bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Periodontal Therapy on Periodontal Bacteria
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      In light of the controversy that are already approved but that however still exists regarding
      the efficacy and influence of the protocols for the management of Periodontitis, the aim of
      this study was to evaluate, at 6 months follow-up, the post-treatment clinical parameters and
      immunological and gingival microbial profiles in patients with periodontitis, treated by
      either SRP in addition to full mouth scaling or quadrant scaling
    

Detailed description: 
      This trial was conducted in accordance with the World Medical Association's Declaration of
      Helsinki of 1975, and reviewed in 2008. The local ethical committee of the University of
      Messina approved the study protocol and each patient was carefully informed about the
      possible inherent risks of the study and provided their informed written consent 88 patients,
      aged 27 to 65 (mean age 57) were assessed for eligibility. In all subjects, subgingival
      plaque was acquired from 4 separate proximal sites at 180 days after therapy.
    

Intervention name(s): Full mouth or quadrant SRP
Intervention type(s): Other
Intervention description(s): Full mouth or quadrant SRP
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients undergo non-surgical quadrant scaling and root planing
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Efficacy of the Combination of Diacerein 100 mg Daily and MTX Versus MTX Alone in the Treatment of Early Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of Diacerein 100 mg daily versus placebo in reducing rheumatoid
      arthritis symptoms, when added to stable oral MTX therapy in patients with active early RA.

      To evaluate the safety of Diacerein 100 mg daily when administrated in combination with oral
      MTX therapy in those patients for up to 24 weeks

      To investigate a potential persistent effect, 4 weeks after Diacerein treatment is stopped
      (carry-over effect)
    


Intervention name(s): Diacerein; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Week 0 to Week 4: Diacerein 50 mg daily for 4 weeks Week 4 to Week 24: Diacerein 100 mg daily for 20 weeks; Week 0 to Week 4: Diacerein 50 mg daily for 4 weeks Week 4 to Week 24: Diacerein 100 mg daily for 20 weeks
Intervention MeSH terms: Diacerein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Efficacy of Diacerein; Safety of Diacerein; Carry-over effect of Diacerein
Genetics of Fatty Liver Disease in Children
Condition: Non Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Observational

Summary: 
      This is a study to investigate genetic predisposition to hepatic steatosis and the expression
      of gluconeogenic and lipogenic genes in livers of obese children and adolescents.

      Hypothesis 1: Common variants recently associated with variation in plasma TG levels
      identified in Genome Wide Association Studies (GWAS) (such as GCKR, PNPLA3) can affect
      accumulation of fat and subsequent development of Non Alcoholic Fatty Liver Disease (NAFLD).
      Gene variants act in additive or synergistic manner with progressive liver fat accumulation
      per additional risk allele.

      Hypothesis 2: With increase in hepatic fat content NASH and fibrosis will increase.
      Furthermore, expression of lipogenic markers (SREBP1c) will increase.
    

Detailed description: 
      To establish a cohort of obese youths to prospectively analyze potential factors (genetic and
      nutritional factors) that might affect the expression and progression of NAFLD. This study
      will determine genetic markers and their ability to convey susceptibility to NAFLD in obese
      children and adolescents. Furthermore, potential mechanisms that might contribute to the
      accumulation of hepatic Triglyceride (TG) accumulation will be, for the first time, assessed
      by genotyping. Additionally, we will examine the presence of intestinal microbiome in the
      development of fatty liver through stool collection.
    

Intervention name(s): ogtt; genotyping; abdominal and liver magnetic resonance imaging; stool sample; liver biopsy
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): oral glucose tolerance test; genotyping to look for risk alleles; magnetic resonance imaging scan of abdomen and liver - abdominal and liver mri; stool sample taken to investigate metabolites; liver biopsy to examine for cellular change and steatosis
Intervention MeSH terms: Liver Extracts
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The majority of the research subjects will be recruited from the Yale Pediatric Obesity
        Clinic and the Endocrine Clinic.
      
Biospecimen description: 
      Subjects with DNA samples collected
    
Keywords: non alcoholic fatty liver; childhood obesity; genetic variants
Mulligan's Bent Leg Raise Technique in Healthy Females
Condition: Hamstring Contractures
MeSH terms: Contracture
Study type: Interventional

Summary: 
      To determine the effects of mulligan's bent leg raise technique on hamstring flexibility and
      lumber spine mobility in healthy females
    

Detailed description: 
      Flexibility is a pivotal constituent of the physical fitness and held as an integral aspect
      that capacitate the person to move smoothly and safely. Although the flexibility of all the
      muscles of the body is essential for normal human function, the flexibility of hamstring
      muscle is much emphasized. Investigations suggest adequate flexibility of the Hamstring
      muscles is compulsory for a healthy lower back. Lack of hamstring muscles extensibility
      conditions a decrease of pelvic mobility. This invariably leads to biomechanical changes in
      the pressure distribution of the spine and consequent spinal disorders.

      This study will be a randomized control trial and will be conducted in health sciences
      collage in Bahawalpur. The study will be completed within the time duration of six months.
      Convenient sampling technique will be used to collect the data. The sample size of 48
      patients will be taken in this study to find the Effects of Mulligan's bent leg raise
      technique on hamstring flexibility and lumber spine mobility in healthy females. Patient will
      be divided into two groups. Static Stretching will be given to both group as a baseline
      treatment. (Group A will be treated with Mulligan's bent leg raise techniques and static
      stretching Group B will be treated with static stretching only. Participants will be assessed
      for hamstring tightness with Active Knee Extension Test (AKET) and readings will be noted and
      lumbar mobility will be assess using Modified Schober Test (MMST). Assessments will be done
      at baseline and post intervention on 5th and 10th day. Intervention will be given 5 days per
      week for two weeks. Data will be analyzed on SPSS 25.
    

Intervention name(s): Mulligan Bent Leg Raise Technique; Static Stretching
Intervention type(s): Other; Other
Intervention description(s): Participant will be in supine lying on a high couch with the resting on the shoulder. A distraction (longitudinal traction force along the long axis of femur) will be investigator in walk stand position lateral to the leg, which to be stretch. Hip and Knee of the side to be stretch will bent at 90˚- 90 ˚. Participant's flexed knee will be placed over the shoulder, the popliteal fossa of the knee applied at the lower end of femur and the participant will ask to push the shoulder with his or her leg followed by voluntary relaxation.The traction will maintained throughout the technique.; It will be given in supine position by performing passive SLR and end range will hold in 30sec.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Post-prandial Glycemic Response to Fiber in Healthy Adults
Condition: Glucose, High Blood; Glucose, Low Blood; Meals
Study type: Interventional

Summary: 
      This randomized, double-blind, comparator controlled trial evaluated the blood glucose and
      insulin responses in healthy adults, after consuming a high fiber or low fiber muffin top.
    

Detailed description: 
      The fiber administered in this trial is a resistant starch type 4 derived from high-amylose
      maize starch. This product is high in dietary fiber (70% total dietary fiber (TDF), AOAC
      2009.01 method) and can be used in a variety of bakery applications. The objective of this
      study was to evaluate the post-prandial blood glucose and insulin responses of healthy adults
      (n=28) after consuming a muffin top made with resistant starch or control muffin top, in a
      randomized, double-blind, crossover study. The muffin tops were matched for total weight,
      total carbohydrate, sugars, protein, and fat. During each 24-hour study period, subjects
      consumed a standard evening meal, fasted for 12 hours, and arrived at the study clinic the
      following morning. Serum glucose, serum insulin, and capillary glucose were measured after
      muffin top consumption. The subjects completed a seven day washout between treatments.
    

Intervention name(s): resistant starch (high fiber muffin top); control (low fiber muffin top)
Intervention type(s): Other; Other
Intervention description(s): Muffin top contained 11 g of fiber per portion; Muffin top contained 1 g of fiber per portion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: postprandial glucose insulin
54135419SUI3002: A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Suicide; Suicidal Ideation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram
      (mg) compared with intranasal placebo in addition to comprehensive standard of care in
      reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in
      participants who are assessed to be at imminent risk for suicide, as measured by the change
      from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24
      hours post first dose.
    

Detailed description: 
      If you or a loved one are having thoughts of suicide, please seek immediate medical help. Go
      to the emergency room or call the National Suicide Prevention Lifeline at 1-800-273-8255.
    

Intervention name(s): Esketamine; Placebo; Standard of Care
Intervention type(s): Drug; Drug; Other
Intervention description(s): Participants will receive intranasal esketamine 84 milligram (mg) two times per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25).; Participants will receive intranasal placebo two times per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25).; The standard of care antidepressant treatment (antidepressant monotherapy or antidepressant plus augmentation therapy) will be determined by the treating physician(s) based on clinical judgement and practice guidelines prior to randomization, and the treatment will be initiated on Day 1.
Intervention MeSH terms: Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Actigraphic Measurement of a Neurosurgical Procedure
Condition: Sleep Disorders; Circadian Rhythm; Pain; Rehabilitation; Mood Lability
MeSH terms: Sleep Wake Disorders
Study type: Interventional

Summary: 
      The study examines and illustrates the utility of utilizing actigraphic measurements to
      assess treatment response.
    

Detailed description: 
      Actigraphic measurements, repeated verbal fluency and multi-symptom operationally defined
      observations will be recorded for an 11 to 12 day baseline period and continued following
      neurosurgical tumor resection until a repeat MRI is completed three months after the
      procedure.
    

Intervention name(s): Re-section of a large left anterior cranial fossa meningioma
Intervention type(s): Procedure
Intervention description(s): Neurosurgical re-section of an incidental large left anterior cranial fossa meningioma
Other intervention name(s): Actigraphy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Neurosurgical outcome; Actigraphy; Treatment Response Measurement
Dulce Digital-Project Dulce 2.0 Texting Study
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Randomized controlled trial testing the efficacy of a text messaging intervention in a low
      income, low health literacy group of Latino patients. Project Dulce 2.0 (PD 2.0) will address
      barriers to participation in health education classes, increasing adherence to treatment and
      medications and improving diabetes self management behaviors and skills. Two community clinic
      organizations that provide services to a large proportion of Latino patients with type 2
      diabetes will participate to randomize 200 patients into one of 2 arms: standard diabetes
      management care (control) only or text messaging and standard care. Comparisons between
      groups will evaluate clinical, behavioral and psychosocial outcomes.

      Intervention: Standard Care and Text Messaging. All participants will receive standard
      diabetes care provided by primary care providers at the clinic. Of the 100 that are
      randomized to the intervention arm will be given instructions on how the text messaging
      component will be addressed throughout the duration of the study.
    


Intervention name(s): SMS texting intervention; Control-Usual Care
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: High risk Latino patients with diabetes
An Open-Trial of Web-Prolonged Exposure (Web-PE) Among Active-Duty Military
Condition: Posttraumatic Stress Disorder; Combat Disorders
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Combat Disorders
Study type: Interventional

Summary: 
      It is urgent to make evidence-based treatments (EBTs) for military personnel readily
      accessible in order to meet the growing demand for effective and efficient treatment for
      posttraumatic stress disorder (PTSD) in a timely manner. Effective EBTs for PTSD are
      available, but barriers to accessing care can deter military personnel from receiving
      treatment. Web-treatments represent an innovative way to overcome these barriers. The
      efficacy of previously developed web-treatments for PTSD appear promising, however, they are
      not based on treatment protocols with strong empirical support for their efficacy. No study
      to date has examined web-treatment of PTSD using a well-established treatment program.

      The purpose of this open trial is to examine the efficacy of 10 sessions of a web-version of
      Prolonged Exposure (PE), "Web-PE," delivered over 8-weeks in 40 active-duty military
      personnel and veterans with PTSD who deployed post 9-11. Up to 60 individuals will be
      consented to obtain data from 40 for analysis. Participants will be assessed at pre-treatment
      and 1- and 3-months after treatment completion.
    


Intervention name(s): Web-PE Therapy
Intervention type(s): Behavioral
Intervention description(s): Ten 60-minute psychotherapy sessions over 8 weeks, focused on gradually confronting distressing trauma-related memories and reminders. Web-PE is an internet-based version of prolonged exposure (PE) for posttraumatic stress disorder (PTSD).
Other intervention name(s): Internet-based prolonged exposure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Combat; Psychological Treatment; Military; Psychotherapy; Trauma; Posttraumatic Stress; Posttraumatic Stress Disorder
Study of Cytokines Serum Levels in Chronic Low Back Pain
Condition: Interleukines
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to:

        -  evaluate if there is an association between elevated levels of cytokines and chronic
           pain due to herniated disk disease

        -  measured cytokines levels in chronic low back pain and in healthy subjects.
    

Detailed description: 
      23 patients with at least three months of back pain due to herniated disk disease were
      selected Diagnosis was confirmed by magnetic resonance imaging (MRI) or computerized
      tomography (CT) imaging of the spine for all patients. In addition, pain severity had to be ³
      5 points on the Numerical Rating Scale (NRS) ranging from zero (no pain) to 10 (worst
      imaginable pain).

      The exclusion criteria were defined as one or more of the following: psychiatric disorders,
      systemic or inflammatory disease, history of allergy, presence of motor deficits, history of
      blood dyscrasia, pregnancy, active infection, tumor, use of analgesic drugs in the week
      before or inability to come to the hospital for evaluation.
    

