bioihbjkbjnl/mcl2 huggingface dataset:
MFR Versus PFS Techniques on Pain,Range of Motion And Disability in Chronic Non Specific Low Back Pain.
Condition: Chronic Non Specific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      To compare effect of myofascial Release versus post facilitation stretch in term of pain
      ,range of motion and disability in chronic non specific low back pain in patients.
    


Intervention name(s): Myofascial Release technique; Post facilitation stretch .
Intervention type(s): Other; Other
Intervention description(s): on low back 3 repetitions (30 second rest between reps), lasting for 30 s for each myofascial track for 1 set to targeted muscles (plantar fascia, gastrocnemius, hamstrings, and erector spinae). The position will be held for 10-15 seconds when a pain point is found lacrosse ball excellent for this type of massage because their surface area is much less than that of foam rollers.; static stretching exercises for the low back (plantar fascia, gastrocnemius, hamstrings, and erector spinae). Static stretching involved 3 sets of 3 repetitions for each muscle with a 30-second hold and 30-second rest interval for each repetition.
Other intervention name(s): Myofascial Release technique for chronic non specific low back pain; Post facilitation stretch for chronic non specific low back pain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic pain,myofascial release technique, Postfacilitation stretch,Technique and low back pain.
Pulse Pressure Variation in Spontaneously Breathing Patients
Condition: Pulse Pressure Variation; Spontaneously Breathing
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      The investigators hypothesized that pulse pressure variation (PPV) could predict fluid
      responsiveness in spontaneously breathing patients undergoing anesthesia induction.
    

Detailed description: 
      Pulse pressure variation (PPV) is known to be a dynamic indicator to predict fluid
      responsiveness in mechanically ventilating patients. PPV is generated by cardiopulmonary
      interaction with respiratory cycles. In spontaneous breathing, the cardiopulmonary
      interaction may lead to PPV by inverted manner. In this study, the investigators will
      evaluate the ability of PPV to predict fluid responsiveness in spontaneously breathing
      patients. Before induction of anesthesia, radial artery cannulation is performed, and
      FloTrac/Vigileo (Edwards Lifesciences Corp., Irvine, USA) system is connected. And then, the
      investigators will measure baseline data including invasive blood pressure, pulse pressure,
      cardiac index, stroke volume variation in two different conditions: during tidal spontaneous
      breathing and during forced spontaneous breathing. All hemodynamic measurement will be
      repeated after infusion of fluid using 6mL/kg of hydroxyethyl starch solution (Voluven), and
      will be averaged over 3 minutes. Patients whose cardiac index increased by >15% to fluid
      infusion is defined as responders. The investigators will compare the hemodynamic parameters
      between responders and non-responders. To evaluate the ability to predict volume
      responsiveness, receiver operating characteristics curves of the PPV will be calculated.
    

Intervention name(s): Hydroxyethyl starch solution (Voluven) infusion
Intervention type(s): Procedure
Intervention description(s): fluid loading will be performed by hydroxyethyl starch solution (Voluven), at 6 mL/kg
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Overweight/Obese Subjects of Japanese or Chinese Descent
Condition: Safety; Healthy Subjects
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, randomized, blinded study to evaluate the safety and pharmacokinetics of
      MEDI0382 following single dose administration to overweight/obese subjects of Japanese or
      Chinese descent
    

Detailed description: 
      This is a phase I, randomized, blinded study to evaluate the safety, tolerability,
      pharmacokinetics and immunogenicity of MEDI0382 following single dose administration to
      overweight/obese but otherwise healthy adult male and female subjects of Japanese or Chinese
      descent
    

Intervention name(s): MEDI0382; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of MEDI0382; Single dose of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: MEDI0382; Safety; Tolerability; Pharmacokinetics; Immunogenicity
A Longitudinal Study of Movement and Participation in Life Activities of Young Children With Cerebral Palsy in Taiwan
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Observational

Summary: 
      This study investigates the longitudinal course of developmental patterns in movement and
      participation in life activities (MPLA) of young children with cerebral palsy (CP) in Taiwan.
      Additionally, the predictors in the initial stage in determining the final developmental
      patterns in movement and participation in life activities MPLA of these children will be
      identified.
    

