bioihbjkbjnl/mcl2 huggingface dataset:
Measuring Blood Flow in the Brain
Condition: Traumatic Brain Injury; Healthy
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      This study will test a method of measuring brain blood flow called near infrared spectroscopy
      (NIRS). It will determine whether NIRS gives the same results as the more commonly used
      technique, functional magnetic resonance imaging (fMRI).

      Healthy normal volunteers between 18 and 60 years of age may be eligible for this study.
      Participants come to the NIH up to six times for experiments using NIRS and fMRI. They do the
      following tasks while they are undergoing NIRS or fMRI:

        -  looking at a computer monitor while a checkerboard pattern changes

        -  wiggling the toes and moving the fingers

        -  Reading words on a computer screen and pushing one button if they are plants and another
           if they are animals.

      For NIRS, a frame is placed on the head and held it in place with a metal band. The frame
      holds sensors that contact the scalp.

      For fMRI, the subject lies on a table that can slide in and out of an MRI scanner, a metal
      cylinder surrounded by a strong magnetic field. fMRI uses a strong magnetic field and radio
      waves to obtain images of the brain while the subject performs tasks. During the procedure,
      The subject wears earplugs to muffle the sound of loud knocking noises that occur during
      scanning.
    

Detailed description: 
      OBJECTIVE: a) to explore the usefulness of Near Infrared Spectroscopy (NIRS) as a means of
      mapping brain activity, to see whether the results are similar to those of fMRI and b) to see
      whether spontaneous brain blood flow changes coincide with changes in behavior.

      STUDY POPULATION: 50 healthy volunteers.

      DESIGN: The study will look for correlations between NIRS and fMRI signal changes in the same
      subjects. It will also detect relationships between spontaneous blood flow shifts and shifts
      and changes in cognitive performance. Finally, NIRS will be combined with a frontal lobe
      activation task to see if blood flow changes can be detected over the hairless skin of the
      forehead in a simple, standardized manner that might yield a diagnostic test for frontal
      injury.

      OUTCOME MEASURES: Graded changes in blood flow and oxygen, measured with NIRS and fMRI and
      variations in response time on a word task.
    

Time perspective: Prospective
Keywords: Cerebral Blood Flow; Cerebral Cortex; Cognition; Optical Imaging; Healthy Volunteer; HV
Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to evaluate the immunogenicity and safety of GSK Biologicals 2-dose
      inactivated hepatitis A vaccine when administered with a pneumococcal conjugate vaccine in
      children as young as 15 months of age.
    

Detailed description: 
      An open, controlled comparison of Havrix administered alone or with Prevnar. The three groups
      evaluated are: 1) Havrix alone, 2) Havrix plus Prevnar and 3) Prevnar followed by Havrix one
      month later.
    

Intervention name(s): GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix); Prevnar™
Intervention type(s): Biological; Biological
Intervention description(s): Two doses, administered intramuscularly in the right anterolateral thigh.; One dose, administered intramuscularly in the left anterolateral thigh.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effect of Microneedling With Low Energy Laser in Androgenic Alopecia Patients.
Condition: Dermatologic Disease
MeSH terms: Alopecia; Skin Diseases
Study type: Interventional

Summary: 
      Androgenetic alopecia is the most common type of hair loss in men, and affects approximately
      50 percent of Caucasian men by age 50. The condition is characterized by the progressive loss
      of terminal hairs on the scalp in a characteristic distribution. The anterior scalp, mid
      scalp, temporal scalp, and vertex of the scalp are typical sites of involvement. "Male
      balding" and "male pattern hair loss" are additional terms used to refer to this condition.

      The aim of this study is to investigate the effect of microneedling in androgenic alopecia
    


Intervention name(s): accupuncture
Intervention type(s): Device
Intervention description(s): accupuncture
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
DDI Potential: Dapivirine Vaginal Ring and Miconazole Nitrate
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will investigate the potential drug-drug interaction between dapivirine vaginal
      Ring-004 and vaginally administered miconazole nitrate, and will evaluate the safety of
      co-administration of the dapivirine vaginal ring and miconazole nitrate in healthy,
      HIV-negative women.
    


Intervention name(s): dapivirine; miconazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dapivirine; Miconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Exercise Intensity, Metabolic Rate and Insulin Sensitivity
Condition: Healthy Women
Study type: Interventional

Summary: 
      The primary goal is to test the hypothesis high interval exercise increases energy
      expenditure and Insulin sensitivity more than 2 days of rest or moderate intensity exercise
      cumulatively over 23 hours during and following the exercise. Secondary goals are to evaluate
      exercise difficulty during moderate intensity exercise and high interval exercise as well as
      difficulty of activities of daily living and free living physical activity following rest,
      moderate intensity exercise and high interval exercise.

      A secondary study is designed to evaluate potential mechanism. Hypotheses are that changes in
      muscle lipid metabolism, mitochondrial function, fat and cellular insulin signals will be
      increased following the high intensity interval exercise. In addition, these changes will be
      related to changes in insulin sensitivity and increases in protein metabolism and muscle
      damage.
    


Intervention name(s): Aerobic
Intervention type(s): Other
Intervention description(s): Exercise training will consist of bicycle ergometer riding starting at 67% of heart rate max for 20 minutes. Exercise Intensity will be progressively increased every week until 80% of heart rate max for 40 minute sessions is reached.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Exercise Intensity; Metabolism; Insulin
Bioequivalence Between Two Explorative Insulin Degludec Formulations and Between Two Explorative IDegAsp Formulations in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted i Europe. The aim of this trial is to test for bioequivalence between
      two explorative formulations of insulin degludec (insulin 454) and between two explorative
      insulin degludec/insulin aspart (IDegAsp - formerly SIAC) formulations, all with or without
      buffer, in healthy male subjects. The investigated formulations are explorative, not similar
      to the proposed commercial formulation.
    


Intervention name(s): insulin degludec; insulin degludec/insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): Each subject will be allocated to 2 single injections of trial product on 2 separate dosing visits, administered subcutaneously (s.c., under the skin).; Each subject will be allocated to 2 single injections of trial product on 2 separate dosing visits, administered subcutaneously (s.c., under the skin).
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pain Using Reduced Fluence Parameters in Photocoagulation for Diabetic Retinopathy.
Condition: Proliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 4

Summary: 
      The used of reduced fluence parameters for panretinal photocoagulation decreases pain as
      perceived by the patient, compared to traditional parameters.
    


Intervention name(s): Retinal laser photocoagulation
Intervention type(s): Procedure
Intervention description(s): Retinal laser photocoagulation using a 532 nm laser
Other intervention name(s): Alcon Eyelite 532 (doubled frequency Nd:Yag)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Proliferative diabetic retinopathy; Laser photocoagulation; Pain
Psychological Study in Children With Mucoviscidosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Cystic fibrosis is the most common serious genetic disease in Europe. It is a
      multi-disciplinary disease, causing multiple organ damage. It is a painful disease and a
      source of anxiety and depression.

      The aim of this study is to assess the link between pain experienced during care and anxiety
      in children aged over 8 with cystic fibrosis.
    


Intervention name(s): Questionnaires
Intervention type(s): Other
Intervention description(s): The questionnaires focus on anxiety, fear and quality of life.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children over 8 and under 18 with cystic fibrosis. Children must be represented by their
        parent.
      
Keywords: Cystic Fibrosis; Children; Pain; Anxiety
A Longitudinal Study of Brain Atrophy in MS Patients Over 5 Years
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Atrophy
Study type: Observational

Summary: 
      The primary aim of this study is to evaluate the effect of using Tysabri on changes in the
      brain using MRI and on disease progression in patients with relapsing-remitting Multiple
      Sclerosis over 5 years.
    

Detailed description: 
      This is a prospective, observational, single-blinded, longitudinal study of natalizumab
      effect on brain atrophy development and disability progression in multiple sclerosis patients
      over 5 years, which will evaluate originally treated patients with natalizumab who
      participated in a prospective 1- and 2-year VWMTR study. (Zivadinov et al., 2011b) All
      subjects will be assessed at 5-year follow-up with the same clinical examinations and will
      obtain 1.5T MRI examination on the same scanner that did not undergo any upgrade changes in
      the period of 5 years.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Multiple Sclerosis - relapsing remitting
      
Keywords: Multiple sclerosis; Tysabri; MRI; Natalizumab
The Impact of Protein Intake on Protein Metabolism During Intensified Training
Condition: Healthy
Study type: Interventional

Summary: 
      Protein requirements in individuals who participate in endurance-based exercise training have
      been suggested to be greater than the current recommended dietary allowance (RDA).

      Our recent study using the minimally invasive indicator amino acid oxidation (IAAO) technique
      have suggested that protein requirements in young men are at least 30% higher than the
      recommended protein intake.

      The present study will investigate the impact of protein sufficiency on protein metabolism
      and performance during intensified training periods as a means to further our understanding
      of the nutritional requirements for the endurance athlete.
    


Intervention name(s): Normal; Moderate; High; Controlled-diet
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): test drink which contains low amount of amino acids (0.14 g/kg/day); test drink which contains moderate amount of amino acids (0.40 g/kg/day); test drink which contains high amount of amino acids (1.03 g/kg/day); the diet containing 0.8 g protein /kg/day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: exercise; performance; recovery; muscle; protein
Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients
Condition: Healthy Subjects; Renal Impairments
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a human pharmacology, single-dose study to investigate the pharmacokinetics of orally
      administered Levetiracetam (LEV) in Japanese subjects with normal renal function and in
      Japanese subjects with various degrees of impaired renal function.
    

Detailed description: 
      The primary objective of this study is to evaluate the plasma and urine PK of Levetiracetam
      (ucb L059) and its metabolite (ucb L057) after a single dose of LEV 250 mg or LEV 500 mg in
      Japanese subjects with normal renal function and in Japanese subjects with various degrees of
      renal impairment.
    

Intervention name(s): Levetiracetam 250 mg; Levetiracetam 500 mg
Intervention type(s): Drug; Drug
Intervention description(s): Tablet containing Levetiracetam 250 mg; Tablet containing Levetiracetam 500 mg
Other intervention name(s): E-Keppra; E-Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Levetiracetam; Oral administration; Japanese; Non-epileptic; Healthy; Renal impaired subjects
Comparison of Serum Trefoil Factor 3 in Patients With Gingivitis and Periodontitis After Scaling and Root Planing
Condition: Gingivitis and Periodontal Diseases
MeSH terms: Gingivitis; Periodontitis; Periodontal Diseases
Study type: Interventional

Summary: 
      This study is intended to measure serum trefoil factor 3 at baseline and 3 months after,
      following nonsurgical periodontal therapy in patients with Gingivitis and Chronic
      Periodontitis.
    

Detailed description: 
      A goal of periodontal diagnostic procedure is to provide useful information to the clinician
      regarding the present periodontal disease type and severity. Advances in diagnostic research
      are moving towards methods where periodontal risk can be identified and quantified by
      objective measures such as Biomarkers.

      Trefoil factors (TFFs) are one such secreted molecules derived from mucin producing
      epithelial cells of the gastro intestinal tracts and other tissues such as Salivary glands,
      Parotid ducts and oral mucosa. Among three Trefoil factors reported, Trefoil Factor 3 (TFF3)
      is the modifying factor for signalling pathway involved in cell survival, cell proliferation
      and cell migration of oral keratinocytes. Hence assessing the marker levels would achieve
      beneficial effects on diagnosing the disease severity.
    

Intervention name(s): Scaling and root planing
Intervention type(s): Procedure
Intervention description(s): After the serum collection is done from the patient for the assessment of trefoil factor 3, Non surgical periodontal therapy is carried out.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be equally divided into two test groups.Group A consists of Gingivitis patients and Group B consists of Periodontitis patients. Both the group patients have been evaluated for Serum Trefoil factor 3 at baseline and treated with non surgical periodontal therapy. After three months both the group patients were again assessed for serum trefoil factor 3.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Phase I Clinical Study Trial of Felbinac Trometamol Injection in China
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      1. To evaluate the tolerances of healthy subjects treated with Felbinac Trometamol
           Injection on multiple dose and single dose

        2. To evaluate the pharmacokinetic characteristics in healthy subjects treated with
           Felbinac Trometamol Injection on multiple dose and single dose
    


Intervention name(s): Felbinac Trometamol Injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Felbinac Trometamol Injection will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump; Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump
Other intervention name(s): 4-Biphenylacetic Acid Trishydroxymettiylaminometnane; normal saline
Intervention MeSH terms: Biphenylylacetic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tolerance; Pharmacokinetic characteristics
Physical and Work Variables in Professional Musicians
Condition: Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain
Study type: Observational [Patient Registry]

Summary: 
      In professional musicians there are characteristic diseases. In this area there is no
      preventive culture and many musicians end their professional careers due to ailments and
      pathologies that cause the abandonment of the profession or they learn to live and play with
      pain. It is a very demanding profession that requires many hours of training without
      respecting the necessary rest, which undoubtedly produces fatigue and muscle overload,
      neurological disorders, etc. Also, the demands to achieve perfection lead to serious work
      problems.

      Given that it is a profession that suffers from pain and psychosomatic alterations and that
      is often accompanied by emotional alterations due to work demands, it is necessary to know
      this problem and to what extent it affects the musician to be able to act from different
      areas and improve his well-being.

      The objective is to know specifically the characteristics of professional musicians, their
      impact variables, both musculoskeletal and emotional, variables related to the workplace and
      to evaluate their quality of life.
    

Detailed description: 
      MATERIAL AND METHODS Subjects. Professional orchestral and band musicians between the ages of
      18 and 65.

      Study design. Descriptive study to be carried out at the University of Valencia. To do this,
      a survey will be carried out through an online platform. All participants will sign the
      informed consent and the study will be carried out in compliance with the data
      confidentiality guidelines. To start the study, the approval of the Ethics Committee of the
      University of Valencia will be necessary and it will be included in an international
      registry.

      Evaluation. In the first place, the anthropometric data (age, sex, weight, height) and the
      characteristics of the sample will be taken through an interview designed for this study that
      will contain questions about the job and instruments they practice. Subsequently, the
      subjects will fill in the assessment instruments that include the physical activity they
      perform, the musculoskeletal alterations, workplace harassment, professional burnout, quality
      of life and anxiety and depression.

      Statistic analysis. The variables will be coded and analyzed using the SPSS v.26 program.
    

Intervention name(s): observational
Intervention type(s): Other
Intervention description(s): Non intervention
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Professional musicians of orchestras and bands
8-week Pilot Study of Relaxation for Weight Loss in Adults With Chronic Kidney Disease
Condition: Obesity
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      Obesity plays a causal role for kidney disease incidence and progression. Moderate weight
      loss reduces the high metabolic demands on the kidney and decreases proteinuria in both
      diabetic and non-diabetic nephropathies. However, maintaining behavioral changes for weight
      loss is very challenging, and common chronic kidney disease (CKD) co-morbidities such as
      decreased exercise capacity only compound this difficulty. Moreover, no weight loss
      medications have been adequately tested in adults with CKD and most are contraindicated in
      this population. Mindful meditation or "mindfulness" in addition to other relaxation
      techniques may help adults lose weight by interrupting learned behavior, curbing compulsive
      eating, and reducing stress and appetite. Although mindful meditation and other relaxation
      techniques have gained the attention of the mainstream media for obesity treatment,
      scientific data on its efficacy remain limited. Due to the short duration of this study,
      substantial weight loss in any participant is not expected. Instead, the primary purpose of
      this study is to examine the feasibility of a randomized controlled trial of mindful
      meditation relaxation techniques combined with standard care compared to standard care alone
      for the treatment of obesity among Veterans with CKD.
    


Intervention name(s): Relaxation methods
Intervention type(s): Behavioral
Intervention description(s): Relaxation methods will include mindful meditation techniques for the intervention and listening to music for the control arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; meditation; chronic kidney disease
Assessment Of Infrared Photobiotherapy for Improved Wound Healing
Condition: Wound Healing
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether or not Low Level Laser Therapy (LLLT) can
      reduce pain and/or improve wound healing in patients with an acute traumatic injury to the
      upper extremity (wrist, forearm, or elbow).
    

Detailed description: 
      This is a prospective, two group, controlled study using random assignment. All eligible
      patients will be randomly assigned to one of two groups: the control group (usual care) or
      the experimental group (usual care plus LLLT). We plan to enroll 50 subjects in this study:
      25 subjects will be randomly assigned to the LLLT group and 25 to the usual care group.

      All subjects will be recruited within one to two days prior to hospital discharge or at the
      time of their first postoperative clinic visit. No subjects will be recruited while sedated
      or receiving intravenous pain medication.
    

Intervention name(s): Low Level Laser Therapy
Intervention type(s): Device
Intervention description(s): Low Level Laser Therapy on Wound
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment