bioihbjkbjnl/mcl2 huggingface dataset:
Transient Elastography to Assess Liver Fibrosis and Portal Hypertension in HCV Cirrhotic Patients Treated With New Antiviral Drugs (SPLEEN-C)
Condition: Chronic Hepatitis C; Cirrhosis; Portal Hypertension
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Hypertension, Portal; Hypertension; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of sustained virological response in
      liver and spleen stiffness in patients with HCV compensated advanced chronic liver disease
      treated with new all oral antiviral drugs in order to determine factors implicated in
      stiffness change and its implications for long-term follow-up.
    

Detailed description: 
      Prospective cohort study including consecutive patients (with baseline liver stiffness
      measurement ≥10 kPa who meet the Baveno VI criteria for compensated advanced chronic liver
      disease) who initiate treatment with new all oral antiviral drugs following current
      recommendations in Spain.

      In all these patients the following parameters will be assessed:

        -  Baseline liver and spleen stiffness and CAP measurements at the time of starting therapy
           and then, during treatment in week 4 and week 12 (end of treatment). After finishing
           therapy, these measurements will be repeated at 6 and 12 months of follow-up.

        -  Routine lab tests, including liver enzymes and viral load, will be performed at
           baseline, 4 and 12 weeks of therapy, and at 3 and 6 months after finishing therapy
           according to standard clinical practice.

        -  Liver ultrasound will be performed every 6 months as a routine procedure in patients
           wiht liver cirrhosis.

        -  Patients who were known to have esophageal varices prior to therapy will be assessed
           with an upper endoscopy 12 months after finishing therapy if they achieve SVR.
    

Intervention name(s): Fibroscan: Liver and Spleen elastography
Intervention type(s): Device
Intervention description(s): In cirrhotic patients treated with antivirals for HCV infection, repeated liver and spleen stiffness measures with Fibroscan will be performed to predict the presence of clinically significant and severe portal hypertension.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cirrhosis; Chronic hepatitis C; Clinically significant portal hypertension; Portal hypertension; Elastography; Antiviral therapy
Study on the Use of Botulinum Toxin Type A in the Treatment of Chronic Post-stroke Spastic Patients
Condition: Spasticity
MeSH terms: Muscle Spasticity
Study type: Observational

Summary: 
      The purpose of this study is to document the effectiveness of treating chronic post-stroke
      spastic patients with Botulinum Toxin type A.
    

Detailed description: 
      As this is a non-interventional study, the decision to prescribe the product must be taken
      prior to, and independently from the decision to enrol the patient. This decision should be
      made in accordance with routine clinical practice at the hospital concerned. The clinical
      justification for prescribing any treatment should be recorded at the outset by the
      prescribing clinician.

      This study will not interfere with the routine practice of the investigator or with the
      patient's treatment plan. Assessments will be done only if performed regularly in routine
      practice.

      This study will be conducted in Brazil, wherein Marketing Authorization has been granted for
      the use of BoNT-A in the treatment of spasticity of the upper and lower limb in adult
      post-stroke patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Untreated chronic post-stroke spastic patients
      
Keywords: Stroke; Spasticity; Botulinum Toxin type A; Dysport
Input of a Multidisciplinary Device to Accompany the Announce of Diagnosis for Young Children With Serious Constitutional Hemorrhagic Disease and Their Families
Condition: Severe Forms of Hemophilia; Other Constitutional Bleeding Disorders
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhagic Disorders
Study type: Interventional

Summary: 
      Severe forms of hemophilia and other constitutional bleeding disorders represent a group of
      rare diseases. In last decades, news therapies have dramatically increased life expectancy
      and joint's protection.

      The investigators propose to set up a single-centre, descriptive, transversal pilot study,
      designed for the inclusion of around thirty children from 2 to 10 years, with haemophilia or
      allied hereditary bleeding disorders (HBD), who were referred to the Hemophilia Treatment
      Center (HTC) of Marseille at diagnosis. For those children who were able to benefit from the
      totality or part of the device accompanying the diagnostic announcement in the past 10 years.
    

Detailed description: 
      Severe forms of hemophilia and other constitutional bleeding disorders represent a group of
      rare diseases. In last decades, news therapies have dramatically increased life expectancy
      and joint's protection. The recurrence of joint bleedings is responsive of multifocal
      arthropathy in the natural history, but nowadays, the orthopedic outcome is good thanks to
      prophylactic treatments.

      However, the announcement of the diagnosis of such hereditary bleeding disorders at a very
      young age represents a real psychological trauma for parents. Such an announcement may induce
      some psycho-developmental impairment.

      An innovative support has been implemented at the Hemophilia Treatment Center in Marseille,
      in conjunction with the French Hemophilia Society. This program is based on a
      multidisciplinary partnership that favors the psychological support and the reinsurance of
      the parents.

      With Rare Diseases Foundation support, the investigators have initiated this pilot study that
      will include more than 20 patients with severe hemophilia or constitutional bleeding
      disorder, who benefit from the device. This descriptive, monocentric, interventional study
      will permit to describe the psychological status, the quality of life of patients and their
      parents, but also to evaluate the impact of the device on initiation and observance of
      treatments like Long Term Prophylaxis.
    

Intervention name(s): Evaluation of psychological and psychopathological
Intervention type(s): Behavioral
Other intervention name(s): Evaluation of quality of life
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Comparison of Dynamic Stretching and Plyometric Push up Training on Upper Body Performance Tests in Cricketers
Condition: Sports Physical Therapy
Study type: Interventional

Summary: 
      A comparison of dynamic stretching and plyometric pushup training on upper body performance
      tests of cricketers was performed.
    

Detailed description: 
      A Randomised control trial was performed for six weeks in which a sample size of 22 was taken
      participants were divided into two groups in which one group performed warm-up and dynamic
      stretching and the other group performed warm-up plyometric pushup.
    

Intervention name(s): Dynamic stretching; Plyometric push up
Intervention type(s): Other; Other
Intervention description(s): Participants in this group performed a 10 minutes warm-up followed by 15 minutes of dynamic stretching exercises which included arm cross-over, scapular scaption, upper body twist walking lunges, cat and cow pose, and rotator cuff movements.; Participants in this group performed 10 minutes of warm-up followed by 15 minutes of plyometric push training which included one-arm push-ups and depth push up
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There were two groups
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: plyometric, dynamic stretching, agility
Treatment of Childhood Social Phobia
Condition: Social Phobia
MeSH terms: Phobic Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 3

Summary: 
      This 4-year study will compare the long-term effectiveness of behavioral treatment,
      fluoxetine (Prozac®), and placebo for treatment of social phobia in children and adolescents.
    

Detailed description: 
      Social phobia affects 3-5 percent of children, and prevalence rises with age. Youth with
      social phobia fear many activities that are part of everyday life and suffer from problems
      such as headaches or stomachaches, panic, avoidance, general anxiety, depression, loneliness,
      and a very restricted range of social relationships. Recent findings indicate a new
      psychosocial treatment called Social Effectiveness Therapy for Children (SET-C) is effective
      in treating children ages 8-11, resulting in reduced emotional distress and improved social
      functioning. Treatment effects have been maintained for up to 6 months. This study will
      examine SET-C in children ages 8-15. Because available data suggest that the drug fluoxetine
      is a promising treatment, SET-C will be compared to fluoxetine in this trial. Durability of
      treatment will be monitored over a 1-year follow-up period.
    

Intervention name(s): Social Effectiveness Therapy for Children (SET-C); Fluoxetine; Pill Placebo
Intervention type(s): Behavioral; Drug; Drug
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phobic Disorders; Mutism
Risk Stratification of Patients Using the Lung Cancer Biomarker Panel in China
Condition: Lung Neoplasms
MeSH terms: Lung Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to verify clinical utility of a simple blood test comprising of
      four protein- based markers for risk stratification of patients presenting symptoms related
      to lung cancer.
    

Detailed description: 
      The study is a multicenter, prospective case-control research. Totally 1,200 cases will be
      collected in the hospitals, with 600 cases in control group, which are not suspected as lung
      cancer from chest CT, and other 600 in suspected group. When inclusion into the two groups,
      clinical information and 10mL blood sample of the patient will be recorded and tested for
      cancer biomarkers, biochemical detection and cardiovascular disease biomarkers, etc. The
      correlation between cancer biomarker panel, CT scan result and clinical pathological
      diagnosis will be investigated through cases follow up. The sample size estimated above was
      set up according to sensitivity and specificity of biomarkers in pre-study, based on lung
      cancer incidence of the population. To compare the diagnostic accuracy among different cancer
      biomarkers through T-test, Mann-Whitney U and receiver operating characteristic (ROC) curve
      with SPSS 15.0 software. In statistic analysis, 0.05 is set as the p value for significance.
      Effectiveness of the four biomarkers panel in lung cancer diagnoses and staging will be
      analyzed.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Totally 1,200 cases will be collected in the hospitals, with 600 cases in control group,
        which are not suspected as lung cancer from chest CT, and other 600 in suspected group.
      
Biospecimen description: 
      10mL blood sample of the patient will be tested for cancer biomarkers, biochemical detection
      and cardiovascular disease biomarkers, etc.
    
Keywords: Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Biological Markers; ROC Curve; Delayed Diagnosis
Prolonged Exposure (PE) Treatment for Post Traumatic Stress Disorder (PTSD) 20 Minutes Versus 40 Minutes
Condition: PTSD
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Comparing the efficacy of 40 minutes PE treatment to 20 minutes of the same treatment
    


Intervention name(s): Prolonged Exposure (PE) therapy; Prolonged Exposure (PE) therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 20 minutes exposure; 40 minutes exposure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post traumatic stress disorder
"SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a non-significant risk, multi-center, randomized, active-controlled study to compare
      the effectiveness of two digital therapies in the management of fibromyalgia over 12 weeks.
      The primary endpoint is mean change from baseline to Week 12 in the weekly revised
      Fibromyalgia Impact Questionnaire (FIQ-R) total score.
    


Intervention name(s): Digital ACT; Digital Symptom Tracker
Intervention type(s): Device; Device
Intervention description(s): Participants in Digital ACT arm complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.; Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prognostic Value of Endothelial Dysfunction and Coronary Complexity
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      The investigators test the additional clinical value of the physiological assessment of
      endothelial function to the morphological assessment of coronary complexity and classical
      risk score in predicting cardiovascular events.
    

Detailed description: 
      The investigators enroll consecutive, stable high risk patients for cardiovascular events.
      The reactive hyperemia peripheral arterial tonometry index (RHI) was measured before coronary
      angiography and coronary lesions were assessed angiographically by SYNTAX Scoring system. The
      investigators all subjects and examined the occurrence of cardiovascular events (CV death,
      non-fatal myocardial infarction and ischemic stroke, unstable angina pectoris,
      hospitalization for HF, coronary revascularization, or non-fatal aortic and peripheral
      vascular disease).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Kumamoto University Hospital and Yokohama City University Medical Center
Sympathetic Nerve Activity During Hypoglycemia and Exercise
Condition: Diabetes Mellitus
MeSH terms: Hypoglycemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine if either hypoglycemia or exercise cause
      differential responses in muscle and skin sympathetic nerve activity.
    

Detailed description: 
      The body has defensive responses to correct low blood sugar (hypoglycemia). A vital component
      of this response is release of glucagon and activation of the sympathetic nervous system,
      which provides the means for raising blood glucose levels towards normal. We can measure
      circulating hormones indicating the level of these responses, but additionally, sympathetic
      nervous system responses can be measured directly. We can measure the sympathetic nerve
      activity that controls blood flow to muscles (MSNA) and blood flow and sweating to skin
      (SSNA). The purpose of this study is to determine if either hypoglycemia or exercise cause
      differential responses in muscle and skin sympathetic nerve activity. We would also like to
      determine what the sympathetic response is to cycling exercise with insulin and normal blood
      sugar. Therefore, we would like to test the sympathetic responses to insulin with normal
      blood glucose, hypoglycemia, and during exercise bouts and normal blood glucose, with or
      without insulin.
    

Intervention name(s): Hyperinsulinemic glucose clamp procedures; moderate exercise
Intervention type(s): Procedure; Procedure
Intervention description(s): 2 hours of either euglycemic or hypoglycemic glucose clamping; 90 minutes of moderate exercise with either hyperinsulinemia or euinsulinemia
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Keywords: exercise; hypoglycemia; sympathetic nerve activity
MQX-503 Applied to the Hand Versus Nitroglycerin Ointment Applied to the Chest: A Pharmacokinetic Comparison
Condition: Raynaud's Phenomenon
MeSH terms: Raynaud Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical study is to compare the pharmacokinetic profiles of a topical
      cream formulation of 0.9% nitroglycerin, MQX 503, and Nitroglycerin Ointment 2%, USP.
    


Intervention name(s): nitroglycerin 0.9 % (MXQ-503); Nitroglycerin ointment 2%, USP
Intervention type(s): Drug; Drug
Intervention description(s): MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.; MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy volunteers
Racotumomab in Patients With High-risk Neuroblastoma
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial will be carried out in children diagnosed with high-risk neuroblastoma
      that have achieved a complete or very good partial response after standard therapy. An
      additional cohort of children who could not achieve these response criteria or that relapsed
      after standard therapy but do not have progressive disease will receive Racotumomab together
      with metronomic chemotherapy.

      The main objectives of this study are to determine the immune response after one-year
      duration immunization with Racotumomab, to describe the response of Racotumomab therapy in
      minimal residual disease (MRD) in bone marrow and to describe the toxicity profile of
      Racotumomab.
    

Detailed description: 
      Neuroblastoma is the most common extra-cranial tumor in childhood but prognosis is still
      poor, even with the advances in its treatment.

      New therapeutic strategies have been examined, and several immunotherapeutic approaches,
      including combined therapy with monoclonal antibodies (anti-GD2), intravenous interleukin-2
      (Il-2) and intravenous granulocyte-macrophage colony-stimulating factor (GM-CSF), and
      anti-idiotype vaccines are currently being assessed.

      Racotumomab is an anti-idiotype antibody capable of inducing anti-N-glycolyl GM3 antibodies
      in patients with neuroblastoma.

      The expression of the ganglioside N-glycolyl GM3 was shown in neuroblastoma and this
      expression could be useful as a specific target for immunotherapy.

      Ractoumomab will be administered once standard therapy for neuroblastoma has been completed.
    

Intervention name(s): Racotumomab
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
In Vivo Quantification of Short Chain Fatty Acids Production in the Human Colon
Condition: Healthy
Study type: Interventional

Summary: 
      During this project the amount of SCFA produced in the colon after consumption of 2 different
      13C-labelled wheat fiber fractions will be quantified.
    


Intervention name(s): Arabinoxylan oligosaccharides; Dietary fiber enriched bran
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Study to Assess GW642444 in Asthma Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study of GW642444M, a long-acting beta 2 specific agonist. This study will examine
      GW642444M via the inhaled route and will assess the efficacy, safety, tolerability,
      pharmacodynamics and pharmacokinetics of a single administration of three inhaled doses (25,
      100 and 400 µg) of GW642444M in persistent asthmatics. This study will be a single-centre,
      placebo-controlled, dose-ascending, five-way crossover in 30 asthmatic patients.

      Key assessments: efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics will
      be assessed by measurement of FEV1, blood pressure, pulse rate, 12-lead ECGs, clinical
      laboratory safety tests, collection of adverse events and blood samples.
    


Intervention name(s): GW642444M; GW642444H; placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): M salt; H salt; placebo
Other intervention name(s): GW642444
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: safety; GW642444M; Single Dose; pharmacodynamics; pharmacokinetics; GW642444H; tolerability
Self-management and Cognitive Function in Adults With Heart Failure
Condition: Cognitive Impairment; Cardiac Disease; Heart Failure
MeSH terms: Heart Failure; Heart Diseases; Cognitive Dysfunction
Study type: Observational

Summary: 
      The purpose of this study is to assess the relationship between cognitive impairment, patient
      self-management, health, and health service use in adults with heart failure (NYHA Class 2
      and 3). The research questions are:

        1. How is cognitive impairment (memory, attention, global and executive function) related
           to various aspects of impaired self-management (knowledge of adherence, adherence to
           sodium restriction and medications, symptom monitoring of weight changes, and decision
           and action to seek care)?

        2. How are these relationships altered when adjusting for medical, demographic, and
           psychosocial factors?

        3. What are the relationships among degree of cognitive impairment, quality
           self-management, health status, and health service use?
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        50-85 years of age, documented diagnosis of systolic heart failure (EF </= 35%) at least 12
        months prior to enrollment
      
Biospecimen description: 
      Urinary sodium
    
Keywords: cognitive impairment; cognitive function; hospitalization; self-management; cardiac disease; heart failure