bioihbjkbjnl/mcl2 huggingface dataset:
Analysis of Change of Optic Nerve Sheath Diameter in Robot Assisted Laparoscopic Radical Prostatectomy
Condition: Optic Nerve Sheath Diameter; Robot Assisted Laparoscopic Radical Prostatectomy
Study type: Interventional

Summary: 
      In the present study, The investigators evaluated whether anesthetic agents effects on Optic
      Nerve Sheath Diameter in patients undergoing Robot Assisted Laparoscopic Radical
      Prostatectomy
    


Intervention name(s): Desflurane; propofol; remifentanil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): In desflurane group, desflurane 6-8 vol% and remifentanil (target controlled infusion 2-3 ng / ml) are used for maintenance of anesthesia during surgical procedure. In propofol group, propofol 3-4 ug/ml and remifentanil 2-3 n /ml using target Controlled Infusion are used for maintenance of anesthesia during surgical procedure; In desflurane group, desflurane 6-8 vol% and remifentanil (target controlled infusion 2-3 ng / ml) are used for maintenance of anesthesia during surgical procedure. In propofol group, propofol 3-4 ug/ml and remifentanil 2-3 n /ml using target Controlled Infusion are used for maintenance of anesthesia during surgical procedure; In desflurane group, desflurane 6-8 vol% and remifentanil (target controlled infusion 2-3 ng / ml) are used for maintenance of anesthesia during surgical procedure. In propofol group, propofol 3-4 ug/ml and remifentanil 2-3 n /ml using target Controlled Infusion are used for maintenance of anesthesia during surgical procedure
Other intervention name(s): DES; PPF; Remi
Intervention MeSH terms: Remifentanil; Propofol; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Radiofrequence Microtenotomy for Treatment of Achilles Tendinose
Condition: Achilles Pain
Study type: Interventional

Summary: 
      Prospective randomized controlled study using radio-frequency microtenotomy or physical
      therapy (eccentric training) for treatment of Achilles tendinose
    

Detailed description: 
      Achilless tendinosis is a major clinical problem. There is a need for new studies to map the
      effectiveness of treatment. This study will compare treatment effectiveness between
      traditional physical therapy with surgical treatment using (RFM). The tendinosis grade will
      be evaluated using MRI and /or ultrasound before and after intervention. The outcome
      measurment include VAS and function using ( FAOS FOOT & ANKLE SURVEY) at 6,12 weeks and 6, 12
      months after intervention.
    

Intervention name(s): RFM
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To evaluate improvement of VAS and functionality before and after treatment of Achilles tendinosis using radiofrequency-plasma based microtenotomy in comparison to traditional physical therapy.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Achilles, tendinose, tendinopathy, pain
The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      To evaluate the scotopic and photopic ERG responses before and after one month of
      intravitreal avastin injection in patients with choroidal neovascularization.

      A positive finding that will reveal a toxic effect of intravitreal avastin injection on any
      component of the retina will have a significant important clinical impact regarding the
      decision whether the benefit of avastin treatment for CNV will prevail over toxic effect.
    

Detailed description: 
      The study will include 20 patients who are diagnosed with CNV and were submitted for
      intravitreal injection of avastin. Patients with uncontrolled glaucoma, any ocular operation
      two months prior to the injection, ocular inflammatory disease, systemic hypertension treated
      with more than one medication, myocardial infarct, congestive heart disease will not be
      included in the study. After the patient will approve to participate in the study and will
      fall in with the inclusion and exclusion criteria, the patient will sign a written consent
      statement (enclosed).

      Medical history and ophthalmic examination will be written in the study file. The patients
      will undergo the full-field ERG test using the ISCEV Protocol. Since the ERG is a non
      invasive test the patient will be admitted on the same day for intravitreal avastin in the
      designated eye. After one month the patient will undergo identical ERG protocol in addition
      to the standard follow-up examinations protocol for intravitreal avastin injection (1 day, 1
      week, 1 month). The other eye will serve as control group.
    

Intervention name(s): ELECTRORETINOGRAM
Intervention type(s): Procedure
Intervention description(s): Bevacizumab 1.25 mg/0.05 ml unilaterally into the vitreous cavity as part of the standard management for choroidal neovascular AMD. ERG responses form both eyes will be measured at baseline and 1 month after intravitreal injection
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Quetiapine Treatment for Cannabis Dependence
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      Marijuana is the most commonly used illicit drug in the United States. However, the treatment
      options for cannabis dependence are limited; notably, no effective pharmacotherapy has been
      developed. Conceptually, the ideal medication treatment for cannabis dependence would:

        1. be safe when administered to patients actively using cannabis

        2. reduce cannabis intake and promote abstinence

        3. treat the symptoms of cannabis withdrawal

        4. reduce craving and relapse risk

        5. have a low abuse liability.
    

Detailed description: 
      Conceptually, the pharmacodynamic and clinical actions of quetiapine suggest that it may be
      useful for cannabis dependence. By antagonizing dopamine, quetiapine may interfere with the
      reinforcing effects of cannabis, while serotonin type 2A, histamine type 1, and adrenergic
      receptor antagonism may reduce cannabis withdrawal symptoms, primarily by sedating and
      anxiolytic effects. The proposed research project is an open-label pilot study to evaluate
      the tolerability and ideal target dosing range for quetiapine treatment of cannabis
      dependence over an eight-week period. The purpose of this pilot study is to obtain
      preliminary data regarding the potential efficacy, tolerability and safety of quetiapine
      treatment of cannabis dependence before conducting a larger double-blind trial.
    

Intervention name(s): quetiapine
Intervention type(s): Drug
Intervention description(s): Quetiapine treatment from 25 mg daily to 300 mg twice daily
Other intervention name(s): Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cannabis; quetiapine
Nutritional Status and Body Composition in Childhood Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      Malnutrition and growth retardation are common in children with inflammatory bowel disease
      (IBD), especially in Crohn's Disease (CD). Malnutrition is associated with disease type,
      anatomical location, severity of disease and age of patient. Recently, it is reported that
      almost all children with CD and half with Ulcerative Colitis (UC) have reduced lean mass,
      however, body fat alteration are not well defined.

      The aim of this prospective and observational study was to evaluate nutritional and growth
      status and body composition of children with IBD using anthropometric measurement and
      bioelectrical impedance during 1 year follow-up.
    

Detailed description: 
      Patients 6 to 18 years of age at the time of enrolment who have IBD at any stage of disease
      activity, on any or no treatment and age- and sex-matched healthy controls will be included.
      All participants will be followed for 1 year.

      Written informed consent will be obtained from the parents or guardians of the participants
      at the time of enrolment. Prospective and retrospective data will be collected. Complete
      family and medical history, physical examination and laboratory findings will be recorded on
      standard case report form. Disease activity will be scored using the Paediatric Crohn's
      Disease Activity Index for children with CD and the Pediatric Ulcerative Colitis Activity
      index for those with UC. Endoscopic data will be reviewed and disease location will be
      classified according to Paris classification. Puberty will be assessed based on the
      development of secondary sexual characteristics. At the time of enrollment and after 1 year,
      anthropometric measurements including height, weight, triceps skin fold thickness, middle arm
      circumference and assessment of body composition by bioelectrical impedance will be performed
      for each child. Anthropometric data will be standardized by generation of z-scores for height
      and weight based on age and gender. Growth deficiency for height and weight measurements will
      be defined as a z-score\-2.
    

Intervention name(s): Assesment of nutritional status and body composition
Intervention type(s): Other
Intervention description(s): At the time of enrollment and after 1 year, anthropometric measurements and assessment of body composition by bioelectrical impedance will be performed for each child
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with IBD at any stage of disease activity, on any or no treatment and age- and
        sex-matched healthy controls
      
Keywords: Body composition; Nutritional status
Role of Branched-chain Amino Acids Infusion as Adjunct Therapy Post Liver Surgery for Patients in Intensive Care Unit
Condition: Liver Function Post BCAA Infusion
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the impact of intravenous BCAAs infusion as adjunct
      therapy post liver surgery in intensive care unit (ICU).
    

Detailed description: 
      Patients will be enrolled in the study&randomly assigned in a 1:1 manner to receive either
      intravenous (IV) BCAAs in a dose of 0.5-1gm/Kg/day for at least 48hours up to maximum 5 days
      immediately post-operative or placebo (sterile normal saline in a volume equal to the study
      drug).

      All demographic data will be obtained including the patients' age, sex, weight,associated
      co-morbidities (diabetes mellitus & hypertension), the presence of chronic liver disease
      (CLD), Child-Pugh score, Sequential Organ Failure Assessment (SOFA), the type of liver
      surgery, & nutritional status according to nutritional risk screening 2002 (NRS 2002);
      well-nourished if NRS 2002 < 3 while malnourished if NRS 2002 ≥ 3 prior BCAAs infusion.

