bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters
Condition: Epidural Anesthesia; Ropivacaine Concentration; Hemodynamics
Study type: Interventional
Phase: Phase 4

Summary: 
      In this trial, the investigators intend to examine whether the concentration of local
      anesthetics during epidural analgesia could be modulating factor for change of hemodynamics
      in patients undergoing major upper abdominal surgery.
    

Detailed description: 
      One hundred and twenty patients scheduled for major abdominal surgery under TEA combined
      general anesthesia were randomized in a double-blinded method to receive one of three
      different concentration study solutions in 8 ml of volume after the induction of anesthesia:
      0.75% ropivacaine (60 mg), 0.375% ropivacaine (30 mg), or 0.2% ropivacane (16 mg).

      In each group, the patients were divided into two subgroups at the age of 60 to perform age
      based analysis. The acquired hemodynamic data after administration of epidural loading dose
      were compared and analyzed between young and elderly groups in each group.
    

Intervention name(s): 0.75% ropivacaine concentration; 0.375% ropivacaine concentration; 0.2% ropivacaine concentration
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia; 0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia; 0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: epidural, local, ropivacaine; epidural administration; stroke volume variability
A PK Study GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male
      Volunteers
    

Detailed description: 
      GL2702 GLARS-NF1 tablet is controlled released formulation which is invented by GL Pharm Tech
      Corp.
    

Intervention name(s): GL2702 GLARS-NF1; Omix Ocas
Intervention type(s): Drug; Drug
Intervention description(s): 0.4mg once a day; 0.4mg once a day
Other intervention name(s): Tamsulosin; Tamsulosin
Intervention MeSH terms: Tamsulosin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Tamsulosin,controlled release formulation
The Effects of Lactobacillus Rhamnosus (JB-1) on Stress and Cognition
Condition: Healthy
Study type: Interventional

Summary: 
      Emerging evidence suggests that microorganisms acting via the Brain-Gut axis may have
      potential benefits for the management of stress-related conditions. The majority of studies
      have focused on animal models. Preclinical studies have identified the Lactobacillus
      Rhamnosus JB-1 strain as a putative psychobiotic with an impact on stress-related behaviours,
      physiology and cognitive performance. Whether such preclinical effects could be translated to
      healthy human volunteers remains unknown.
    

Detailed description: 
      30 healthy male volunteers will be recruited in a randomized single blind placebo controlled
      cross over trial. Study participation will involve a screening visit followed by a baseline
      cognitive test battery, EEG and stress visit (socially evaluated cold-pressor test). These
      measures will be repeated after 4 weeks of daily probiotic and placebo capsules.
    

Intervention name(s): Lactobacillus Rhamnosus (JB-1); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lactobacillus Rhamnosus (JB-1) capsule; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Psychobiotic; Brain-gut axis; Stress; Cognition; EEG
Mobile Continuing Care Approach for Youth
Condition: Addiction
MeSH terms: Behavior, Addictive
Study type: Interventional

Summary: 
      The primary purpose of this study is to test the effectiveness of a pilot mobile based
      continuing care program (monitoring/feedback texting) relative to standard continuing care as
      usual in reducing relapse and improving psychosocial functioning outcomes in a youth
      population (under 24) with substance abuse problems.
    

Detailed description: 
      This study will include approximately 80 participants randomized to either 12 weeks of mobile
      continuing care (intervention) or standard continuing care as usual (control). Participants
      will be recruited from the treatment programs in Los Angeles County, including Matrix
      Institute on Addictions, Tarzana Treatment, Twin Town, Phoenix House, and Cri-Help. During
      the 12-week active program, participants will be monitored monthly via telephone data
      collection. Both groups will be followed for 10-months using repeated assessments
      (self-report and urine specimens) at baseline (month 0) and at follow-up points (months 3, 6,
      and 9).
    

