bioihbjkbjnl/mcl2 huggingface dataset:
Methodological Evaluation of Gingival Crevicular Fluid Volume and Elastase Level
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      The mechanisms underlying the formation and composition of gingival crevicular fluid (GCF)
      and its flow into and from periodontal pockets are not understood very well. The aim of this
      study was to evaluate the length of sampling time and sequential sampling of GCF neutrophil
      elastase (NE) enzyme activity by using intracrevicular and orifice methods.
    

Detailed description: 
      Twenty adults (mean age of 41.8 years. ranged 31-60 years. 18 males. 2 females) with chronic
      periodontitis were enrolled and all completed the 3-day study. Three-hundred-sixty samples of
      GCF were harvested from the interproximal sites of each of the two maxillary non-molar teeth
      according to the orifice method. Each site was sampled three times with 1-min intervals
      between repeat samples. By using intracrevicular method, the other 360 samples of GCF were
      collected on the same sites following 10-minutes interval. In first day, 2nd day and 3rd day
      the length of sampling time in seconds and order were 5. 10. 30; 10. 30. 5 and 30. 5. 10.
      respectively. GCF elastase activity was determined by hydrolysis of neutrophil specific
      substrate N-methoxysuccinyl-Ala-Ala-Pro-Val-p-nitroanilide and was expressed as concentration
      (microU/microl) and total enzyme activity (microU).
    

Intervention name(s): Gingival crevicular fluid collection with filter paper
Intervention type(s): Other
Intervention description(s): Gingival Crevicular Fluid Dynamics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Latin American Survey of Nutrition and Health / Estudio Latinoamericano de Nutrición y Salud
Condition: Dietary Habits; Physical Activity; Overweight and Obesity
MeSH terms: Overweight
Study type: Observational

Summary: 
      This study aims to make a proper scientific assessment on the dietary intake and physical
      activity levels of a representative sample of the urban population of 8 Latin American
      countries (Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Perú and Venezuela). The
      study was based on complex, multistage sample design, stratified by conglomerates, being all
      regions of each country represented, and random selection of main cities within each region
      according to probability proportional to size method. Sample will be stratified by gender,
      age (15 to 65 years old), and socioeconomic level. Socioeconomic levels will be balanced and
      divided in three strata (high, medium and low) based on national indexes used in each
      country. All the study sites are university-based and will adhere to a common study protocol
      for training, implementation of fieldwork, data collection and management, and quality
      control procedures to be performed simultaneously. All participants will be required to
      provide a written informed consent. A pilot study at small scale will be performed in each
      country in order to test procedures and tools involved in ELANS. Anthropometric variables,
      including body weight, height, waist, hip and neck circumferences will be measured according
      to a standardized protocol. Nutritional intake evaluation will be performed using two 24-hour
      dietary recalls, with 'multiple pass' procedure and a food frequency questionnaire.
      Nutritional data will be entered in Nutrition Data System for Research (NDS-R, Minnesota
      University) after a harmonization process between local foods and NDSR database. Physical
      activity and energy expenditure will be assessed by IPAQ-long version questionnaire and 7-day
      accelerometry.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The sample will include subjects of both sexes, between 15 and 65 years old, considering
        four age ranges (as see below), that belong to high, middle or low socioeconomic levels
        (SEL), living in private households in the major cities and other relevant cities in terms
        of population weight, according to the regions of each of the countries selected for the
        study.
Effects of Cognitive Behavioral Therapy (CBT) on Weight Maintenance After Successful Weight Loss
Condition: Obesity; Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of CBT after a successful weight loss by a
      comprehensive weight loss plan on weight maintenance in obese female adults.
    


Intervention name(s): CBT + Hypo-energetic Diet; Hypo-energetic Diet only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This group will have cognitive behavioral therapy classes + follow the hypo-energetic diet after losing at least 10% of their body weight by using a weight loss program. They will also have monthly follow-up to 6 months by fortnightly dietician visit.; This group will receive the hypo-energetic diet only after losing at least 10% of their body weight by using a weight loss program. They will also have monthly follow-up to 6 months by fortnightly dietician visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: weight maintenance; cognitive behavior therapy; successful weight loss
Erythrocyte Transfusion Based on the Measurement of Central Venous Oxygen Saturation in Postoperative Cardiac Surgery
Condition: Cardiac Surgery
Study type: Interventional

Summary: 
      Postoperative erythrocytes transfusion is associated with morbidity and excess mortality,
      which should lead to ask the indication for RBC transfusions only on metabolic needs.
      Currently, the majority of studies used to put hemoglobin values indicating red cell
      transfusions. Two observational studies have confirmed that a transfusion strategy based on a
      metabolic index (ScvO2) individual was accompanied by a different transfusion strategy than
      using the hemoglobin threshold values. We propose to conduct the first randomized multicenter
      study to evaluate erythrocyte transfusion strategy in postoperative cardiac surgery using the
      ScvO2 each patient versus a threshold value usually recommended for all patients.
    

Detailed description: 
      Postoperative erythrocytes transfusion is associated with morbidity and excess mortality,
      which should lead to ask the indication for RBC transfusions only on metabolic needs.
      Currently, the majority of studies used to put hemoglobin values indicating red cell
      transfusions. Two observational studies have confirmed that a transfusion strategy based on a
      metabolic index (ScvO2) individual was accompanied by a different transfusion strategy than
      using the hemoglobin threshold values. We propose to conduct the first randomized multicenter
      study to evaluate erythrocyte transfusion strategy in postoperative cardiac surgery using the
      ScvO2 each patient versus a threshold value usually recommended for all patients.
    

Intervention name(s): SVO2 group / control group
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ScVO2; Post operative red cell transfusion
Soft Mist Spray Device for Airway Anaesthesia During Awake Videolaryngoscopy
Condition: Airway; Anesthesia, Local
Study type: Interventional

Summary: 
      Rationale:

      Effective and fast topical anaesthesia of the upper airway is of paramount importance in
      awake (conscious) videolaryngoscopy of the airway in order to avoid patient discomfort.
      Different methods of anesthetizing the airway have been described. Conventional topical
      airway anaesthesia is not always effective due to non-optimal flow patterns and generation of
      ineffective local anaesthetic aerosols. Other methods of anaesthetizing the airway are more
      invasive. In order to optimize topical anaesthesia of the airway a soft mist spray device
      (Trachospray) for topical anaesthesia of the airway has been developed, in which optimal
      airflow patterns are obtained and local anaesthetic aerosols are generated which will reach
      the target zone for anesthetizing the airway.

      Objective: In this study, the Trachospray will be used for awake videolaryngoscopy, to
      evaluate its use, effectiveness and comfort level for patients and anaesthesiologist.

      Study design: Interventional study.

      Study population: 20 healthy human volunteers, ASA 1, 18-60 years old.

      Intervention: Subjects will be asked to inhale 4 ml lidocaine 4% via the Trachospray device

      Main study parameters/endpoints:

      Anaesthesia of the airway as evaluated with successful awake videolaryngoscopy with minimal
      discomfort for the subject.

      Nature and extent of the burden and risks associated with participation:

      Risk management on the Trachospray device shows that all user risks are mitigated and no
      residual risks remain for the use of the device. Testing of the device and the application of
      the device in daily practice has no additional risks than the present technique of performing
      anaesthesia of the airways.There may be some discomfort during the procedure, mainly airway
      irritation which may cause coughing or gag reflex.
    


Intervention name(s): Trachospray for awake videolaryngoscopy
Intervention type(s): Device
Intervention description(s): Subjects will be asked to inhale 4 ml lidocaine 4% via the Trachospray device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Bioequivalence of a 2.5 mg Linagliptin / 500 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 500 mg Tablets Administered Together in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to demonstrate bioequivalence of a 2.5 mg linagliptin / 500 mg metformin fixed dose
      combination (FDC) tablet compared to single tablets of linagliptin 2.5 mg and metformin 500
      mg administered together
    


Intervention name(s): Linagliptin/Metformin FDC; Linagliptin; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Measurement of Bite Force in Humans
Condition: Dental Pulp Necrosis; Periapical Periodontitis
MeSH terms: Periodontitis; Dental Pulp Necrosis; Periapical Periodontitis; Necrosis
Study type: Observational

Summary: 
      This protocol is for a clinical trial to evaluate the reliability of the bite fork as a
      diagnostic instrument in subjects with pulpal necrosis and apical periodontitis.
    

Detailed description: 
      This clinical trial consists of two parts. We will first use the bite fork in normal
      volunteers to evaluate its test-retest and inter-rater reliability. We will then use the bite
      fork in subjects with differing endodontic diagnoses and compare these results with the
      standard clinical diagnostic test (percussion).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Normal subjects and patients with orofacial pain presenting in the dental clinic.
      
Keywords: pain; Normal pulp and normal periodontal status; Chronic apical periodontitis of pulpal origin
Post Stroke Walking Kinematics Using the Honda Walking Assist Robotic Exoskeleton
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      To investigate the effect of a robotic exoskeleton on kinematics, muscle activity, ground
      reaction forces and spatiotemporal characteristics during walking in persons post stroke.
    

Detailed description: 
      Following stroke walking dysfunction is prevalent. Traditional rehabilitation methods fall
      short of achieving desirable walking outcomes for most people who experience stroke. Robotic
      methods to assist walking, such as the Honda Walking Assist Device (HWA) Robot from Honda R &
      D Americas Inc., are being explored as a means of improving the recovery of walking post
      stroke. Prior to examining the effectiveness of exoskeletal robots for walking recovery it is
      important to understand their effect on kinematic and muscle responses during walking.
      Kinematic and muscle responses at the hip during walking with the HWA were recently
      described.

      The purpose of this study is to quantify the effect of walking with the HWA on body segments
      remote from the hip. These segments include knee, ankle, trunk and arm. The non-invasive
      measures used will include: walking kinematics (measurement of joint angles using cameras),
      muscle activity (Electromyography), ground reaction forces (detected by a force plate in the
      floor) and spatiotemporal characteristics (such as walking speed). Measures will be collected
      under three conditions: 1) walking at self-selected pace (control), 2) walking at
      self-selected pace with the HWA (4 Newton-meter assist mode for hip flexion and extension),
      3) walking immediately following HWA use (aftereffect).
    

Intervention name(s): Robotic exoskeleton for walking assist
Intervention type(s): Device
Intervention description(s): Participants will have two testing sessions in this within-subject design experiment. The conditions under which walking will be evaluated are control (normal) walking, walking with the exoskeleton assistance and walking immediately following exoskeleton walking. The conditions under which stair walking (ascending and descending) will be evaluated include control (normal) stairs and exoskeleton assisted stairs. Assistance is provided by The Honda Walking Assist (HWA) System is a robotic device developed by Honda R&D Corporation ®, Japan. The devices computer-activated motors use hip angle information to guide assistance delivered through the thigh straps to the legs in time with the walking cycle. The maximum torque delivered is 4 Newton-meters.
Intervention model: Single Group Assignment
Intervention model description: Within-subject design
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: exoskeleton; gait; kinematics; EMG; stair climbing
Redirected Auto T Cells for Advanced Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to 1) evaluate the safety and tolerability of autologous
      genetically modified T cells transduced to express the high affinity NY-ESO-1c259 TCR in
      HLA-A2+ subjects and 2) measure the incidence of GVHD in patients following infusion of TCR
      modified autologous T cells.
    

Detailed description: 
      The primary objective of this study is to evaluate the safety and tolerability of autologous
      genetically modified T cells. Genetic material is transferred into the subject's previously
      harvested autologous T cells to redirect them to target myeloma cells rather than their usual
      target. Study subjects must have systemic or multifocal myeloma requiring autologous stem
      cell transplantation whose disease has relapsed or incompletely responded to prior therapy or
      have high-risk features. Subjects must also have measureable disease on study entry, as
      defined by quantifiable or detectable levels of serum or urine paraprotein or elevated serum
      free light chains with an abnormal ratio.
    

Intervention name(s): Autologous Genetically modified T cells
Intervention type(s): Genetic
Intervention description(s): Patients will undergo myeloma restaging at days +42, +100, 6 months, 9 months and 1 year post infusion. At this point, in accordance with FDA Guidelines, all patients will enter long term follow up (LTFU) and be followed biannually for monitoring for gene transfer delayed adverse events until year 5 post infusion. From year 5, all patients will require annual LTFU visits for monitoring for delayed adverse events until year 15 after receiving the genetically modified T cells.
Patients whose disease progresses prior to year 1 will enter LTFU at time of progression; however these patients will be seen quarterly from progression until year 1 post infusion and then follow the LTFU schedule mentioned above.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple myeloma; Received initial treatment previously; Autologous stem cell transplantation
Present- Versus Past-focused Therapy for PTSD and Substance Use Disorder
Condition: Posttraumatic Stress Disorder; Substance Use Disorder; Alcohol Use Disorder
MeSH terms: Substance-Related Disorders; Alcoholism; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This study compares Creating Change, a new past-focused behavioral therapy for posttraumatic
      stress disorder (PTSD)/substance use disorder (SUD), to Seeking Safety, an evidence-based
      present-focused behavioral therapy for PTSD/SUD.
    

Detailed description: 
      This study evaluates a new behavioral therapy model, Creating Change (CC) for PTSD/SUD. CC
      helps clients explore the past as a step in their recovery process. It has major public
      health relevance in that it is a low-cost, flexible model designed for all trauma and
      substance abuse types, both genders, and all clinical settings. It has particular relevance
      for VA in that many veterans suffer from PTSD and SUD. The new model demonstrated positive
      results in two pilot studies.
    

Intervention name(s): Creating Change (CC); Seeking Safety (SS)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Creating Change is a past-focused, integrated, cognitive-behavioral therapy for PTSD/SUD. It has 17 topics, which in this study were delivered in weekly one-hour sessions, in individual format. The treatment explores how PTSD and SUD arose and interacted across the patient's life, including constructing a narrative of its meaning, processing associated emotions and memories, and exploring themes related to these.; Seeking Safety is a present-focused, evidence-based cognitive-behavioral therapy for integrated treatment of patients with PTSD/SUD. It is a cognitive-behavioral therapy comprising 25 topics, each a coping skill relevant to both disorders. In this study 17 of the 25 topics were conducted, one per weekly, one-hour, individual session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Posttraumatic stress disorder; Substance use disorder; Treatment efficacy; Randomized trial; Trauma; Substance abuse; Addiction
A Placebo-Controlled Trial of Buspirone for Treatment of Marijuana Dependence
Condition: Marijuana Abuse
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if buspirone combined with motivational enhancement
      therapy is effective in reducing marijuana use in marijuana-dependent adults.
    


Intervention name(s): Buspirone; Motivational enhancement therapy
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Buspirone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Pediatric Patients With Mild Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to compare the safety and efficacy of Protopic and Elidel in treating mild Atopic
      Dermatitis in pediatric patients
    


Intervention name(s): tacrolimus ointment; pimecrolimus cream
Intervention type(s): Drug; Drug
Intervention description(s): topical; topical
Other intervention name(s): Protopic; FK506 ointment; Elidel
Intervention MeSH terms: Pimecrolimus; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Mild Atopic Dermatitis; Protopic; Pediatric
Interaction of Apelin and Angiotensin in the Human Forearm Circulation
Condition: Heart Disease; Vasodilation
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      The apelin-APJ system is a relatively new discovery. It has generated interest in part due to
      it's apparent ability to counteract the renin-angiotensin system, which is frequently
      overactive in many cardiovascular disease.

      Angiotensin has a powerful ability to cause blood vessels constrict and reduces their
      diameter. One of the actions of apelin is to cause blood vessels to relax and the
      investigators specifically wish test the hypothesis that apelin will cause blood vessels
      constricted by angiotensin II to relax.
    


Intervention name(s): Apelin infusion; Sodium nitroprusside infusion
Intervention type(s): Drug; Drug
Intervention description(s): Infusion of up to 10picmol/min will be administered intra-arterially to induce vasoconstriction. Thereafter infusions of apelin (0.1, 1.0, 3.0nmol/min) will be given for 6mins each. During the same study, sodium nitroprusside will given (1.0, 2.0, 4.0 microg/min) for 6mins.; Infusion of up to 150-600picmol/min will be administered intra-arterially to induce vasoconstriction. Thereafter infusions of apelin (0.1, 1.0, 3.0nmol/min) will be given for 6mins each. During the same study, sodium nitroprusside will given (1.0, 2.0, 4.0 microg/min) for 6mins.
Intervention MeSH terms: Nitroprusside
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Renin Angiotensin System