bioihbjkbjnl/mcl2 huggingface dataset:
A Multicenter Efficacy Study of a Diclofenac+Menthol Gel in Subjects With Ankle Sprain
Condition: Pain
MeSH terms: Ankle Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase III pivotal efficacy study will assess efficacy and onset of pain relief of
      MFC51123 gel vs. placebo and MFC51123 gel vs. 1% diclofenac gel and 3% menthol gel in
      participants with an ankle sprain to support topical MFC51123 gel registration.
    

Detailed description: 
      This is a multi-center, randomized, double-blind, repeat-dose, placebo-controlled,
      parallel-group trial in participants with ankle sprain. Eligible participants will be
      randomly assigned to one of four treatment groups (1% diclofenac plus 3% menthol gel, 1%
      diclofenac plus 0.09% menthol gel, 3% menthol gel or placebo gel with 0.09% menthol).
      Treatment will be self-administered by participants four times daily on an out-patient basis.
      Participants will rate pain intensity score (NRS) at rest and on movement, pain relief score
      (PRS) and cooling and soothing sensations. After leaving the clinic, participants will
      continue to complete scheduled pain intensity and pain relief assessments and answer
      questions about cooling sensation by answering questions in a paper diary card. The
      investigator (or designee) will measure the ankle swelling via the 'figure-of-eight' method
      on treatment Days 1 (at Baseline), 3, 7 and 10.

      Participants will continue treatment until they are pain free or for up to 10 days, whichever
      occurs first. At the end of the treatment, participants will be assessed for function of the
      injured joint by the investigator. In addition, the participants will evaluate treatment
      satisfaction, sensory features of the gel and provide a global assessment of the treatment by
      using a questionnaire.
    

Intervention name(s): 1% diclofenac sodium plus 3% menthol; 1% diclofenac sodium plus 0.09% menthol; 3% menthol; Placebo with 0.09% menthol gel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): To be applied four times daily for 10 days.; To be applied four times daily for 10 days.; To be applied four times daily for 10 days.; To be applied four times daily for 10 days.
Intervention MeSH terms: Diclofenac; Menthol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Safety Extension Study With Benralizumab for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to continue to characterize the safety profile of benralizumab
      administration and monitor the pharmacodynamic activity of the drug in those asthma patients
      who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor
      study D3250C00021 (BORA, NCT02258542).
    

Detailed description: 
      This is an open-label safety extension study designed to evaluate the safety and tolerability
      of a fixed 30 mg dose of benralizumab administered subcutaneously (SC) in severe asthma
      patients on inhaled corticosteroid and long-acting β2 agonist (ICS-LABA) therapy with or
      without chronic oral corticosteroids (OCS) and/or other asthma controllers. All patients will
      receive active drug on the same dosing regimen they received in BORA (NCT02258542). In order
      to protect the blind of BORA, patients will remain blinded to treatment regimen allocation
      until they have completed all end of treatment (EOT) assessments in BORA and signed informed
      consent for participation in this study, after which treatment allocation will be unblinded
      to both the investigator and the patient.
    

Intervention name(s): Benralizumab; Benralizumab
Intervention type(s): Biological; Biological
Intervention description(s): Benralizumab administered subcutaneously every 4 weeks; Benralizumab administered subcutaneously every 8 weeks
Intervention MeSH terms: Benralizumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases; Obstructive Lung Diseases
Generalization of Training in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      This study examines whether patients with schizophrenia can benefit from a problem-solving
      training intervention and whether a work-related social skills training intervention leads to
      improvements in the patient's performance at work.
    


Intervention name(s): Problem-Solving Training; Work-Related Social Skills Training
Intervention type(s): Behavioral; Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Schizophrenia; vocational rehabilitation; neuropsychology
Rehabilitation Needs of the Malaysian Haematological Cancer Survivors
Condition: Haematological Malignancy; Leukemia, Acute; Lymphoma; Myeloma Multiple; Blood Cancer; Quality of Life
MeSH terms: Hematologic Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Observational [Patient Registry]

Summary: 
      Many cancers are being treated more effectively nowadays due to the raised awareness and
      early detection as well as advancement in researches and technology. Despite the rising
      number of cancer survivors in the coming years, these survivors are still plagued by the poor
      quality of life due to physical and psychological impairment. According to the National
      Cancer Registry Report from 2007-2011, haematological cancer is one of the ten most common
      cancers in Malaysian population. Many haematological cancer survivors in Malaysia are
      reportedly having poor quality of life due to multiple physical and emotional impairments
      which leads to further disability in life. It is thus an important effort to identify the
      rehabilitation needs in these cancer survivors to implement alternatives to improve the
      disease outcome through cancer rehabilitation.
    

Detailed description: 
      A cross-sectional questionnaire-based study will be employed to identify the rehabilitation
      needs and predictors of needs in outpatient hemato-oncological cohort at UMMC Hemato-oncology
      Clinic for 12 months. The validated questionnaire employed evaluates the potential
      disabilities that could affect the aforementioned patients in domains such as communication,
      independence in mobility, self-care, social participation, handling relationships and
      domestic activity of daily living a month prior to the survey.

      Participants of age between 18 to 80 years old, diagnosed with haemato-oncological illnesses
      will be screened; excluding potential participants who are too ill or cannot understand
      English, Malay, or Chinese; to be recruited in the research.

      Based on the findings from the analysis, rehabilitation needs could be tailored accordingly
      to improve quality of life of these patients
    

Intervention name(s): WHODAS 2.0 Questionnaire
Intervention type(s): Other
Intervention description(s): 36-item WHODAS 2.0 questionnaire will be used for each patient to identify difficulty faced by patient over past 30 days from the day of interview
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patient diagnosed with haematological malignancy under follow up at UMMC Haemato-oncology
        clinic
      
Keywords: Cross sectional study
Role of Interleukin (IL)-1 in Postprandial Fatigue - The Chäschüechli 2 Study
Condition: Adiposity
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Role of IL-1 in postprandial fatigue - The Chäschüechli 2 Study It is a randomized, single
      dose, placebo-controlled, double blind, cross-over, proof-of-concept study.

      16 healthy young men will be included in this study. The objective of this study is to
      evaluate if severity of postprandial fatigue is driven by IL-1.

      Since fatigue is associated with increased cytokine levels, and since fatigue in chronic
      inflammatory settings, such as type 2 diabetes, can be reduced by inhibition of IL-1β,
      postprandial fatigue might also respond to anti-inflammatory intervention with IL-1
      inhibition.

      The aim of the study is to investigate whether postprandial fatigue is, at least in part,
      driven by the IL-1 system.
    


Intervention name(s): Anakinra; NaCl
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive Anakinra infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.; subjects will receive NaCl infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.
Other intervention name(s): Kineret; sodium chloride
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Lumbar Intervertebral Motion in Asymptomatic Male Participants
Condition: Lumbar Intervertebral Motion
Study type: Interventional

Summary: 
      The investigators aim to analyze the physiological segmental motion of the lumbar spine
      during flexion and extension cinematographic recordings of asymptomatic individuals.
    

Detailed description: 
      In this study the investigators aim to define the lumbar spines' physiological motion by
      analyzing sequence of initiation of motion and sequence of maximum contribution in segmental
      translation and rotation of each vertebra L1, L2, L3, L4, L5 and S1 by using flexion and
      extension cinematographic recordings in asymptomatic male participants. Participants will
      undergo two cinematographic recordings with an interval of two weeks. Segmental translation
      and rotation of each segment will be plotted against total range of motion of the lumbar
      spine for each individual participant. With these graphs the investigators can analyze if
      there are specific physiological motion patterns during flexion and extension of the lumbar
      spine. In the future, the investigators hope to compare these physiological motion patterns
      to potential abnormal motion patterns in patients suffering from lumbar spinal pathology or
      after lumbar spine surgery to gain knowledge about complaints and, for example, adjacent
      level disease.
    

Intervention name(s): Cinematographic recording
Intervention type(s): Radiation
Intervention description(s): Cinematographic recording during flexion and extension of the lumbar spine.
Intervention model: Single Group Assignment
Intervention model description: Fundamental research with 11 male participants in one study arm, all performingflexion and extension of the lumbar spine during cinematographic recordings twice.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Lumbar intervertebral motion; Flexion; Extension; Cinematographic recording; Segmental rotations; Segmental translation; lumbar spine; asymptomatic participants
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)
Condition: Safety Issues
MeSH terms: Typhoid Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the safety of Vi-DT vaccine in adults and children.
    

Detailed description: 
      To describe the safety of this vaccine following first and second dose immunization.

      To assess preliminary information of immunogenicity following Vi-DT vaccine immunization.
    

Intervention name(s): Vi-DT (Bio Farma); Vi polysaccharide vaccine; Influenzae vaccine; Pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Typhoid Conjugate Vaccine; Vi polysaccharide vaccine; 1 dose of Influenzae vaccine; 1 dose of Pneumococcal conjugate Vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Evaluate Pharmacokinetic/Pharmacodynamic and Safety/Tolerability of AYP-101 in Healthy Subjects
Condition: Healthy Subjects; Submental Fat
Study type: Interventional
Phase: Phase 1

Summary: 
      To Evaluate Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of
      AYP-101 S.C. injection in Healthy Subjects

      A Randomized, Double-blind, Placebo-controlled, Single Center and Single Dose
    

Detailed description: 
      This study is planed to Evaluate Pharmacokinetic/Pharmacodynamic Characteristics and
      Safety/Tolerability of AYP-101 S.C. injection in Healthy Subjects.
    

Intervention name(s): Polyene Phosphatidylcholine
Intervention type(s): Drug
Intervention description(s): AYP-101 1 - 25 mg of essential phospholipids in 1 mL AYP-101 2 - 50 mg of essential phospholipids in 1 mL Placebo - Essential phospholipids in 1 mL 00 mg
Other intervention name(s): AYP-101 1; AYP-101 2; Placebo
Intervention MeSH terms: Polyene phosphatidylcholine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: submental fat
Efficacy of ONE A DAY Weightsmart Advanced Versus Caffeine and Placebo on Energy Expenditure, Thermogenesis and Perceived Energy Levels in Women.
Condition: Energy Expenditure
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is considered research because efficacy (how well a drug works) information is
      needed in healthy, 25-45 year-old, female subjects with moderate caffeine intake. The
      investigational product is available in the United States without a prescription
      (over-the-counter) as a nutritional supplement. The purpose of this study is to assess
      whether One-A-Day Weightsmart Advanced is safe and can increase metabolism and perceived
      energy in female subjects compared with caffeine or placebo (inactive drug). Participation in
      this study will last approximately 4 weeks and require about 4 outpatient visits to St.
      Luk's-Roosevelt Hospital Center. About 21 subjects are expected to participate in this study.
    

Detailed description: 
      - Primary efficacy endpoints are area under the curve (AUC) over the first 2 hours and the
      last 2 hours of Resting Metabolic RateRespiratory Quotient- The secondary efficacy endpoints
      are:Perceived Energy scales Visual Analog Scale (VAS) Change from baseline for Systolic Blood
      Pressure (SBP), Diastolic Blood Pressure (DBP) respiration, average heart rate over 1st 20
      minutes, average heart rate over last 20 minutes, and temperature
    

Intervention name(s): One-A-Day Weight S.A. (Multi-Vitamins, BAY94-9350); Caffeine; Placebo
Intervention type(s): Dietary Supplement; Drug; Drug
Intervention description(s): One A Day Weight Smart Advanced 1 tablet at 1st visit; Caffeine 100 mg 1 tablet at 1st visit; Placebo 1 tablet at 1st visit
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Energy expenditure; Nutritional; Weight control
Reducing Suicide Risk Associated With Weight Loss
Condition: Eating Behavior; Self Harm; Weight Loss
MeSH terms: Body Weight; Weight Loss; Suicide; Self-Injurious Behavior
Study type: Interventional

Summary: 
      The purpose of this study is to examine the efficacy of an intervention aimed at promoting a
      healthy lifestyle and reducing risk factors associated with eating pathology, nonsuicidal
      self-injury, and suicidal behavior. We are also interested in assessing whether this
      intervention has the potential to prevent future symptoms of eating problems and self-harm
      urges and behaviors. The broader goal of this research is to identify factors that may help
      us better understand the prevention of self-harm behaviors and develop more effective
      treatments for these problems.
    

Detailed description: 
      The current study was designed as a proof-of-concept study to test the association between
      weight suppression (WS; difference between one's highest and lowest weight) and non-suicidal
      self-injury (NSSI). Previous research has found an association between current WS and
      lifetime NSSI and that this association was mediated by depressive symptoms and drive for
      thinness. The current study therefore modified an existing online cognitive dissonance-based
      program (the e-Body Project) using mixed gender content (from the Body Project 4 All scripts)
      to target posited mediators, i.e., depressive symptoms and weight and shape concerns, in a
      sample of individuals with WS and engagement in current NSSI.
    

Intervention name(s): Body Acceptance Program
Intervention type(s): Behavioral
Intervention description(s): The Body Acceptance Program is a mixed-gender modification of the eBody Project, an online intervention in which cognitive dissonance principals are used to reduce eating pathology.
Other intervention name(s): eBody Project
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Masticatory Muscle Activity in Patients With Pain-related Temporomandibular Disorders
Condition: TMD
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Observational

Summary: 
      The aim of this study was to evaluate masticatory muscle electrical activity in patients with
      pain-related and pain-free temporomandibular disorders (TMD) as well as in subjects with no
      TMD. Ninety children with mixed dentition were recruited to the study. Of this total, 30
      subjects were diagnosed with pain-related TMD, 30 with pain-free TMD, and 30 without TMD. We
      used Axis I of the Research Diagnostic Criteria for TMD (RDC/TMD) to assess the presence of
      TMD in the examined children. The electromyographical (EMG) potentials of the temporalis and
      masseter muscles were measured with a DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany)
      at rest and during maximum voluntary clenching (MVC).
    


Intervention name(s): electromyography
Intervention type(s): Diagnostic Test
Intervention description(s): Surface electromyography (sEMG) was used as an additional non-invasive tool for assessing patients with TMD.The electromyographical (EMG) potentials of the temporalis and masseter muscles were measured with a DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany) at rest and during maximum voluntary clenching (MVC).
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The subjects were selected from patients who had been referred to the Orthodontic Clinic in
        Szczecin, Poland for orthodontic treatment.
      
Keywords: masticatory muscles; surface electromyography; muscle activity
Mechanisms Underlying Asthma Exacerbations Prevented and Persistent With Immune-Based Therapy
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Asthma is a growing problem, especially in children. It causes frequent wheezing, shortness
      of breath, chest tightness, and cough. A cold that is caused by a virus (viral cold) can
      sometimes make asthma symptoms worse. This study will help investigators learn about the way
      colds are related to asthma attacks among children who need higher amounts of medications to
      control their asthma. Investigators want to learn why viral colds sometimes cause asthma
      attacks and other times do not by studying the immune system response in samples taken from
      the nose and blood.
    

Detailed description: 
      This study is a prospective, longitudinal, nested case-control study designed to identify
      changes in gene transcription predictive of and associated with asthma exacerbations in
      children ages 6 to 17 years with difficult-to-control, exacerbation-prone asthma.

      Participants will be followed prospectively for the onset of a cold and a subsequent asthma
      exacerbation. An internet-based asthma and cold symptom diary will be accessed by
      participants using a hand-held device. When the participant reports development of a cold, a
      clinic visit will be scheduled as soon as possible (within 48 hours of cold symptom onset) to
      collect blood and nasal samples. A second clinic visit will occur 4-6 days from the onset of
      cold symptoms to obtain samples after the initial cold, but prior to the use of systemic
      corticosteroids. Participants will be followed for up to two colds or approximately 6 months
      after Visit 0, whichever comes first.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The MUPPITS study will enroll inner-city children 6-17 years of age with
        difficult-to-control, exacerbation-prone asthma. Approximately 150 children will be
        enrolled and followed prospectively.
      
Biospecimen description: 
      Blood, Nasal Samples.
    
Keywords: asthma; nested case-control study; difficult-to-control asthma; asthma exacerbations; cold symptoms; gene expression
A Study to Assess the Effect of AK3280 on Renal Function in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      AK3280 is being developed to further improve the long-term efficacy and tolerability of
      treatment options for patients with fibrotic disorders.This study will evaluate the effect of
      AK3280 treatment on renal function and safety, and the PK of AK3280 compared with placebo in
      healthy subjects.
    


Intervention name(s): AK3280; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral; Active Substance: Placebo, Pharmaceutical Form: Tablet, Route of Administration: Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment