bioihbjkbjnl/mcl2 huggingface dataset:
Cognitive, Behavioral, and Functional Change in Behavioral Variant Frontotemporal Dementia (bvFTD)
Condition: Frontotemporal Dementia; Behavioral Variant Frontotemporal Dementia
MeSH terms: Dementia; Alzheimer Disease; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
Study type: Observational

Summary: 
      The objectives of the study are to; (1) estimate the change in disease -related cognitive
      decline over 1 year on a battery of cognitive tests administered to participants with
      early-stage symptomatic Behavioral Variant Frontotemporal Dementia (bvFTD) phenotypic
      variant; (2) identify the cognitive test or brief battery of cognitive tests which are the
      most sensitive to detect bvFTD progression; (3) determine the optimal schedule of
      administration of cognitive tests to detect bvFTD progression; (4) evaluate the relationship
      between cognitive tests and measures of behavior, function, caregiver's burden, quality of
      life (QOL); and (5) obtain blood samples for genetic and exploratory biomarkers correlations.
    


Intervention name(s): Assessments
Intervention type(s): Other
Intervention description(s): Cognitive, Behavioral and Functional as described in the Outcome Measures
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Academic centers, Hospitals, Clinics
      
Biospecimen description: 
      Whole blood samples
    
Keywords: Longitudinal; Caregiver; Cognitive assessments; Behavioral assessments; Functional assessments
Asian Outcomes of Primary Breast Augmentation
Condition: Breast Augmentation
Study type: Interventional

Summary: 
      In 162 Asian patients, primary breast augmentations were performed by a single surgeon during
      5 years. The purpose of this study evaluates Asian outcomes in primary breast augmentation
      using single antibiotic breast irrigation by a single surgeon's practice and examines the
      comparison of Asian and Western outcomes in primary breast augmentation.
    

Detailed description: 
      A retrospective chart review was performed to examine a total of 162 patients received the
      same brand of implants for primary breast augmentation under sedative anesthesia (propofol
      infusion) in a single surgeon's practice. Asian patients' demographics, preoperative and
      postoperative measurements, surgical technique (single antibiotic breast irrigation), implant
      type, size, texture, soft tissue coverage, implant placement, incision approach,
      complications, and incidence of reoperation were documented.
    

Intervention name(s): primary breast augmentation
Intervention type(s): Procedure
Intervention description(s): With the patient under sedative anesthesia, wide preparation and draping by using povidone-iodine are performed with using talc-free gloves and povidone-iodine gauze nipple shields. Tumescent solution is infiltrated in the precise plane. Pockets are developed precisely with blunt dissection with fingers and instruments under both direct and indirect visions simultaneously, if needed, with using endoscopy, while careful hemostasis done. After dissection, two pockets are irrigated with 300ml of single antibiotic solution without active evacuation of the irrigation. When re-draping and re-preparation by using povidone-iodine are performed before implant insertion, a new pair of talc-free gloves is used and cleansed with the single antibiotic solution.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: capsular contracture; reoperation; breast augmentation
A comparatiVe Study on Efficacy and Safety of Lipegfilgrastim in Comparison to Pegfilgrastim in Elderly Patients With Aggressive B Cell Non-HOdgkin Lymphomas at hIgh Risk for R-CHOP-21-inDuced Neutropenia
Condition: Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Neutropenia; Aggression
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to demonstrate non-inferiority of lipegfilgrastim to
      pegfilgrastim for the duration of severe neutropenia in the first cycle of chemotherapy.
    


Intervention name(s): lipegfilgrastim; pegfilgrastim
Intervention type(s): Drug; Drug
Intervention description(s): 6 mg; 6 mg
Other intervention name(s): XM22; Neulasta®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neutropenia; NHL; Non-Hodgkin lymphomas; R-CHOP-21
The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers
Condition: Migraine; Headache; Pain
MeSH terms: Headache
Study type: Interventional

Summary: 
      To investigate the hemodynamic effects of PACAP38 after glibenclamide administration.
    

Detailed description: 
      22 healthy participants will randomly be allocated to receive PACAP38 infusion followed by
      glibenclamide or placebo on two different days.

      The aim of the study is to investigate the vascular effect of PACAP38 after glibenclamide
      administration.

      Repeated measurements covering the arteria radialis (RA), superficial temporal artery (STA)
      and middle cerebral artery (MCA) before and after PACAP38 infusion and glibenclamide/placebo
      administration
    

Intervention name(s): glibenclamide; PACAP38
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of glibenclamide/placebo. To investigate the role of PACAP38 on cranial arteries in healthy volunteers after glibenclamide/placebo administration .; PACAP38 infusion
Other intervention name(s): Pituitary adenylate cyclase activating polypeptide-38
Intervention MeSH terms: Glyburide; Pituitary Adenylate Cyclase-Activating Polypeptide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Glyburide; Physiological Effects of Drugs; Hypoglycemic Agents
Efficacy and Safety of Fluticasone Propionate(FP)/ Salmeterol Xinafoate (SLM) Hydro Fluoro Alkane (HFA) Metered Dose Inhaler (MDI) in Pediatric Patients With Bronchial Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a multicenter, stratified, randomized, active control, double-blinded,
      parallel-group comparative study with an open-label extension period. The study is designed
      to evaluate the efficacy and safety of FP/ SLM HFA MDI 50/25 microgram (mcg) one or two
      inhalation twice daily (BID) for 8 weeks in comparison with FP HFA MDI 50 mcg one or two
      inhalation BID, in 6-month to 4-year-old Japanese patients with bronchial asthma. The study
      is also designed to evaluate the safety of long-term treatment of FP/ SLM HFA MDI 50/25 mcg
      one or two BID for 16 weeks.

      The subjects meeting the eligibility criteria will enter the run-in period of 2 weeks and
      receive FP 50 mcg 1 or 2 inhalation bid (FP 100 or 200 mcg/day), before randomization. The
      subjects under 2 years of age at Visit 1 will receive only 1 inhalation bid during the run-in
      period. The subjects who meet the eligibility criteria for randomization will be stratified
      according to their age (<2 or >=2 year-old) at Visit 1 and randomized to one of the two
      treatment groups.

      The total duration of participation in the study will be 10 weeks for a comparison period
      completion and 27 weeks for a completion.
    


Intervention name(s): FP/ SLM HFA MDI 50/25 mcg; FP HFA MDI 50 mcg
Intervention type(s): Drug; Drug
Intervention description(s): Metered-dose aerosol product containing 50 mcg of fluticasone propionate and 25 mcg of salmeterol per inhalation; Metered-dose aerosol product containing 50 mcg of fluticasone propionate per inhalation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: FP/SLM; Asthma; Infant; Efficacy; Safety
Intranet-based Tobacco Prevention Program for Children
Condition: Health Promotion; Tobacco Smoking
Study type: Interventional

Summary: 
      The purpose of this research is to create an effective, disseminable, and exciting
      computer-based tobacco prevention program for 5th and 6th grade students. The goal of this
      school-based program is to decrease children's behavioral intentions and willingness to use
      tobacco, and to prevent or delay their initiation of tobacco use.

      We will augment the 5th grade program with a booster program in 6th grade, and evaluate the
      long-term efficacy of the entire tobacco prevention program by conducting a randomized
      controlled trial in elementary and middle schools.
    

Detailed description: 
      The aims of this randomized trail are as follows:

        -  Conduct a randomized trial to assess the effectiveness of the Tobacco Free Town (TFT)
           program at preventing or delaying initiation of tobacco by 7th grade, and decreasing
           behavioral intentions and willingness to use tobacco, as compared to the usual
           tobacco-prevention curriculum implemented in schools. The TFT program consists of 17
           effective components delivered in eight sessions over a four-week period in 5th grade
           with two booster sessions delivered within a one-week period in 6th grade.

        -  Develop and test the effectiveness of 7 components to include in the booster sessions in
           6th grade using an iterative development process including qualitative evaluation using
           focus and user groups, and culminating in a quantitative evaluation assessing the
           effectiveness of individual program components.

        -  Develop a program guide for teachers to accompany the program and develop parent
           newsletters for teachers to send home with students after each session.

        -  Examine change from 5th to 7th grade in the mechanisms that the TFT program is designed
           to target, and assess if these cognitive mechanisms serve to mediate the effects of the
           program on smoking outcomes.
    

Intervention name(s): Click City
Intervention type(s): Behavioral
Intervention description(s): School-based intranet delivery of tobacco use prevention program for 5th and 6th graders using interactive and engaging game-like multi-media technology.
Other intervention name(s): Tobacco Free Town
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: School Based Services; Prevention; Children
Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus; Insomnia; Sleep Disorder; Inflammation
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias; Dyssomnias; Diabetes Mellitus; Diabetes Mellitus, Type 2; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators aim to determine the effect of suvorexant on subjective total sleep time
      (TST) in suboptimally controlled Type 2 diabetics with chronic insomnia in a randomized
      placebo-controlled trial for 3 months.
    

Detailed description: 
      Type 2 diabetes results from a progressive insulin secretory defect on the background of
      insulin resistance and is a growing pandemic and a leading cause of morbidity and mortality.
      Sleep disturbance is one of the underappreciated and important features of Type 2 diabetes,
      and may contribute to the development of the disease. In those with established Type 2
      diabetes, there is emerging evidence from cross-sectional studies that sleep disturbance
      affects glycemic control. Although cross-sectional studies suggest a relationship between
      sleep disturbance and glycemic control in Type 2 diabetes, causality is best investigated by
      interventional studies. Suvorexant has a comparatively benign side effect profile compared to
      many of the hypnotic agents typically prescribed for insomnia. The investigators aim to
      determine the effect of suvorexant on subjective total sleep time (TST), as well as
      subjective wake after sleep onset, Insomnia Severity Index, HbA1c levels and insulin
      sensitivity, inflammatory markers, and other subjective sleep endpoints.
    

Intervention name(s): Suvorexant; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 10-mg or 20-mg Suvorexant capsules; Matching placebo capsules
Other intervention name(s): Belsomra
Intervention MeSH terms: Suvorexant
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Sequential Parallel Comparison Design: subjects will be randomized in a 1:2 ratio to suvorexant 10-20 mg or equivalent placebo for six weeks, followed by re-randomization of placebo non-responders to either suvorexant or placebo in a 1:1 design for six weeks.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Lipid-lowering Effect of Plant Stanol Drink
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      To determine the effect of investigational products on serum LDL cholesterol.
    


Intervention name(s): Drink that contains plant stanols; Placebo drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of the Efficacy and Safety of Inhaled Technosphere Insulin in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objective to evaluate the effect of a 12-week treatment period with prandial
      administration of Technosphere Insulin on glucose control in subjects with T2 DM. Secondary
      objective is to Evaluate the safety and tolerability of a 12-week treatment period of
      Technosphere Insulin and Technosphere Placebo.
    


Intervention name(s): Technosphere Insulin; Technosphere Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Technosphere Insulin Inhalation Powder; Technosphere Inhalation Powder
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Text Message for Adolescents With Poorly Controlled Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to assess HbA1c reduction after supportive care by SMS among
      adolescents with poorly controlled type 1 diabetes.
    

Detailed description: 
      In 2010, the number of children with type 1 diabetes in France is estimated at 12,000 with
      60% of them aged 12 to 17 years. Compliance is a major issue during adolescence. Mobile text
      message is one of the strategies to enhance adherence. The main aim of this study is to
      assess HbA1c reduction after a 6 month SMS support among adolescents with poorly controlled
      type 1 diabetes. Adherence and quality of life will also be assessed at the end of the trial.
      This study is a prospective randomized monocentric trial. Sixty adolescents with type 1
      diabetes and HbA1c equal or higher than 8.5 % will be randomized according to the method of
      Zelen in two groups : standard treatment versus standard treatment plus support by SMS. The
      patients will receive one SMS before each injection of insulin.
    

Intervention name(s): Text message arm
Intervention type(s): Behavioral
Intervention description(s): Text message sent before each injection of insulin
Other intervention name(s): Mobile phone short text message
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: adolescents; type 1 diabetes; poorly controlled; SMS; Improve glycaemic control; HbA1c reduction; poorly controlled type 1 diabetic adolescents
Association of Host Genetics With Vaccine Efficacy and Study of Immune Correlates of Risk From a Tetravalent Dengue Vaccine
Condition: Dengue Fever; Dengue Haemorrhagic Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Study type: Observational

Summary: 
      Primary objectives:

        -  To assess how dengue vaccine efficacy varies across participant subgroups regarding
           polymorphism in human leukocyte antigen (HLA) alleles of interest.

        -  To assess the association between HLA alleles and, serotype-specific neutralization
           antibody titers and summary neutralization measure in the vaccine and placebo groups.

        -  To assess the association between the polymorphism in HLA alleles of interest and
           susceptibility to Dengue fever and Dengue Haemorrhagic fever.

      Secondary objectives:

        -  To assess whether dengue serotype-specific neutralizing antibody titers and associated
           summary neutralization measure at 28 days post-dose 3 are related to the rate of
           occurrence of symptomatic Virologically-confirmed dengue infection after post-dose 3

        -  To evaluate whether the dengue serotype-specific neutralizing antibody and associated
           summary neutralization measure at 28 days post-dose 3 are related to the level of
           vaccine efficacy against dengue viruses after post-dose 3.
    

