bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Soft Tissue Response to Titanium Healing Abutments Treated by Erbium: YAG Laser or Plasma Spray
Condition: Peri-implant Mucositis
MeSH terms: Mucositis
Study type: Interventional

Summary: 
      The attachment of peri implant soft tissue to the implant serves as a biological seal that
      can prevent the development of inflammatory peri-implant diseases. Presence of contaminants
      has been suggested to be associated with tissue damaging inflammation and titanium wear
      microparticles were demonstrated to activate osteoclastic action. Er: YAG laser has been
      extensively investigated clinically for applications for treating periimplantitis either
      independently or in combination with other techniques, showing favorable outcomes. Plasma
      spray treatment can decontaminate surfaces without modifying their topography. It is also
      able to increase the surface energy by obtaining more hydrophilic surfaces, which may
      increase the capacity of the titanium oxide layer to interact with cells and proteins of
      surrounding tissue improving cell adhesion to the treated surface.
    

Detailed description: 
      This study was conducted on 24 patients seeking implant placement. A total number of 33
      healing abutments were included in this study, they were divided into 3 groups. Group 1
      (Laser group): 8 patients in this group received 11 healing abutments treated with Er:YAG
      laser, group 2 (Plasma group): 8 patients in this group received 11 healing abutments treated
      with plasma sprayand group 3 (control group): 8 patients in this group received 11 healing
      abutments with no surface treatment.Three months after implants placement, patients included
      in the study were randomly assigned to one of the three study groups, second stage surgery
      was performed and patients received healing abutments without surface treatment in control
      group, surface treatment was performed in plasma and laser groups. After two weeks, clinical
      assessment was done using PI and GI before taking biopsies from peri-implant soft tissue for
      histological assessment. H&E stain was used for measuring inflammatory cells count and
      Masson's Trichrome stains for measuring collagen fibers area fraction. Analysis of the
      abutments surface was done using SEM.
    

Intervention name(s): Er: YAG laser; plasma spray
Intervention type(s): Device; Device
Intervention description(s): surface treatment with Er: YAG laser for heating abutments; surface treatment with plasma spray for heating abutments
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: comparison between three groups
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: healing abutment; plasma spray; Er: YAG laser
Effect of Tiotropium on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to investigate whether tiotropium therapy can increase duration of steady-state
      exercise by decreasing dynamic and static lung hyperinflation in COPD patients.
    


Intervention name(s): Tiotropium inhalation capsules; Placebo inhalation capsules
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of tirzepatide in participants with
      type 2 diabetes.
    


Intervention name(s): Tirzepatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): LY3298176
Intervention MeSH terms: Tirzepatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Rosuvastatin on Aortic Stiffness in Hemodialysis Patients in the AURORA Study
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the effect of rosuvastatin compared to placebo on the aortic stiffness in
      hemodialysis patients as measured by pulse wave velocity (at 3, 6 and 12 months)
    


Intervention name(s): Rosuvastatin; aortic pulse wave velocity measurements
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: high blood cholesterol levels
Transport Distraction Osteogenesis for Ramus-Condyle Unit
Condition: Bilateral or Unilateral Deficient Ramus-condyle Unit
Study type: Interventional

Summary: 
      this study was done to evaluate the use of transport distraction osteogenesis in restoring
      the deficient condyle/ramus unit of patients with unilateral or bilateral TMJ ankylosis to
      correct the resultant deformity
    

Detailed description: 
      10 patients with post ankylosis deficient ramus /condyle unit who underwent release procedure
      in the Maxillofacial and Plastic Surgery Department, Faculty of Dentistry, Alexandria
      University, Egypt.

      all patients were assessed clinically and by imaging using OPG, lateral and PA cephalometry,
      and cone beam CT to assess the deficient ramus/condyle unit (RCU) then patients were operated
      using transport distraction osteogenesis to lengthen the RCU. Then follow up of all patients
      both clinically and radiographically was adopted.
    

