bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Zerafil® (Omalizumab) in Participants With Uncontrolled Moderate to Severe Allergic Asthma
Condition: Allergic Asthma; Uncontrolled Moderate to Severe
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Omalizumab produced by
      CinnaGen compared with Xolair® (Genentech, Inc., USA And Novartis Pharmaceuticals Corp,
      Switzerland) in subjects with uncontrolled Moderate to Severe Allergic Asthma

      All the participants will receive one of the following regimens:

      Omalizumab (CinnaGen) or Xolair® (Genentech, Inc., USA And Novartis Pharmaceuticals Corp,
      Switzerland), as subcutaneous injections, Omalizumab was administered every 2 or 4 weeks to
      provide a dose of at least 0.016 mg/kg/IgE for a duration of 28 weeks

      The primary objective of this study is to assess whether the efficacy of Omalizumab
      (CinnaGen, Iran) is equivalent to Xolair® (Genentech, Inc., USA and Novartis Pharmaceuticals
      Corp, Switzerland) as measured by rate of protocol-defined asthma exacerbations during the
      28-week treatment period
    


Intervention name(s): Omalizumab (CinnaGen); Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)
Intervention type(s): Biological; Biological
Intervention description(s): Omalizumab (CinnaGen, Iran) was administered via subcutaneous injection; Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland) was administered via subcutaneous injection
Other intervention name(s): Zerafil®; Xolair®
Intervention MeSH terms: Omalizumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Omalizumab; Exacerbation Rate; Monoclonal
A Randomized Trial of NSAID Dosing Strategies
Condition: Musculoskeletal Pain; Acute Pain
MeSH terms: Musculoskeletal Pain; Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare the efficacy of two different non-steroidal anti-inflammatory drugs
      (NSAIDs) ketorolac and ibuprofen for people with acute moderate or severe musculoskeletal
      pain. The investigators will also determine whether taking acetaminophen prior to the NSAID
      impacts efficacy
    


Intervention name(s): NSAID
Intervention type(s): Drug
Intervention description(s): We will administer oral NSAIDs
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Adjunctive Effect of Probiotics to Non Surgical Treatment of Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of clinical and microbiological effect of lactobacillus reuteri probiotics.
    

Detailed description: 
      The present randomized controlled clinical trial was conducted to evaluate the effects of
      Lactobacillus reuteri-containing probiotic suspension as an adjunct to scaling and root
      planing (SRP).

      Material and Methods: Twenty sites from twelve chronic periodontitis patients were recruited
      and monitored clinically and microbiologically at baseline, three, and six months after
      therapy for plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD) and
      clinical attachment level (CAL) and microbiologically or Porphyromonas gingivalis (P.
      gingivalis) load. Patients meeting the inclusion criteria were scheduled within one week for
      two sessions of SRP performed using ultrasonic scalers and hand instrumentation. After SRP,
      oral hygiene measures were reassured and then sites were randomly allocated to one of the two
      groups 10 sites each. group I (SRP only) and group II (SRP + probiotic). Group II received
      SRP and sub-gingival delivery of 1ml of probiotic L. reuteri suspension at baseline
      (immediately after SRP), one, two and four weeks using blunt syringe. Periodontal dressing
      was applied after placement of the drug.
    

Intervention name(s): Lactobacillus Reuteri Oral Drops; Scaling and root planing
Intervention type(s): Drug; Procedure
Intervention description(s): Subgingival delivery of probiotic suspension; Scaling and root planing using hand and ultrasonic instruments
Other intervention name(s): Scaling and root planing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic periodontitis
Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age
Condition: Pertussis; Diphtheria
MeSH terms: Whooping Cough; Diphtheria
Study type: Observational

Summary: 
      To compare the reactogenicity of ADACEL® vaccine given at intervals of 2 to 9 years with the
      reactogenicity of ADACEL® vaccine given at an interval of 10 or more years following the last
      previous administration of vaccine containing Diphtheria and Tetanus Toxoids (referred to as
      TD/Td).
    


Intervention name(s): Tetanus and diphtheria toxoids and acellular pertussis
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular
Other intervention name(s): ADACEL®
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children and Adolescents 7 to 19 Years of Age, who have previously recieved Tetanus and
        Diphtheria Toxoids Vaccine
      
Keywords: Pertussis; Tetanus; Diphtheria
Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Nails Affected by Psoriasis
Condition: Nail Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to confirm the clinical efficacy and the safety of P-3073 in
      patients affected by isolated psoriatic nail(s) and/or those with psoriatic nails and
      concomitant mild to moderate plaque psoriasis.
    


Intervention name(s): P-3073; Vehicle of P-3073
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Nail psoriasis
Molecular Mechanisms of Antipsychotic-induced Insulin Resistance
Condition: Adverse Effect of Other Antipsychotics and Neuroleptics; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will investigate the molecular mechanisms of atypical-antipsychotic induced
      insulin resistance. This will be accomplished by administering olanzapine or placebo to
      healthy subjects for 7 days and analyzing genetic and protein changes in peripheral tissues
      known to play an important role in insulin resistance pathophysiology.
    


Intervention name(s): olanzapine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): atypical antipsychotic; placebo control
Other intervention name(s): Zyprexa
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
AMO-01 to Treat Adolescents and Adults With Phelan-McDermid Syndrome (PMS) and Co-morbid Epilepsy
Condition: Phelan-McDermid Syndrome; Epilepsy
MeSH terms: Epilepsy; Chromosome Disorders; Syndrome; Chromosome Deletion
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the safety, tolerability and efficacy of a single
      6-hour intravenous infusion of AMO-01 to treat adolescents and adults with PMS and co-morbid
      epilepsy. Phelan-McDermid Syndrome (PMS) is a neurodevelopmental disorder characterized by a
      chromosomal deletion or mutation at 22q13.3 that contains the SHANK3/ProSAP2 gene. A key
      co-morbidity in PMS is the presence of epilepsy. Currently there are no approved treatments
      for PMS. Furthermore, there has been relatively little clinical study of pharmacological
      interventions for PMS. AMO-01 may provide benefit to PMS patients exhibiting behavioral
      abnormalities and seizures.
    


Intervention name(s): AMO-01
Intervention type(s): Drug
Intervention description(s): Subjects will receive a single 6-hour intravenous infusion for a total dose administration or 120 mg/m2 of AMO-01.
Intervention model: Single Group Assignment
Intervention model description: Single Group, open label
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AMO-01; Shank3; Clinical Trial
Study to Assess the Effect of the New HFA-152a Propellant on Mucociliary Clearance
Condition: Mucociliary Clearance
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the effect of multiple doses of the HFA-152a
      propellant and the HFA-134a propellant on mucociliary clearance (MCC).
    

Detailed description: 
      This clinical trial is a Phase I, single-centre, multiple-dose, randomised, open-label,
      controlled, 2-way cross-over study to assess the effect on MCC of the new HFA 152a propellant
      (5 inhalations BID for 8 days) versus the marketed HFA 134a propellant (5 inhalations BID for
      8 days) in adult healthy volunteers by measuring the clearance from the lungs of inhaled
      radioaerosol.

      A total of 20 subjects will be randomised in the study.

      Standard safety assessments will be conducted during the Study, including safety blood and
      urine laboratory tests, vital signs, physical examinations, ECGs, spirometries and
      observations of any adverse events.
    

Intervention name(s): Placebo formulated with HFA-152a propellant via pMDI; Placebo formulated with HFA-134a propellant via pMDI
Intervention type(s): Other; Other
Intervention description(s): 5 inhalations BID (morning and evening) for 8 consecutive days, starting from the morning of Day 1 until the morning of Day 8; 5 inhalations BID (morning and evening) for 8 consecutive days, starting from the morning of Day 1 until the morning of Day 8
Intervention MeSH terms: Norflurane
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Assess the Electrophysiology, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Response Using Magnetic Resonance Imaging of SAGE-718 Using a Ketamine Challenge in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a phase 1, double-blind, placebo-controlled crossover study of SAGE-718 using a
      ketamine challenge, to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamic response using magnetic resonance imaging in healthy subjects
    


Intervention name(s): SAGE-718; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SAGE-718 in combination with Ketamine; Placebo in combination with Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Influenced the Type of Laryngoscopy the Intraoperative Nerve Monitoring During Thyroid Surgery
Condition: Thyroid; Airway Morbidity
MeSH terms: Thyroid Diseases
Study type: Interventional

Summary: 
      A randomized controlled prospective study of laryngoscopy and evaluation of the
      Intraoperative nerve monitoring during thyroid surgery comparing direct laryngoscopy and the
      C-MAC videolaryngoscope.
    

Detailed description: 
      Intraoperative nerve monitoring (IONM) is used in addition to the visual the nerve in thyroid
      surgery. Here, the IONM can be done by placing electrodes on an endotracheal tube. In order
      to guarantee a sufficient signal quality of the IONM, the electrode must be adequately
      positioned on the glottis. The present study pursued the question of whether the conventional
      direct laryngoscopy compared with video laryngoscopy allows a visually adequate tube
      placement.
    

Intervention name(s): CMAC Videolaryngoscope; Macintosh Laryngoscope
Intervention type(s): Device; Device
Intervention description(s): In a randomised order we evaluate the quality of the IONM after securing the airway with the CMAC; In a randomised order we evaluate the quality of the IONM after securing the airway with the conventional Macintosh Laryngoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Intraoperative nerve monitoring, airway management
Clinical Practice of Inhalation Anesthesia With Sevoflurane in China
Condition: Anesthesia, General
MeSH terms: Respiratory Aspiration
Study type: Observational

Summary: 
      Until recently, there was a lack of understanding and consensus among Chinese
      anesthesiologists how they should practice general anesthesia with volatile anesthetics,
      since there was no standard of inhalation practice. In August 2011, the Anesthesiology branch
      of the Chinese Medical Association launched the first version of Chinese Consensus of
      Standard Clinical Practice for Inhalation Anesthesia (Consensus) in order to standardize the
      practice in China.

      The proposed registry is aimed to evaluate the current inhalation practice one year after the
      Consensus has been released, and related patient outcome. This registry evaluated sevoflurane
      anesthesia, including screening, induction, maintenance, emergence, and follow-up within 24
      hours post-operation.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chinese patients undergoing surgery require general anesthesia (sevoflurane) with
        endotracheal intubation or laryngeal mask.
      
Keywords: Economics, Pharmaceutical; Physician's Practice Patterns; Chinese; Sevoflurane
Multi-intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Heart Failure With Reduced Ejection Fraction（PRIME-HFrEF Study）
Condition: Heart Failure, Systolic
MeSH terms: Heart Failure; Heart Failure, Systolic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is an exploratory clinical study to observe the safety and efficacy of the
      Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in the heart failure patients
      with reduced ejection fraction. The study was a 12 months single center, randomized,
      double-blind, placebo-controlled trial that included 12 weeks of treatment, and 9 months of
      follow-up.
    

Detailed description: 
      The study was a 12-month single center, randomized, double-blind, placebo-controlled trial
      that included 12 weeks of treatment, and 9 months of follow-up.We plan to recruit 40
      subjects，which were divided into experimental group and control group. The volunteers of the
      experimental group will be given peripheral intravenously infusion a dose of 1.0*10^6/kg
      human umbilical cord mesenchymal stem cell (HUC-MSC) respectively at 0,6,12 week. The control
      group will be given the same dose of 1 percent human serum albumin injection. Then
      centralization visit was conducted at 0,7 day, 6,12 week, 6 and 12 month. The primary safety
      end point is the incidence of any treatment emergent serious adverse events within12 months
      after intravenous MSC infusion, including death, nonfatal MI, stroke, sustained ventricular
      arrhythmias (>15 seconds or causing hemodynamic compromise), and other adverse events such as
      infection, tumor formation and clinical abnormal, which will be evaluated by monitoring for
      serial troponin, hematology, chemistry, urinalysis, 24-hour Holter, CTscans and ultrasound of
      abdomen.There are independent data and safety monitoring committees to monitor patient safety
      throughout the duration the trial.The primary efficacy endpoint is a change in Left
      Ventricular Ejection Fractions (LVEF) measured by left ventricular opacification (LVO) with
      contrast echocardiography and magnetic resonance imaging (MRI) at 12th month.
    

Intervention name(s): human umbilical cord mesenchymal stem cells; human serum albumin
Intervention type(s): Biological; Other
Intervention description(s): Human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group.; Saline solution containing 1 percent human serum albumin will be infused to the control group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Human Umbilical Cord Mesenchymal Stem Cells; Heart Failure
'Activity Pacing' in PLWH With Fatigue Symptoms.
Condition: Hiv
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Physical activity helps to improve health and prevent chronic diseases. However, the fatigue
      usually hampers the training and execution of physical exercises, especially in people with
      chronic fatigue syndromes (CFCs), such as persons living with HIV (PLWH). We hypothesize that
      the "activity pacing", i.e. the strategy to optimize daily physical activity into manageable
      exercises in a way that should not exacerbate fatigue symptoms, may help a progressive
      improvement in physical activity of a group of PLWH with fatigue symptoms. Motivation and
      adherence to exercise will be monitored through the use of digital supports.
    


