bioihbjkbjnl/mcl2 huggingface dataset:
ADAMTS-13 and Von Willebrand Factor Levels and Activities in Children With Cirrhosis and/or Portal Hypertension
Condition: Coagulation Disorder; Cirrhosis, Liver
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Hypertension; Hemostatic Disorders; Blood Coagulation Disorders; Fibrosis
Study type: Observational

Summary: 
      Hemostasis-related disorders are common in cirrhosis and portal hypertension. However, it is
      not known whether the net effect of changes in hemostasis in the sense of predisposition to
      hemorrhagic or thrombotic state. It is suggested that increasing the concentration and
      activities of Von Willebrand factor (vWF) and decline ADAMTS-13 (A Disintegrin and
      Metalloproteinase with Trombospondin type 1 motif, member 13) may cause thrombophilic changes
      in cirrhosis and portal hypertension. The aim of this study was to investigate the changes in
      ADAMTS-13 (A disintegrin and metalloproteinase with thrombospondin motifs 13) and von
      willebrand factor (vWF) levels and activities in patients with cirrhosis and portal
      hypertension.
    

Detailed description: 
      Patients of 3 months to 18 years of age, followed-up or newly diagnosed in pediatric
      gastroenterology unit, who had cirrhosis or non cirrhotic portal hypertension included to the
      study. Written informed consent obtained from the parents and/or patients. The subjects was
      grouped in three. The first group consisted of patients with cirrhosis (with or without
      portal hypertension). The second group consisted of patients with non-cirrhotic portal
      hypertension (developed due thrombosis of portal vein). The last group consisted of healthy
      volunteers.

      2 ml of EDTA blood was taken from the patients and healty volunters. Samples will be tested
      for vWF and ADAMTS-13 levels and activities at the end of the study.

      The clinical scoring methods, PELD, MELD and Child Pugh scores, treatments received by
      patients, data from endoscopic, radiological screening, and blood analysis of patients were
      recorded.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with cirrhosis and/or portal hypertension who were treated in Pediatric
        Gastroenterology Department of Ataturk University Hospital included to the study.
      
Biospecimen description: 
      Blood product
    
Keywords: Von willebrand factor; ADAMTS-13; Children; Cirrhosis; Portal hypertension
Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH
Condition: Dentin Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This will be multi-centered, triple blinded, randomized, four parallel treatments assigned
      study to compare clinical efficacy of commercially available dentifrices with placebo for
      immediate and sustained relief from Dentin Hypersensitivity after short term use.

      Condition or disease: Dentin hypersensitivity Intervention/Treatment: Product 1;
      Fluoro-Calcium-Phospho-silicate based BioMin F Product 2; Pro-Argin formula based Colgate
      Sensitive Pro-Relief Product 3; Strontium Acetate based Sensodyne Rapid Action Product 4;
      Sodium Fluoride based Colgate Total
    

Detailed description: 
      It is a randomized controlled clinical trial with non invasive topical intervention in 140
      adult patients of 18 to 60 years age, that will be selected randomly after screening and
      diagnosis of dentin hypersensitivity, in dental Out Patient Department of Periodontology.
      Written informed consent will be obtained. Participants will be allocated randomly into four
      equal study arms for parallel treatment assignment with dentifrices named BioMin F, Colgate
      Sensitive Pro-Relief Trade Mark,Sensodyne rapid action Trade Mark and Colgate Total Trade
      Mark dentifrices. Colgate total Trade Mark dentifrices does not claim pain relief in Dentin
      Hypersensitivity. Interim efficacy will be assessed immediately after topical application on
      sensitive teeth, in one minute, after 5 minutes, on day three and week 4 respectively. Dentin
      hypersensitivity will be tested with mechanical stimulus, evaporative air blast stimulus and
      water jet stimulus. It will be measured on Visual Analogue Scale and Schiff cold air
      sensitivity scale (SCASS). Statistical analysis will be done using ANOVA in Statistical
      Package for Social Sciences software 21.
    

Intervention name(s): Fluoro-Calcium-Phospho-Silicate based dentifrices; 8% Arginine based dentifrices; 8% Strontium Acetate; Sodium Fluoride
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Bio-Active glass based formulation; Tubular occluding formulation; Tubular occluding formulation; No claim of relieving Dentin Hypersensitivity
Other intervention name(s): BioMin F; Colgate Sensitive Pro-Relief TM; Sensodyne Rapid ActionTM; Colgate Total TM
Intervention MeSH terms: Listerine; Calcium; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dentine hypersensitivity; Dentine Sensitivity; Oral dentifrices; Bio-active glasses
Telephone-Based Genetic Counseling or Standard Genetic Counseling in Women at Risk of Carrying the BRCA1 or BRCA2 Mutation
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Genetic counseling may work as well over the telephone as it does in-person. It is
      not yet known whether genetic counseling by telephone is more effective than standard
      (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.

