bioihbjkbjnl/mcl2 huggingface dataset:
Training Study to Characterize Biomarkers to Flu Vaccines
Condition: Healthy
Study type: Interventional

Summary: 
      It is thought that vaccines trigger innate inflammatory responses to induce antigen-specific
      adaptive immunity (the desired effect), but excessive inflammation may lead to serious
      inflammatory complications or unwanted side effects. Currently there is a lack of reliable
      biomarkers (a measurable biological response that predicts something) able to predict severe
      inflammation and this has resulted in the development of several vaccines being terminated
      and the withdrawal of some licensed vaccines which were associated with inflammatory
      complications.

      This study is part of the BIOVACSAFE project which is a 5-year 30 million Euro project funded
      by the Innovative Medicines Initiative. The project involves a series of clinical studies
      using licensed vaccines as benchmarks to generate clinical data on inflammation and identify
      biomarkers that can be used to predict acceptable reactogenicity. The target is to identify
      biomarkers that can predict the occurrence of beneficial and detrimental effects in response
      to a vaccine. Such biomarkers could be used in future vaccine development programs to
      optimise selection of vaccine candidates with a profile that will be unlikely to generate
      worrisome safety signals once they are in generalised use.

      This study is one in a series of "training" studies which will each use different licensed
      vaccines that are prototypical representatives of a class of vaccine used in a particular
      population. Forty-eight subjects will be randomised into three groups to receive: a) Fluad
      (n=20), b) Agrippal (n=20), c) saline placebo (n=8). Following a screening visit,
      participants will undergo a seven-day residential visit which will include immunisation and
      intensive monitoring of physiological (e.g. heart rate, oral temperature, blood pressure)
      metabolic and immune (innate and adaptive) parameters. This visit will be followed up by four
      outpatient visits with further monitoring and blood samples.
    


Intervention name(s): Fluad; Agrippal; Placebo
Intervention type(s): Biological; Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Comparative Effects of Radial and Focused Extracorporeal Shock-wave Therapies in Coccydynia
Condition: Coccyx Injury
Study type: Interventional

Summary: 
      Comparison of the efficacy of coccydynia treatment with two different probes of the ESWT
      device
    


Intervention name(s): ESWT
Intervention type(s): Device
Intervention description(s): Extracorporeal Shock-wave Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of PF-04447943 compared to placebo on
      cognitive, behavioral and overall symptoms of Alzheimer's disease; evaluate the safety and
      tolerability of PF-0444793 compared to placebo; and determine the levels of PF-04447943 in
      the plasma over the course of the study.
    


Intervention name(s): PF-04447943; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): tablets, 25 mg every 12 hours for 12 wks; matching placebo tablets, every 12 hours for 12 wks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's disease; PF-04447943; efficacy; safety; plasma concentrations
Effect of the Interaction Between the Type of Artificial Turf and Boots Model of Bone Health in Children Soccer Players
Condition: Soccer; Bone Density; Physical Fitness
Study type: Interventional

Summary: 
      The number of turf fields has experienced an important increase in public and private
      facilities during the last years. This artificial surface will be predominant in any soccer
      field in the next years. Among turf fields there are many different types depending on their
      construction characteristics (with and without asphalted base, elastic base, rubber filling,
      etc.). Officially all types of artificial turfs should have similar stability and impact
      absorption characteristics. On the other hand there is a great variety of soccer-boots,
      especially for youth soccer players, similar to the football stars.

      Many evidences support the fact that when a person exercises many different type of
      impacts-stimulus are necessary in order to stimulate bone and skeletal muscle systems.
      However, it is not known yet whether this effect can be extended or shortened depending on
      the type of artificial surface and soccer-boots used, or even more whether it could be more
      or less dangerous and/or provoke injuries/disagreement among the users. Little information is
      available in youth soccer player pointing in the same direction but still controversial.
      Furthermore, bone strength do not only depends on bone mass but on bone structure and
      microarchitecture. The cross sectional area, cortex thickness or trabecular density are
      important aspects of bone health. There are few studies on the effect of interaction between
      turf field and soccer boots on bone architecture of youth soccer players. This information is
      relevant for present and future health of adolescents practicing football and for all the
      organizations promoting this sport.

      Due to the fact that turf fields are preferentially used by youth populations, it is
      important to know the real effects of the interaction between of different type of artificial
      surfaces and soccer boots on children bone mass development. Nowadays, there are no data
      and/or defined guidelines that can answer those unresolved questions, thus the main aim of
      the present project is to identify which turf field and soccer boots are the most adequate to
      optimize the acquisitions of bone mass in children soccer players.
    


Intervention name(s): Soccer boot intervention
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Human Faecal Microbiota in Type 2 Diabetes
Condition: Type 2 Diabetes; Healthy; Overweight
MeSH terms: Diabetes Mellitus, Type 2; Overweight
Study type: Interventional

Summary: 
      The main objective of the clinical trial is to investigate whether overweight type 2 diabetic
      patients have a different fecal microbiota profile compared with age, gender, BMI matched
      subjects and with lean healthy subjects before and after the consumption of fiber rich cereal
      bars.
    

Detailed description: 
      Gut microbiota refers to the bacterial communities in the gastrointestinal tract. The
      diversity and quantity of bacteria vary depending on age of the individuals, daily diet and
      the segment of the intestine, which makes the gut microbiota one of the most complex
      bacterial ecosystems known to men. In general, over trillions of bacteria reside in human
      gut. Recent evidence indicates that gut microbiota could be involved in host metabolism by
      multiple pathways leading to the development of obesity and type 2 diabetes. Increased fat
      storage or obesity has become one of the leading public health issues in many developed and
      developing countries. However, it is not clear whether type 2 diabetes is associated with a
      unique gut microbiota profile. Therefore, the primary objective of the study is to compare
      the fecal microbiota of overweight type 2 diabetic subjects to that of age, gender and BMI
      matched subjects as well as with lean non-diabetic subjects. In addition, the investigators
      hypothesize that microbiota modifications with consumption of fiber rich food products can
      improve the metabolic outcomes of type 2 diabetics. To test this hypothesis, the
      investigators plan to provide each overweight participant with two cereal bars per day for 4
      weeks. Anthropometric measurements and plasma parameters as well as the fecal microbiota will
      be determined.
    

Intervention name(s): Fiber rich cereal bars
Intervention type(s): Other
Intervention description(s): Two cereals per day and per subject for 4 weeks
Other intervention name(s): Nutren balance bars
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: diabetes mellitus type 2; healthy subjects; human microbiome; cereal bar
KW-136 With Sofosbuvir for Chinese Adults With Chronic Hepatitis C
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aimed to confirm efficacy and safety of KW-136, an investigational anti-hepatitis
      C virus (HCV) drug, combined with sofosbuvir for treatment of naive and experienced adults
      chronically infected with HCV. Three hundred and sixty (360) non-cirrhotic and cirrhotic
      subjects were medicated with KW-136 60 mg daily and sofosbuvir 400 mg daily. The treatment
      course lasted 12 successive weeks; thereafter all the study participants entered into a
      12-week treatment-free follow-up period and an additional 12-week extension treatment-free
      follow-up period.
    

Detailed description: 
      It is estimated that China has a population of over 10 million infected with HCV and also a
      highly variable HCV genotype geographic distribution. A simple, universal,
      non-genotype-specific treatment regimen is preferred for anti-HCV treatment in clinical
      practice and public health. KW-136 and sofosbuvir are potent anti-HCV agents targeting at
      different HCV proteins, namely, nonstructural protein 5A and 5B, respectively. The
      combination regimen of KW-136 and sofosbuvir is expected to completely suppress HCV
      replication in subjects chronically infected with HCV and achieve a sustained virologic
      response (SVR12), namely, HCV not detected or below a predefined limit in plasma, 12 or 24
      weeks after cessation of treatment.

      In a previous phase 2 exploratory study, an all-oral, ribavirin-free regiment of KW-136, an
      investigational HCV NS5A inhibitor, combined with sofosbuvir, demonstrated a ~99% SVR12 in
      treatment-naive adult subjects chronically infected with major genotypes of HCV found in
      China, including those with compensatory cirrhosis. This phase 3 study aimed to confirm the
      efficacy and safety of this combined regimen in a large scale of target patient population,
      including interferon-experienced subjects. This simple, uniform regimen is expected to be the
      solution to HCV eradication in China from the perspective of public health.
    

Intervention name(s): KW-136 capsule; Sofosbuvir
Intervention type(s): Drug; Drug
Intervention description(s): KW-136 60 mg was provided in a single capsule of 60 mg.; Sofosbuvir was provided in a single tablet of 400 mg.
Other intervention name(s): Coblopasvir
Intervention MeSH terms: Sofosbuvir
Intervention model: Single Group Assignment
Intervention model description: Single-arm, external (historic) control
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatitis C; Hepatitis C virus; Eradication; KW-136; Sofosbuvir; Nonstructural protein 5A; Nonstructural protein 5B; Panogentypic regimen; Confirmatory study
The Effect of Anticholinergics on Cognitive Function in the Elderly
Condition: Mental Competency; Urinary Bladder, Overactive; Cognitive Function
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 4

Summary: 
      Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of
      this medication is cognitive dysfunction. OAB is more prevalent in the elderly population - a
      group that also has a higher baseline risk of cognitive dysfunction. Our objective is to
      evaluate the effect of an anticholinergic medication on cognitive function in elderly women.
    

Detailed description: 
      Subjects will be randomized to: 1) trospium chloride or 2) placebo.

      There are three aims:

        1. To evaluate changes in cognitive function in elderly women taking trospium versus
           placebo, using validated cognitive assessment tests

        2. To develop a useful battery of cognitive screening tests for monitoring the cognitive
           safety of OAB management

        3. To understand how the timing of cognitive changes relates to the timing of improvement
           in OAB symptoms. The investigators will recruit 60 women aged ≥ 50 with the diagnosis of
           OAB. Cognitive assessments will be performed at baseline and Week 1 and 4 after drug
           initiation using paper-based validated questionnaires. OAB improvement will be assessed
           with validated questionnaires.
    

Intervention name(s): Trospium Chloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit.
Other intervention name(s): Sanctura XR
Intervention MeSH terms: Trospium chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: COGNITIVE FUNCTION; OVERACTIVE BLADDER; [C23.888.942.343.780]
Specific Effects of Escitalopram on Neuroendocrine Response
Condition: Healthy
Study type: Observational

Summary: 
      Citalopram, a selective serotonin reuptake inhibitor (SSRI), is used as a neuroendocrine
      probe in human subjects to assess serotonin (5-hydroxytryptamine; 5-HT) function as reflected
      in prolactin and plasma cortisol release. Citalopram is a racemic mixture of equal parts of
      the S(+) and R(-) enantiomers. The S(+) form ("escitalopram") has been identified as being
      the active isomer and inhibitor of serotonin reuptake and consequently antidepressant
      activity is associated almost exclusively with the S-enantiomer. Escitalopram has been shown
      to be approximately twice as potent as citalopram at the primary, high-affinity binding site
      on the human serotonin transporter. Interestingly, investigations have suggested an
      antagonistic interaction of the R- and S-enantiomer at an allosteric binding site on the
      serotonin transporter. This antagonism has been shown in animal studies where the addition of
      R-citalopram to escitalopram treatments significantly counteracts the antidepressant and
      anti-anxiolytic effects of escitalopram. From these clinical and experimental data, the
      researchers can anticipate that escitalopram would increase cortisol and prolactin in the
      neuroendocrine challenge paradigm more effectively than citalopram.
    

Detailed description: 
      See above.
    

Intervention name(s): Citalopram; Escitalopram; Dexamethasone; Cold Pressor Test
Intervention type(s): Drug; Drug; Drug; Behavioral
Intervention description(s): 40 mg, pill, single dose; 20 mg, pill, single dose; 1 mg, pill, single dose; single test
Other intervention name(s): Celexa
Intervention MeSH terms: Dexamethasone; Citalopram; Escitalopram
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Normal healthy people
      
Keywords: antidepressive agents
Iron Stores and Skeletal Muscle Metabolism in Chronic Heart Failure
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      Iron deficiency may contribute to exercise intolerance by altering mitochondrial oxidative
      capacity in skeletal muscle. Functional iron deficiency is common in heart failure patients,
      but the relationship to exercise intolerance and mitochondrial oxidative capacity is unknown.
      This is a pilot study to determine the feasibility of the use of specialized 31P-MRS and MRI
      techniques for measurement of skeletal muscle bioenergetics in patients with heart failure
      with and without functional iron deficiency.
    

Detailed description: 
      This study will obtain pilot feasibility data to explore the relationship between blood
      biomarkers of functional iron deficiency and skeletal muscle mitochondrial oxidative capacity
      with 31P-magnetic resonance spectroscopy (MRS) and imaging in heart failure patients.

      Twenty (20) subjects will be recruited from the clinical practice of the NYU Advanced Cardiac
      Therapeutics group at NYU Langone Medical Center.

      Twenty (20) subjects will be recruited from the practice of the NYU Advanced Cardiac
      Therapeutics group at NYU Langone Medical Center. The study will require a maximum of four
      (4) visits over a period of five (5) weeks. Eligibility for Visits 2-4 will be determined by
      the screening criteria in Visit 1. It is anticipated that 50% of the screened subjects at
      Visit 1 will be eligible to participate in Visit 2. Eligibility for participation in Visits 3
      and 4 will be determined by the results of the iron biomarkers obtained at Visit 2. We
      anticipate that 50% of the subjects at Visit 2 will be eligible to participate in Visits 3
      and 4. Only subject with functional iron deficiency will participate in Visits 3 and 4. There
      is no clinical care component for this study.
    

Intervention name(s): Ferric carboxymaltose infusion
Intervention type(s): Drug
Intervention description(s): Subjects with functional iron deficiency determined by the results of iron biomarker results at Visit 2 will receive a single dose of intravenous ferric carboxymaltose . The dose of Injectafer will be calculated from a modified Ganzoni equation adapted from previous heart failure clinical trials The maximum dose of Injectafer will be 750 mg. The calculated dose of Injectafer will be diluted in normal saline solution (4 mg/ml) and administered via a volumetric pump administered over 30 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Iron deficiency
Molecular Associations With Reproductive Failure
Condition: Spontaneous Abortions; Infertility
MeSH terms: Infertility; Abortion, Spontaneous
Study type: Observational

Summary: 
      The overall hypothesis to be tested is: women with the molecular phenotype of highly skewed X
      chromosome inactivation are at increased risk of spontaneous abortion.
    

Detailed description: 
      The overall hypothesis to be tested is: women with the molecular phenotype of highly skewed X
      chromosome inactivation are at increased risk of spontaneous abortion.

      We will investigate this hypothesis through two complimentary aims. In the Background and
      Significance section, we first present data on a 53-member pedigree segregating an X-linked
      recessive lethal defect that results in skewed X inactivation in the carrier females via
      secondary selection against those cells with the defective X chromosome active. We have
      characterized this deletion to be a 500 kb (approximate) deletion in distal Xq28. Moreover,
      the carrier females show a statistically significant increase in the frequency of spontaneous
      abortion as compared to non-deletion carrying relatives. Secondly, in the Preliminary Studies
      section, we present data from a population based case-control study wherein highly skewed X
      chromosome inactivation is significantly correlated with idiopathic recurrent spontaneous
      abortion. This protocol attempts to elucidate the mechanism underlying this association.

      The first specific aim is to determine if women with highly skewed X chromosome inactivation
      are at risk of pregnancy loss. This will be accomplished through a prospective protocol,
      analyzing X chromosome inactivation patterns in pregnant women and investigating a possible
      association between X chromosome inactivation and pregnancy outcome. The second aim will
      study the nature of pregnancy loss in women with skewed X chromosome inactivation. This aim
      will correlate maternal X inactivation patterns with abortus karyotype.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients are recruited through Genetics during a counseling session.
Comparison of Intratechal Levobupivacaine and Adding With Sufetanil and Fentanyl in Ceserean Section
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      45 pregnant women undergoing cesarean section were enrolled in the study in november 2006 to
      march 2007. 2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I, 1 ml of 15
      µcg of fentanyl in group II and 1 ml of 1,5 µcg sufentanil in group III by intratechal
      administration. Hemodynamic parameters, characteristics of sensory and motor blockade,
      peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the
      first analgesic requirement and adverse effects were recorded.
    

Detailed description: 
      45 pregnant women undergoing cesarean section were enrolled in the study in november 2006 to
      march 2007. Using CSE technique, 2 ml of 0.5% levobupivacaine was added to 1 ml of saline in
      group I, 1 ml of 15 µcg of fentanyl in group II and 1 ml of 1,5 µcg sufentanil in group III
      by intratechal administration. Hemodynamic parameters, characteristics of sensory and motor
      blockade, peri-operative and postoperative visual analogue scale (VAS) pain scores, the time
      to the first analgesic requirement and adverse effects were recorded.
    

Intervention name(s): Levobupivacaine; Fentanyl; Sufentanil; Levobupivacaine; Levobupivacaine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): this used in intratechal area and for spinal anesthesia in ceserean section; this used in intratechal area and for spinal anesthesia in ceserean section; this used in intratechal area and for spinal anesthesia in ceserean section; this used in intratechal area and for spinal anesthesia in ceserean section; this used in intratechal area and for spinal anesthesia in ceserean section
Other intervention name(s): chirocaine; sufenta; chirocaine; chirocaine
Intervention MeSH terms: Fentanyl; Sufentanil; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: regionel anesthesia; levobupivacaine; ceserean section