Detailed description: 
      The enrolled population will include both, virologically-confirmed (VC) dengue cases and
      subjects not having experienced a VC dengue infection (control subjects) from the first Proof
      of Concept efficacy study conducted in Thailand Analyses for correlates will be performed on
      samples collected in the context of the first proof of concept efficacy study. Sequencing of
      dengue viruses will also be done on samples collected within the same context. Immunogenetic
      testing will be performed on saliva samples collected at the study enrollment visit.

      No intervention or vaccine will be provided or administered as part of this study.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will include both, virologically-confirmed (VC) dengue cases and subjects not
        having experienced a VC dengue infection (control subjects) from the first Proof of Concept
        efficacy study CYD57 (NCT01983553) conducted in Thailand
      
Keywords: Dengue Fever; Dengue Haemorrhagic Fever; Tetravalent Dengue Vaccine
Does Cognitive Impairment Affect Rehabilitation Outcome in Parkinson's Disease?
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Cognitive Dysfunction
Study type: Interventional

Summary: 
      In order to explore the question how an intensive, goal-based and aerobic rehabilitation
      treatment, addressed to act on motor and mental aspects, affects motor and functional
      symptoms in PD patients with normal cognition and with different level of cognitive
      impairment. Hypothesis is that a specific rehabilitation program based on motor-cognitive
      training and repetition, can affect positively the rehabilitation outcome regardless of
      baseline cognitive profile.
    

Detailed description: 
      Objective: This study is aimed to evaluate the impact of cognitive decline on rehabilitation
      outcomes in Parkinson's disease (PD). While cognitive status is considered as a determinant
      of rehabilitation outcome, no studies about this issue have been performed before.

      Methods: 438 PD patients hospitalized for a 4-weeks Multidisciplinary Intensive
      Rehabilitation Treatment (MIRT) were enrolled. According to Mini Mental State Examination
      (MMSE), patients were divided into: normal cognition (MMSE 27-30), mild cognitive impairment
      (MMSE 21-26), moderate or severe cognitive impairment (MMSE ≤ 20). According to Frontal
      Assessment Battery (FAB), subjects were divided into patients with normal (FAB ≥ 13.8) and
      pathological (FAB < 13.8) score. The outcomes measures were: Unified Parkinson's Disease
      Rating Scale (UPDRS), Berg Balance Scale (BBS), Timed Up and Go Test (TUG), Six Minutes
      Walking Test (6MWT), Parkinson's Disease Disability Scale (PDDS).
    

Intervention name(s): MIRT
Intervention type(s): Behavioral
Intervention description(s): MIRT consists of a 4-week physical therapy, in a hospital setting, which entails four daily sessions for five days and one hour of physical exercise on the sixth day. The duration of each session is about one hour. The first session consists of a one-to-one session with physical therapist involving muscle stretching. The second session includes aerobic exercises to improve balance and gait using different devices: a stabilometric platform, treadmill plus, crossover and cycloergometer. The third is a session of occupational therapy to improve autonomy in everyday activities. The last session includes one hour of speech therapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Cognition Impairment; Rehabilitation; Parkinson's Disease
Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent
      of patients don't respond to current treatments. MBS2320, the drug being tested in this
      trial, represents a new approach to treating RA, with the potential not only to reduce levels
      of inflammation but to also directly prevent bone damage. The aim of this project is to test
      the safety, tolerability and efficacy of MBS2320 in patients with RA in combination with an
      existing treatment, methotrexate.

      Approximately 224 participants with moderate to severe active RA who have not responded to
      treatment with Methotrexate will be enrolled from around 45 to 55 sites around the world.
      Participants will be randomly assigned to receive 1 of 3 doses of MBS2320 (5 mg, 20 mg, or 40
      mg) or placebo (a "dummy" drug).

      The maximum duration of study participation for a participant will be 22 weeks, which
      consists of a Screening Period of up to 4 weeks, Treatment Period of 12 weeks, and a
      Follow-up Period of 6 weeks.

      Participants on the study will be asked to attend the hospital or clinic for regular visits
      during which they will have planned study assessments to evaluate the effectiveness,
      tolerability and safety of the study drug.
    


Intervention name(s): MBS2320 5 mg; MBS2320 20 mg; MBS2320 40 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral capsule; Oral capsule; Oral capsule; Oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis (RA); MBS2320