Intervention name(s): Mobile Continuing Care
Intervention type(s): Behavioral
Intervention description(s): Behavioral: Mobile Texting 12-week intervention. Delivers daily Recovering monitoring, self-management feedback, and education/social support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Continuing Care; Youth Substance Abuse; Recovery Support; Mobile Texting
A Study to Compare Capsule and Tablet Forms of MDV3100 (Enzalutamide) After Administration of a Single Set Dose Under Fasted Conditions in Healthy Male Subjects
Condition: Healthy Subjects; Castration Resistant Prostate Cancer (CRPC); Relative Bioavailability; MDV3100
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the bioavailability (BA) of a single oral dose of MDV3100 (enzalutamide)
      formulated as a solid spray dried tablet compared to oral liquid-filled capsules, and the
      safety and tolerability of oral formulations.

      Subjects are admitted to the clinic from days 1 to 5, followed by outpatient assessments up
      to Day 50. They return to the clinic for an end of study visit (ESV) 7-10 days after the last
      pharmacokinetic (PK) sampling or after early withdrawal.
    


Intervention name(s): MDV3100
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): enzalutamide; Xtandi
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; Enzalutamide; Relative bioavailability of MDV3100; Immediate release oral formulation; Xtandi
Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the long-term safety and tolerability of escitalopram (Lexapro) in
      children 7 to 11 years of age with major depressive disorder (MDD).
    


Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): Patients who meet eligibility criteria will receive open-label escitalopram. 10-20mg oral administration (10mg tablets) once daily for 24-weeks with a 2-week downtaper period.
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; major depressive disorder; escitalopram; Lexapro; pediatric
Immunotherapy for the Treatment of Breast Cancer Related Upper Extremity Lymphedema (BCRL)
Condition: Breast Cancer; Upper Extremity Lymphedema
MeSH terms: Breast Neoplasms; Lymphedema
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of QBX258, a compound developed by
      Novartis Corporation composed of two antibodies, in reducing arm volume excess in women with
      stage I-II breast cancer related lymphedema.
    


Intervention name(s): QBX258
Intervention type(s): Drug
Intervention description(s): Once patients are registered for the trial, they will be treated with QBX258 (VAK694 3mg/kg and QAX576 6mg/kg) delivered via peripheral intravenous injection once every 4 weeks (+ 1 week) for 4 treatments.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: QBX258; human monoclonal antibodies; VAK694; QAX576; 15-085
Exercise-induced Changes in Exosomes
Condition: Exosomes; Connective Tissue; Exercise
Study type: Interventional

Summary: 
      The proposed study aims to shed light on the function/importance/relevance of
      exercise-induced changes in exosomes to connective tissues. Exosomes are known to increase
      robustly in response to exercise. We have previously shown that serum isolated from subjects
      after they lift heavy weights increases human engineered ligament collagen content and
      mechanics more than serum from before they lift weight. Further, we showed that
      exercise-induced changes in hormones could not explain the change in ligament structure or
      function. These data indicate that there is a significant gap in our understanding of
      muscle-connective tissue crosstalk. To address this gap, the current proposal seeks to: i)
      isolate and sequence exosomal RNA (long non-coding, miR, and mRNA) and ii) determine whether
      exosomes isolated from serum after exercise increase engineered ligament mechanics and
      collagen content.
    


Intervention name(s): Resistance Exercise
Intervention type(s): Procedure
Intervention description(s): Participants will perform a bout of lower body resistance exercise consisting of leg press, leg extension and leg curls.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Comparisons of Effects of Core Stability Exercise and Tai Chi on Core Muscle Performances in Elderly
Condition: Tai Ji
Study type: Interventional

Summary: 
      Core muscles and core stability has a key component in the postural control or balance.
      However, no clear evidence has been found for the positive relationship between core
      stability and postural control in the elderly, and the effects of core stabilizing training
      on postural control or balance in the elderly. The purposes of this project are to
      investigate the effects of core stability training program on muscle strength, muscle
      performance, and balance outcomes in elderly adults.
    

Detailed description: 
      In this pretest, posttest design study, elderly adults enrolled and assigned to the core
      exercise group or Tai Chi exercise group, the core exercise group received core exercise
      intervention comparing to Tai Chi exercise group participated Tai chi exercise program as a
      control group.

