bioihbjkbjnl/mcl2 huggingface dataset:
Exercise, Statins, and the Metabolic Syndrome
Condition: Metabolic Syndrome; Obese; Sedentary
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Here we tested if statins or exercise plus statins had a greater capacity to lower metabolic
      syndrome risk factors in sedentary individuals with at least 2 metabolic syndrome risk
      factors. We also examined if statins impacted exercise response for mitochondrial content in
      muscle or aerobic fitness.
    

Detailed description: 
      OBJECTIVES: Determine if simvastatin impairs exercise training adaptations.

      BACKGROUND: Statins are commonly prescribed in combination with therapeutic lifestyle
      changes, including exercise, to reduce cardiovascular disease risk in patients with the
      metabolic syndrome. Statin use has been linked to skeletal muscle myopathy and impaired
      mitochondrial function, but it is unclear whether statin use alters adaptations to exercise
      training.

      METHODS: We examined the effects of simvastatin on changes in cardiorespiratory fitness and
      skeletal muscle mitochondrial content in response to aerobic exercise training. Sedentary
      overweight or obese adults with at least 2 metabolic syndrome risk factors (defined according
      to National Cholesterol Education Panel Adult Treatment Panel III criteria) were randomized
      to 12 weeks of aerobic exercise training or to exercise in combination with simvastatin (40
      mg per day). The primary outcomes were cardiorespiratory fitness and skeletal muscle (vastus
      lateralis) mitochondrial content (citrate synthase enzyme activity).
    

Intervention name(s): Statin; Exercise only; Statins + Exercise
Intervention type(s): Drug; Other; Other
Intervention description(s): Statins (40mg/day)for 12 weeks; 12 weeks of exercise training (5 days a week for 45-50 min a session); Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks
Other intervention name(s): simvastatin; Physical activity; Statins + Physical Activity
Intervention MeSH terms: Simvastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mitochondria; fitness; statins; cholesterol; metabolic syndrome
Evaluatation of Appscent Device Safety and Effectiveness for Relief of Obstructive Sleep Apnea (OSA) Syndrome in Adults.
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of
      upper airway obstruction that occur during sleep.

      The standard treatment for apnea remains a device consisting of a pump and nasal mask that
      provide continuous positive airway pressure (CPAP). The major disadvantage of CPAP is the
      relatively low compliance.

      Appscent developed a non-contact effortless bedside solution based on the following: odors
      modify respiratory patterns during wake . Mildly trigeminal and pure olfactory odorants do
      not arouse or wake.
    

Detailed description: 
      Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of
      upper airway obstruction that occur during sleep. OSA lead to desaturation and often lead to
      an arousal.

      Associated features include loud snoring and fragmented non-refreshing sleep and have
      profound impact on quality of life, on safety on the roads and at work, and on the
      cardiovascular and metabolic systems.

      The standard treatment for apnea remains a device consisting of a pump and nasal mask that
      provide continuous positive airway pressure (CPAP). CPAP acts as a pneumatic splint that
      elevates and maintains a constant pressure along the upper airway during inspiration and
      expiration that prevents airway collapse. The major disadvantage of CPAP is the relatively
      low compliance.

      Appscent developed a non-contact effortless bedside solution based on the following: odors
      modify respiratory patterns during wake . Mildly trigeminal and pure olfactory odorants do
      not arouse or wake. Odorants transiently presented during sleep induced a respiratory
      rejection type response, this suggests that manipulating the respiratory system without
      waking is viable .
    

Intervention name(s): Appscent Device
Intervention type(s): Device
Intervention description(s): computer-controlled, low pressure compressed air based, with disposable odorant capsules solution provided an odor environment at the nose,
Intervention model: Single Group Assignment
Intervention model description: Prospective, self-controlled, feasibility study.
Masking: None (Open Label)
Primary purpose: Treatment
Enalapril Folic Acid Tablets Combined With CCB or Diuretic to Prevent Stroke in Patients With Type H Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Hypertension is a common condition that can cause serious events such as stroke, coronary
      heart disease and heart failure. Homocysteine (Hcy) is a substance in the body that is
      harmful to blood vessels. Hyperhomocysteinemia (plasma Hcy≥10 mol/L), which is associated
      with hypertension, significantly increases the risk of stroke. This type of high blood
      pressure is called type "H" hypertension. Enalapril folic acid tablet is an innovative drug
      developed independently in China and is the first choice for the treatment of H type
      hypertension. Patients with type H hypertension should be treated with enalapril folic acid
      tablets to reduce stroke.

      However, some patients had poor blood pressure control after monotherapy. At this time, other
      antihypertensive drugs should be used in combination. Amlodipine and Hydrochlorothiazide are
      the most commonly used and the best combination.

      The purpose of this study was to observe the difference in the efficacy of enalapril folic
      acid tablets in patients with uncontrolled blood pressure who were well tolerated and
      randomized to aminoclodipine or hydrochlorothiazide in reducing stroke and other
      cardiovascular and cerebrovascular events, and to explore the relationship between various
      alternative measures and efficacy.
    


Intervention name(s): Enalapril Folic Acid Tablets Combined With amlodipine; Enalapril Folic Acid Tablets Combined With hydrochlorothiazide
Intervention type(s): Drug; Drug
Intervention description(s): Enalapril Folic Acid Tablets 10.8mg Combined With amlodipine 5 or 10mg; Enalapril Folic Acid Tablets 10.8mg Combined With hydrochlorothiazide 12.5 or 25mg
Intervention MeSH terms: Folic Acid; Vitamin B Complex; Amlodipine; Hydrochlorothiazide; Enalapril; Enalaprilat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oocyte Recipient's Decision in the Number of Embryos to be Transferred
Condition: Decision Making; Infertility, Female; Counseling
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      Multiple pregnancies are considered an ART complication. The only effective way to reduce its
      incidence is to transfer a single embryo. Nonetheless, there is some reluctance among the
      patients to accept this strategy. In IVF/ICSI programs, it has been demonstrated that, after
      receiving the information about the similar cumulative live birth rate after single embryo
      transfer (SET) and double embryo transfer (DET) and the obstetric and perinatal risks of
      multiple pregnancy, a significant number of patients opt for SET. Up to date, no comparable
      studies have been published in oocyte recipients. The aim of this study is to evaluate if the
      information given to the patients influence their preference on the number of embryos to be
      transferred. It also seeks to identify factors which determine the initial preference and
      factors which can explain a hypothetic change in this preference.
    


Intervention name(s): Oral and written counselling
Intervention type(s): Behavioral
Intervention description(s): Recipients were informed about success rates of SET and DET and also about the possible risks of DET. All the information was given orally and written.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: oocyte donation; recipient counselling; single embryo transfer (SET); double embryo transfer (DET); decision-making
Biomarker and Genetic Predictors of Erenumab Treatment Response
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      To explore the relationship between clinical response to erenumab and genetic biomarkers
    

Detailed description: 
      This is a phase 4 open-label study aiming to explore the relationship between clinical
      response to erenumab and genetic biomarkers.

      Subjects with episodic or chronic migraine will be treated with Erenumab 70mg or 140mg for a
      4-week baseline/screening period, followed by a 24-week treatment period.

      Subjects will collect migraine-related parameters daily using an eDiary and blood samples
      will be collected for biomarker research. All analysis will be descriptive in nature.
    

Intervention name(s): Erenumab
Intervention type(s): Drug
Intervention description(s): Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)
Intervention MeSH terms: Erenumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Episodic and Chronic Migraine; Link between clinical response and biomarker; Phase 4
Shoes on Balance, Muscular Endurance and Functional Skills
Condition: Healthy
Study type: Interventional

Summary: 
      In daily life, stiletto heeled shoes which are popularly preferred by women have different
      heel heights. This study aims to investigate the effects of these differences on balance,
      muscular endurance and functional skills. Heel heights were chosen as 4 and 10 cm. Other
      features of shoes (stiletto type/colour etc.) will be same. The tests will be randomly done
      barefoot, 10 cm, and 4cm shoes.
    

Detailed description: 
      The evaluations will include Functional Forward Reach Test for dynamic balance and Single Leg
      Standing for static balance, heel raising and squat-up test for muscular endurance of plantar
      flexor and quadriceps muscles, ascending stairs for functional skills.

      Measuring distance will be used for Functional reach test and timing will be used for single
      leg standing test. Timing and repetition number will be used for muscular endurance tests.
      Timing will be used to climb up 10 stairs with and without heel contact.
    

Intervention name(s): Shoes
Intervention type(s): Other
Intervention description(s): Shoes with different heel heights
Other intervention name(s): Women wearing shoes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: women; shoes; balance; muscles
Detemir: Role in Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      Study of blood sugars in the children with Type 1 Diabetes Mellitus (T1DM), who are given
      insulin detemir and a rapid acting insulin (aspart). It is hypothesized that there is no
      difference in the patterns of blood sugars when detemir is given in the same syringe or in
      separate syringes with rapid acting insulin.
    

Detailed description: 
      One of the barriers to good glycemic control in children with type 1 diabetes is multiple
      daily insulin injections. Mixing rapid-acting (detemir) and slow- acting insulins (aspart) in
      the same syringe would decrease the number of injections and may improve adherence

      This study hypothesized that slow-acting insulin detemir mixed with aspart would have
      equivalent effects on blood glucose versus giving them as separate injections in children
      with type 1 diabetes.

      Eighteen pediatric subjects with type 1 diabetes (11 males and 7 females) were recruited.
      However only 14 subjects completed this 20-day, randomized, crossover, and open-labeled
      study. The subjects were randomly assigned to either Study A (both insulin detemir and rapid
      acting insulin (RAI)) or Study B (either detemir or aspart) for the first 10 days. They were
      then crossed over for the last 10 days. Each subject underwent 72 h of continuous glucose
      monitoring (CGM) during the last 72 h, for both Study A and Study B.Data of 48 h from
      midnight of the 1st day to mid- night of the 3rd day of the 72-h (CGM) were used for analysis
      to ensure the same starting and ending times of monitoring for all subjects.Sustained glucose
      values over time were calculated as area under the curve (AUC), index of blood glucose
      control as M-value and glucose excursion as mean amplitude of glucose excursion (MAGE)
    

Intervention name(s): Insulin Detemir mixed with RAI injection; Insulin Detemir and RAI injection
Intervention type(s): Drug; Drug
Intervention description(s): Insulin Detemir mixed with RAI injection is given twice daily as subcutaneous injection; Insulin detemir and RAI are given as separate injections, twice daily as subcutaneous injection
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Detemir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: blood sugar; glycemic
Comparative Immunogenicity Study Comparing TPI-120 to Neulasta® in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare treatment emergent incidence rate of ADA between TPI-120 and US
      licensed Neulasta in normal healthy adult subjects
    

Detailed description: 
      Healthy subjects have been selected as the study population for this comparative study
      because this population is more homogenous with respect to immune response and offers
      significant advantages with regards to recruitment and logistical aspects. This study will
      comprise of two cycles with each cycles will have a single dose of PEG FILGRASTIM
      administration to all study subjects as per the randomization schedule. Subjects will be
      confined from at least 10 hours prior to dosing, at the time indicated by the CRU, until 36
      hours post-dose on day 2 in each Cycle. Dosing in each Cycle are separated by 21 days.

      Subjects will return for all subsequent blood draws and ADA assessments, as indicated in The
      Schedule of Event
    

Intervention name(s): PEGFILGRASTIM
Intervention type(s): Drug
Intervention description(s): Pegfilgrastim is a covalent conjugate of recombinant methionyl human granulocyte colony-stimulating factor and monomethoxy polyethylene glycol.
Other intervention name(s): PEG GCSF, Neulasta
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a single blind parallel comparative immunogenicity study
Masking: Single (Participant)
Primary purpose: Treatment
Kinesio Taping in Cerebral Palsy Upper Extremity Functionality
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      Purpose: The aim of this study is to investigate the effects of kinesio taping on upper
      extremity functionality in participants with Cerebral Palsy.

      Methods: This study included 14 children aged 6-16 years, diagnosed with Cerebral Palsy. The
      children with Cerebral Palsy were divided into 2 groups, the study group and the control
      group. Assessments were done three times for each group (beginning - 45min later - 1 week
      later). Frenchay Arm Test was used to evaluate upper extremity functionality in participants
      with Cerebral Palsy. Kinesio taping was applied to study group to improve posture and
      function in shoulder area.
    


Intervention name(s): Kinesio taping
Intervention type(s): Other
Intervention description(s): Before applying the tape, it was checked whether the children were allergic. Tape was first started from the distal part of the fingers and taped with 0% tension with Kinesio Taping Functional Correction Technique. Another I tape was applied from palmar area of the hand to spina scapula for supination of the forearm and external rotation of the shoulder with %0 tension to make functional correction (Figure 2). Kinesio Taping Functional Correction method is suggested to be done with 75% of tension but for children, we applied it with 0% tension to minimize the shear effects to the skin4. Kinesio Tex Light Touch Plus tape was used for taping application (Kinesio Co., USA).
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: The children with Cerebral Palsy included in this study consisted of 2 groups, the study group and the control group. No application was made to the control group. The same participant group was included as the experimental group after 1 week of rest. The assessments were done three times for each group (beginning - 45min later - 1 week later)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kinesiotape; Cerebral palsy; upper extremity functionality
Investigation of Acute Effects of Local Vibration and Whole-Body Vibration Applications
Condition: Ataxia
MeSH terms: Ataxia
Study type: Interventional

Summary: 
      This study was designed as a single-blind, randomized and cross-over study to investigate and
      compare the acute effects of local vibration (LV) and whole-body vibration (WBV) applications
      on postural control in adult patients with ataxia.

      The study will be included in patients aged 18-50 years, including ataxia diagnosed by the
      neurologist and able to walk independently. Patients with pregnancy status, epilepsy,
      spasticity, implant / endoprosthesis / pacemaker, benign paroxysmal positional vertigo,
      history of fracture in the last 6 months and other neurological diseases other than ataxia
      will not be included in the study. Between the applications, a washout period of one week
      will be given to each patient to apply both local and whole body vibrations. The order of
      application will be decided by the coin toss randomization method. Descriptive evaluations of
      the patients will be done with Mini-BESTest and Trunk Impairment Scale. Stability limits and
      postural sways (Bertec Balance Check ScreenerTM), gait time - distance characteristics
      (GAITRite), functional mobility skills (Timed Up and Go Test), and static balances (One Leg
      Stance Test) before, 1 minute after the application and 60 minutes after the application.
    


Intervention name(s): whole body vibration / local vibration
Intervention type(s): Device
Intervention description(s): Both the whole-body vibration application and the local vibration application will be applied to the patients in our cross-over study. Between the two applications will be given a washout period of one week. Patients will be evaluated both local and whole body vibration applications, 1 minute and 60 minutes after the end of the applications. After the evaluation, the patient will be rested in the sitting position until the evaluation at the 60th minute.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Between the applications, a washout period of one week will be given to each patient to apply both local and whole body vibrations.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: local vibration, whole body vibration, postural control
Effects From a Mandibular Repositioning Appliance in Patients With Obstructive Sleep Apnea and Snoring
Condition: Sleep Apnea Syndromes; Snoring; Disorders of Excessive Somnolence
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Disorders of Excessive Somnolence; Syndrome; Snoring; Sleepiness
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate effects from a mandibular repositioning appliance on
      obstructive sleep apneas, symptoms, blood pressure and markers of stress, inflammation and
      cardiovascular health in patients with mild to moderate obstructive sleep apnea/hypopnea
      syndrome and in patients with symptomatic snoring.
    

Detailed description: 
      Mandibular repositioning appliances for the treatment of snoring and sleep apneas are
      increasingly used over the world, although the number of prescriptions of this therapy varies
      between countries. The appliance widens the upper airways during sleep in order to reduce
      sleep-disordered breathing. The device is easy to use and has become popular among patients.
      Despite this, the evidence for effects of this treatment is not very strong and based on only
      a few studies. The aim of this study is therefore to test the hypothesis that a mandibular
      repositioning appliance reduces sleep apneas, daytime sleepiness and other sleep apnea
      symptoms and increases the quality of life in sleepy patients with mild to moderate
      obstructive sleep apnea and in patients with symptomatic snoring. Secondary outcomes include
      effects on headaches, blood pressure and markers of stress, inflammation, cardiovascular
      health and oxidative stress. At baseline and after 4 month's treatment, the patients will
      respond to questionnaires about symptoms and quality of life. They will undergo measurements
      of sleepiness, sleep apneas and blood pressure as well as sampling of saliva, urine and
      blood. Factors that predict a successful treatment outcome will be analyzed in order to more
      exactly clarify the indications for this treatment modality in a group of patients who have
      been suggested to benefit from mandibular repositioning appliances according to previous
      studies and reviews.
    

Intervention name(s): Mandibular repositioning appliance, adjustable
Intervention type(s): Device
Intervention description(s): Comparison between mandibular repositioning appliance for nightly use and a placebo device regarding effects on sleep apneas and daytime symptoms as well as blood pressure and markers of oxidative stress and sleepiness.
Other intervention name(s): Herbst appliance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleep apnea syndromes; Snoring; Mandibular advancement; Activator appliances; Disorders of excessive somnolence; Blood pressure; Inflammation; Oxidative stress; Hormones; Markers of Metabolic Syndrome X