Intervention name(s): Distraction Osteogenesis for Reconstruction of Ramus-Condyle
Intervention type(s): Device
Intervention description(s): transport distraction osteogenesis in restoring the deficient condyle/ramus unit of patients with TMJ ankylosis to correct the resultant deformity either unilaterally or bilaterally.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Aging on Bariatric Surgery-induced Changes in Metabolism and Cognition
Condition: Insulin Resistance; Cognitive Impairment
MeSH terms: Insulin Resistance
Study type: Observational

Summary: 
      The investigators hypothesize that the improvements in insulin sensitivity, beta (β)-cell
      function, and inflammation will be greater, and the improvement in sarcopenic obesity will be
      less, in younger versus older individuals after substantial weight loss induced by sleeve
      gastrectomy bariatric surgery.
    

Detailed description: 
      With an aging population that is increasingly susceptible to obesity and obesity-related
      comorbidities including sarcopenia and diabetes, effective and safe treatment options
      tailored to the needs of older adults are imperative. While medication and lifestyle
      interventions generally fail to achieve sustained large-scale weight loss, bariatric surgery
      is the most effective long-term weight loss treatment for obese patients and improves many of
      the medical complications associated with obesity. Sleeve gastrectomy (SG) results in
      substantial weight loss and may be more appropriate for older adults due to its low rate of
      complications and mortality. Therefore, SG has been proposed as a reasonable primary
      treatment modality in older obese individuals, with a substantial recent increase in the
      number of interventions performed. Despite the potential benefits, very little is known of
      the physiologic and metabolic effects of bariatric surgery, including SG, on glucose
      homeostasis and muscle physiology in older adults. A fundamental understanding of the effects
      of excess adiposity and weight loss interventions is of profound importance, especially with
      emerging evidence that earlier treatment of obesity may delay/prevent many comorbidities. An
      underlying inflammatory state has been implicated in the pathogenesis of sarcopenia and
      insulin resistance and may provide an important connection to the age-related declines seen
      in older obese patients. Therefore, this study aims to evaluate the modifying effect of age
      and inflammation on the SG-induced changes in body composition, muscle physiology, and
      insulin sensitivity. This protocol will be conducted in two age cohorts (greater than 60 and
      less than 50 years old).
    

Intervention name(s): Sleeve gastrectomy
Intervention type(s): Procedure
Intervention description(s): Type of bariatric surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled to undergo laparoscopic sleeve gastrectomy (SG) at The Ohio State
        University (OSU) Wexner Medical Center will be divided into two cohorts: 1). Greater than
        or equal to 60 years of age and 2). Less than 60 years of age.
      
Biospecimen description: 
      Blood samples are retained.
Study Evaluating the Safety and Efficacy of Etanercept in Patients With Idiopathic Pulmonary Fibrosis
Condition: Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to evaluate the safety and efficacy of etanercept in comparison
      with placebo in a double-blind, parallel, randomized fashion in subjects with idiopathic
      pulmonary fibrosis (IPF) who failed previous therapy. The treatment period will be up to 1
      year. The primary objective is evaluation of safety and efficacy. Secondary: The secondary
      objective is to evaluate quality of life (QoL) and pharmacokinetics (PK).
    


Intervention name(s): Etanercept
Intervention type(s): Drug
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Idiopathic Pulmonary Fibrosis; Fibrosis, Pulmonary; Pulmonary Fibroses; Fibroses, Pulmonary
Dose Titration of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension
Condition: Primary Hypertension; Secondary Hypertension
MeSH terms: Neoplasm Metastasis; Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This open label 4 month study will evaluate efficacy (blood pressure lowering effects) and
      safety of lisinopril in children 1-18y whose parents grant permission to participate. This
      dose titration study is being conducted to support the statement that personalized titration
      of lisinopril (based on blood pressure and renin-aldosterone ratio) can increase patient
      response.
    


