bioihbjkbjnl/mcl2 huggingface dataset:
Trial of Two Dietary Programs on Cardiometabolic Risk Factors in Subjects With Metabolic Syndrome
Condition: Metabolic Syndrome; Overweight; Obesity; Hypercholesterolemia
MeSH terms: Overweight; Metabolic Syndrome; Hypercholesterolemia; Syndrome
Study type: Interventional

Summary: 
      The objective of this study was to investigate from 3 sites (University of Connecticut,
      University of Florida, and University of California, Irvine) whether enhancement of a
      modified Mediterranean-style, low glycemic load diet (MED) with specific phytochemicals (soy
      protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED) could improve
      cardiometabolic risk factors in women with metabolic syndrome.
    

Detailed description: 
      As the worldwide dietary pattern becomes more westernized, the metabolic syndrome is reaching
      epidemic proportions. Lifestyle modifications including diet and exercise are recommended as
      first-line intervention for treating metabolic syndrome. Previously, we reported that
      specific phytochemical supplementation for 12 weeks (soy protein, phytosterols, rho iso-alpha
      acids and proanthocyanidins) increased the effectiveness of the modified Mediterranean-style
      low glycemic load dietary program on variables associated with metabolic syndrome and CVD in
      subjects with metabolic syndrome and elevated LDL cholesterol. In this study, we propose to
      conduct a multi-center randomized trial to confirm our previous findings.
    

Intervention name(s): UltraMealPlus 360 (Medical food); Low-glycemic-load diet
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED); Modified Mediterranean-style low-glycemic-load diet
Other intervention name(s): UltraMealPlus 360
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metabolic syndrome; Serum lipid; Dietary intervention; Lifestyle modification; Glycemic load; Phytochemical; Hops; Acacia; Mediterranean diet; Kinase modulator
Effect of Non-surgical Periodontal Treatment
Condition: Periodontal Diseases; Adverse Effects
MeSH terms: Periodontal Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Objective: The objective of this research was to compare the effect of a single session
      supragingival scaling in a group of pregnant women with periodontal disease with a group that
      received supra and subgingival scaling.

      Methods: The investigators included 34 pregnant women between 15 and 43 who had at least 4
      teeth with probing depth ≥ 4 mm or clinical attachment loss ≥ 3 mm, with bleeding on probing
      in the same place. Women were divided into two groups, the group 1 received supra and
      subgingival scaling associated with oral hygiene orientation (OHO) and the group 2 received
      only supragingival scaling with OHO too.
    


Intervention name(s): Supra/subgingival scaling using periodontal curette scraping; Supra and subgingival scaling
Intervention type(s): Procedure; Procedure
Intervention description(s): The experimental group received supra and subgingival therapy with periodontal curettes; The experimental group received supra and subgingival scaling.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Treatment; pregnant women; periodontitis; dental scaling; dental plaque
Effectiveness of Adacel Vaccination in Pregnancy at Preventing Pertussis in Infants < 2 Months of Age in the United States
Condition: Pertussis (Whooping Cough)
MeSH terms: Whooping Cough
Study type: Observational

Summary: 
      The purpose of this study is to determine the effectiveness of Adacel against pertussis
      disease in infants < 2 months when administered during pregnancy following the current
      Advisory Committee on Immunization Practices (ACIP) recommendations, i.e., from 27 to 36
      weeks of gestation, and 14 days or more before delivery.
    

Detailed description: 
      The original study included cases recorded from 01 January 2011 through 31 December 2014,
      based on retrospective case-control methodology.
    

Intervention name(s): Not applicable / dataset analysis
Intervention type(s): Other
Intervention description(s): Not applicable / dataset analysis
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Infants between 2 days to < 2 months of age for whom a case of pertussis was reported to
        one of 6 Emerging Infection Program (EIP) network sites included in the original Skoff et
        al. study (in 2017) and their respective control infants, for the study period.
Effects of Lifeskills Workshop on BP in Hypertensive Employees
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      A number of psychosocial risk factors have been strongly related to a range of health
      problems (chief among them CVD). Clinical research has shown that behavioral interventions
      have enormous promise to ameliorate the psychosocial distress, the health-damaging effects
      and the costs associated with these risk factors. However, few such programs have been
      implemented in a large-scale way. Corporations are increasingly interested in providing such
      services for their employees, but they have encountered difficulties in knowing which
      programs are most effective. Until these programs are developed as products that can be
      tested and shown to produce consistent benefits, dissemination of these beneficial programs
      will be hindered. Taken together, these findings make a strong case that the development of a
      standardized, protocol-driven behavioral intervention package that can be delivered in a wide
      range of corporate settings presents a remarkable commercial opportunity. The overall goal of
      this SBIR Fast-Track-funded project is to gain empirical evidence in a RCT that documents the
      effectiveness of the Williams LifeSkills Workshop (a protocol driven 6-session workshop) in
      reducing BP, psychosocial risk factors, and promoting positive health outcomes in a cost
      effective manner in a corporate setting. This empirical support, tested in a setting
      independent of the program developers and by an experienced research team, will then be used
      to help market the product in the corporate wellness marketplace. It is hypothesized that
      participants (employees in an urban medical center) in the LifeSkills intervention will
      experience greater reductions in blood pressure and improvements in measures of psychosocial
      well-being than those receiving usual medical care and given educational materials on
      reducing BP.
    


Intervention name(s): Lifeskills Workshop Intervention
Intervention type(s): Behavioral
Intervention description(s): Intervention participants attended 10 one-hour weekly group sessions. The content of the groups followed the LifeSkills Workshop manual and Video ( (Williams LifeSkills, Inc, Durham NC). The LifeSkills Workshop is a structured psycho-educational group intervention using workbooks and videotapes that draw on cognitive-behavioral techniques and stress reduction approaches.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension; stress reduction
The Comparison of Two Different Methods of Partial Inflation of Cuff for Facile Insertion of Laryngeal Mask Airway in Adult Patients
Condition: General Anesthesia
Study type: Interventional

Summary: 
      Partial cuff inflation before insertion is generally used for laryngeal mask airway insertion
      in adult patients. However, it is not proven how much the cuff should be inflated. The aim of
      this study is to compare efficacy between the method using the resting volume and the method
      using half the maximum volume for partial cuff inflation.
    


Intervention name(s): The cuff inflation by the resting volume; The cuff inflation by half the maximum volume
Intervention type(s): Procedure; Procedure
Intervention description(s): 80 patients are randomly allocated into two groups : resting volume group (n=40), half the maximum volume group (n=40). In the resting volume group, the pilot balloon valve is connected to syringe without piston for keeping the valve open to the atmosphere and allowing the pressure within the cuff of LMA to equalize with atmospheric pressure. In the half the maximum volume group, the cuff of LMA is completely emptied and then the cuff is filled with the half the maximum volume.; 80 patients are randomly allocated into two groups : resting volume group (n=40), half the maximum volume group (n=40). In the resting volume group, the pilot balloon valve is connected to syringe without piston for keeping the valve open to the atmosphere and allowing the pressure within the cuff of LMA to equalize with atmospheric pressure. In the half the maximum volume group, the cuff of LMA is completely emptied and then the cuff is filled with the half the maximum volume.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Pan European Collaboration on Antipsychotic Naïve Schizophrenia II
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is a prospective 2 year multimodal follow-up study of initially antipsychotic-naïve
      first-episode psychotic patients involving a standardized intervention with monotherapy with
      aripiprazole during the first 6 weeks. Patients and matched healthy controls will be examined
      after 6 weeks, 6 months and 2 years. They will be examined with MR-scannings, neurocognitive
      tests, EEG, and PET-scannings.
    

Detailed description: 
      The study is a prospective 2 year multimodal follow-up study of initially antipsychotic-naïve
      first-episode psychotic patients involving a standardized intervention with monotherapy with
      aripiprazole during the first 6 weeks. Patients and matched healthy controls will be examined
      at baseline and after 6 weeks, 6 months and 2 years.

      Levels of glutamate and gamma-aminobutyric acid (GABA) are measured by proton magnetic
      resonance spectroscopy (1H-MRS) in the anterior cingulate cortex ACC and thalamus.
      Presynaptic Dopamine level is measured with Positron Emission Tomography Computed Tomography
      (PET/CT)-scanning using 3,4-dihydroxy-6-[18F]fluoro-L-phenylalanine (18F-DOPA). Disturbances
      of the reward system is measured with functional magnetic resonance imaging (fMRI) . Regional
      cerebral blood flow and activity in the same regions are measured with Pseudo-continuous
      arterial spin labelling (pCASL). The default mode network, functional and structural
      connectivity in the associated macro circuits are measured with resting state fMRI, EEG, and
      diffusion tensor imaging. Structural brain changes (in grey and white matter) are measured
      with MRI. Cognitive functions are measured with a neuropsychological test battery, and early
      information processing with event related EEG and electromyography (EMG) (psychophysiological
      examinations). Further patients psychopathology will be rated.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): 6 weeks of individual doses of aripiprazole
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glutamate; dopamine; cognition; cortical thickness; ppi; p50
Safety, Tolerability and Pharmacokinetics of Multiple Doses of VAK694 in Atopic Subjects With Seasonal Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety and tolerability of multiple doses of VAK694 as well as
      change in symptoms and biomarkers in patients with seasonal allergic rhinitis
    


Intervention name(s): Placebo; VAK694; Fluticasone
Intervention type(s): Biological; Biological; Drug
Intervention MeSH terms: Fluticasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Allergic rhinitis,; atopic patients,; seasonal allergy,; ragweed allergy
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Abnormal Contraction or Twitch of the Eyelid
Condition: Bilateral Blepharospasm (BEB)
MeSH terms: Blepharospasm
Study type: Interventional
Phase: Phase 3

Summary: 
      This phase 3 study will serve to collect efficacy and safety data of two different doses of
      NT 201 in subjects suffering from Bilateral Blepharospasm (BEB) who are BTX treatment-naïve.

      In this study, BTX treatment-naïve subjects are defined as those who have not received BTX
      treatment within the last 12 months for the treatment of BEB. This definition aims to avoid
      bias by comparison of treatment effects in the subject's assessments. Furthermore, this study
      will substantiate the existing efficacy and safety database for the indication BEB.
    

Detailed description: 
      Subjects to receive one injection with NT 201 or placebo at baseline of the
      placebo-controlled first cycle. Thereafter, all subjects entering the Open-Label Extension
      Period (OLEX) to receive a second injection of NT 201 (second injection cycle).
    

Intervention name(s): IncobulinumtoxinA (Xeomin), 25 Units; IncobotulinumtoxinA (Xeomin), 12.5 Units; Placebo; IncobotulinumtoxinA (Xeomin), 35 Units
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): IncobotulinumtoxinA (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Main Period: 25 Units per eye.; IncobotulinumtoxinA (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Main Period: 12.5 Units per eye.; Main Period: Placebo to IncobotulinumtoxinA (Xeomin), powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).; IncobotulinumtoxinA (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Open-Label Extension: up to 35 Units per eye.
Other intervention name(s): NT 201; Xeomin; Botulinum toxin type A (150 kiloDalton), free from complexing proteins; NT 201; Xeomin; Botulinum toxin type A (150 kiloDalton), free from complexing proteins; NT 201; Xeomin; Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Stockholm Sleepy Brain Study: Effects of Sleep Deprivation on Cognitive and Emotional Processing in Young and Old
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      The main purpose of this study is to investigate the effects of partial sleep deprivation
      (PSD) on resting state brain connectivity, emotional contagion, empathy, and emotional
      regulation.
    


Intervention name(s): Partial sleep deprivation allowing 3 h sleep at night; Full sleep
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants sleep at home while monitored with ambulatory polysomnography. For the full sleep condition, they are instructed to go to bed and to get up at the usual times that they would normally do that. For the sleep deprivation condition, they are instructed to go to bed 3 hours before the time when they would usually get up, and then to get up at that time.; Participants sleep at home while monitored with ambulatory polysomnography. For the full sleep condition, they are instructed to go to bed and to get up at the usual times that they would normally do that. For the sleep deprivation condition, they are instructed to go to bed 3 hours before the time when they would usually get up, and then to get up at that time.
Other intervention name(s): Sleep restriction; Sleep loss
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Sleep; resting state; functional connectivity; emotional contagion; empathy; emotional regulation
Efficacy and Tolerability of Flunarizine for the Treatment of Schizophrenia: Comparison With Haloperidol
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Flunarizine is a calcium channel blocker traditionally used for the treatment of vertigo and
      migraine. It also has the mechanism of action associated with antipsychotic activity (D2
      receptor blockade), but has never been tested as such. The investigators hypothesis is that
      flunarizine can be an atypical antipsychotic.
    

Detailed description: 
      The main advantage of flunarizine over other D2 receptor blockers is its long half-life, so
      that it may be administered weekly or may delay relapse if medication is interrupted.
    

Intervention name(s): Flunarizine
Intervention type(s): Drug
Intervention description(s): For 1 week, 40 mg/day. From week 2 to 3, 20 mg/day. Form week 4 onwards, dosage increment or reduction of 10mg/day was allowed according to efficacy and tolerability.
Intervention MeSH terms: Flunarizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: flunarizine; schizophrenia; antipsychotic
The Optimal Dosage of Rocuronium for Intraoperative Neuromonitoring During Thyroid Surgery
Condition: THYROIDECTOMY
MeSH terms: Thyroid Diseases
Study type: Observational

Summary: 
      The investigators tried to explore an alternative non-depolarizing muscle relaxant
      (rocuronium) and its optimal dosage to replace succinylcholine for IONM during thyroid
      surgery.Time frame of outcome measure was during 30 to 70min after rocuronium injection.
      Specific time points at which the will be assessed and for EMG signals will be presented.
    

Detailed description: 
      Recurrent laryngeal nerve (RLN) palsy is the most common and serious complication after
      thyroid surgery, and ranks among the leading reasons for medicolegal litigation of surgeons.
      Intraoperative neuromonitoring (IONM) are being applied to prevent RLN injury during thyroid
      surgery. IONM has been used as a means not only to localize and identify the RLN, but also to
      predict cord function and elucidate the surgical pitfalls during preparation of RLN.

      Muscle relaxant is necessary for general anesthesia; it can facilitate tracheal intubation
      and stable conditions for surgery. However, the use of muscle relaxant might diminish the EMG
      response during IONM and interfere with the interpretation of IONM results. Eighty patients
      were randomized to receive one (group 1, n=40) or two (group 2, n=40) effective dose (ED95)
      of rocuronium to facilitate EMG endotracheal tube insertion. Evoked potentials were obtained
      per 5 minutes by stimulating vagus nerve from the time point of 30 to 70 minutes after
      administration of rocuronium. The magnitude of evoked potential at each time point and
      tracheal intubating condition were compared between groups. Accelerometry [twitch (% TW)] was
      used to monitor the quantitative degree of neuromuscular transmission. The aim of this study
      was to explore an alternative non-depolarizing muscle relaxant (Rocuronium) and its optimal
      dosage to replace succinylcholine for IONM. The ED95 of rocuronium is 0.3mg/kg and 2×ED95 is
      generally recommended as a standard intubation dosage.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who were planned to receive thyroidectomy
      
Keywords: Intra-operative neuromonitoring; Neuromuscular blocking agent; Rocuronium; Thyroid surgery
Virtual Reality in Children With Hemiparesis
Condition: Physical Disability
MeSH terms: Paresis
Study type: Interventional

Summary: 
      children with cerebral palsy have impaired selective motor control and upper limb functions
      that affect their performance
    

Detailed description: 
      Twenty volunteer children diagnosed with hemiparetic cerebral palsy will be recruited from
      national institute of neuromotor system. they will be randomly assigned to intervention and
      control group.
    

Intervention name(s): designed occupational therapy program; Wii virtual reality games
Intervention type(s): Other; Other
Intervention description(s): Exercises facilitating hand skill patterns will include basic reach, grasp, carry and release and the more complex skills of in-hand manipulation and bilateral hand use.; Bowling
Frisbee
Basketball
Boxing
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Control grouprecivedvDesigned occupational therapy programe including Exercises facilitating hand skill patterns will include basic reach, grasp, carry and release and the more complex skills of in-hand manipulation and bilateral hand use.
• study group will recieve Wii virtual reality games
Bowling
Frisbee
Basketball
Boxing
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cerebral palsy; selective motor control; upper limb coordination; virtual reality
Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the effect of multiple doses of BI 207127 combined
      with faldaprevir on cardiac safety parameters in healthy subjects
    


Intervention name(s): BI 207127; BI 207127 placebo; Faldaprevir placebo; Faldaprevir; Moxifloxacin (Avalox®)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Medium dose oral administration; Medium dose oral administration
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Study to Evaluate HZN-457 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this first in human study is to assess safety, pharmacokinetics,
      pharmacodynamics, and immunogenicity of single ascending doses of HZN-457.
    


Intervention name(s): HZN-457; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HZN-457 will be given in one subcutaneous administration; Placebo will be given in one subcutaneous administration
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other