bioihbjkbjnl/mcl2 huggingface dataset:
Molecular Biomarkers Associated With Degenerative Joint Disease in the Knee
Condition: Cartilage Diseases
MeSH terms: Joint Diseases; Osteoarthritis; Cartilage Diseases
Study type: Observational

Summary: 
      This investigation describes a novel complex of structural degradation proteins that is
      associated with pain in individuals with meniscal pathology undergoing arthroscopic partial
      meniscectomy. The presence of the complex in the synovial fluid of the knee is sensitive and
      specific for the painful state compared with similar aged controls. The absence of the
      complex in asymptomatic controls makes it a useful biomarker for the disease state.
    

Detailed description: 
      Background: Molecular biomarkers associated with knee pain may be useful as diagnostic tools,
      prognostic indicators, and surrogate endpoints for therapeutic trials. This study describes a
      novel complex of structural degradation proteins which are present in the knees of patients
      with meniscal pathology.

      Methods: This prospective cohort study included 30 patients with knee pain, mechanical
      symptoms, and MRI positive for meniscus tear who elected for arthroscopic partial
      meniscectomy after failing conservative management. Synovial fluid was aspirated at the time
      of surgery and assayed for a complex of structural degradation proteins by means of
      heterogeneous ELISA. The results were compared to knee aspirates from 10 asymptomatic
      volunteers with no pain. The complex was identified by a proteomic analysis of including
      multiplexed-bead immunoassay, purification by anion exchange and size exclusion
      chromatography, and mass spectrometry of individual chromatographic fractions.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The operative group consisted of patients 18 years of age or greater with a history of knee
        pain for more than three but less than six months who failed conservative management
        including NSAIDs, physical therapy, and activity modification.
      
Biospecimen description: 
      synovial fluid ananysis
    
Keywords: biomarker; knee arthroscopy; pain
A Single Intravenous Dose Study of E3112 in Japanese Healthy Adult Male Subjects
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The study (E3112/CP1) is a single-center, randomized, double-blind, placebo-controlled,
      single intravenous ascending dose study conducted in Japanese healthy adult males to evaluate
      the pharmacokinetics (PK), safety, and immunogenicity of E3112 following a single intravenous
      dose of E3112.
    


Intervention name(s): Placebo; E3112
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous infusion; Intravenous infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: E3112; Pharmacokinetics; Japanese
Study of Myopia Acquisition and Prevention
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      Purpose:

      To determine whether the use of reading glasses blocks the near work mediated increased
      incidence of myopia in healthy school children.

      Methods:

      SMART enrolled 115 emmetropic children (ages 7-9 years). The children were recruited in the
      Principality of Liechtenstein. They were randomly assigned to either the control group (n=52)
      or to receive reading glasses with a lens power of +2.0 dioptres (n=63). The primary outcome
      measure was progression towards myopia as determined by autorefraction after cycloplegia. The
      secondary outcome measure was change in biometry measurements of corneal curvature, axial
      length, anterior chamber depth, crystalline lens thickness, and vitreous chamber depth using
      partial coherence interferometry.
    


Intervention name(s): Wearing of reading glasses during prolonged near work
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Myopia; Prevention
The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: RCT
Condition: Chronic Kidney Disease; Periodontitis
MeSH terms: Periodontitis; Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Periodontal disease is a bacterially-induced inflammation. As such, it can become a point of
      entry of bacteria, toxins and cytokines into the systemic blood circulation, thus adversely
      affecting the function of kidneys. This is turn can aggravate the condition of patients with
      CKD.

      The study hypothesis is that periodontal therapy can improve renal function in patients with
      CKD and lower the blood levels of markers for systemic inflammation.
    


