bioihbjkbjnl/mcl2 huggingface dataset:
Facet Versus Trigger Point Injections for Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      A) Background Chronic neck pain is a significant and common issue which is difficult to
      treat. Tight bands of muscle (trigger points) can be a source of chronic neck pain and they
      are sometimes injected to manage chronic neck pain. However, these injections seldom lead to
      significant, long-lasting relief. In some cases, these trigger points may originate from
      injury or damage to a specific joint in the neck (the facet joint). Treatment of this joint
      with cortisone injection may lead to improved pain relief and function.

      B) Hypothesis By injecting the facet joint with cortisone, the pain associated with tight
      bands of muscle in the neck and shoulders will be relieved to a greater extent than that
      attained through trigger point injection.

      C) Methods Patients with neck pain will have a test to determine if any pain originates from
      the facet joint. Among those who have significant pain from these joints, a comparison
      between the effect of cortisone injection into these joints versus injection into the trigger
      points will be evaluated.

      D) Expected Results and Significance

      It is expected that injection with cortisone into the facet joints will lead to improved pain
      and function when compared to that attained from trigger point injection. In addition, the
      number of trigger points, and the pain and headache that originate from these trigger points,
      are expected to decrease with cortisone injection into the facets to a statistically and
      clinically significant extent. Results from this pilot study will then influence the design
      of future trials into chronic neck pain treatment, leading to better clinical
      recommendations. A peer-reviewed publication and conference presentations will facilitate
      dissemination.
    


Intervention name(s): Betamethasone; Dexamethasone; Intramuscular Lidocaine; Home Exercise
Intervention type(s): Procedure; Procedure; Procedure; Behavioral
Intervention description(s): 6 mg/mL injected into the facet joint as dictated by modified dual-comparative medial branch block diagnostic protocol; 4mg/mL; 2%; Standardized home exercise program
Other intervention name(s): Betaject/Celestone
Intervention MeSH terms: Dexamethasone; Betamethasone; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neck; chronic pain; facet injection
Evaluation of a Probiotic (Bifidobacterium in the Treatment of Infantile Colic (IC)
Condition: Infantile Colic
MeSH terms: Colic
Study type: Interventional

Summary: 
      Infantile colic (IC) criteria includes all of the following in subjects aged ≤ 4 months:
      paroxysms of irritability, fussing, or crying that start and stop without obvious cause;
      episodes lasting 3 or more hours per day and occurring at least 3 days per week for at least
      1 week; and no failure to thrive. The condition is very common in the first 4 months of life
      (10-30 % of infants) with a peak prevalence at 6-8 weeks and is characterized by excessive
      and inconsolable crying without an identifiable cause. Infantile colic cause considerable
      stress for the baby and the family, huge medical expenses (the IC cause 10-20 % of all
      pediatric visits in the first 4 months of life) and frequent formula changes.

      The pathophysiology of IC is still poorly defined, but differences in gut microbiota
      composition seem to be involved. In particular, differences in the number and species of
      Lactobacilli spp, Klebsiella spp and Escherichia coli spp have been demonstrated in subjects
      with IC, and it has been postulated that these alterations could be responsible for an
      abnormal gas production within gut lumen resulting in distension and abdominal pain. These
      findings suggest the potential role of probiotics as preventive and therapeutic strategy for
      the IC.
    


Intervention name(s): probiotic (BIfidobacterium, BB-12®); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): probiotic (Bifidobacterium, BB-12®); Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of the Brochure on Testicular Self-Exam
Condition: Testicular Cancer
MeSH terms: Testicular Neoplasms
Study type: Interventional

Summary: 
      This study aims to examine the effect of the educational brochure given to university
      students on testicular cancer and its early diagnosis on their health beliefs and
      self-examination; In non-randomized groups, pretest-posttest was conducted in a
      quasi-experimental design with control group. The research was carried out with students
      studying in the psychological counseling and guidance department of a state university in
      Turkey. The study group consisted of 92 students, 48 of which were experimental and 44 were
      control. Only the experimental group was given an educational brochure about testicular
      cancer and testicular self-examination. Data; Personal information form, testicular cancer
      and health beliefs scale about testicular self-examination were collected with the form for
      self-examination. In the evaluation of the data; Mann Whitney U, Wilcoxon and chi-square
      analyzes were performed.
    


Intervention name(s): Education brochure
Intervention type(s): Other
Intervention description(s): In the content of the brochure about testicular cancer and CCTM prepared in line with the literature; It includes information such as the definition of testicular cancer, testicular cancer risk factors and symptoms, the importance of early diagnosis in testicular cancer, how CCTM is performed, and what to do in case of differences after the examination. Expert opinion was obtained from three faculty members (a professor from the Department of Urology, a professor in Public Health Nursing and a physician faculty member) regarding the content validity of the educational brochure created before the research.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: testicular cancer; screening; university student
Identification of Cardiovascular Risk Factors Linked to Renal Failure Progression
Condition: Chronic Renal Failure
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      The aim of this study is to appreciate the influence of renal failure progression on
      vasculopathy (coronary calcifications and left ventricular hypertrophy) and cardiovascular
      risk factors.
    

Detailed description: 
      The aim of this study is to appreciate the relationship between:

        -  extension of coronary calcifications and chronic renal failure progression

        -  extension of coronary calcifications and levels of osteoprotegerin (bone disease marker)

        -  cardiovascular risk factors and coronary calcifications

        -  cardiovascular risk factors and existence of cardiovascular diseases
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic
      
Biospecimen description: 
      whole blood white cells serum plasma urine
    
Keywords: Chronic renal failure; Vasculopathy; Cardiovascular risk; Chronic renal failure patients
Dietary Supplement on Symptom Awareness and Heart Rhythm in Patients With Cardiac Arrhythmia
Condition: Cardiac Arrhythmia
MeSH terms: Arrhythmias, Cardiac
Study type: Interventional
Phase: Phase 3

Summary: 
      The main aim of this study, which was carried out in two parallel groups, is testing the
      efficacy of a specific micronutrients combination in adults with heart rhythm disturbances
      and accompanying symptoms.

      It is therefore the investigators hypothesis that daily oral administration of the specific
      micronutrients combination will lead to a decrease of symptoms awareness and to a reduction
      of heart rhythm disturbances in adults with or without structural heart disease. The
      principal endpoints will be a decrease in the total score of symptoms awareness.
    


Intervention name(s): MNC-01; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks; twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: heart rhythm disturbances and symptoms; dietary supplement
Apioc Contact Lens Feasibility
Condition: Ametropia; Myopia; Hyperopia; Astigmatism; Presbyopia
MeSH terms: Astigmatism; Presbyopia; Hyperopia; Refractive Errors
Study type: Interventional

Summary: 
      This clinical trial will document the feasibility of the Apioc lens design by assessing which
      lens shape parameters yield successful on-eye-fit and movement of the Apioc contact lens
      design and evaluate the subjectively-reported comfort of the Apioc contact lens design.
    

Detailed description: 
      This is a one-site, non-dispensing clinical trial using the Apioc contact lens design. This
      soft contact lens study will determine the feasibility of this design by determining which
      parameters of the shape of the Apioc Contact Lens design will yield a successful fit across
      subjects. We will also determine the percentage of subjects who can be successfully fitted
      with the Apioc Contact Lens Design. Because the feasibility of the lens design may be
      dependent upon age, a total of 50 subjects (10 subjects each across 5 decades of life) will
      complete the study. The data will be collected in a single visit for most subjects. A few
      subjects may be asked to return for a second visit if additional contact lens parameters need
      to be ordered to achieve a successful fit. The key assessments for this study will be
      demonstration of feasibility of fit, documentation of movement in all gazes, including
      translation, and subjective reports of comfort. Subjects will only wear contact lenses while
      in the office.
    

Intervention name(s): Apioc Contact Lens Design
Intervention type(s): Device
Intervention description(s): Novel soft contact lens design.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: contact lens; soft contact lens; feasibility
Trial to Evaluate the Effectiveness of a Digital Therapeutics in Adults Diagnosed With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This study compares the effectiveness of 2 digital therapeutics in adult subjects diagnosed
      with MDD who are on antidepressant therapy (ADT) monotherapy for the treatment of depression.
    

Detailed description: 
      This is a phase 3, 13-week, multi-center, randomized, controlled trial to evaluate the
      effectiveness and safety of two digital therapeutics in adult subjects diagnosed with MDD who
      are on antidepressant therapy (ADT) monotherapy for the treatment of depression.

      The trial consists of a 3-week screening period, a 6-week treatment period, and a 4-week
      extension period. Trial visits will be conducted remotely either by video visit or telephone.
      The screening visit may be performed in person at the discretion of the investigator.
      Eligible subjects will be randomized to 1 of 2 digital therapeutics within a mobile
      application that will reside on the subject's personal iPhone or smartphone.

      The trial population will include male and female subjects between 22 and 64 years of age
      with a primary diagnosis of major depressive disorder (MDD) who are on an ADT for the
      treatment of depression. This trial will analyze data gathered from approximately 360
      subjects in the United States. An interim analysis will be conducted when a targeted sample
      of the first 180 subjects has completed week 6 or discontinued the trial prior to week 6.
    

Intervention name(s): MIRAI Depression Study Digital Therapetic
Intervention type(s): Device
Intervention description(s): Two different versions of the MIRAI Depression Study digital therapeutics will be compared.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001
Condition: Chronic Kidney Disease (CKD)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The primary objective of this clinical study is to evaluate the preliminary safety and
      effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF)
      in patients requiring chronic hemodialysis.
    


Intervention name(s): Endovascular AVF (EndoAVF)
Intervention type(s): Device
Intervention description(s): The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access.
Other intervention name(s): FLEX
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic kidney disease; Arteriovenous fistula (AVF); Hemodialysis; Vascular access; Endovascular AVF (EndoAVF)
The Effect of Mother and Father Kangaroo Care on Newborn and Parent Outcomes in Premature Infants
Condition: Kangaroo Care
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      First aim is to determine the effect of mother and father kangaroo care on the premature
      baby's Comfort Behavior level and physiological parameters (respiratory rate, heart rate,
      oxygen saturation and body temperature). Second aim is to determine the effect of mother and
      father kangaroo care on Parental Satisfaction and Neonatal Intensive Care Parental Stress
      level.

      The study was a a randomized crossover study with pretest-posttest design. It was carried out
      in the neonatal intensive care unit of Selçuk University Faculty of Medicine Hospital in
      Konya province. Study data were collected from 19 mother and 19 father and their premature
      newborns between February 2023 and August 2023.
    

Detailed description: 
      In the study, the mother applied kangaroo care to her premature baby for 65 minutes, and
      after a 24-72 hour washout period, the father applied kangaroo care for 65 minutes. The order
      of mother and father application was determined randomly.

      Data were collected using Physiological Parameters Form, Neonatal Comfort Behavior Scale,
      Parental Satisfaction Scale and Neonatal Intensive Care Unit Parental Stress Scale.

      In the study, physiological parameters and Neonatal Comfort Behavior Scale scores of
      premature infants and Neonatal Intensive Care Unit Parental Stress Scale and Parental
      Satisfaction Scale scores of parents were evaluated. Pearson Chi-Square Test, Yates
      Correction and Fisher's Exact Test were used to compare categorical data according to groups.
      Two Independent Sample t Test was used to compare normally distributed variables and Mann
      Whitney U Test was used to compare non-normally distributed variables. Statistical
      significance level was accepted as p˂0.05.
    

Intervention name(s): kangaroo care application
Intervention type(s): Other
Intervention description(s): In the study, the mother applied kangaroo care to her premature baby for 65 minutes, and after a 24-72 hour washout period, the father applied kangaroo care for 65 minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Mother Kangaroo Care; Father Kangaroo Care; Cross Over Study
Functional Dyspepsia (FD) - Clinical Response to Montelukast in Children
Condition: Eosinophilia; Dyspepsia
MeSH terms: Eosinophilia; Dyspepsia
Study type: Observational

Summary: 
      Duodenal eosinophilia has been associated with dyspepsia in adults and the investigators have
      previously described the finding of duodenal mucosal eosinophilia in 71-79% of children
      undergoing diagnostic endoscopy. Previous studies in children have shown positive response to
      montelukast with approximately 50% finding complete relief and 20-30 percent showing no
      response.

