bioihbjkbjnl/mcl2 huggingface dataset:
Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury
Condition: Multiple Sclerosis; Traumatic Brain Injury
MeSH terms: Multiple Sclerosis; Brain Injuries; Brain Injuries, Traumatic; Sclerosis; Wounds and Injuries
Study type: Interventional

Summary: 
      This study will examine the efficacy of a clinical intervention for improving emotional
      processing in individuals with MS and TBI.(1)The main outcome measure will be changes in
      emotional processing measures from pre to post treatment.

      (2)This study will also assess the impact of the emotional processing intervention on changes
      in pre and post treatment depression and anxiety, as well as fatigue.(3) This study will
      additionally measure the impact of the emotional processing intervention on cognitive
      functioning, specifically processing speed, attention and executive abilities. This will be
      accomplished through the completion of a neuropsychological battery prior to and following
      the completion of treatment.(4)Finally, the investigators will measure the impact of the
      intervention on quality of life and social functioning, utilizing a pre and post treatment
      assessment consisting of measures of self-efficacy, quality of life, functional abilities,
      and awareness.
    


Intervention name(s): Emotional Processing Training; Placebo Control
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Processing Speed; Intervention; Multiple Sclerosis; Traumatic Brain Injury; Cognition
Study of Light Treatment and Laser Treatment for Melasma
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional

Summary: 
      The purpose of this study is to determine the efficacy of light treatment and laser treatment
      for melasma. These treatment options have not been thoroughly explored in the treatment of
      melasma. By studying the effect of different treatments, a better treatment plan may be
      developed for people with melasma.
    

Detailed description: 
      The objective of this study is to determine the efficacy of light treatment and laser
      treatment for melasma. These treatment options have not been thoroughly explored in the
      treatment of melasma. By studying the effect of different treatments, a better treatment plan
      may be developed for people with melasma.
    

Intervention name(s): Light Treatment; Laser Treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): Light treatment applied to half of the face at each study visit; Laser treatment applied to half of the face at each study visit
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Mobility Training Using a Bionic Knee Orthosis in Patients Chronic Post-Stroke: A Case Series
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      This pilot study examined the effect of task-oriented mobility training in three persons
      chronic post-stroke using a novel, wearable, mobile intention-based robotic orthosis (Tibion
      Bionic Leg).
    


Intervention name(s): Tibion Bionic Leg
Intervention type(s): Device
Intervention description(s): A programmable, carbon-fiber robotic leg orthosis (Tibion Bionic Leg, Tibion Corporation, Sunnyvale, CA) was used during therapy to actively supplement concentric and eccentric quadriceps function on the participant's impaired side. The device uses internal sensors at the foot and knee joint to detect intention of movement and, once a variable force threshold is passed, the devices provides appropriate assistive and resistive adjustments.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Tibion; Bionics; Rehab; Therapy; Robotics; Intention
A Randomised Trial Comparing Anterior Versus Posterior Approach in Total Hip Replacement
Condition: Osteoarthritis; Rheumatoid Arthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      This is a single-centre, randomised, prospective clinical follow-up study to evaluate
      clinical outcome and gait analysis after total hip arthroplasty using the standard
      postero-lateral approach or the minimally invasive anterior approach.
    


Intervention name(s): Minimally Invasive Anterior Approach; Standard postero-lateral approach
Intervention type(s): Procedure; Procedure
Intervention description(s): Anterior minimally invasive surgery (AMIS)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Intrathecal Fentanyl or Sufentanil in 1 mg Bupivacaine Spinal Anesthesia for TURP in Elderly Patients
Condition: Adequate Anesthesia With Unimpaired Motor Strength
Study type: Interventional

Summary: 
      Adequate sensory block for surgical procedure without side effects and immediate mobilization
      after surgery are desirable anesthetic technique in various surgeries. Considering the
      sensory innervations to the prostate, a sensory block up to L1 - T12 is adequate to the TURP.
      Low-dose intrathecal local anesthetics may meet these criteria, but occasional lack of
      sufficient sensory block could be troublesome. In this randomized study, the investigators
      evaluated the spinal anesthetic characteristics following intrathecal administration of
      bupivacaine 1 mg with fentanyl or sufentanil in elderly patients undergoing TURP.
    


Intervention name(s): Fentanyl; Sufentanil
Intervention type(s): Drug; Drug
Intervention description(s): 1mg 0.5% bupivacaine + fentanyl 20 mcg + 1.8 ml glucose ( total 2.4-ml) VS 1mg 0.5% bupivacaine + sufentanil 5 mcg + 2.1ml glucose (total 2.4-ml) intrathecally.; 1mg 0.5% bupivacaine + fentanyl 20 mcg + 1.8 ml glucose ( total 2.4-ml) VS 1mg 0.5% bupivacaine + sufentanil 5 mcg + 2.1ml glucose (total 2.4-ml) intrathecally.
Intervention MeSH terms: Fentanyl; Sufentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Effects of Infliximab on Insulin Sensitivity and Beta Cell Function in Insulin Resistant Human Obesity
Condition: Obesity; Insulin Resistance; Metabolic Syndrome
MeSH terms: Obesity; Metabolic Syndrome; Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to test whether neutralizing TNF-alpha with infliximab affects
      insulin resistance and phenotypical manifestations of the metabolic syndrome as fasting
      plasma insulin, total body fat, plasma lipid profile or vascular endothelial function in
      obese male subjects.
    

Detailed description: 
      Overweight and obesity are rapidly becoming one of the most pressing health problems. Obese
      subjects face an increased risk for cardiovascular events that is closely related to a
      cluster of metabolic disturbances (i.e. insulin resistance, hypertension, dyslipidemia and
      impaired fibrinolysis), collectively referred to as syndrome X. The actual mechanism
      underlying development of syndrome X has not been elucidated. Increased TNF-alpha activity
      has been proposed as a key factor.

      The objectives of the study are to test whether neutralizing TNF-alpha with infliximab in
      obese subjects affects insulin resistance and phenotypical manifestations of the metabolic
      syndrome such as:

        -  fasting plasma insulin

        -  ivGTT derived parameters of insulin resistance and beta-cell function

        -  total body fat

        -  plasma lipid profile

        -  vascular endothelial dysfunction
    

Intervention name(s): Infliximab
Intervention type(s): Biological
Intervention description(s): 5 mg/kg body weight, maximal dose 500 mg; intravenous administration
Other intervention name(s): Remicade; EU/1/99/116/001-003
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      Alopecia Areata is a common condition. This study investigated the efficacy of calcipotriol
      versus Narrow Band Ultraviolet B in treatment of Alopecia areata and their effects on serum
      vitamin D3 levels.
    


Intervention name(s): Calcipotriol; Narrow Band UVB; vitamin D3 level
Intervention type(s): Drug; Device; Diagnostic Test
Intervention description(s): Calcipotriol ointment (0.005%); NB-UVB (311nm) phototherapy; vitamin D3 (ng/ml)
Intervention MeSH terms: Vitamin D; Cholecalciferol; Calcipotriene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alopecia Areata; Calcipotriol; Narrow Band-UVB; Vitamin D3
Evaluate the Use of the Magnetic Resonance Spectroscopy in Determining if the Breast Tumor is Benign or Malignant
Condition: Breast Tumors
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Magnetic Resonance Spectroscopy (MRS) is a novel imaging technique for noninvasive probing of
      biochemical properties of tissue. While MRS does not generate images of tumor per se it
      allows biochemical spectroscopic data to be obtained in vivo from user defined
      region-of-interest. In this manner, biochemical information elucidated by MRS can be
      interpreted in relation to detailed anatomy and images of metabolite distribution can be
      created. The aim of MRS is to identify presence and concentration of metabolites
      characteristic for normal and abnormal (tumor) cellular activities hence allow differential
      normal tissue from pathological tissue, as well as allow differentiating malignant from
      benign tumors.
    

Detailed description: 
      Recent in vivo studies have reported successful use of 1H and 31P MRS in differentiating
      between benign and malignant tumors in breast tissue. These studies demonstrated an increase
      in the choline metabolite peak that reflects an increase in choline-containing metabolites in
      70-80% of breast carcinomas, as compared to 14-18% of benign breast tumors.The objectives
      would be to determine sensitivity/specificity of MRS in the context of breast CA, We will use
      normal volunteers to test software and to develop and optimize MR scan sequences prior to or
      during the testing of target subjects with suspicious breast lesion.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited from two ongoing clinical studies of the breast at SUNY Upstate
        Medical University.
      
Keywords: breast; diagnostic radiology; suspicious breast tumors; MRI
Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 4 Weeks of Use on Subjects With Atopic Dermatitis
Condition: Atopic Diathesis; Eczema-Prone Skin
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional

Summary: 
      The aim of this study is to compare the efficacy and tolerability of a cosmetic product to
      one that is already available on the market (benchmark product). Efficacy is assessed by
      instrumental measurements of skin condition, clinical examinations, and questionnaires.
    

Detailed description: 
      The objective of this exploratory study is to investigate the efficacy and tolerability of a
      cosmetic product on subjects with atopic dermatitis after 4 weeks of use in comparison to a
      benchmark product.

      The efficacy will be evaluated via instrumental measurements of skin hydration by
      Corneometer, transepidermal water loss by Tewameter and erythema by Chromameter. Furthermore,
      the efficacy was evaluated by dermatological assessment using the local SCORing Atopic
      Dermatitis (SCORAD) rated by a dermatologist in the children, the dermatological assessment
      rated by a dermatologist (objective) and the dermatological assessment rated by adult subject
      (subjective) in the test areas, respectively.

      Additionally, at the beginning and at the end of the study the Patient-Oriented Eczema
      Measure (POEM) will be evaluated by the subjects or the subjects' parents/legal guardians by
      questionnaires.

      The SCORAD evaluation and the objective and subjective dermatological assessments will also
      be used for the tolerability assessment of the test products.
    

Intervention name(s): Lotion BNO 3732; Body Lotion Benchmark product
Intervention type(s): Other; Other
Intervention description(s): Crem body lotion twice daily; Crem body lotion twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: intra-individual comparison
Masking: Single (Participant)
Primary purpose: Other
Identifying Young Inflammatory Bowel Disease Patients at Risk for Herpes Zoster
Condition: Herpes Zoster; Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
MeSH terms: Herpes Zoster; Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      Inflammatory bowel disease (IBD) patients under the age of 50 can have a greater risk than
      the general population above age 50. IBD patient are commonly treated with immunosuppression
      that increases the risk for Herpes Zoster. A new HZ vaccine is available that could decrease
      the risk of HZ in IBD patients.
    

Detailed description: 
      Inflammatory bowel disease (IBD) is a group of chronic inflammatory disorders of the
      gastrointestinal tract. A recent national survey from the CDC estimates that the prevalence
      of IBD in the United States (US) is nearly 3.1 million cases. IBD is often associated with
      debilitating symptoms, hospitalizations, decreased quality of life, frequent procedures
      and/or surgery. Treatment options include immunosuppressive therapies, such as
      corticosteroids, immunomodulators (thiopurines and methotrexate) and anti-tumor necrosis
      factor alpha (TNF) agents. Although they are effective in achieving clinical remission and
      decrease the risk of complications, they also increase the risk for serious infections,
      including herpes zoster (HZ).

      The primary goal is to study those patients with IBD who are thought to be at the highest
      risk for HZ reactivation by evaluating cell mediated immunity (CMI) to VZV.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        IBD patients with confirmed IBD
      
Biospecimen description: 
      ELISPOT
Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged 12 to <18 Years)
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This was an open-label study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics
      (PD), and efficacy of migalastat treatment in pediatric participants 12 to <18 years of age
      with Fabry disease and amenable gene encoding α-galactosidase A (GLA) variants.
    

Detailed description: 
      This was a Phase 3b, 2-stage, open-label, uncontrolled, multicenter study to evaluate the
      safety, PK, PD, and efficacy of migalastat treatment in pediatric participants 12 to <18
      years of age and weighing ≥ 45 kilograms (99 pounds) with Fabry disease and amenable GLA
      variants. Participants must have been naïve to enzyme replacement therapy (ERT) or have
      stopped ERT at least 14 days at the time of screening.

      Stage 1 was a treatment period of approximately 1 month (4 weeks); Stage 2 was a treatment
      period of 11 months and a 30-day (untreated) safety follow-up period. There was no break in
      treatment between Stages 1 and 2. Prior to Stage 1, there was a screening period lasting at
      least 14 days and up to 30 days (or more, if GLA genotyping was required). Stages 1 and 2
      together consisted of a 12-month treatment period, and a 30-day safety follow-up period, for
      a total of approximately 13 months. Upon study completion, participants had the option to
      enroll in a long-term extension study conducted under a separate protocol (NCT04049760).

      Participants were randomly assigned 1:1:1 to 1 of 3 PK sampling groups using interactive
      response technology (IRT). Four blood samples for the determination of migalastat
      concentrations in plasma were collected during Stage 1 study drug administration, and 1 PK
      (trough) sample was collected at Month 6 and again at Month 12.
    

Intervention name(s): Migalastat HCl 150 mg
Intervention type(s): Drug
Intervention description(s): migalastat HCl 150 mg capsule
Other intervention name(s): AT1001; Galafold
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lysosomal storage disease; migalastat; AT1001; Galafold
Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine
Condition: Acute Migraine; Migraine Headache; Headache Disorders
MeSH terms: Migraine Disorders; Headache Disorders; Headache
Study type: Interventional

Summary: 
      The purpose of this study is to Compare the efficacy of zolmitriptan 5 mg nasal spray vs.
      eletriptan 40 mg tablet in the acute treatment of migraine.

      To develop and evaluate a set of importance weights for a predefined set of treatment
      attributes for migraine suffers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg
      tablet.

      To contrast the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet at
      early time points.

      To analyze the patterns of self-reported tolerability of migraine sufferers using
      zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.
    

Detailed description: 
      An open-label, randomized, cross-over study comparing the efficacy of zolmitriptan 5 mg nasal
      spray with eletriptan 40 mg tablet at early time points. Satisfaction endpoints include
      global assessment of preference, overall satisfaction and effectiveness as well as
      tolerability of both medications.
    

Intervention name(s): Zolmitriptan 5 mg Nasal Spray; Eletriptan 40 mg tablet
Intervention type(s): Drug; Drug
Intervention description(s): Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan.; Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray
Intervention MeSH terms: Zolmitriptan; Eletriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine; Acute Migraine; Headache
12-hour Versus 24-hour Postpartum Magnesium Sulphate for Preeclamptic Patients
Condition: Maternal Care Patterns
Study type: Interventional

Summary: 
      To compare the use of magnesium sulfate for 12 hours versus 24 hours in postpartum women with
      pre-eclampsia with severe features , to ensure maximum efficacy of anticonvulsant action that
      can be achieved with least exposure to Mgso4 side effects.
    

Detailed description: 
      Hypertensive disorders of pregnancy constitute one of the leading causes of maternal and
      perinatal mortality worldwide. It has been estimated that preeclampsia complicates 2-8% of
      pregnancies globally.

      Preeclampsia is a disorder of pregnancy associated with new-onset hypertension, which occurs
      most often after 20 weeks of gestation and frequently near term. Although often accompanied
      by new-onset proteinuria, hypertension and other signs or symptoms of preeclampsia may
      present in some women in the absence of proteinuria. Recently preeclampsia is divided into
      preeclampsia with severe features, preeclampsia without severe, features. One of serious
      complication of preeclampsia is occurrence of eclampsia. Eclampsia refers to the occurrence
      of new-onset, generalized, tonic-clonic seizures or coma in a woman with preeclampsia.
      Eclampsia can be prevented with magnesium sulphate, which decreases the risk of seizures by
      50%, paralleled by a reduction in maternal mortality. It is considered as the gold standard
      of management of eclampsia Although magnesium sulphate administration is recommended for all
      women with severe preeclampsia, consensus has not yet to be reached on the ideal duration of
      prophylactic postpartum anticonvulsant therapy. The use of magnesium sulphate has been
      recommended for 24 hours following delivery, the period of greatest risk for the occurrence
      of eclampsia. There are other regimen 12-hour, 6-hour Use of magnesium sulphate therapy is
      not without complications, consequently longer duration therapy possesses the risk of
      magnesium toxicity such as respiratory depression, renal and neuromuscular dysfunction. Risks
      of these complications require regular supervision; hence it is particularly important to
      assess the minimum effective duration of treatment
    

Intervention name(s): Magnesium sulfate for 12 hour; Magnesium sulfate for 24 hour
Intervention type(s): Drug; Drug
Intervention description(s): drug used to prevent convulsions in patients having preeclampsia with severe features; drug used to prevent convulsions in patients having preeclampsia with severe features
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Regional Observation of the Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      The aim of the study, is to assess the prevalence of metabolic syndrome in Italy on a
      regional basis, defined according to National Cholesterol Education Program/Adult Treatment
      Panel III (NCEP/ATPIII) guidelines criteria.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic
      
Keywords: Metabolic syndrome; Lipids; Waist Circumference; HDL; hypertension
Angiographie and OCT in Macula and Retinal Diseases
Condition: Macular Edema
MeSH terms: Macular Edema
Study type: Observational

Summary: 
      The purpose of this study is to investigate the morphological and angiological retinal
      changes in different macular diseases.
    

Detailed description: 
      Recently, a new generation of OCT devices relying on spectral domain technology (SD-OCT) has
      been introduced and allows for higher-resolution imaging. Based on this technology we can
      identify variable changes at the retinal surface such as, retinal thickening with cyst
      formation, swelling in the inner and outer nuclear layers and subretinal fluid. The
      introduction of an eye-tracking mode has allowed a better insight into the development of
      retinal morphologic changes The aim of this study was to investigate the incidence and
      structural morphology of PCME after successful uncomplicated cataract surgery in patients
      with previous pars plana vitrectomy (PPV) and indocyanine green-assisted peeling of an
      epiretinal membrane and the internal limiting membrane (ILM).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Twenty eyes of 20 patients with previous 23-gauge PPV and ILM peeling (PPV group) and 15
        consecutive eyes with senile cataract with a healthy macula (control group) were included.
      
Keywords: vitrectomy; cataract; macular edema