bioihbjkbjnl/mcl2 huggingface dataset:
Cardiovascular Function in Adult Survivors of Childhood Malignancies
Condition: Childhood Cancers
MeSH terms: Neoplasms
Study type: Observational

Summary: 
      Anthracyclines have been used commonly to treat children with solid tumours and
      haematological malignancies and have led to their increased survival. Nonetheless,
      anthracycline has the side effect of cardiotoxicity. The purpose of this study is to assess
      the impact of anthracycline therapy on heart deformation and fibrosis, heart-vessel
      interaction, usefulness of circulating biomarkers in the assessment of heart function and
      potential genetic predisposition to heart failure in adult survivors of childhood cancers.
    

Detailed description: 
      Incorporation of anthracyclines into chemotherapy protocols has improved the survival of
      children with solid tumours and haematological malignancies. Nonetheless, longitudinal
      studies have implicated the absence of a safe anthracycline dose that is free of
      cardiotoxicity. Substantial risk for cardiovascular disease has been shown recently in large
      cohorts of adult survivors of childhood and adolescent survivors. Serial monitoring of
      cardiac function is hence of paramount importance in childhood cancer survivors for early
      detection of myocardial damage and timely institution of interventions. The optimal
      monitoring of cardiac function in the long term in these at-risk patients remains to be
      established. Novel noninvasive imaging modalities including echocardiography and cardiac
      magnetic resonance allow interrogation of myocardial deformation and fibrosis, while
      circulating biomarkers are increasingly used to monitor the cardiac status in heart failure
      patients. Additionally, genetics of heart failure are increasingly unveiled.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients will be recruited from the 5 public hospitals in Hong Kong (Prince of Wales
        Hospital, Princess Margaret Hospital, Queen Elizabeth Hospital, Queen Mary Hospital, and
        Tuen Mun Hospital) that treat the vast majority of childhood cancers, with the number of
        patients recruited from each hospital proportional to the respective new case-loads in the
        past 10 years.
      
Biospecimen description: 
      plasma, serum
    
Keywords: anthracycline; cardiac function; echocardiography; biomarkers
Pilot Social Network Weight Loss Intervention
Condition: Diet, Healthy; Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      Specific Aim #1: Pilot test a social network-informed CBPR-derived health promotion program
      for feasibility outcomes with overweight or obese adults from two immigrant communities.

      Specific Aim #2: Assess the preliminary impact of embedding a social network-informed
      CBPR-derived intervention within a regional health promotion resource hub on sustainability
      and uptake outcomes.
    

Detailed description: 
      The intervention will consist of 12 community-based mentoring and education sessions, group
      activities and application of a community toolkit for healthy weight loss delivered by
      trained interventionists from Hispanic and Somali communities to their social networks. Using
      a pre-post study design, 4 social networks of adults with approximately 32 network
      participants will receive the intervention. Primary outcomes, measured 3 months after
      implementation, will include feasibility measures of acceptability, implementation, and
      practicality. Secondary outcomes will include BMI, waist circumference, blood pressure,
      fasting blood glucose, total cholesterol, physical activity level, dietary change, and
      health-related quality of life.

      Eligibility criteria include (1) self-identification as Hispanic or Somali, (2) member of an
      HPs social network, (3) age≥18 and <65 (4) willingness to participate in all aspects of the
      study; and (5) provision of informed consent. Exclusion criteria include (1) pregnancy at the
      time of enrollment and (2) serious medical conditions or disabilities that would make
      physical activity difficult.

      We will test how best to integrate a social network intervention within an existing
      evidence-based regional health promotion infrastructure (WellConnect) that will enhance its
      potential dissemination and community-wide uptake
    

Intervention name(s): Mentoring/educational session
Intervention type(s): Behavioral
Intervention description(s): 12 mentoring/educational sessions focused on physical activity and healthy nutrition by Mayo Clinic experts.
Intervention model: Single Group Assignment
Intervention model description: Behavioral intervention
Masking: None (Open Label)
Primary purpose: Basic Science
PF-04191834 Single Dose Bronchodilatory Study In Asthma.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in
      patients with asthma
    


Intervention name(s): PF-04191834; PF-04191834; PF-04191834; zileuton; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 30mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets.; 100mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets, single dose.; 2000mg PF-04191834, single dose, oral dispersion + 2 x placebo tables, single dose; 1200mg, 2 x 600mg tablets, single dose + placebo oral dispersion, single dose.; 2 x placebo tablets + placebo oral dispersion, single dose.
Intervention MeSH terms: Zileuton
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bronchodilator
Influences of Balance Training With a Dynamometric Platform in Total Knee Arthroplasty
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Knee osteoarthritis produces degeneration and joint wear that greatly affects the patient's
      proprioceptive system increasing instability. After total knee arthroplasty intervention, it
      is recommended that the patient performs a rehabilitation procedure to minimize deficits
      caused by surgery. In this job it is essential to insist on the importance of recovering
      balance after total knee arthroplasty intervention, and assess a specifically designed
      protocol to restore its function. An intervention which includes a dynamometric platform as a
      training method was proposed. The randomized clinical trial compared a control group that
      performed balance exercises on parallel bars, unstable plates, ramps and stairs against an
      experimental group that included dynamometric platforms training as a differentiator.
    


Intervention name(s): Functional Recovery; Balance Training; Dynamometric Platform Training
Intervention type(s): Other; Other; Other
Intervention description(s): Rehabilitation protocol based on muscle strengthening with isometric, isotonic and counter-resistance with progressive load exercises. Intervention consisted of warm-up phase with passive, active-assisted and active movements, and a work-out phase; Balance and proprioception training using parallel bars, unstable plates, ramps and stairs; Stability tests, weight changes and stability limits, performing both anterior-posterior and medial-lateral movements simultaneously in some cases
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: total knee replacement; total knee arthroplasty; rehabilitation; physical therapy; balance
COMorbidities and EDucation in SPondyloArthritis Study
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Study type: Interventional

Summary: 
      Giving both the gap existing between the current recommendations to prevent/detect
      comorbidities and the clinical practice in patients suffering from spondyloarthritis and also
      the specificity of some recommendations to rheumatic diseases, it seems logical to check
      these recommendations in a rheumatologic "environment".

      This study with its two parts should be able to demonstrate:

        -  The importance of a systematic evaluation of comorbidities in Spondyloarthritis,

        -  The utility of a nurse-led program of self-assessment and self-management of the disease
    

Detailed description: 
      Patients with spondyloarthritis will be invited by their rheumatologists to participate at
      this study in 21 centers in France.

      500 patients are planned to be included.

      After written informed consent will be obtained, the patients will be randomized in two arms:

        -  comorbidities

        -  self-assessment/self-management The patients will be seen again in the same center 12
           months later in order to collect the outcome measures

      The two primary objectives of this trial are :

        -  To evaluate the impact of a nurse led program of self-assessment of disease
           activity/severity and self-management on the level of satisfaction/coping

        -  To evaluate the impact of a nurse led program of assessment of comorbidities on the
           management of such comorbidities

      The Secondary objectives are:

        -  To evaluate the prevalence of comorbidities in SpA;

        -  To evaluate the level of adherence to recommendations of prevention of comorbidities;

        -  To evaluate the impact of the nurse led program of self-assessment / self-management on
           the amount of NSAID (Non-steroidal Anti-Inflammatory Drugs) intake and the level of
           disability (e.g. functional disability)
    

Intervention name(s): self-assessment/self-management; Comorbidities (detection/prevention)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Nurse led-program of self-assessment/ self-management of spondyloarthritis; Standardized assessment of comorbidities by nurses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Axial Spondyloarthritis; Education; Co-morbidities; Nurse
Volatile Anaesthesia and Perioperative Outcomes Related to Cancer Feasibility Study
Condition: Cancer, Breast; Cancer Colorectal; Cancer Prostate; Cancer, Lung; Cancer Melanoma Skin; Cancer, Other
MeSH terms: Breast Neoplasms; Lung Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      A multicentre, prospective randomized, active-controlled feasibility trial of volatile-based
      anaesthesia vs. propofol-based total intravenous anaesthesia to investigate the impact of
      anaesthesia on long-term (i.e. 5-years) patient cancer outcomes in patients undergoing
      elective major cancer surgery.
    

Detailed description: 
      This study aims to assess the feasibility of conducting a phase IV, multi-centre,
      single-blinded, randomized control trial (VAPOR-C (Main)).

      Primary aims To measure the ability to recruit eligible patients into the study.

      To measure the ability to successfully deliver each of the two anaesthetic techniques
      (volatile-based general anaesthesia and propofol-based anaesthesia) according to the research
      protocol.
    

Intervention name(s): Propofol; isoflurane, sevoflurane or desflurane
Intervention type(s): Drug; Drug
Intervention description(s): General Anaesthesia; General Anaesthesia
Intervention MeSH terms: Propofol; Sevoflurane; Desflurane; Isoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: major surgeries lasting >2 hours
Study of the Nasal Decolonisation of Staphylococcus Aureus (SA) and the Safety and Tolerability of XF-73 Nasal Gel in Healthy Subjects
Condition: Staphylococcus Aureus Infection
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Study to determine the efficacy, safety and tolerability of two concentrations of XF-73 nasal
      gel in combination with body and face washing with chlorhexidine gluconate cloths in
      eradicating nasal carriage of Staphylococcus aureus.
    


Intervention name(s): XF-73 nasal gel; Placebo nasal gel; Chlorhexidine gluconate 2% topical cloths
Intervention type(s): Drug; Drug; Other
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Nitrate Supplementation and Muscle Blood Flow
Condition: Vasodilation; Blood Pressure; Active Hyperemia; Aging
MeSH terms: Hyperemia
Study type: Interventional

Summary: 
      The main purpose of this study is to evaluate the effects of an acute dose of dietary nitrate
      in the form of beetroot juice on skeletal muscle blood flow in response to dynamic knee
      extension exercise in healthy older adults. All subjects will receive active (rich in dietary
      nitrate) or placebo (devoid of nitrate) supplementation.
    

Detailed description: 
      Dietary nitrate (beetroot juice) is reduced to nitrite and nitric oxide within the digestive
      system of humans. Nitric oxide exerts potent vasodilator effects, which have been shown to
      reduce blood pressure and enhance exercise economy in humans. This pressure reducing effect
      may have implications within the regulation of blood flow during dynamic exercise in older
      adults.
    

Intervention name(s): Super Beets; Beetroot powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Nitrate rich beetroot powder (10g) acutely; Nitrate devoid beetroot powder (10g) acutely
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: exercise hyperemia; vasodilation; nitric oxide; dietary nitrate
Socket Shield With Immediate Implant Stability
Condition: Dental Implant
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate socket shield technique either placing implant in direct contact to tooth
      fragment versus gap created between the tooth and implant.
    

Detailed description: 
      Patients with a non-restorable tooth located in anterior maxillary arch was included in this
      study, patients were divided into two groups, eight implants per group, both groups had
      socket shield, group 1 will have implant in direct contact with shield, second group had a
      gap between dental implant and shield. soft tissue stability, bone width and implant
      stability was assessed preoperatively, immediate and 6 months postoperative.
    

Intervention name(s): Dental implant
Intervention type(s): Device
Intervention description(s): Comparative
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Nitrate and Brain Insulin-Sensitivity
Condition: Nitrate; Brain Insulin-sensitivity; Vascular Function
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      Disturbances in brain insulin-sensitivity are not only observed in abdominal obesity and type
      2 diabetes mellitus (T2D), but also during brain aging and in dementia. Inorganic nitrate may
      improve brain insulin-sensitivity, which can be quantified by measuring the gray-matter
      cerebral blood flow (CBF) response to intranasally administered insulin, through beneficial
      effects on brain vascular function. Therefore, we now hypothesize that inorganic nitrate,
      which can be found in several vegetables such as beetroot, improves brain
      insulin-sensitivity, as assessed by the gray-matter CBF response to intranasally administered
      insulin, in abdominally obese men.
    


Intervention name(s): Potassium nitrate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Acute intervention (5.5 hours); Acute intervention (5.5 hours)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Phase 1 Placebo-controlled, Randomized Trial of an Adenoviral-vector Based Norovirus Vaccine
Condition: Norovirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the
      Safety and Immunogenicity of an Adenoviral-Vector Based Norovirus Vaccine (VXA-G1.1-NN)
      Expressing GI.1 VP1 and dsRNA Adjuvant Administered Orally to Healthy Volunteers
    

Detailed description: 
      The study will enroll 66 subjects in four cohorts. All subjects will receive a single
      administration of VXA-G1.1-NN at a low dose, a high dose or placebo.

      Two sentinel groups will enroll 3 subjects each in an open-label manner (Cohorts 1 and 3) to
      receive VXA-G1.1-NN prior to enrolling either of the randomized, controlled cohorts (Cohorts
      2 and 4). Within the double-blinded Cohorts (2 and 4), placebo subjects will receive the same
      number of tablets as the vaccine subjects in that Cohort. Subjects will be enrolled and dosed
      in the low dose groups prior to initiation of dosing in the high dose group.

      Cohort 1: 3 subjects at low dose Cohort 2: 20 subjects at low dose and 10 placebo Cohort 3: 3
      subjects at high dose Cohort 4: 20 subjects at low dose and 10 placebo

      Subjects will be followed for 28 days post vaccination for preliminary immunogenicity.
      Subjects will continue to be followed for 1 year post-vaccination for long term safety.
    

Intervention name(s): VXA-G1.1-NN (high dose) Oral Vaccine Tablet; VXA Placebo Tablets; VXA-G1.1-NN (low dose) Oral Vaccine Tablet
Intervention type(s): Biological; Other; Biological
Intervention description(s): The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the high dose.; The placebo will be provided as small white enteric-coated tablets that are similar in size and number to the active drug product tablets.; The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the low dose.
Other intervention name(s): H1N1 (high dose) Oral Vaccine Tablet; Placebo Control; H1N1 (low dose) Oral Vaccine Tablet
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Combination Therapy With MYOCET® (Doxorubicin HCL Liposome for Injection) in Participants With HER2-Positive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy and safety of treatment with MYOCET® (doxorubicin hydrochloride) in
      combination with cyclophosphamide and trastuzumab, 4 cycles, followed by docetaxel plus
      trastuzumab, 4 cycles, in women with stage II or III breast cancer whose tumour overexpresses
      the human epidermal growth factor receptor 2 (HER2) gene.
    


Intervention name(s): Liposomal doxorubicin hydrochloride; Cyclophosphamide; Trastuzumab; Free doxorubicin hydrochloride; Docetaxel
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Liposomal doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description.; Cyclophosphamide will be administered per dose and schedule specified in the arm description.; Trastuzumab will be administered per dose and schedule specified in the arm description.; Free doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description.; Docetaxel will be administered per dose and schedule specified in the arm description.
Other intervention name(s): Myocet®; Anthracycline
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin; Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study to Evaluate MN-221 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      In MediciNova's clinical development plan for MN-221, it was recognized that treatment of
      COPD exacerbations may necessitate more than one single i.v. infusion and that patients in
      this population may have more co-morbidities (and concomitant medications) than has been
      generally studied so far. Thus, the primary objective of this clinical study is to determine
      the repeated administration safety and tolerability of intravenous (i.v.) MN-221 compared to
      placebo with repeated administration over several days in moderate to severe COPD patients
      who may also have co-morbidities and concomitant medications (CM) common in this population.
      Secondary outcomes include pharmacokinetics (PK) and preliminary efficacy (FEV1).

      This Phase 1b trial follows naturally upon a Phase 1b COPD trial completed last year
      (MN-221-CL-010) and is additionally well-supported by relevant animal safety data and human
      clinical trial information.
    


Intervention name(s): MN-221; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): This drug is intravenously infused and delivers 1200 mcg to the patient in 1 hour duration. This dose is repeated over 4 days (Day 1 1200 mcg once; Day 2 1200 mcg twice; Day 3 1200 mcg twice; Day 4 1200 mcg once).; This intervention consists of a placebo intravenous infusion, one that contains no active medication. During the double-blind procedure, patients will be infused with placebo intravenously one time on Day 1, twice on Days 2 and 3, and one time on Day 4.
Other intervention name(s): Bedoradrine Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: safety; pharmacokinetics; spirometry
Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Severe Diabetic Gastroparesis
Condition: Gastroparesis; Diabetes Mellitus
MeSH terms: Gastroparesis; Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether TZP-101 is effective in the treatment of
      symptomatic gastroparesis due to diabetes.
    

Detailed description: 
      Subjects are randomized according to an adaptive randomization procedure.
    

Intervention name(s): 5% dextrose in water; TZP-101; TZP-101; TZP-101; TZP-101; TZP-101
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 60 ml IV infusion over 30 minutes; 40 micrograms/kg iv 2ml/minute for 30 minutes
1 infusion/day for 4 consecutive days; 80 micrograms/kg iv 2ml/minute for 30 minutes
1 infusion/day for 4 consecutive days; 160 micrograms/kg iv 2ml/minute for 30 minutes
1 infusion/day for 4 consecutive days; 320 micrograms/kg iv 2ml/minute for 30 minutes
1 infusion/day for 4 consecutive days; 600 micrograms/kg iv 2ml/minute for 30 minutes
1 infusion/day for 4 consecutive days
Other intervention name(s): D5W
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: delayed gastric emptying; symptomatic gastroparesis; diabetes mellitus