bioihbjkbjnl/mcl2 huggingface dataset:
Flaxseed Modulates Inflammation and Oxidative Stress in CF
Condition: Cystic Fibrosis; Oxidative Stress; Inflammation
MeSH terms: Cystic Fibrosis; Fibrosis; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      Flaxseed (FS) is a safe and well tolerated supplement with an ability to fight inflammation
      and oxidative stress - a byproduct of daily stress the human body faces everyday and
      especially with chronic diseases. Cystic fibrosis (CF) is a genetic disease resulting from a
      mutation in sodium and chloride transport channels that results in pancreatic insufficiency,
      chronic sinusitis and chronic lung infections. The investigators hypothesize that chronic
      inflammation and oxidative stress are a part of the chronic exacerbations that are a part of
      cystic fibrosis. The investigators believe that flaxseed with its anti-inflammatory and
      antioxidative properties can help dampen these stressors on the CF lung and potentially
      result in fewer exacerbations of CF, fewer antibiotics, fewer hospitalizations, and improved
      well-being.
    

Detailed description: 
      Ten patients with steady-state cystic fibrosis (CF) - not hospitalized, not on intravenous
      antibiotics, with stable FEV1 40-100% predicted were enrolled in a four week long pilot study
      where-in each patient consumed 40 grams of flaxseed each day, in the form of finely ground
      flaxseed, however they wished. Prior to starting flaxseed, each week, and then four weeks
      after each patient had finished taking flaxseed, markers of inflammation and oxidative
      stress, as well as measurements of flaxseed metabolism were collected. F2-isoprostanes,
      8-oxo-dGuo, as well as cytokines including IL-6, TNF-a, IFN-g among others were measured to
      trend flaxseed effects. Enterolignans - enterodiol and enterolactone (products of flaxseed
      metabolism) were measured each week as well.
    

Intervention name(s): finely ground flaxseed powder
Intervention type(s): Dietary Supplement
Intervention description(s): 40 grams finely ground flaxseed powder daily for one month to patients with cystic fibrosis
Other intervention name(s): flaxseed; Flax; Linseed oil; SDG; Bene-flax
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cystic fibrosis; isoprostanes; 8-oxo-dGuo; oxidative stress; inflammation; flaxseed; enterodiol; enterolactone
Effect of Inspiratory Muscle Training During Pulmonary Rehabilitation on Balance in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Chronic obstructive pulmonary disease (COPD) is a respiratory disease that results in
      progressive airflow limitation and respiratory distress. Physiopathological features of COPD
      suggest that people who suffer from this disease have many risk factors for falls that have
      been identified in older individuals.

      The benefit of inspiratory muscle training (IMT) combined with a pulmonary rehabilitation
      programme (PRP) is uncertain. The investigators aimed to demonstrate that,in chronic
      obstructive pulmonary disease (COPD) patients, IMT performed during a PRP is associated with
      an improvement of Balance.
    

Detailed description: 
      Chronic obstructive pulmonary disease COPD is a preventable and treatable disease(GOLD,
      2017). According to the WHO, COPD would be the third leading cause of death by 2030 (WHO,
      2017). This disease is characterized by airflow limitation that is not fully reversible. The
      airflow limitation is usually progressive and associated with an abnormal inflammatory
      response of the lung to noxious particles or gases(GOLD, 2017). However, emerging data showed
      that COPD patients demonstrate important deficits in balance and control which associated to
      a high risk of fall ( Butcher et al, 2004 ; Smith et al, 2009 ; Beauchamp et al, 2009 ;
      Beauchamp et al, 2010). Inspiratory muscle training (IMT) has been shown to be an effective
      modality for COPD patients for improving the maximal inspiratory muscle strength, the dyspnea
      and health-related quality of life (GI COPD, 2016). However, the effect of inspiratory muscle
      training on balance is not studying. The purpose of this study is to evaluate the effect of
      the inspiratory muscles training on balance in COPD patients.
    

Intervention name(s): Pulmonary rehabilitation
Intervention type(s): Other
Intervention description(s): The experimental group receives inspiratory muscle training and aerobic exercise. The Active Comparator group received only aerobic exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: COPD; IMT; ABC; BBS; TUG; SLS
A Phase I Study of Immunotherapy With GSC -Loaded Dendritic Cells in Patients With Recurrent Glioblastoma
Condition: de Novo Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Mono-center, un-controlled, open label, first in human, clinical trial. Approximately 20
      patients (in order to achieve 12 valuable patients). The expected accrual time would range
      between 12 and 18 months. Follow-up, including clinical, immune and radiological monitoring
      will end two years after the initial surgery of the last patient enrolled. The primary
      objective will be to assess the activity of immunotherapy in terms of its effect on immune
      response. In particular we will investigate the effect of treatment on effector cells
      including CD8 T cells, NK cells and Natural Killer T (NKT) cells. The sample size of 12
      eligible patients was identified on ethical and practical considerations, rather than by a
      formal sample size calculation.
    


Intervention name(s): GSC-loaded autologous dendritic cells
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Misoprostol Versus Active Management of Labour in CS
Condition: Cesarean Section
Study type: Interventional
Phase: Phase 1

Summary: 
      Several treatment strategies are emplemented to prevent post delivery hemorage and decreasing
      maternal morbidity and mortality .
    

Detailed description: 
      Many approved drugs are used in prophylaxis against postpartum hemorage from these
      medications are the (syntocinon combined with methergine ) that are known as active
      management of labour drugs .

      Moreover there is misotac , that also guards against postpartum hemorage .

      All these medications act in a different way to cause uterine contraction post delivery to
      prevent uterine atony .

      -Here we are comparing the additive value of misotac intrauterine to syntocinon and
      methergine in comparison to the usually used syntocinon plus methergine .
    

Intervention name(s): Misoprostol + syntocinon and using extra uterotonic drugs when needed ; methergine; Syntocinon and using extra uterotonic drugs when needed ; methergine carboprost
Intervention type(s): Drug; Drug
Intervention description(s): medical prophylaxis against postpartum atony and postpartum hemorage by giving misoprostol plus syntocinon and using extra uterotonic drugs when needed ; methergine, carboprost; medical prophylaxis against postpartum atony and postpartum hemorage by giving syntocinon and using extra uterotonic drugs when needed ; methergine, carboprost
Other intervention name(s): DrugsMisoprostol plus syntocinon and using extra uterotonic drugs when needed ; methergine , carboprost; drugs ( syntocinon and using extra uterotonic drugs when needed ; methergine, carboprost
Intervention MeSH terms: Misoprostol; Carboprost; Oxytocin; Methylergonovine; Carboprost tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Effects of Transverse Thoracic Mobilization With and Without Lower Trapezius Strengthening Exercises
Condition: Mechanical Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Mechanical neck pain is a common musculoskeletal problem, worldwide. Patients with neck pain
      often have subjective complaints of muscle stiffness, tension, or tightness in addition to
      their pain located between the occiput and the third thoracic vertebra Approximately 68% of
      the total population has experienced neck pain at least once in their lifetime, and it easily
      transforms into a chronic state (that persists for more than 3 months). In today's society,
      this is conspicuous in many laborers due to the increased use of computers, where the neck
      and shoulders are maintained in static abnormal postures to look at the computer screens and
      become vulnerable to cause neck pain. The aim of the study is to determine the comparative
      effects of transverse thoracic mobilization with and without lower trapezius strengthening
      exercises on pain, disability and range of motion in patients with mechanical neck pain.
    

Detailed description: 
      A Randomized controlled trial will be conducted in physiotherapy outpatient department of
      Syed Medical Complex and Islam Hospital, Sialkot. Non-probability consecutive sampling will
      be used to collect the data. Sample size of 20 subjects with age group between 18 to 40 years
      will be taken. Data will be collected by using tools Numeric Pain Rate Scale (NPRS) for pain,
      Neck Disability Index (NDI) for disability and Universal Goniometer (UG) for range of motion
      of neck. An informed consent will be taken. A total of 20 subjects will be selected by
      following inclusion and exclusion criteria and will equally divided in to two groups by
      random number generator table. Both groups will come thrice per week for a total of 4 weeks.
      The data will be analyzed using SPSS software version 25. After assessing normality of data
      by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be
      used within a group or between two groups
    