Intervention name(s): Home-based physical activity
Intervention type(s): Behavioral
Intervention description(s): Participants will follow a personalized activity pacing program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Correlation Between Circulating Resistin and Vascular Inflammation Measured by 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) (18FDG-PET)
Condition: Atherosclerosis
MeSH terms: Atherosclerosis; Inflammation
Study type: Observational

Summary: 
      Vascular inflammation is a key factor in both the pathogenesis and outcome of
      atherosclerosis.Resistin was shown to induce vascular endothelial dysfunction and vascular
      smooth muscle cell proliferation.

      18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for
      identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore,
      the purpose of the study is to demonstrate the correlation between circulating resistin and
      vascular inflammation detected by 18FDG-PET in obese persons.
    


Intervention name(s): Cross sectional study
Intervention type(s): Other
Intervention description(s): This is not intervention study. The purpose of the study is to examine the relationship between various adipokine levels and PET imaging at the cross section setting
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy participats who underwent a medical health check in the health promotion center in
        Korea Guro University
      
Biospecimen description: 
      Plasma, whole blood, serum
    
Keywords: atherosclerosis; vascular inflammation; resistin; adiponectin; 18FDG-PET
Eating Disorders Programs: An Indicated Trial
Condition: Body Image; Eating Disorders
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effectiveness of two body acceptance programs for
      women. Participants may experience reduction of eating pathology and prevention of future
      obesity and eating disorders; may derive a sense of altruism and contribution to furthering
      understanding of a public health problem.
    


Intervention name(s): Group-based Therapy
Intervention type(s): Behavioral
Intervention description(s): Young women with body dissatisfaction will be randomized to one of two conditions: 1) an educational-support group condition; or 2) a counter-attitudinal therapy condition. We will test if a brief dissonance-based eating disorder prevention program produces intervention effects when delivered to participants with sub-threshold and threshold eating disorders.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics and Safety/Tolerability Profile of CKD-379
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to compare the pharmacokinetics and safety/tolerability between CKD-379 tablet and
      D759, D745, D150 combination
    

Detailed description: 
      A randomized, open-label, single dose, 3-period, 6-treatment, crossover study to compare the
      pharmacokinetics and safety/tolerability of CKD-379 in healthy subjects under fed conditions
    

Intervention name(s): CKD-379 I; CKD-379 II; D759+D745+D150
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet administration under fed condition; 1 tablet administration under fed condition; 3 tablet coadministration under fed condition
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Blood Flow Response and Acute INterval Exercise
Condition: Stroke; High Intensity Interval Exercise
MeSH terms: Stroke
Study type: Observational

Summary: 
      The objective of this project is to study the cerebrovascular response to a single bout of
      high intensity interval exercise (HIIT) in 25 individuals with chronic stroke compared to 25
      age- and sex- matched healthy controls (CON). We will enroll 25 young healthy adults
      (CONyoung) as a reference group. Our hypothesis is that the cerebrovascular response in
      individuals with chronic stroke will be significantly lower: 1) during a single bout of HIIT,
      and 2) during the recovery immediately following and 30 minutes after HIIT, compared to CON.

      This study has 2 visits at the University of Kansas Medical Center Research in Exercise and
      Cardiovascular Health Laboratory. For the first visit, we will perform questionnaires about
      heart health, physical activity and overall health. Participants will then complete a
      submaximal exercise test on a seated stepper. Participants will also have a familiarization
      session to practice HIIT. The second visit will include cerebrovascular measures before,
      during, immediately after, and 30 minutes after performing HIIT.
    


Intervention name(s): Single, acute bout of high intensity interval exercise
Intervention type(s): Behavioral
Intervention description(s): Individuals will perform a single bout of high intensity interval exercise on a seated recumbent stepper. Participants will perform the pattern of high intensity interval exercise by switching between 1-minute high intensity stepping followed by 1-minute light, active recovery stepping for a total of 10 minutes.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        We will recruit individuals with chronic stroke, age- and sex-matched controls (CON) and
        young healthy controls (CONyoung) within the community.
      
Keywords: Cerebral Blood Velocity; Cerebral Autoregulation