bioihbjkbjnl/mcl2 huggingface dataset:
Sierra High Definition Ano-Rectal Manometry
Condition: Constipation; Fecal Incontinence
MeSH terms: Fecal Incontinence; Constipation
Study type: Observational

Summary: 
      Hypotheses: High definition manometry (HDM) is safe and feasible in humans; HDM accurately
      characterizes anorectal anatomy and function in healthy humans; HDM provides comparable
      information regarding the structure and function of the anorectal region, to that obtained
      from ano-rectal manometry and anal ultrasonography (AUS), in patients with fecal incontinence
      or constipation.

      Methods: 20 healthy volunteers, 20 patients with fecal incontinence, 20 patients with
      constipation will be recruited. Because anorectal disorders are more common in women, the
      investigators will recruit approximately 8 men and 12 women in each group. Each subject will
      undergo anorectal manometry, anal ultrasound and high definition manometry.

      Data Analysis: Spearman correlational analysis will be performed to compare the parameters
      listed above. Also, the diagnostic yield of anal ultrasonography vs HDM in identifying
      anatomic sphincter defects will be assessed.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We will recruit 20 healthy volunteers, 20 patients with fecal incontinence, 20 patients
        with constipation. Because anorectal disorders are more common in women, we will recruit
        approximately 8 men and 12 women in each group. Because it is possible subjects may sign
        consent but not participate in the study, or drop out of the study before completion, we
        will recruit a total of 80 subjects.
Transesophageal Echocardiographic Evaluation of the Effect of Dexmedetomidine Infusion as an Adjuvant to General Anesthesia on the Cardiac Function
Condition: Anesthesia
Study type: Interventional

Summary: 
      Dexmedetomidine is a selective alpha-2 adrenergic agonist that can be considered as an
      adjuvant to propofol or inhalational anesthetics. Dexmedetomidine mediate its cardiovascular
      effect through activation of receptors in central and peripheral nervous system. The classic
      cardiovascular response of dexmedetomidine is the biphasic with initial short-term increase
      in blood pressure followed by long-lasting decrease in BP and HR. There were several reports
      about these hemodynamic changes of dexmedetomidine, but not the evaluation of direct effects
      on cardiac function. The purpose of this study is to evaluate the effects of dexmedetomidine
      as an anesthetic adjuvant on cardiac function by using the transesophageal echocardiography.
    


Intervention name(s): Dexmedetomidine, Transesophageal echocardiography(TEE); Saline will be infused for 60 minutes at the same rates as dexmedetomidine group.
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for 10 minutes; resulting in a loading dose of 1 mcg/kg, followed by an infusion of 0.5 μg/kg/hr for 50 minutes.
Other intervention name(s): Precedex; Saline
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Analgesic Effects of Gabapentin After Scoliosis Surgery in Children
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary aim of this study is to determine whether the use of gabapentin will improve
      postoperative analgesia and reduce opioid consumption and side effects in children undergoing
      corrective spinal surgery for idiopathic scoliosis. Secondary aims are to evaluate whether
      use of gabapentin reduces pain scores, decreases postoperative nausea and vomiting, decreases
      persisting pain and improves patient satisfaction.
    

Detailed description: 
      Surgical correction of scoliosis involves major orthopedic surgery, and can lead to severe
      acute postoperative pain and persistent neuropathic pain. The mainstays of treating
      postoperative pain are acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs),
      systemic opioids, and local anesthetic techniques. Despite being effective, their use is
      limited by adverse side effects. Acute postoperative pain involves multiple mechanisms and
      neural pathways, therefore a combination of different analgestic medications acting through
      different mechanisms, may be the most effective treatment. This strategy may also reduce the
      need for, and side effects of, using high doses of any one particular class of drugs.

      Gabapentin is safe and well tolerated with few side effects and has minimal interactions with
      other drugs. The use of gabapentin to treat acute postoperative pain may improve quality of
      analgesia, result in decreased requirements for opioids and might consequently reduce the
      incidence of opioid induced side effects. It may also have a direct effect on postoperative
      nausea and vomiting, and decrease the incidence of persistent neuropathic pain. These
      qualities make gabapentin an attractive agent for use in management of postoperative pain in
      children undergoing corrective spinal injury.

