bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Association Between Osteoporosis and Postural Balance in Postmenopausal Women
Condition: Postural Balance
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      The incidence of osteoporosis has been increasing, as have fractures resulting from falls.
    

Detailed description: 
      The overall objective of this study is to evaluate bipodal postural balance in postmenopausal
      women with and without lumbar osteoporosis. The specific objective is to determine the
      relationship between the degree of thoracic kyphosis and dosing of 25 OH vitamin D with
      postural balance in postmenopausal women with lumbar osteoporosis.

      One hundred and twenty-six postmenopausal women between 55-65 years of age were evaluated and
      separated into two groups according to the bone mineral density values of their lumbar spine:
      the osteoporosis group and the control group.

      Functional mobility was evaluated through the Timed Up and Go Test. Postural balance was
      evaluated using a AccuSway® model portable force platform, in standard standing position,
      with eyes open and closed, for 60". Data were collected, stored, and processed by the Balance
      Clinic® program, configured to 100 Hz frequency, with a frequency cut-off filter at 10 Hz.

      Muscle strength was evaluated via a Biodex® isokinetic dynamometer in the
      concentric/concentric knee extension mode at 60o/s.

      Dosing of 25 OH vitamin D and thoracic spine x-rays to determine the degree of kyphosis
      measured by the Cobb angle were performed in the osteoporosis group.
    

Intervention name(s): Biomechanical analysis; Kiphosis analysis; Vitamin D level
Intervention type(s): Other; Other; Other
Intervention MeSH terms: Vitamin D
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Postmenopausal women
      
Keywords: Postural balance; Osteoporosis; Postmenopause; Vitamin D; Kyfhosis; Muscle strength
Palmitoylethanolamide Combined With Luteoline in Frontotemporal Dementia Patients. A Randomized Controlled Trial
Condition: Frontotemporal Dementia
MeSH terms: Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
Study type: Interventional
Phase: Phase 2

Summary: 
      Frontotemporal dementia (FTD) is a devastating neurodegenerative disorder. It is the second
      most frequent cause of presenile neurodegenerative dementia in those less than 65 years of
      age. Currently, there is no effective pharmacological treatment to slow down the progression
      of FTD. Recently, it has been proposed that neuroinflammation could be involved in specific
      forms of FTD and that novel drugs targeting neuroinflammation could potentially be useful in
      FTD treatment. An available form of ultra-micronized PEA combined with luteoline (PEA-LUT)
      has gained attention for its proven anti-inflammatory and neuroprotective properties reported
      in neurodegenerative conditions related to FTD, such as Amyotrophic Lateral Sclerosis. The
      administration of PEA-LUT treatment may have a clinical impact in behavioural variant FTD
      (bv-FTD) patients. In particular, PEA-LUT treatment could be able to reduce behavioural
      disturbances, the more disabling symptoms in bv-FTD, with a related improvement of daily
      living activities of affected people. Moreover, a multimodal approach
      (cognitive/neurophysiological) can be used to assess the brain correlates related to the
      clinical improvement associated with PEA-LUT treatment, thus making remarkable strides in
      understanding how FTD affects the brain. Potentially the proposed project could provide a
      valid treatment for cognitive and behavioural dysfunction in FTD patients, with consistent
      impact for the National Health Systems and minimum cost for the patients.
    


Intervention name(s): PEA-LUT; PLACEBO
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): PEA-LUT administration at the oral dosage of 700 mg x 2/day; PLACEBO administration at the oral dosage of 700 mg x 2/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: dopamine; frontal cortex; GABA
Title: Recombinant Plague Vaccine rF1V in Healthy Volunteers
Condition: Healthy Volunteers
MeSH terms: Plague
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2(a) clinical trial is designed as a dose-blinded, block-randomized, multi-center
      study to select a dosage and schedule of rF1V vaccine for further studies based on the immune
      response up to Day 210. Additional immunogenicity and safety/reactogenicity data will be
      collected through Day 540. Selection of dosage and schedule will be based on GMCs and
      seroconversion rates for anti-F1, anti-V and anti-rF1V antibody titers. Approximately 400
      healthy adult volunteers will be enrolled (100 per group) in this study.
    

Detailed description: 
      Primary Objective: To select a dosage and schedule of rF1V vaccine for further study based on
      the immune response to F1 and V antigens up to Day 210.

      Secondary Objectives: 1) To assess the safety of three injections of rF1V vaccine
      administered IM at two dosage levels.

      2) To assess the onset and duration of the humoral immune response to F1 and V antigens.

      3) To assess the humoral immune response to rF1V antigen. 4) To collect and store blood
      samples for future plague related research.

      Exploratory Objectives:

      To assess additional humoral immune responses to rF1V vaccine antigens.
    

Intervention name(s): rFIV vaccine; rF1V vaccine; rF1V vaccine; rF1V vaccine 160 mcg given on Study Days 0, 56, 182
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): rF1V vaccine 80 mcg given by intramuscular (IM) injection into the arm on study Days 0, 28, 182; rF1V 80 mcg vaccine given by intramuscular (IM) injection into the arm on study Days 0, 56, 182; rF1V 160 mcg vaccine given by intramuscular (IM) injection into the arm on Study Days 0, 28, 182; rF1V 160 mcg vaccine given by Intramuscular (IM) injection into the arm on Study days 0. 56, 182
Other intervention name(s): Recombinant Plague Vaccine rF1V; Recombinant Plague Vaccine rF1V; Recombinant Plague Vaccine rF1V; Recombinant Plague Vaccine rF1V
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Opioid dependence is a substantial problem associated with significant morbidity and
      mortality. Extended-release naltrexone has been found effective at reducing opioid use and
      maintaining abstinence, but its use has been limited by the difficulties encountered with
      treatment initiation, which involves detoxification from opioids and oral naltrexone
      titration. Improving the likelihood of a successful transition to naltrexone is therefore an
      important public health goal.

      N-methyl-D-aspartate receptor (NMDA) antagonism has been found to alleviate the signs and
      symptoms of withdrawal from opioids, as well as to address adaptations associated with
      chronic opioid use, such as opioid-induced hyperalgesia (increased pain sensitivity). These
      benefits may persist for at least 72 hours after a single dose. NMDA antagonism may therefore
      facilitate a rapid transition to naltrexone by reducing discomfort, improving motivation, and
      ameliorating adaptations associated with drug dependence, such as craving and arousal.

      The purpose of this trial is to assess the feasibility of NMDA antagonist-assisted naltrexone
      initiation in opioid dependent individuals. After administration of extended-release
      naltrexone, participants will be followed for 4 weeks, and transitioned to appropriate care
      subsequently (oral naltrexone, extended-release naltrexone).
    


Intervention name(s): CI-581aa; Naltrexone titration and XR-NTX initiation
Intervention type(s): Drug; Drug
Intervention description(s): 92 minute infusion of CI-581aa; participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX
Other intervention name(s): NMDA antagonist; naltrexone
Intervention MeSH terms: Naltrexone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LY2216684 and Digoxin in Healthy Subjects
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine how much digoxin gets into the blood stream and how
      long it takes the body to get rid of it when given with LY2216684. Information about any side
      effects that may occur will also be collected.
    


Intervention name(s): LY2216684; Digoxin
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Intervention MeSH terms: Digoxin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Development of a Fetal Sex Assay From Maternal Whole Blood
Condition: Fetal Sex Determination
Study type: Observational

Summary: 
      Whole blood from pregnant women will be collected to develop a noninvasive fetal sex test.
    

Detailed description: 
      This is an observational study whereby samples will be tested to determine the presence or
      absence of fetal Y chromosome genes to test for the fetal sex of the baby. The blood draw
      will occur between 6 to 16 weeks of gestation. The fetal gender will be requested at or soon
      after delivery if fetal sex was not previously obtained by CVS or amniocentesis genetic
      analysis.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women between 6 and 16 weeks of gestation.
      
Biospecimen description: 
      Plasma and PBMCs
    
Keywords: pregnant; fetal sex determination; gender determination; noninvasive test; fetal DNA
Electroacupuncture Analgesia for EUS: a Randomized Controlled Trial
Condition: Patients Undergoing Endoscopic Ultrasound
Study type: Interventional
Phase: Phase 2

Summary: 
      Endoscopic ultrasound (EUS) has evolved to become an important diagnostic tool and its
      interventional role is rapidly expanding. In order to improve patient's comfort and
      satisfaction during and after procedure, the use of sedation is usually recommended. However,
      sedation may be associated with serious adverse events of including hypotension, aspiration
      and respiratory depression. Moreover, the cost of performing the procedure would be increased
      due to the costs of the medications and the need of additional personnel in monitoring of the
      patient. As a result, the drive to seek alternative and safer approaches of pain-relief
      during EUS is ever present. Electroacupuncture (EA) has been used in Traditional Chinese
      Medicine (TCM) for more than 2000 years. The benefits and success of EA in treatment of acute
      and chronic pain of various origins have been well-recognised. Many researches have been
      performed to address the role of EA in treating pain and anxiety during OGD and colonoscopy.
      However, only limited data is availabe in the Chinese and the Western literature concerning
      the use of EA in EUS. Therefore it is worthwhile to conduct a well-designed study to evaluate
      the role of EA in treating pain during EUS.
    


Intervention name(s): Electroacupuncture
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Biological Age in Worksite Health Promotion
Condition: Health Behavior; Biomedical Technology
Study type: Observational

Summary: 
      This cohort study investigates how implementation of Biological Age technology in worksite
      health promotion, affects health behavior in the general Danish working population.
    

Detailed description: 
      This cohort study is designed on the basis of Body Age tests, executed by a private Danish
      health care company in the period from 2010 to 2013.

      The dataset comprises pre- and post Body Age tests from >4000 individuals. They used a
      standardised protocol and educated staff ( physiotherapists or with a degree in sports
      science) to carry out the tests. Body Age tests apply biometrics, fitness level and health
      status data of the employee. The test results are characterized by a Body Age score, which
      defines the employee's biological age (in years).

      This design categorises as a register study why The Danish National Committee is not applied
      for.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The volunteers are employees in either private or governmental companies. A total of 18
        different companies are included in this study, primarily related to banking, pension and
        pharmaceutical work areas. The Body Age test is voluntary and part of the companies health
        strategy and fringe benefits.
      
Keywords: Biological Age; Motivation
Single and Repeat Dose First Time in Human Study for an Intranasal H1/H3 Dual Antagonist in Healthy Male Subjects
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, placebo-controlled, randomized single dose escalation study and a
      double-blind, placebo-controlled, randomised parallel group 14-days once daily repeat dose
      study to investigate safety, tolerability and pharmacokinetics of an intranasal H1/H3 dual
      antagonist compound in healthy male subjects.
    

Detailed description: 
      A double-blind, placebo-controlled, randomized single dose escalation study and a
      double-blind, placebo-controlled, randomised parallel group 14-days once daily repeat dose
      study to investigate safety, tolerability and pharmacokinetics of an intranasal H1/H3 dual
      antagonist compound in healthy male subjects.
    

Intervention name(s): GSK1004723; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK1004723 will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.; Placebo will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.
Allocation: Randomized
Intervention model: Sequential Assignment
Primary purpose: Treatment
Keywords: first time in human; Allergic rhinitis,
Nippon Ultra-Rapid Insulin and Diabetic Complication Evaluation-Study (NICE-Study)
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      For the purpose of comparing efficacy of intensive therapy between 1) ultrarapid-acting type
      insulin (insulin aspart) and 2) conventional rapid-acting type insulin (R), a Multicenter
      Open Label Randomized Controlled Trial was planned in Japan using the occurrence of
      cardiovascular events in patients with diabetes, a high risk factor, as an index.
    

Detailed description: 
      A survey shows that the most frequently observed direct cause of death in diabetic patients
      is cardiovascular disorder. However, investigations and surveys such as DCCT, UKPDS and
      KUMAMOTO-study, etc. clarified that strict control of blood sugar level prevented development
      and progress of diabetic microangiopathy, but could not show a significant effect on great
      vessel disorder. Recently, the DECODA-study, DECODE-study and Honolulu-study have
      demonstrated that postprandial high blood sugar is involved in great vessel disorder.
      Therefore, possible prevention of great vessel disorder in diabetic patients is suggested by
      improving the postprandial blood sugar level as achieved using ultrarapid-acting type
      insulin, which has become available recently. Even with results in Europe and the US
      obtained, the life-style and incidence of complications in Japanese people are different, and
      there are many points that remain uncertain with respect to the direct application of foreign
      results to Japanese people. Therefore, in Japan also, it is necessary to conduct a
      large-scale clinical study and to establish high-level evidence using mainly Japanese people
      through hospitals having many patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Japanese outpatients and inpatients aged 20 years or more but younger than 85 years. Men or
        women. Patients with type 2 diabetes based on the diagnostic standard of the Japanese
        Diabetes Society/American Diabetes Association. No specific restriction on the current
        treatment. Patients having switched treatment are also accepted.
      
Keywords: type2 diabetes mellitus; cardiovascular disease; macrovascular event
Efficacy of Core Strengthening and Intensive Dynamic Back Exercises in Patient With Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The study aimed to investigate the efficacy of core strengthening and intensive dynamic back
      exercises on pain, muscle strength, endurance, and functional disability in patients with
      chronic non-specific low back pain.
    

Detailed description: 
      The study will be based on a three-arm parallel group randomized control design. Forty-five
      participants with chronic non-specific low back pain will be recruited from the Physiotherapy
      department, at Integral University, India. Study objectives and procedure will be properly
      explained and written informed consent will be obtained at the beginning of the study. All
      the participants will be randomly divided into three groups A, B, and C. Experimental group A
      will be receiving the hot pack, active Stretching, isometric exercise intervention, and core
      strengthening exercises while group B will receive the hot pack, active Stretching, isometric
      exercise intervention, and intensive dynamic back exercises, control group C will receive the
      hot pack, active Stretching, isometric exercise intervention.
    

Intervention name(s): Core strengthening exercise; intensive dynamic back exercise; Control group
Intervention type(s): Other; Other; Other
Intervention description(s): Isolated lumbar stabilization muscle training:
Bridge track:
Dead bug track:
Quadruped Track:
Supine Track:
Side-support Track:
Prone Track:
Standing Track:; Trunk lifting Prone on a couch, hips at the edge, upper part of the body free but supported by the hands against the floor. Strap fixation over the calves. With hands on the forehead, the trunk is lifted to the greatest possible extension in hips and spine. If necessary, starting with support from physical therapist. During pauses a chair in front of the couch supports the patient.
Leg lifting Standing by the end of the couch, leaning over to a prone position with the hips against the edge in 90 degree flexion, knees 45 degree and feet on the floor. Strap fixation over the chest. Straps around knees to keep legs together. Both legs are straightened and lifted to the greatest possible extension in hips and spine. Again support from physical therapist is necessary.
Pull to neck Sitting on a tool with the arms straight and abducted over the head and hands grasping a weight lever. Against sub-maximal resistance the lever is pulled behind neck and shoulders.; Hot Pack was given for twenty minutes, slow sustained stretching exercises ( 20 second hold, 10- second relaxation) were given, and isometric exercise of the back((10 repetitions of two sets with 10 seconds hold) alternate days for six weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Extracorporeal Shock Wave Therapy on Spasticity
Condition: Spasticity
MeSH terms: Muscle Spasticity
Study type: Interventional

Summary: 
      The effect of traditional treatment for spasticity is barely satisfactory. The shock wave has
      been used to treat the spasticity with expressively response and the effect could persist for
      1-3 months in different studies. However most sutdies lack the sham or control group. The
      purpose of this study was to assess the effect of shock wave for spasticity in wrist and
      hand.
    

Detailed description: 
      The patients with spasticity for at least 6 months were randomized for 3 groups. Group I:
      patients receive one session of shock wave per week for 3 weeks; Group II: patients receive
      only one session of shock wave; Group III: patients receive the sham shock wave per week for
      3 weeks. The outcome measurements include Modified Asthow scale, passive range of motion,
      Disability Assessment Scale and Fugl-Meyer Assessment Scale (hand function and wrist
      control).
    

Intervention name(s): Shock wave
Intervention type(s): Device
Intervention description(s): Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (< 10 ns) and short duration (10 μs) is conveyed by an appropriate generator to a specific target area with an energy density in the range of 0.003-0.890 mJ/mm2.
Different studies and clinical experiments have demonstrated the efficacy of shock waves in the treatment of musculoskeletal system such as chronic tendinopathies, calcific tendinitis of the shoulder, lateral epicondylitis, plantar fasciitis, and several tendon diseases.
Other intervention name(s): E-SWT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Shock wave; Spasticity; Effect
Safety and Immune Response to an Investigational Vaccine Against Respiratory Syncytial Virus in Healthy Adults
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates an investigational vaccine designed to protect humans against infection
      with respiratory syncytial virus (RSV). The investigational vaccine (MV-012-968) is
      administered as drops in the nose. This study specifically analyzes the safety of, and the
      immune response to, the vaccine when administered to healthy non-pregnant adults between the
      ages of 18 and 40 years.
    


Intervention name(s): RSV vaccine MV-012-968 (dosage #1); RSV vaccine MV-012-968 (dosage #2)
Intervention type(s): Biological; Biological
Intervention description(s): Single dose administered intranasally on Day 1; Single dose administered intranasally on Day 1
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each enrolled subject will be allocated to 1 of 2 study groups. Group 1 will receive one dosage of the investigational RSV vaccine, and Group 2 will receive a different dosage of the same vaccine.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaccine; live attenuated; safety; immunogenicity; viral shedding; phase 1 clinical trial