given in the fed state.; It is believed that for increasing doses of this compound the eye blink rate (EBR) will also increase. This arm will use EBR measurement technology to verify this hypothesis. In each dosing period, 4 subjects will be given a placebo as a comparator.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; Randomized; Double Blind; Placebo-Controlled; Single-Dose Escalation; Safety; Tolerability; PK; PD; PF-06412562
The Effect Of Interactive Robot on Children's After The Surgery
Condition: Pediatric Surgery
Study type: Interventional

Summary: 
      This project will be conducted with 5-10-year-old children who will undergo an outpatient
      surgery in Trakya University Health Research and Application Center at Pediatric Surgery
      Clinic and their parents. It is reported in the literature that technology-based applications
      and robot use are promising innovations in reducing pain, anxiety, and fear in children. This
      was the main starting point in the planning of the study. In this study, by using interactive
      robot, it was aimed to reduce postoperative mobilization anxiety, to increase frequency /
      duration of the mobilization and to increase parental satisfaction of the children undergoing
      outpatient surgery.
    

Detailed description: 
      The use of interactive robots is expected to reduce the child's anxiety by ensuring that the
      child is physically, psychologically, and socially optimal. It is foreseen that the child
      with reduced anxiety will be willing to mobilize with the interactive robot and it will
      increase the mobilization time and the frequency of the mobilization during the day.
      Decreasing the anxiety of children and increasing the desire for mobilization will increase
      the satisfaction of the families.

      The study will be conducted with 84 children (42 Experiment + 42 Control) aged 5-10 years.
      The study was planned as a randomized controlled study. Data will be collected by
      "Questionnaire Form" and "Child Anxiety Scale-State Anxiety" and Parental Satisfaction
      Scoring-Visual Analog Scale" and "Mobilization Chart". Families will be informed about the
      research and before the surgery, families, and children in both groups will be informed about
      the benefits of mobilization. Two hours after the operation, just before the mobilization,
      the children in the experimental group will be introduced to the robot, and the children in
      the control group will be asked to mobilize with their parents.

      When the child is first mobilized at the time recommended by the physician for all groups
      after the surgery, the child's anxiety for mobilization will be assessed using the Child
      Anxiety Scale (State Anxiety). The mobilization time of the children will be measured by
      stopwatch and recorded in the Mobilization Schedule together with the frequency of
      mobilization. Parental Satisfaction Scale- Visual Analogue Scale will be applied to evaluate
      the satisfaction of the parents towards the application.
    

Intervention name(s): Interactive robots
Intervention type(s): Other
Intervention description(s): Children will mobilize with the interactive robot when control group will mobilize with nurse.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Non-Randomized study with control group
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: interactive robot; child; surgery; mobilization; anxiety; parental satisfaction
Effect of Khat Chewing on Blood Pressure and Heart Rate Among Healthy Adults
Condition: Blood Pressure; Heart Rate
Study type: Observational

Summary: 
      This study is a cross sectional study
    

Detailed description: 
      Objective: This study aims to investigate .ht short-term effect of khat on the diastolic and
      systolic blood pressure (DBP, SBP) and heart rate (HR) of yemeni adults. Factors associated
      with Khat chewing and Khat-dependence were also investigated. That the khat chewing is a
      growing public habit among yemeni people.
    

Intervention name(s): electronic apparatus (visocor OM50).
Intervention type(s): Device
Intervention description(s): Measurement of blood pressure and heart rate
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        This is a cross-sectional study conducted from April to September 2021 in Taiz, Yemen. 100
        healthy adults were selected using a random sampling method.
      
Keywords: Khat-SDS; Blood Pressure; Heart Rate
A Study to Assess Intranasal Repeat Dose Effect of Levocabastine in the Subjects With Allergic Rhinitis
Condition: Rhinitis, Allergic, Perennial and Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be a randomized, double blind, placebo controlled, 3-way cross over design in
      allergic rhinitis subjects. Subjects will receive repeat doses of intra-nasal levocabastine
      for 7 days in each period and the duration of the study will be about 13 weeks. An
      Environmental Exposure Chamber (EEC) will be used in this study. The primary objective of the
      study is to investigate the non-inferiority effect of 7 days treatment with levocabastine on
      nasal symptoms elicited by an EEC when administered once daily (QD) compared with twice daily
      (BID). Also study will be conducted to investigate the superiority of effect of 7 days
      treatment with levocabastine (QD and BID) on nasal symptoms elicited by an EEC in subjects
      compared to placebo.
    


Intervention name(s): Levocabastine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intranasal aqueous 50 mcg microsuspension of levocabastine supplied in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension; Intranasal aqueous 0 mcg microsuspension supplied in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension
Intervention MeSH terms: Levocabastine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergic rhinitis; levocabastine; allergen challenge
Multiparametric Heart Failure Evaluation in Internal Cardioverter Defibrillators (ICD) Patients
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The Boston Scientific Energen family is capable of measuring the respiratory rate trend (RRT)
      on a daily basis and transmission of data via the Remote Monitoring technology. This may
      result in early detection of imminent decompensation at a presymptomatic stage. The study
      will assess the respiratory trends correlation with clinically relevant heart failure events.
    


Intervention name(s): CRTD or ICD (Energen)
Intervention type(s): Device
Intervention description(s): RRT measurement by cardiac resynchronization therapy devices and implantable cardioverter defibrillators
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients implanted with an Energen device or successor using the RRT diagnostic
        tool
      
Keywords: Congestive Heart Failure; Cardiac Resynchronization Therapy; Internal Cardioverter Defibrillators
Socioeconomic Profile and Patient Satisfaction Assessment
Condition: Satisfaction; Dentist-Patient Relations
Study type: Observational

Summary: 
      The aim of the study was to evaluate the socioeconomic patient's profile and their level of
      satisfaction in the general dental practice clinic. A cross-sectional quantitative study was
      accomplished with 80 patients assisted at the referred service. A solely-applied
      questionnaire was used regarding the following aspects: structure and environment, fear and
      anxiety, reliability, empathy and commitment, resolutivity and quality of the accomplished
      services. It was observed that the assisted patients' profile consisted predominantly of a
      female sample (71,2%), that completed the medium learning (31,2%) and/or that didn't finish
      the fundamental level (26,2%). Moreover 50% of them presented a family income of 1 to 2
      minimum salaries and 41,2% were unemployed. As the quality of the rendered technical service,
      nearly 70% of the users considered it great, as well as the clinic's structure and
      environment. Regarding the satisfaction with to the received treatment, 76,2% of the
      interviewees gave the maximum score of 10 and 95% would recommend the attendance to others.
      It is concluded that the patients are satisfied with the clinical attendance accomplished by
      the students in the general practice dental clinic at UNIFOR, in what refers to its technical
      and functional quality.
    


Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients assisted in the general dental practice clinic at UNIFOR Ceará - Brazil.
      
Keywords: Patient satisfaction; Dentist-Patient relations; Answering services