bioihbjkbjnl/mcl2 huggingface dataset:
The Effectiveness of Diode Laser 980-nm in Iraqi Face Hemangioma: a Randomized Within Patients Trial
Condition: Hemangioma
MeSH terms: Hemangioma
Study type: Interventional

Summary: 
      In an academic, government clinic, uni-center, randomized within patients trial study of the
      effects of 980-nm diode laser treatment included 15 cases of facial hemangiomas in patients
      with a history of discomfort due to lesions that were not suitable for removal using
      traditional methods. The study was carried out at the University of Baghdad/Institute of
      Laser for Postgraduate Studies/Laser Medicine Research Clinics from 15 October 2018 to 15
      April 2019. Primary end-point is improvement of conditions at 6 months. Secondary end-points
      are quality of life, disappear lesions and safety administration of diode laser. Each patient
      received 12 sessions at two-week intervals. Lesions were photographed before and after laser
      treatment and digital image histograms were generated as a graphical representation of the
      tonal distribution.

      Following treatment, the lesions were less elevated, smoother in texture, and the color
      changed from dark red to light pink.

      There is a need to improve the treatment of face hemangiomas. Results from this randomized
      within patient trial will serve as preliminary evidence of the future role of diode laser in
      hemangioma treatment and a basis for design and power estimations of future studies. Based on
      the skin texture, color and elevation of the hemangioma as well as patient satisfaction, this
      type of laser is a safe and effective modality for the treatment of facial hemangioma in
      Iraqi patients.
    


Intervention name(s): Diode laser 980-nm
Intervention type(s): Procedure
Intervention description(s): Before starting the laser session, cosmetics or makeup were removed and the skin was cleaned. The area was anesthetized by the application of as EMLA lotion (lidocaine 2.5% + prilocaine 2.5%) [ONLY MEDICAL; CAT No. R331/72394/P001] 20 minutes before the session. During the procedure, the laser probe was held perpendicular to the lesion and a guide beam was used to direct the application. The patient wore protective eye goggles [CE; DIR 8001100L4]. After the session, cool air was applied to the whole region. Each patient received a maximum of six sessions, delivered at two-week intervals. Patients reported itchiness and erythema during the session.
Intervention model: Single Group Assignment
Intervention model description: uni-center, government clinic, randomized within patient trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemangioma; Randomized within patient; Diode laser; Histogram
Vertical Versus Inclined Implant to Retain Locator Maxillary Overdenture
Condition: Implant Complication; Bone Loss
Study type: Interventional

Summary: 
      Objectives: evaluate the success rate, prosthetic maintenance , clinical and radiologic
      results of vertical implants with straight abutments versus inclined implants with angled
      abutments to retain locator maxillary overdentures. There were two groups : 1) The control
      group 2) The study group
    

Detailed description: 
      the aim of the present investigation was to evaluate the success rate, prosthetic maintenance
      , clinical and radiologic results of vertical implants with straight abutments versus
      inclined implants with angled abutments to retain locator maxillary overdentures.

      Materials and Methods conducted on 12 patients (6 males and 6 females) aged 58 to 68 years
      with completely edentulous maxillary ridges opposing implant-retained mandibular
      overdentures. Patients admit to the prosthodontic department, Faculty of Dentistry, Mansoura
      University for oral rehabilitation by implant-supported maxillary prostheses. Patients were
      allocated into one of two treatment groups: 1) The control group ; included 6 patients (3
      males and 3 females) who will receive 4 vertical implants with straight trans mucosal
      abutments retaining locator maxillary overdenture 2) The study group; include 6 patients (3
      males and 3 females) who will receive 4 inclined implants with angled trans mucosal abutments
      for retaining locator maxillary overdenture. Randomization and allocation of patients into
      treatment groups was made by dental personnel who is blind to treatment groups.
    

