bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in Adults
Condition: Genital Herpes Simplex Type 2
MeSH terms: Herpes Simplex; Herpes Genitalis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to test the safety and effectiveness of two experimental
      therapeutic vaccines against herpes simplex virus, type 2 (HSV-2).
    

Detailed description: 
      This is a dose escalation study to evaluate the safety, immunogenicity, and efficacy of 3
      doses of HSV plasmid DNA (pDNA) vaccines formulated with Vaxfectin® in subjects with a
      minimum of 1 year of reported history of genital herpes, and either 2 to 9 recurrences within
      the year prior to screening, or 2 to 9 recurrences per year prior to starting suppressive
      therapy.
    

Intervention name(s): VCL-HB01; VCL-HM01; PBS
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®; Plasmid DNA vaccine encoding one HSV-2 protein; formulated with Vaxfectin®; Phosphate-buffered saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Herpes Simplex Virus, Type 2; Herpes; HSV-2
Reactogenicity, Safety and Immunogenicity Study of a Allantoic Split Inactivated Seasonal Influenza Vaccine
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial
      that explored the safety and immunogenicity of single dose a allantoic split inactivated
      seasonal influenza vaccine in healthy adults.
    


Intervention name(s): influenza vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): A allantoic split inactivated seasonal influenza vaccine has been prepared on eggs and is made from inactivated parts of the following influenza virus strains:
NIBRG-121xp (A/California/7/2009 (H1N1)v and А/PR/8/34 (H1N1)), NYMC X-217 (A/Victoria/361/2011(H3N2) and А/PR/8/34 (H1N1)), NYMC BX-49 (B/Texas/06/2011 (Yamagata lineage) - like High Yield Reassortant (1:1:6) With B/Lee/40 NP, B/Panama/45/90 NS genes).; water for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vaccine; 1 phase; safety
Corestability Training in Overweight Children
Condition: Childhood Obesity; Child Obesity; Children, Only
MeSH terms: Obesity; Overweight; Pediatric Obesity
Study type: Interventional

Summary: 
      A total of 52 overweight children aged between eight and sixteen years will be recruited by
      criterion based purposive sampling to participate in the two groups pretest post test
      randomized clinical study. Random allocation of the eligible subjects for treatment will be
      done by the block randomization method with matrix of thirteen rows and four columns (13x4).
      The subject will be allotted to the group randomly, based on the chit selected by the person
      other the primary researcher.Once the block is filled, the next row block will be opened.
      Thus equal distribution of overweight children in the each group will be ensured.

      Group A will be receiving actual core stability training (Level 1 - Mat exercises and Level 2
      - Swiss Ball exercises) for 6 weeks with a frequency of three sessions per week.Group B will
      receive no training. Each session will last for 30 minutes of duration. The static and
      dynamic balance, foot pressure distribution and core strength will be assessed at the
      baseline and at the end of the treatment sessions.
    


Intervention name(s): Corestability training; No Intervention
Intervention type(s): Other; Other
Intervention description(s): Level -1: Mat exercises
Abdominal muscle contraction,bridging,cat stretch,single limb circle and superman.:
Level- 2: Swiss Ball Exercises Abdominal contraction,bridging and squats.; No Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two group pre-test post-test design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Noncommunicable disease; Balance; Posture; Childhood obesity; Overweight
Minnesota HealthSolutions Cellular Car Seat Study
Condition: Child Safety Seat Harness Tension
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to evaluate an innovative child safety seat user engagement
      system (CCS system) designed to actively educate, instruct, and alarm caregivers with
      information associated with automatically-sensed safety seat misuses/errors via a smartphone
      application.
    

