bioihbjkbjnl/mcl2 huggingface dataset:
Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 3c
Condition: Healthy
Study type: Observational

Summary: 
      This study will determine if gas can pass between the environment and the middle ear by way
      of the eardrum. This route of gas exchange was observed in animals but has not been studied
      in humans. If gas exchange across the eardrum is documented and the rate is sufficiently
      high, this can help explain certain past observations such as why middle ear pressure does
      not change very much in some children and adults when they have a cold or flu. The
      investigators also expect that the rate of gas exchange across the eardrum will depend on
      whether or not the eardrum has scarred or abnormally thin regions.
    

Detailed description: 
      Middle-ear (ME) pressure is a measure of the number of contained gas moles, and processes
      that addd or remove gas moles from the relatively fixed volume ME cavity change its pressure.
      Experimental results from animal studies document significant gas exchange across the
      tympanic membrane and if confirmed for humans may explain some of the paradoxical findings
      for children with poor Eustachian tube function such as the preservation of an aerated ME
      when the normal routes of gas supply are disrupted. This study measures the rates of reactive
      and inert gas exchange across the adult tympanic membrane with and without structural
      abnormalities and determines if these transfers are purely diffusive phenomena. The resulting
      data will be used to develop species-specific rate-constants that will be used as parameters
      in modeling ME pressure regulation.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Adults 18-50 years old with at least one intact and effusion-free middle ear
      
Keywords: otitis; gas diffusion; Eustachian tube; tympanic membrane
Assessment of Response to Treatment of Osteoporosis With Oral Bisphosphonates in Patients With Muscular Dystrophy
Condition: Osteoporosis; Muscular Dystrophy; Cystic Fibrosis
MeSH terms: Osteoporosis; Muscular Dystrophies; Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      By supplying an adequate amount of calcium and vitamin D with the addition of weekly
      bisphosphonate, the investigators will be able to increase bone mass and decrease the
      incidence of fragility fractures in these children with muscular dystrophy.

      The investigators think this treatment will also decrease the intensity of pain frequently
      present in these patients and slow the progression of scoliosis.
    

Detailed description: 
      Children with muscular dystrophy, as well as children with other chronic diseases (e.g.
      cystic fibrosis, chronic inflammatory arthritis) are at risk to develop fragility fractures
      both due to the disease itself and to drugs (mostly corticosteroids) used to treat the
      diseases.

      In addition, children with muscular dystrophy frequently complain of diffuse pain making
      daily care more difficult and almost always develop structural scoliosis.

      The objective of the present protocol is to offer these children a preventive treatment aimed
      at maintaining or increasing their bone mass. We also propose that maintaining bone mass will
      decrease fracture rates, as well as pain and the rate of progression of scoliosis.

      Rigorous care to ensure adequate intake of calcium and vitamin D, as well as addition of a
      weekly bisphosphonate, are the central aspect of the project. In addition, we will monitor to
      avoid possible side-effects such as hypercalciuria and kidney stones.
    

Intervention name(s): Bisphosphonate treatment
Intervention type(s): Drug
Intervention description(s): Treatment with Calcium, vitamin D and a weekly bisphosphonate. Comparison of bone mass, fracture rate, pain intensity and scoliosis progression before and after treatment
Other intervention name(s): Risedronate; Alendronate
Intervention MeSH terms: Alendronate; Risedronic Acid; Diphosphonates
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Osteoporosis; Severe muscular dystrophy; Cystic fibrosis
A Personalized Nutrition Intervention for Adolescent Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study is being done to test the feasibility of a personalized nutrition eating plan in
      adolescents with depression. Evidence suggests that dietary quality may affect an
      individual's mood. A healthy diet includes vegetables, fruit, nuts, seeds, and olive oil, as
      well as minimally processed whole grains, legumes, and moderate amounts of lean meat, fish,
      and dairy.

      The investigators will examine the feasibility of a personalized nutrition eating plan for
      children and youth with depression. Previous research has shown that it helps improve
      depressive symptoms in adults, but it is not clear if the same is true for children and
      youth.
    

Detailed description: 
      The proposed 8-week, mixed-methods, single-arm study aims to examine the feasibility of an
      adjunctive personalized dietary intervention for adolescents with major depressive disorder.
      The secondary aims are to determine potential barriers and facilitators of implementation and
      to improve adherence and uptake.
    

Intervention name(s): Dietary Intervention
Intervention type(s): Other
Intervention description(s): Four nutrition counselling sessions conducted over eight weeks, in conjunction with food items to assist in meal preparation and with weekly educational information messages sent via email.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: adolescents; diet
IMPACTS OF BRAXTON-HICKS CONTRACTIONS ON COMPUTERISED CARDIOTOCOGRAPHY PARAMETERS: A POTENTIAL LINK.
Condition: Braxton Hicks' Contractions
Study type: Observational

Summary: 
      Several types of research examined the relationship of Braxton-Hicks contractions and uterine
      flow. Nevertheless, no one considered the relationship of the maternal perception of
      Braxton-Hicks contractions with the fetal wellbeing quantifies through computerised
      cardiotocography. Our study wants to estimate the correlation between the maternal perception
      of Braxton-Hicks contractions and antepartum computerised cardiotocography parameters.
    


Intervention name(s): antepartum computerised cardiotocography analysis
Intervention type(s): Diagnostic Test
Intervention description(s): A common obstetric methodical to evaluate the fetal well-being is the antepartum fetal heart rate (FHR) monitoring through cardiotocography (CTG)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We included pregnant who were referred for the fetal antepartum cardiotocography monitoring
        to the outpatient clinic of the "Luigi Vanvitelli" University of Campania in Naples, Italy.
        All patients had an uncomplicated pregnancy and to define a pregnancy uncomplicated we
        adopted Chappell's definition: "a normotensive pregnancy, delivered at >37 weeks, ending in
        a live-born baby who was not small for gestational age and did not have any other notable
        pregnancy complications"
      
Keywords: Braxton Hicks' contractions; uterine contractions; fetal well-being; Computerized cardiotocography (cCTG); Fetal heart rate (FHR); Pregnancy
Onabotulinumtoxin Type A Reconstitution With Preserved Versus Preservative-free Saline in Chronic Migraine.
Condition: Chronic Migraine, Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      A growing body of literature on the cosmetic use of OnabotulinumtoxinA has suggested that the
      use of preserved saline exerts a local anesthetic effect, and reduces the procedure
      discomfort when used in reconstitution in lieu of preservative-free saline. However, this has
      never been studied in chronic migraine.

      While reducing discomfort is a desirable target in all procedures, it has a special
      importance in the use of OnabotulinumtoxinA for chronic migraine due to the numerous
      injection locations each session (31 sites) and the ubiquity of scalp tenderness in this
      population. In addition, the pain during procedure is a known migraine trigger for many of
      these patients.

      We hypothesize that preserved saline (known as bacteriostatic saline) produces lower
      procedure-related discomfort when used as a dissolving solution for OnabotulinumtoxinA in
      individuals with chronic migraine as opposed to using preservative-free saline.

      In addition, we hypothesize that reduction of procedure-relate pain during the injections
      will also result in reduced migraine/headache attacks in the week immediately following the
      procedure.
    


Intervention name(s): Preserved saline in reconstitution of Botox
Intervention type(s): Drug
Intervention description(s): The intervention consists of using 4 ml of preserved saline for the reconstitution of OnabotuliniumtoxinA prior to its use in subjects with chronic migraine.
Other intervention name(s): Bacteriostatic saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Migraine; Onabotulinumtoxin A; Botox; Reconstitution; Saline
Correlation Between Oocyte and Embryo Mechanical Properties on Embryo Development and Clinical Pregnancy After In Vitro Fertilization
Condition: Infertility; Pregnancy, Multiple
MeSH terms: Infertility
Study type: Observational

Summary: 
      The purpose of this study is to determine whether oocyte and embryo mechanical properties
      measured during in vitro fertilization can predict embryo development outcomes and clinical
      pregnancy.
    

Detailed description: 
      In the current practice of in vitro fertilization (IVF), clinicians often transfer multiple
      embryos to the patient at once in an effort to maximize chances of pregnancy. This practice
      results in a high rate of multiple births which increase the risks of complications for
      mothers and children.

      The investigators in this study have developed a novel, noninvasive marker of embryo
      viability which is based on measuring embryo mechanical properties at the oocyte or the
      1-cell stage. The investigators would like to test whether human oocyte or embryo mechanical
      properties are predictive of subsequent development, clinical pregnancy, and compare their
      predictive power to that of a morphological assessment (the current gold standard). Using
      this approach, clinicians could more confidently move toward single embryo transfer, provided
      more individualized counseling for patients undergoing oocyte cryopreservation, as well as
      improve pregnancy rates after IVF.

      This is a pilot observational study. Although investigators will measure the mechanical
      properties of all participant oocytes and embryos, no prediction of embryo viability will be
      made, and there will be no intervention in choosing which embryos to transfer to
      participants. The data from this study will eventually be used to find a range of oocyte and
      embryo mechanical parameters which are predictive of high developmental potential, and will
      serve as the basis for an interventional study in the future.
    

Intervention name(s): EmbryoHug
Intervention type(s): Procedure
Intervention description(s): An oocyte or embryo will be gently held by a micropipette, and a small inward pressure will be applied to the edge of the oocyte or embryo. The response of the embryo to this pulling force will allow the investigators to measure its stiffness and viscosity. The term "micropipette aspiration" refers to the pressure applied to the edge of the embryo -- this procedure is not invasive and does not involve any sort of puncture or removal of material from the oocyte or embryo.
Other intervention name(s): Micropipette Aspiration; Mechanical Measurement
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients undergoing in vitro fertilization at the Stanford IVF clinic, the Shenzhen IVF
        clinic, or Taiwan IVF group are eligible.
      
Keywords: embryo; in vitro fertilization; IVF
Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy
      obtaining sustained virologic response (SVR) in 77% of naïve patients with genotype 1-3
      Studies rarely address the issues of improving host factors. The current study examines
      whether adding vitamin D with Peg/RBV, a potent immunomodulator, could improve viral
      response(SVR)compared to Peg/RBV.
    

Detailed description: 
      The working hypothesis is that Adding vitamin D to conventional Peg/RBV therapy for naïve,
      genotype 1-3 patients with chronic HCV infection significantly improves RVR, EVR
      additionally.
    

Intervention name(s): Vit D
Intervention type(s): Drug
Intervention description(s): 800IU/day
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Control: Peg-ING + ribavirin Treatment: peg-INF+ ribavirin + Vitamin D
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic hepatitis C; SVR; Vit D; Peginterferon alfa 2a; Ribavirin
The Effect of Kinesiophobia on Physical Activity, Balance and Falling in Parkinson's Disease Patients
Condition: Parkinson Disease; Kinesiophobia; Physical Activity; Balance; Falling
MeSH terms: Parkinson Disease; Kinesiophobia
Study type: Observational

Summary: 
      The kinesiophobia; defined as irrational fear of movement, which may occur after painful
      injury and reduce physical activity. It develops the idea that movement in individuals will
      cause re-injury and cause additional pain to existing pain. Studies have shown that this
      situation leads to a decrease in physical fitness, avoidance of activity, decrease in quality
      of life and even depression in the long term. It is known that functional problems such as
      balance problems and decrease in physical activity level occur in patients with Parkinson's
      disease. However, in the literature, there is no study investigating the presence of
      kinesiophobia in patients with Parkinson's disease. Therefore, the aims of our study were to
      1) determine the presence / absence of kinesiophobia in patients with Parkinson's disease 2)
      determine the relationship between kinesiophobia and falling, balance, physical activity
      level in the presence of kinesiophobia.
    


Intervention name(s): Tampa Kinesiophobia Scale, Berg-Balance Test, International Physical Activity Questionnaire-Short Form, Falls Efficacy Scale
Intervention type(s): Other
Intervention description(s): Tampa Kinesiophobia Scale: The TSK is a 17-item self report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or (re)injury.
Berg-Balance Test: 14-item scale designed to measure balance of the older adult in a clinical setting.
International Physical Activity Questionnaire-Short Form: This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.
Falls Efficacy Scale: A 16- item self-administered questionnaire designed to assess fear of falling in mainly older population
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The population of the study consisted of patients with Parkinson's disease who were in 1-3
        stages according to Hoehn-Yahr Scale.

        The sample consisted of 60 patients who applied to Istanbul University Cerrahpaşa Medical
        Faculty Neurology Department Movement Disorders Unit, complied with the inclusion criteria,
        read the information form and signed an informed consent form.
      
Keywords: Parkinson's Disease, Kinesiophobia, Physical Activity, Balance, Falling
Dexamethasone and Ketamine on Change of Postoperative Mood
Condition: Depressive Symptoms
MeSH terms: Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      Ketamine and dexamethasone have been known to be effective postoperative pain. Many studies
      also have reported these two drugs might change mood such as depression. This study aimed to
      investigate the effect of each drug individually with their combination on perioperative
      change of mood in patients undergoing gynecologic surgery
    

Detailed description: 
      After receiving by IRB approval and obtaining informed consent from patients, 93 patients who
      are aged between 18 and 70 years old and classified as American Society of Anesthesiologists
      (ASA) classes I and II.

      Afterward, the patients will be randomly (sealed envelopes) allocated into one of three
      treatment; Group K (n = 31) will receive a single dose of ketamine 0.5 mg/kg i.v. plus 2 ml
      normal saline, Group D (n = 31) receive dexamethasone 0.5 mg/kg i.v. and a maximum dose of 8
      mg plus 2 ml saline, and Group KD (n = 31) receive ketamine 0.5 mg/kg i.v. and dexamethasone
      0.5 mg/kg i.v. at 5 minutes after the induction of anesthesia in a double-blinded method.
    

Intervention name(s): Ketamine Hydrochloride, dexamethasone, and combination of two drugs
Intervention type(s): Drug
Intervention description(s): After receiving by IRB approval and obtaining informed consent from patients, 93 patients who were aged between 18 and 70 years old and classified as American Society of Anesthesiologists (ASA) classes I and II. Afterward, the patients are randomly (sealed envelopes) allocated into one of three treatment; Group K (n = 31) receives a single dose of ketamine 0.5 mg/kg i.v. plus 2 ml normal saline, Group D (n = 31) receives dexamethasone 0.5 mg/kg i.v. and a maximum dose of 8 mg plus 2 ml saline, and Group KD (n = 31) receiveds ketamine 0.5 mg/kg i.v. and dexamethasone 0.5 mg/kg i.v. at 5 minutes after the induction of anesthesia in a double-blinded method.
Intervention MeSH terms: Dexamethasone; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ketamine, dexamethasone, mood
Pharmacodynamics and Safety of CDFR0209
Condition: Stomach Ulcer; Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Stomach Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, two-way crossover study to investigate the
      pharmacodynamics(24 hour gastric pH) and the safety between repeated doses of CDFR0209 and
      Losec in Healthy Male Volunteers
    

Detailed description: 
      Eligibility for participation of this study was determined from demographic information,
      medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests
      within 4 weeks before study drug administration. Subjects suitable for this study were
      admitted to the Clinical Trial Center of Ajou University Medical Center on the 2 day before
      dosing (Day -2).

      On Day -1 around 8 AM, ambulatory intragastric pH recording was performed using ZepHr® pH
      Monitoring System (Sandhill Scientific, Inc., Highlands Ranch, CO, USA) without dosing for 24
      hours.

      On Day 1, subjects was dosed Losec 40 mg or CDFR0209 (Omeprazole 40 mg & sodium bicarbonate
      1,100 mg) around 8 AM and ambulatory intragastric pH recording was continued upto 24 hours
      after dosing.

      From Day 2 ~ 6, subjects were dosed Losec 40 mg or CDFR0209 around 8 AM. On Day 7, subjects
      was dosed Losec 40 mg or CDFR0209 (Omeprazole 40 mg & sodium bicarbonate 1,100 mg) around 8
      AM and ambulatory intragastric pH recording was performed upto 24 hours after dosing.

      After 14 days of washout period, subjects was dosed Losec 40 mg or CDFR0209 by crossover
      manner and ambulatory intragastric pH recording was performed.
    

Intervention name(s): CDFR0209; Losec
Intervention type(s): Drug; Drug
Intervention description(s): Immediate release omeprazole 40 mg and sodium bicarbonate 1,100 mg; Losec 40 mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immediate release omeprazole; Integrated gastric acidity
Performance of Acceleromyography With and Without Preload
Condition: Neuromuscular Blockade
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the precision, bias and limits of agreement when
      monitoring the neuromuscular block with acceleromyography with and without preload and
      compare the method to the gold standard, mechanomyography.
    


Intervention name(s): Hand Adapter (Organon, Oss, the Netherlands); Placebo
Intervention type(s): Device; Device
Intervention description(s): Randomization of acceleromyography with or without Hand Adapter to dominant or non-dominant arm. Contralateral neuromuscular transmission is measured with mechanomyography (The gold standard of neuromuscular monitoring); placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Role of Exercise Training in the Treatment of Resistant Hypertension
Condition: Resistant Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The main purpose of this study is to assess whether exercise training reduces ambulatory
      blood pressure in patients with resistant hypertension. To accomplish these goals 60 patients
      with resistant hypertension will be recruited and randomized into exercise training or
      control groups and followed up for 6 months. The patients in the exercise group will
      participate in a 3-month outpatient program. The control group will receive usual medical
      care. At baseline, after the intervention and 3 months after the end of the intervention both
      groups will undergo several evaluations, including casual and ambulatory blood pressure, body
      composition, cardiorespiratory fitness, quality of life, arterial stiffness, autonomic
      function, and endothelial and inflammatory biomarkers.
    


Intervention name(s): Exercise Group
Intervention type(s): Other
Intervention description(s): The 12-week exercise-training program will include three sessions of aerobic exercise per week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise training; Ambulatory blood pressure; Resistant Hypertension; Nitric Oxide