      PURPOSE: This randomized phase III trial is studying telephone-based genetic counseling to
      see how well it works compared to standard (in-person) genetic counseling in women at risk of
      carrying the BRCA1 or BRCA2 mutation.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the impact of telephone genetic counseling (TGC) versus standard genetic
           counseling (SGC) on utilization of BRCA1/BRCA2 testing in women at risk of carrying the
           BRCA1/BRCA2 mutation.

        -  Compare the relative efficacy of TGC versus SGC on satisfaction with the counseling
           process, informed decision making, psychosocial distress, and quality of life.

      Secondary

        -  Identify participant characteristics that predict differential response to TGC.

        -  Explore the mechanisms by which TGC or SGC impact distress and quality of life.

      OUTLINE: This is a randomized, multicenter study. Participants are stratified according to
      participating site. Participants are randomized to 1 of 2 groups.

        -  Group 1 (standard genetic counseling): Participants undergo an in-person genetic
           counseling session. Participants are then given the option of providing blood for
           genetic testing at the study site. Participants who choose to undergo genetic testing
           receive their results in-person from their genetic counselor.

        -  Group 2 (telephone-based genetic counseling): Participants undergo a telephone-based
           genetic counseling session. Participants who choose to undergo genetic testing receive a
           pre-labeled blood kit in the mail. Participants receive their results over the phone
           from their genetic counselor.

      After completion of genetic counseling, all participants are followed periodically for 1
      year.

      PROJECTED ACCRUAL: A total of 600 participants will be accrued for this study.
    

Intervention name(s): Telephone Genetic Counseling; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive all genetic counseling via telephone; subjects will receive standard in-person genetic counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: breast cancer
Study of Meningococcal B Vaccine and ACWY Conjugate Vaccine in Healthy Adults
Condition: Meningococcal Meningitis, Serogroup A; Meningococcal Meningitis, Serogroup B; Meningococcal Meningitis, Serogroup C; Meningococcal Meningitis, Serogroup Y; Meningococcal Meningitis, Serogroup W
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study involves the measurement of immune response to vaccination with three doses of a
      meningococcal B vaccine and a single dose of a meningococcal ACYW conjugate vaccine in
      healthy adults (Laboratory workers). The study will be completed at the Manchester Medical
      Microbiology Partnership in the UK and will enrol staff who may be at potential occupational
      exposure to meningococci. Blood samples will be taken before and after each vaccination and
      used to determine if the vaccines induce protective responses.
    

Detailed description: 
      Laboratory staff at the Manchester Medical Microbiology Partnership may be at potential
      occupational exposure to meningococci. No licensed vaccine is available against serogroup B
      meningococci and the available plain polysaccharide serogroup ACYW vaccine is poorly
      immunogenic. Novartis Vaccines have developed an investigational serogroup B vaccine and a
      conjugated ACYW vaccine. This study will investigate these vaccines ability to induce a
      protective response in laboratory staff from the Manchester Medical Microbiology Partnership.
      Three doses of the meningococcal B vaccine will be administered at 0, 2 and 6 months and a
      single dose will be administered at 0 months. Blood samples will be taken before and after
      each vaccination and functional antibodies determined.
    

Intervention name(s): meningococcal B vaccine & meningococcal ACYW conjugate vaccine
Intervention type(s): Drug
Intervention description(s): Meningococcal B vaccine will be administered at 0, 2 and 6 months and a single dose of meningococcal ACYW vaccine will be administered at 0 months, concomitantly with the first dose of the meningococcal B vaccine.
Other intervention name(s): Meningococcal ACYW vaccine- MenVeo
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal; Vaccine; Meningitis
To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Non-Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting
      conditions.
    


Intervention name(s): Clarithromycin 250 mg Tablets (Geneva Pharmaceuticals, USA); Biaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, USA)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clarithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antibiotic
The Effect of OPCSP on Adherence and Clinical Outcomes Among Patients With Rheumatic Diseases
Condition: Rheumatic Diseases
MeSH terms: Rheumatic Diseases; Collagen Diseases
Study type: Interventional

Summary: 
      This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services
      Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic diseases.The
      purpose of this study is to evaluate:

        1. rates of medication adherence in the OPCSP program compared with usual care in an
           integrated health care system.

        2. total direct costs and clinical outcomes in the OPCSP program compared with usual care
           in an integrated health care system.
    

Detailed description: 
      This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services
      Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic
      diseases.Three types of rheumatic diseases were included in the study, Systemic lupus
      erythematosus (SLE), Ankylosing spondylitis (AS), and Rheumatoid Arthritis(RA). The purpose
      of this study is to evaluate:

        1. rates of medication adherence in the OPCSP program compared with usual care in an
           integrated health care system.

        2. total direct costs and clinical outcomes in the OPCSP program compared with usual care
           in an integrated health care system.
    

Intervention name(s): pharmacists involved OPCSP
Intervention type(s): Other
Intervention description(s): This was an open labelled randomised study. Rheumatic diseases patients were recruited and arbitrarily divided into the intervention group (usual care plus OPCSP) and the non-intervention group (usual care only). Those enrolled in the research were scheduled for follow-up for eight consecutive visits. Improvements in lab results and direct costs were compared longitudinally (pre and post analysis) between the groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pharmaceutical Care; Medication Adherence; Direct Costs
Safety, Tolerability and Immunogenicinity of a Coronavirus-Like Particle COVID-19 Vaccine in Adults Aged 18-55 Years.
Condition: SARS-CoV 2
MeSH terms: Coronavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be a randomized, partially-blinded, prime-boost, staggered dose-escalation
      Phase 1 study intended to assess the safety, tolerability, and immunogenicity of the
      Coronavirus-Like Particle COVID-19 Vaccine at three dose levels (3.75 µg, 7.5 µg, and 15 µg
      VLP) unadjuvanted or adjuvanted with either CpG 1018 or AS03 in healthy adults 18 to 55 years
      of age, who have been tested for the absence of SARS-CoV-2 antibodies.

      At each dose level, the vaccine will initially be administered to a small number of subjects.
      Vaccinations of the first 6 subjects at the lowest dose level will be staggered so that each
      vaccination must be performed at least 30 minutes apart. Vaccination of the remaining
      subjects at the same dose level and the next higher vaccine dose level will be administered
      with approval of the Independent Data Monitoring Committee (IDMC). The same process will be
      followed for the second vaccine administration. All subjects will be followed for a period of
      12 months after the second administration of the vaccine for safety and immunogenicity
      testing at the end of the follow-up period.
    


Intervention name(s): Intramuscular Vaccine
Intervention type(s): Biological
Intervention description(s): Subjects will receive two intramuscular (IM) injections 21 days apart (Day 0 and Day 21), into the deltoid region of the alternating arm (each arm will be injected once), with their assigned vaccine.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Remote Ischemic PreConditioning Effect on Postsurgical Pain
Condition: Pain
MeSH terms: Ischemia
Study type: Interventional

Summary: 
      Remote Ischemic PreConditioning (RIPC) will improve the postoperative pain experience in
      patients undergoing abdominal surgery. Although abdominal surgery can be a lifesaving
      procedure many people have a significant amount of postsurgical pain. Severe postsurgical
      pain may lead to chronic pain in some people. "Remote Ischemic Preconditioning" may reduce
      the amount of postsurgical pain. Remote ischemic preconditioning is done by inflating a
      balloon (very similar to a blood pressure cuff) on the leg until it blocks blood flow for a
      few minutes. The cuff is then deflated and blood flow resumes. The process is repeated up to
      three times. This procedure causes the body to increase its natural pain relief system that
      may help to decrease the amount of postsurgical pain.
    


Intervention name(s): Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1); Sham RIPC
Intervention type(s): Device; Device
Intervention description(s): Disposable sterile thigh tourniquet; Disposable sterile thigh tourniquet
Other intervention name(s): VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1; VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Remote Ischemic Preconditioning; Acute Pain
The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion
Condition: Gender Difference in V2 Receptor Function in Response to dDAVP Infusion; Nocturia; Nocturnal Enuresis
MeSH terms: Enuresis; Nocturnal Enuresis; Nocturia
Study type: Interventional

Summary: 
      There is substantial evidence that women throughout life have significantly lower plasma
      levels of the antidiuretic hormone vasopressin (pAVP) compared to men. The importance of this
      is not yet fully elucidated, but in relation to the observations of lower pAVP levels, no
      significant difference in renal response parameters was found. This could be interpreted an
      increased renal sensitivity in females compared to males. The theory of increased renal
      sensitivity in females is supported by a few pharmacodynamic studies currently available on
      this topic. However none of the studies was designed with the purpose of investigate the
      gender difference.

      The aim of this study is to investigate possible gender differences in the renal sensitivity
      to dDAVP and the effect of age on these differences. This will be done by low dose graded
      infusion of the synthetic AVP analog dDAVP.

      Participants are 80 healthy volunteers equally distributed between four age groups, 8-10
      years of age, 16-18 years of age, 25-40 years og age and 65+ years of age.
    


Intervention name(s): dDAVP infusion
Intervention type(s): Drug
Other intervention name(s): desmopressin; minirin
Intervention MeSH terms: Deamino Arginine Vasopressin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Well-being and the HM App Pilot (WHAP) Study
Condition: Well-being
Study type: Interventional

Summary: 
      There is no single definition of well-being, but consensus exists that positive functioning
      beyond the absence of detrimental mental health symptoms is central. Building on related
      "eudaimonic" frameworks of psychological flourishing that identify qualities like
      environmental mastery, positive relations with others, and personal growth, this study
      targets brain-based skills that underlie the active cultivation of such qualities (e.g.,
      regulating attention, empathic care, mental flexibility), and thus offers straightforward
      hypotheses about mechanisms of change.

      The Healthy Minds Program (HMP) is designed to promote and protect psychological well-being
      through sustainable skills training. The program is grounded in constituents of psychological
      well-being identified in empirical literature. HMP provides core content, with instruction
      administered through a curriculum of high-quality guided practices. HMP is based on research
      on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that
      underlie these qualities (e.g., regulation of attention, mental flexibility). HMP practices
      address 4 constituents of well-being: awareness, connection, insight, and purpose. This pilot
      focuses on awareness, connection, and insight.
    


Intervention name(s): Awareness; Connection; Insight
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The program foundation targets attention and awareness skills that are integral to many conceptions of mindfulness.; The Connection module targets skills underlying social connection, which refers to the sense of having close and positively experienced relationships with others in the social world.; The Insight module targets skills underlying dynamic self-inquiry and experiential self-knowledge.
Other intervention name(s): Healthy Minds Program; Healthy Minds Program; Healthy Minds Program
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Rosuvastatin on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Moderate Head Injury
Condition: Head Injury
MeSH terms: Craniocerebral Trauma; Amnesia; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether rosuvastatin is effective in the management
      of moderate head injury by improving amnesia and orientation.
    

Detailed description: 
      The head injury is a frequent problem of health, which produces high morbid-mortality. Today
      is the main cause of death and disability between 18 and 40 years. In addition it originates
      expensive expenses in health care systems.

      Head injury produces damage by primary mechanisms related to impact, then by biochemical ways
      which are activated and they carry to secondary damage. Many studies have been conducted for
      explaining secondary injury, the majority conclude there is a kind of ischemic lesion related
      maybe with changes in cerebral flow and metabolism. The management today is trying to avoid
      progression in secondary damage without good outcome. Many drugs and measures has been
      ineffective.

      In the last years has been demonstrated in head injury microvascular damage like stroke.
      Statins o inhibitors of HMG CoA reductase are drugs used in dyslipidemia, frequently for
      reduction in LDL. Experimental and clinical studies in stroke have shown improvement in
      outcome. The toxicity related to statin is myopathy and hepatopathy, both with low incidence
      without fatal cases. Rosuvastatin has been postulated be the most powerful with longest life
      and toxicity similar to another statins.

      We have designed this study for demonstrate if the administration of rosuvastatin in the
      first 24 hours and by 10 days has improvement in amnesia and orientation, furthermore
      outcome.
    

Intervention name(s): rosuvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg oral, during 10 days
Other intervention name(s): Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: moderate head injury; rosuvastatin; statin; amnesia; orientation
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
Condition: Scar Prevention
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare how well EXC 001 works to improve the appearance of scars in subjects
      undergoing breast scar revision surgery. The study will also evaluate the safety of EXC 001
      in healthy adult subjects.
    


Intervention name(s): EXC 001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple intradermal injections of EXC 001 and placebo; Multiple intradermal injections of EXC 001 and placebo
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Scarring; Cicatrix; Fibrosis; Pathologic Process