Detailed description: 
      The primary objective of the study is to evaluate whether child safety seat users correct
      more critical misuse errors in child safety seat usage with the seat with the CCS system than
      the same seat with no sensor system. The CCS system will provide ongoing, tailored support to
      users at the time of an error. Videos will be available to users via a smartphone and provide
      short "how to" instructions that demonstrate how to correctly perform each safety seat
      behavior (e.g., tighten harness straps) and how to avoid common mistakes. The overall goal of
      the CCS system is to prevent child safety seat critical misuses and reduce deaths and
      injuries in children riding in motor vehicles. In the proposed study, adult participants will
      be asked to attend one in-person study visit and complete three (3) scenarios in which they
      will be asked to identify and correct errors in child safety seat use. Participants will be
      randomized to either the intervention group which will use the CCS system during each
      scenario or the control group which will not use the CCS system during each scenario.
    

Intervention name(s): CCS System- Prototype; CCS System- Control
Intervention type(s): Device; Device
Intervention description(s): Participants will be exposed to each of the 3 scenarios with the sensor system enabled (with feedback); The participants will be exposed to each of the 3 scenarios with the system disabled (no feedback).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a randomized control trial with 2 arms (intervention and control). The intervention group will participate in a series of three safety seat misuse scenarios with the CCS system enabled, and participants in the control group will participate in the same series of three safety seat misuse scenarios without the CCS system. Misuse scenarios include insecure attachment of the seat to the vehicle, incorrect harness straps, and improper orientation of the safety seat. In each scenario, participants will be asked to identify and correct each error. Each participant will be randomly assigned to either the control or intervention group. Each participant will receive the same scenarios in the same order.
Masking: Single (Participant)
Primary purpose: Other
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure
Condition: Pediatric Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study consists of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate
      the way the body absorbs, distributes, metabolizes and removes the drug LCZ696. This will
      help determine the proper dose of LCZ696 for Part 2 of the study.

      The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in
      a double-blind manner, in pediatric heart failure patients over 52 weeks of treatment.
    

Detailed description: 
      This study consists of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate
      the way the body absorbs, distributes, metabolizes and removes the drug LCZ696. This will
      help determine the proper dose of LCZ696 for Part 2 of the study.

      The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in
      a double-blind manner, in pediatric heart failure patients over 52 weeks of treatment.
    

Intervention name(s): LCZ696; Enalapril; Placebo of LCZ696; Placebo of Enalapril; LCZ696
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): LCZ696: 3.125 mg granules (packaged in capsules containing 4 or 10 granules); Enalapril tablets: 2.5 mg, 5 mg, 10 mg dosage strengths; LCZ696: 3.125 mg granules (packaged in capsules containing 4 or 10 granules), tablets: 50 mg, 100 mg, 200 mg dosage strengths
Intervention MeSH terms: Enalapril; Enalaprilat; Sacubitril and valsartan sodium hydrate drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pediatric Heart failure,; systemic left ventricle,; reduced ejection fraction
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

        -  To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein
           cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in
           participants with LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) on ongoing stable atorvastatin
           therapy.

      Secondary Objectives:

        -  To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment
           in comparison with placebo

        -  To evaluate the safety and tolerability of alirocumab

        -  To evaluate the development of anti-alirocumab antibodies

        -  To evaluate the pharmacokinetics of alirocumab
    

Detailed description: 
      The duration of study participation depended on the status of the participant at screening:

        -  For participants receiving atorvastatin 10 mg, 20 mg, or 40 mg at a stable dose for at
           least 6 weeks prior to screening, the study participation was to be approximately 21
           weeks including a screening period of 1 week, a double-blind treatment period of 12
           weeks and a follow-up period of 8 weeks.

        -  For participants receiving a lipid-lowering treatment other than atorvastatin or not at
           stable dose of atorvastatin 10 mg, 20 mg, or 40 mg for at least 6 weeks prior to
           screening, or drug naive participants, the study participation was to be approximately
           27 weeks including a screening period of 1 week, a run-in treatment period with
           atorvastatin 10 mg, 20 mg, or 40 mg at a stable dose of 6 weeks, a double-blind
           treatment period of 12 weeks, and a follow-up period of 8 weeks.
    

Intervention name(s): Alirocumab; Placebo (for alirocumab); Atorvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two SC injections in the abdomen only.; Two subcutaneous (SC) injections in the abdomen only.; Orally once daily at a stable dose of 10 mg, 20 mg, or 40 mg as background therapy.
Other intervention name(s): SAR236553; REGN727
Intervention MeSH terms: Atorvastatin; Alirocumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Obese Patients With Type 2 Diabetes
Condition: Obesity; Type 2 Diabetes Mellitus in Obese
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multiple dose study to evaluate the safety, tolerability, PK, and PD of K-757 and
      K-833 when co-administered in overweight/obese patients with Type 2 diabetes mellitus (T2DM).
    


Intervention name(s): K-757 and K-833; Matching placebo to K-757 and K-833
Intervention type(s): Drug; Drug
Intervention description(s): Both administered orally; Both administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Obesity; Type 2 Diabetes Mellitus
Skeletal Muscle as a Mediator of Exercise Induced Effects on Metabolism & Cognitive Function: Role for Myokines & miRNAs
Condition: Mild Cognitive Impairment; Alzheimer Disease; Parkinson Disease; Healthy Volunteers
MeSH terms: Parkinson Disease; Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to determine specific changes in muscle secretory profile
      (myokines, miRNA) in association with neurodegenerative disease progression and metabolic
      dysfunction. Next the investigators would like to determine the shift in the muscle secretory
      activity induced by regular exercise intervention, which the investigators think could be
      translated into the beneficial changes in clinical phenotypes, determined by neuroimaging,
      cognitive function tests and metabolic phenotyping.
    

Detailed description: 
      Standard Operating Procedures for patient recruitment, data collection, data management, data
      analysis routinely used in University Hospital Bratislava and in Institute of Experimental
      Endocrinology Slovak Academy of Sciences will be employed.

      Statistical analysis will be employed to address the primary and secondary objectives, as
      specified in the study protocol.
    

Intervention name(s): 3 months exercise intervention program
Intervention type(s): Behavioral
Intervention description(s): 3 months exercise intervention program which is given 3-times per week, 60 min session duration, 65-75% repetition maximum or heart rate maximum, combined strength & aerobic exercises
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: MicroRNAs; exercise; skeletal muscle; metabolism
Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity
Condition: Time Restricted Feeding; Intermittent Fasting; Obesity; Overweight and Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      Time-restricted eating (TRE) is a dietary approach that aims to increase fasting time and
      decrease the eating window. Promising TRE effects on weight loss and some cardiometabolic
      risk factors have been reported. However, there is a lack of randomized clinical trials that
      directly investigate the effect of TRE at different times of the day (early vs. delayed) in
      individuals with overweight and obesity. The present study investigates the effects of 8
      weeks of TRE performed at different moments of the day on body composition and
      cardiometabolic parameters in adults with overweight and obesity.
    


Intervention name(s): Dietary Approach
Intervention type(s): Behavioral
Intervention description(s): Dietary approaches with energy restriction performed at different times of the day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Assessment of Dermatologic Family Impact Scale in the Parents of Children With Psoriasis
Condition: Psoriasis; Quality of Life
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      The Dermatological Diseases Family Impact Scale (DeFIS) was developed to assess different
      aspects of health-related quality of life in the relatives of the patients with various skin
      diseases. The preliminary validation of this instrument was performed for the Turkish
      population. In the pilot study, this 15-item-questionnaire was shown to be easy to complete
      and score, and reliably help to evaluate the family members' quality of life.

      Psoriasis is a chronic disease which can be expected to have a significant impact on the
      quality of life of the patients and parents/family members alike. In line with this
      assumption, previous studies demonstrated that psoriasis psychosocially affects not only the
      patients, but also their close relatives. The psoriasis family index has been developed in an
      effort to objectively measure the health-related quality of life of the family members of
      patients with psoriasis. Nevertheless, data regarding the health-related quality of life of
      the parents of pediatric patients with psoriasis in the Turkish population are relatively
      scarce.