      The primary aim of this study is to determine whether the use of gabapentin will improve
      postoperative analgesia and reduce opioid consumption and side effects in children undergoing
      corrective spinal surgery for idiopathic scoliosis. Secondary aims are to evaluate whether
      use of gabapentin reduces pain scores, decreases postoperative nausea and vomiting, decreases
      persisting pain and improves patient satisfaction.
    

Intervention name(s): Gabapentin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients in this arm of the study will receive two identical capsules, containing 300 mg of oral gabapentin each, 1 hour before surgery.; Patients in this arm of the study will receive two identical placebo capsules 1 hour before surgery.
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatrics; Scoliosis; Gabapentin
Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER and CSG452
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical trial is to demonstrate the bioequivalence of single oral
      administration of K-001 relative to single oral co-administration of separate tablets of
      K-877-ER and CSG452 in healthy adult volunteers, and to characterize the food effect on the
      Pharmacokinetics(PK) of K-001.
    


Intervention name(s): K-001; K-877-ER; CSG452
Intervention type(s): Drug; Drug; Drug
Intervention description(s): K-877-ER and CSG452 combination tablet; K-877-ER tablet; CSG452 tablet
Intervention MeSH terms: 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Randomized, open-label, six-sequence, three-period, crossover study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study investigates the hypothesis that instability in mood in patients with borderline
      personality disorder will respond the mood stabilizing medication lamotrigine.
    

Detailed description: 
      Affective instability is one of the most prominent symptoms in borderline personality
      disorder. Currently there are no prospective studies of treatment of this symptom with mood
      stabilizing medications. This study examines the effectiveness of lamotrigine compared to
      placebo in reducing emotional instability of several types in borderline patients. The types
      of emotional instability studied involve anger, anxiety, depression, and elation. Subjects
      entering this 12 week study will be blind to whether they are receiving active medication or
      placebo. They will be asked to report levels of instability in their mood on a weekly basis.
      They will also be asked weekly to rate the intensity of other symptoms of borderline
      personality disorder symptoms, such as unstable relationships, self-harm, and impulsive
      behaviors.
    

Intervention name(s): Lamotrigine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subject in active active drug group will receive lamotrigine tablets 12.5 per day for the first week of the study. Dose of lamotrigine can be increased to 25mg per day during the second week of the study and may be increased each week thereafter for the next 9 weeks by 25mg per day. Subjects in active treatment group will receive lamotrigine for total of 12 weeks; Subjects will receive 12.5mg of inert placebo per day during the first week of the study. Inert placebo can be increased to 25mg per day during the second week of the study and by 25mg per day each week for the next 9 weeks. Subjects can receive a total of 12 weeks of placebo.
Other intervention name(s): Lamictal
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Affective Lability; Borderline Personality Disorder; Pharmacotherapy
Study of Pyridoxine for Hand-Foot Syndrome
Condition: Hand-foot Syndrome
MeSH terms: Hand-Foot Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Although pyridoxine has been used empirically for the prevention of capecitabine associated
      hand-foot syndrome (HFS), its efficacy needs to be demonstrated in prospective controlled
      trials. The investigators therefore performed a prospective randomized double-blind study to
      determine whether pyridoxine 200 mg/day can prevent the development of HFS when given
      concurrently with capecitabine. The investigators also tested the ability of pyridoxine to
      treat primary occurrence of grade 2-3 HFS.
    

Detailed description: 
      Although pyridoxine has been used empirically for the prevention of capecitabine associated
      HFS, its efficacy needs to be demonstrated in prospective controlled trials. We estimated
      that the HFS rate with placebo and pyridoxine would be 0.35 and 0.18, respectively, and we
      therefore calculated that a sample size of 345 patients would be necessary to detect these
      hazard rates with an 80% power (β=0.2) and two-sided significance level of α=0.05. We assumed
      a follow up loss rate of 10%, thus requiring 380 patients to be randomized.
      Chemotherapy-naive patients with gastrointestinal tract cancers who were scheduled for
      capecitabine-containing chemotherapy were assigned to receive oral pyridoxine or placebo in
      randomized double-blind placebo controlled study. Pyridoxine 100 mg b.i.d was prescribed to
      the patients in the pyridoxine group, identical placebo 100 mg b.i.d was prescribed in the
      placebo group by the closed envelop randomization. Patients were stratified by chemotherapy
      regimen: capecitabine alone (X), capecitabine and cisplatin (XP), or docetaxel, capecitabine,
      and cisplatin (DXP). Patients were observed until NCI CTC grade 2 or 3 HFS developed or
      capecitabine-containing chemotherapy ended. Patients in the placebo group who developed grade
      2 or 3 HFS were randomized to receive pyridoxine or placebo for the next chemotherapy cycle
      to determine whether pyridoxine could improve HFS, and the same treatment was continued for 2
      chemotherapy cycles.
    

Intervention name(s): Pyridoxine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100mg BID/daily, Per oral; placebo 100mg BID/daily, Per oral
Intervention MeSH terms: Pyridoxine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: hand-foot syndrome; capecitabine; pyridoxine; prevention
Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The aim of this subject-masked prospective study is to evaluate the clinical performance of
      habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere
      lenses.
    

Detailed description: 
      The aim of this subject-masked prospective study is to evaluate the clinical performance of
      habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere
      lenses for 4 weeks of daily wear.
    

Intervention name(s): somofilcon A contact lens; fanfilcon A contact lens
Intervention type(s): Device; Device
Intervention description(s): Contact Lens; Contact Lens
Other intervention name(s): clariti elite; Habitual lens; Avaira Vitality; Test lens
Intervention model: Single Group Assignment
Intervention model description: First pair of study lenses (habitual lenses) will be dispensed and worn for 4 weeks for daily wear, then second pair of lenses (test lenses) will be dispensed and worn for 4 weeks for daily wear.
Masking: None (Open Label)
Primary purpose: Treatment
Phase I Study of MLN0128 and MLN8237 in Patients With Advanced Solid Tumors and Metastatic Triple-negative Breast Cancer
Condition: Metastatic Breast Cancer; Solid Tumors
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase Ib study designed to evaluate the safety and toxicity of the combination of
      Alisertib and MLN0128 in patients with advanced solid tumors with an expansion cohort in
      patients with previously treated metastatic TNBC.
    

Detailed description: 
      The purpose of this study is to evaluate the combination of Alisertib and MLN0128 in patients
      with advanced solid tumors refractory to standard treatment followed by an expansion cohort
      of patients with metastatic TNBC with exploratory correlative studies.
    

Intervention name(s): Alisertib; MLN0128
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.; Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.
Other intervention name(s): Dual TORC1/2 Inhibitor; MLN8237 (Aurora A inhibitor)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MLN0128; Dual TORC1/2 Inhibitor; MLN8237; Aurora A inhibitor; Alisertib; Triple-Negative Breast Cancer
The Fifth-year Follow-up Study for the Phase IV Clinical Trial of Hepatitis A Vaccine in Healthy Children
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Study type: Observational

Summary: 
      The purpose of this follow-up study is to evaluate the five-year immune persistence of one
      injection of inactivated and attenuated alive hepatitis A vaccine in healthy children.
    

Detailed description: 
      In the previous double-blind, randomized, phase IV clinical trial in 2008, 300 healthy
      Chinese children aged 18 to 35 months old were administered with one dose of inactivated and
      attenuated alive hepatitis A vaccine. Series of serum samples were taken for immunogenicity
      and immune persistence evaluation. Safety observations were performed after vaccination. This
      trial was also approved by Tianjin CDC Biomedical Ethics Committee in 2008.

      This study is the fifth-year follow-up research for the previous clinical trial.
    

Intervention name(s): Inactivated HAV vaccine; Attenuated alive HAV vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Inactivated vaccine: 0.5 ml per dose containing 250 u antigen, one dose; Attenuated alive vaccine: 1.0 ml per dose containing 6.50 lgCCID50 alive virus, one dose
Intervention MeSH terms: Vaccines
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Chinese children aged 18 to 35 months old
      
Biospecimen description: 
      Serum samples were taken from subjects.
    
Keywords: hepatitis A; inactivated hepatitis A vaccine; attenuated alive hepatitis A vaccine; immune persistence
"We Walk": Impact of Exercise Dose on Health Outcomes Among Women Ages 60-75
Condition: Condition
Study type: Interventional

Summary: 
      The overall goal is to determine whether any energy expenditure compensation in response to
      16 weeks of aerobic exercise at a higher-dose is greater compared to a lower-dose
      intervention in older women, and to begin to investigate underlying physiological mechanisms
      that influence energy expenditure changes in older women.
    

Detailed description: 
      The overall goal is to determine whether any energy expenditure compensation in response to
      16 weeks of aerobic exercise at a higher-dose is greater compared to a lower-dose
      intervention in older women, and to begin to investigate underlying physiological mechanisms
      that influence energy expenditure changes in older women. Changes in all components of energy
      expenditure, as well as concentrations of plasma leptin and serum free T3, in response to the
      two different exercise programs (14 and 8 kcal/kg body weight weekly, 60-65% VO2max, 4
      days/wk) will be compared in older, non-obese women (60-75 yrs, BMI=18-30 kg/m2).

      Specific Aim 1: To determine whether differential changes in total daily energy expenditure
      and its components occur in older women in response to two exercise programs of different
      doses. State-of-the-art methods will be used (total daily energy expenditure by doubly
      labeled water; non-exercise activity thermogenesis using Physical Activity Monitoring System;
      resting metabolic rate and thermic effect of food via indirect calorimetry).

      Primary Hypothesis: Due to a greater decline in NEAT, women will exhibit a smaller increase
      in total daily energy expenditure in response to the higher-dose, compared to the lower-dose,
      exercise program, despite greater increases in resting metabolic rate and thermic effect of
      food.

      Specific Aim 2: To explore whether differential changes occur in plasma leptin and serum free
      triiodo-L-thyronine (free T3) concentrations in older women in response to 16-week aerobic
      exercise programs of two different doses.

      We hypothesize that in response to the higher-dose exercise program, women will exhibit
      larger decreases in plasma leptin and serum free T3 concentrations, compared to the
      lower-dose exercise program.

      We will also determine whether women exhibit greater improvements in plasma lipids, insulin
      sensitivity (using homeostasis model assessment, HOMA, score), blood pressure, and aerobic
      fitness in response to the higher-dose, compared to the lower-dose, exercise program.
    

Intervention name(s): Low Dosage; High Dosage
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Exercise dose of 8kcal/kg/week; Exercise dose of 14kcal/kg/week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
The Effects and Predictors of Patella Taping in the Treatment of Patellafemoral Pain Syndrome
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      Background: Taping has been used for more than 20 years for patellofemoral pain syndrome
      (PFPS) but the effectiveness is still controversial.

      Purpose: This prospective study was conducted to investigate the effect and predictors of
      effectiveness of taping in treating PFPS.

      Study design: Prospective cohort study Methods: One hundred consecutive patients with the
      diagnosis of PFPS were included in the study. Factors including sex, age, body mass index
      (BMI), Q angle, lateral patella displacement (LPD), lateral patellofemoral angle (LPA) and
      pre-taping pain score were measured. One well-trained therapist applied adhesive tape to each
      patient by McConnell approach. Before and after taping, patients completed a visual analog
      pain scale (VAS) after performing a step-down from an 8-inch platform. Paired-t test was used
      for the difference of the VAS score measured before and after taping. Patients with
      improvement of more than 1 point in VAS score after taping were considered responsible, and
      others were non-responsible. The results were analyzed by logistic regression.
    


Intervention name(s): taping
Intervention type(s): Other
Intervention description(s): Briefly, the patella was manually displaced medially, and maintained in the position by Tex Tape (Kinesio Holding Corporation, Albuquerque, NM)
Other intervention name(s): McConnell taping, patella tapping
Intervention model: Single Group Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Managing Patient Expectations in Pediatric Weight Management
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      As part of Children's Hospital Association's Focus on a Fitter Future III Obesity Task Force,
      this project will target patient and family expectations across the domains of nutrition,
      physical activity and behavior change/family support as a means of patient engagement and
      retention in pediatric weight management. This will be a prospective, non-randomized,
      uncontrolled, single-arm trial for children between 2 and 18 years of age and a
      parent/guardian, who are starting a pediatric weight management program/clinic in one of the
      participating centers. The parent/guardian and child if 12 years of age or older receive a
      survey at the first visit, which asks about their expectations and goals for the visit. This
      information will then be used as part of clinical care to tailor treatment. After 3 months,
      the parent/guardian and adolescent, if applicable, will receive a follow up survey asking
      about their progress in these areas.
    


Intervention name(s): Patient Expectations; Patient Expectations
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Baseline Expectations survey (parent/guardian and adolescents 12 and older); 3 month follow up survey (parent/guardian and adolescents 12 and older)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Obesity; Children; Adolescents; Attrition