bioihbjkbjnl/mcl2 huggingface dataset:
Nonsurgical Periodontal Therapy on Banded First Molars
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study was to evaluate the effect of nonsurgical periodontal therapy on first
      molars banded for fixed orthodontic treatment.
    

Detailed description: 
      A total of 30 patients who were about to undergo fixed orthodontic therapy were selected and
      divided into two groups.

      Group A comprised of 15 patients who were treated with routine full-mouth supragingival
      scaling and subgingival scaling only around all banded first molars.

      Group B comprised of 15 patients who were treated with full-mouth supragingival scaling and
      subgingival scaling only around all banded first molars followed by irrigation with 0.2%
      chlorhexidine gluconate solution (Trade name: HEXIDINE), an antiseptic - antiplaque agent.
      Treatment for both the groups was performed at 3rd month, 6th month and 9th month.

      Parameters such as radiographic evidence of alveolar crestal bone level, gingival index,
      probing pocket depth and clinical attachment level around the banded first molars and
      full-mouth plaque index were recorded as a change from baseline to 12th month. The
      differences between the values were assessed and sent for statistical analysis.
    

Intervention name(s): Full-mouth supragingival scaling; Subgingival scaling; Subgingival irrigation
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Control group comprised of 15 patients who were treated with routine full-mouth supragingival scaling.; Test group comprised of 15 patients who were treated with subgingival scaling only around all banded first molars.; Test group comprised of 15 patients who were treated with subgingival irrigation only around all banded first molars with 0.2% chlorhexidine gluconate solution (Trade name: HEXIDINE), an antiseptic - antiplaque agent.
Other intervention name(s): Oral prophylaxis; Deep scaling; Chemical plaque control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nonsurgical periodontal therapy; Orthodontic bands
Platelet Function in Diabetic Patients With and Without Renal Impairment, and the Effects of Lipid Lowering Treatment
Condition: Diabetes Mellitus; Impaired Renal Function
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is compare the effects of simvastatin+ezetimibe with those of
      simvastatin alone on platelet activity, platelet-leukocyte interactions and inflammatory
      variables in diabetic patients with or without impaired renal function.
    

Detailed description: 
      A detailed study protocol is available.
    

Intervention name(s): Ezetimibe
Intervention type(s): Drug
Intervention description(s): After a placebo only run-in period patients (two groups) are treated with simvastatin + ezetimibe and simvastatin + placebo in a cross-over trial. Ezetimibe effects on top of simvastatin will be evaluated as the primary aim; simvastatin effects compared to run-in on placebo will be evaluated as a secondary aim.
Other intervention name(s): Simvastatin; Ezetrol
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Topical 5%Potassium Hydroxide vs Liquid Nitrogen in the Treatment of Plane Warts
Condition: Plan Warts
MeSH terms: Warts
Study type: Interventional
Phase: Phase 1

Summary: 
      ABSTRACT Objective: To study the efficacy while comparing Potassium hydroxide 5% with liquid
      nitrogen in treatment of plane warts.

      Study design: Randomized-controlled trial (RCT), (Double-blind). Study setting and duration:
      Dept dermatology, CMH-Abbottabad, Nov-2022 / April-2023.

      Methodology: The sample size of 60 patients (children and adults aged 4 to 30 years) was
      calculated using Openepi app sample size RCT calculator, after informed consent by using
      non-probability consecutive sampling technique. Patients randomly assigned into two groups
      i.e. In group-A 30 patients were given topical 5%-potassium hydroxide solution on affected
      area once at night upto 4 weeks and in group-B 30 patients treated with cotton bud method of
      cryotherapy with liquid nitrogen once every two weeks. Patients were reassessed at every two
      weeks and final assessment was done at 12th week whereas followed up for 3 months to monitor
      recurrence. Demographic information and frequency percentages were calculated for qualitative
      variables by using SPSS26. To determine statistical significance taking p-value <0.05 as
      significant, and χ2-square test was used.
    


