bioihbjkbjnl/mcl2 huggingface dataset:
Glucose Metabolism in Different PCOS Phenotypes
Condition: Polycystic Ovary Syndrome; Glucose Intolerance; Liver Fat; Glucose Metabolism Disorders
MeSH terms: Polycystic Ovary Syndrome; Metabolic Diseases; Glucose Metabolism Disorders; Glucose Intolerance
Study type: Observational

Summary: 
      In the present study glucose metabolism and ectopic lipids in the liver, heart and muscle
      were investigated in women with the polycystic ovary syndrome (PCOS) and in healthy control
      subjects.
    

Detailed description: 
      In detail an oral glucose tolerance test (OGTT) was conducted in women with the PCOS defined
      by the Rotterdam and the NIH-criteria, as well as in healthy control subjects. In addition
      1H-magnetic resonance spectroscopy and Imaging was used for the assessment of the ectopic
      lipid content in the liver, heart and skeletal muscle. The aim of the present study was to
      compare the glucose metabolism and the ectopic lipid conent in the liver, heart and muscle
      between women with the PCOS defined by the NIH-criteria, Rotterdam-criteria and healthy
      control subjects.
    

Intervention name(s): Oral glucose tolerance test (OGTT); 1H-magnetic resonance spectroscopy
Intervention type(s): Diagnostic Test; Other
Intervention description(s): For the assessment of glucose metabolism, including beta-cell function and insulin sensitivity an 75g-OGTT was conducted.; The amount of ectopic lipids in the liver, heart and the skeletal muscle was measured using 1H-magnetic resonance spectroscopy.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        In the present study women with the Polycystic Ovary Syndrome, defined according to the
        NIH-criteria and the Rotterdam criteria were included. The control Group consisted of
        healthy volunteers without a diagnosis of prediabetes, Diabetes or the PCOS.
Comparing HEPES-buffered With Bicarbonate-buffered as Handling Media During the ICSI Procedure on Live Birth Rate
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The pH stability during human gamete handling for intracytoplasmic sperm injection (ICSI) is
      physiologically sound. As the pH change for bicarbonate-buffered medium, scientists assumed
      whether the use of HEPES or MOPS buffered medium would provide more stable pH, thereby better
      outcomes. However, the oil use and time frame outside the incubators have not been accounted
      for. This study is to evaluate the use of HEPES buffered medium compared with the
      bicarbonate-buffered medium on ICSI outcomes.
    


Intervention name(s): Bicarbonate-buffered handling medium
Intervention type(s): Other
Intervention description(s): The investigators will evaluate whether the usual bicarbonate culture medium can replace the HEPES buffered medium effectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
High Risk Populations Among COPD Patients in Japan
Condition: COPD
Study type: Observational

Summary: 
      The patients with complications of COPD and asthma have features mixed with two diseases,
      COPD and asthma. Therefore, the outcomes are worsened if the patients with COPD have symptoms
      overlapped with asthma, however, no sufficient data exist in Japan for estimating the
      prevalence of ACOS in patients with COPD. The primary objective of this NIS is to clarify the
      proportion of ACOS defined by GINA and GOLD in patients with COPD. The main secondary
      objectives are To explore the features of history of COPD exacerbations, symptoms,
      eosinophilic inflammation and patient background in patients with ACOS, to clarify the
      history of COPD exacerbations in patients with COPD, to evaluate the degrees of eosinophilic
      inflammation of the respiratory tract in patients with COPD and to evaluate the symptoms in
      patients with COPD. This is a cross-sectional study targeting COPD patients receiving
      outpatient treatment and follow-up by physicians in Japan. FSI is scheduled as 2Q 2015 and
      DBL would be locked by 3Q 2015.
    

Detailed description: 
      Study Site(s), number of subjects planned Number of study sites planned for this research
      study (scheduled) 60 (undetermined) Number of subjects planned for this research study
      (scheduled) 1,100 patients
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with a diagnosis of COPD
Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients
Condition: Anxiety
MeSH terms: Pain; Anxiety Disorders
Study type: Interventional

Summary: 
      With the virtual reality application in patients with bronchoscopy, it is aimed to reduce the
      fear, stress and tension arising from the possibility of the development of pain and
      complications in the patients. The research will be carried out in the form of
      pretest-posttest application with 30 experimental and 30 control groups. The researcher aims
      to minimize the fear and stress in the patient by applying the virtual reality application to
      the patient in the experimental group 10 minutes before the procedure and 5-10 minutes during
      the procedure.
    

Detailed description: 
      This study includes the examination of the effect of applying virtual reality interventions,
      which are used for the treatment of anxiety problems, to patients who will undergo
      bronchoscopy. For this purpose, first of all, a relaxation intervention will be designed in a
      virtual reality environment. The virtual reality environment will be organized on the basis
      of relaxation exercise. In this direction, first of all, an image will be created by taking
      3D modeling service and the text of the relaxation exercise prepared in the presence of a
      professional sound artist will be transferred to the image with sound.
    

Intervention name(s): Virtual Reality Based Relaxation Program
Intervention type(s): Other
Intervention description(s): Virtual Reality Based Relaxation Program
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Virtual Reality Based Relaxation Program
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Virtual Reality; Anxiety; Pain; Endoscopy Patients
Effects of Macular Buckle Versus Vitrectomy on Macular Schisis and Macular Detachment in Highly Myopic Eyes
Condition: Retinoschisis; Macular Detachment; High Myopia
MeSH terms: Myopia; Retinoschisis; Dissociative Disorders
Study type: Interventional

Summary: 
      Macular schisis associated with macular detachment is a one of the complications of high
      myopia. There is controversy in the primary treatment for this situation. This study will
      compare the effects of macular buckling + gas injection versus vitrectomy + internal limiting
      membrane peeling + gas tamponade in a cohort of highly myopic eyes with macular retinal
      detachment associated with macular schisis.
    

Detailed description: 
      A randomized, open label, single center study comparing the efficacy of macular muckle + gas
      injection versus internal limiting membrane peeling + gas tamponade on macular schisis
      associated with macular detachment in eyes with high myopia.
    

Intervention name(s): Macular buckling; Vitrectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Surgical procedures of macular buckling, drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis, and inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous body through pars plana, under systemic anesthesia.; Surgical procedures of small gauge vitrectomy, internal limiting membrane peeling, and gas (C3F8, 14%) tamponage, under local or systemic anesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Alterations in Central Control of Shoulder Muscles in Office Workers With Non-specific Chronic Neck Pain
Condition: Non-specific Chronic Neck Pain; Office Workers; Transcranial Magnetic Stimulation; Neuromuscular Control
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Non-specific chronic neck pain (NCNP) is commonly seen in office workers. Individuals with
      NCNP not only demonstrate impaired neck movement control and muscle activation, but also show
      abnormal scapular kinematics and muscle activation timing. Office workers with NCNP also show
      higher activity of upper trapezius during computer typing and have difficulty relaxing upper
      trapezius after typing. These changes related to scapula may increase strain over neck. In
      addition to the altered neuromuscular control, recent studies found neuroplasticity changes
      in the central nervous system on patients of chronic musculoskeletal disorders. Therefore,
      few studies found shifts and alterations of motor cortex representation of neck muscles in
      individuals with NCNP, which was correlated with delayed muscle activation of deep neck
      flexors muscle in functional activities. However, no studies have explored that whether this
      corticospinal adaptation also happens over scapular muscles, especially after a computer
      typing task. The objectives of this proposal are to investigate the differences in
      corticospinal and neuromuscular control of shoulder complex between office workers with and
      without NCNP. Thirty-five individuals with NCNP and 35 healthy controls will be recruited.
      Twenty young healthy subjects will be also recruited for a pilot study to test the
      reliability of all the measures. Scapular kinematics and muscle activation will be tested
      during arm elevation. Corticospinal parameters of trapezius and serratus anterior will be
      tested with transcranial magnetic stimulation (TMS), including active motor threshold, motor
      evoked potential, cortical silent period, short interval intracortical facilitation, short
      interval intracortical inhibition and cortical mapping. Corticospinal parameters, except
      cortical mapping, will be measured again after a 30-minute computer typing task. Scapular
      muscle activation will be also recorded during the typing task.
    