      There are a number of factors that have the potential to contribute to the observed
      variability in response to montelukast. These include variability in:

        1. systemic drug exposure (drug absorption, biotransformation and/or elimination)

        2. regulation of leukotriene biosynthesis

        3. cysteinyl leukotriene receptors and downstream mediators

        4. patient disease phenotype (e.g. Functional Gastrointestinal Disorder (FGID) disease
           classification, psychologic profile)

      In this study, the investigators propose to utilize biopsy specimens stratified by drug
      response to identify candidate gene expression modules that will be validated in a
      prospective study design. The overall goal of this program is to develop a signature of
      montelukast response that can be applied not only to eosinophilic gastroenteritis, but more
      generally to other diseases, such as asthma, where the drug is widely used with variable
      success.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Up to 50 subjects (allowance of 20 additional subjects for screen fails and those who will
        not complete Phase 3 of the study) will be recruited from a cohort of patients referred to
        the Abdominal Pain Clinic at Children's Mercy Hospitals and Clinics and enrolled prior to
        routine initial endoscopy.
      
Biospecimen description: 
      Samples retained, with potential for extraction of DNA from at least one of the types of
      samples retained.
    
Keywords: Duodenal Eosinophilia; Functional Dyspepsia; Mucosal Eosinophilia
Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will
      receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive
      substance) in addition to an FDA approved antidepressant in order to determine if the study
      medication is effective as an add on treatment of MDD.
    


Intervention name(s): OPC-34712; Placebo; ADT
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 1 - 3 mg OPC-34712; Placebo
Other intervention name(s): FDA Approved Antidepressant (ADT)
Intervention MeSH terms: Antidepressive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: OPC-34712; Major Depressive Disorder; Adjunctive Treatment
Safety and Efficacy of AGN 210669 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma
Condition: Ocular Hypertension; Glaucoma
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in
      comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each
      morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will
      be followed for 2 weeks.
    


Intervention name(s): AGN-210669 ophthalmic solution, 0.075%; AGN-210669 ophthalmic solution, 0.05%; AGN-210669 ophthalmic solution, 0.025%; bimatoprost ophthalmic solution 0.03%; AGN-210669 vehicle ophthalmic solution
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.; AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.; AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.; Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.; AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
Other intervention name(s): Lumigan®
Intervention MeSH terms: Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results Stratified
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      Antimicrobial resistance is a significant challenge facing global healthcare. The unnecessary
      use of antibiotics is a key driver in the development of antibiotic resistance. Cystic
      Fibrosis (CF) represents a unique disease model to study bacterial resistance and to explore
      therapeutic strategies for same, as chronic lung infection overlaps with acute lung
      exacerbation's caused by a multitude of organisms. With time, chronic polymicrobial infection
      develops, with the most dominant infecting organism being Pseudomonas aeruginosa. In acute CF
      infections, empiric intravenous antibiotics are usually given for two weeks. Recurrent
      infections and treatments result in increasing antimicrobial resistance, and alterations in
      pathogen host interactions in the lung and gut flora. Next-generation DNA sequencing
      technology now offers DNA-based personalised diagnostics and treatment strategies. Enhancing
      our knowledge of the microbiome allows the use of stratified targeted antibacterial therapy
      that can be compared with standard empirical antibacterial therapy currently used. Cystic
      Fibrosis Microbiome-determined Antimicrobial Therapy Trial in Exacerbations: Results
      Stratified (CFMATTERS) will provide a randomized multi-centre controlled trial of
      microbiome-derived antimicrobial treatments versus current empirical therapy.
    


Intervention name(s): Ceftazidime; Tobramycin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tobramycin; Ceftazidime
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Cystic Fibrosis; Microbiome; Stratified Antibacterial therapy; Resistance; Pathogen Host Interaction