Intervention name(s): 5%potassium hydroxide; Liquid nitrogen
Intervention type(s): Drug; Drug
Intervention description(s): . In group-A 30 patients were given topical 5% potassium hydroxide solution on affected area once at night for upto 4 weeks; in group-B 30 patients treated with cotton bud method of cryotherapy with liquid nitrogen once every two weeks. Patients were reassessed at every two weeks. The treatment carried out upto 12 weeks or until complete recovery from warts.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Hemodynamic Effects of Cascade Hemofiltration in Septic Shock
Condition: Sepsis
MeSH terms: Shock, Septic
Study type: Interventional

Summary: 
      Septic shock is a major cause of mortality and morbidity in critically ill patients. Septic
      Shock is associated with an overwhelming, systemic overflow of pro inflammatory and
      anti-inflammatory mediators, which leads to generalized endothelial damage, multiple organ
      failure, and altered cellular immunological responsiveness. Although our understanding of the
      complex pathophysiological alterations that occur in septic shock has increased greatly as a
      result of recent clinical and preclinical studies, mortality associated with the disorder
      remains unacceptably high, ranging from 30% to 50%. To date, attempts to improve survival
      with innovative, predominantly anti-inflammatory therapeutic strategies have been
      disappointing. A standard hemofiltration rate of 35 ml/kg/hour has been successfully used to
      treat acute renal failure. However, this dose does not alter plasma levels of inflammatory
      mediators, suggesting that its ability to clear these mediators is suboptimal. Higher doses
      of hemofiltration (up to 120 ml/kg per hour) have been demonstrated to improve cardiac
      function and hemodynamics in several animal models of sepsis. High-volume hemofiltration
      (HVHF) was thus conceived and applied in patients with septic shock, showing an improvements
      in hemodynamics with decreased vasopressor requirements and improved survival in patients
      admitted after a cardiac arrest.

      The main benefit described with high volume hemofiltration is a hemodynamic improvement (e.g
      reduction in catecholamines' requirement). This improvement seems to be due to the removal of
      a badly defined network of middle molecular weight peptides. To remove efficiently these
      middle molecular peptides, a high filtration rate is needed. However, with high filtration
      rates, there is also a high clearance for smaller molecules, including antibiotics,
      electrolytes, vitamins, trace elements and amino acids.

      The cascade hemofiltration system has been designed for a more efficient removal of middle
      molecular weight peptides with a limited solute consumption.

      The goal of this study is the evaluation of the hemodynamic improvement using cascade
      hemofiltration in patients treated for septic shock.
    


Intervention name(s): Cascade; Standard treatment
Intervention type(s): Device; Other
Intervention description(s): Cascade treatment over 48h; Standard therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Satisfaction With Care and Quality of Life
Condition: Chronic Disease
MeSH terms: Chronic Disease
Study type: Observational

Summary: 
      Investigating the predictive value of patient satisfaction with care on 6 months and 1-year
      quality of life.
    

Detailed description: 
      Background: Evaluating the impact of complex procedures of patient care for chronic disease
      patients is one of the objectives and priorities defined in the French framework of the
      Public Health Act of August 2004. The relevant indicators that predict the impact of the
      medium-term hospitalization on the quality of life remain to be explored.

      Preliminary data showed that care satisfaction, usual indicator of quality of care, was
      associated with quality of life away from the hospital, especially in the field of
      orthopedics (prosthetic surgery). Satisfaction is an indicator currently collected in routine
      periodic surveys in all establishments. This project will test the hypothesis of the
      prognostic role of this satisfaction after a medical or a surgical treatment in people
      hospitalized for chronic disease.

      Objective: The objective of this research is to investigate the prognostic value of
      satisfaction with care on the quality of life of patients with chronic disease hospital, at 6
      months and 1 year of discharge.

      Patients and methods: A multicenter cohort of 1520 patients hospitalized in medical and
      surgical units for chronic disease (in the field of cardiovascular, musculoskeletal,
      nephrology, urology, digestive, pulmonary or endocrine). Patients will respond to PJHQ
      satisfaction questionnaire at the waning of their hospital stay. The quality of life (SF-36)
      will be measured at 6 months and 1 year after hospitalization.

      The socio-demographic characteristics, diagnosis, anxiety state (HAD), optimistic /
      pessimistic personality (LOT-R), comorbidities (Charlson and Functional comorbidity index),
      major health events (rehospitalization, death ) and the characteristics of the stays and care
      structure (cluster services) who welcomed them will be saved.

      The number of subjects required was calculated based on a cluster sampling (13 poles or
      services between institutions) to highlight with a power of 80% a difference of 5 points of
      quality of life among the satisfied and less satisfied subjects.

      Statistical analysis will study the relationship of satisfaction scores with QoL dimensions
      at 6 months and 1 year, in hierarchical regression multilevel models adjusted for confounding
      variables.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Population-based
Nicotine and Cotinine Levels in Smokers With Schizophrenia and Schizoaffective Disorder - 2
Condition: Schizophrenia and Disorders With Psychotic Features; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder; Schizophrenia; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
Study type: Observational

Summary: 
      Nicotine dependence is very common among individuals with schizophrenia and schizoaffective
      disorder. Cotinine is a chemical that is made by the body from nicotine. Measuring levels of
      nicotine and cotinine is an accurate way to determine how much cigarette smoke enters a
      person's body. The purpose of this study is to measure nicotine and cotinine levels in
      smokers with schizophrenia or schizoaffective disorder to determine if such individuals
      absorb more nicotine per cigarette than smokers without schizophrenia-related disorders.
    

Detailed description: 
      Schizophrenic individuals have higher urinary cotinine levels compared to non-schizophrenic
      individuals with a similar smoking history. This suggests that schizophrenic individuals may
      absorb higher doses of nicotine. The purpose of this study is to determine whether smokers
      with schizophrenia or schizoaffective disorder have higher serum nicotine and cotinine levels
      in comparison to smokers without schizophrenic-related disorders.

      This observational, case-control study will enroll 150 participants, of which 100 will be
      smokers with schizophrenic-related disorders and 50 will be smokers without a mental illness.
      Upon completing baseline assessments, participants will smoke a single cigarette.
      Approximately two minutes following, 3 to 4 ounces of blood will be analyzed for nicotine and
      cotinine levels. An expired carbon monoxide reading will also be measured. This measurement
      correlates with the amount of smoke inhalation. Individual participant studies will be
      completed in 1 to 2 hour-long sessions.
    

Time perspective: Prospective
Keywords: nicotine dependence
Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study was to examine the effect of zoledronic acid and alendronate on bone
      metabolism as measured by biomarkers in postmenopausal women with osteoporosis.
    


Intervention name(s): Zoledronic acid 5 mg solution; Alendronate 70 mg tablets; Calcium/Vitamin D
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Zoledronic acid was supplied as a concentrate of 5.33 mg zoledronic acid monohydrate in a 100 ml solution. 5.33 mg zoledronic acid monohydrate equals 5 mg zoledronic acid.; Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal.; Combined elemental calcium / vitamin D chewable tablets. Participants took 2 tablets a day, for a daily dose of calcium 1200 mg/vitamin D 800 IU.
Intervention MeSH terms: Vitamin D; Zoledronic Acid; Alendronate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: osteoporosis; bisphosphonate; biomarker; zoledronic acid; alendronate; postmenopausal
Reducing Obesity Health Disparities in Hispanic Youth
Condition: Overweight; Family Relations; Adolescent Behavior; Drug Use; Sexual Behavior
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      The proposed study will evaluate the efficacy of a family-based obesity prevention
      intervention in increasing physical activity and improving the quality of dietary intake
      among Hispanic Youth. Additional primary outcomes that will be examined include drug use and
      sexual risk behaviors. Secondary outcomes include examining the effects of family functioning
      and BMI. The knowledge expected to be gained in this study will have strong implications for
      prevention as well as contribute to the reduction of obesity-related health disparities seen
      in Hispanic youth.
    

Detailed description: 
      This study's aims are: AIM 1: To examine the relative efficacy of Familias Unidas, extended
      to target obesity, in increasing physical activity and improving the quality of dietary
      intake among overweight Hispanic youth and AIM 2: To examine whether and to what extent
      family functioning partially mediates the effects of Familias Unidas on physical activity and
      quality of dietary intake.

      H1: Familias Unidas will be efficacious, compared to Community Practice, in increasing
      Hispanic youth's past moderate to vigorous physical activity over time.

      H2: Familias Unidas will be efficacious, compared to Community Practice, in improving
      Hispanic youth's past quality dietary intake (defined as decreases in dietary intakes of
      sugar-sweetened beverages, fast foods, and increases in dietary intakes of fresh fruits and
      vegetables) over time.

      H3: Familias Unidas' effects on youth's past day moderate to vigorous physical activity and
      youth's past quality dietary intake will be partially mediated by changes in family
      functioning over time.
    