      In study, the investigators primarily aim to utilize DeFIS to assess the impact of childhood
      psoriasis on the quality of life of the patients' parents. Further, the investigators attempt
      to investigate the relation between the quality of life of the patients and their parents,
      and reveal disease characteristics which might influence the quality of life.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients clinically (andif necessary histopathologically) diagnosed with psoriasis < 18
        years of age
Evaluation of a New Self-Assessed, Home-Based Symptom Score Test in Cat Allergic Patients
Condition: Cat Allergy
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of this study is to better standardize the symptom recording of cat allergic
      persons under real-life conditions. A new self-assessed, home-based symptom score will be
      tested.
    

Detailed description: 
      In order to bring research on cat dander allergy a step further we aim to investigate cat
      dander allergy symptoms and record them in a natural environment, respectively, i.e. at the
      participant's home. For this purpose we aim to test a new self-assessed, homebased symptom
      score (called HypoScore). The participants will perform 8 provocation tests. Every
      provocation test consists of petting the cat until the participants become symptomatic. The
      participants have to pet the cat everytime in the same manner. Directly before and after the
      provocation test the symptoms will be recorded in the eCRF by using an iPad mini.
    

Intervention name(s): Provocation test
Intervention type(s): Other
Intervention description(s): The participants will perform 8 provocation tests. Every provocation test consists of petting the cat until the participants become symptomatic. The symptoms of cat allergic participants with the cat owner's cat will be recorded before and after petting the cat.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: cat allergy; symptom score
Intranasal PH94B for Management of the Symptoms of Generalized Social Phobia
Condition: Social Phobia; Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobic Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of PH94B, a new class of therapeutic
      compound, administered intranasally for the management of acute anxiety in patients diagnosed
      with generalized social phobia.
    

Detailed description: 
      The essential features of generalized social phobia are defined by the Diagnostic and
      Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), criteria as a marked and
      persistent fear of most (generally accepted as four or more) social or performance situations
      in which the patient believes embarrassment could occur as a consequence of exposure to
      unfamiliar people and/or possible scrutiny by others. The anxiety resulting from the social
      or performance situation is profound. The avoidance, fear, or anxious anticipation of these
      situations interferes significantly with the person's daily routine, having a marked impact
      on occupational functioning and/or social life. The disorder has a lifetime prevalence
      estimated at up to 13%, with onset typically in the mid-teens, and it is diagnosed slightly
      more frequently in females than in males. Social phobia tends to be a chronic disorder with
      periods of exacerbation, with a reported mean duration of illness of approximately 20 years.

      There are two subtypes of social phobia: (i) generalized (discrete), which is suffered by
      approximately 50% of social phobia patients and in which fear and avoidance extend to a wide
      range of social situations, and (ii) non-generalized, in which the patient fears only one or
      a few circumscribed situations. Speaking in front of large groups is by far the most
      prevalent of social fears (Lang and Stein, 2001).

      Social phobia has a lifetime comorbidity rate of approximately 81% with other psychiatric
      disorders (particularly affective disorders, other anxiety disorders, and substance abuse
      disorders), as well as to being associated with increased nonpsychiatric medical
      difficulties. People with social phobia identify social impairment, inadequate social
      support, overall role impairment, specific impairment in education, work, and other
      activities, as well as interference in their efforts at self-improvement. Unfortunately, for
      these patients, there is a strong consensus that social phobia is one of the least commonly
      recognized and treated mental disorders
    

Intervention name(s): PH94B intranasal spray
Intervention type(s): Drug
Intervention description(s): Comparison of PH94B single dose intranasal spray and Placebo single dose intranasal spray
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Generalized Social Phobia; Social Anxiety Disorder; Social Phobia; Phobic Disorders; Phobias