Intervention name(s): blood collect
Intervention type(s): Other
Intervention description(s): Five milliliters of venous blood was drawn in the morning from subjects and immediately centrifuged.
Other intervention name(s): serum levels
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Cytokines; Low back pain; Intervertebral disk displacement; Interleukins; Tumor necrosis factor-alpha
Study of 24-hour Intragastric pH Profiles of Esomeprazole 40 mg and Lansoprazole 30 mg in Healthy Volunteer Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is intended to evaluate whether intravenous (iv) esomeprazole (Nexium® ) offers
      better intragastric acid suppression than iv lansoprazole (Prevacid ®
    


Intervention name(s): Nexium; Prevacid
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lansoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: N/A this study is being conducted with healthy volunteers
Comparison of Prilosec Over-the-counter (OTC)® Versus Prevacid® for Gastric Acid Suppression
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to compare Prilosec OTC® to Prevacid® for gastric acid
      suppression.
    


Intervention name(s): Prilosec OTC (omeprazole-magnesium); Prevacid
Intervention type(s): Drug; Drug
Intervention description(s): Prilosec OTC (omeprazole-magnesium 20.6 mg) tablet to be taken with a glass of water prior to breakfast; Prevacid (15 mg lansoprazole) capsule to be taken with a glass of water prior to breakfast
Intervention MeSH terms: Omeprazole; Lansoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Normal Healthy Subject Population
Uterine Tourniquet at Open Myomectomy
Condition: Myomectomy; Uterine Leiomyoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss
      at open myomectomy.
    

Detailed description: 
      Single tourniquet is applied to uterine isthmus to occlude uterine arteries. Triple
      tourniquet is applied to both infundibulopelvic ligaments and uterine isthmus.
    

Intervention name(s): triple tourniquet; Single tourniquet
Intervention type(s): Procedure; Procedure
Intervention description(s): Triple tourniquet consist of two tourniquet applied both infundibulopelvic ligaments and one uterine isthmus to occlude the left and right ovarian vessels and to occlude the uterine arteries. For this purpose, a small opening is made in the avascular place of the broad ligament on either side of the uterine isthmus superior to the uterine vessels. A pediatric Foley catheter is threaded through the two holes and tied tightly anteriorly around the cervix at the level of the internal os.
Through the same openings in the broad ligament each side a Foley catheter looped around the infundibulopelvic ligament lateral to the fallopian tube and ovary.; Single tourniquet is tourniquet applied uterine isthmus to occlude the uterine arteries. For this purpose, a small opening is made in the avascular place of the broad ligament on either side of the uterine isthmus superior to the uterine vessels. A pediatric Foley catheter is threaded through the two holes and tied tightly anteriorly around the cervix at the level of the internal os.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemorrhage; Leiomyoma; Myofibroma; Uterine Myomectomy; Tourniquet
Daily Activities Are Sufficient to Induce Dynamic Pulmonary Hyperinflation and Dyspnea in Chronic Obstructive Pulmonary Disease Patients
Condition: Dynamic Lung Hyperinflation; COPD Patients; Activities of Daily Livin.
Study type: Observational

Summary: 
      Introduction: Chronic obstructive pulmonary disease is a condition characterized by airflow
      limitation usually progressive and associated with inflammatory response of lung noxious
      particles. During a physical activity chronic obstructive pulmonary disease patients may
      develop dynamic pulmonary hyperinflation, increased dyspnea perception and decreased activity
      performance. The investigators hypothesize that some specific activities of daily living
      induce dynamic pulmonary hyperinflation in COPD patients. Objective: To measure dynamic lung
      hyperinflation and its influence in dyspnea perception in moderate and severe chronic
      obstructive pulmonary disease patients after activities of daily living. Methods: The
      investigators measured inspiratory capacity, dyspnea sensation, peripheral oxygen saturation,
      heart rate and respiratory rate in 19 chronic obstructive pulmonary disease (COPD) patients.
      These measurements were taken at rest and after daily living activities (such as going up and
      down a set of stairs, going up and down a ramp and sweeping and mopping a room).
    


Intervention name(s): Hyperinflation and ADL
Intervention type(s): Other
Intervention description(s): Assessment of dynamic pulmonary hyperinflation during activities of daily living in COPD patients.
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The investigators included 19 COPD patients (13 male) with moderate to very severe degree
        of airway obstruction, with a mean post bronchodilator forced expiratory volume in the
        first second (FEV1) of 48.7 ± 7.1% predicted and mean age of 64.1 ± 5.3.
      
Keywords: COPD; activities of daily living; pulmonary hyperinflation; exercise