bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Research on the Efficacy of Thread-embedding Acupuncture on Herniated Intervertebral Disc of Lumbar Spine
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement
Study type: Interventional

Summary: 
      This clinical trial is designed to evaluate the efficacy and safety of thread-embedding
      acupuncture for treatment of lumbar herniated intervertebral disc (L-HIVD) by assessing pain,
      function, and quality of life.
    

Detailed description: 
      Seventy patient between the ages of 19 and 70 with L-HIVD will be recruited by eligibility
      criteria and randomly allocated to the thread-embedding acupuncture (TEA) group and sham
      thread-embedding acupuncture (STEA) group. Both groups will receive treatment on predefined
      23 acupoints once a week for 8 weeks, and needle with thread removed will be used in STEA
      group instead of normal TEA. 100 mm visual analogue scale (VAS) for low back pain will be
      assessed as a primary outcome. Also, 100mm VAS for radiating pain, Oswestry disability index
      (ODI), Rolland Morris disability questionnaire (RMDQ), EQ-5D-5L and global perceived effect
      (GPE) will be measured as secondary outcomes. All the outcomes will be assessed at baseline,
      4 weeks after screening, treatment end (8 weeks, primary end point) and follow-up sessions
      (12 and 16 weeks).
    

Intervention name(s): Thread-embedding Acupuncture (TEA); Sham Thread-embedding Acupuncture (STEA)
Intervention type(s): Procedure; Procedure
Intervention description(s): The acupoints and size of TEA are as follows:
Both EX-B2 of herniated intervertebral disc level, its upper level and its lower level (6 acupoints): perpendicular insertion, 4cm
Both BL24: transverse insertion toward L1 level along the erector muscle of spine, 6cm
Both BL25: transverse insertion toward iliac crest, 4cm
Both BL26: transverse insertion toward L1 level along the erector muscle of spine, 6cm
Both BL26: oblique insertion toward iliolumbar ligament, 6cm
Both EX-B7: oblique insertion toward gluteus medius muscle, 6cm
Both BL28: oblique insertion toward sacroiliac ligament, 6cm
Both GB30: perpendicular insertion, 6cm
Symptomatic side GB34, BL57 and ST36: oblique insertion toward foot, 4cm; All procedure of STEA group, including acupoints and size of TEA will be same as that of TEA group. However, thread-removed TEA will be used for STEA group instead of normal TEA, and removing procedure of thread will be performed aseptic and secretly for patient-blinding and prevention of infection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thread-Embedding Acupuncture; Herniated Intervertebral Disc of Lumbar Spine; Low Back Pain; Radiculopathy
Quality of Life (QOL), Coping and Psychological Symptoms in Children and Adolescents With Cyclic Vomiting Syndrome
Condition: Vomiting Syndrome
MeSH terms: Syndrome; Vomiting
Study type: Observational

Summary: 
      1. Characterize the quality of life of young children with CVS (i.e., psychological,
           social, physical, school functioning) and the impact of the child's illness on the
           parent's and family's quality of life (i.e., emotional, social, cognitive functioning,
           communication, worry, daily activities and family relationships).

        2. Assess symptoms of depression, anxiety, ADHD and behavioral problems in what our
           preliminary data suggests is a psychiatrically vulnerable population.

        3. Evaluate the associations between quality of life and psychiatric symptoms and the
           frequency and intensity of CVS attacks.

