bioihbjkbjnl/mcl2 huggingface dataset:
Denosumab Effect on Bone Quality and Function After Lumbar Fusion Surgery
Condition: Osteopenia; Spine Fusion; Denosumab Allergy
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      Degenerative lumbar spinal diseases have become a common health problem and the most frequent
      indication for spinal surgery in elderly individuals. It mainly contain lumbar spinal
      stenosis and spondylolisthesis, occurs in most people over 60 years of age, and patients
      primarily diagnosed with lumbar degenerative disease are more likely to have osteoporosis.
      Our study was to explore denosumab effect on bone quality and functional status in osteopenia
      patients with lumbar degenerative diseases after lumbar fusion surgery.
    

Detailed description: 
      However, It was still unknown for denosumab effect on osteopenia patients after lumbar
      fusion. Bone mineral density(BMD), bone turnover marker, lumbar functional status
      Roland-Morris Disability Functioning Questionnaire (RMDQ) and quality of life EuroQol
      Five-Dimension (EQ-5D), and Quality of Life Questionnaire of the European Foundation for
      Osteoporosis-31 (QUALEFFO-31) score, rate of new fracture, re-operation, lumbar fusion,
      complications or adverse events were still unknown. Our study will explore the effect of
      denosumab on lumbar, total hip, femoral neck BMD and bone turnover markers, functional status
      EQ-5D, QUALEFFO-31 and RMDQ score of participants after lumbar fusion at 12 months follow-up.
    

Intervention name(s): Denosumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Denosumab 60 mg per 6 month were injected subcutaneously on the same day after lumbar fusion surgery, and all participants received calcium supplementation 1200 mg/D and vitamin D 800 IU/D.; Equal volume of saline (0.9%) as placebo Q6M were injected subcutaneously on the same day after lumbar fusion surgery, and all participants received calcium supplementation 1200 mg/D and vitamin D 800 IU/D.
Other intervention name(s): Denosumab 6 month/subcutaneous; Placebo 6 month/subcutaneous
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Scouting Nutrition and Activity Program
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of the study was to evaluate the effectiveness of an intervention designed to
      prevent obesity by improving the environmental characteristics of Girl Scouts troop meetings.
    

Detailed description: 
      Girls and parents affiliated with Girl Scouts Juniors programs completed a questionnaire
      prior to the beginning of an intervention program, and again after the program. Children
      responded to previously validated questionnaire items assessing demographics, parent-child
      connectedness, parent-child physical activity, screen time usage, family meal-time
      environment, consumption of fruits and vegetables, soda, and fast food. Parents completed a
      similar questionnaire, assessing demographics, parent-child connectedness, parent-child
      physical activity, family mealtime environment, parenting style and parenting practices.
      Children were also assessed on height and weight to characterize their risk for overweight
      status. Questionnaires and environmental observations were used to assess the effectiveness
      of an intervention designed to improve the family meal-time environment at home, as well as
      helping to assess the relationships between parental factors and family health-related
      behavior.
    

Intervention name(s): Scouting Nutrition and Activity Program; Standard-care attentional control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intervention group will receive a curriculum based on social cognitive theory, wherein children will be taught skills in a supportive environment to improve their self efficacy and proxy efficacy toward eating healthful meals and being physically active with a parent. Troop leaders and parents will provide support, and help girls to create healthy opportunities in the home environment. Simultaneously, girls will be taught skills to improve the family mealtime environment, to bolster asking skills toward healthy behavior, to self-monitor healthy behavior, and to set goals for healthy behavior.; Control troops complete usual troop meeting activities. Control troops receive equal observation time, equal pretest and posttest assessment, and equal study scrutiny.
Other intervention name(s): SNAP; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: obesity prevention; girl scouts; physical activity; family meals; fruits and vegetables; health promotion
Sperm DNA Damage to Intracytoplasmic Sperm Injection Outcome
Condition: Infertility, Male
MeSH terms: Infertility; Infertility, Male
Study type: Observational

Summary: 
      In the current era of assisted reproductive techniques where technology can help overcome
      defects in sperm function, the value of semen analysis has become even more inaccurate.
      Initial reports of intracytoplasmic sperm injection revealed its ability to bypass the
      natural selection process and enable men with severely impaired semen parameters to achieve
      both clinical pregnancy and live birth
    


Intervention name(s): Sperm DNA integrity by flow cytometry
Intervention type(s): Diagnostic Test
Intervention description(s): flowcytometric test where sperm DNA breaks are evaluated indirectly through the DNA denaturability. The assay measures the susceptibility of sperm DNA to acid-induced DNA denaturation in situ, followed by staining with the fluorescence dye acridine orange. By using a flow cytometer 5.000-10.000 sperm can be analyzed within few seconds and thus provide a less subjective result compared to the World health organization analysis where only 1-300 cells are analyzed.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will include all infertile couples undergoing intracytoplasmic sperm injection in
        The Department of Dermatology and Andrology with assisted reproductive unit at women's
        health hospital, Assiut University Hospital.
Occlusal Outcomes by OGS After a Finishing Protocol
Condition: Malocclusion; Orthodontics
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      Evaluation of the effects of the implementation of a new finishing protocol in orthodontics
      patients
    

Detailed description: 
      Patients who are being treated in the postgraduate orthodontic clinics and who meet the
      inclusion and exclusion criteria, will be subject to a detailed evaluation according to the
      OGS criteria and upon meeting the treatment completion criteria they will be placed an
      aligner with setup for 3 weeks. The scores obtained before and after the aligner will be
      compared with a historical control group The OGS score obtained for each group, will be
      compared and the impact of the protocol and the aligner will be evaluated
    

Intervention name(s): T1 before aligner; T2 after the aligner; Historic control group
Intervention type(s): Device; Other; Other
Intervention description(s): The UDEA2 finishing protocol include: Training of the clinicians, evaluation of finishing records, checklist according OGS items, using of aligner with set-up); The UDEA2 finishing protocol include: Training of the clinicians, evaluation of finishing records, checklist according OGS items, using of aligner with set-up)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: One historic control group (UDEA1)comparing with intervention group (UDEA2) ( before and after)
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Finishing protocol; Aligner
BIDI Stick ENDS Abuse Liability and Puffing Topography Assessment
Condition: E-cigarette Use; Cigarette Smoking
Study type: Interventional

Summary: 
      This study assessed the abuse liability (measured by assessing how much nicotine enters the
      body when the BIDI Stick is used, and how this makes users feel) and puffing topography (puff
      characteristics like volume and duration) of the BIDI Stick ENDS, a type of electronic
      cigarette.
    

Detailed description: 
      This is a part-randomized, open label abuse liability assessment (ALA) and puffing topography
      study of nicotine-containing products carried out in 18 healthy adult volunteers who smoke
      combustible cigarettes.

      Subjects will attend the study site 8 times (Visits 2-9) during the main study for ALA and
      puff topography assessments. Prior to each visit, subjects will be required to refrain from
      using any nicotine-containing products for a period of at least 12 hours before study product
      use.

      At Visit 2, the subjects will smoke their usual brand cigarette during 2 use sessions. In the
      first session, subjects will smoke a single combustible cigarette of their usual brand by
      taking 10 puffs, 30 seconds apart. Blood samples will be obtained for plasma nicotine
      analysis, and blood pressure and heart rate will be recorded. Subjects will be asked to
      complete subjective effects questionnaires at various points either before, during, or after
      product use.

      In the second session, which will begin immediately after the last blood draw following the
      first session and after all questionnaires have been completed, subjects will be allowed to
      take ad libitum puffs on their usual brand cigarette for a period of 60 minutes (1 hour). In
      a randomly-selected subset of 8 subjects, during this ad libitum puffing session puffing
      topography measurements will be made with a CReSS Pocket device. Subjects may smoke as many
      cigarettes as they like. In all subjects, a blood sample for nicotine PK analysis will be
      drawn at the end of the session. Blood pressure and heart rate will be recorded at this time.
      Subjective effects questionnaires will also be completed at specified timepoints.

      At Visits 3-9, the subjects will use their randomly-assigned ENDS product during 2 use
      sessions. These use sessions, and the assessments made, will be the same as at visit 2. Prior
      to visit 3-9, subjects will be provided with a supply of their randomly-assigned product to
      use at home before their next visit (familiarization). This familiarization period should
      last a minimum of 2 and a maximum of 5 days.
    

Intervention name(s): Tobacco products
Intervention type(s): Other
Intervention description(s): Products will be used under defined (10 puffs, 30 seconds apart) and ad libitum puffing conditions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System
Condition: Surgical Wound
MeSH terms: Surgical Wound
Study type: Interventional

Summary: 
      The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical
      Closer Vascular Sealing System in sealing femoral arterial access sites.
    

Detailed description: 
      The objective of the trial is to demonstrate the safety and effectiveness of the Rex Medical
      Closer Vascular Sealing System (VSS) in sealing femoral arterial access sites and providing
      reduced times to hemostasis (TTH) compared with performance goals at the completion of
      diagnostic or interventional procedures performed through 5, 6 or 7 Fr procedural sheaths.
      This study will be considered a success (from a statistical perspective) if it meets both the
      Closer VSS superiority goal for the primary effectiveness analysis and the Closer VSS
      performance goal for the primary safety analysis.
    

Intervention name(s): Closer VSS
Intervention type(s): Device
Intervention description(s): At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.
Other intervention name(s): Rex Medical Closer TM Vascular Sealing System (VSS)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: arteriotomy; vessel closure; femoral access site
Characterizing the Pharmacokinetic Profile of a Novel Encapsulated Caffeine Beverage and Associated Mood and Physiological Effects
Condition: Alertness
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to compare self-reported mood states for encapsulated caffeine
      compared to dose-matched free caffeine, when consumed as a ready-to-drink beverage in healthy
      subjects. Additionally, this study will characterize the plasma caffeine pharmacokinetic
      profile for the encapsulated and free caffeine beverages. Two different caffeine levels, 160
      and 250 mg will be included, which represent more common caffeine consumption from typical
      energy drinks.

      The primary outcomes are alertness ratings from the Caffeine Research visual analog scale
      (VAS) and PK parameters over 12 hours. Secondary outcomes are Caffeine Research VAS scores
      (beyond alertness), three other symptom VAS scores, and vital signs for safety.
    


Intervention name(s): Flavored caffeinated beverage
Intervention type(s): Other
Intervention description(s): 16.9 oz (500 cc), carbonated, zero calorie
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: caffeine; beverage; energy; mood; encapsulated; Caffeine Research VAS
Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)
Condition: Varicose Veins
MeSH terms: Varicose Veins
Study type: Interventional
Phase: Phase 1

Summary: 
      Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and
      may cause discomfort. In this study, patients with varicose veins in the legs will be
      participating. The purpose of this research study is to evaluate the pharmacokinetic profile
      of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM), an
      investigational treatment for varicose veins.
    


Intervention name(s): Polidocanol Endovenous Microfoam (PEM)
Intervention type(s): Drug
Intervention description(s): Pharmacokinetic comparison of different doses of drug
Intervention MeSH terms: Polidocanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Varicose Veins; SFJ Reflux
Trauma Services Intervention to Prevent Violence
Condition: Skin Injury Due to Violence; Gunshot Wound, Contact
MeSH terms: Wounds, Gunshot
Study type: Interventional

Summary: 
      Primary outcome: Research participants and their network contacts will be followed over 6
      months to assess whether a social work case management protocol results in reduction of
      trauma services recidivism and criminal violence arrests.
    

Detailed description: 
      Allegheny County, PA continues to suffer between 100-120 homicides each year, with perhaps
      2-3 times as many gunshot injuries that require hospitalization. Firearm homicides
      overwhelmingly affect African American men aged 15-35. Building on prior efforts in violence
      prevention, the investigators propose to launch a hospital trauma service intervention that
      will take advantage of a "teachable moment" in the emergency room. All four hospitals
      providing Level I Trauma services in Allegheny County have agreed to host the program, an
      evidence-based effort developed by the National Network of Hospital Violence Intervention
      (NNHVI). Adaptation of the NNHVI model will focus on the social networks of gunshot victims
      as well as the victims themselves. Intervention efforts will range from job training and
      mentoring to relocation to different communities. The investigators will offer the
      opportunity to participate in the research and receive the intervention to all gunshot
      victims identified in county Level I trauma services. Participants in the research protocol
      will be asked to recruit their high-risk social network members for the intervention.
    

Intervention name(s): Social Work Case Management
Intervention type(s): Behavioral
Intervention description(s): The National Network of Hospital Violence Intervention (NNHVI) suggests that intervening when gunshot victims are receiving treatment in hospital trauma services may be effective in linking high-risk individuals to appropriate case management services, and that this service linkage may lower the risk of further violence. Our adaptation of the NNHVI model will focus on the social networks of gunshot victims as well as the victims themselves. Intervention efforts will range from job training and mentoring to relocation to different communities.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Violence; firearm; guns; homicide; trauma; injury
Reduction of Sweetened Beverages and Intrahepatic Fat
Condition: Obesity; Dyslipidemia; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Dyslipidemias
Study type: Interventional

Summary: 
      The study will enroll 68 overweight male and female subjects with a high (> 2 3dl-can
      soda/day) consumption of sweetened beverage per day. After a run-in period of 4 weeks,
      subjects will be randomized to either a 12-week intervention arm in which sweetened beverages
      will be replaced by artificially sweetened, calorie-free beverages, or to a control arm. The
      following measurements will be performed at the end of the run-in period and at the end of
      the intervention period

        -  intrahepatic fat concentration

        -  visceral fat volume

        -  changes in day-long metabolic profile from baseline(plasma glucose, insulin, and
           triglyceride concentrations)

        -  changes in food intake and daily energy, carbohydrate and sugars intake from baseline
    


Intervention name(s): artificially sweetened sodas
Intervention type(s): Other
Intervention description(s): subjects will be allowed unlimited consumption of calorie-free, artificially-sweetened sodas, water, tea or coffee
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: sugar; sweetened beverages; hepatic steatosis; visceral obesity; metabolic syndrome
Phenylephrine or Norepinephrine for a Better Hemodynamic Stability
Condition: Hypotension; Fluid Therapy
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 3

Summary: 
      A prospective, double-blinded study. The present study consisted in applying Stroke volume
      variation fluid guided therapy to old patients (65 years old) undergoing radical resection of
      colon surgery. The aim of this study is to compare the effects of norepinephrine and
      phenylephrine in treating perioperative hypotension, and to find the safest and most
      effective vasopressor for elderly.
    

Detailed description: 
      Fluid management has a great influence on patient's morbidity, mortality and on the overall
      outcome.Goal directed therapy was proved by multiple studies to be a goal therapy in
      maintaining a stable hemodynamic state. Nevertheless, as the population worldwide is aging,
      elderly presenting for surgery are also increasing. This population is known for the multiple
      comorbidities and physiological changes which makes them prone to dehydration and
      hypotension. That's when we are going to use either Norepinephrine in one group or
      Phenylephrine in the other and compare the effects of both vasopressors.

      Parameters we are going to use are: Hemodynamic (HR, MAP, CO, CI, SVV, SV); Tissue
      Oxygenation and perfusion (DO2, VO2, ERO2, CRT, Lactate, blood gas); Urine output.
    

Intervention name(s): phenylephrine; Norepinephrine
Intervention type(s): Drug; Drug
Intervention description(s): phenylephrine 100ug/ml IV infusion at a rate of 5ml/h in case of hypotension.; Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of hypotension
Other intervention name(s): α1-adrenergic receptor agonist; vasopressor; noradrenaline; catecholamine
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Norepinephrine; Adrenergic Agonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: svv; norepinephrine; phenylephrine; elderly
Psychological Influences on Postoperative Recovery
Condition: Care, Postoperative; Pain, Postoperative; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures; Tonsillectomy; Adenoidectomy
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary hypothesis tested in this project is that the preoperative behavioral stress
      response predicts postoperative behavioral and clinical recovery of children undergoing
      surgery.
    


Intervention name(s): Preoperative Preparation Program (Child Life Specialist); Midazolam; Parental Presence during Induction of Anesthesia; PPIA preparation program PLUS Midazolam premedication
Intervention type(s): Behavioral; Drug; Behavioral; Other
Intervention description(s): This group will receive the standard preoperative visit to the hospital with Child Life intervention; 0.5 mg/kg oral midazolam; One parent will be present during induction of anesthesia of the child. The parent will be accompanied out of the OR by a nurse once the induction is completed. These parents will have completed a parent preparation program.; Subjects in this group will receive both interventions 2 and 3.
Other intervention name(s): Versed; PPIA Preparation Program
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Drug-Drug Interaction (DDI) Study of LY3437943 in Obese Participants
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine the effect of LY3437943 when administered
      subcutaneously on the levels of midazolam, warfarin and caffeine in the blood stream when
      administered orally as a drug cocktail in obese participants. This study will last up to
      approximately 25 weeks for each participant.
    


Intervention name(s): LY3437943; Midazolam; Warfarin; Caffeine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered SC.; Administered orally.; Administered orally.; Administered orally.
Intervention MeSH terms: Midazolam; Caffeine; Warfarin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Overweight; Obesity; Drug Interaction; Cocktail; Pharmacokinetic