      Vital signs including the heart rate, mean arterial pressure (MAP), central venous pressure
      (CVP), arterial oxygen saturation (SaO2), insulin requirements, urine volume & fluid balance
      will be recorded on admission (day 0), then will be followed up and recorded at regular
      intervals during treatment on 1, 3, 5 &7days.

      Laboratory investigations including the complete blood profile (white blood cells, band%,
      lymphocytes), prothrombin time (PT), liver enzymes; Aspartate aminotransferase (AST), Alanine
      aminotransferase (ALT),serum bilirubin, serum albumin, C-reactive protein (CRP)& kidney
      functions will be recorded at randomization as a baseline (day 0)& will be assessed on day
      0,1, 3, 5 & 7 of the study. Thirty-day survival & infectious morbidity will be followed by
      phone calls to the patient or one of his/her first-degree relatives.
    

Intervention name(s): BCAA preparation Intravenous infusion; sterile normal saline
Intervention type(s): Drug; Drug
Intervention description(s): BCAA IVi in a dose 0.5-1 gm/Kg/day for 2-5 days post liver surgery versus sterile normal saline in a volume equal to the study drug; sterile normal saline in a volume equal to the study drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Efficacy of Polygonatum Sibiricum on Sleep Quality Improvement
Condition: Healthy Adults With Subjective Sleep Complaints
Study type: Interventional

Summary: 
      This study aims to investigate the efficacy and safety of Polygonatum sibiricum for sleep
      quality improvement.
    


Intervention name(s): Polygonatum sibiricum; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Polygonatum sibiricum 800mg, 30-60 minutes before sleep, once a day for 4 weeks; Placebo 800mg, 30-60 minutes before sleep, once a day for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Acute Effects of Exercises Combined With Blood Flow Restriction in Healthy Individuals
Condition: Healthy Individuals
Study type: Interventional

Summary: 
      Purpose of the study is; to investigate the acute effects of exercises combined with blood
      flow restriction on strength, proprioception and functional motor performance in healthy
      individuals. The investigators hypothesized that blood flow restriction exercises has a
      positive effect on strength, proprioception and functional motor performance.
    

Detailed description: 
      60 healthy individuals will randomized into 3 groups of 20 people each. Participants will be
      held in a familiarization session before 3-4 days the actual evaluation. Elbow bending
      exercises with blood flow restriction will be performed to the blood flow restriction (BFR)
      group, elbow bending exercises without blood flow restriction will be performed to the
      exercise group and control group will not receive any interventions. Participants will be
      evaluated before and after the exercise session. Control group is going to rest for 10
      minutes before the second evaluation. Evaluation protocol includes; muscle strength
      measurement with digital hand dynamometer, shoulder and elbow proprioception evaluation with
      inclinometer, Upper Extremity Closed Kinetic Chain Stabilization Test, Functional Throwing
      Performance Index and Modified Pull-Up Test.
    

Intervention name(s): exercise with blood flow restriction; exercise
Intervention type(s): Other; Other
Intervention description(s): Elbow bending exercises with blood flow restriction will be performed to the exercise group.; Elbow bending exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: blood flow restriction; acute
Comparison of High Flex and Standard Rotating Platform Total Knee Arthroplasty (TKA)
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The goal of this study is to determine if the rotating platform high flex design provides
      improved flexion compared to the standard rotating platform TKA.
    


Intervention name(s): Rotating Platform High-Flex Cruciate Substituting TKA; Rotating Platform Cruciate Substituting TKA
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: total knee replacement; high flexion; range of motion; rotating platform; TKA
Treatment De-Intensification and Residual HIV-1 in Youth
Condition: HIV-1; HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      This laboratory-based sub-study of ATN 061 and ATN 071 will examine the effect of early
      treatment followed by treatment de-intensification to atazanavir/ritonavir (ATV/r)
      monotherapy on steady-state frequencies of replication-competent CD4+ T cell Human
      Immunodeficiency Virus (HIV)-1 reservoirs or cell-associated infectivity (CAI) and persistent
      low-level viremia (LLV), and their contribution to successful long-term control of HIV-1
      replication among HIV-1 infected adolescents and young adults.
    


