bioihbjkbjnl/mcl2 huggingface dataset:
the Effect of Preoperative Sodium Ibuprofen on Postoperative Endodontic Pain
Condition: Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is to clinically compare post-operative pain levels after
      administration of preoperative single dose of sodium ibuprofen versus placebo for patient
      with symptomatic irreversible pulpitis related to mandibular molar teeth.
    

Detailed description: 
      Oral pharmacologic agents have been the primary option, and the use of drugs has increased
      exponentially. Many pharmacological agents have been used to manage endodontic pain,
      including Non-steroidal Anti-inflammatory Drugs (NSAIDs),.administration of NSAIDs before
      root canal treatment will reduce inflammatory process before it begins. NSAIDs are widely
      used to control post endodontic pain They act by blocking the activity of cyclooxygenase (COX
      1 and 2) enzyme. In human dental pulps with irreversible pulpitis, a higher level of
      expression of COX 2.In cases of irreversible pulpitis NSAIDS can be administered
      preoperatively since they reduce the level of prostaglandinE2(PGE2) which is responsible for
      sensitization of nociceptors. Ibuprofen is one of the most commonly used NSAIDs and a potent
      inhibitor of prostaglandin (PG) synthesis that can manage various pain types and has
      anti-inflammatory activity. Enhancements in ibuprofen acid's pharmacokinetics have led to the
      development of ibuprofen salts with a faster dissolution rate and onset of action. These
      ibuprofen salts.Fast acting ibuprofen like Sodium ibuprofen delivers maximum plasma drug
      concentrations at about 30-40 min, compared with around 90-120 min for standard ibuprofen
      acid formulations
    

Intervention name(s): nurofen
Intervention type(s): Drug
Intervention description(s): tablet
Other intervention name(s): sodium ibuprofen
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patient with symptomatic irriversible pulpitis
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
The Water Intake Trial: Pilot Phase
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators are conducting a six-week randomized controlled pilot trial to assess the
      feasibility and safety of increased water intake in patients with chronic kidney disease.The
      investigators will study 30 patients (age 30 to 80 with an estimated glomerular filtration
      rate between 30 and 60 ml/min/1.73m2 and microalbuminuria [albumin to creatinine ratio >2.8
      mg/mmol (if female) or >2.0 mg/mmol if male)].The investigators will randomize patients (in a
      2:1 ratio) to a fluid-intervention group or control group. Participants who are randomized to
      the hydration-intervention group will be asked to consume 1.0 to 1.5 L water per day
      (depending on sex and weight) in addition to usual consumed beverages, for 6 weeks.
      Participants in the control group will be advised to consume their usual amount of fluid.

      The investigators hypothesize that patients will be able to increase and maintain a higher
      fluid intake with stable blood chemistry, particularly serum sodium.
    


Intervention name(s): Hydration
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to assess the efficacy and safety of vildagliptin 50 mg bid
      add-on therapy to improve overall glycemic control in patients with T2DM inadequately
      controlled by insulin, with or without concomitant metformin treatment. It was agreed with
      PMDA to conduct a postmarketing clinical trial to further collect the efficacy and safety
      data of vildagliptin especially in Japanese patients when it iwas used on top of insulin.
    


Intervention name(s): Vildagliptin (LAF237); Placebo; Insulin; Metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Corresponds to vildagliptin (LAF237) 50 mg tablets twice daily; Matching placebo of vildagliptin 50 mg twice daily; Patients continued their prescribed insulin dose. The dose of insulin remained within a 10% increase of the baseline dose throughout the trial (with no change in frequency or insulin type) unless dose adjustments were required for safety reasons.
The insulin dose was allowed to be decreased for safety reasons at anytime without specific dose limits at the Investigator's discretion.; Patients continued their prescribed metformin dose, if applicable.
Other intervention name(s): Vildagliptin
Intervention MeSH terms: Metformin; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus (DM) ,; diabetes,; noninsulin-dependent diabetes mellitus (NIDDM),; adult-onset diabetes,; high blood sugar,; T2DM
Comparison of Bacteriostatic Saline to Buffered Lidocaine for Ultrasound Guided Hip Joint Injection Local Anesthesia
Condition: Hip Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare infiltration pain and anesthetic efficacy between
      lidocaine and Bacteriostatic saline (BS) for ultrasound (US) guided intraarticular hip
      injections.
    

Detailed description: 
      Local anesthesia is commonly used to reduce pain during joint injections, particularly for
      deep joints like the hip. Lidocaine is the most commonly used local anesthetic in most
      medical practices. It is well known that lidocaine infiltration itself is painful. Many
      strategies have been studied to minimize pain associated with lidocaine administration,
      including buffering, warming, and slowing infiltration rate. BS is an alternative local
      anesthetic that has been shown to be less painful when injected into subcutaneous tissues
      compared with lidocaine. However, BS use has not been widely implemented for local
      anesthesia, and it has not been studied in the context of joint injections.
    

Intervention name(s): bacteriostatic saline; buffered lidocaine
Intervention type(s): Drug; Drug
Other intervention name(s): 0.9% benzyl alcohol; 1% lidocaine combined (9:1) with sodium bicarbonate
Intervention MeSH terms: Lidocaine; Benzyl Alcohol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week
      study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets)
      taken daily at bedtime for the treatment of fibromyalgia.
    


Intervention name(s): TNX-102 SL; Placebo SL Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.; Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
Other intervention name(s): Low dose cyclobenzaprine sublingual tablets; Placebo sublingual tablets
Intervention MeSH terms: Cyclobenzaprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Sleep; Fibromyalgia; FM
Study on Safety, Tolerability and Immunogenicity of an MVA Vaccine Administered to Healthy Subjects
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to collect information on the safety, tolerability and
      immunogenicity of an investigational smallpox vaccine at different doses and using different
      routes of administration in vaccinia-naive and vaccinated healthy volunteers
    


Intervention name(s): MVA-BN
Intervention type(s): Biological
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY 987517)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation-SR15-68_R84-089)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Field Trial of a Relapse Prevention Program for Adolescents Receiving Substance Use Treatment
Condition: Substance-Related Disorders
MeSH terms: Recurrence; Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to provide a comprehensive evaluation of the new, Navigating my
      Journey program for adolescents receiving treatment in an outpatient substance abuse center.

      The primary hypotheses are that, relative to the control condition, Navigating my Journey
      will be associated with significantly higher motivation, higher self-efficacy, improved
      relapse coping skills, and lower substance use. The secondary hypotheses are that, relative
      to the control condition, Navigating my Journey will be associated with increased therapeutic
      alliances with counselors.
    

Detailed description: 
      The randomized, control trial will compare clients receiving treatment in an outpatient
      substance abuse center in the following two conditions -- (1) Experimental: Navigating my
      Journey (includes 12 core lessons and 8 supplemental lessons); and (2) Attention Control
      (treatment as usual plus online health information) -- using a longitudinal design.
    

Intervention name(s): Navigating my Journey program; Attention Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The online relapse prevention program called Navigating my Journey is designed for adolescents who are receiving outpatient treatment for substance abuse. Since the Navigating my Journey program will be available to adolescents 24/7, it is easy for them to access at their convenience. The program functions as an adjunct to treatment and is designed to complement and enhance the work the adolescent does with the counselor during counseling sessions. The core intervention is expected to last for 12 weeks.; Client participants in the control group will receive their typical course of counseling and a link to online online health information in PDF form as an attention control.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Online adolescent substance abuse relapse prevention program
Minimal HePatic Encephalopathy Among CiRrhotics. A Cross SEctional, Clinico-EpidEmiological, Multi-Centre, Study in Patients of PakisTan
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Observational

Summary: 
      The Preempt study is likely to help determine the frequency of patients suffering from
      Minimal Hepatic Encephalopathy (MHE) and are cirrhotics. It will also enable us to know about
      the Quality of life of these patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary Care Clinic/Private Clinic
Use of CBCT-based Tooth Replica in Tooth Autotransplantation to Improve the Outcome of Tooth Replacement in Children
Condition: Increase Success Rate of Tooth Transplantation
Study type: Interventional

Summary: 
      The aim of this study lies in comparing the outcome of the proposed technique in a large
      sample size group to the outcome of the conventional tooth autotransplantation method and to
      provide sufficient evidence for improving the long-term success rate of the tooth
      autotransplantation procedure.
    


Intervention name(s): stereolithography tooth replica
Intervention type(s): Other
Intervention description(s): Tooth replica will be made and used for preparing the receiving tooth socket during autotransplantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tooth autotransplantation; stereolithography tooth replica; CBCT; Outcome
Comparison of Measurement of Arterial Blood Pressure by L&T NIBP Module With Invasive Arterial Blood Pressure in Neonates
Condition: Blood Pressure
Study type: Observational

Summary: 
      The purpose of this study is to compare Measurements of Arterial Blood Pressure by L&T NIBP
      Module With Invasive Arterial Blood Pressure in Neonates.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Total 20 numbers Neonates in NICU were studied during this study.
      
Keywords: Non-Invasive Blood Pressure(NIBP)
The Norwegian Cervical Arthroplasty Trial
Condition: Radiculopathy, Cervical
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      The study will compare cervical arthroplasty with cervical discectomy and fusion, in the
      treatment of cervical radiculopathy. The 0-hypothesis is that there is no difference between
      the two methods, when comparing primary and secondary outcome variables.
    

Detailed description: 
      Anterior discectomy and fusion (ACDF) is in Norway currently the most common operative method
      against cervical radiculopathy, caused by disc herniation and/or spondylosis. In the last
      decade cervical arthroplasty has emerged as a new alternative operative method. Arthroplasty
      is claimed to preserve the natural motion of the spine, thereby preventing adjacent level
      disc disease and providing better clinical results. However, this hypothesis has not yet been
      adequately proven. In our study, we will prove if there is any real difference in terms of
      clinical effect between cervical arthroplasty and ACDF.We will also compare the overall costs
      of the two methods, including cost-utility analyses. Moreover, we will study the development
      of adjacent level disease by use of MRI scans, and analyze cervical spine motion and disc
      height by use of Distortion Compensated Roentgen Analysis (DCRA).
    

Intervention name(s): Cervical arthroplasty; Anterior cervical discectomy and fusion (ACDF)
Intervention type(s): Procedure; Procedure
Intervention description(s): Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc; Anterior cervical discectomy and decompression, followed by insertion of a PEEK cage, which induces fusion.
Other intervention name(s): Discover™ Artificial Cervical Disc; Cage is made of polyetheretherketone (PEEK)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Radiculopathy, cervical; Nerve Root Compression; Disc, intervertebral; Intervertebral Disk Displacement; Spondylosis; Spinal Osteophytosis; Arthroplasty, replacement; Diskectomy; Spinal Fusion
The Efficacy, Safety and Genetic Polymorphism of Hypoca and Adalat OROS in Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Nifedipine and barnidipine act as calcium channel blockers, and are widely prescribed for
      pressure control of prehypertension and stage 1 hypertension.

      CYP3A4 is responsible for the metabolism of nifedipine and nifedipine, while the contribution
      of CYP3A5 remains ambiguous. This study is aimed to analyze the association between
      antihypertensive effects of nifedipine as well as barnidipine and single nucleotide
      polymorphisms of CYP3A4, CYP3A5 and calcium channels.
    

Detailed description: 
      For each drug, 20 patients will be enrolled. Patients' blood pressure and heart rates will be
      measured at first visit, followed by visits at week4 , week 8 and week 12. Blood samples will
      be drawn at week 4 and week 12 for following analyses of drug plasma concentrations. SNPs in
      CYP3A4, CYP3A5 and calcium channel v 1.2 will be genotyped using SNPstream.

      The differences in the decrease of blood pressures and the durg plasma concentrations between
      genotypes will be analyzed.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Hypertension patients living in Taiwan
      
Biospecimen description: 
      Extract DNA from buffy coat. Test drug concentration in plasma.
    
Keywords: Hypertension; SNP; Nifedipine; Barnidipine
Sphenopalatine Ganglion Block for Postdural Puncture Headache
Condition: Postdural Puncture Headache
MeSH terms: Ganglion Cysts; Post-Dural Puncture Headache; Headache; Wounds and Injuries
Study type: Observational

Summary: 
      Background: Postdural puncture headache (PDPH), which is one of the complications of spinal
      anesthesia, is a condition that negatively affects the quality of life of patients, causes
      late mobilization and prolonged hospital stay. Sphenopalatine ganglion block (SGB) has
      created a minimally invasive, easy, and safe treatment alternative.

      Objective: Evaluating the effectiveness of topical SGB on PDPH treatment. Design:
      Retrospective observational study Setting: Single center tertiary level of care hospital
      study. The files of PDPH patients between Jan 2018 and Jan 2020 were scanned.

      Patients: PDPH patients aged 18-65 are included and any patients with primary/secondary
      headache history are excluded.

      Main outcome measures: Patients were divided into 2 groups. The group that given only
      conservative treatment was named as Group C, and the group of patients who had additionally
      been applied SGB was named as Group SGB. Headache severity was measured with Visual Analogue
      Scale (VAS) at the 1st,3rd, 12th and 24th hours of the treatment, in supine and upright
      position.
    


Intervention name(s): Conservative Treatment for Postdural Puncture Headache
Intervention type(s): Other
Intervention description(s): The patients in Group C were given continuous bed rest in the supine position, 3000 mL daily hydration, 6 mg kg-1 aminophylline , 2 g day-1 paracetamol and 65 mg day-1 caffeine as conservative treatment. Topical SGB was applied to patients in Group SGB in addition to conservative treatment.
Other intervention name(s): Sphenopalatine Ganglion Block
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Postdural Puncture Headache patients
      
Keywords: Sphenopalatine Ganglion Block; Postdural Puncture Headache
Blood microRNA Depression Change After DHCA
Condition: Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm
Study type: Observational

Summary: 
      Collect the blood sample per-operation experience deep hypothermia cardiac arrest for aorta
      artery replacement surgery Collect the blood from the CPB machine and from intravenous
      injection tube which already set at different time point.
    

Detailed description: 
      Collect the blood sample per-operation experience deep hypothermia cardiac arrest for aorta
      artery replacement surgery Collect the blood from the CPB machine and from intravenous
      injection tube which already set at different time point Test the blood sample of DHCA,
      analysis the correlation between miR-194 and temperature.
    

Intervention name(s): collect blood
Intervention type(s): Other
Intervention description(s): collect blood at different time point
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        20-100
Comparative Bioavailability Study of Two Test Products of Fixed Dose Combination Capsule of Acetylsalicylic Acid (ASA) and Pantoprazole (Each Capsule Contains ASA 100 mg and Pantoprazole 20 mg) Under Fed Conditions
Condition: Ulcers, Duodenal and Gastric
MeSH terms: Duodenal Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, balanced, randomized, three-treatment, three-period, six-sequence, cross-over,
      single dose, comparative bioavailability pilot study under fed conditions. For fed condition,
      after check-in, subjects will receive a standard dinner consisting (1000 - 1200 calories)
      after which they will be required to fast overnight (for at least 10 hours). Thereafter they
      will receive a non-vegetarian high calorie, high-fat breakfast (800-1000 calories) before
      dosing, and a standard meal (1700 - 1900 calories) for lunch, snacks and dinner.
    


Intervention name(s): Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation one; Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation two; ASA 100 mg tablet; Pantoprazole 20 mg gastro-resistant tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Formulation Test 1 of a fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) manufactured by Piramal Healthcare Limited, India for GSK; Formulation Test 2 of a fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) manufactured by Piramal Healthcare Limited, India for GSK; Aspirin® Protect 100 mg tablets (Each tablet contains ASA 100 mg) manufactured by Bayer vital GmbH, 51368 Leverkusen, Germany; Protium® 20 mg gastro-resistant tablets (Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate)) marketing authorisation holder Nycomed GmbH, Byk-Gulden-Straβe 2, D-78467, Konstanz, Germany
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acetylsalicylic acid; Pantoprazole; Fixed dose combination