Intervention name(s): lisinopril, ACE-inhibitor
Intervention type(s): Drug
Intervention description(s): Lisinopril 0.1mg/kg/d, titration with + 0.1mg/kg/d. Max; daily dose: 0.4mg/kg. CAVE: dose reduction in case of renal impairment
Intervention MeSH terms: Lisinopril; Angiotensin-Converting Enzyme Inhibitors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study To Assess The Safety And Tolerability Of GSK189075 When Given With A Total Daily Dose Of >/ 2000mg of Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess safety and tolerability of metformin plus GSK189075 in people with
      Type 2 Diabetes. About 48 people will participate in this study. Volunteers will not know if
      they are receiving GSK189075 or a placebo. Participation will last about 5 weeks including a
      run-in period of up to 2 weeks if necessary to increase metformin up to 2000mg daily, a
      13-day treatment period, and a follow-up visit about 1 week after the treatment period.
      Volunteers will remain in the research clinic beginning 2 days before they receive the first
      dose of GSK189075 until after the morning dose on the fourth day and from the afternoon of
      the 12th day of dosing until the morning after the last dose. They will have clinic visits on
      dosing Days 6, 8, and 10. Volunteers will be given equipment and instructions for measuring
      their blood sugar at home and will be asked to keep a study diary. Blood pressure, heart
      rate, laboratory tests on blood and urine, physical examinations, reports of drug side
      effects and ECGs will be obtained during the clinic visits to assess safety.
    


Intervention name(s): GSK189075; Metformin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK189075 will be available as an oral tablet with dosing strengths of 500 milligrams and 250 milligrams.; Metformin will be available as an immediate release oral tablet with dosing strengths of 500 milligrams and 850 milligrams.; Placebo will be available as an oral tablets.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tolerability; GSK189075,; Metformin,; Safety,; Diabetes,
Restoration of Physical Function in Patients Following Total Knee Replacement: Comparison Between Resistive Strength Training Exercises & Ankle Weights
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Techniques used to restore the physical functions in TKR patients
    

Detailed description: 
      to restore the physical functions in TKR patients by the use of ankle weights and resistance
      exercises. Total 40 patients were included in this study and two groups had been formulated
      one as experimental and other as control. 2 sessions were given to each group for 6 weeks.
    

Intervention name(s): Resistance exercises; Ankle weights
Intervention type(s): Other; Other
Intervention description(s): Resistance exercises; Ankle weights
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A single blind RCT in which two groups were formulated. One as Control and other as an experimental
Masking: Single (Participant)
Primary purpose: Other
A Study to Assess The Relative Bioavailability of New Tablet Formulations of GSK1265744 in Healthy Adult Subjects
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate two new GSK1265744 sodium salt tablet formulations and provide data
      for selection of one of these tablet formulations for use in Phase 3. This is a
      single-center, randomized, two part, open-label, crossover study in healthy adult subjects.
      Part A is a randomized, open-label, 3-way balanced cross-over design in 24 subjects to assess
      the oral bioavailability of two GSK1265744 sodium salt tablet formulations relative to the
      current GSK1265744 sodium salt formulation being used in the phase IIb studies under fasting
      conditions. Part A treatment periods will be separated by a 14 day washout. After completion
      of Part A, preliminary PK data will be analyzed and a decision will be made based on
      pre-specified criteria, as to which formulation will be used to conduct Part B. Fifteen
      subjects who will have participated in Part A will participate in Part B and receive the
      selected formulation with a moderate fat meal. All treatments will be administered as single
      30 mg doses of GSK1265744. Safety evaluations and serial PK samples will be collected during
      each treatment period. A follow-up visit will occur 10 - 14 days after the last dose of study
      drug.
    


Intervention name(s): GSK1265744 Reference formulation; GSK1265744 New formulation 1; GSK1265744 New formulation 2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK1265744 (micronized) reference formulation is available as 30 mg tablet to be orally administered with 240 mL of water; GSK1265744 (micronized) New formulation 1 is available as 30 mg tablet to be orally administered with 240 mL of water; GSK1265744 (un-micronized) New formulation 2 is available as 30 mg tablet to be orally administered with 240 mL of water
Intervention MeSH terms: Cabotegravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: integrase inhibitor; pharmacokinetics; HIV; relative bioavailability; food; GSK1265744
Retrospectively Analyze the Risk Factors of VTE in 5774 Patients With Thoracic Trauma From 33 Hospitals in China, and Established a Risk Prediction Model
Condition: Thorax Injuries; Embolism Vein; Embolism, Pulmonary; Rib Fractures
MeSH terms: Pulmonary Embolism; Embolism; Rib Fractures; Thoracic Injuries
Study type: Observational

Summary: 
      Retrospectively analyze the risk factors of VTE in 5774 patients with thoracic trauma from 33
      hospitals in China, and established a risk prediction model
    

Detailed description: 
      In order to explore the risk factors of VTE after acute thoracic trauma, we collected the
      diagnosis and treatment information of 5774 patients with thoracic trauma from 33 hospitals
      in China, retrospectively analyzed the risk factors of VTE in patients with thoracic trauma,
      and established a risk prediction model.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients 18-80 years of age who were admitted within 3 days of chest trauma, did not have
        VTE prior to admission and were not receiving prophylactic anticoagulation. The chest
        trauma AIS score of QI patients with multiple injuries was greater than or equal to 3, and
        the chest trauma score of other combined injuries was less than or equal to 2.
      
Keywords: venous thrombus embolism; Thorax Injuries; risk factors; prediction model
Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions
Condition: Dry Mouth
MeSH terms: Xerostomia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The objective of this study was to prove the bioequivalence of Roxane Laboratories'
      Cevimeline 30 mg under fasted conditions
    


Intervention name(s): Cevimeline
Intervention type(s): Drug
Other intervention name(s): Evoxac
Intervention MeSH terms: Cevimeline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Dexamethasone on Sleep Related Breathing Disturbances in Patients With COPD at Altitude
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing sleep
      related breathing disturbances in lowlanders with chronic obstructive lung disease travelling
      from 700 m to 3200 m.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy
      of dexamethasone prophylaxis in sleep related breathing disturbances in lowlanders with
      chronic obstructive pulmonary disease travelling to altitude. Participants living in the
      Bishkek area, Kyrgyzstan (700m), will be transferred by car within 4h to the Tuja Ashu high
      altitude clinic (3200 m), and stay there for 2 days. Dexamethasone 2x4mg/day (or placebo),
      will be administered before departure at 700 m and during the stay at altitude. Outcomes will
      be assessed during the stay at 3200 m
    

Intervention name(s): Dexamethasone; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: airway disease; bronchitis; emphysema; lung; treatment; sleep
Dexpramipexole Renal PK Study
Condition: Amyotrophic Lateral Sclerosis; Renal Insufficiency
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, open-label, single-dose, PK and safety study in subjects with various
      stages of renal impairment.
    

Detailed description: 
      Dexpramipexole (BIIB050, KNS-760704;
      (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazolediamine dihydrochloride monohydrate) is a
      synthetic amino-benzothiazole. Data from multiple in vitro and in vivo assays have suggested
      that dexpramipexole is neuroprotective. It is being investigated for the treatment ALS.

      As dexpramipexole is principally eliminated from the body by the kidneys a single oral dose
      of dexpramipexole will be administered to subjects with various stages of renal impariment
      comprising the following categories: mild, moderate, severe and ESRD subjects. Healthy
      volunteers will be matched to each catergory of renal impaired subjects.
    

Intervention name(s): Dexpramipexole (dose 1); Dexpramipexole (dose 2)
Intervention type(s): Drug; Drug
Other intervention name(s): BIIB050; BIIB050
Intervention MeSH terms: Pramipexole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess, the safety and tolerability of single ascending doses
      of S 95010 and to assess the pharmacokinetics (PK) of S 95010.
    


Intervention name(s): S 95010; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Single administration of S 95010 in healthy volunteers; Single administration of placebo in healthy volunteers
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: healthy volunteer; antimiR; single ascending dose