Intervention name(s): Full Mouth Non-Surgical Periodontal Therapy
Intervention type(s): Procedure
Intervention description(s): Non-surgical Periodontal Therapy provided in two sessions, one for the right half and one for the left half of the dentition. Treatment sessions are provided within one week. No antibiotics or other adjunctive medications are to be used
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: CKD, Renal, Chronic Kidney Disease, Periodontitis, Perio
The Clinical and Subjective Performance of Three Different MPDS With Silicon Hydrogel Lenses
Condition: Adverse Reaction to Contact Lens Solution
Study type: Interventional

Summary: 
      The purpose of the clinical investigation is to assess the clinical and subjective
      performance of three novel multipurpose disinfecting solutions (MPDS) in daily wear with two
      silicone hydrogel contact lenses (Lotrafilcon B and Comfilcon A).
    


Intervention name(s): Contact lens care solution
Intervention type(s): Device
Intervention description(s): Comparison of clinical and subjective performation of the contact lens care solutions used with two types of contact lenses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Contact lens; Care solution; MPDS; comfort
Effect of Antibiotics on Gut Microbiome and Plasma Metabolome
Condition: Microbial Colonization
MeSH terms: Communicable Diseases; Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      In recent years it has been observed that the gut microbiome can produce metabolites into
      systemic circulation and thus have important health effects even outside the gastrointestinal
      system. These metabolites may play a role in the pathogenesis of common public health
      problems such as diabetes, obesity and cardiovascular disorders. Modern techniques of mass
      spectrometry-based metabolomics from peripheral blood and gut metagenome sequencing now
      enable detailed examination of these processes. Using samples from the FINRISK 2002 cohort,
      collected by the National Institute for Health and Welfare, we are currently determining the
      gut microbiome and plasma metabolome from > 7000 participants with 15 years of follow-up for
      various health outcomes. This is one of the largest materials of its kind world-wide. The
      design does not, however, allow us to draw causal conclusions on the roles of gut bacteria in
      the composition of plasma metabolome. To enable conclusions which go beyond statistical
      associations, we now propose an extension to the FINRISK 2002 study, where we alter the gut
      bacteriome with a short course of antibiotics and then examine whether a change in plasma
      metabolomics profile will follow. At the same time the trial will give important novel
      information about the effects of commonly used antibiotics on gut bacteriome and on general
      health.
    


Intervention name(s): Amoxicillin; Azithromycin; Vancomycin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Amoxicillin (po) 500 mg x 3 per day for 3 days.; Azithromycin (po) 500 mg x 1 on day 1, 250 mg x 1 on day 2, and 250 mg x 1 on day 3.; Vancomycin (po) 125 mg x 4 per day for 3 days.
Intervention MeSH terms: Amoxicillin; Azithromycin; Vancomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: microbiota; metabolize
Erector Spinae Plane Block For Lumbar Disc Hernia Repair
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative; Hernia
Study type: Interventional

Summary: 
      Pain management after lomber disc hernia repair surgery is a challenging issue for
      anesthetists. Erector Spinae plane block is a novel analgesic technique which could be used
      for this purpose. Primary aim of this double blinded randomized controlled study is to
      compare the analgesic efficacy of this new block technique with control group in this group
      of patients.
    


Intervention name(s): Erector Spinae Plane block; Sham block; Bupivacaine Hydrochloride; PCA
Intervention type(s): Procedure; Procedure; Drug; Device
Intervention description(s): Erector Spinae plane block will be done according to hernia level using bupivacaine hydrochloride; Sham block will be done with serum physiologic.; 20 ml 0,25% Bupivacaine will be used for block performances; Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lomber disc hernia; Erector spinae plane block; Postoperative pain
Efficacy/Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) and SSG/PM Combination to Treat V Leishmaniasis
Condition: Visceral Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of SSG 30 days alone, PM 21
      days alone and SSG and PM as a combination course of 17 days in the treatment of patients
      with VL.
    

Detailed description: 
      Currently in the three countries, Sudan, Kenya and Ethiopia many of the patients present
      themselves in remote areas and need to be treated in relative resource poor settings. It is
      for this reason that standardised treatment with proven efficacy is much needed. A shorter
      course of treatment is not only advantageous for the patient but also reduces the overall
      case load in the clinics thus reducing the risk of disease outbreaks in already
      immuno-compromised kala-azar patients. Paromomycin, either alone or in combination with SSG
      would decrease the treatment duration substantially. An additional added value of combination
      therapy is that it is likely to reduce the chances of development of parasite resistance
      against the individual drugs.