Detailed description: 
      Most researches investigated the longitudinal study of functions in adolescent or adult with
      CP, however, few researches investigate these functions in children with CP. Knowledge of
      these developmental patterns in movement and participation in life activities MPLA may be
      helpful in understanding, anticipating, and managing the problems of these children. We
      hypothesize that the course of developmental patterns in MPLA of young children with CP
      evolves with their age. This study investigates the longitudinal course of developmental
      patterns in MPLA of young children with CP in Taiwan. This study includes a validity and
      reliability study and a prospective longitudinal study of young children with CP over
      one-year. This study will be executed in 4 years and a validity and reliability study in the
      first year.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children with cerebral palsy
Development of Novel Non-invasive Inflammometry Following Lipopolysaccharide, Endotoxin (LPS) Challenge in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is to further profile and develop the Lipopolysaccharide, endotoxin
      (LPS) challenge models (both by instillation and inhalation) by investigating the utility of
      various non-invasive monitoring methods.
    

Detailed description: 
      The hypothesis of the project is that local inflammatory changes in the lung induced by LPS
      can be captured by gas-enhanced Magnetic resonance imaging (MRI) and analysis of exhaled
      breath. While MRI is able to provide localized information on inflammatory processes, exhaled
      breath analysis can capture integral information over time. Assuming that these novel
      techniques correlate with cellular measures of inflammation, repetitive measurements to
      investigate onset and duration of action of investigational new drugs will be made possible.

      The evaluation whether LPS induced changes in the lung can be captured and monitored by MRI
      will be performed by correlation of multiple endpoints describing the cellular composition of
      the airways with variables derived from MRI and breath analysis.
    

Intervention name(s): LPS challenge
Intervention type(s): Procedure
Intervention description(s): LPS inhalation and bronchial instillation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Prevalence of Genital HPV Infection in Males Following Introduction of Universal Male HPV Vaccination
Condition: Human Papillomavirus
MeSH terms: Papillomavirus Infections
Study type: Observational

Summary: 
      This study will examine how common HPV infection is in teenage males in Australia before and
      after the introduction of universal school based vaccination of males in Australia.
    

Detailed description: 
      Males aged 17 to 19 in Australia will be recruited from 2014. Men will undergo sampling from
      the penis for HPV. The prevalence of HPV infection will be determined in 2014-2015 and
      compared to the prevalence in 2016-2017.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Males aged 17-19 recruited from sexual health clinics and community sources
      
Biospecimen description: 
      Penile sampling for HPV DNA
    
Keywords: Prevalence; HPV; Human papillomavirus; Vaccination
Epidemiological Study in Subjects With Vulvovaginal Candidiases
Condition: Vulvovaginal Candidiases
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Study type: Observational

Summary: 
      Epidemiological study about the clinical and microbiological progress in subjects under
      treatment for a severe vulvovaginal candidiases episody
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with VVC symptomatology and positive culture
      
Keywords: Candidiases; Vaginal Infections
Vitamin C Intravenously With Chemotherapy in Advanced Colorectal Cancer
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Preclinical study has shown that human colorectal cancer cells harboring KRAS or BRAF
      mutations are selectively killed by high levels of ascorbic acid (AA). High dose of AA aslo
      impairs tumor growth in Apc/KRASG12D mutant mice. Previous phase Ⅰ studies have found that
      high dose iv AA is well tolerated in cancer patients.This protocol is a phase Ⅲ study of AA
      infusions combined with treatment with FOLFOX +/- bevacizumab versus treatment with FOLFOX
      +/- bevacizumab alone as first-line therapy in patients with recurrent or advanced colorectal
      cancer.
    

Detailed description: 
      Linus Pauling and Dr Ewan Cameron have published two retrospective studies about using high
      dose vitamin C to treat cancer patients forty years ago. Their studies have shown that high
      dose vitamin C usage could significantly prolong overall survival of patients with advanced
      cancer. Recently, preclinical study has shown that human colorectal cancer cells harboring
      KRAS or BRAF mutations are selectively killed by high levels of ascorbic acid (AA). High dose
      of AA impairs tumor growth in Apc/KRASG12D mutant mice. Previous phaseⅠ clinical trials have
      found that high dose (1.5g/kg or 90g/m2) iv AA is well tolerated in cancer patients. This
      protocol is a phase Ⅲ, study of ascorbic acid (AA) infusions combined with treatment with
      FOLFOX +/- bevacizumab versus treatment with FOLFOX +/- bevacizumab alone as first-line
      therapy in patients with recurrent or advanced colorectal cancer.
    

Intervention name(s): ascorbic acid; Chemotherapy
Intervention type(s): Drug; Drug
Intervention description(s): 1.5g/kg/day, D1-3, every 2 weeks; mFOLFOX6
Oxaliplatin 85 mg/m² d1 concurrent with
Leucovorin 400 mg/m², followed by
Bolus 5FU 400 mg/m² , followed by
Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks
with or without bevacizumab 5mg/kg, every 2 weeks
Other intervention name(s): Vitamin C; mFOLFOX6+/- bevacizumab
Intervention MeSH terms: Ascorbic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients
Condition: Lymphoma, Non-Hodgkin; Multiple Myeloma
MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with
      chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to
      determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if
      it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold
      before apheresis, and if transplantation with the apheresis product was successful, as
      measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).
    

Detailed description: 
      An open label, multi-center, phase 2 study was conducted in patients with MM or NHL who were
      to be treated with peripheral blood stem cells (PBSC) autologous transplantation. The only
      change to the standard of care was the addition of plerixafor to a mobilization regimen of
      chemotherapy and G-CSF. Patients were first given a mobilizing regimen of chemotherapy as per
      local practice guidelines and G-CSF (at customary doses) and apheresis was performed. After
      the first apheresis, plerixafor was given at 10PM, 10-11 hours before the second apheresis
      the next day or in the morning of the second day, 6 hours before the second apheresis. The
      change in the patient's peripheral CD34+ cell count between the plerixafor dose and the start
      of apheresis was measured. The apheresis yields on Day 1 and Day 2 were compared.

      This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was
      acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
    

Intervention name(s): G-CSF and plerixafor
Intervention type(s): Drug
Intervention description(s): G-CSF and plerixafor were administered as described in the treatment arms.
Other intervention name(s): Mozobil; AMD3100
Intervention MeSH terms: Plerixafor
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-Hodgkin's Lymphoma; Multiple Myeloma; Stem cell mobilization
Phase II Study to Evaluate the Cardiac Safety of 2 Doses of CHF5993 Both Combined With CHF1535 BID Versus CHF1535 BID in Patients With Moderate to Severe COPD
Condition: Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      Cardiac Safety Study
    

Detailed description: 
      The purpose of this study is to demonstrate equivalence between CHF1535 plus CHF5992 (two
      different dosages) over CHF1535 alone in change from baseline in average 24-hour heart rate,
      as primary end point, and other ECG parameters.
    

Intervention name(s): CHF1535 + CHF5992 dose 1 BID; CHF1535 + CHF5992 dose2 BID; CHF1535 daily dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CHF1535 + CHF5992 dose 1 BID for 14 days; CHF1535 + CHF5992 dose 2 BID for 14 days; CHF1535 daily dose for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps
Condition: Sinusitis
MeSH terms: Sinusitis; Nasal Polyps
Study type: Interventional

Summary: 
      Chronic rhinosinusitis is a common disease that effects millions of people world wide.
      Despite its frequency it is unclear what treatment options are the best for these patients.
      Typically patients with chronic rhinosinusitis without nasal polyps (CRSsNP) are given a long
      term antibiotic (3 weeks), nasal steroid sprays, saline nasal irrigation and occasionally
      oral steroids. Oral steroids benefit patients with chronic rhinosinusitis with nasal polyps
      (CRSwNP) however their role in non polyp patients is less clear. It is the goal of this study
      to see if oral steroids benefit the treatment outcomes in those patients with chronic
      rhinosinusitis without nasal polyps. In addition this study will look to see if a short
      course (5 day burst) versus a longer course (21 day taper) of oral steroids make a difference
      in outcomes.
    

Detailed description: 
      The investigators will compare patients with CRSsNP who are treated with antibiotics/nasal
      steroid sprays, and compare them to chronic sinusitis patients who receive antibiotics/nasal
      steroid spray along with a course of oral steroids. The goal is to determine if oral steroids
      have a role in CRSsNP, and if so, the most effective dosage.
    

Intervention name(s): 6 day Prednisone; Augmentin; 21 day Prednisone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 6 day prednisone burst; Antibiotic augmentin for 3 weeks; 21 day prednisone burst
Intervention MeSH terms: Amoxicillin-Potassium Clavulanate Combination; Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Vildagliptine and Glimepiride on Glucose Variability
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to analyze the differences of blood sugar level and glycemic
      variability between sulfonylurea and DPP-4 inhibitor groups applying CGMS for a chosen number
      of type 2 DM patients. The investigators also reveal influences of each drugs on
      cardiovascular risk factors by measuring related biomarkers.
    

Detailed description: 
      We enroll patients with type 2 DM with uncontrolled glucose level on Metformin monotherapy
      over 1000mg /day (HbA1C over 7%).

      Before drug administration, we conduct basal lab study including CGMS. After 3 month of
      random administration of vildagliptin or glimepiride, we check CGMS, glucose levels, CV
      biomarkers, and estimate hypoglycemic index. We replace with the other drug for 3 months, and
      then conduct the same measurements. No wash-out period is necessary since result variables
      are measured after the 3 months of administration for a different drug.
    

Intervention name(s): Glimepiride; Vildagliptin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Glimepiride; Vildagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating the Safety and Immunogenicity of AGS-v PLUS, a Universal Mosquito-Borne Disease and Mosquito Control Vaccine
Condition: Mosquito-Borne Infectious Diseases
MeSH terms: Communicable Diseases; Infections; Vector Borne Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of AGS-v PLUS, a
      universal mosquito-borne disease and mosquito control vaccine, in healthy volunteers.
    

Detailed description: 
      This study will evaluate the safety and immunogenicity of AGS-v PLUS, a universal
      mosquito-borne disease and mosquito control vaccine, in healthy volunteers.

      Participants will be randomly assigned to five groups.

      Participants in Group 1 will receive placebo on Days 1 and 22.

      Participants in Group 2 will receive unadjuvanted AGS-v PLUS vaccine on Days 1 and 22.

      Participants in Group 3 will receive Montanide ISA-51 adjuvanted AGS-v PLUS vaccine on Day 1
      and placebo on Day 22.

      Participants in Group 4 will receive Montanide ISA-51 adjuvanted AGS-v PLUS vaccine on Days 1
      and 22.

      Participants in Group 5 will receive Alhydrogel® adjuvanted AGS-v PLUS vaccine on Days 1 and
      22.

      Participants will be in the study for approximately 12 months. During this time, they will
      attend several study visits, which may include physical examinations, blood collection, skin
      biopsies, and a mosquito feeding procedure. Study staff will also follow up with participants
      by phone several times throughout the study.
    

Intervention name(s): AGS-v PLUS Vaccine; Montanide ISA-51 Adjuvant; Alhydrogel® Adjuvant; Saline Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection; Administered by subcutaneous injection; Administered by subcutaneous injection
Intervention MeSH terms: Aluminum Hydroxide; Monatide (IMS 3015)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Hormone Therapy on Serum Ischemia Modified Albumin in Menopausal Women
Condition: Hormone Therapy Induced Morphologic Change; Surgical Menopause
MeSH terms: Ischemia
Study type: Observational [Patient Registry]

Summary: 
      Women suffer from cardiovascular diseases 10 years later than men, therefore female sex has
      been considered as a 'protective factor'. However, the risk of cardiovascular disease in
      women increases rapidly after menopause and the declining levels of endogenous estrogen is
      thought to be the causative factor. Furthermore, Postmenopausal hormone therapy (HT)
      decreases the severity and intensity of menopausal symptoms and improves women's quality of
      life. Until the last 10 years, based on the results of observational studies, postmenopausal
      HT may protect women against cardiovascular events and decrease the risk of coronary artery
      disease by 35-50%. However, recent randomized primary and secondary prevention trials did not
      support the cardioprotective effect of HT.

      The aim of this study is to assess the effect of hormone therapy on serum ischemia modified
      albumin (IMA) levels. Thirty surgical menopausal women who admitted to Karadeniz Technical
      University, Faculty of Medicine, Department of Obstetrics and Gynecology during 1-year period
      and diagnosed as menopause and planned to have hormone therapy for menopausal symptoms were
      enrolled for this prospective study. The serum İMA levels were recorded before and after (3
      months, 6 months, 12 months later) hormone treatment (2 mg Estradiol Hemihidrat).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Within 10 months of the study period, estradiol hemihydrate for all patients who underwent
        TAH + BSO for gynecology and obstetrics in our clinic and evaluated with the diagnosis of
        surgical menopause in the postoperative period (6th week) was prescribed. These cases were
        evaluated in terms of inclusion and exclusion criteria after they were determined to be
        volunteers to participate in the study.
      
Keywords: IMA; menopause; hormone therapy; cardiovascular risk