Intervention name(s): Blood draw
Intervention type(s): Other
Intervention description(s): This sub-study does not involve additional treatment of any ATN 061 or ATN 071 study subjects. The only intervention involved is the requirement for whole blood collection (40 ml and 60 ml) to be drawn at the same time as four ATN 061 study visits (36, 48, 56, and 80 weeks) for subjects co-enrolled into ATN 061. When these time points coincide with ATN 061 Central Laboratory samples, the 60 ml blood sample will not be collected. For subjects co-enrolled into ATN 071, there are also two samples of whole blood collection (40 ml and 60 ml) required to be drawn at four time points but at weeks 36, 48, 56, and 80 after the initiation of HAART.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Twenty-five subjects enrolled in Arm A of ATN 061 who started highly-active antiretroviral
        therapy (HAART) at CD4+ T cells > 350 cells/cubic millimeter (mm3) and are undergoing
        treatment de-intensification at week 48 of HAART.

        Twenty-five "control" subjects initiating HAART based on current Department of Health and
        Human Services (DHHS) guidelines at CD4+ T cell levels < 350 cells/mm3 and maintained on
        standard HAART.
      
Biospecimen description: 
      Whole blood
    
Keywords: de-intensification; HAART; monotherapy; persistent low-level viremia (LLV); treatment experienced
A Clinical Study Assessing the Potential of Piboserod for the Treatment of Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether piboserod, a serotonin-4 receptor
      antagonist, is effective for the treatment of patients with congestive heart failure.
    

Detailed description: 
      Despite intensive research for decades, mortality and morbidity in chronic heart failure
      remains quite high. There is an obvious need for new drugs, especially drugs which may have a
      different mode of action than the existing ones on the market.

      The purpose of this trial is to evaluate whether a new drug candidate, piboserod, has
      beneficial biological effects in stable outpatients with symptomatic heart failure receiving
      evidence based treatment for heart failure and to assess safety and tolerability of this
      treatment.
    

Intervention name(s): Piboserod
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
An Exploratory Clinical Trial to Evaluate and Compare Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers
Condition: Healthy Subject
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to Evaluate and Compare Safety and Pharmacokinetic Characteristics after
      Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers.
    

Detailed description: 
      The purpose of this study is to explore the differences in pharmacokinetics and safety
      characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202108,
      DWC202109) in healthy adults with fasting state: Randomized, open-label, oral, single-dose,
      four-treatment, three-period, non-replicated crossover study
    

Intervention name(s): Ursodeoxycholic Acid 250 Mg Oral Tablet
Intervention type(s): Drug
Intervention description(s): Administration of Ursodeoxycholic Acid 250 Mg Oral Tablet or Ursodeoxycholic Acid 100 Mg Oral Tablet
Other intervention name(s): Ursodeoxycholic Acid 100 Mg Oral Tablet
Intervention MeSH terms: Ursodeoxycholic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 4 by 3 cross-over study
Masking: None (Open Label)
Primary purpose: Treatment
Tooth Mousse and Fluoride in Dentin Hypersensitivity Treatment
Condition: Dentin Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Observational

Summary: 
      GC Tooth Mousse, a complex containing amorphous calcium phosphate (ACP) and casein
      phosphopeptide (CPP), is recommended in dentin hypersensitivity reduction due to its ability
      to block opened dentinal tubules. It acts synergistically with fluorine in slowing caries
      progression. Whether CPP-ACP can act synergistically with fluorine in the dentin
      hypersensitivity treatment is unknown. The aim of this study was to assess the effect of
      CPP-ACP combined with fluoride varnish in cervical dentin hypersensitivity treatment.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        primary care clinic
      
Keywords: Dentin hypersensitivity; Tooth Mousse; fluoride varnish
Evaluation of the Link Between Bladder Sensation and Changes in Skin Electrical Conductance and Heart Rate.
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      Measuring sympathetic skin response or heart rate variability can provide an objective
      biomarker of bladder sensation and its modulation by drug with potential to treat overactive
      bladder.
    

Detailed description: 
      Evaluation of the link between bladder sensation and changes in skin electrical conductance
      and heart rate.
    

Intervention name(s): Tolterodine; Filling cystometry; Intravesical neurostimulation
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): Single dose per patient as determined by protocol.; This is a procedure.; This is a procedure.
Intervention MeSH terms: Tolterodine Tartrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other