bioihbjkbjnl/mcl2 huggingface dataset:
Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa
Condition: Anorexia Nervosa; Osteoporosis
MeSH terms: Osteoporosis; Anorexia; Anorexia Nervosa
Study type: Interventional
Phase: Phase 2

Summary: 
      Decreased bone strength is a common and serious medical problem present in many women with
      anorexia nervosa. Women with decreased bone strength are more likely to suffer broken bones
      than women with normal bone strength.

      This study will investigate whether the use of transdermal estrogen can improve bone mineral
      density (BMD) and bone microarchitecture in women with anorexia nervosa anorexia nervosa when
      used for 6 months.
    

Detailed description: 
      Anorexia nervosa (AN) is a prevalent psychiatric disorder affecting up to 1% of college-aged
      women in the US and an increasing number of women over 30 years of age. Among the many
      medical co-morbidities associated with AN, the most common is significant bone loss, which
      can persist despite weight recovery. Nearly 50% of women with AN have osteopenia with an
      additional 30% meeting WHO criteria for osteoporosis. Importantly, this severe bone loss is
      associated with an increased fracture risk. Nearly 30% of women with AN report a history of a
      fracture and a prospective study demonstrated a 7-fold increased risk of fracture in women
      with AN compared to age-matched controls. Because AN is a chronic disease that can persist
      despite psychiatric and nutritional counseling, the bone loss and increased fracture risk can
      persist and lead to lifelong morbidity. Therefore, finding a treatment for bone loss
      associated with AN is of critical importance.

      This 6 month open-label study will investigate in women (ages 25 to 50 years old) with AN
      whether treatment with transdermal estrogen replacement will increase bone mineral density
      (BMD), improve parameters of bone microarchitecture as assessed by high-resolution peripheral
      quantitative computed tomography (HR-pQCT), and improve bone strength as estimated by
      microfinite element analysis.
    

Intervention name(s): estradiol 0.045 mg/levonorgestrel 0.015mg
Intervention type(s): Drug
Other intervention name(s): Climara Pro transdermal patch
Intervention MeSH terms: Levonorgestrel; Estradiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anorexia Nervosa; Osteoporosis; Eating Disorder; Disordered Eating; Estrogen; Bone
Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is:

        1. To evaluate the prevalence of preclinical atherosclerosis in Chinese patients with RA
           compared to healthy controls.

        2. To determine those clinical and biological measures that best predict the presence of
           plaque and increased arterial stiffness.

        3. To ascertain the efficacy and safety of rosuvastatin in the prevention of
           atherosclerosis in patients with RA measured by carotid intima-media thickness (IMT) and
           pulse wave velocity (PWV).
    

Detailed description: 
      150 consecutive RA patients followed at the Rheumatology clinic of the Prince of Wales
      Hospital will be recruited for this double-blind, randomized, placebo-control trial. Patients
      were matched to 150 controls on the basis of age (within 5 years), sex, body mass index
      (+/-5Kg) and ethnicity for the cross sectional study on the prevalence of subclinical
      atherosclerosis. Controls were healthy individuals recruited from the same community who
      underwent similar imaging protocols of the IMT and PWV assessments.

      Primary outcome is the improvement of atherosclerosis by Rosuvastatin therapy, evaluated by
      IMT and PWV.

      Secondary outcomes:

        -  Prevalence of premature atherosclerosis in RA patients compared to healthy controls in
           terms of the presence of plague and PWV.

        -  Correlation between clinical parameters, inflammatory markers (CRP/hsCRP, TNF-alpha and
           IL-6) and atherosclerosis (evaluated by IMT, the presence of plaque and PWV).

        -  Relation among PWV, ABI and AI in RA patients, and clinical significance of their
           combination.

        -  Determine which segment's PWV has a better relation with RA disease activity.
    

Intervention name(s): Rosuvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks; 5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks
Other intervention name(s): crestor; crestor
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HMG-CoA reductase inhibitors; Crestor; Rosuvastatin
Doctors' Understanding of Survival Statistics
Condition: Screening
Study type: Observational

Summary: 
      The probably most commonly used measure for expressing the pay-offs of early detection and
      treatment are survival rates. Yet, over time and groups this metric comes with several biases
      and thus, is not reliable for judging such benefits. Epidemiologists recommend using
      reduction of disease-specific mortality rates instead, which is unbiased. The purpose of the
      study is to investigate how primary care physicians understand and use different survival
      measures for determining the benefit of cancer screening tests.
    


Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        301 primary care physicians (internal, general, and family medicine physicians)
      
Keywords: survival rates; risk communication; screening counselling; screening recommendation; understanding of medical risk
Inspiratory Flow Using the Osmohaler
Condition: Asthma
MeSH terms: Respiratory Aspiration
Study type: Observational

Summary: 
      The OsmohalerTM is a registered device in Australia. It is used to deliver a dry powder a
      commercial preparation of mannitol registered as AridolTM to test if a person has irritable
      airways such as active asthma.

      The overseas regulatory authorities need to know that people of all ages can achieve an
      adequate inspiratory flow through this device during a controlled deep inspiration. Adequate
      flow is generally regarded as greater than 30 litres per minute in children and 60 litres per
      minute in adults. The OsmohalerTM is a device with low resistance and is already in use in
      Australia to deliver mannitol. However there is a need to document inspiratory flows through
      the device during a controlled deep inspiration. The protocol requires subjects to perform a
      controlled deep inspiration from the device on three or five occasions. No substance will be
      inhaled.
    


Time perspective: Prospective
Keywords: Asthmatic; healthy
The Phonophoresis of Lidocaine Gel and Its Effect on Sensory Blockage
Condition: Pain; Impairment, Light Touch Sensation
MeSH terms: Somatosensory Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The optimisation of drug absorption through skin is of great value in modern
      therapy.Phonophoresis is the use of therapeutic ultrasound to increase percutaneous drug
      absorption. However,few studies have compared pulsed and continuous modes of therapeutic
      ultrasound.This study compared these two modes by investigating the effect of lidocaine
      phonophoresis on sensory blockade.

      Ninety-three healthy volunteers, assigned at random to one of three ultrasound
      groups:pulsed(ultrasound+lidocaine),continuous(ultrasound+lidocaine)and control(sham
      ultrasound+lidocaine).

      Lidocaine was administered transdermally using a transducer.Two point discrimination, touch
      and maximum pain thresholds were assessed before and after the intervention in each group.

      Pulsed ultrasound with topical lidocaine gel induced greater anaesthetic effect compared with
      continuous ultrasound with topical lidocaine gel and lidocaine application alone. The
      mechanical properties of pulsed ultrasound appear to be responsible for greater drug
      penetration.
    

Detailed description: 
      Lidocaine is a common local anaesthetic drug that is used topically to relieve pain,itching
      and burning, and also for minor surgery.However,its application via this conductive
      method,has been confined to surface anaesthesia because it seems that it is not possible to
      have a deep transmission with local drug massage, without injection or systematic
      administration.On the other hand,the injection of lidocaine can lead to tissue injury and
      pain,and its use is not advised in children. Phonophoresis is one of the common procedures
      for reducing these problems. Therefore, the main aim of this study was to compare the two
      modes of therapeutic ultrasound by assessing the effect of lidocaine gel phonophoresis on
      percutaneous absorption and sensory blockade.
    

Intervention name(s): pulsed ultrasound device with lidocaine; off device; continuous ultrasound device with lidocaine
Intervention type(s): Device; Other; Device
Intervention description(s): Lidocaine (approximately 2 cc) was administered transdermally using a transducer (pulsed ultrasound); off device with Lidocaine (approximately 2 cc) was administered transdermally; Lidocaine (approximately 2 cc) was administered transdermally using a transducer (continuous ultrasound )
Other intervention name(s): lidocainegel(Akron,Inc.,Lake Forest,CA,USA); ultrasound(Enraf,Sonopuls 434,Netherlands); ultrasound(Enraf,Sonopuls 434,Netherlands); lidocaine gel(Akron, Inc.,Lake Forest,CA,USA); ultrasound (Enraf,Sonopuls 434,Netherlands)
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2)
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study
      evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.
    


Intervention name(s): CSF-1; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): One drop bilaterally twice daily for approximately 2 weeks.; One drop bilaterally twice daily for approximately 2 weeks.
Other intervention name(s): pilocarpine HCl 0.4%
Intervention MeSH terms: Pilocarpine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Hormones and Cognition in the Menopausal Transition
Condition: Age-associated Memory Impairment; Alteration of Cognitive Function
Study type: Observational

Summary: 
      The purpose of this study is to determine if the menopausal transition is associated with
      subjective and objective cognitive declines that ameliorate in menopause. The investigators
      hypothesize that perimenopause is associated with both subjective memory complaints and
      objective declines in attentionally mediated cognitive tasks. The investigators also
      hypothesize that this is time-limited. The investigators predict that as women transition
      from early perimenopause to late perimenopause their performance on attentionally mediated
      and verbal memory tasks will decline, and that as they transition from late perimenopause to
      menopause, their performance will improve.
    

