bioihbjkbjnl/mcl2 huggingface dataset:
Exercise Training Intervention in Children With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Type 1 diabetes mellitus (T1DM) is associated with multiple co-morbidities, such as
      hypertension, dyslipidemia, coronary heart disease and osteoporosis. The foundation of these
      conditions lays in childhood. Exercise is known to have a positive influence on bone mineral
      density (BMD) and some impact on cardiovascular disease risk factors in healthy children, but
      little is known about these associations in children with T1DM.

      The main purpose of this study is to assess the effects of a 9-month weight-bearing exercise
      training program on skeletal development in children with T1DM, compared to healthy subjects.
      The second aim is to evaluate whether the program influences also cardiovascular diseases
      risk factors.

      This is a randomized controlled study incorporating 30 children with T1DM and 30 healthy
      children. Both groups are randomly divided (1:1) in an exercise or a control group: 1)
      exercise diabetic, 2) controls diabetic, 3) exercise healthy, 4) controls healthy.

      Exercise groups participate to an identical weight-bearing exercise training program 2 x 90
      minutes per week and controls are relatively inactive.

      Main measures include: total body, lumbar spine and hip BMD by DXA, body fat and fat-free
      mass, bone biomarkers levels, resting and ambulatory blood pressure and fasting blood lipids.
    


Intervention name(s): Exercise training program
Intervention type(s): Behavioral
Intervention description(s): Exercise Diabetic and Healthy groups perform a similar training program including two exercise sessions per week, of 90 minutes each, during 9 months (excluding holidays) under supervision by physical education teachers and pediatricians. Sessions comprise various weight-bearing activities: rope skipping, jumping, ball games and gymnastics.
Control groups are relatively inactive.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 1 Diabetes, Bone mineral density, Growth; Cardiovascular diseases, Exercise, Training,; Child, Adolescent
Evaluation of the Benefits of Adaptive Physical Activity in Children and Adolescents With Osteogenesis Imperfecta
Condition: Osteogenesis Imperfecta
MeSH terms: Osteogenesis Imperfecta
Study type: Interventional

Summary: 
      Osteogenesis imperfecta (OI) is a rare genetic disorder of increased bone fragility and low
      bone mass. It is conceivable that children and adolescents with OI are less active than
      healthy peers because of frequent fractures, immobilization,functionals limitations and no
      adapted physicals activity(APA). The hypothesis is that an Adapted physique activity could
      improve access of activity for patients with Osteogenesis Imperfecta (OI).

      The aim of the study is to evaluate benefice of APA,improve aerobic capacity, cardiovascular
      and bone benefits, and gain of quality of life.

      Children with OI between 6 and 18 years old will have a program of supervised "adapted
      training program" during one year. The program is adapted at each individual and without risk
      for the patient.
    


Intervention name(s): Adapted sports practices
Intervention type(s): Other
Intervention description(s): Adapted sports practices for 30 minutes twice a week
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: osteogenesis imperfecta; Adapted sport; Quality of life
Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome
Condition: Depressive Disorder, Major; Metabolic Syndrome X
MeSH terms: Microvascular Angina; Metabolic Syndrome; Syndrome; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to begin to test whether or not pioglitazone, an FDA approved
      medication used to treat high blood sugar, may be safe and effective in treating Major
      Depressive Disorder (MDD) in patients with comorbid Metabolic Syndrome (METSYN).
    


Intervention name(s): Pioglitazone
Intervention type(s): Drug
Intervention description(s): An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
Other intervention name(s): Actos
Intervention MeSH terms: Pioglitazone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depressive Disorder, Major; Metabolic Syndrome X; pioglitazone
Prospective Study Evaluating the Treatment of Hyperdynamic Forehead Wrinkles
Condition: Wrinkles
Study type: Observational

Summary: 
      To evaluate the safety and effectiveness of the iovera° device with the blunt tip cannula for
      the treatment of forehead wrinkles.
    


Intervention name(s): Cryotherapy for the utilization of wrinkle reduction (iovera)
Intervention type(s): Device
Other intervention name(s): iovera
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects, male or female, age 18 - 65 with forehead wrinkles deemed significant per
        protocol inclusion criteria.
Three-Part Program for Parents With Premature Infants
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This study evaluated the efficacy of a comprehensive, three-part program for parents of
      premature infants. This program was designed to improve development in preterm children and
      includes an educational video, tests to evaluate the child's strengths and abilities, and
      instruction in infant massage.
    