      The young adults group were also enrolled for a reference group, not received any exercise
      intervention and just only received the measurements once.

      Participants in the two elderly group will receive 12-week, 36-session exercise-based core
      stability training class. The each 60 minutes core exercise class focuses on exercise for
      improving strength, endurance of core muscles and trunk stability.

      Participants need complete baseline assessments of muscle performance, and balance ability
      measures 1 week prior and 1 week and 12 weeks following the intervention.
    

Intervention name(s): Core exercise; Tai Chi exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive12-week, 60 minutes, 36-session exercise-based core stability training class. Participants need complete baseline assessments of muscle performance, and balance ability measures 1 week prior and 1 week and 12 weeks following the intervention. All subjects will receive two post-exercise measurements at 13th week and 25th week.; Participants will receive 12-week, 60 minutes, 36-session Tai Chi exercise training class. Participants need complete baseline assessments of muscle performance, and balance ability measures 1 week prior and 1 week and 12 weeks following the intervention. All subjects will receive two post-exercise measurements at 13th week and 25th week.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of the Intradermal Injection of rHuPH20 or Placebo in Participants With Nickel Allergic Contact Dermatitis
Condition: Dermatitis, Allergic Contact
MeSH terms: Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the effect and safety of rHuPH20 or placebo for the
      prevention and treatment of skin allergic reaction to nickel. The study drug and placebo will
      be administered by intradermal injection.
    

Detailed description: 
      This study will involve 2 regimens which will run in parallel. Each participant's upper back
      will be divided into 2 equal spaces for Regimen 1 and 2. Each of the 4 treatment sites in
      each space will be independently randomized to placebo or rHuPH20 treatment in a 1:1 ratio.
      Thus, each participant will serve as their own control. Regimen 1 will evaluate the treatment
      of cutaneous reactions to nickel and Regimen 2 will evaluate the prevention as well as the
      treatment of cutaneous reactions to nickel. At screening, the nickel sulfate concentration
      (1%, 2.5%, or 5%) applied to the skin of the upper back with a patch, that will cause no more
      than a ++ reaction according to the scale of the International Contact Dermatitis Research
      Group (ICDRG) will be determined. This concentration will be used to elicit cutaneous
      reactions during the study period.
    

Intervention name(s): rHuPH20; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.25 milliliter (mL) Intradermal (ID) syringe push bolus injection of rHuPH20; 0.25 mL ID syringe push bolus injection of placebo control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: rHuPH20; Recombinant Human hyaluronidase
Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of co-administration of
      Canagliflozin (TA-7284) and Teneligliptin (MP-513) once daily for 24 weeks in Japanese
      patients with Type 2 diabetes mellitus who are receiving treatment with Canagliflozin and
      have inadequate glycemic control.
    


Intervention name(s): Canagliflozin; Teneligliptin; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Canaglu, TA-7284; Tenelia, MP-513
Intervention MeSH terms: Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MT-2412; MP-513; TA-7284; Teneligliptin; Canagliflozin
Efficacy of Subfascial Approach in Thyroidectomy to Quality of Life in Thyroid Disease Patients
Condition: Thyroid Cancer
MeSH terms: Thyroid Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Subfascial approach method in thyroidectomy maybe result in better quality of life than
      conventional approach method in thyroid disease patients
    


Intervention name(s): subfascial flap; subplatysmal flap
Intervention type(s): Procedure; Procedure
Intervention description(s): subfacial dissection to thyroid; subplatysmal approach to thyroid
Other intervention name(s): sub-strap muscle fascial flap approach; subplatysmal mucle flap approach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment
Condition: Cerebral Infarction
MeSH terms: Cerebral Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to compare the safety of clopidogrel 50mg and 75mg in cerebral
      infarction with respect to incidence of bleeding adverse events.
    