Intervention name(s): implants
Intervention type(s): Procedure
Intervention description(s): Four implants in the maxilla with locator attachments
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled clinical trial study conducted on 12 participants with completely edentulous maxillary ridges. Patients were allocated into one of two treatment groups: 1) The control group ; included 6 patients (3 males and 3 females) who will receive 4 vertical implants with straight trans mucosal abutments retaining locator maxillary overdenture 2) The study group; include 6 participants (3 males and 3 females) who will receive 4 inclined implants with angled trans mucosal abutments for retaining locator maxillary overdenture. A new maxillary conventional dentures will be constructed with a bilateral balanced occlusal concept for all patients. Maxillary dentures were duplicated into heat cure acrylic resin dentures to be used as a radiographic template. Four implants were inserted in the maxilla . For both groups, locator abutments were screwed to the abutments .Clinical and radiographic evaluations were done.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: maxillary overdentures; angled abutment; locator
Ghrelin Changes After Roux-en-Y Gastric Bypass
Condition: Obesity; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Observational

Summary: 
      The purpose of this study is to determine whether gastric division (via Roux-en-Y gastric
      bypass) with resultant fundic isolation will alter the pattern(s) of Ghrelin secretion in the
      early post-operative period following feeding in morbidly obese subjects.
    


Intervention name(s): Liquid diet for 3 days
Intervention type(s): Other
Intervention description(s): The control group were given a 3 -day liquid diet similar to the RYGB post-op diet
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects were morbidly obese, scheduled for RYGB with gastric tube placement. Controls were
        matched to subjects by BMI, age, gender.
      
Biospecimen description: 
      plasma, tissues
    
Keywords: Obesity; Insulin resistance; Gastric tube; Ghrelin
Determinants of Pterygium Occurrence and Recurrence in a Rural African Population
Condition: Pterygium
MeSH terms: Pterygium; Recurrence
Study type: Interventional

Summary: 
      The aim of the study is to find out why pterygium occurs and recurs in a rural African
      population. Participants will be interviewed on personal and lifestyle information, family
      history of pterygium, environmental exposure and history of previous eye inflammation. They
      will undergo eye examination and photography. Those with pterygium will be operated on to
      remove pterygium and followed up to detect any recurrence and complications of surgery. The
      excised pterygium will be examined pathologically and genetically; participant's blood will
      also be examined genetically. Data will be analyzed for statistically significant differences
      in findings between pterygium and pterygium free participants.

      The study hypothesis is that multiple factors are responsible for the occurrence and
      recurrence of pterygium in a rural african population.
    


Intervention name(s): Pterygium excision followed by grafting
Intervention type(s): Procedure
Intervention description(s): Pterygium will be excised followed by either free conjunctival or limbal conjunctival graft obtained from the upper part of the globe. The graft will be kept in place by sutures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
A Clinical Study, Randomized, Double-blind, Placebo-controlled, Single Dose Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary

      - To investigate the safety and tolerability of LCB01-0371 after a single oral dose

      Secondary

        -  To investigate the pharmacokinetic characteristics of LCB01-0371 after a single oral
           dose

        -  To investigate the safety of LCB01-0371 after a single oral dose
    

Detailed description: 
      -  To investigate the pharmacokinetic characteristics of LCB01-0371 after a single oral
           dose

        -  To investigate the safety of LCB01-0371 after a single oral dose
    

Intervention name(s): LCB01-0371; Linezolid
Intervention type(s): Drug; Drug
Intervention description(s): LCB01-0371 50mg (Cohort 1) 100mg (Cohort 2) 200mg (Cohort 3) 400mg (Cohort 4) 600mg (Cohort 5); Linezolid 600 mg (Cohort 9) none
Intervention MeSH terms: Linezolid; Delpazolid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: LCB01-0371
A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability
      of S-217622 in participants with mild and moderate hepatic impairment compared with control
      participants with normal hepatic function.
    


Intervention name(s): S-217622
Intervention type(s): Drug
Intervention description(s): Tablet for oral administration
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Development of a New HIV Vaccine
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the safety of a new HIV vaccine and to evaluate the
      immune response to the vaccine. Only some HIV genes are used to make the vaccine and
      therefore the vaccine cannot itself cause HIV or AIDS.
    

Detailed description: 
      HIV-1 presents several challenges to vaccine design, including: 1) high mutation rates
      resulting in tremendous diversity of virus envelope, the target of neutralizing antibody,
      such that antibody elicited to one envelope may not protect from virus with a distinct
      envelope; 2) envelope from infected persons differs from envelopes obtained from T-cell line
      cultures, the usual source of envelope for vaccines; and 3) envelope glycoprotein exists as
      oligomers on the virion surface, not as the monomers used in previous vaccines. This study
      will test a new vaccine that has been designed to meet these challenges by delivering
      diverse, patient-derived, oligomeric envelopes to induce multiple type-specific responses
      capable of recognizing native envelope on natural variants. The vaccine vector used in this
      vaccine trial is recombinant vaccinia virus based on the NYCDH vaccinia isolate.

      Participants in this study will receive the PolyEnv1 HIV vaccine and will be followed for one
      year. Laboratory tests will be performed at 10 study visits to monitor the participants'
      immunologic response and assess the safety of the vaccine. Patients will also have numerous
      HIV tests throughout the study period.
    

Intervention name(s): PolyEnv1
Intervention type(s): Biological
Intervention description(s): Recombinant vaccinia virus vaccine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Preventive Vaccine; HIV Seronegativity
Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech
Condition: Alzheimer Disease; Preclinical Alzheimer's Disease; Prodromal Alzheimer's Disease; Alzheimer's Disease (Incl Subtypes); Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Observational [Patient Registry]

Summary: 
      The primary objective of the study is to evaluate whether a set of algorithms analysing
      acoustic and linguistic patterns of speech can detect amyloid-specific cognitive impairment
      in early stage Alzheimer's disease, as measured by the AUC of the receiver operating
      characteristic (ROC) curve of the binary classifier distinguishing between amyloid positive
      (Arms 1 and 3) and amyloid negative (Arms 2 and 4) Arms. Secondary objectives include (1)
      evaluating whether similar algorithms can detect amyloid-specific cognitive impairment in the
      cognitively normal (CN) and MCI Arms respectively, as measured on binary classifier
      performance; (2) whether they can detect MCI, as measured on binary classifier performance
      (AUC, sensitivity, specificity, Cohen's kappa), and the agreement between the PACC5 composite
      and the corresponding regression model predicting it in all Arms pooled (Wilcoxon signed-rank
      test, CIA); (3) evaluating variables that can impact performance of such algorithms of
      covariates from the speaker (age, gender, education level) and environment (measures of
      acoustic quality).
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All participants of the study are based in the UK.
      
Keywords: Alzheimer's disease; Preclinical Alzheimer's disease; Prodromal Alzheimer's disease; Mild Cognitive Impairment; Normal Cognition; Amyloid; Speech; Acoustic; Language; Linguistic; Machine Learning; Artificial Intelligence
Nonsurgical Periodontal Treatment Associated or Not With Systemic Antibiotics and Photodynamic Therapy
Condition: Aggressive Periodontitis, Generalized
MeSH terms: Periodontitis; Aggressive Periodontitis; Aggression
Study type: Interventional

Summary: 
      To assess the local effect of the antimicrobial therapy using clarithromycin association with
      photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP).
    

Detailed description: 
      The aim of the present study was to evaluate the local effect of the antimicrobial therapy
      using clarithromycin (CLM) association with photodynamic therapy (PDT) in the treatment of
      generalized aggressive periodontitis (GAgP). Sixty periodontal pockets were select and
      randomly assigned into four groups: Periodontal Debridement (PD) (n=15): periodontal pockets
      that received periodontal debridement (PD) with placebo; PD+CLM (n=15): periodontal pockets
      that received periodontal debridement associated with clarithromycin; PD+PDT (n=15):
      periodontal pockets that received periodontal debridement associated with photodynamic
      therapy; PD+CLM+PDT (n=15): periodontal pockets that received periodontal debridement
      associated with clarithromycin and photodynamic therapy. Probing depth (PD),gain in clinical
      attachment level (CAL) and bleeding on probing (BOP) were evaluated at baseline, 3 and 6
      months post- operatively.
    

Intervention name(s): periodontal debridement; photodynamic therapy; systemic clarithromycin
Intervention type(s): Procedure; Procedure; Drug
Other intervention name(s): Ultrassonic periodontal debridement; antimicrobial photodynamic therapy; antibiotic
Intervention MeSH terms: Anti-Bacterial Agents; Clarithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: clarithromycin; photodynamic therapy; Antimicrobial therapy; Periodontal pocket
Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Subjects
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the pharmacokinetics of RLX030 during and after administration in
      subjects with mild to severe hepatic impairment and matched healthy control subjects.

      20 to 24 patients and 20 to 24 healthy subjects will be enrolled.
    


Intervention name(s): RLX030A
Intervention type(s): Drug
Intervention description(s): RLX030 is administered as a continuous 24 hour infusion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hepatic impairment; healthy volunteers; RLX030; pharmacokinetics
Respiratory Muscle Strength in Patients With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Respiratory muscle strength, dyspnea perception, physical activity and quality of life
      measurements will be performed and groups will be compared in two groups consisting of
      patients with idiopathic pulmonary fibrosis referred to pulmonary rehabilitation clinic and
      healthy volunteers in similar age range.
    

Detailed description: 
      The patients who have agreed to participate in the study from patients diagnosed with
      idiopathic pulmonary fibrosis referred to the center of pulmonary rehabilitation from the
      interstitial lung disease polyclinic will be included in the study. In addition, a healthy
      adult control group will be established from similar age groups. The two groups will be
      compared in terms of outcome measures.The study outcome measurements are maximum
      inspiratory/expiratory muscle strength , international physical activity questionaire,
      modified Medical Research Council dyspnea scale, Short form 36 quality of lide questionaire,
      fatigue severity scale, six minute walking test.
    

Intervention name(s): no intervention - cross-sectional observational only
Intervention type(s): Other
Intervention description(s): no intervention - cross-sectional observational only
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patients who have agreed to participate in the study from patients diagnosed with
        idiopathic pulmonary fibrosis referred to the center of pulmonary rehabilitation from the
        interstitial lung disease polyclinic will be included in the study. In addition, a healthy
        adult control group will be established from similar age groups. The two groups will be
        compared in terms of outcome measures.
      
Keywords: idiopathic pulmonary fibrosis; respiratory muscle strength; physical activity; quality of life; dyspnea; fatigue severity; exercise capacity
Pharmacodynamic Characterization of Dienogest
Condition: Pharmacodynamics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be investigated what mechanism of action Dienogest has. The growth of the
      follicles, the endometrium, the hormones in the blood and the mucus that is produced by the
      cervix that will be looked upon. Four different dosages of Dienogest (0.5 mg, 1 mg, 2 mg and
      3 mg) will be investigated in healthy young women over two cycles, or up to a maximum of 72
      days.
    


Intervention name(s): Dienogest (81150037); Dienogest (81150231); Dienogest (SH T00660A); Dienogest (81150746)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): daily oral intake of 0.5 mg dienogest over two cycles or a max. of 72 days; daily oral intake of 1.0 mg dienogest over two cycles or a max. of 72 days; daily oral intake of 2.0 mg dienogest over two cycles or a max. of 72 days; daily oral intake of 3.0 mg dienogest over two cycles or a max. of 72 days
Intervention MeSH terms: Dienogest; Nandrolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
A Study of the Effects of Risperidone and Olanzapine on Blood Glucose (Sugar) in Patients With Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess and compare how risperidone and olanzapine, two
      antipsychotic medications, affect the regulation of glucose (sugar) in the body.
    

Detailed description: 
      The newer antipsychotic medications risperidone and olanzapine effectively treat
      schizophrenia and related disorders, and they may cause fewer side effects than the older
      antipsychotic drugs do. However, some of the newer antipsychotic medications could have a
      negative effect on the regulation of blood glucose (sugar) in the body. This negative effect
      could make the patient gain weight and even develop diabetes mellitus. This randomized,
      double-blind study will assess and compare how risperidone and olanzapine affect the
      regulation of glucose in the body in patients with schizophrenia and schizoaffective
      disorder. Patients will be randomly assigned to receive risperidone (target oral dose of 6
      milligrams per day) or olanzapine (target oral dose of 20 milligrams per day) for 6 months.
      Repeat laboratory measurements will be performed and questions will be asked of the patients
      to evaluate the safety and effectiveness of the drugs. The primary laboratory test used to
      assess the patient's regulation of blood glucose will be the Disposition Index derived from
      the Frequently Sampled Intravenous Glucose Tolerance Test. Risperidone 2 milligram
      oven-encapsulated tablets taken orally once a day for 6 months; olanzapine 5 milligram
      tablets taken orally once a day for 6 months
    

Intervention name(s): Olanzapine; Risperidone
Intervention type(s): Drug; Drug
Intervention description(s): Target oral dose of 20 milligrams per day for 6 months; Target oral dose of 6 milligrams per day for for 6 months
Intervention MeSH terms: Olanzapine; Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: schizophrenia; blood glucose; glucose metabolism; diabetes mellitus; risperidone; olanzapine