bioihbjkbjnl/mcl2 huggingface dataset:
Alternative Antibiotic Regimen in Periodontitis Treatment
Condition: Amoxicillin; Metronidazole; Ofloxacin; Periodontitis; Root Planing
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Context and Aims: Several studies have demonstrated an association between obesity,
      periodontitis, and exercise. This study aimed to investigate the effects of regular exercise
      on obese women with periodontal disease, using serum, saliva, and gingival crevicular fluid
      (GCF) samples.

      Settings and Design: A before-after study design was adopted to evaluate the effects of 12
      weeks of regular exercise on obese women grouped according to periodontal status, without a
      control group (no exercise).

      Methods and Material: The study sample comprised fifteen patients without periodontitis (NP
      group) and 10 patients with chronic periodontitis (CP group), from whom periodontal
      parameters were measured and serum, saliva, and GCF samples were collected. Body mass index
      (BMI), anthropometric measurements, somatotype-motoric tests, and maximal oxygen consumption
      (VO2max) were recorded at baseline and after exercise.

      Statistical analysis used: MedCalc was used for statistical analysis.
    


Intervention name(s): Ofloxacin; Amoxicillin; Metronidazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 400 mg, 1 time per day for 5 days; 500 mg, 3 times per day for 7 days; 500 mg, 3 times per day, for 7 days
Intervention MeSH terms: Amoxicillin; Metronidazole; Ofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Cystine Capacity Clinical Study (CysCap)
Condition: Cystinuria
MeSH terms: Cystinuria
Study type: Observational

Summary: 
      The purpose of this study is to determine whether urinary cystine capacity, an assay used to
      measure the amount of cystine in the urine, can be used to predict stone recurrence in
      patients with cystinuria.
    

Detailed description: 
      Cystinuria is a rare genetic cause of kidney stones that leads to significant morbidity due
      to the recurrent nature of the disease. Despite recent advancements in knowledge about
      cystinuria, such as the discovery of the genetic defects that cause the disease, there have
      been very few studies of clinical determinants of recurrent stone formation. An optimal
      method of measuring cystine solubility in the urine has been lacking, and therefore response
      to pharmacologic and dietary therapy is often not known. Recently, a new assay to measure the
      amount of cystine in the urine was developed called Cystine Capacity, or CysCap. It is an
      assay that adds a pre-formed amount of cystine crystals to urine and measures the amount of
      cystine the urine can take up from the solid phase (in undersaturated urine) or gives up to
      solid phase (in supersaturated urine). This study seeks to examine how well this measure of
      urinary cystine predicts stone occurrence, with the ultimate goal of helping to guide therapy
      and preventing kidney stones in cystinurics.

      This is an observational study over 3 years. Subjects who are enrolled in the study will
      perform semi-annual 24-hour urine collections. They will undergo imaging of the kidneys every
      6 months to monitor kidney stone formation or growth, in order to correlate urinary
      parameters with clinical events. The study will examine how well the urinary cystine capacity
      predicts stone formation.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        For patients to be enrolled in this study they must have a diagnosis of cystinuria.
      
Keywords: Renal aminoaciduria; cystinuria; D-penicillamine; renal tubular transport; inborn errors; tiopronin; urolithiasis
Prophylactic PRP in Moderate NPDR
Condition: Eye Diseases; Diabetes; Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Eye Diseases
Study type: Observational

Summary: 
      Diabetic retinopathy (DR) is a challenge to ophthalmic practice in communities with poor
      socioeconomic development. The COVID 19 pandemic has accentuated the challenge. DR is one of
      the leading causes of vision loss worldwide, estimated to account for 1.25% of moderate to
      severe visual impairment and 1.07% of blindness. Pan retinal photocoagulation (PRP) remains
      the gold standard treatment for preventing visual loss in PDR. Scatter photocoagulation is
      not recommended for eyes with mild or moderate non-proliferative diabetic retinopathy (NPDR)
      provided careful follow-up can be maintained,. When retinopathy is more severe, scatter
      photocoagulation should be considered and should not be delayed if the eye has reached the
      high-risk proliferative stage. As many as 27% of patients with moderate NPDR are estimated to
      progress to PDR in 1 year; therefore, they should be seen every 4 to 8 months. This ideal,
      good as it is, is not what ophthalmic practice has to deal with in communities of
      low-resource settings, where patients often seek medical advice due to visual complaints from
      the complications of PDR without being diagnosed in the non-proliferative stage or high risk
      PDR. Screening protocols are not followed, a situation aggravated during the COVID pandemic
      lockdown.
    


Intervention name(s): PRP
Intervention type(s): Procedure
Intervention description(s): Single session prophylactic early Pan-retinal Photocoagulation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with moderate NPDR at high risk
A Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AMG 592 in Healthy Participants
Condition: Chronic Graft-versus-host Disease (cGVHD)
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety, tolerability and
      immunogenicity profile of single and multiple dose administrations of AMG 592 in healthy
      participants.
    


Intervention name(s): AMG 592; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Administered as SC injection; Administered as SC injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Chronic Graft-versus-Host Disease; AMG 592; Inflammatory Conditions
Obstructive Sleep Apnea and Diabetes Mellitus
Condition: Obstructive Sleep Apnea; Diabetes Mellitus
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Diabetes Mellitus
Study type: Interventional

Summary: 
      The investigators hypothesize that obstructive sleep apnea (OSA) contributes to impaired
      glucose homeostasis and associated vasculopathy, and nCPAP treatment of OSA should improve
      glycemic control and vascular function in OSA patients with type II diabetes mellitus. This
      study aims to investigate the therapeutic effects of nCPAP on glycemic control and vascular
      function in patients with OSA and type II diabetes mellitus.
    

Detailed description: 
      Obstructive sleep apnoea (OSA) has been reported to be common (17%) in patients with diabetes
      mellitus (DM). Both OSA and DM are highly associated with cardiovascular morbidity and
      mortality. There is growing evidence that OSA may trigger or worsen pre-existing adverse
      metabolic profile indicative of cardiovascular risk. Treatment of OSA with nasal Continuous
      Positive Airway Pressure (nCPAP) has been shown to reduce blood pressure and hence to reduce
      the risk of atherogenesis. In patients with DM, the therapeutic effect of nCPAP is still not
      known, it would be important to delineate any independent effect of OSA on DM and the
      therapeutic effect of nCPAP on glycemic control to reduce the long term risk of macrovascular
      and microvascular complications.
    

Intervention name(s): nasal Continuous Positive Airway Pressure
Intervention type(s): Device
Intervention description(s): A standard treatment for OSA. A portable machine delivers positive pressure through a mask to the upper airway during sleep at night.
Other intervention name(s): nCPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea; Type II diabetes mellitus; Randomized controlled trial
Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Anterior Wall Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Study hypothesis :

      The purpose of this study is to determine whether Intracoronary infusion of autologous bone
      marrow derived progenitor cells to patients undergoing primary angioplasty for acute anterior
      myocardial infarction will lead to an improvement in cardiac function greater than that seen
      by placebo alone.

      Aims

        -  To demonstrate that it is safe and feasible to deliver autologous bone marrow derived
           stem cells within hours of the primary angioplasty procedure

        -  To demonstrate the effects of autologous bone marrow derived stem cells on cardiac
           function using cardiac MRI (or cardiac CT), echocardiography and left ventriculography.

        -  To demonstrate the effect of autologous bone marrow derived stem cells in addition to
           standard care leads to improvement in cardiac function compared to patients
           saline(placebo) and standard care.
    


Intervention name(s): Bone marrow derived progenitor cells or placebo infusion; Placebo infusion
Intervention type(s): Other; Other
Intervention description(s): Over-the-wire balloon catheter delivers infusion into coronary vessel using a stop-flow technique; Placebo infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Heart attack; Anterior Myocardial infarction (MI); adult stem cells; bone marrow progenitor cells; bone marrow stem cells; autologous; left ventricular function; intracoronary injection
Concentration-Controlled Ribavirin for the Treatment of Patients With Chronic Hepatitis C Virus Infection
Condition: Hepatitis C Virus
MeSH terms: Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if concentration-controlled ribavirin dosing can
      achieve a targeted level of plasma exposures and if it appears safe and effective compared
      with standard weight-based ribavirin dosing. Forty, previously treatment-naive participants
      with genotype 1 disease will be randomized to receive concentration-guided or standard
      weight-based ribavirin. Peginterferon alfa 2a,ribavirin, and telaprevir will be provided
      through the study.
    


Intervention name(s): ribavirin
Intervention type(s): Drug
Intervention description(s): Randomization to standard weight based ribavirin dosing (1000 or 1200 mg daily) or concentration-guided dosing based on first dose AUC0-12
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ribavirin; pharmacokinetics; Hepatitis C virus
MK0524B Bioequivalence Study (0524B-070)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate:

        1. the bioequivalence of simvastatin and simvastatin acid following dose of simvastatin
           (ZOCOR™) given together with one tablet of MK0524A or as a component of the triple
           combination tablet MK0524B.

        2. the bioequivalence of laropiprant and ER niacin when administered as the triple
           combination tablet MK0524B or as the double combination tablet MK0524A given together
           with simvastatin.
    


Intervention name(s): MK0524B (ER niacin (+) laropiprant (+) simvastatin); MK0524A (ER niacin + laropiprant); Simvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.; Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.; Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.
Other intervention name(s): MK0524B; MK0524A; Zocor™
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids; Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation
Condition: Acromioclavicular Joint Dislocation
MeSH terms: Joint Dislocations
Study type: Interventional

Summary: 
      The study aims to answer if surgery with hook plate for acute dislocation of the
      acromioclavicular joint (AC joint) grade III and V according to Rockwood is superior to
      conservative treatment.
    


Intervention name(s): hook plate; Physiotherapy
Intervention type(s): Procedure; Other
Intervention description(s): Surgery with hook plate followed by physiotherapy; Patients will be following a program specific for AC joint dislocations
Other intervention name(s): hook plate by Synthes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: acromioclavicular joint dislocation; ac joint dislocation; acromioclavicular joint separation; hook plate; Rockwood
Sucrose Practices for Pain in Neonates
Condition: Pain
Study type: Interventional

Summary: 
      Recent studies show that babies in hospital undergo an average of 4 to 5 painful procedures,
      such as heel lances, every day. Sucrose (sugar water) has been shown to be effective for
      reducing pain during invasive procedures and is a standard of care for painful procedures.
      The purpose of this study is to see what is the least amount of sucrose that can be given to
      a baby to reduce pain during procedures.
    

Detailed description: 
      Infants in the NICU receive an average of 4 - 5 painful procedures daily for diagnostic and
      therapeutic purposes; less than half receive interventions to manage pain. Both immediate and
      long term effects of unmanaged pain in these vulnerable infants have been reported, including
      impaired brain development. To ensure optimal outcomes for hospitalized infants in NICUs,
      there is a crucial need to minimize procedural pain and its associated consequences. Multiple
      clinical trials have identified sucrose as an effective strategy for reducing procedural pain
      in infants. Despite its inclusion in neonatal pain guidelines, standards, and consensus
      statements sucrose has been inconsistently used. The under-utilization of sucrose may be
      explained by knowledge gaps in relation to the minimally effective dose and the influence of
      concurrent opioid analgesia, as well as the short and long-term effects of repeated
      administration. Once infants in the NICU are determined to be eligible for the study and
      parents consent, infants will be randomized to one of 3 dose of sucrose and their pain will
      be assessed using a validated pain assessment measure.
    

Intervention name(s): sucrose
Intervention type(s): Other
Intervention description(s): Sucrose will be administered by a research nurse experienced in neonatal intensive care using a standardized procedure and timing consistent with policies in the participating units, including: (a) administering sucrose 2 minutes prior to the heel lance to ensure peak effects; (b) giving the total volume of sucrose drop by drop via syringe on the anterior surface of the tongue, as tolerated, over a period of up to 1 minute to allow for individual infant swallowing rates and to ensure analgesic effects are sustained during the heel lance procedure; and (c) offering a pacifier for non-nutritive sucking (NNS) immediately following sucrose administration.
Other intervention name(s): Brand name = Tootsweet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Pain management; Hospitalized; Infants; Sucrose
Home Management of Malaria and Pneumonia
Condition: Malaria; Pneumonia
MeSH terms: Pneumonia; Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      A well-implemented community-based program of early and appropriate treatment of
      fevers/malaria episodes and pneumonia,will improve child survival as measured by a reduction
      of the less than five mortality rate.
    

Detailed description: 
      An integrated approach of home and community management of malaria and pneumonia may increase
      the proportion of children receiving prompt treatment; improve child survival as measured by
      a reduction of the under five mortality rate. To test this hypothesis, a cluster randomised
      controlled trial will be performed, involving children less than 5 years of age, in Burkina
      Faso using a community-based supplying community health workers (CHWs), a core group of
      mothers (KOLs) with Coartem and cotrimoxazole specially packed in age-specific blisters
      containing a full course of treatment. The study will be carried out in 111 clusters of a
      rural district in Burkina Faso where malaria and pneumonia are two major mortality causes in
      under five mortality.
    

Intervention name(s): home/community case management
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Impact of home management of malaria and pneumonia on child mortality; home management of malaria and pneumonia
Vitamin D Supplementation for the Prevention of Acute Respiratory Infections: a RCT in Young Finnish Men
Condition: Vitamin D Deficiency; Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Vitamin D Deficiency
Study type: Interventional

Summary: 
      Vitamin D intervention effects on the prevention of acute respiratory tract infections among
      Young Finnish Men
    


Intervention name(s): Vitamin D3; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 20 mikrog vitamin D3 daily; Placebo
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
School-based Treatment of Anxiety Research Study (STARS)
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This research is being done to compare two types of talk therapy to see which is most
      effective in helping school children with anxiety disorders. The investigators will compare
      usual care (UC) with cognitive behavioral therapy (CBT). Both therapies will be administered
      by the school mental health counselors to see if they help children with anxiety disorders to
      feel less scared or worried.
    

Detailed description: 
      This four year study involves a blocked randomized controlled trial (RCT) comparing the
      effectiveness of school-based CBT to usual care (UC) for approximately 375 students ages 7-17
      diagnosed with an anxiety disorder. Randomization will occur at the school level and the
      investigators propose to conduct the study in approximately 46 schools (23 in CBT; 23 UC).
      Evaluations will be conducted by study staff to measure treatment progress at the end of the
      12-week treatment program, at a three month follows up, and at natural termination.
    

Intervention name(s): CBT; UC
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): Cognitive Behavioral therapy; Usual Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anxiety; Fear; Worry; Therapy; Cognitive behavioral therapy
The Use of X-ray in Bariatric Surgeries
Condition: Complications of Bariatric Procedures; X-rays; Effects
Study type: Observational

Summary: 
      examination of the importance of the use of X-ray in bariatric surgery outcome.
    

Detailed description: 
      the x-ray will be used in order to evaluate the number of complications occured during
      bariatric surgeries such as bleeding, leak, etc. a retrospective analysis of patients with
      those complications will be performed and the presence of the x-ray and its findings will
      also be documented.
    

Intervention name(s): x-ray
Intervention type(s): Device
Intervention description(s): x-ray for the detection of leaks and bleeding
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients underwent bariatric surgery between 2011-2015
Intranasal Dexmedetomidine vs Midazolam-ketamine Combination for Premedication of Pediatric Patients
Condition: Premedication; Oculocardiac Reflex
MeSH terms: Strabismus
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is using intranasal dexmedetomidine versus intranasal
      midazolam-ketamine combination for premedication and preventing the oculocardiac reflex of
      pediatric patients undergoing strabismus surgery.
    

Detailed description: 
      Preanesthetic medication in pediatrics is very helpful in relieving anxiety, fear and
      psychological trauma due to maternal deprivation. Midazolam and ketamine are commonly used
      for this purpose. Dexmedetomidine is an alpha 2 -agonist with a more selective action on the
      alpha 2 adrenoreceptor when administered via the nasal mucosa bioavailability of
      dexmedetomidine is too high. Intranasal route is an effective way to administer premedication
      and sedation to children. The oculocardiac reflex is a major complication of pediatric
      strabismus surgery.
    

Intervention name(s): Dexmedetomidine; Ketamine
Intervention type(s): Drug; Drug
Intervention description(s): via intranasal route 1 mcg/kg; via intranasal route 7,5 mg/kg ketamine and 0,1 mg/kg midazolam
Other intervention name(s): precedex; ketalar
Intervention MeSH terms: Dexmedetomidine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dexmedetomidine; intranasal; strabismus surgery; premedication; oculocardiac reflex