bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Ultrasound-guided Injection of 5% Dextrose for Meralgia Paresthesia
Condition: Meralgia Paresthetica
MeSH terms: Paresthesia; Femoral Neuropathy
Study type: Interventional

Summary: 
      Meralgia paresthetica (MP) is one of the most common peripheral entrapment neuropathies of
      the lower limbs. It is characterized by paresthesia, pain, tingling, numbness,
      hypersensitivity, or other abnormal skin sensations on the anterolateral aspect of the thigh.
      The condition results from compression of the lateral femoral cutaneous nerve (LFCN) along
      its course, often occurring as the nerve exits the pelvis.The injection of 5% dextrose (D5W)
      under ultrasound guidance is a novel treatment method for peripheral nerve entrapment.
      However, there is limited evidence about the efficacy of this method for patients with MP.
      The investigators found D5W was more safe and effective than corticosteroids for patients
      with MP. Thus, this study aimed to evaluate the 6-month efficacy of ultrasound-guided
      injection of D5W for MP patients.
    


Intervention name(s): injection
Intervention type(s): Other
Intervention description(s): 10ml D5W injection for MP patients
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ultrasound; meralgia paresthetica; D5W
Microsurgery in the Elderly in a Private Practice Setting
Condition: Aged; Microsurgery
Study type: Observational

Summary: 
      This study reports the experience in free tissue transfer in the elderly population by a
      single surgeon in the private practice setting in Mexico city and the potential criticism
      that could arise from adverse events in lower-volume practice situations will be addressed.
      Investigator will answer the question about the age as the variable of interest in this
      series in which age was not a factor in deciding reconstructive methods, and examine
      complication rates.
    

Detailed description: 
      Investigators will evaluate the outcomes of 17 flaps in 14 patients who required
      microsurgical reconstruction with free flaps and microvascular vessels anastomosis. All
      patients more than 65 years old. Demographic data will be reported as: obesity, American
      Society of Anesthesiology (asa) level, radiotherapy, combined surgery. And the results of
      investigation will include: Flap survival, local complications, systemic complications,
      re-interventions, 30-day mortality.
    

Intervention name(s): Observation of flap survival and complications
Intervention type(s): Other
Intervention description(s): We will report the flap survival and complications in this population group underwent to microsurgical procedures in a private practice setting
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients more than 65 years old, with indications for a free flap reconstruction.
Safety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3 in Multiple Sclerosis
Condition: Multiple Sclerosis; Vitamin D Deficiency
MeSH terms: Multiple Sclerosis; Vitamin D Deficiency; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and the immunologic effects of
      supplementation with low-dose and high-dose cholecalciferol (vitamin D3) in patients with
      multiple sclerosis.
    


Intervention name(s): Cholecalciferol; Cholecalciferol
Intervention type(s): Drug; Drug
Intervention description(s): Cholecalciferol (Vitamin D3) 10,000 IU in tablet form will be taken once daily for the duration of the trial (6 months); Cholecalciferol (Vitamin D3) 400 IU in tablet form will be taken once daily for the duration of the trial (6 months)
Other intervention name(s): Vitamin D3; Vitamin D3
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cholecalciferol; multiple sclerosis; vitamin D; D3
Feasibility of Cetuximab Associated With Concomitant Radio-Chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer
Condition: Non-Small-Cell Lung Carcinoma
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II, randomised, controlled, non comparative study with 2 parallel groups:

        -  Arm A: patients will receive induction chemotherapy (cisplatin and docetaxel) followed
           by a concomitant radio-chemotherapy including 2 cycles of cisplatin and vinorelbine
           associated with a weekly cetuximab infusion during the radiotherapy.

        -  Arm B: patients will receive induction chemotherapy (cisplatin and docetaxel) followed
           by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide
           associated with a weekly cetuximab infusion during the radiotherapy.
    


Intervention name(s): cisplatin, vinorlebine, cetuximab; cisplatine, etoposide, cetuximab
Intervention type(s): Drug; Drug
Intervention description(s): patient will receive 2 cycles of cisplatine 80 mg/m² at day 29 and day 50 more vinorelbine 15 mg/m² at day 29, day 36 and day 50 and 57 associated to cetuximab 400 mg/m² at day: 22,29, 36, 43, 50, 57, 64 and 71; patient will receive 2 cycles of cisplatine 50 mg/m² at day 29, 36, 57, and 64 + étoposide 50mg/m² during day 29-33, day 57-61associated to cetuximab 400 mg/m² at day: 22,29, 36, 43, 50, 57, 64 and 71
Intervention MeSH terms: Etoposide; Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pediatric Infectious Disease Precision Medicine Using Sequencing Evaluation of CSF
Condition: Infection; Meningitis
MeSH terms: Infections; Meningitis
Study type: Observational

Summary: 
      Prospective, multi-site, study to evaluate the diagnosis rate of DNA and RNA sequencing of
      cerebrospinal fluid for identification of pathogens directly in patients who have already had
      a spinal tap to evaluate for infection and were found to have a pleocytosis. Diagnostic rate
      and clinical utility of concurrent standard testing will be compared to diagnostic rate and
      clinical utility of DNA and RNA sequencing.
    

Detailed description: 
      IDbyDNA, Inc. has developed a robust sequencing reference database for viruses, bacteria,
      fungi and parasites and developed novel analysis methods to analyze next-generation (NGS)
      sequencing data to rapidly identify infectious agents. This technology suite, known as the
      Explify™ platform, holds the promise to improve patient care and efficiently guide provider
      treatment planning for those suffering from infectious disease.

      The PIPSEC trial, developed by pediatric physicians specializing in genomic medicine, is
      intended to facilitate the acquisition of high quality and clinically annotated biospecimens
      for the purpose of research discovery. This project intends to advance metagenomics,
      microbial genetics, bioinformatics and data analytics, for pathogen detection utilizing
      cerebral spinal fluid (CSF) specimens to contribute to the diagnosis of infectious agents
      impacting the central nervous system among pediatric patients. Clinically annotated specimens
      will facilitate continued development and validation of the Explify test and its clinical
      utility for providers treating central nervous system (CNS) infections.

      The primary objective is to assess clinical utility of the Explify test compared to
      concurrent standard of care testing to identify pathogens from CSF fluid within a pediatric
      patient population.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This project will enroll children who are having an evaluation for central nervous system
        (CNS) infection and have already had a lumbar puncture to obtain cerebrospinal fluid (CSF)
        to evaluate for infection and host immune response. As such enrolled patients will be
        undergoing an evaluation for suspected meningitis, encephalitis, ventriculitis and VP shunt
        infection.

        Patients in whom there is CSF remaining after standard testing has been obtained and who
        meet the other inclusion criteria will be approached for enrollment in the study.
      
Biospecimen description: 
      Residual cerebrospinal fluid collected for standard of care clinical diagnostic purposes
    
Keywords: Pediatric
Effect of Dexamethasone on the Action of Sugammadex
Condition: Neuromuscular Blockade
Study type: Interventional

Summary: 
      This study aims to investigate the possible clinical effect of dexamethasone on the action of
      sugammadex when it is administered to reverse deep neuromuscular blockade caused by
      rocuronium in laparoscopic cholecystectomies.
    


Intervention name(s): Dexamethasone; Normal Saline; sugammadex
Intervention type(s): Drug; Drug; Drug
Intervention description(s): active comparator; placebo controlled intervention; sugammadex is administered in both groups to reverse deep neuromuscular blockade at the end of surgery
Other intervention name(s): N/S 0.9%
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Keywords: sugammadex; dexamethasone; neuromuscular blockade
Comparison of New and 3-Month-Old Toothbrush in the Removal of Plaque in Children
Condition: Plaque Removal
Study type: Interventional

Summary: 
      This study aimed to validate or invalidate non-inferiority in the plaque removal efficacy of
      old versus new toothbrushes in the hands of 7-9 year old children. This study was conducted
      in 93 Iranian students aged between 7-9 year old.
    

Detailed description: 
      At baselines, each student is given a new toothbrush which they will use for 3 months. The
      amount of wearing the 3-month-old brushes will determine by measurement of brushing surface
      areas using NIH imaging software. The outcomes will be measured after 3 month. The tooth
      brush which used in this study is "Jordan" with the following specifications: Length: 128 mm,
      9 rows of bristles, 27 tufts, 24 monofilaments per tuft, height of monofilaments 10 mm and
      diameter of filaments 0.3 mm. The students will attend on two occasions following 48 hour
      periods of no oral hygiene. Following plaque scoring, students will brush with a new tooth
      brush at one visit and with a brush that they had used previously for 3 months at the other
      visit. Brushing time was 60 seconds. Plaque then will be re-scored and the percentage
      reduction in plaque score will be calculate using the Turesky plaque index. All plaque
      scoring will be performed by one examiner who is blind with the groups allocations.
    

Intervention name(s): old toothbrush; New tooth brush
Intervention type(s): Other; Other
Intervention description(s): All children will receive new tooth brush 3 months before starting the study, at the end of 3 month the worn tooth brushes will be returned and the surface area within the outline will be determine using NIH (national institutes of health) image software.; The tooth brush which will be use in this study is "Jordan". A new Jordan toothbrush will be give to all children, and in "new tooth brush" group they will use these toothbrushes.
Other intervention name(s): worn toothbrush; unused toothbrush
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Old tooth brush; Plaque removal
Tea and Forearm Blood Flow
Condition: Vascular Function
Study type: Interventional

Summary: 
      The study will explore the benefit of tea for microcirculation. Subjects will consume tea ar
      a placebo matched for taste and appearance in a blinded cross over design.
    

Detailed description: 
      Epidemiological studies indicate that regular consumption of black tea reduces the risk of
      cardiovascular diseases. Tea consumption can result in improvements in endothelial function
      of conduit arteries as measured by flow mediated dilation.

      Less is known however about its effects in other vascular beds. The study will test the
      hypothesis that tea affects endothelial function in the muscle microcirculation. This will be
      done by assessment of forearm blood flow using venous occlusion plethysmography after
      consumption of black tea against or placebo in a randomised, full cross-over study in 20
      healthy middle-aged to elderly subjects
    

Intervention name(s): Tea; Placebo
Intervention type(s): Other; Other
Intervention description(s): Black tea infusion equivalent to approximately 530 mg total polyphenols expressed as gallic acid equivalents; Placebo matched to tea with respect to taste and appearance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Exercise Study on Cardiac Function in Patients With Diabetes Mellitus Type 2 and Diastolic Dysfunction
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of the study is to compare the effects of aerobic interval training and the IDF
      recommendations on physical activity on cardiac function and CV risk factors in patients with
      diabetes. The hypothesis is that AIT more than MCT, will improve myocardial dysfunction in
      patients with subclinical LV disease, improve both endothelial function and VO2max and thus
      reducing CV risk factors and CV disease. HbA1c will be more stable.

      The aims of this study are to address the exercise prescription recommendations for patients
      with (T2DM) who have subclinical heart disease. The prescription recommendations will be
      assessed by randomising T2DM patients with subclinical heart disease to one of the following
      2 groups for 3 months followed by a 9 month home-based program:

      Moderate Intensity Exercise Group (ME). Home exercise equivalent to the present exercise
      recommendations of the International Diabetes Federation.

      Aerobic interval training (AIT). Exercise equivalent to the current guidelines achieved
      through high-intensity interval training.
    

Detailed description: 
      The investigators primary hypotheses are that in patients with type 2 diabetes and
      subclinical heart disease:

      Moderate Intensity Exercise will:

      Not significantly improve myocardial function compared to controls,

      Despite significant improvement (compared to controls) in:

      Glycaemic control (HbA1c) Cardiorespiratory fitness (VO2max) Body composition (DXA)

      Aerobic Interval Training Group will:

      Significantly improve myocardial function compared to controls,

      Significantly improve (compared to moderate intensity exercise group):

      Glycaemic control (HbA1c) Cardiorespiratory fitness (VO2max) Body composition (DXA)
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Moderate Intensity Exercise Group (ME). Exercise equivalent to the current exercise guidelines. In total 210 minutes per week of continuous moderate intensity (70% HRmax) exercise. Home based training.
Aerobic interval training (AIT). Exercise equivalent to the current guidelines achieved through high-intensity interval training.The exercise starts with warming-up for 10-min at 70% of HRmax before performing 4x4min intervals at 90-95% of HRmax, with 3-min active recovery at 70% of HRmax between each interval, and a 5-min cool-down period, giving a total of 40-min.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes type 2; exercise; tissue Doppler velocity
Efficacy and Safety of Antidepressant Augmentation With Lamotrigine
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study reports a clinical trial evaluating lamotrigine safety and efficacy as an
      antidepressant augmentation agent in treatment resistant depression, therefore adding more
      empirical evidence to the limited number of studies on the use of lamotrigine.
    

Detailed description: 
      Objective: This study reports a clinical trial evaluating lamotrigine safety and efficacy as
      an antidepressant augmentation agent in treatment resistant depression, therefore adding more
      empirical evidence to the limited number of studies on the use of lamotrigine.

      Method: A double-blind pilot study was conducted with 34 nonbipolar, nonpsychotic patients
      who had DSM-IV major depressive disorder and were resistant to at least 2 antidepressants.
      The subjects were on taking antidepressant therapy and were randomly assigned to receive
      placebo or lamotrigine as an adjunct therapy for 8 weeks. They were evaluated on a biweekly
      basis in order to access assess the efficacy and the safety of the drug.
    

Intervention name(s): Lamotrigine; Amide
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Lamotrigine was added to the ongoing antidepressant. The doses were titrated to 200mg/day.; Capsule of amide were given to this group of patients. They continued the ongoing antidepressants.
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Treatment; Augmentation; Resistant depression; Lamotrigine
A Study Investigating Lu AG22515 in Healthy Adults
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The main goal of this study is to learn more about the safety of a drug called Lu AG22515.
      During the trial, healthy adult participants will receive a single dose of Lu AG22515 or a
      placebo (normal saline solution).
    


Intervention name(s): Lu AG22515; Placebo; Immune System Activator
Intervention type(s): Drug; Drug; Drug
Intervention description(s): sterile solution for infusion; sterile solution for infusion; sterile powder for injection
Other intervention name(s): APB-A1
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Developmental Origins of Attention Deficit Hyperactivity Disorder
Condition: Inattention; Impulsivity; Anxiety
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Impulsive Behavior
Study type: Interventional

Summary: 
      This is a study evaluating the relationship between prenatal nutrition and neural development
      in infants born to mothers with Attention Deficit Hyperactivity Disorder (ADHD). We are
      hypothesizing that women randomized to a whole food, nutrient-dense diet during their 3rd
      trimester of pregnancy will have infants with more advanced neural development as compared to
      infants born to mothers receiving standard-of-care treatment.
    

Detailed description: 
      Pregnant women with ADHD will be recruited from the patient population at Oregon Health &
      Science University (OHSU). They will be recruited during their 1st or 2nd trimester. After
      consent, baseline measures will be collected including height, weight, body composition
      measurements using calipers, 24-hour dietary recalls, and blood and urine samples. Women will
      also complete questionnaires regarding ADHD symptoms, stress, depression, and lifestyle.
      Women will be given a one-week food diary to fill out at home, which will be mailed in upon
      completion. Upon receipt of the food diary, women will be randomized into either a nutrition
      intervention group or a standard-of-care group. Women who are randomized to the intervention
      group will receive individual nutritional counseling every 2 weeks during their 3rd trimester
      of pregnancy. Before delivery, the baseline measures described above will again be collected.
      At delivery, placenta and cord blood samples will be taken. After birth, the infant will
      undergo an MRI between 2 and 5 weeks of age. The scan is completed while the baby sleeps, and
      special ear protection is worn to limit sleep disruption from the noise of the MRI. When the
      infant is 3 months old, mothers will complete questionnaires about infant feeding, sleep and
      behavior.
    

Intervention name(s): Whole Food, Nutrient-Dense Dietary Intervention; Standard of Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The dietary intervention will be a whole food, nutrient-dense diet which restricts processed foods high in food additives while optimizing micronutrient intake.; Normal standard-of-care for pregnancy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Attention Deficit and Hyperactivity Disorder; Nutrition; Diet; Developmental Origins of Disease
tDCS Effects on Associative Learning in Older Adults of Working Age
Condition: Healthy Older Adults
Study type: Interventional

Summary: 
      The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual
      associative memory leads to a performance improvement in healthy older individuals.
    


Intervention name(s): tDCS; training
Intervention type(s): Device; Behavioral
Intervention description(s): Transcranial direct current stimulation; Cognitive training
Other intervention name(s): intensive training of picture-word associations
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: tDCS
Effects of Bariatric Surgery on Different Compositions of Trunk Fat and Mechanisms
Condition: Bariatric Surgery Candidate; Adiposity; Fat Redistribution
MeSH terms: Obesity
Study type: Observational [Patient Registry]

Summary: 
      This is a prospective, single-center, observational study to explore effects of bariatric
      surgery on different compositions of trunk fat and mechanisms.
    

Detailed description: 
      This is a prospective, single-center, observational study to explore effects of bariatric
      surgery on different compositions of trunk fat and mechanisms. The primary outcome is effects
      of bariatric surgery on different compositions of trunk fat evaluated with MRI for patients
      pending bariatric surgery before and 3 months after surgery. The secondary outcome is the
      associations of trunk fat reduction with improvement in metabolism indicators. Before
      patients are enrolled in this observational study, the researchers will do a detailed
      screening of the subjects based on the inclusion criteria and the exclusion criteria to
      determine if the patients are appropriate for the study. Patients who meet the conditions of
      the study will be required to sign an informed consent form.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients pending bariatric surgery.
      
Biospecimen description: 
      Plasma for estimates of metabolism indicators