Detailed description: 
      Premature birth is a major cause of developmental delay, and cost-effective, replicable
      methods to promote development in preterm children are needed. Despite the success of first
      generation interventions, little is understood about why early intervention does not affect
      all parents and preterms to the same degree.

      This study assessed the efficacy of a three-component intervention (psychoeducational video,
      serial administrations of the Brazelton Neonatal Behavioral Assessment Scale, and
      parent-administered infant massage) that targets preterm infants and their mothers and
      fathers. Outcome measures included infant physical, intellectual, and socioemotional
      development; parental sensitivity; and infant-parent attachment. The project also assessed
      the role of parental state of mind regarding attachment and parental commitment to the
      intervention.

      Participants in this study were urban African American mothers and fathers of preterm, low
      birthweight infants admitted to the neonatal intensive care unit. Fathers were eligible for
      the study if nominated by the child's mother. Participants were randomly assigned to an
      intervention group or a control group. Both groups were comparable with respect to race,
      maternal pregnancy history, education, income, presence/absence of partner, infant
      gestational age, infant small-for-date status, and infant gender.

      The intervention group viewed a videotape about preterm infant abilities. Over the course of
      the study, the intervention group administered infant massage and completed multiple
      administrations of the Brazelton Neonatal Behavioral Assessment Scale with increasing
      parental involvement.

      The intervention began when infants were 32 to 36 weeks post-conceptual age (PCA) and ended
      when infants are 52 to 56 weeks PCA. The efficacy of the intervention and the moderating
      roles of adult attachment and parental commitment to the intervention were evaluated in terms
      of infant physical, mental, motor, and social development, and parental adjustment and
      sensitivity to the infant during the first 2 years.
    

Intervention name(s): Psychoeducational video; Infant massage; Brazelton Neonatal Behavioral Assessment Scale
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Prematurity; low birthweight; parenting; intervention
SGB in Management of Patients With PDPH Using TCD
Condition: Post-Dural Puncture Headache
MeSH terms: Post-Dural Puncture Headache; Headache
Study type: Interventional

Summary: 
      This study aims to investigate the ability of SPGB in the management of PDPH. Transcranial
      Doppler is also used as an measure to assess the block success by detecting the variability
      in the cerebral hemodynamics before and after the block.
    

Detailed description: 
      This clinical trial is performed in postoperative orthopedic unit. In this study, 120
      patients were enrolled who had an epidural anesthesia; 60 patients who developed PDPH joined
      the treatment group (A) and received the SP block. They are assessed before the procedure by
      NRS and at 30 mins, 2h, 4h, 6h, 12h, and 24h after the procedure. Patients are also assessed
      by TCD before and after the block. The control group (B) included 60 patients with no PDPH.
    

Intervention name(s): Sphenopalatine Ganglion Block using 2% lidocaine
Intervention type(s): Drug
Intervention description(s): Sphenopalatine Ganglion Block is performed by a hollow culture swab that is connected with a 21-gauge syringe filled with three ml 2% lidocaine, inserted parallel to the floor of the nose until resistance is felt. The swab is at the posterior pharyngeal wall superior to the middle turbinate. The applicator was kept in the nostril for five to ten mins. The same procedure is done also in the second nostril. The patients are then examined by TCD.
Other intervention name(s): Transcranial Doppler (TCD) is also utilized
Intervention MeSH terms: Lidocaine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is carried out in the Orthopedic unit and included 120 patients divided into two groups: the treatment group (A) and the control group (B). Group A recruit 60 patients with a past history of epidural anesthesia who suffered from of PDPH within five days after the dural puncture. Group B included 60 patients with a history of epidural anesthesia with no PDPH.
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Accidental dural puncture; Post dural puncture headache; Sphenopalatine ganglion block; Transcranial Doppler
Effect of Segmental Muscle Vibration on Upper Limb Function in Post Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The aim of this study is to observe and to compare effects of segmental vibration on flexors
      versus extensor muscle groups on upper limb function in post-stroke patients. This study will
      be helpful in finding out that either low frequency segmental vibration on flexors muscle
      group is better in improving upper limb function or low frequency segmental vibration on
      extensor muscle group is more beneficent in improving upper limb function.
    

Detailed description: 
      Stroke is the leading cause of long-term disability and is often associated with persistent
      involvement of upper limbs.Several disturbances are the manifestation of UL impairments after
      stroke (i.e., muscle weakness, changes in muscle tone, joint disturbances, impaired motor
      control) . Muscular weakness and spasticity are most commonly observed in post stroke
      patients. There are many strategies are developed to improve functional status and to reduce
      spasticity pattern in post stroke patients. Among the different approaches to improve motor
      functions in post stroke patients, vibration therapy gives strong stimulatory effects in post
      paretic limb. Segmental muscle vibration (SMV) is a fairly new technique that has been used
      to improve motor function and inhibit spasticity in the hemiplegic upper extremity of
      patients following a stroke. In SMV, a vibratory stimulus is applied to a specific muscle
      tendon using a mechanical device unit.The aim of this study is to observe and to compare
      effects of segmental vibration on flexors versus extensor muscle groups on upper limb
      function in post-stroke patients. This study will be helpful in finding out that either low
      frequency segmental vibration on flexors muscle group is better in improving upper limb
      function or low frequency segmental vibration on extensor muscle group is more beneficent in
      improving upper limb function.
    

Intervention name(s): segmental muscle vibration
Intervention type(s): Device
Intervention description(s): Segmental muscle vibration will delivered over the target muscles by means of vibrator with general physical therapy session
Other intervention name(s): general physical therapy session
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: segmental muscle vibration,spasticity,upper limb function
Vitamin E Supplementation in Hyperinsulinism/Hyperammonemia Syndrome
Condition: Hyperinsulinism-Hyperammonemia Syndrome
MeSH terms: Hyperinsulinism; Syndrome; Hyperammonemia
Study type: Interventional

Summary: 
      Investigators will assess the tolerability of oral Vitamin E supplementation in subjects with
      congenital hyperinsulinism (HI) and hyperammonemia (HA) syndrome.
    

Detailed description: 
      Congenital hyperinsulinism (HI) is a rare disorder of pancreatic beta cell insulin secretion
      that causes persistent and severe hypoglycemia starting at birth.
      Hyperinsulinism/hyperammonemia (HI/HA) syndrome is the second most common type of congenital
      HI and is caused by activating mutations in glutamate dehydrogenase (GDH). Patients with
      HI/HA exhibit fasting hyperinsulinemic hypoglycemia, protein-induced hypoglycemia,
      hyperammonemia, seizures, and intellectual disability independent of hypoglycemia. These
      effects result from abnormal GDH activity in the beta cells, liver and kidney cells, neurons,
      and astrocytes. The only available treatment for HI/HA syndrome is diazoxide, which acts on
      the beta cells to decrease insulin secretion but has no effect on GDH activity itself or on
      other cell types. Thus, there remains a significant unmet need for improved therapies for
      this disorder. Preliminary data show that Vitamin E (alpha-tocopherol) inhibits GDH activity
      in cell lines and improves hypoglycemia in a GDH HI mouse model. Based on these preclinical
      studies, Investigators hypothesize that Vitamin E will inhibit GDH activity and may impact
      hyperinsulinemic hypoglycemia and hyperammonemia in subjects with HI/HA syndrome. This
      hypothesis will be tested in a future study. In this initial pilot study, investigators will
      assess the tolerability of oral Vitamin E supplementation in subjects with HI/HA syndrome.
    

Intervention name(s): Vitamin E
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects will take an oral Vitamin E (alpha-tocopherol) supplement once daily with a fat-containing meal for 2 weeks. The dose will be based on subject age (150 IU if 1-3 years old, 300 IU if 4-8 years old, 450 IU if 9-17 years old, 600 IU if >17 years old). Formulations include 50 IU/mL liquid and 200 IU capsules. The liquid formulation will be used for subjects who will receive <600 IU daily, or for any subjects who prefer liquid medication to capsules.
Other intervention name(s): alpha-tocopherol
Intervention MeSH terms: Vitamin E; Tocopherols; alpha-Tocopherol
Intervention model: Single Group Assignment
Intervention model description: This open-label tolerability and feasibility pilot clinical study will use a before-and-after design, with blood tests and fasting oral protein tolerance test performed prior to and after 2 weeks of daily oral Vitamin E supplementation in individuals with HI/HA syndrome.
Masking: None (Open Label)
Primary purpose: Other
Keywords: hyperinsulinism; hyperammonemia; hypoglycemia; vitamin e
Assessment of CMV-specific ELISPOT Assay for Predicting CMV Co-infection in Patients With Pneumocystitis Pneumonia (ACE-PCP)
Condition: Non-HIV Patients With Pneumocystis Jiroveci Pneumonia
MeSH terms: Infections; Pneumonia; Pneumonia, Pneumocystis; Coinfection
Study type: Observational

Summary: 
      PCP (Pneumocystis jiroveci pneumonia) is one of the important opportunistic infections in
      immunocompromised patients including HIV-infected patients, transplant recipients, and
      immunosuppressant users. About one third of non-HIV patients with PCP have the evidence of
      co-infection with CMV. In this difficult clinical situation, physicians have difficulty to
      decide on whether anti-CMV treament will help patients with any evidence of CMV co-infection.
      However, there is no objective test to differentiate true co-infection of CMV from innocent
      bystander of CMV in those with PCP. The investigators thus evaluate the usefulness of
      CMV-specific ELISPOT assay in patients with PCP to differentiate true co-infection of CMV
      from inocent bystander of CMV. This findings may guide physicians to decide anti-CMV
      treatment in patients with PCP and CMV co-infection.
    

Detailed description: 
      PCP (Pneumocystis jiroveci pneumonia) is one of the important opportunistic infections in
      immunocompromised patients including HIV-infected patients, transplant recipients, and
      immunosuppressant users. About one third of non-HIV patients with PCP have the evidence of
      co-infection with CMV. In this difficult clinical situation, physicians have difficulty to
      decide on whether anti-CMV treament will help patients with any evidence of CMV co-infection.
      However, there is no objective test to differentiate true co-infection of CMV from innocent
      bystander of CMV in those with PCP. The investigators thus evaluate the usefulness of
      CMV-specific ELISPOT assay in patients with PCP to differentiate true co-infection of CMV
      from inocent bystander of CMV. This findings may guide physicians to decide anti-CMV
      treatment in patients with PCP and CMV co-infection.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Non-HIV patients with PCP
      
Keywords: Pneumocystis jiroveci, cytomegalovirus, co-infection
Investigation of the Pharmacokinetic Properties of Biphasic Insulin Aspart 50 in Healthy Chinese Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Asia. The aim of this clinical trial is to investigate the
      pharmacokinetic properties (the rate at which the trial drug is eliminated from the body)
      after a single subcutaneous (under the skin) injection of biphasic insulin aspart 50 (BIAsp
      50). In addition, the safety and tolerability of BIAsp 50 will be observed
    


Intervention name(s): biphasic insulin aspart 50
Intervention type(s): Drug
Intervention description(s): A single dose of 0.3 U/kg BIAsp 50 for subcutaneous (under the skin) injection
Intervention MeSH terms: Insulin Aspart; Biphasic Insulins
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Hinge Location on Corneal Sensation and Dry Eye After LASIK: A Systematic Review and Meta-analysis
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Observational

Summary: 
      The purpose of this study is to investigate the possible effect of hinge location on corneal
      sensation and dry eye syndrome after laser in situ keratomileusis (LASIK).
    

Detailed description: 
      Dry eye symptoms are a frequent postoperative complication of laser in situ keratomileusis
      (LASIK). Although estimates of the incidence of dry eye syndrome vary widely, from 3% to 59%,
      almost all patients will have transient dry eye during the immediate postoperative
      period.Because of the variability in corneal innervation patterns, altering flap
      characteristics in LASIK may affect postoperative corneal sensation and dry-eye disease. Some
      studies have reported that postoperative corneal sensation may be higher and recovery faster
      in eyes with horizontal flaps (nasal- or temporal-hinge) than in eyes with vertical flaps
      (superior- hinge). However, some other studies have not established an association between
      corneal sensation and hinge position. This study reviewed the published literature and
      performed a meta-analysis aimed to investigate the effects of hinge location on corneal
      sensation and dry-eye symptoms after LASIK.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients were scheduled to undergo LASIK and randomized to different hinge locations
      
Keywords: hinge position; dry eye
Effect of Acute Red Raspberry Consumption on Post-prandial Oxidative Stress
Condition: Oxidative Stress; Antioxidants
Study type: Interventional

Summary: 
      Eight healthy adult subjects will be given a meal of one, two or four cups red raspberries,
      or two slices white bread with or without 200 mg vitamin C, after an overnight fast and
      consumption of a low polyphenol diet for two days. Blood samples will be taken at various
      time points over an eight hour period to measure oxidative stress and antioxidant levels in
      the blood. Each subject will attend 5 study visits with one week intervals and be given each
      meal in a random order. It is hypothesized that raspberry consumption at higher doses will
      greater protect against meal-induced oxidative stress compared to bread controls.
    


Intervention name(s): red raspberries; bread controls
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): single serving of one, two or four cups red raspberries; two slices white bread alone or with 200 mg vitamin C supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: red raspberries; post-prandial; oxidative stress; antioxidants; polyphenols; vitamin C; acute dietary intervention