Intervention name(s): Familias Unidas
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: prevention; Hispanic adolescents; obesity and overweightness; family functioning; sexual risk behavior
6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the long-term efficacy of eszopiclone administered for up to 6 months in subjects
      with primary insomnia on subjective sleep measures, compared to placebo.
    

Detailed description: 
      This is a double blind, randomized (2:1; eszopiclone : placebo), placebo-controlled,
      multicenter, study of eszopiclone in subjects with primary insomnia. The study will involve
      up to 9 visits and subject participation will be approximately 224 days. After meeting all
      screening criteria, subjects will be randomized to either eszopiclone 3 mg QD or placebo.
      This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired
      by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to
      Sunovion Pharmaceuticals Inc.
    

Intervention name(s): Eszopiclone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Eszopiclone 3 mg; Placebo tablet
Other intervention name(s): Lunesta; S-Zopiclone
Intervention MeSH terms: Eszopiclone; Zopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers
Condition: Healthy Adult Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of two dose levels of
      OP0201 and placebo, when administered intranasally in healthy adults subjects.
    


Intervention name(s): Drug: OP0201; Drug: Placebo
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Drug OP0201; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a multicenter, open-label study to evaluate the dose of Orenitram® (treprostinil)
      Extended Release Tablets achieved at 16 weeks after a short-term course of Remodulin®
      (treprostinil) Injection in subjects with pulmonary arterial hypertension (PAH).
    

Detailed description: 
      Subjects were initiated on subcutaneous (SC) or intravenous (IV) treprostinil and titrated to
      a dose that improved the symptoms of PAH while minimizing excessive pharmacologic effects.
      After achieving a minimum SC/IV treprostinil dose of 20 ng/kg/min, subjects began a
      transition to oral treprostinil at the Transition Visit, which occurred at the Week 2, 4, or
      8 study visit. After the Transition Visit, oral treprostinil titration continued through Week
      16 to reach the maximum tolerated dose (MTD).
    

Intervention name(s): Intravenous/Subcutaneous Treprostinil; Oral Treprostinil
Intervention type(s): Drug
Intervention description(s): Short-term course of IV or SC treprostinil continuous infusion followed by transition to oral treprostinil extended-release (XR) tablets taken 3 times daily (TID)
Other intervention name(s): Remodulin; Orenitram
Intervention MeSH terms: Treprostinil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary hypertension; Treprostinil; Pulmonary arterial hypertension; Remodulin; Orenitram
A Study of 18F-AV-45 in Healthy Volunteers
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed
      throughout the body.
    


Intervention name(s): florbetapir F 18
Intervention type(s): Drug
Intervention description(s): IV injection, 370MBq (10mCi), single dose
Other intervention name(s): 18F-AV-45; Amyvid; florbetapir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Amyloid imaging; Positron Emission Tomography; 18F-AV-45; florbetapir F 18; Diagnostic imaging
A Phase ll Study of IMM-124E for Patients With Non-alcoholic Steatohepatitis
Condition: Non-alcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and preliminary efficacy of two dose levels of IMM-124E
      in reducing liver fat and/or serum alanine aminotransaminase (ALT) compared with placebo.
    

Detailed description: 
      Subjects who provide voluntary written informed consent will be screened for eligibility.
      Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to
      participate.

      Eligible subjects will be randomized at the Baseline visit to receive one of the three study
      treatments three times daily for a period of 24 weeks. Each subject will return to the study
      clinic for assessment and required study procedures on Day 7, 14 and 28 and every 4 weeks
      thereafter until Week 24.
    

Intervention name(s): IMM-124E; Placebo
Intervention type(s): Biological; Other
Intervention description(s): IMM-124E; Matched placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Optimizing Adherence and Glycemia in Youth With New Insulin-dependent Diabetes Mellitus (IDDM)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This 2-year randomized, controlled trial examined the impact of a clinic-based, family
      teamwork intervention on glycemic control in youth with recently diagnosed type 1 diabetes.
    


Intervention name(s): Family Teamwork Intervention
Intervention type(s): Behavioral
Intervention description(s): Families in the teamwork group received quarterly psychoeducational interventions at regular clinic visits, focusing on promoting family teamwork and reducing diabetes-specific family conflict and diabetes burnout.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes; glycemic control; family conflict; quality of life; parental involvement