Intervention name(s): Lower Trapezius Strengthening Exercises
Intervention type(s): Other
Intervention description(s): Lower Trapezius strengthening exercise includes:
Latissimus pull down
Prone V- raise
Modified Prone Cobra
Other intervention name(s): Standardized Physical Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Neck Pain; Trapezius muscle; Muscle strength; Range of Motion
Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
Condition: Nocturia; Daytime Sleepiness
MeSH terms: Disorders of Excessive Somnolence; Sleepiness; Nocturia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of the study is to evaluate armodafinil as a wakefulness-promoting therapy as a
      means of improving residual daytime sleepiness in patients with treated nocturia.
    


Intervention name(s): Armodafinil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.; Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nocturia; Daytime sleepiness
The Effect of Age on the Hemodynamic Response During Rest and Exercise in Healthy Humans
Condition: Hemodynamics
Study type: Interventional

Summary: 
      Primary: To observe how hemodynamic parameters are affected by age during rest and exercise
      in healthy humans. Furthermore, how an acute fluid challenge changes hemodynamic parameters.

      Secondary: To thoroughly examine this population with regard to cardiac performance and
      function, anthropometrics, metabolic status, exercise capability, constitution, pulmonary
      status, and humoral markers of organ functions. This population will serve as a healthy
      control group, to which different populations can be compared, hence the need for a
      comprehensive characterization.

      Hypotheses:

      Diastolic function and parameters associated with diastolic function gradually deteriorate
      with increasing age. The gradual deterioration is unmasked at an earlier age during exercise
      and fluid challenge, compared to measurements made at rest.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cardiac physiology; ageing; gender differences; diastole; fluid challenge
Incidence of Non Receptive Endometrium in Obese Women
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      This study evaluates the incidence of Non Receptive endometrium in obese infertile women
      compared to infertile normal weight women using Endometrial Receptivity Array (ERA) test,
      containing 238 genes, identifying the receptivity status of an endometrial sample and
      diagnosing the patient's Window of Implantation, regardless of the histological appearance of
      the sample. An endometrial biopsy is collected from the uterine fundus, either in a natural
      cycle or in a hormonal replacement therapy (HRT) cycle and the test is performed.
    


Intervention name(s): Endometrial Receptivity Array analysis of endometrial biopsy
Intervention type(s): Other
Intervention description(s): A biopsy of endometrium is peformed and Endometrial Receptivity Array analysis is carried out, as well as analysis of fat distribution and risk factors of Metabolic Syndrome.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
NSAIDS Versus Opioids in Acute SER II Ankle Fractures
Condition: Ankle Fracture
MeSH terms: Fractures, Bone; Ankle Fractures
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is being conducted to evaluate whether NSAIDS are more or less effective in bone
      healing than opioids in acute fracture pain. Participants will be randomized to one of three
      groups for first line treatment of pain related to the fracture.
    

Detailed description: 
      Pain management in acute fractures is challenging and influenced by several factors
      contributing to pain perception. These factors include but are not limited to tissue damage
      by the local impact, mechanical stress at the fracture ends, and central perception of the
      noxious stimulus. Tissue damage and mechanical stress leads to inflammation and further to
      local swelling. Swelling itself is significant contributor in pain development.

      Ideal pain management would attack pain development at most sites possible. The current
      clinical practice in the US applies a derivate of an opioid analgesic combined with
      acetaminophen, thereby influencing pain development at central perception by the opioid
      analgesic and acetaminophen and a peripheral analgesic effect of acetaminophen. The exact
      mechanism of the peripheral effect is not known.

      This clinical practice disregards the positive effect of medications influencing the
      peripheral inflammatory response, namely nonsteroidal anti-inflammatory drugs (NSAIDs).
      NSAIDs affect pain development by blocking the synthesis of arachidonic acid metabolites,
      inhibiting peripheral inflammatory response and central pain perception. The major reason for
      not applying NSAIDs in the treatment of acute fracture pain is an experimental animal study
      showing decreased bone healing in relation to NSAID usage.

      However, clinical data thus far is inconclusive, whether bone healing is affected in humans
      and whether NSAIDs should be avoided in the setting of bone fractures.

      This proposed study will give an answer whether the usage of NSAIDs in acute fractures has a
      negative effect on bone healing.
    

Intervention name(s): Ibuprofen; Acetaminophen/hydrocodone
Intervention type(s): Drug; Drug
Intervention description(s): Ibuprofen 400 mg and 800 mg; Norco 5/325 mg and 10/325 mg
Other intervention name(s): Motrin; Norco
Intervention MeSH terms: Acetaminophen; Ibuprofen; Acetaminophen, hydrocodone drug combination; Hydrocodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Efficacy and Safety of XC221 in Patients With COVID-19
Condition: SARS-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      The innovative drug XC221 100 mg tablet is designed for the treatment of COVID-19 (SARS-CoV-2
      infection). A multicenter, adaptive, randomized, double-blind, placebo-controlled Phase III
      clinical study is aimed to assess the efficacy and safety of XC221 100 mg tablet, in COVID-19
      patients during a 14-day treatment.

      The primary objective of the study is to demonstrate the efficacy of XC221 100 mg tablet (200
      mg daily dose) in achieving clinical improvement of COVID-19 symptoms.

      The secondary objective of the study is to evaluate the safety of XC221 100 mg tablet (200 mg
      daily dose) in COVID-19 patients.
    

Detailed description: 
      11 Russian centers will participate in this study. The trail will consist of three periods:
      screening (duration not more than 1 day, it may coincide with the randomization visit and
      beginning of drug administration), treatment period (14 days) and follow-up period (14 ± 1
      days after completion of treatment with XC221 / Placebo). The duration of participation in
      the study for each patient will be no more than 30 days.

      118 eligible patients with confirmed COVID-19 will be randomized into two groups (Group A and
      Group B) in a 1:1 ratio: Group A - XC221 200 mg daily (59 patients); Group В - Placebo (59
      patients).

      During the treatment period (14 days), 1 tablet of XC221 / Placebo will be administered 2
      times a day in addition to the standard of care (SoC) for COVID-19 according to The Temporary
      guidelines for the prevention, diagnosis and treatment of SARS-CoV-2 infection of the
      Ministry of Health of the Russian Federation (the MoH Temporary Guidelines). The follow-up
      period will last for 14 days.
    

Intervention name(s): XC221; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive XC221 100 mg 2 times a day during 14 days; Participants will receive Placebo 2 times a day during 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COVID19; Coronavirus
A Relative Bioavailability Study of Gabapentin 400 mg Capsules Under Non-fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the relative bioavailability of gabapentin 400 mg capsules (Purepac) with that of
      NEURONTIN® 400 mg capsules (Parke-Davis) in healthy adult male subjects under non-fasting
      conditions, and to compare the differences in plasma levels after dosing the test formulation
      with and without food
    

Detailed description: 
      Study Type: Interventional Study Design: Single dose, randomized, three-period,
      three-treatment, six-sequence crossover study under non-fasting conditions (test and
      reference) and fasting (test) conditions

      Official Title: A relative Bioavailability Food Challenge Study of Gabapentin 400 mg Capsules

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Gabapentin 400 mg capsules; NEURONTIN® 400 mg capsules; Gabapentin 400 mg capsules, single dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A: Experimental Subjects received Purepac formulated products under fed conditions; B: Active comparator Subjects received Parke-Davis's marketed product; C: Experimental Subjects received Purepac formulated products under fasting conditions
Other intervention name(s): Gabapentin; Gabapentin; Gabapentin
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Gabapentin; Healthy subjects
Stented Biliary Anastomosis in Living Donor Liver Transplantation
Condition: Liver Transplant
Study type: Interventional

Summary: 
      Determination of biliary complications in stented group compared to duct to duct anastomosis
      without stent
    

Detailed description: 
      30 patients included in the study. patients will be randomly allocated in two equal groups.
      In group A anastomosis will be done on intraductal stent and in group B anastomosis done
      without stent .the patients will be followed for one year to compare the result of two groups
      as regard biliary complications.
    

Intervention name(s): living donor liver transplantation with internal biliary stent
Intervention type(s): Procedure
Intervention description(s): living donor liver transplantation without internal biliary stent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: living donor liver transplantation; intraductal stent; biliary complications after liver transplantation