bioihbjkbjnl/mcl2 huggingface dataset:
Low-intensity Shockwaves Therapy for the Treatment of Patients With Moderate Vasculogenic Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      This is a double-blind, sham-controlled randomized, 2 parallel arms, clinical trial with a
      12-month recruitment period. All patients will be PDE5I users/responders. After 1 month
      wash-out period, ED patients will be screened, in order to randomize 70 men with vasculogenic
      ED.Patients will be randomized in 2 groups (35 subjects in each group) to receive shockwave
      treatments (12 sessions for all subjects, 5000 shockwaves at each session), twice a week
      (total of 6 weeks) either at energy level 7 or at sham-control , without treatment interval.
      The IIEF-ED domain will be evaluated at Visit 1 and, consequently, at baseline and all follow
      up visits together with the SEP diaries.
    


Intervention name(s): Dornier Aries2 device; Dornier Aries2 device (sham probe)
Intervention type(s): Device; Device
Intervention description(s): The Dornier Aries2 device and will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft and the 2 crura(two sites).; The Dornier Aries2 device and will be used for the purpose of the study but the active probe will be replaced by an identical sham probe.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A 2-Part Study to Evaluate the Safety of Supra-Therapeutic Doses of RO4602522 and to Investigate the Effect of RO4602522 on the QTc Interval
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2 part study to evaluate the safety and tolerability of supra-therapeutic doses of
      RO4602522 (Part A); and to investigate the effect of RO4602522 on the QTcF interval in
      healthy volunteers (Part B). Part A of the study will be a multiple-dose, randomized,
      double-blind, placebo-controlled study. Participants will be randomized to receive daily,
      oral doses of either RO4602522 or placebo for ten days. Part B of the study will be a
      multiple-dose, randomized, double-blind, double-dummy, placebo controlled, positive-control,
      parallel group study. Participants will be randomized to receive either multiple or single
      doses of RO4602522 or to receive single doses of moxifloxacin for 11 days. Pharmacokinetic
      parameters will be assessed for Parts A and B; and continuous ECG recordings will be made
      during Part B.
    


Intervention name(s): Placebo RO4602522; RO4602522; RO4602522; moxifloxacin; moxifloxacin placebo
Intervention type(s): Other; Drug; Drug; Drug; Other
Intervention description(s): Daily oral doses; Daily oral doses; Single, oral dose; 400 mg oral dose given on Day 1 or 11; Dose given orally on Days 1 and/or 11
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Psychoeducation for Vietnamese Families With a Patient With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Families with a patient with schizophrenia and the patient are randomly assigned to receive
      either a 3 session psychoeducation program, or no psychoeducation. Other treatment for
      schizophrenia and other mental illness are provided as usual.
    

Detailed description: 
      Families with a patient with schizophrenia and the patient are randomly assigned to receive
      either a 3 session psychoeducation program, or no psychoeducation. Other treatment for
      schizophrenia and other mental illness are provided as usual. The psychoeducation program
      focuses on: (a) explaining schizophrenia as a medical, biological illness, (b) the prognosis
      for schizophrenia (e.g., that it is possible to lead a normal life), and (c) what the family
      and patient can do to maximize the outcome.
    

Intervention name(s): Psychoeducation
Intervention type(s): Behavioral
Intervention description(s): 3 session psychoeducation program with the family, and 3 session psychoeducation program with the patient, after psychosis is controlled. Psychoeducation focuses on explaining schizophrenia as a medical illness, the prognosis, and how the patient and family can increase the likelihood of better outcome.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; psychoeducation; Vietnam
Safety and Efficacy of CJ-50300 in Healthy Volunteers
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The currently available stock of smallpox vaccine would be insufficient in the face of an
      incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine are
      urgently needed because previous manufacturing methods using calf lymph are no longer
      acceptable in the view of current standards. Recently, CJ corporation in Republic of Korea
      has developed cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by
      infecting MRC-5 cells. The aim of this clinical trial were to assess safety, reactogenicity,
      and immunogenicity of CJ-50300.
    


Intervention name(s): smallpox vaccine CJ-50300
Intervention type(s): Biological
Intervention description(s): Conventional dose group: 2.5 x 10 5 pfu/dose Diluted dose group:2.5 x 10 4 pfu/dose
Other intervention name(s): CJ-53300
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Smallpox vaccine efficacy
Regulation of Endogenous Glucose Production by Brain Insulin Action
Condition: Insulin Resistance, Diabetes
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      It is well known that the hormone insulin lowers blood glucose in part by acting directly on
      the liver and reducing hepatic glucose production. Animal studies have shown that the hormone
      insulin can act on the brain to indirectly lower glucose production by the liver. We aim to
      test whether this is true in humans by giving insulin intranasally. It has previously been
      shown that a nasal spray can deliver insulin directly to the brain without affecting
      circulating insulin concentration.
    

Detailed description: 
      Each study participant will be admitted to hospital the evening prior to the study. Following
      admission each study participant will be provided with a standardized dinner. At 7am (t=0)
      the next day we will begin a primed, constant intravenous infusion d2 glucose (a stable
      isotope of glucose, the enrichment of which can be measured by gas chromatography mass
      spectrometry, allowing us to calculate endogenous glucose production rates) and continue this
      for 8 hours. At the same time (7am) a pancreatic clamp will be started as described above for
      8 hours. Blood samples will be analysed with a glucometer for instant blood glucose readings
      At 9 am (+120 minutes) intranasal placebo or insulin will be administered. The insulin
      (Humalog Lispro 100 IU/ml, Eli Lily, Canada) and placebo (diluent) will be transferred to a
      metered nasal device (Pharmasystems, Ontario UPC: 063636 802721, Item 10271) immediately
      prior to use. This device dispenses 0.1ml (10 IU) per puff. 4X0.1 ml puffs/vials (2 per
      nostril) will be administered at rate of 2 (one in each nostril) every 60 seconds. Blood will
      be drawn at t=0, 30, 60, 120 and every 10 minutes thereafter for 6 hours. In order to match
      peripheral lispro concentrations between study visits, a small dose of Humalog (lispro)
      insulin will be administered intravenously at 9am, during the placebo arm of the study. Based
      on the pharmacokinetics of Humalog lispro (personal communication from Eli Lilly), we propose
      to administer 0.005 IU/kg over 30 minutes. 20% dextrose will be administered to maintain
      euglycemia as necessary. Insulin, glucagon, and glucose isotopic enrichment will be measured.
      The enrichment data and glucose infusion will be used to calculate steady state glucose
      production.
    

Intervention name(s): Intranasal insulin; Intranasal placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intranasal spray; Intranasal spray
Other intervention name(s): Humalog lispro 40 IU intranasally; Diluent intranasally
Intervention MeSH terms: Insulin; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Insulin resistance; Brain insulin action; Type 2 Diabetes
Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012
Condition: Kawasaki Disease
MeSH terms: Mucocutaneous Lymph Node Syndrome
Study type: Observational

Summary: 
      To investigate the epidemiological pictures of Kawasaki disease (KD) in Shanghai from 2008
      through 2012, and illustrate the risk factors of coronary arterial lesions .
    

Detailed description: 
      A questionnaire form and diagnostic guidelines for KD will be sent to 50 hospitals providing
      pediatric medical care in Shanghai, China. All patients with KD diagnosed during January 2008
      through December 2012 will be recruited and analyzed. Distribution of age at onset and
      seasonal features of disease incidence wil be described. Univariate and multivariate
      association analyses will be performed to identify risk factors to Coronary arterial lesions
      (CAL) defined as ectasia or aneurysm by using multivariate logistic regression model.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients with KD diagnosed during January 2008 through December 2012 in Shanghai
      
Keywords: Kawasaki disease; Epidemiology; Incidence; Coronary arterial lesions; Shanghai
Assess the Efficacy and Safety of Multi-target Therapy in Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy and safety of multi-target therapy in the
      treatment of class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ lupus nephritis.
    

Detailed description: 
      1. To assess the efficacy of FK506 combined with MMF vs intravenous cyclophosphamide (CTX)
           pulses in treatment of class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ Lupus Nephritis (LN).

        2. To investigate the safety and tolerability of FK506 combined with MMF vs intravenous CTX
           pulses in the treatment of class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ LN.
    

Intervention name(s): Tacrolimus+Mycophenolate mofetil; Cyclophosphamide
Intervention type(s): Drug; Drug
Intervention description(s): FK506 4mg/d,MMF 1.0g/d; CTX 0.75g/m2 BSA
Other intervention name(s): FK506+MMF; CTX
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lupus nephritis;multi-target therapy; MMF; FK506
Assessing Effects of Lateral Tilt on Cardiac Output Using a Non-invasive Technique
Condition: Cardiac Output
Study type: Observational

Summary: 
      In pregnant term patients, we intent to use a non invasive cardiac output monitor to detect
      the changes in cardiac output as the patient is being placed in different positions.

      The patient will be placed on her back, flat, and in left lateral tilt at two different
      angles. Measurements of cardiac output will be recorded.
    

Detailed description: 
      Aortocaval compression compromising tissue perfusion has always been of a concern in term
      pregnant women undergoing caesarian delivery or regional anesthesia when placed in the supine
      position. It is believed that this phenomena happens when the gravid uterus compresses the
      inferior vena cava (IVC)resulting in decreased venous return and hence cardiac output (CO)
      leading to low placental perfusion and associated fetal heart rate changes.

      Hence, due to these concerns, left lateral tilt is currently a common practice in obstetrics
      and it is believed to relief aortocaval compression and to improve blood flow to the fetus.

      Supporting evidence for this intervention remains controversial, and shows conflicting
      results. Some studies suggest that lateral tilt does not affect neonatal outcomes (1) or
      changes in cardiac output in patients with no regional anesthesia (2). While others suggest
      it can actually increase the volume of the IVC, especially when the patient is tilted 30
      degrees or more (3) and may lead to increases in CO (4).

      Non-invasive hemodynamic monitoring (NICOM, Cheetah Medical), an FDA approved device, is
      currently being used to detect changes in CO in the United States. Its use has been validated
      in different clinical settings (5,6).

      Our hypothesis is that CO is increased in pregnant women that were placed in the lateral tilt
      position.

      We intend to compare CO measurements using the non-invasive hemodynamic monitoring among term
      pregnant patients in supine vs lateral tilt position.
    

Intervention name(s): supine position; 15 degrees lateral tilt; 30 degrees lateral tilt
Intervention type(s): Other; Other; Other
Intervention description(s): The patient will be placed in a supine position. Changes in cardiac output will be measured.; The patient will be placed in 15 degrees lateral tilt position. Changes in cardiac output will be measured.; The patient will be placed in 30 degrees lateral tilt position. Changes in cardiac output will be measured.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Term Pregnant women presenting for delivery
Manual Ankle Rocking Training on Postural Control and Foot Function in Children With Down Syndrome
Condition: Down S Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      Down syndrome occurs due to abnormal cell division of extra chromosome 21. It is a genetic
      disorder that causes postural un stability, leads to poor foot function and causes them
      difficulty that they can't fulfill their daily life activities and can't be independent.
      Strengthening exercise of lower limb and core strengthening of trunk muscle will provide
      postural stability and lower limb strengthening. Aim of this research is to determine the
      effects of manual Ankle rocking training on postural control and foot function in children
      with Down syndrome. Those who are diagnosed with down syndrome and are between age 8-15 and
      both of the genders are included in this research and those who have any surgical issue,
      visual impairment and musculoskeletal contractures are not included in the study we will use
      static standing balance test to check postural control and foot function index for Ankle
      rocking training from two group in which one will be given the baseline treatment of lower
      limb exercise and core strengthening with ankle rocking training and the other group without
      ankle rocking training and then the collected data will be analyzed by SPSS. 22
    


Intervention name(s): Manual ankle rocking training; Conventional
Intervention type(s): Other; Other
Intervention description(s): Group will receive manual ankle rocking training with lower limb exercise and core strengthening of trunk; Group will receive lower limb exercises and core strengthening of trunk. Sessions will be 4 days in a week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Down syndrome; Postural control; Postural stability; Balance
Evaluation of Handheld Colonoscopy Force Monitor by Expert Endoscopists in the Performance of Colonoscopy
Condition: Identify Characteristics of Colonoscopists During Endoscopy
Study type: Observational

Summary: 
      The purpose of this study is to evaluate a handheld Colonoscopy Force Monitor(CFM™), a
      push-pull force and torque measuring device, that grips the shaft of the colonoscope and
      wirelessly transmits and records all the forces applied by the endoscopist during
      colonoscopy.
    

Detailed description: 
      Colonoscopy requires a skilled endoscopist to use visual and tactile information to advance
      and withdraw the instrument through a series of fixed and stationary loops. To develop and
      maintain the skills necessary to perform colonoscopy safely and effectively requires
      extensive training and ongoing education. Quantification of tactile information provides the
      opportunity to understand the "feel" used by the endoscopist to perform colonoscopy. The
      identification of force application patterns has the potential to enhance training and
      improve performance. CFM™ is a handheld device that uses load cells to transform applied
      force to electric signals and to transmit wirelessly the signal to a computer for storage and
      visual display. The device is designed so that the endoscopist maintains a conventional hand
      position and uses an electronically controlled grip and release mechanism to fix the position
      on the instrument. Several expert endoscopists from multiple institutions will use the CFM™
      to perform colonoscopy. The data will be recorded and analyzed for differences by patient
      characteristics(e.g. gender, age, pain sensation, surgical history) and by endoscopist.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All adult male and female patients between the ages of 30 and 75 presenting to the Chevy
        Chase Endoscopy Center for screening or diagnostic colonoscopy to be performed by any of
        the investigators will be considered for inclusion.
      
Keywords: Colonoscopy; Instrumentation; Force Monitoring; Quality Control; Training
Muscle Activity and Kinematic Changes With Dry Needling
Condition: Healthy
Study type: Interventional

Summary: 
      This study assesses the effects of dry needling with electrical stimulation to the low back
      on muscle activity and changes in movement. The investigators hypothesize that dry needling
      and electrical stimulation will elicit changes in muscle activity as well as changes in
      movement.
    

Detailed description: 
      This study will utilize a Vicon motion capture system in conjunction with a Noraxon wireless
      surface electromyography system to analyze movements and muscle activity of each participant
      pre and post needling.
    

Intervention name(s): Dry needling with electrical stimulation
Intervention type(s): Other
Intervention description(s): Paravertebral dry needling to L3, 4, 5 multifidi. Electrical stimulation will be applied through the needles for up to 10 minutes total or to the participant's tolerance.
Intervention model: Single Group Assignment
Intervention model description: single group pre-test/post-test study design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lumbar multifidi; dry needling; electromyography; kinematic
Cognitive and Behavioral Outcomes of School-aged Children Who Were Born Preterm
Condition: Very Low Birth Weight Infants
MeSH terms: Birth Weight
Study type: Observational

Summary: 
      This study evaluates the cognitive and behavioral outcomes including image findings of
      school-aged children who were born preterm compared with who were born term gestational age.
    

Detailed description: 
      There are lots of studies published that school-aged children who were born preterm has some
      behavioral problems in school and they also have poor academical achievement.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Among the infants who were born and admitted to Seoul National University Hospital from
        2008 to 2009, the birth weight of the infants less than 1,500g or gestational age less than
        32 weeks patients were enrolled.

        The infants who were born from 2008 to 2009 with term gestational age will also be
        enrolled.
Double-blind Placebo-controlled Trial of Generic Clindamycin/Benzoyl Peroxide Gel Versus Onexton Gel in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75%
      gel. This study is designed to evaluate the safety and efficacy of this formulation in
      subjects with Acne Vulgaris
    

Detailed description: 
      This is a randomized, double blind, three-arm, parallel group, placebo control bioequivalence
      study with clinical endpoint, at multiple study sites, designed to establish bioequivalence
      of clindamycin 1.2% and benzoyl peroxide 3.75% gel of Actavis and Onexton® (clindamycin 1.2%
      and benzoyl peroxide 3.75%) gel in the treatment of subjects with Acne Vulgaris.

      The primary objective is to evaluate the bioequivalence of a generic of clindamycin 1.2% and
      benzoyl peroxide 3.75% gel to Onexton® in the treatment of subjects with acne vulgaris.
    

Intervention name(s): Onexton; Clindamycin/benzoyl peroxide gel; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Topical gel for treating acne; Generic Clindamycin/benzoyl peroxide gel for treating acne; Vehicle gel used as a placebo
Other intervention name(s): Clindamycin/benzoyl peroxide gel; Clindamcyin Phosphate; BPO; Vehicle
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment