bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Circadian Variation of EEG Using BIS Monitor in ICU Patients
Condition: EEG Circadian Variation of ICU Patients
Study type: Observational

Summary: 
      The investigators propose to evaluate circadian variation of EEG using BIS (bispectral index)
      monitor in ICU patients in three different groups: non-sedated, only sedated and sedated and
      curarized. BIS monitor values as SR (suppression rate), SEF (Spectral edge frequency),
      bispectral index and EMG (electromyography) during 24 hours in admitted patients except acute
      neurological disease.
    


Intervention name(s): BIS monitor
Intervention type(s): Device
Intervention description(s): Monitoring circadian variation of EEG
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        ICU patients
AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the effectiveness of the study drug, AEGR-733 alone and
      in combination with the medication, atorvastatin (Lipitor), on cholesterol in volunteers with
      moderately high cholesterol.
    

Detailed description: 
      Recent studies suggest more intensive cholesterol lowering treatment for people at very high
      risk of a heart attack, specifically for patients who have heart disease plus major risk
      factors. Available medications used alone at even the highest approved doses are not expected
      to reach these new target recommendations for cholesterol in a large number of subjects.
      Thus, the development of new medications that can provide additional cholesterol lowering may
      be beneficial.

      This study tests the effectiveness of different doses of the study drug, AEGR-733 alone and
      in combination with the approved cholesterol lowering drug, atorvastatin (Lipitor), on
      cholesterol. Volunteers will be randomized to one of 6 different study treatments and will
      take the assigned medication (3 capsules daily) for 8 weeks.
    

Intervention name(s): Atorvastatin 20 mg; AEGR-733 5 mg; AEGR-733 10 mg; Placebo; AEGR-733 5 mg + atorvastatin 20 mg; AEGR-733 10 mg + atorvastatin 20 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: cholesterol
Study of Vitamin C, Vitamin E and Their Combination to Treat Restless Legs Syndrome in Hemodialysis Patients
Condition: Restless Legs Syndrome; Kidney Failure, Chronic
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Renal Insufficiency; Kidney Failure, Chronic; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether vitamin C, vitamin E and their combination
      are effective in the treatment of RLS in hemodialysis patients.
    

Detailed description: 
      RLS is a common problem in hemodialysis patients; 20 to 40% of hemodialysis patients suffer
      from RLS. Hemodialysis patients have a high oxidative stress status. Oxidative stress has
      been proposed to play an important role in the pathogenesis of RLS. Vitamin C and vitamin E
      are potent antioxidant agents that have already been shown to be effective in the treatment
      of periodic limb movement disorder (PLMD) in hemodialysis patients. PLMD is closely
      associated with RLS in hemodialysis patients. The aim of this study was to evaluate the
      efficacy of vitamin C, vitamin E and their combination in the treatment of RLS in
      hemodialysis patients.
    

Intervention name(s): Vitamin C & Vitamin E; Vitamin C; Vitamin E; Vitamin C Placebo & Vitamin E Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The patients in this arm received one tablet of vitamin C (200 mg) and one capsule of vitamin E (400 mg) daily for 8 weeks; The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.; The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.; The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.
Intervention MeSH terms: Vitamins; Ascorbic Acid; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dialysis, Restless legs syndrome, Ascorbic acid, Vitamin E
A Study of KHK4827 (Brodalumab) in Subjects With Moderate to Severe Psoriasis in Korea
Condition: Moderate to Severe Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the efficacy and safety of KHK4827 in
      subjects with moderate to severe plaque psoriasis randomized in a double-blind manner to
      receive KHK4827 or placebo for 12 weeks
    


Intervention name(s): KHK4827; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered KHK4827 by subcutaneous (SC) injection until week 62.; Administered placebo by subcutaneous (SC) injection until week 12. Administered KHK4827 by SC injection from week 13 until week 62.
Other intervention name(s): Brodalumab
Intervention MeSH terms: Brodalumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: KHK4827 (brodalumab)
Effects of Isotretinoin on the Growth Rate and Thickness of the Nail Plate
Condition: Isotretinoin; Nail Abnormality
MeSH terms: Nails, Malformed
Study type: Observational

Summary: 
      The nail is an important skin appendage which can provide information about the person's
      overall health status in addition to having several important functions such as protection,
      tactile sensation, grasping. Many nail abnormalities which can have considerable
      psychological impact are side effects of drug administration. Retinoids have various effects
      on nails. Although isotretinoin as a retinoid has been associated with both decreased and
      increased nail growth, the great majority of such associations are not evidence-based. So, it
      was aimed to investigate the effects of isotretinoin on morphology, growth rate, and
      thickness of the nail plate.
    

Detailed description: 
      Isotretinoin has various side effects that affect many organ systems. Some side effects such
      as nail changes, which do not require treatment cessation, can limit the use of isotretinoin
      by impairing the patient's quality of life. Although it is known that isotretinoin has
      various effects on the nails, there is very limited data on effects of isotretinoin on the
      nails. Therefore, it was aimed to investigate the effect of isotretinoin on the morphology,
      growth rate, and thickness of the nail plate. The patients aged 18-45 that were planned to
      begin treatment with isotretinoin for acne in the outpatient clinic and a control group
      consisting of healthy volunteers are planned to be included in the study. A dermatological
      examination of skin and nails is conducted in all participants. Isotretinoin treatment at 0.5
      mg/kg per day in 2 divided doses will be started to patients with acne. The length and
      thickness of nail plate are measured by digital caliper before isotretinoin treatment, and
      repeated during the control visits of the participants at 30 day intervals for 6 months. All
      the examination and measurements are carried out in both groups.
    

Intervention name(s): Isotretinoin
Intervention type(s): Drug
Intervention description(s): The effects of isotretinoin on morphology, growth rate, and thickness of the nail plate
Other intervention name(s): Roaccutane; Zoretanin; D10BA01
Intervention MeSH terms: Isotretinoin
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All participants who are admitted to the outpatient clinic of our tertiary referral
        hospital were planned to include in the study.
      
Keywords: isotretinoin; nail growth rate; nail thickness; 13-cis-retinoic acid
Cracking the Code of Crying Babies: How Familiarity Changes the Interpretation of Cries
Condition: Magnetic Resonance Imaging; Neuronal Activity
Study type: Interventional

Summary: 
      Understanding babies' signals is essential to meet their needs. Recent works suggest that
      crying provides useful information, not only allowing parents to recognize their baby among
      others (static information), but also to distinguish between mild discomfort and pain cries
      (dynamic information). The perception of this information by adults involves a "parental"
      brain network including brain areas involved in empathy, attention, emotional regulation,
      motor as well as regions of the limbic system or associated with the reward network.
    

Detailed description: 
      This network is involved when listening to cries of familiar babies, or pain cries. How do we
      become specialist of a baby's cries? To date, no functional imaging study has examined the
      specific brain activations when listening to the cries of a familiar baby in different
      situations, particularly painful ones.
    

Intervention name(s): inclusion and familiarization; fMRI acquisition and closure
Intervention type(s): Behavioral; Behavioral
Intervention description(s): presentation of the study purpose and the protocol to the volunteer
clinical examination to check inclusion and exclusion criteria
Familiarization with the crying of one assigned baby, by listening to several bath cries from this baby; Second phase of familiarization, listening again to bath cries of "their" assigned baby. These cries will be different from those listened during the first familiarization phase.
MRI acquisition: after acquisition of the anatomical images (5 min), the subjects will listen to 64 cries divided into 4 functional MRI sessions of 10 minutes each. The cries will be those of "their" baby or of unknown babies, evoked in a painful (vaccination) or a non-painful (bath) situation, presented in a pseudo-random order. Participants will be asked to assess whether they recognize "their" baby (yes/no) and whether they recognize a pain cry (yes/no).
debriefing
Protocol ending
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Group with parental experience caring for infants (20 men and 20 women) Group with professional experience in caring for infants (20 women)
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: baby cries; pain; brain responses; fmRI; familiarity
Dental Plaque Removal Study
Condition: Gingivitis; Gum Disease
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      The purpose of this research study is to investigate water flow in dental devices and to
      understand the function of water flow behind oral hygiene improvements. Understanding this
      mechanism may help with the design of future products.
    

Detailed description: 
      The overall clinical response (plaque, gingivitis, bleeding) in participants with varying
      stages of gingival health as well as the causative or indicative hallmarks of selected
      biological responses underpinning the overt clinical manifestations described above will be
      evaluated. The chief biological response that will be investigated is how a reduction in the
      concentration of bacterial lipopolysaccharide endotoxins (LPS) in interproximal plaque may
      influence improvements in the clinical response (e.g., through mitigation of bleeding) when
      compared to a change in the plaque biomass within which a large component of the endotoxins
      reside. The hypothesis is that improvements in clinical bleeding may result more from the
      removal or reduction of toxic bacterial products that serve as the direct impetus of the
      inflammatory response rather than from sheer bulk removal of interproximal plaque. From a
      methods development perspective, this study will also assess the feasibility of measuring
      endotoxin load from clinical samples. Ultimately it is anticipated that a comprehensive
      evaluation of clinical benefits conferred by continuous fluid streaming will emerge upon
      analysis of the relationships between clinical and biological data sets, particularly where
      causal relationships may exist between both parameters.

      The devices used in this study are subject only to Class I (general controls) and considered
      exempt from the premarket notification procedures and not subject to section 510(k), 515, or
      520(m,) of the FDC Act in order to be legally marketed. Thus, the study does not meet the
      definition of an Applicable Clinical Trial.
    

Intervention name(s): Manual Toothbrush only; MTB + Waterpik Ultra Water Flosser 'High'; MTB + Floss (MTB+Floss)
Intervention type(s): Other; Other; Other
Intervention description(s): ADA (American Dental Association) Reference Manual Toothbrush (MTB); MTB + Waterpik Ultra Water Flosser 'High'; MTB + Floss (MTB+Floss)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Basic Science
Keywords: plaque removal methods; oral hygiene devices
Treatment for Lifting Upper Arm Lax Skin
Condition: Lax Skin
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with
      masked evaluation.
    

Detailed description: 
      Eligible patients will receive 2 treatments on both upper arms (4-6 weeks apart) using the
      Sofwave System.

      Treatment may be administered after the enrollment and screening at the first visit, or it
      may occur later following the enrollment and screening activities based on site scheduling
      availabilities. All patients will return to the clinic for follow up visit at 3 months ± 2
      weeks post last treatment (FU1).

      Methodology described in the protocol to evaluate efficacy and safety of treatments will be
      carried out at each visit at the clinic.
    

Intervention name(s): Sofwave
Intervention type(s): Device
Intervention description(s): The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.
Other intervention name(s): SUPERB
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: upper arms, lax skin
Local Metabolic Effects of Ghrelin in Skeletal Muscle and Adipose Tissue
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The metabolic effects of ghrelin is investigated by microdialysis technique. Subjects are
      healthy young men. End points are interstitial concentrations of glucose, lactate, and
      glycerol.
    


Intervention name(s): Acyl ghrelin; Placebo (Ringer acetate)
Intervention type(s): Drug; Drug
Intervention description(s): Acyl ghrelin 12.5 pg/min infused continuously for 300 minutes; Ringer acetate 2 microliter/min for 300 minutes
Other intervention name(s): Human acyl ghrelin; Ghrelin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Ghrelin; Microdialysis; Controls; Metabolic effects of ghrelin
Topical Hyaluronic Acid and Recurrent Aphthous Stomatitis.
Condition: Recurrent Aphthous Stomatitis
MeSH terms: Stomatitis; Stomatitis, Aphthous; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was conducted to estimate the hypothesis that the topical hyaluronic acid
      mouthwash have no role in the treatment of recurrent aphthous stomatitis
    

Detailed description: 
      Recurrent aphthous stomatitis (RAS) is a common and widely recognized disorder involving the
      oral mucosa. It occurs typically as a single or multiple well-defined painful self-limiting
      ulcerative lesions influencing the nonkeratinized oral mucous membrane surrounded by red
      halo. The prevalence of RAS is up to 25% in the world population, with recurrence rate of 50%
      every 3 mouths. The exact cause of RAS is uncertain, and accordingly numerous components are
      as yet being implicated such as genetic, hormonal, traumatic, nutritional, allergic,
      immunological, and psychological factors.
    

Intervention name(s): Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash
Intervention type(s): Drug
Intervention description(s): Topical mouthwash used three times daily for one week and patients were not allowed to eat or drink for one hour after rinsing.
Other intervention name(s): (Aftamed; Bioplaxpharma, UK)
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: recurrent aphthous stomatitis; chlorhexidine; hyaluronic acid; pain; topical
A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin's Lymphoma
Condition: Hodgkin's Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A clinical study of safety and efficacy of treatment with Nivolumab and Bendamustine (NB) in
      patients with relapsed/refractory Hodgkin's lymphoma.
    


Intervention name(s): Nivolumab; Bendamustine Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): 3 mg/kg IV infusion on day 1,14 up to 3 cycles; 90 mg/kg IV infusion on day 1 up to 3 cycles
Other intervention name(s): Opdivo; Ribomustin
Intervention MeSH terms: Nivolumab; Bendamustine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hodgkin's Lymphoma; Nivolumab; Bendamustine Hydrochloride
School Based Physical Activity Interventions and Its Impact on Wellbeing and Educational Outcomes
Condition: Physical Activity; Health Behavior
Study type: Interventional
Phase: Phase 1

Summary: 
      A school based Physical Activity intervention for pupils (8-9 years old) to promote fitness
      and wellbeing
    

Detailed description: 
      The experimental group will participate in a 24 week multi-component programme that includes
      four strands:

        -  A physical literacy programme focusing on core elements of strength, agility, speed,
           balance and flexibility. Delivered by external facilitators for one hour per week over
           16 weeks of the programme (2 x8week blocks).

        -  'Golden Mile' - pupils and teachers participate 15min walk/run a min of 2 times per week

        -  After schools club (not compulsory) featuring mind-set component delivered by external
           facilitators

        -  Healthy kidz app with reward system

      The control group will continue doing physical activity including physical education as is
      normal for their school

      All groups will participate in fitness assessments at week 1 and week 24 of the programme and
      pupils will also complete questionnaires based on measures described above at week 1 and week
      24.
    

Intervention name(s): HealthyKidz physical activity programme
Intervention type(s): Behavioral
Intervention description(s): A 24 week physical activity intervention to promote fitness and wellbeing in primary schools
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of Auto Antibodies in Oral Sub Mucous Fibrosis
Condition: Oral Submucous Fibrosis
MeSH terms: Oral Submucous Fibrosis; Fibrosis
Study type: Observational

Summary: 
      The etiology of OSMF is considered to be multifactorial. However, Role of autoimmunity had
      been suggested as one of the factors but remains unproven.

      The present study is undertaken to evaluate the presence of auto antibodies in OSMF patients
      to pave a way for new arena of treatment with the etiology of this persistent condition
    

Detailed description: 
      Oral submucous fibrosis (OSMF) is a potentially malignant disorder affecting any part of the
      oral cavity, sometimes pharynx associated with juxta epithelial fibrosis causing progressive
      trismus leading to dysphagia. It is mainly seen in the Asian countries with more prevalence
      in India.

      Etiology of OSMF is considered to be multifactorial. However, it is strongly associated with
      the use of arecanut in various forms and also in combination with other compounding factors.
      Autoimmunity had been suggested as one of the factors yet unproven.

      Few studies reveal that there is high incidence of Autoantibodies including antinuclear
      (ANA), Anti smooth muscle (SMA), Anti thyroid microsomal (TMA), and anti reticulin antibodies
      in OSMF patients. These findings have not been consistent in further studies which needs
      further more research in this.

      A study concentrated on quantitation of circulating immune complexes (CIC) levels which was
      established in patients with oral cancer and oral precancerous lesions. The levels were
      compared with that in normal controls and chronic chewers of betel quid with no signs of any
      disease. Both patients with oral cancer and oral precancerous lesions had elevated CIC when
      compared to both the control groups. The most interesting observations were (a) the CIC
      levels in the chewing controls were significantly raised when compared to normal controls;
      and (b) the CIC levels in the patients with premalignant lesions were elevated almost to the
      same levels as in the oral cancer patients.

      HLA-typing was carried on areca nut chewers. however, it was unable to demonstrate a specific
      pattern of HLA-antigen frequencies in chewers with or without the disease. It is not
      necessarily a HLA-associated susceptibility in Oral Submucous Fibrosis.

      Due to less number of articles published on autoantibodies, this study is done to evaluate
      the presence of such auto antibodies in OSMF patients thereby paving way for new arena of
      treatment on par with the etiology of this persistent condition.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total number of patients were 70 patients (Group A- 35 OSMF patients, Group B- 35
        controls) of both the genders
      
Keywords: Autoantibodies, Oral Submucous Fibrosis