Intervention name(s): clopidogrel (SR25990C)
Intervention type(s): Drug
Intervention description(s): oral administration
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Platelet Aggregation Inhibitors; Ischemic cerebrovascular disease
Comparison of Two Topical Formulations Containing Clindamycin and Clotrimazole in Patients With Vaginal Infections
Condition: Vaginal Infections
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, Parallel Group, Active Controlled Trial to compare effectiveness and tolerability
      of 2 different vaginal formulations containing 200mg clotrimazole and clindamycin phosphate
      equivalent to 100mg clindamycin for 3 days in women clinically diagnosed to have infective
      vaginitis.
    

Detailed description: 
      -  This is a Randomized, Comparative, Prospective, Open label, Single center study to
           compare the 3 day treatment course of intravaginal soft gelatin capsule containing
           clindamycin and clotrimazole versus intravaginal ER tablets of clindamycin and
           clotrimazole in patients with vaginal discharge and clinical diagnosis of bacterial,
           trichomonal, candidal or mixed vaginitis with respect to efficacy and tolerability; and
           to study the in vitro drug release pattern of intravaginal soft gelatin capsule and
           intravaginal ER tablets containing clindamycin and clotrimazole.

        -  The study will be conducted in B.J. Medical College & Sassoon General Hospitals, Pune.
           The study will be completed in 60 patients [30 patients in each group].

        -  The primary outcome measure is absence of any clinical sign suggestive of infective
           vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal
           vaginitis at 8th day after start of treatment [Effectiveness in inducing a remission].

        -  The secondary outcome measures will be

             1. absence of any clinical sign suggestive of infective vaginitis and

             2. a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis at
                29th day after start of treatment [Effectiveness in maintaining a remission] and
                ability to complete the 3day course without any break or experiencing intolerable
                side effects [Tolerability].
    

Intervention name(s): ClinSupV3 -soft gelatin capsule; ClinSupV3ER- Extended release tablet
Intervention type(s): Drug; Drug
Intervention description(s): 3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg clotrimazole; 3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg Clotrimazole
Other intervention name(s): Clindamycin plus Clotrimazole; Clindamycin plus Clotrimazole
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Clotrimazole; Miconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clindamycin; Clotrimazole; Vaginal formulation; Bacterial vaginosis; Candidiasis; Trichomoniasis; Mixed vaginitis; Infective vaginitis
Mechanism of Growth Hormone Effects on Adipose Tissue
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      Growth hormone treatment in humans has been shown to decrease body fat. This study aims to
      determine what adipose tissue depots are affected by GH and what is the mechanism.
    

Detailed description: 
      Growth hormone (GH) replacement in GH deficient adults results in an improvement in metabolic
      status, an increase in lean body mass and a reduction in visceral adiposity. GH might also
      decrease visceral adiposity in obese adults that are not GH deficient.

      The objective of the study is to determine the effects of GH on the metabolic syndrome and
      visceral adiposity in men with low blood levels of IGF-1 and the durability of these effects
      after stopping GH therapy. We will use a double blind, placebo controlled 6 month
      intervention trial followed by a blinded follow-up period of 6 months. Thirty non-diabetic
      middle aged men with central adiposity (BMI > 27 kg/m2, waist circumference > 102 cm) will
      participate.
    

Intervention name(s): rhGH
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: growth hormone, obesity, visceral adiposity
Pediatric Diabetics Type 1 Using InsuPatch
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a prospective, single-center, open label, randomized; two-arms cross over
      study.

      This is the test protocol for the InsuPatch device, whose purpose is to improve insulin
      delivery into the blood when the insulin is infused using an insulin-infusion pump by
      controlled heating of the area surrounding the point of infusion.
    

Detailed description: 
      Twenty(20) type 1 children with Type 1 Diabetics Mellitus (TIDM) who are meeting the
      inclusion/exclusion criteria as outlined below and who provide written Informed Consent will
      be enrolled in the study.

      The study will consist of an outpatient enrollment visit and two admissions(One clamps with
      the InsuPatch and one clamp without the InsuPatch) . Each Subject will thus serve as his/her
      own control.
    

Intervention name(s): InsuPatch
Intervention type(s): Device
Intervention description(s): device which apply local heating at 38.5 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TIDM