      Leishmaniasis experts in the three countries are in agreement that there are potential
      benefits of the combination treatment of SSG and PM and that its efficacy should be evaluated
      with the view to introduce this protocol if proven efficacious and safe. There is ample
      circumstantial evidence of the use of this combination therapy and its efficacy and
      tolerability as a standardized protocol. This can only be confirmed through a randomised
      controlled study with 6 months follow up.
    

Intervention name(s): Sodium Stibogluconate; Paromomycin sulphate; SSG and Paromomycin sulphate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sodium Stibogluconate 20mg/kg/day for 30 days; Paromomycin sulphate; SSG and Paromomycin Sulphate 17 days
Intervention MeSH terms: Paromomycin; Antimony Sodium Gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Visceral Leishmaniasis; Combination
To Study The Influence Of Genomic Factors On Metabolism And Effects Of Clomiphene In Asian Normogonadotrophic Anovulatory Patients.
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female; Anovulation
Study type: Observational

Summary: 
      The purpose of this study is to match the genetic component and clinical attributes of
      anovulatory patients with response to clomiphene treatment.

      By improving our understanding on patient-specific clomiphene response will allow
      optimization of treatment, reduction of side-effects and shorten the time-to-pregnancy.
    

Detailed description: 
      Anovulation is the commonest cause for infertility, with clomiphene being the standard
      treatment. Pharmacogenetic causes of variability in the pharmacokinetics and pharmacodynamics
      of clomiphene is not well characterized in anovulatory Asian women. Although recent findings
      suggest that the pharmacokinetics and pharmacodynamics of clomiphene may be influenced by
      several polygenic pathways involving genes regulating its metabolism (CYP3A4, CYP3A5, CYP2B6,
      CYP2C8, CYP2C19, CYP2D6), thus contributing significantly to the wide variability in
      dose-response relationships observed in clinical practice. There has not been objective
      evidence thus far from an unbiased genome-wide perspective. It is likely that polymorphisms
      at the CYP cluster of genes encoding for their respective cytochrome proteins may not explain
      all of the variability with regards to clomiphene's dose-response relationship.

      The investigators hypothesize that the pharmacokinetics and pharmacodynamics of clomiphene is
      under strong control by genetic loci and that these genetic variants could also strongly
      determine the therapeutic outcome in Asian normogonadotrophic anovulatory patients. The
      contribution by candidate genes mentioned above will also be clarified in a definitive manner
      by this study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Asian Normogonadotrophic Anovulatory Women
      
Biospecimen description: 
      Plasma, serum and Genomic DNA.
    
Keywords: Anovulatory; Clomiphene
Airway Pressure During Nasal High Flow and CPAP in Neonates
Condition: Respiratory Insufficiency
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and
      often produce similar clinical outcomes. The aim of the study was to investigate airway
      pressure during NHF and CPAP in neonates.
    

Detailed description: 
      Methods: A physiological study which measured pressure intra-nasally with micro (750 µm)
      pressure probes (Millar, USA) in 10 (5M / 5F) healthy newborns with mean gestation age 37.18
      (SD 1.29) wk and mean birth weight of 2414 (SD 503.13) g. NHF was applied at 8 L/min (AIRVO
      2) through smaller (OPT 314) and larger (OPT 316) Optiflow nasal cannula; CPAP 5 cmH20 was
      produced by a Bubble CPAP system and nasal mask interface at constant flow 8 L/min (Fisher &
      Paykel Healthcare, NZ). Values are expressed in cmH20 as means and standard deviations (SD).
    