Intervention name(s): 30-minute computer typing task; 30-minute rest
Intervention type(s): Other; Other
Intervention description(s): The subject sits in front of a computer screen and perform computer typing tasks for 30 minutes. The same computer table and chair were used for all subjects. The height of the table and screen, and the distance of the keyboard from the subject were adjusted according to their familiar and comfortable position.; Rest for 30 minutes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Non-specific chronic neck pain; Transcranial magnetic Stimulation; Corticospinal system; Scapular kinematics; Scapular muscles activation
Effectiveness of a Decision Aid for Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The main goal of this study is assess the effectiveness of a DA for patients with knee
      osteoarthritis candidates to ART
    

Detailed description: 
      The number of knee total arthroplasty (ART) interventions has increased in the last 10 years
      in European countries, partly due to the aging of the population and partly because of the
      increase in the use of these interventions to improve the quality of life among elderly
      patients. According to the Organization for Economic Cooperation and Development (OECD) 2012,
      from 2000 to 2010 in Spain the percentage of knee ART has doubled in recent years. .

      The role of citizens in decisions affecting their health is changing. Individual factors such
      as improving educational attainment and access to medical information, and collective factors
      such as training of patient groups and changes in legislation (informed consent, autonomy
      principle) have motivated the transition from a paternalistic model to a co-responsibility
      model. Shared decision-making (TDC) has been proposed in recent years as a model of care that
      promotes users' involvement in the decisions about their treatment, in those situations where
      there is uncertainty and / or the scientific evidence reports a balance between benefits and
      risks that is similar for two or more therapeutic options. Decision aids (DA) are tools
      designed to promote and facilitate patients' involvement in medical decisions concerning
      their health

      Objectives:

      To assess the effectiveness of a DA for patients with knee osteoarthritis candidates to ART

      Methodology:

      Randomized controlled trial to evaluate the effectiveness of the DA versus usual care in
      reducing decisional conflict, increasing knowledge of the disease/treatments, informed choice
      and the satisfaction with the decision making process, and decreasing decisional regret.
    

Intervention name(s): Decision aid
Intervention type(s): Other
Intervention description(s): Decision aids are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Knee ostheoartritis; Arthroplasty; Clinical trial; Decision aids
A Study to Compare to the Pharmacokinetic Profile of Two Paracetamol Formulations
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A repeat dose pharmacokinetic study investigating two paracetamol formulations
    


Intervention name(s): Experimental paracetamol formulation; Marketed paracetamol; Higher dose marketed paracetamol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): experimental; Marketed paracetamol; Higher dose marketed paracetamol
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: pharmacokinetic; paracetamol; Healthy volunteer; steady state
Effects of Exercise Training on Cognitive Function and Neurotrophic Factors in Overweight Adults
Condition: Cognitive Function; Motor Activity; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The BrainFit Study aims to examine acute effects of High Intensity Interval- vs Resistance or
      Combined program has benefits on Cognitive Function as well as on secretion and regulation of
      neurotrophic factors or neurotrophins in a cohort of sedentary, overweight adults (aged 18-30
      years) from Bogota, Colombia.
    


Intervention name(s): Experimental: High Intensity Interval; Resistance training; Plus: High Intensity Interval + Resistance Training; Non-exercise
Intervention type(s): Behavioral; Behavioral; Behavioral; Other
Intervention description(s): Walking on a treadmill 4min at 80-90% peak heart rate and recovery 4 min at 65% peak heart rate until expenditure of 500 kcal; Completing a resistance circuit (including upper and lower muscle groups) as many times as needed according to subject weight until expenditure of 500 kcal; Walking on a treadmill as intervention 1 until 50% the energy expenditure prescribed is reached, then completing a resistance circuit until 100% energy expenditure is reached; This group will receive the usual clinical care according to the consensus recommendations of the national goals for cardiovascular health promotion and disease reduction of the American Heart Association and Colombian guidelines COLDEPORTES.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting
Condition: Influenza Vaccine; Papillomavirus Infection; Pertussis
MeSH terms: Papillomavirus Infections
Study type: Observational

Summary: 
      PURPOSE To develop, implement, and evaluate the effectiveness of a program designed to assist
      community Ob/Gyns in vaccinating adolescent and adult women against vaccine-preventable
      diseases.

      SPECIFIC AIMS

        1. Determine the feasibility of implementing a successful vaccination program for
           adolescent and adult women in Ob/Gyn offices by direct assessment of medical personnel &
           office staff on their:

             -  Attitudes towards vaccination of women against preventable diseases

             -  Perceived barriers to implementing a program to vaccinate women in their offices

             -  Ideas on how to overcome barriers to successful program implementation

             -  Current vaccination practices and office-specific administrative processes

        2. Design & implement a program for Ob/Gyns to vaccinate women against human
           papillomavirus, influenza, & pertussis

        3. Determine the effectiveness of the vaccination program based on

             -  Pre- and post-program vaccination rates

             -  Program satisfaction amongst Ob/Gyn providers and office staff

             -  Willingness to continue and possibly extend the program to additional vaccines

        4. Quantify the level of support and resources needed to develop and implement the
           vaccination program
    


Intervention name(s): Vaccination Program
Intervention type(s): Other
Intervention description(s): Design & implement a program for Ob/Gyns to vaccinate women against human papillomavirus, influenza, & pertussis
Sampling method: Non-Probability Sample
Study population: 
        Population Groups:

        Adults

        Minors

        Patients

        Pregnant Women

        Fetuses
      
Keywords: HPV vaccine; Tdap vaccine
Study of AMG 256 in Adult Subjects With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of AMG 256 in adult participants and to determine the
      maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
    


Intervention name(s): AMG 256
Intervention type(s): Drug
Intervention description(s): AMG 256 administered as an intravenous (IV) infusion.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Pulsed Electromagnetic Field Therapy as an Adjunct Modality to Warm-up Exercise
Condition: Knee Range-of-motion; Quadriceps Muscle Stiffness
Study type: Interventional

Summary: 
      The goal of this clinical trial is to assess the effectiveness of pulsed electromagnetic
      field therapy as an adjunct to warm-up exercises, in healthy participants. Researchers will
      investigate both the immediate effect of one round of pulsed electromagnetic field therapy
      (PEMF) and after a warm-up exercise, on participants' range-of-motion (ROM) at the knee and
      quadriceps' muscle stiffness, measured through shear wave elastography, an ultrasound
      technique. This may be useful in future interventions to protect against sports injuries.

      Participants will have their knee ROM and quadriceps' muscle stiffness measured thrice, once
      at baseline, once after PEMF/sham treatment, and once after 5 minutes of warm-up stationary
      bike exercises.

      Researchers will compare with sham treatment to see if there are any significant effects from
      PEMF therapy.
    

Detailed description: 
      The goal of this clinical trial is to assess the effectiveness of pulsed electromagnetic
      field therapy as an adjunct to warm-up exercises, in healthy participants. Researchers will
      investigate both the immediate effect of one round of pulsed electromagnetic field therapy
      (PEMF) and after a warm-up exercise, on participants' range-of-motion (ROM) at the knee and
      quadriceps' muscle stiffness, measured through shear wave elastography, an ultrasound
      technique. This may be useful in future interventions to protect against sports injuries.

      Participants will have their knee ROM and quadriceps' muscle stiffness measured thrice, once
      at baseline, once after PEMF/sham treatment, and once after 5 minutes of warm-up stationary
      bike exercises.

        -  Baseline measurement of knee ROM and quadriceps' muscle stiffness

        -  Receive PEMF for ten minutes around their knee joint

        -  Interim measurement of knee ROM and quadriceps' muscle stiffness

        -  Perform 5 minutes of warm-up exercise on a stationary bike

        -  Final measurement of knee ROM and quadriceps' muscle stiffness

      Researchers will compare with sham treatment to see if there are any significant effects from
      PEMF therapy.
    

Intervention name(s): Pulsed electromagnetic field therapy; Sham treatment
Intervention type(s): Device; Device
Intervention description(s): Pulsed electromagnetic field therapy for 10 minutes, using a PEMF device, at 1 mT, 15 Hz.; Sham treatment, using the same PEMF device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Evaluate the Safety and Efficacy of XC221 in Patients With Uncomplicated Influenza or Other Acute Viral Upper Respiratory Infections
Condition: Influenza; Respiratory Viral Infection
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Virus Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of the study was to evaluate the effectiveness of XC221, tablets, at a dose
      of 200 mg/day compared to placebo in patients with uncomplicated influenza or other acute
      respiratory viral infections (ARIs).

      An additional purpose of the study was to evaluate the safety of XC221, tablets, at a dose of
      200 mg/day compared to placebo in patients with uncomplicated influenza or other ARIs.
    


Intervention name(s): XC221; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg/day, for 5 days; 2 tablets/day, for 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
The Pharmacokinetic Drug-drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers
Condition: Healthy Male Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the pharmacokinetic Drug-drug interaction
    

Detailed description: 
      The purpose of this study is to investigate the pharmacokinetic Drug-Drug(telmisartan,
      amlodipine and/ or rosuvastatin) interaction and safety in healthy male volunteers.
    

Intervention name(s): Telmisartan; Amlodipine; Rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Amlodipine; Telmisartan; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care