        4. Use the data generated from this study to develop a psychosocial intervention targeted
           at young children with CVS and their families who evidence risk for functional
           disability, with the aim of intervening as early as possible to limit the psychological
           and social morbidity experienced by children with CVS and their and families.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children aged 9-10 will complete 5 questionnaires Adolescents aged 11-18 will complete 6
        questionnaires Youth aged 11-18 will fill out an additional questionnaire that asks how
        they cope with stress related to CVS symptoms Parents will complete 4 questionnaires
      
Keywords: Youth; Consensus; Criteria; CVS
Methadone in Ambulatory Surgery
Condition: Post-operative Pain; Anesthesia
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The μ-opioid receptor agonist methadone is frequently used in adult anesthesia and adult pain
      therapy. Methadone has an extremely long half-life, which confers therapeutic advantage by
      providing more stable plasma concentrations and long-lasting pain relief. Methadone
      perioperative pharmacokinetics and effectiveness in perioperative pain relief in inpatients
      is well characterized. There is, however, no information on methadone use in an ambulatory
      surgery setting and outpatient procedures. This pilot investigation will determine
      effectiveness of intraoperative methadone in reducing postoperative opioid consumption and
      providing improved pain relief in patients undergoing moderately painful, ambulatory surgical
      procedures.
    


Intervention name(s): methadone; Control (Intra-operative administration of opioids, other than methadone)
Intervention type(s): Drug; Drug
Intervention description(s): Escalating dose of methadone up to .3mg/kg.; Intra-operative administration of opioids, other than methadone
Other intervention name(s): Dolophine; morphine fentanyl
Intervention MeSH terms: Fentanyl; Morphine; Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: fentanyl, morphine; methadone
Anti-infection of Low-does IL-2 in SLE
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional

Summary: 
      The objective of this clinical study is to evaluate the potential effect of anti-infection of
      low-does IL-2 in patients with SLE.
    

Detailed description: 
      Systemic lupus erythematosus (SLE) is a chronic autoimmune syndrome affecting various
      organs.Many feel that glucocorticoid and immunosuppressor are the standard therapy for
      patients with SLE. While it can improve the risk of infection among SLE patients. A novel
      therapy to treat SLE with low-does IL-2 has been identified recently. IL-2 also used to
      against some virus infect. So we hypothesized that low-dose IL-2 could reduce risk of
      infection in SLE patients.

      Methods: A total of SLE patients (n=30) were divided into two groups randomly. One received
      standard therapy, while another one administrate with low-does IL-2 plus standard
      therapy.Each patient will be treated with low-dose IL-2. The end points are clinical and
      immunologic response.

      Expected Results: This trail wlii provide both clinical and basic profe that low-dose IL-2
      plus standard therapy have lower infection risk in SLE patients.
    

Intervention name(s): Interleukin-2
Intervention type(s): Drug
Intervention description(s): Patients receive low dose recombinant human Interleukin-2（HrIL-2）
Other intervention name(s): Recombinant Human Interleukin-2,125Ala, SL Pharm
Intervention MeSH terms: Interleukin-2
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: SLE,IL-2
Prognosis of Vestibular Dysfunction in Patients With Idiopathic Sudden Sensorineural Hearing Loss
Condition: Vestibular Disorder; Sudden Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural; Vestibular Diseases; Hearing Loss, Sudden
Study type: Observational

Summary: 
      Idiopathic sudden sensorineural hearing loss (ISSNHL) refers to idiopathic sensorineural
      hearing loss of at least 30 dB over at least three test frequencies occurring over a 72-hour
      period. Vertigo has been considered a risk factor of poor prognosis in patients with ISSNHL.
      However, the clinical outcome and development of vestibular function in these patients have
      not been reported yet. We'd like to conduct a study on the problem whether these patients
      resulted in a complete recovery of the peripheral vestibular functions or compensation of the
      central vestibular system. If the answer is the former one, these cases might be supportive
      evidence of regeneration of hair cells in vestibular disorders.
    

Detailed description: 
      This study is designed as a prospective cohort study with only one cohort. Enrolment and data
      collection are performed by trained research staff who are not involved in the care of the
      patients. The primary measurement is the vestibular function tests including SOT, the caloric
      reflex test, vHIT, VEMP (cVEMP and oVEMP). The secondary measurements included PTA, DHI, and
      VAS. The sample size was set at 60 patients. The continuous variables were expressed as means
      ± standard deviation (SD) whereas categorical variables were expressed as frequency and
      percentage for data description. P <0.05 was considered statistically significant.
    

Intervention name(s): ISSNHL with vertigo
Intervention type(s): Other
Intervention description(s): Participants who suffered from ISSNHL with vertigo will be included in this study. Participants will undergo vestibular function tests including caloric test, sensory organization test, video head impulse test and vestibular evoked myogenic potentials at baseline and 2 months after onset as primary outcome, to evaluate the damage and prognosis of vestibular function.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who suffered from ISSNHL with vertigo and the onset of this disease was within 30
        days, will be included in this study cohort. The enrollment of the participants will be
        held in the clinic of Eye and ENT Hospital of Fudan University.
      
Keywords: idiopathic sudden sensorineural hearing loss; vestibular dysfunction
Effect of Digene Total (Buffered Pantoprazole) on 24 Hour Gastric Potential Hydrogen (pH) in Patients From Acid Peptic Disorder After Single and Repeated Dosing.
Condition: Acid Peptic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective, open label, single-center and non-comparative study is designed to generate
      data on Digene Total's (buffered pantoprazole) rapid and sustained gastric acid inhibition
      effect in patients suffering from acid peptic disorders.
    


Intervention name(s): Buffered pantoprazole; Buffered pantoprazole
Intervention type(s): Drug; Drug
Intervention description(s): Buffered pantoprazole 40 mg QD; Buffered pantoprazole 40 mg QD
Other intervention name(s): ABT-897, Buffered Pantoprazole, Digene Total; ABT-897, Buffered Pantoprazole, Digene Total
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Home-exercise Program for Children and Adolescent Survivors of Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      -  Exercise programs in children and teenagers with Acute Lymphoblastic Leukemia (ALL)
           strengthens their physical fitness.

        -  Exercising improves muscular and functional mobility fitness after finalizing
           chemotherapy in children and teenagers diagnosed with ALL.

        -  Assess cardiological changes
    

Detailed description: 
      Children and adolescents survivors of ALL will be randomly assigned to the intervention group
      and to the control group. A home-exercise program will be designed for 16 weeks with 55
      sessions, combining aerobic, strength and flexibility exercises of light and moderate
      intensity. The following tests will be performed to evaluate the effects of the intervention
      program: Echocardiography, Tape treadmill test using a ramp protocol to assess
      cardiorespiratory fitness, hand grip test to assess muscular grip strength, Timed Up test And
      Go Test (TUG) and Timed Up and Down Stairs Test (TUDS) to assess functional mobility, the sit
      and reach test to assess flexibility and a questionnaire to assess levels of physical
      activity. The control group will perform their usual physical activity
    

Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): An exercise program will be designed over 16 weeks with 55 sessions, moderately increasing the volume and intensity of the load every 4 weeks. The program will consist of strength exercises, flexibility and aerobic endurance, which will be explained in videos and are going to be available in an online platform.
The physiotherapist will contact the patient and/or tutor weekly so as to answer and doubts they may have with respect to the exercise program and to further supervise their compliance (group with intervention).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Physical therapy; Cardiorespiratory fitness
Exercise and Transcranial Magnetic Stimulation: Increasing Brain Plasticity in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      This is a feasibility and exploratory study consisting of two parts: first, a cross-sectional
      (one-time) biomarker measurement comparing BDNF-TrkB (Brain-derived neurotrophic factor
      (BDNF) and its receptor, TrkB,) signaling and cortical plasticity in patients diagnosed with
      Parkinson's Disease (PD) vs. healthy controls matched by age. Second, a prospective,
      randomized, double blind trial of Transcranial Magnetic Stimulation (TMS) MAGSTIM Rapid2
      Therapy System (TMS) (real or Sham) and aerobic exercise. This exploratory feasibility study
      will look at BDNF-TrkB signaling and cortical plasticity.
    

Detailed description: 
      Twenty-four PD patients (n=24) will be randomly assigned to receive one of two interventions
      for a duration of two weeks. In Group 1, subjects will participate in daily sessions of
      sham-rTMS followed by supervised aerobic exercise (Sham rTMS+Aerobic); in Group 2, subjects
      will participate in a combination of rTMS and supervised aerobic exercise (Real
      rTMS+Aerobic). Serum BDNF-TrkB signaling in lymphocytes and TMS-based electrophysiological
      measures of LTP-like plasticity will be measured. A comparison of such measures in a group of
      patients with PD and in a group of age-matched controls (n=12) will be analyzed to establish
      the effect of the disease on indices of plasticity.
    

Intervention name(s): Sham rTMS; Real rTMS; Supervised aerobic exercise
Intervention type(s): Behavioral; Other; Behavioral
Intervention description(s): Subjects will participate in daily sessions of sham-rTMS; Subjects will participate in a combination of rTMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Transcranial Magnetic Stimulation; Exercise; Brain Plasticity
Trigger Point Incidence After Lumbar Disc Herniation Surgery
Condition: Trigger Point Pain, Myofascial
MeSH terms: Intervertebral Disc Displacement; Myofascial Pain Syndromes
Study type: Observational

Summary: 
      Our purpose is to determine the incidence of trigger points in patients who remain in a fixed
      position for a long time during lumbar disc herniation surgery.
    

Detailed description: 
      The 110 participants between 30-70 years are chosen from patients who had lumbar disc
      herniation surgery. The trigger points are determined by manually palpating quadratus
      lumborum, iliocostalis lumborum, gluteus Maximus, gluteus minimus, gluteus medius, ve
      piriformis muscles before and after surgery. Data will be recorded on the patient assessment
      file and transferred to the computer and analyzed. Data analysis will be performed with
      SPSS.20.
    

Intervention name(s): Manual palpation for incidence determination
Intervention type(s): Diagnostic Test
Intervention description(s): The patients are positioned in a sitting and prone lying posture. Trigger points are discrete, local, hypersensitive spots located in a taut band of muscles. Palpation of the trigger point will cause elicitation pain over the affected area and radiation of pain toward a zone of reference and a local twitch response.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patients having lumbar disc herniation surgery
Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response
Condition: Ovarian Failure; Infertility, Female
MeSH terms: Infertility; Infertility, Female; Menopause, Premature; Primary Ovarian Insufficiency
Study type: Interventional

Summary: 
      The objective of this study is to perform a prospective randomized controlled trial seeking
      to characterize the effects of intra-ovarian injection of platelet rich plasma (PRP) on
      biomarkers of ovarian reserve as well as IVF outcomes in women with primary ovarian
      insufficiency (POI) and poor ovarian response (POR) who decline the use of an egg donor to
      establish a pregnancy.
    

Detailed description: 
      Patients will be randomized to either receive the intra-ovarian PRP injection procedure or
      not. Regardless of randomization patients will be re-assessed at the same time points for
      ovarian reserve parameters. If antral follicles are detected at follow up, patients will
      undergo controlled ovarian hyperstimulation and a routine in vitro fertilization cycle as per
      protocol.
    

Intervention name(s): intra-ovarian platelet rich plasma injection
Intervention type(s): Other
Intervention description(s): patients will undergo a transvaginal intra-ovarian platelet rich plasma injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Screening Type 2 Diabetes Mellitus on the 2nd Day After Delivery in Women With Gestational Diabetes Mellitus
Condition: Diabetes, Gestational
MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Gestational diabetes mellitus (GDM) is defined as a hyperglycemia with onset or first
      recognition during pregnancy. GDM complicates 5 to 25% of pregnancies, depending on the
      diagnostic criteria used and the population being studied.

      GDM is an important red flag: up to 70% women with GDM will develop type 2 diabetes mellitus
      (T2DM) during their lifetime. Accordingly, professional associations recommend T2DM
      postpartum screening (T2DM-pP-S), 6-to-24 weeks after delivery. A 75g oral glucose tolerance
      test (OGTT) should be performed for diagnosis (gold standard). Nevertheless, this T2DM-pP-S
      recommendation has failed worldwide for the same reasons: the presently impractical pattern
      of the testing. A solution is direly needed.

      Our overall goal is to improve detection of pre-diabetes and diabetes and more specifically,
      to facilitate the recommended T2DM-pP-S in women diagnosed with GDM.

      We hypothesize that, in GDM women, results of an OGTT performed after delivery, before
      hospital discharge (OGTT-1) predict results of the recommended OGTT at 6-to-12 weeks
      postpartum (OGTT-2). Our aims are:

        1. To validate in Caucasian women the predictive threshold value of the 2hr-glucose of
           OGTT-1 established by our Stage-1 study.

        2. To determine, in a multiethnic non-Caucasian cohort, the threshold value for the
           2hr-glucose of OGTT-1 that is predictive of abnormal glucose tolerance at OGTT-2.

        3. To define the OGTT time preference of women (before hospital discharge vs. 6-to-12 weeks
           postpartum).

      If our results are in line with our Stage-1 data, most redundant 6-to-24 weeks postpartum
      OGTT will be avoided. Medical practice will change.
    


Intervention name(s): Type 2 diabetes diagnosis test
Intervention type(s): Procedure
Intervention description(s): Participants will perform type 2 diabetes diagnosis test the day of hospital discharge after delivery and the same test around 8 weeks later.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Stroke Therapy With Brain Oscillation Synchronized Stimulation
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This randomized, controlled, double-blind clinical pilot trial investigates the therapeutic
      potential of a novel personalized therapeutic brain-stimulation protocol in chronic stroke
      patients with spasticity. Stroke patients will either receive ipsilesional 100 Hz
      transcranial magnetic stimulation (TMS) triplet burst protocol synchronized to the ongoing
      µ-alpha oscillation or contralesional 1 Hz repetitive TMS (rTMS) protocol. Motor recovery is
      assessed directly after as well as three months after completion of the therapy.
    

Detailed description: 
      Stroke is one of the leading cause for long-term disability worldwide. The standard approach
      to treat deficits after stroke is a rehabilitation therapy, that follows the stroke event
      directly. This therapy mainly includes physiotherapy and occupational therapy. Yet, despite
      intensive rehabilitation efforts, more than half of all stroke patients remain greatly
      disabled.

      Repetitive TMS is capable of inducing plasticity-like effects in the brain, that are expected
      to enhance adaptive plasticity processes leading to functional regain after stroke. In the
      motor cortex, brain oscillation-synchronized TMS, i.e. TMS triggered dependent on the phase
      of instantaneous µ-alpha oscillations as detected by real-time EEG (electroencephalography)
      analysis, has been shown to consistently increase motor cortical excitability and plasticity
      effects. We therefore hypothesis that a greater therapeutic potential of TMS to modulate
      dysfunctional brain networks can be exploited by personalizing TMS therapy to individual
      brain states (i.e. brain oscillations).

      This study aims to investigate the effectiveness of an ipsilesional 100 Hz TMS triplet burst
      protocol synchronized to the ongoing µ-alpha oscillation compared to the current TMS standard
      therapy of contralesional 1 Hz rTMS in chronic stroke patients. Both groups will undergo
      stimulation therapy three times a week, with each session directly followed by physiotherapy.
      Motor recovery will be assessed directly after as well as three months after completion of
      the therapy.
    

Intervention name(s): Negative peak triggered 100 Hz triplet burst TMS; 1 Hz rTMS
Intervention type(s): Device; Device
Intervention description(s): MagVenture MagPro X100: Ipsilesional negative peak triggered 100 Hz triplet burst TMS.; MagVenture MagPro X100: Contralesional 1 Hz rTMS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment