bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety and Effectiveness Assessments of Restylane-Defyne for Punctual Occlusion
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      A study which participants with mild to moderate dry eye disease will have a punctum of one
      eye injected with 0.1ml Restylane Defyne and the other eye injected with 0.2ml Restylane
      Defyne. Participants will be evaluated over four visits.
    


Intervention name(s): Restylane Defyne
Intervention type(s): Device
Intervention description(s): Restylane is a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Dry Eye Disease; Restylane-Defyne
Tolerability, Safety and Immunogenicity Trial of the Flu-M Quadro, Tetravalent Inactivated Split Influenza Vaccine
Condition: Influenza; Influenza, Human; Influenza Viral Infections; Vaccine Reaction; Vaccination; Infection
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Virus Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The goal of this clinical trial is to assess tolerability, safety and immunogenicity of the
      Flu-M Quadro vaccine as compared to the Ultrix® Quadri vaccine in volunteers aged between 18
      and 60.

      Participants were given Flu-M Quadro [inactivated split influenza vaccine] with preservative
      or Flu-M Quadro [inactivated split influenza vaccine] without preservative or Ultrix® Quadri
      vaccine.The volunteers of each group were vaccinated with a single dose vaccine.

      Researchers assessed the tolerability, safety and immunogenicity of the Flu-M Quadro
      quadrivalent inactivated split influenza vaccine.

      Researchers performed a comparative assessment of the tolerability, safety, and
      immunogenicity of the Flu-M Quadro quadrivalent inactivated split influenza vaccine and the
      Ultrix® Quadri vaccine.
    


Intervention name(s): Influenza vaccine [inactivated]; Influenza vaccine [inactivated]; Influenza vaccine [inactivated]
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Solution for intramuscular injection, 0.5 ml (1 dose) Vaccination with a single dose vaccine; Solution for intramuscular injection, 0.5 ml (1 dose) Vaccination with a single dose vaccine; Solution for intramuscular injection, 0.5 ml (1 dose) Vaccination with a single dose vaccine
Other intervention name(s): Flu-M Quadro (with a preservative); Flu-M Quadro (without preservative); Ultrix® Quadri
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza; Flu; Vaccine; Vaccination; SPbSRIVS; Flu-M Tetra; Flu-M Quadro; Quadrivalent; Inactivated; Split
Self Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Pain in Older Adults With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to determine the feasibility and preliminary efficacy of a
      two-week self tDCS and mindfulness-based meditation for pain in older adults with knee
      osteoarthritis (OA).
    


Intervention name(s): Self Transcranial Direct Current Stimulation (tDCS); mindfulness-based meditation; Sham Self Transcranial Direct Current Stimulation (tDCS); sham meditation
Intervention type(s): Device; Behavioral; Device; Behavioral
Intervention description(s): tDCS with a constant current intensity of 2 milliamps (mA) will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.; The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.; For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.; For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Denosumab vs Zoledronate After Vertebroplasty
Condition: Denosumab Allergy; Zoledronic Acid Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      Osteoporotic vertebral compression fracture (OVCF) patients had a proportion of secondary
      fractures after percutaneous vertebroplasty (PVP). Denosumab and zoledronate acid is both
      effective to prevent bone loss for OVCF postmenopausal women. However, trial evidence
      comparing effect of denosumab vs zoledronate after PVP was unknown. The study aims to assess
      the efficiency of denosumab vs zoledronate for OVCF patients bone mineral density (BMD), bone
      turnover markers (BTMs), secondary fracture and adverse events after PVP.
    

Detailed description: 
      Whether denosumab was non-inferior than zoledronate in improving bone mineral density (BMD),
      bone turnover markers (BTMs), functional status questionnaires, and secondary fracture in
      elderly patients with OVCF after PVP remains unknown. A prospective, randomized,
      placebo-controlled clinical trial in OVCF patients with PVP was performed. This study aimed
      to investigate the efficiency of denosumab vs zoledronate on BMD, BTMs, functional status,
      secondary fracture rate, and adverse events in OVCF patients after PVP during a 12-month
      follow-up period.
    

Intervention name(s): Denosumab Injection; Zoledronate
Intervention type(s): Drug; Drug
Intervention description(s): 1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months (Q6M); Intravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months
Other intervention name(s): Denosumab 6 month/subcutaneous; Zoledronic acid intravenous once a year
Intervention MeSH terms: Zoledronic Acid; Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System
Condition: Degenerative Joint Disease
MeSH terms: Joint Diseases; Osteoarthritis
Study type: Observational

Summary: 
      The objective of this study is to determine the long-term safety and effectiveness from the
      R3 Acetabular Hip System. The study hypothesis is that implant survivorship of the R3 cup is
      at least 97% at 3 years, 95% at 5 years, 93% at 7 years, and 90% at 10 years follow-up.
    

Detailed description: 
      This is a multicenter prospective observational post-market clinical follow-up study that
      will include 500 patients who will have total hip replacement with the R3 Acetabular System
      and either cemented or cementless hip stem.

      Effectiveness will be assessed by comparison of changes in parameters contained in the HOOS
      questionnaire and based upon incidence of revision and change in Harris Hip Score and UCLA
      Rating. Safety will be measured by assessing all adverse events experienced by patients from
      study enrolment through to study completion.
    

Intervention name(s): Total Hip Arthroplasty
Intervention type(s): Device
Intervention description(s): Total hip arthroplasty with the R3 Acetabular Hip system.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This clinical study can fulfill its objectives only if appropriate subjects are enrolled.
        All relevant medical and non-medical conditions should be taken into consideration when
        deciding whether a particular patient is suitable. Subjects will be enrolled consecutively.
      
Keywords: Degenerative joint disease; Total Hip Arthroplasty
Safety Study of VM202 to Treat Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the safety and tolerability of intramuscular
      injections of VM202 at different injection sites in people with amyotrophic lateral
      sclerosis.
    

Detailed description: 
      A phase I/II, open label, single center study designed to assess the safety and tolerability
      of intramuscular injections of VM202 inpatients with ALS. Study enrollment will be staged.
      Enrollment will be halted after the sixth subject qualifies for treatment. A Data Safety
      Monitoring Board (DSMB) will conduct a safety evaluation after the first patient treated
      completes the Day 60 follow-up evaluation and the five other sequentially enrolled subjects
      complete at least the Day 30 follow-up. Enrollment will be suspended until a formal
      recommendation to proceed (or not proceed) is made by the DSMB.

      Patients aged ≥ 21 years, but ≤ 75 years diagnosed with clinically definite, clinically
      probable, or clinically probable-laboratory supported Amyotrophic Lateral Sclerosis (ALS).

      This study is not powered to detect differences in efficacy measures. However, descriptive
      statistics (N, mean, median, SD, minimum and maximum values, where applicable) of clinically
      meaningful endpoints will be tabulated
    

Intervention name(s): VM202
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ALS; Lou Gehrig's disease; neurodegenerative disease
Efficacy and Safety of Coumarin and Troxerutin in the Symptomatic Treatment of Chronic Venous Insufficiency
Condition: Chronic Venous Insufficiency
MeSH terms: Venous Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of the fixed-dose
      combination of coumarin and troxerutin versus placebo in the symptomatic treatment of chronic
      venous insufficiency.
    

Detailed description: 
      The drug being tested in this study is the fixed-dose combination of coumarin and troxerutin
      called Venalot®. Venalot is being tested to treat the symptoms of chronic venous
      insufficiency. This study will look at symptom relief in people who take Venalot®.

      The study will enroll approximately 808 patients. Participants will be randomly assigned (by
      chance, like flipping a coin) to one of the two treatment groups-which will remain
      undisclosed to the patient and study doctor during the study (unless there is an urgent
      medical need):

        -  Combination coumarin + troxerutin extended release tablets

        -  Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has
           no active ingredient.

      All participants will be asked to take two tablets three times a day throughout the study.

      This multi-centre trial will be conducted in Brazil. The overall time to participate in this
      study is up to 18 weeks. Participants will make 6 visits to the clinic.
    

Intervention name(s): Coumarin/troxerutin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Coumarin + troxerutin fixed-dose combination tablets; Coumarin + troxerutin placebo-matching tablets
Other intervention name(s): Venalot®
Intervention MeSH terms: Troxerutin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Prospective randomized study. Compare two techniques for high tibial osteotomy (HTO) for
      treatment of medial knee osteoarthritis.

      Opening wedge osteotomy using Puddu plate vs Closing wedge osteotomy using cramp fixation. We
      will compare functional results and patient satisfaction with repetitive evaluations from
      preoperatively to 2 years postoperatively.
    

Detailed description: 
      Determination of the time course of patient-relevant functional outcome and the time course
      of Range of Motion (ROM) following HTO. Comparison of the Opening wedge and Closing wedge
      methods.

      Time-dependent improvement in functional outcome following High tibial Osteotomy. Medial
      opening wedge vs Lateral closing wedge. A two-year prospective randomized study involving 70
      patients.

      In a prospective randomized study, we plan to include 70 patients aged 30-60 years operated
      with valgus high tibial osteotomy. 2 groups: 35 opening wedge, and 35 closing wedge
      osteotomies. Data are collected by independent investigators (physiotherapists)
      preoperatively and at 3 months, 6 months, 1 year, and 2 years postoperatively. Knee injury
      and Osteoarthritis Outcome Score (KOOS) and ROM are determined at all follow-ups.
    

Intervention name(s): High tibial osteotomy
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: osteoarthritis; osteotomy; closing; opening; wedge; kne; tibia
Use of a Novel Neuroplasticity-based Neurobehavioral Intervention for PTSD
Condition: Anxiety; Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The present study will explore the effectiveness of a computer based neurobehavioral
      intervention in alleviating symptoms and improving emotion regulation in individuals with
      PTSD. It will increase understanding of psychopathology at a neural-circuit level and aid
      development of new non-pharmacological treatment for PTSD. The study is managed by the Etkin
      Lab at Stanford University in California, but participants from the entire US are welcome to
      participate as the study is delivered online.
    


Intervention name(s): Computerized Neurobehavioral Intervention
Intervention type(s): Behavioral
Intervention description(s): Targeted, computerized interventions completed from the participants' own home on a computer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Computerized neurobehavioral intervention
Exenatide and Impaired Hypoglycaemic Awareness in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1; Hypoglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Approximately 25% of patients with type 1 diabetes have lost the capacity to timely detect
      hypoglycaemia, a condition referred to as impaired hypoglycaemic awareness (IHA) that causes
      a six-fold higher risk of severe, potentially hazardous, hypoglycaemia. IHA is usually the
      end-result of a process of habituation to recurrent hypoglycemia that is potentially
      reversible. Treatment with glucagon-like peptide (GLP)-1 Receptor Agonists (1RAs) in addition
      to insulin therapy may decrease the incidence of hypoglycaemia in patients with type 1
      diabetes. This study will test the hypothesis that treatment with the GLP-1RA, exenatide,
      added to basal-bolus insulin therapy will improve awareness of hypoglycaemia in patients with
      type 1 diabetes and IHA. In a randomized doubleblind placebo-controlled cross-over trial,
      patients will be treated for 6 weeks with exenatide (or placebo), after which hypoglycemic
      symptoms and counterregulatory hormone responses will be examined during a hyperinsulinemic
      hypoglycemic glucose clamp study.
    


Intervention name(s): Exenatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 6 weeks treatment with exenatide on top of insulin treatment; 6 weeks treatment with placebo on top of insulin treatment
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucagon-Like Peptide 1; Impaired hypoglycemic awareness
A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if an otic formulation is safe and effective in
      treating peri-operative tube otorrhea.
    


Intervention name(s): Moxidex otic solution; Moxifloxacin otic solution; Tympanostomy tubes
Intervention type(s): Drug; Drug; Device
Intervention description(s): 4 drops into the infected ear(s) twice daily (morning and evening) for 7 days; 4 drops into the infected ear(s) twice daily (morning and evening) for 7 days; Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Intervention MeSH terms: Moxifloxacin; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ear tubes; ear infection; ear drops; ear tube surgery; acute otitis media
The Influence of Non-Caloric Artificial Sweeteners on Youth With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The investigators aim to further the understanding of environmental factors that may underlie
      variations in body composition seen in youth with Type 1 diabetes (T1D). Non-caloric
      artificial sweeteners, broadly consumed in many individuals with T1D, are a modifiable
      dietary factor that may be associated with negative health outcomes, particularly those
      relevant to the future risk of diabetes-related complications.

      Investigators will measure body composition (the amount of fat and muscle in the body and
      where the fat is stored) using a bioelectrical impedance analysis machine and DEXA scanner.
      Blood will be drawn for the following labs: HbA1c, lipid panel, comprehensive metabolic panel
      and leptin. Participants will also answer questions about their diets and consumption of
      artificial sweeteners.
    


Intervention name(s): Bioelectrical Impedance Analysis; Total Body Dual-energy X-ray Absorptiometry; Blood draw
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): BIA is a radiation-free and clinically accessible measure of body composition [47, 49]. An electrode is placed on the youth's extremities and they are asked to sit for 10 minutes. The youth's height and weight is manually inputted and the measure is obtained (approx. 90 seconds to complete). BIA sends a low level of electrical current through the body and measures the impedance to the current based on fat, muscle, bones providing a measure of body composition.; The DXA total body scan provides measurements of percent body fat, lean and fat free mass throughout the body. Youth lay on a table while the machine moves around them. The process takes about 3 minutes and 20 seconds.; Blood will be drawn to assess the following labs: HbA1c, leptin, lipid panel and comprehensive metabolic panel.
Other intervention name(s): BIA; DXA
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Youth receiving care at the Children's Hospital of Wisconsin Diabetes Clinic.
      
Biospecimen description: 
      Blood plasma will be used for metabolomic analyses. Samples will be stored and used until
      none is left.
TMS Augmented Exposure Therapy
Condition: Phobia
Study type: Interventional

Summary: 
      This study investigates the beneficial effects of prefrontal brain stimulation (with a
      facilitating TMS protocol) before exposure therapy in acrophobic patients. The two exposure
      sessions were realized in virtual reality. Before and after therapy, the phobic symptoms were
      measured on a subjective, behavioral and physiological level. The placebo-controlled single
      blinded study includes 50 phobic patients, which were randomized into verum or sham TMS.
    


Intervention name(s): Experimental: Verum TMS; Experimental: Sham TMS
Intervention type(s): Device; Device
Intervention description(s): Intensity of 100 % of the resting motor threshold with 10 Hz and intertrial interval (ITI) of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.; Sham stimulation with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: TMS; virtual reality (VR); Exposure therapy; TMS augmentations of exposure therapy
Inducing Children's Emotional Eating
Condition: Emotional Eating Behaviour
Study type: Observational

Summary: 
      Background: Children's emotional eating is related to greater BMI and less healthy diet but
      little is known about the early development of this behavior.

      Objective: This study aimed to examine the relationships between preschool children's
      emotional eating and parental feeding practices using experimental manipulation of child mood
      and food intake in a laboratory setting.

      Design: 25 3-5 year old children and their mothers sat together and ate a standard meal to
      satiety. Mothers completed questionnaires about their feeding practices. Children were
      assigned to a control or negative mood condition. Children's consumption of snack foods in
      the absence of hunger was measured.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        healthy 3-5 year old children in the UK (within approx. radius of 10 miles of Loughborough
        University).
      
Keywords: Emotional eating; Eating in the absence of hunger; emotion induction
Uterine Microbiome in Women With Repeated Implantation Failure and Normal Fertile Women
Condition: Repeated Implantation Failure; Normal Fertile
Study type: Observational

Summary: 
      Characterization of the uterine microbiome in women with repeated implantation failure as
      well as in normal fertile women.
    

Detailed description: 
      In the midluteal phase of the cycle, a vaginal swab and endometrial biopsy will be obtained.
    

Intervention name(s): Vaginal swab + endometrial biopsy
Intervention type(s): Other
Intervention description(s): In the midluteal phase of the cycle, a vaginal swab (E swab) and endometrial biopsy (TAO brush) will be obtained.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  For RIF women: absence of pregnancy after transfer of in total 5 embryos of high
             quality embryos

          -  For NF women: live birth after spontaneous conception or IUI (max 9x)
      
Biospecimen description: 
      Microbiome analysis using 16S ribosomal RNA sequencing