bioihbjkbjnl/mcl2 huggingface dataset:
Pragmatic Randomized Controlled Trial of Non-pharmacological Treatment for Lumbar Disc Herniation : A Pilot Study
Condition: Lumbar Disc Prolapse With Radiculopathy
MeSH terms: Intervertebral Disc Displacement; Radiculopathy; Prolapse
Study type: Interventional

Summary: 
      This is a 2-arm parallel pragmatic randomized controlled trial that will compare
      non-pharmacological treatment with pharmacological therapy for lumbar disc herniation.
    

Detailed description: 
      Participants who voluntarily signed informed consent form and eligible for the study were
      randomly assigned in a 1:1 ratio (15:15) for non-pharmacological treatment and
      pharmacological treatment group. Participants of each group will receive twice a week for
      total 8 weeks of intervention. This is a pragmatic randomized controlled trial, so physicians
      will have medical decision making according to each participant's conditions and choose the
      specific intervention and dosage of pharmacological and non-pharmacological treatment.
    

Intervention name(s): KM non-pharmacological treatment group; Pharmacological treatment group
Intervention type(s): Other; Other
Intervention description(s): This is a pragmatic setting, and specific intervention is not determined prior to the study. Non-pharmacological treatment including Korean medicine, such as acupuncture, electroacupuncture and chuna, etc, will be chosen by professional physician according to the medical condition of each subject.; This is a pragmatic setting, and specific intervention is not determined prior to the study. The pharmacological treatment will be chosen by professional physician according to the medical condition of each subject.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Crossover Study to Compare Pharmacokinetic Property of SYO-1126 and Glivec Film Coated Tab in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by
      comparing pharmacokinetics characteristics between the SYO-1126 and Glivec Film Coated tab 4T
      (400mg) when administered a single-dose to healthy male volunteers.
    

Detailed description: 
      Healthy volunteers are administrated single-dose over the period I and II (crossover) of
      SYO-1126 and Glivec Film Coated tab 4T (400mg) as of imatinib 400mg.

      Every time before and after each medication, pharmacokinetic (PK) parameters and safety of
      SYO-1126 and Glivec Film Coated tab 4T (400mg) is performed using a blood sample and
      conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively.
    

Intervention name(s): SYO-1126; Glivec film coated tab 4T(400mg)
Intervention type(s): Drug; Drug
Intervention description(s): Imatinib 400mg/tablet, PO, 1 tablet once daily for I&II D1(crossover); Imatinib 100mg/tablet, PO, 4 tablets once daily for period I&II D1(crossover)
Other intervention name(s): Imatinib 400mg; Imatinib 100mg; Glivec film coated tab
Intervention MeSH terms: Imatinib Mesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Evaluation of the pharmacokinetics equivalence; Healthy volunteers; Single dose over the period I and II(crossover); Healthy male volunteers
Effect of an Exercise Program of the Scapular Muscle Stabilizers in Amateur Kayakers Shoulder Pain
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a specific strengthening program for the
      stabilizing scapular muscle can reduce shoulder pain of amateur kayaker.
    


Intervention name(s): Exercise program of the scapular muscle stabilizers
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: strength training; scapular stabilization; kayakers.
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the difference between the optic nerve sheath
      diameter measured during total intravenous anesthesia and the optic nerve sheath diameter
      measured during inhalation anesthesia in patients undergoing robot-assisted laparoscopic
      prostatectomy.
    

Detailed description: 
      The purpose of this study was to evaluate the difference between the optic nerve sheath
      diameter measured during total intravenous anesthesia with propofol and remifentanil and the
      optic nerve sheath diameter measured during inhalation anesthesia with sevoflurane and
      remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy.
    

Intervention name(s): Total intravenous anesthesia; Inhalation anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Total intravenous anesthesia with propofol and remifentanil; Inhalation anesthesia with sevoflurane and remifentanil
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the exposure of BI 425809 in cerebrospinal fluid relative to plasma as well as
      safety and tolerability, and to evaluate the effect of different doses of BI 425809 on
      biomarkers levels in cerebrospinal fluid.
    


Intervention name(s): BI 425809
Intervention type(s): Drug
Intervention MeSH terms: BI 425809
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of T4K Versus Twin Block in Developing Class II Division I Malocculsion
Condition: Orthodontic Appliances
Study type: Interventional

Summary: 
      The aim of this study was to evaluate and compare the effect of myofunctional trainer T4K
      versus twin block functional appliance on the dentoalveolar changes in children with class II
      division I malocclusion
    

Detailed description: 
      This study was a parallel arm randomized comparative clinical trial including 20 healthy
      children age ranged from 9-12 years showing Angle's class II division I malocclusion due to
      mandibular retrusion. Preoperative photographs, radiographs and study casts were taken,
      children were randomly assigned into two groups according to the appliance used; Group 1:
      T4k, and Group II: twin block. Follow up was done every 4 weeks for 9 months. Postoperative
      cephalometric X ray, study casts and photographs were retaken for measurements and
      comparison.
    

Intervention name(s): T4k Appliance; Twin block appliance
Intervention type(s): Device; Device
Intervention description(s): The pre-fabricated, hard, polyurethane, pink T4K™ (Myo functional research Co., Australia) was used in the study. It consisted of: facial bows, lingual bows / tongue guard, lingual tag / tongue tag, dental channels with a pre-determined bite position and a lip bumper. In the first week, the patients were instructed to gradually increase the wearing time of the appliance during the daytime. By the second week, the patients were instructed to wear the appliance achieving at least 8 hours during sleeping. The Trainer usually needs no adjustments. The patients were asked to place it themselves inside their mouths. The distal ends of the appliance were trimmed 2-3 mm with an acrylic bur on a straight hand piece if they were too long or the patient could not keep his lips together. By the end of the first 4 weeks, the patients were wearing the appliances minimum of 1 hour during the day plus the overnight wear following the manufacturer's instructions.; The twin block was used, and instructions were given to wear the appliance nearly full-time. Selective sequential inter-occlusal trimming was done monthly after the 2nd month in the occlusal surface of the maxillary bite blocks to clear over the mandibular molars allowing their eruption in a more favourable mesial direction and to increase the vertical dimension. Trimming was done in the fitting surface over the maxillary and mandibular premolars whenever needed to allow their full eruption and to level the occlusal plane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in Patients w Favorable Prognosis Inoperable Stage IIIA/B NSCLC
Condition: STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators propose this phase I/II study to use weekly Nab-Paclitaxel (Abraxane) and
      carboplatin with concurrent radiation in local-regionally advanced lung cancer. There are no
      published human studies combining Nab-Paclitaxel (Abraxane) with radiation. The investigators
      will first confirm the tolerated dose (TD) of concurrent Nab-Paclitaxel (Abraxane) at
      50mg/m2, and then will begin enrolling patients into the phase II component using either
      Nab-Paclitaxel (Abraxane) at the TD with carboplatin concurrent with daily radiation or
      paclitaxel with carboplatin concurrent with daily radiation.
    


Intervention name(s): NAB-PACLITAXEL; PACLITAXEL; NAB-PACLITAXEL
Intervention type(s): Drug; Drug; Drug
Intervention description(s): nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks; nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks
Other intervention name(s): Abraxan; Abraxan
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is Phase I/II study. Phase I has 1 arm and Phase II has 2 arms (total 3 arms)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER
The Effect of Lower Back Massage on Perceived Labor Pain
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      The aim of the study was to assesment the change in pain scores with lower back massage, a
      non-pharmacological method, on perceived labor pain in the early active phase of the first
      stage of labor.
    