Detailed description: 
      Two groups of women will be recruited, those in early perimenopause and those in mid to late
      perimenopause. Tests of attention, working memory, mental flexibility, processing speed, and
      retentive memory will be administered to each subject at 6 month intervals for 5 years.
      Additionally, women will be asked to fill out questionnaires about their mood, memory
      functioning, health, and quality of life. The investigators will also calculate each
      subject's Body Mass Index (BMI) and waist circumference at each visit. Finally, serum levels
      of reproductive hormones will be taken. Measures of interest will be the percentage of women
      in each group with absolute and relative cognitive deficits, change over time in performance
      on neuropsychological tests and scores on depression and anxiety scales, and correlations
      between cognitive function, mood and hormone level.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women between the ages of 40 and 60.
      
Biospecimen description: 
      Subjects will have 20 mL of blood drawn by venipuncture by a trained nurse
Fetuin-A Phosphorylation Status in Insulin Resistance and Metabolic Syndrome
Condition: Obesity; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Interventional

Summary: 
      Fetuin-A has been identified as a novel physiological regulator of insulin action in vitro,
      in intact cells and in vivo in animals. Previous research has shown that circulating levels
      of fetuin-A were increased in animal models of insulin resistance and diabetes. Additionally,
      several human investigation studies demonstrate a correlation of fetuin-A levels with body
      mass index, insulin resistance, and a fatty liver. Recently, the investigators have
      elucidated the role of fetuin-A phosphorylation in the regulation of insulin action,
      demonstrating that phosphorylation is critical for the inhibitory activity of fetuin-A. The
      objectives of this study are twofold: (1) Quantitate phosphorylated fetuin-A levels in
      individuals with insulin resistance and metabolic syndrome, and (2) Investigate the effects
      of lifestyle modifications (acute or chronic exercise and dietary modifications) on fetuin-A
      phosphorylation and insulin sensitivity.
    

Detailed description: 
      There are several objectives of this study: (1) Quantitate phosphorylated fetuin-A levels and
      the daily variation in these levels in individuals with insulin resistance and metabolic
      syndrome; (2) Investigate the short-term responses of fetuin-A phosphorylation and changes in
      insulin resistance that occur with a single session of aerobic exercise; (3) Characterize and
      compare the total and temporal changes in fetuin-A phosphorylation and insulin resistance
      that occur with an 8 to 10% weight loss induced by chronic exercise training and dietary
      modification, and; (4) Investigate the influence of weight loss on the short-term responses
      of fetuin-A phosphorylation and changes in insulin resistance that occur with a single
      session of aerobic exercise. Our hypothesis is that phosphofetuin-A levels are tightly
      correlated with insulin resistance and that lifestyle modifications will improve insulin
      sensitivity and decrease phosphorylated fetuin-A levels.
    

Intervention name(s): Weight loss
Intervention type(s): Other
Intervention description(s): Compare the total and temporal changes in fetuin-A phosphorylation and insulin resistance that occur with an 8 to 10% weight loss induced by chronic exercise training and dietary modification
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS
Condition: Group B Streptococcal Infections
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is an extension to the completed first-in-human C1091001 study (NCT03170609) and
      is to evaluate the safety and immunogenicity of a single booster vaccine dose of GBS6,
      administered approximately 2 years or more after a primary GBS6 dose, to healthy adult males
      and nonpregnant women. The study will determine whether individuals who received a primary
      dose of GBS6 have additional benefit following a booster dose.
    


Intervention name(s): Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)
Intervention type(s): Biological
Intervention description(s): 2 formulations at 1 dose level
Other intervention name(s): GBS6
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: There are two arms in the study however based on the prior formulation received participants can only be enrolled into one predetermined arm in the study. Participants are assigned by an interactive response technology (IRT) based on prior formulation received.
Masking: None (Open Label)
Primary purpose: Prevention
Growth Hormone in Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Several drugs have been proposed for ALS. These drugs included: Topiramate, Lamotrigine,
      creatine, Vit. E, Pentoxifylline, etc. Although most of the trials showed a positive trend,
      none of them reached a statistically significant result. The only exception is the Riluzole
      trial, that demonstrated a small but significant reduction in mortality between treated and
      untreated patients. Aim of our study is to determine if the add-on of GH to treatment with
      Riluzole is able to reduce neuronal loss in the motor cortex of ALS patients.
    

Detailed description: 
      Several drugs have been proposed for ALS. These drugs included: Topiramate, Lamotrigine,
      creatine, Vit. E, Pentoxifylline. Although most of the trials showed a positive trend, none
      of them reached a statistically significant result. The only exception is the Riluzole trial,
      that demonstrated a small but significant reduction in mortality between treated and
      untreated patients. When administered to SOD-1 transgenic mice, IGF-I prolongs survival,
      ameliorates muscular strength, and reduces weight and motor neuron loss, astrocyte gliosis,
      and ubiquitin positive protein inclusions.

      Two clinical trials have been performed in ALS patients with s.c. administration of IGF-I
      indicating a possible beneficial effect, and a third clinical trial is in progress. Methionyl
      growth hormone (mGH) showed no effect on survival, disease progression and muscular strength.
      MGH was administered at a fixed dose and peripheral production of IGF-I appeared to be
      normal. We propose a double-blind trial of Growth Hormone (GH) as add-on therapy to Riluzole,
      with an individually regulated dose based on the peripheral response of IGF-I. Aim of our
      study is to determine if the add-on of GH to treatment with Riluzole is able to reduce
      neuronal loss in the motor cortex of ALS patients. As secondary objectives, effect of GH on
      mortality, QoL, and motor function will be assessed.
    

Intervention name(s): Growth Hormone (Somatropin); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The initial dose will be 2U s.c. every other day. The dose will be progressively increased to reach 1.5-2x the normal levels of IGF-I.; Same as for Growth hormone group
Other intervention name(s): Saizen 8mg; Saizen 8mg placebo
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amyotrophic Lateral Sclerosis; ALS; Growth Hormone; IGF-I
Effect of Aldosterone Blockade on Arterial Compliance
Condition: Arterial Stiffness; Arterial Elasticity
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study investigated the long-term (12 months) effect of spironolactone treatment
      on glucose homeostasis, metabolic parameters and vascular properties.
    


Intervention name(s): Spironolactone
Intervention type(s): Drug
Intervention description(s): Spironolactone orally, at a dose of 50 mg/day for 12 months
Intervention MeSH terms: Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Aldosterone Blockade; Arterial elasticity; Glycemic control
Goal-directed Intraoperative Fluid Therapy in High-risk Surgery
Condition: Postoperative Complications; Fluid Overload
MeSH terms: Postoperative Complications
Study type: Observational

Summary: 
      This study is aim to assess the effect of goal-directed intraoperative fluid therapy on
      patient's postoperative incidence rates of complications, length of hospitalization and
      hospitalization cost.

      This is an observational study followed cohort study design, due to the two therapies were
      not randomized assigned to the two cohorts. The details are described as follow.
    

Detailed description: 
      The study will be conducted in patients undergoing either elective laparotomy of
      gynecological malignancies or elective major orthopaedic surgery under prone position in
      Peking Union Medical College Hospital. The study included two stages.

      In the first stage, one cohort of 300 participants with conventional fluid therapy will be
      involved, in which 150 patients will be selected with laparotomy of gynecological
      malignancies and150 patients will be selected with orthopedic surgery. All the participants
      in this stage will follow conventional fluid therapy to direct the amount of intraoperative
      fluid. Specifically, the fluid will be administered based on the principle crystalloid
      solution (colloid solution =2-3:1). The total volume of fluid will be adjusted in accordance
      with blood pressure, heart rate and urine output of each patient. It is a standard procedure
      in Peking Union Medical College Hospital. Then, the incidence of postoperative complications
      of each group will be recorded. In addition, sample size will be estimated based on above
      study's results (estimated 100 participants).

      In the second stage, goal-directed therapy will be applied to another cohort of 300
      participants, in which 150 patients undergoing laparotomy of gynecological malignancies and
      150 patients undergoing orthopedic surgery. Specifically, the fluid will be administered
      based upon real-time monitoring stroke volume variation and cardiac output achieved by the
      Flo-Trac monitoring system. The incidence of postoperative complications of each group will
      be recorded.
    

Intervention name(s): Applying goal-directed fluid therapy by continuous hemodynamic monitoring system; Conventional fluid therapy
Intervention type(s): Other; Other
Intervention description(s): Applying continuous hemodynamic monitoring system ( Vigileo/Flotrac) to monitor Stroke Volume Variation and Cardiac Output and further manage intra-operative fluid therapy.; Applying conventional fluid therapy according to Peking Union Medical College Hospital standard.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients underwent either laparotomy of gynecological malignancies or orthopedic surgery
      
Keywords: goal-directed fluid therapy; intraoperative hemodynamics; postoperative complications