bioihbjkbjnl/mcl2 huggingface dataset:
Time Restricted Feeding to Reduce Weight and Cardiometabolic Risk
Condition: Obesity; Metabolic Syndrome; Pre Diabetes
MeSH terms: Metabolic Syndrome; Prediabetic State; Syndrome
Study type: Interventional

Summary: 
      The obesity rate in Malaysia is higher than the average world obesity rate. Central obesity
      is a component of metabolic syndrome (MetS) which is also made up of dyslipidemia, impaired
      glucose tolerance, and hypertension. MetS is a continuum in the risk of developing
      cardiometabolic complication. Time Restricted Feeding (TRF) involves an extended
      physiological overnight fast. Researchers believe that the timing of meal intake that matches
      with the circadian rhythms is as important as the calories intake to prevent obesity and its
      complications. The investigators hypothesize that TRF is effective in weight control and
      improvement of metabolic severity. Subjects will be randomized into either the control group,
      which practices QQH dietary plan or intervention group, which practices TRF as an adjunct to
      QQH dietary plan.

      Subjects will be followed up at week 12 and week 24 to assess adherence, efficacy and safety
      of TRF.

      This study intends to fill a few research gaps as follows:

        1. Longer study duration of 6 months.

        2. This is the first study amongst the Asian population.

        3. Adherence level to TRF in real life setting is measured. This information can
           potentially predict the intensity level of TRF that are feasible for practice in real
           life and also its association with the efficacy of TRF.

        4. TRF is defined as eating within a≤12-hour period and fasting for at least 12 hours per
           day. This is the shortest fasting window studied so far.
    


Intervention name(s): Time Restricted Feeding; Standard Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects practise TRF (2-3 meals) as an adjunct to the QQH healthy plate diet. Subjects of the intervention group can eat during the pre-determined 8-12 hours eating window, but they are only allowed to drink water and calorie-free drinks for the remaining 12-16 hours. Subjects are allowed to decide the time of their first and the last meal of the day as long as they eat within the 8-12 hour window period. However, skipping breakfast and having late dinner are discouraged.; Subjects practice the QQH healthy plate diet as per guidelines set by the Health Ministry the guidelines.QQH refers to a normal food plate (23cm in diameter), divided into a quarter of rice (carbohydrates), a quarter of meat (protein) and a half plate of vegetables and fruits. Additionally, no calories specification is required and snacks are discouraged.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pharmacokinetic Pilot Study on Budesonide/Formoterol
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and
      Formoterol after administration of 3 different product variants of Budesonide/Formoterol
      Easyhalers and Symbicort turbuhaler.
    


Intervention name(s): Budesonide; Formoterol; Easyhaler; Turbohaler Forte
Intervention type(s): Drug; Drug; Device; Device
Intervention description(s): Single inhalation; Single inhalation; Inhaler device; Inhaler device
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy volunteer study
Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants
Condition: Diphtheria; Tetanus; Poliomyelitis; Acellular Pertussis; Haemophilus Influenzae Type b; Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines
MeSH terms: Tetanus; Diphtheria; Poliomyelitis; Tetany
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster
      vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with
      GSK Biologicals' rotavirus vaccine or Placebo.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will
      be enrolled in this study. 3-4-5 month schedule with a booster dose at 18 months
    

Intervention name(s): GSK Biologicals' combined DTPa-IPV/Hib vaccine
Intervention type(s): Biological
Intervention description(s): 4 intramuscular injections
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Sex Differences in Postoperative Sleep Quality and Inflammation
Condition: Sex Differences; Postoperative Sleep Quality; Postoperative Pain; Inflammation Function
MeSH terms: Inflammation; Pain, Postoperative
Study type: Observational

Summary: 
      Video-Assisted Thoracoscopic Surgery(VATS) is among the most common and disabling persistent
      pain and inflammation conditions, with increasing prevalence in the developed world, and
      affects women to a greater degree than men. And sleep disruption also remains a challenging
      problem in surgical settings. Postoperative sleep disturbances (POSD) are defined as changes
      in the sleep structure and quality of patients during the early stages after surgery, which
      are manifested as significantly shortened rapid eye movement (REM) sleep, prolonged awake
      time, and sleep fragmentation. Long-term POSD may increase the risk of postoperative delirium
      or cognitive dysfunction and delay recovery, thereby worsening the patient's physical
      condition. The aim of the study was to investigate the effect of sex differences on
      postoperative pain, inflammation and sleep quality among patients who have undergone
      video-assisted thoracoscopic surgery under general anesthesia.
    


Intervention name(s): Video-Assisted Thoracoscopic Surgery
Intervention type(s): Other
Intervention description(s): patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients undergoing video-assisted thoracoscopic surgery under general anesthesia
      
Keywords: sex differences; postoperative sleep quality; postoperative pain; inflammation function
Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner
Condition: Clinical Study of Activa Bioactive Restorative; Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      electromyographic activity as well as clinical performance of bulk-Fill composite resins with
      Activa Bioactive Liner
    


Intervention name(s): Activa Bioactive
Intervention type(s): Other
Intervention description(s): Before cavity preparation and restoration, masticatory muscles activity will be evaluated by using electromyography. An electromyography detects the electrical potential generated by muscle cells. A total of 40 posterior teeth will be selected for this study and grouped into 2 main groups (20 for each group)) according to presence of caries in one or both side in patient (unilateral or bilateral). Split mouth technique will be used. The affected teeth will be treated by removing the caries and restored tooth with bulk fill composite material, after restoring the affected teeth. Masticatory muscles activity will be evaluated by using electromyography to detect any changes in masticatory muscles activity before and after restoration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Study of PK and Safety of OXC (Oxcarbazepine) XR (Extended Release) as Adjunctive Therapy in Pediatric Epilepsy Patients
Condition: Epilepsies, Partial
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the pharmacokinetics, safety, and tolerability of OXC XR as adjunctive
      therapy in pediatric subjects with refractory partial epilepsy.
    

Detailed description: 
      This was an open-label, multiple dose, multicenter study consisting of a Screening Period (up
      to 14 days), a Dosing Period (7 days), and a Follow-up Period (7 days). In-clinic visits
      occurred at screening, Visit 1 (Day 0), and Visit 2 (Day 7)/Early Discontinuation. All
      subjects received open-label SPN 804O as adjunctive therapy during the Dosing Period. At
      Visit 1, eligible subjects were assigned to 1 of 4 treatment groups (150, 300, 450, or
      600mg/day) based on weight (15-<30, 30-<45, 45-<60, >=60kg). The Dosing Period consisted of
      six consecutive days of a daily dose, taken at home, followed by a final day with the dose
      taken on-site and including blood draws for PK analysis.
    

Intervention name(s): SPN-804O
Intervention type(s): Drug
Intervention description(s): Open Label study
Other intervention name(s): oxcarbazepine extended-release; OXC XR; Oxtellar XR
Intervention MeSH terms: Oxcarbazepine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Precision Dosing of Alemtuzumab
Condition: Allogeneic Hematopoietic Cell Transplantation
Study type: Interventional

Summary: 
      The purpose of this study is to conduct a pilot trial of a Precision Dosing approach to
      alemtuzumab dosing for allogeneic hematopoietic cell transplantation of patients with
      non-malignant diseases. The investigators will measure the ability to use a population PK
      model of alemtuzumab to target patient Day 0 alemtuzumab levels to 0.15-0.6ug/mL in a pilot
      study of 20 patients.
    

Detailed description: 
      The hypothesis is that the model-informed dosing regimen will prospectively allow the
      precision dosing of alemtuzumab to target Day 0 levels to fall between 0.15-0.6ug/mL in
      greater than 80% of patients. The investigators have chosen a conservative pilot study
      approach, and the aim is to achieve Day 0 alemtuzumab levels between 0.15-0.6ug/mL in greater
      than 60% of 20 patients enrolled in this pilot study based on a Simon two-stage design as
      detailed below.

      A Simon two-stage design (Simon, 1989) is being used. The null hypothesis that 30% of
      patients will achieve a Day 0 alemtuzumab level between 0.15-0.6ug/mL will be tested against
      a one-sided alternative that the alemtuzumab dose modification will result in 60% of patients
      achieving a Day 0 alemtuzumab level between 0.15-0.6ug/mL. In the first stage, 7 patients
      will be accrued. If there are 2 or fewer patients that achieve Day 0 alemtuzumab levels
      within the range of 0.15-0.6ug/mL, the study will be stopped. Otherwise, 13 additional
      patients will be accrued for a total of 20. The null hypothesis will be rejected if 11 or
      more patients achieve a Day 0 level of 0.15-0.6ug/mL within the total 20 patients. This
      design yields a type I error rate of 0.04 and power of 0.82 when the true response rate is
      0.60. The investigators will enroll up to 30 patients in order allow for subject withdrawal,
      but will stop enrollment once 20 patients reach Day 0.
    

Intervention name(s): Alemtuzumab
Intervention type(s): Drug
Intervention description(s): Alemtuzumab (Campath®) is a recombinant DNA-derived humanized monoclonal antibody directed against CD52. Alemtuzumab is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Neomycin is not detectable in the final product. Alemtuzumab is a sterile, clear, colorless, isotonic pH 6.8-7.4 solution for injection. Alemtuzumab is supplied in single-use clear glass ampules containing 30 mg of Alemtuzumab in 3 mL of solution. Single use vial of alemtuzumab contains 30 mg alemtuzumab, 8 mg sodium chloride, 1.44 mg dibasic sodium phosphate, 0.2 mg potassium chloride, 0.2 mg monobasic potassium phosphate, 0.1 mg polysorbate 80, and 0.0187 mg disodium edetate dihydrate.
Other intervention name(s): Campath
Intervention MeSH terms: Alemtuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Joint School-Health Project of the Neapolitan Child
Condition: No Condition
Study type: Interventional

Summary: 
      Unhealthy lifestyle habits during the childhood could negatively impact the health status
      actual and during the later stages of life.

      The School represents the major Institution to implement actions aim at promoting healthy
      lifestyles habits.

      The Joint School-Health Project of the Neapolitan Child aimed at assessing the impact of a
      health education programme to improve lifestyle habits during the childood. To evalute the
      effects of this educational programme, the dietary habits, the sleep hours, the hours spent
      in sedentary behaviors (tv, smartphone) and the hours of physical activity will be evaluate
      at the baseline and at the end of the programme.
    


Intervention name(s): Healthy lifestyle
Intervention type(s): Behavioral
Intervention description(s): An educational programme to promote healthy lifestyle will be performed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Volunteers With Varying Degrees of Kidney Function
Condition: Renal Insufficiency; Healthy
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the
      drug) and pharmacodynamics (ie, how the drug affects the body) of canagliflozin
      (JNJ-28431754) after administration of a single dose to non-diabetic volunteers with normal
      kidney function and non-diabetic volunteers with varying degrees of kidney impairment
      (including volunteers with end-stage renal disease requiring hemodialysis).
    

Detailed description: 
      This study will be an open label (all volunteers and study staff know the identity of the
      assigned treatment), single-dose, multicenter (the study will be conducted at more than one
      center), parallel-group study (each group of volunteers will be treated at the same time) to
      assess the pharmacokinetics and pharmacodynamics of canagliflozin (a drug currently being
      investigated for the treatment of type 2 diabetes mellitus) in volunteers with varying
      degrees of kidney function. The study will consist of 3 phases: a screening phase, an
      open-label treatment phase, and an end-of study (or follow-up) phase. Volunteers will be
      assigned to 1 of 5 groups (depending on kidney function): group 1 will have normal kidney
      function; group 2 will have mild kidney impairment; group 3 will have moderate kidney
      impairment; group 4 will have severe kidney impairment; and group 5 will comprise volunteers
      requiring hemodialysis. Volunteers in groups 1 through 4 will receive a single dose of
      canagliflozin on Day 1. Volunteers in group 5 will receive a single dose of canagliflozin
      following dialysis and then, approximately 10 days later, they will receive a second dose
      before dialysis. Volunteers in groups 1 through 4 will participate in the study for 27 days.
      Volunteers in group 5 will participate in the study for 40 days.
    

Intervention name(s): Canagliflozin (JNJ-28431754)
Intervention type(s): Drug
Intervention description(s): Volunteers in groups 1 through 4 will receive one 200mg tablet orally (by mouth) on Day 1. Volunteers in group 5 will receive one 200mg tablet orally on Day 1 (one hour after hemodialysis) followed, approximately 10 days later, by one 200mg tablet orally (2 hours before hemodialysis).
Other intervention name(s): JNJ-28431754
Intervention MeSH terms: Canagliflozin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal Insufficiency; Healthy; Canagliflozin (JNJ-28431754); Pharmacokinetics; Pharmacodynamics; Dialysis
Brain Circuits in Schizophrenia and Smoking
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Observational

Summary: 
      The principle aim of the project is to identify the key brain circuits associated with
      smoking and especially smoking in high risk population. The investigators hope that the study
      will provide concrete biomarkers for new therapeutic development and ultimately reducing the
      smoking related health burden.
    

Detailed description: 
      There are several studies and hypotheses to be tested. This project includes (1) a
      cross-sectional study design that measures brain imaging, smoking, clinical diagnosis and
      symptoms, cognitive functional assessments, distress tolerance, and genetic information,
      which is also the baseline for the longitudinal study; and (2) a longitudinal study design
      for smoking cessation option for 1 year in some smokers and a longitudinal follow-up for all
      available subjects.

      During the baseline portion of the study, subjects are expected to complete clinical symptom
      assessments, a computer challenge task to measure distress tolerance, MRI scan, role-play
      test to measure cognitive and functional abilities, and blood draw. Subjects who are eligible
      will participate in the longitudinal follow-up study where the research team will call
      subjects regularly regarding smoking related information (smoking risk and treatment
      options).
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Smokers, nonsmokers, schizophrenia patients, family members
      
Biospecimen description: 
      -  Whole Blood

        -  Saliva
    
Keywords: MRI; Smoking; Schizophrenia
Safety and Efficacy of SA09012 in Asthma
Condition: Mild to Moderate Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial
      Asthma Patients
    


Intervention name(s): SA09012 Low dose; SA09012 High dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet, b.i.d; Tablet, b.i.d; Tablet, b.i.d
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma
Age-related Changes of Shoulder Muscles
Condition: Electromyography
Study type: Observational

Summary: 
      A cross-sectional descriptive study, in which the surface electromyographic activity of five
      shoulder muscles was compared in three populations: older adults, middle-aged adults and
      young adults. The evaluation of the electromyographic data offers a suitable foundation to
      understand aging process.

      This supports that surface electromyography provide information about the aged shoulder
      muscles. Loss of functionality is suffered by a high percentage of older adults, which
      greatly limits their physical activity. In this sense, this paper presents findings that
      might be related with possible therapeutic approaches in subsequent studies.
    

Detailed description: 
      The purpose of the present work was to assess neuromotor abnormalities in aging shoulder.
      Twenty young adults (20-42), 20 middle-aged adults (43-67) and 20older adults (>68) were
      recruited. A comparative electromyography (EMG) study was performed on the upper and lower
      trapezius, middle deltoid, infraspinatus and serratus anterior. The EMG measurement (root
      mean square (RMS)) and onset time of isometric contractions were analyzed. Body mass index
      and strength were also tested.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants came from Madrid and Castilla La Mancha (Spain) and voluntarily attended the
        Unit of the Research Group "Physical Therapy in Women´s Health Processes" in the Department
        of Physical Therapy, University of Alcalá, and the Ocaña Senior Center.
cAd3-Marburg Vaccine in Healthy Adults
Condition: Marburg Virus Disease
MeSH terms: Virus Diseases; Marburg Virus Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      RV 507 was a Phase I, open-label study to examine the safety, tolerability and immunogenicity
      of an investigational Marburg vaccine given by intramuscular (IM) injection to healthy
      adults. The study was a dose escalation of VRC-MARADC087-00-VP, a chimpanzee adenovirus
      serotype 3 (cAd3) vector vaccine, which encodes wild type (WT) glycoprotein (GP) from
      Marburgvirus.
    

Detailed description: 
      A total of 40 participants were evenly split, with 20 in each of the two dosage groups, to
      receive the investigational cAd3-Marburg vaccine at a dose of either 1x10^10 particle units
      (PU) (Group 1) or 1x10^11 PU (Group 2). The dose escalation plan included daily review of any
      new safety data by a study clinician, regular review of safety data by the protocol team and
      a staged enrollment plan with required interim safety reviews. The study began with
      enrollment of 3 participants into Group 1 (1x10^10 PU) at a rate of 1 participant per day.
      After at least 7 days of follow-up for the first 3 vaccinated participants, an interim safety
      review occurred before enrollment of additional participants into the group. No safety issues
      were identified; therefore, an additional 17 participants were enrolled to complete Group 1.
      When there was a minimum of seven days of follow-up safety data from the last enrolled
      participant in Group 1, an interim safety review occurred. Once no safety issues were
      identified, enrollment of participants into the next dose level began with the enrollment of
      3 participants at a rate of 1 participant per day. After at least 7 days of follow-up for the
      first 3 vaccinated participants in Group 2 (1x10^11 PU), an interim safety review occurred
      before the enrollment of additional participants into Group 2. No safety issues were
      identified and an additional 17 participants were enrolled to complete Group 2. Participants
      were followed for approximately 48 weeks.
    

Intervention name(s): cAd3-Marburg vaccine
Intervention type(s): Biological
Intervention description(s): The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
Other intervention name(s): VRC-MARADC087-00-VP
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Dose escalation
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Marburg virus; Marburg vaccine; cAd3-Marburg vaccine