Intervention name(s): lower back massage
Intervention type(s): Procedure
Intervention description(s): Lower back massage performance: In the study, Linda Kimber's massage protocol was used. First, the researcher ensured that the patient was holding the bed, squatting, or bent over on the bed, which is suitable for the massage, between two contractions. The pregnant woman was instructed to breathe deeply and exhale audibly when her contractions began. Gloves were worn during the massage and liquid Vaseline, which does not contain any active substance, was used to provide lubricity. The circular hip massage was applied at the beginning of the contraction, and lower lateral area and sacral pressure massage was applied towards the end of the contraction as per the massage protocol, and simultaneously with the inhaling sound of the pregnant woman
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study of LY2922083 in Healthy Participants and Participants With Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this trial is to evaluate the safety of the study drug in healthy participants and
      participants with diabetes. It will investigate how much of the study drug gets into the
      blood stream and how long it takes the body to get rid of it. Information about any side
      effects that may occur will also be collected.

      The study consists of two parts. Part A will study healthy participants in up to 3 dosing
      periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3
      dosing periods over approximately 6 weeks.
    


Intervention name(s): Placebo; LY2922083
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally as capsules; Administered orally as capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Evaluation of Panel Reactive Antibody in Children Following Stage I Palliation for Hypoplastic Left Heart Syndrome
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital; Hypoplastic Left Heart Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to determine whether children and adolescents 8-18 years of age
      with HLHS and related lesions who have undergone stage I palliation during infancy using an
      allograft patch demonstrate continued evidence of HLA antibody formation.
    

Detailed description: 
      This study will be of a prospective cross-sectional design, consisting of three groups. The
      first two groups (study groups) will consist of (1) subjects with HLHS and other related
      lesions who have undergone stage I palliation using an allograft patch during infancy and (2)
      subjects with "single ventricle" lesions who have undergone stage II palliation using
      allograft without antecedent stage I palliation. The third group (control group) will consist
      of subjects who have undergone corrective or palliative surgery for CHD during infancy in
      which an allograft patch was not used, and in which there have been no further exposures to
      allograft. We have chosen to study both (1) subjects who have undergone stage I and II
      palliation and (2)subjects who have undergone stage II palliation only in an attempt to
      distinguish between sensitization that may occur from allograft exposure during stage I
      palliation and that which may occur during stage II palliation.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children and adolescents between 8 and 18 years of age
Study of Venous Endothelial Cells in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      Heart disease is the major contributor of early death in rheumatoid arthritis (RA) and is not
      influenced by traditional risk factors. Blood vessel dysfunction has been associated with
      heart disease and complications such as heart attack. The vessel dysfunction is thought to be
      mediated in part to inflammation. RA patients have evidence of vessel dysfunction seen on
      ultrasound that improves after medications are given.

      The purpose of this study is to evaluate patients with controlled or uncontrolled rheumatoid
      arthritis to determine if there is a difference in the protein expression in the cells that
      line the blood vessels compared to healthy people.
    

Detailed description: 
      The study will consist of a cross sectional analysis of venous endothelial cells in
      rheumatoid arthritis patients who have controlled or uncontrolled disease and healthy
      controls. We will collect venous endothelial cells by placing an IV in antegrade position in
      the forearm and a thin wire will be inserted to collect the cells from the inner lining of
      the vein. The cells will processed and stained for markers of endothelial function and
      oxidative stress including endothelial nitric oxide synthase (eNOS), phospho-eNOS, nuclear
      factor kappa B (NFκB), and nitrotyrosine using immunofluorescence technique. Flow mediated
      dilation (FMD) by ultrasound of the brachial artery on the contralateral arm will be used as
      an additional marker of endothelial function. A blood sample will be taken for analysis of
      inflammatory markers (sedimentation rate, C-reactive protein) and cytokine analysis (IL-1,
      IL-6, TNFa) by cytokine bead array and flow cytometry.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Rheumatoid arthritis patients will be selected from arthritis clinics associated with UT
        Southwestern Medical Center and Parkland Memorial Hospital. Healthy controls will be
        collected from primary care clinics who refer to these specialty clinics.
      
Biospecimen description: 
      Serum collected by serum separator tube. Will be processed and frozen at -80degrees.
    
Keywords: Rheumatoid Arthritis
Comparison of Deep Serratus Anterior Plane Block and Superficial Serratus Anterior Plane Block
Condition: Pain, Postoperative; Serratus Anterior Plane Block; Thoracic Surgery, Video-Assisted
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery.
      Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods
      such as thoracic paravertebral block (TPVB), intercostal block, serratus anterior plane block
      (SAPB) and erector spina plane block (ESPB) are widely used for VATS. Among these methods,
      ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of
      application of plane blocks as a component of multimodal analgesia has been increased. ESPB
      and SAPB are some of them. There are two techniques for SAPB application. In Deep SAPB
      (DSAPB) application, local anesthetic agent is given under the serratus anterior muscle. In
      the Superficial SAPB (SSAPB) application, the local anesthetic agent is given above the
      serratus anterior muscle. The mechanisms of regional analgesia techniques used after thoracic
      surgery operations are also different from each other. Therefore, in this study, the
      analgesic efficacy of two different methods, DSAPB and SSAPB, will be compared.
    


Intervention name(s): Two different blocks with same local anesthetic volume
Intervention type(s): Procedure
Intervention description(s): Deep serratus anterior block and superficial serratus anterior plane block will be applied to the patients under real-time ultrasound guidance.
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative Pain; Serratus Anterior Plane Block; Video-Assisted Thoracic Surgery; VATS
Timing of Smoking Intervention in Alcohol Treatment (Nicotine Patch)
Condition: Alcoholism; Smoking
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will attempt to determine the best time to begin a smoking cessation program in
      individuals who undergo intensive treatment for alcohol dependence. The goal of this trial is
      to determine whether a smoking cessation program is more effective if it occurs at the same
      time as or after treatment for alcohol dependence. The study also will attempt to determine
      the effect of smoking cessation programs on the outcome of treatment for alcohol dependence.
    


Intervention name(s): nicotine replacement patch
Intervention type(s): Drug
Intervention MeSH terms: Nicotine
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
National Evaluation of Quality of Childcare
Condition: Child Rearing; Mental Health Wellness 1; Health Behavior
Study type: Interventional

Summary: 
      This evaluation seeks to assess the impact of a training program on childcare center
      environments and child/caregiver wellbeing in El Salvador. Through a longitudinal, randomized
      control trial, over 200 childcare centers participating in the program will be assigned to
      various treatment arms receiving different components of the program. A community comparison
      cohort will also be enrolled.
    

Detailed description: 
      Whole Child International (WCI) is a U.S.-based non-governmental organization. Its focus is
      on improving the caregiving environments for vulnerable children by effecting changes within
      child care centers and orphanages.

      This evaluation will assess the impact of an educational training and technical assistance
      program offered by WCI in collaboration with the El Salvadoran government. The program
      consists of a series of educational trainings (for local government officials, directors of
      childcare and residential centers, and center caregivers) and technical assistance including
      infrastructural changes within centers.

      To evaluate this intervention, a longitudinal, randomized controlled trial will be used to
      assign participating centers to one of seven treatment arms that will receive different
      components of the intervention. A community comparison cohort will also be enrolled to
      identify selection effects as well as local norms and standards. The central research
      question is, "Does providing training for institution providers and caregivers improve child
      outcomes?"

      Ethnographic research will also explore local cultural norms regarding child caregiving, and
      seek to understand how the intervention is received within communities.
    

Intervention name(s): Promotores Training; Delayed Promotores training; Caregiver training; Delayed caregiver training; Materials support; Delayed materials support; Technical assistance; Delayed technical assistance
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Effects of Ulinastatin on Myocardial Protection and Blood Loss in Patients Undergoing Aortic Valve Replacement
Condition: Abnormal Aortic Valve
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      According to TEG (thromboelastography), as maximum amplitude is increased the amount of
      bleeding and transfusion and Cardiac enzyme is reduced by using ulinastatin.
    


Intervention name(s): ulinastatin
Intervention type(s): Drug
Intervention description(s): Administer 30000U/ulinastatin. Comparison of different dosages of drug.
Intervention MeSH terms: Urinastatin