Intervention name(s): NHF small cannula; NHF big cannula; CPAP
Intervention type(s): Device; Device; Device
Intervention description(s): NHF 8 l/min by Airvo 2 by small cannula; NHF 8 l/min by Airvo 2 by large cannula; Nsal CPAP 5cm H2o by face mask
Other intervention name(s): Optiflow, HFNC; Optiflow, HFNC
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Nasal High Flow; CPAP; airway pressure; newborn
Evaluation of Pain in the Course of in Vitro Fertilization
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      25 to 50% of endometriotic patients are infertile and use medically assisted procreation. In
      general, the assessment of pain in medically assisted procreation is very little studied.
      Pain assessment studies in endometriotic patients remain limited to a quantitative assessment
      of pain symptomatology, without contextualization of painful manifestations. The primary
      objective of our study is the qualitative and contextualized assessment of pain during In
      Vitro Fertilization (IVF) protocol in endometriotic and non-endometriotic patients. The
      secondary objectives of our study are the quantitative study of pain, the measurement of the
      impact of personal efficiency on painful symptomatology, evaluation of depression, the
      results of IVF (implantation, pregnancy and live birth rates), and compare pain between
      endometriotic or non-endometriotic patients and between primary infertility and secondary
      infertility. According to the results obtained in this study, therapeutic strategies for the
      management of pain could be proposed, with the aim of improving the quality of life and the
      results of IVF in these patients.
    


Intervention name(s): Using different survey to evaluate pain
Intervention type(s): Other
Intervention description(s): Survey will be at different time of the IVF protocol (at the first medical appointment in the medically assisted department, after stimulation, after oocytes retrieval, after embryo transfer, one month after the IVF protocol)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients who start an IVF cycle in the medically assisted procreation department of the
        Jeanne de Flandre Hospital (CHRU Lille)
      
Keywords: Infertility; In Vitro Fertilization; Endometriosis; pain evaluation
Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Adenotonsillectomy Surgery
Condition: Preoperative Anxiety; Postoperative Delirium
MeSH terms: Delirium; Emergence Delirium; Anxiety Disorders
Study type: Observational

Summary: 
      The effects of preoperative anxiety and preemptive analgesia on PAED in children undergoing
      adenotonsillectomy surgery.
    

Detailed description: 
      It is known that the frequency of postoperative delirium increases in children with
      preoperative anxiety.

      The Modified Yale Preoperative Anxiety Inventory (m-YPAS) was developed as a tool to assess
      children's preoperative anxiety, and m-YPAS≥30 was considered 'anxious'.

      Post-Anesthesia Recovery Agitation (PAED) is a self-limiting condition seen in children upon
      awakening from anesthesia in the first 15-20 minutes.

      There are factors such as inhalation agents, preoperative anxiety and postoperative pain in
      its etiology.
    

Intervention name(s): The Modified Yale Preoperative Anxiety Scale (m-YPAS) of children
Intervention type(s): Other
Intervention description(s): Postoperative 0,5,10,15,30,45,60.and 120 minutes , PAED and WBYAS values
Other intervention name(s): Post-Anesthesia Recovery Agitation (PAED) is a self-limiting condition seen in children upon awakening from anesthesia in the first 15-20 minutes.; The Wong Baker Facial Pain Scale (WBYAS) is used to evaluate postoperative pain in children.
Intervention MeSH terms: Anesthetics
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        64
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia; Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses
      (50 and 100 mg) of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia
      (TD) symptoms.
    

Detailed description: 
      This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group
      study to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of
      NBI-98854 administered once daily for up to 2 weeks. The study will also allow for an
      evaluation of the efficacy of NBI-98854 50 mg once daily for up to 6 weeks and the safety and
      tolerability of NBI 98854 50 mg once daily for up to 12 weeks.

      The double-blind placebo-controlled treatment period the study has three arms:

        -  NBI-98854 50 mg once daily for 6 weeks

        -  NBI-98854 100 mg once daily for 2 weeks followed by 50 mg once daily for the remaining 4
           weeks

        -  placebo

      At the end of the 6-week placebo-controlled double-blind treatment period, subjects will
      continue in the study for an additional 6-week open-label period where all subjects who have
      completed the double-blind treatment period will receive NBI-98854 50 mg once daily. Two and
      four weeks after the last dose of study drug, follow-up assessments will be performed.
    

Intervention name(s): NBI-98854; NBI-98854; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 25 mg capsule; 50 mg capsule
Intervention MeSH terms: Tetrabenazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment