bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Yogurt Containing BB12 in Subjects With GI Symptoms
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine if probiotics bacteria, specifically
      bifidobacterium lactis (BB12) improve gastrointestinal symptoms in subjects with functional
      gastrointestinal symptoms (i.e., non-patients IBS/functional bowel disorders).
    

Detailed description: 
      The apparent success of the use of probiotics in several gut disorders (e.g., IBD and
      rotavirus diarrhea) together with the greater understanding of the role of inflammation and
      intestinal microflora in the pathophysiology of functional bowel disorders has led to
      increased interest in use of probiotics in patients with these symptoms. The data on the use
      of probiotic in certain functional GI disorders (e.g., IBS, bloating, diarrhea) is limited
      but several reported studies show encouraging results and suggest some symptomatic response
      and parallel improvement in quality of life. Functional Bowel Disorders (FBD) - According to
      the Rome II criteria FBD refer to symptoms attributed to the mid or lower GI tract. FBD
      include several clinical subgroups including irritable bowel syndrome (IBS), functional
      diarrhea, functional constipation, functional abdominal bloating, and an unspecified group.
      This study will examine 'Non-Patients IBS,' these are people who have functional
      gastrointestinal (GI) symptoms but do not sought out medical care for their GI symptoms and
      therefore they are referred to as 'Non-patients'. This study will investigate the overall
      effect of probiotic bacteria (BB12) on GI symptoms in non-patients subjects with functional
      bowel symptoms (FBS).
    

Intervention name(s): Probiotic BB12 - Bifidobacterium lactis; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Bifidobacterium lactis (3.1 oz yogurt) administered once a day for 6 weeks; Placebo administered once a day for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Probiotics; BB12; Gastrointestinal Symptoms
The Effectiveness and Safety of Niacinamide 4% and Virgin Coconut Oil 30% for Secondary Prevention of Occupational Hand Dermatitis
Condition: Contact Dermatitis of Hands
MeSH terms: Dermatitis; Dermatitis, Contact
Study type: Interventional

Summary: 
      Occupational hand dermatitis (OHD) often occurs in intensive care unit (ICU) nurses,
      especially in individuals who are vulnerable due to irritant exposure e.g. hand rub alcohol
      and repeated hand washing activities. The use of moisturizer is one of the recommendations
      for skin care in OHD. Niacinamide which has anti-inflammatory effects and can improve the
      skin barrier function. Virgin coconut oil (VCO) is rich in lipids and lauric acid, and has an
      occlusive effect. Until now there are no guidelines and reference types of moisturizers for
      secondary prevention in DTAK.
    

Detailed description: 
      The aim of this study is identify the effectiveness and safety between moisturizing cream
      containing niacinamide 4% and VCO 30% for secondary prevention of occupational hand
      dermatitis in ICU nurses This study also measured HECSI , TEWL, and SCap before and after
      treatment
    

Intervention name(s): Niacinamide 4%; Virgin Coconut oil 30%
Intervention type(s): Other; Other
Intervention description(s): cream moisturizer; cream moisturizer
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There were 46 subjects in the niacinamide 4% arm and 46 subjects in the VCO 30% arm
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Occupational Hand Dermatitis; Moisturizer; Niacinamide; Virgin coconut oil; HECSI; TEWL; SCap
RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)
Condition: Surgical Wound
MeSH terms: Surgical Wound
Study type: Interventional

Summary: 
      The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva
      VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites. Hypothesis:
      The Cardiva VASCADE™ VCS provides times to hemostasis (TTH) and time to ambulation (TTA)
      results that are less than manual compression by a clinically meaningful and statistically
      significant margin. The rate of major access site-related complications with the Cardiva
      VASCADE™ VCS is non-inferior to the major complication rates of manual compression for
      sealing femoral arterial access sites.
    

Detailed description: 
      A prospective, randomized, controlled multi-center clinical trial designed to evaluate the
      safety and effectiveness of the study device in sealing femoral arterial access sites and
      providing reduced times to hemostasis and ambulation compared with manual compression at the
      completion of diagnostic or interventional endovascular procedures performed through 6 Fr or
      7 Fr introducer sheaths. Subjects will be randomized in a 2:1 treatment device to control
      ratio.
    

Intervention name(s): Manual compression; Cardiva VASCADE™ Vascular Closure System
Intervention type(s): Other; Device
Intervention description(s): Standard of Care; Investigational Hemostatic Vascular Closure System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vascular closure system; manual compression; femoral arteriotomy; percutaneous endovascular procedures
Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor
Condition: Labor Pain; Induced; Birth
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      A total of 60 parturients undergoing induction of labour will be consented to participate in
      the study where they will be randomized to receive either spinal fentanyl (20 µg) or epidural
      analgesia (fentanyl 100µg and lidocaine 80 mg).

      They will be monitored for the development of analgesia for a duration of 30 minutes.
    


Intervention name(s): Fentanyl Citrate; Lidocaine 1% Injectable Solution; Fentanyl Citrate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fentanyl citrate 20 µg in 2 ml of saline injected into csf; Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume; Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume
Intervention MeSH terms: Lidocaine; Fentanyl; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 60 parturients randomized to two different treatment arms (30 in each group)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: epidural analgesia; spinal analgesia; labor pain
Functional MRI in Lupus Nephritis
Condition: Healthy; Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Observational

Summary: 
      The primary objectives of the study are as follows: To develop and optimize a renal
      functional magnetic resonance imaging (MRI) protocol consisting of Diffusion-Weighted
      Magnetic Resonance Imaging (DW-MRI), Blood-Oxygen- Level-Dependent MRI (BOLD-MRI), Arterial
      Spin Labeling MRI (ASL-MRI), Phase Contrast MRI (PC-MRI), and T1rho-MRI; To compare renal
      functional MRI cross-sectional readouts between normal healthy volunteers (NHV) and lupus
      nephritis (LN) participants.

      The secondary objectives of this study are as follows: Explore whether renal functional MRI
      techniques discriminate between renal inflammatory activity and damage in lupus nephritis
      (LN); To examine whether renal functional MRI measurements correlate with laboratory features
      of renal involvement and renal function in participants with lupus nephritis (LN).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic, community sample. 30 Normal Healthy Volunteers 30 Participants with
        documented diagnosis of Lupus Nephritis
      
Biospecimen description: 
      Blood Samples, Urine samples and Renal biopsy tissue samples.
    
Keywords: lupus nephritis; normal healthy volunteer; MRI
Androgens Level in the Third Trimester of Pregnancy in Patients With Preeclampsia
Condition: Pre-Eclampsia
MeSH terms: Pre-Eclampsia; Eclampsia
Study type: Observational

Summary: 
      This study aims to compare between androgens level (serum total and free testosterone) in
      women with preeclampsia and normal ones in the third trimester of pregnancy (28-40 weeks).
    

Detailed description: 
      Methodology:

      All women in this study will be subjected to:

        -  All women are candidates for this study according to inclusion and exclusion criteria.

        -  History taking with special emphases on last menstrual period to determine the exact
           Gestational age.

        -  A reliable date is defined as the occurrence of regular menstrual cycles (28±7 days) in
           patients who have not taken oral contraceptives during the three months before
           conception and have no irregular bleeding.

        -  General and abdominal examination for each patient to determine those patients matching
           with the inclusion criteria.

        -  Preeclampsia refers to the new onset of hypertension (systolic blood pressure ≥140 mmHg
           ,or diastolic blood pressure≥ 90 mmHg ,or both, measured on two occasions > 6 hours
           apart) and either proteinuria or end organ dysfunction after 20 weeks of gestation in a
           previously normotensive woman.

        -  At Ain Shams University Hospitals, the investigator will use ELISA based test system
           intended for the quantitative measurement of total and free testosterone for patients of
           both groups.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Study Site:

        Ain Shams University Maternity Hospital

        Study Design:

        This study is a case control study.

        Study Population:

        Patients will be divided into two groups:

        Case group:

        This group will include forty (40) preeclamptic patients at the third trimester (28-40
        weeks) admitted at Ain Shams University Maternity Hospital.

        Control group:

        This group will include forty (40) normotensive pregnant women at term admitted at Ain
        Shams University Maternity Hospital.
The Effect of Ultrasound on Orthodontic Tooth Movement
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      To study whether or not the Aevo System™ medical device enhances the rate of tooth movement
      in human subjects who use orthodontic braces.
    

Detailed description: 
      The study will involve comparing the effects of tooth movement with and without ultrasound
      treatment in a split mouth design. Treatment will consist of using the Aevo System™ device
      for one 20 minute period per day for the duration of the trial (up to 24 weeks). Tooth
      position measurements will be taken from eligible patients prior to commencing usage of the
      study device. Follow-up visits will be scheduled for intra-oral clinical measurements and to
      take full-arch impressions. The Aevo System™ consists of an ultrasound emitting mouthpiece
      which is wire connected to an external handheld device. The mouthpiece is placed over the
      teeth and over the braces every day for 20 minutes in order to deliver the therapy.
    

Intervention name(s): Ultrasound; Sham comparator
Intervention type(s): Device; Device
Intervention description(s): The Aevo System™ is an ultrasound emitting dental device.; Ultrasound not activated in the comparator side of the device.20 minutes per day of ultrasound treatment on the active side of the device. The device consists of a mouth guard type device with transducers embedded in the mouth guard. In the split mouth design, the treatment arm consist of the side of the mouth with the transducers activated while the comparator arm has the transducers deactivated.
Other intervention name(s): Aevo System.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Orthodontics; Braces; Tooth
Evaluation of a Fasting Mimicking Diet
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Randomized, open-label, 7-month trial in eighty (80) adult subjects. Forty (40) subjects will
      be randomized to the intervention FMD arm with a 5 day meal program every month for four (4)
      months. Forty subjects will be randomized to a follow a Mediterranean diet plan for four
      months. Both arms will have a final study visit at month 7.
    

Detailed description: 
      Determine the effects of the FMD on cardiovascular (CV) biomarkers, coronary heart disease
      (CHD) risk factors (body weight, body mass index (BMI), body composition, blood pressure,
      serum lipid levels and dysglycemia blood measurements), noninvasive cardiovascular testing
      for endothelial function, arterial stiffness of large and small arteries and autonomic
      function testing in adult subjects over a seven-month study period.
    

Intervention name(s): FMD Arm
Intervention type(s): Dietary Supplement
Intervention description(s): ProLon Fasting Mimicking Diet Plan
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, open-label, 7-month trial in eighty (80) adult subjects. Forty (40) subjects will be randomized to the intervention FMD arm with a 5 day meal program every month for four (4) months. Forty subjects will be randomized to a follow a Mediterranean diet plan for four months.
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will test the effectiveness and safety of treatment with MK-0893 in combination
      with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.
    


Intervention name(s): MK-0893; Sitagliptin; Metformin; Placebo for MK-0893; Placebo for Sitagliptin; Placebo for Metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period (4 weeks).; Sitagliptin Phosphate administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).; Metformin taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin then administered throughout the double-blind treatment period (4 weeks).; Matching placebo for MK-0893 was orally administered for the loading dose (200 mg) and for the following daily treatment (40 mg) over the 4 week double blind treatment period.; Matching placebo for Sitagliptin (100 mg) administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).; Metformin-matched placebo taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin-matched placebo then administered throughout the double-blind treatment period (4 weeks).
Other intervention name(s): JANUVIA™; MK0431; GLUCOPHAGE®
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
High-tone External Muscle Stimulation for Pain Reduction
Condition: Chronic Radicular Back Pain; Lumboischialgia; Cervico Brachialgia
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      Sciatica is a common pain problem that affects not only the patient but also constitutes a
      socioeconomic burden and thus affects the whole society. So far, current pharmacologic
      therapies are inadequate for many patients. Therefore, we evaluated application of high-tone
      external muscle stimulation (HTEMS) compared to transcutaneous electrical nerve stimulation
      (TENS) on radicular pain associated with sciatica.
    

Detailed description: 
      Hospital patients (n=100) with chronic sciatica and stable oral analgesic regimen were
      included into this randomized controlled cross-over trial. Each intervention was administered
      for a period of 45 min 5 times within 10 days, with a 3-day wash-out period before
      cross-over. Health impairments had been assessed using the visual analog scales (VAS) for
      radicular pain before and after intervention and differences in radicular pain between groups
      were analysed with the Mann-Whitney test.
    

Intervention name(s): HTEMS; TENS
Intervention type(s): Device; Device
Other intervention name(s): HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany); Dumo 2.4 (CEFAR Medical, Lund, Sweden)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: back pain; sciatica; electrotherapy; HTEMS; TENS
Effects of Deep Brain Stimulation in Treatment Resistant Major Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators will investigate in a sham controlled design antidepressant effects and
      safety of DBS to the superolateral branch of the main medial forebrain bundle (slMFB).
    

Detailed description: 
      The target point for DBS in major depression disorder is located lateral to the ventral
      tegmental area (VTA) in the midbrain at the branching point of the superolateral branch
      (slMFB) from the main medial forebrain bundle (MFB).

      The exact stimulation coordinates are:

      MNI152 coordinates:

      left: x(lat.)=-5, y(ap)=-14, z(vert.)=-8 right: x(lat.)=5, y(ap)=-14, z(vert.)=-9

      MCP coordinates:

      eft: x(lat.)=-6, y(ap)=-1, z(vert.)=-6 right: x(lat.)=4, y(ap)=-1, z(vert.)=-7

      All coordinates refer to the MNI152 brain. Legend: slMFB = superolateral branch of medial
      forebrain bundle, MNI152=Montreal Neurologic Institute brain 152 coordinates, MCP =
      mid-commissural point coordinates, lat. = lateral, ap= antero-posterior, vert. = vertical.

      More information can be found at: http://goo.gl/n9sWV

      In addition to the described intervention, we will record EEG activity within the implanted
      regions during cognitive paradigms (Fell and Axmacher, Nat Rev Neurosci 2011). Specifically,
      we will investigate the neural mechanisms underlying classification learning, working memory
      and exploration of rewarded spatial locations and explore oscillatory responses following
      stimulation of the target regions. These experimental paradigms will be conducted on the
      first day after electrode implantation.
    

Intervention name(s): DBS; No Stimulation (Sham)
Intervention type(s): Device; Device
Intervention description(s): 130Hz, 90us pulsewidth, 4V Amplitude; 130Hz, 90us pulsewidth, 0V Amplitude
Other intervention name(s): INS; INS
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Muscle Energy Technique and Static Stretching on Pain Intensity and Functional Disability in Patients With Mechanical Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain; Pain
Study type: Interventional

Summary: 
      Neck pain is becoming increasingly common throughout the world with a considerable impact on
      individuals, communities, health-care systems and businesses (Hoy et al, 2011).Neck pain is a
      common problem within our society affecting individual's physical and social functioning
      considerably and interfering with the patient's daily activities. There is lack of evidence
      to allow conclusions to be drawn about the effectiveness of MET when compared with stretching
      exercises for relieving mechanical neck pain. Therefore, this study is designed to examine
      the effect of MET, static stretching and to compare their effects on pain intensity and
      functional disability in patient with mechanical neck pain.
    

Detailed description: 
      This experimental study purposively recruited 24 subjects (male: n=10, female: n = 14) with
      mechanical neck pain from the Outpatient Physiotherapy Department of the Obafemi Awolowo
      University Teaching Hospitals Complex, Ile-Ife. Subjects were randomly allocated into the MET
      and SS groups. Subjects in MET group received 6 treatment sessions of Muscle Energy Technique
      in addition to conventional physiotherapy treatments. Patients in SS group received 6
      treatment sessions of Static Stretching in addition to conventional physiotherapy treatments.
      All subjects were treated twice a week for six weeks. Visual Analogue Scale (VAS) and Neck
      Disability Index (NDI) were used to assess the pain intensity and functional disability at
      baseline, 3rd week and 6th week of treatment sessions respectively. Descriptive and
      Inferential statistics were used to analyse the data. Alpha level was set at < 0.05.
    

Intervention name(s): Muscle Enery Techniques; Static Stretching
Intervention type(s): Device; Device
Intervention description(s): Group of patients that underwent muscle energy technique as a mean of treatment for the complaint; Set of patients that had static stretching technique for the treatment for the complaint
Other intervention name(s): MET; SS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects for this study were patients diagnosed of mechanical neck pain in Physiotherapy Outpatient Department of Obafemi Awolowo University Teaching Hospital Complex (OAUTHC), Ile-Ife. Individuals who meet the inclusion criteria were randomly allocated to Muscle Energy Techniques Group and Static Stretching Group using the simple random assignment method without replacement (Fish Bowl).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Static stretching, ,; neck pain,; muscle energy techniques; visual analogue scale,; neck disability index