bioihbjkbjnl/mcl2 huggingface dataset:
Diabetes Intervention Accentuating Diet and Enhancing Metabolism
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Diabetes is one of the greatest challenges faced by healthcare services worldwide. It is
      associated with serious complications such as heart attacks, stroke, and peripheral artery
      disease as well as kidney disease, eye disease, and nerve dysfunction. Data from weight loss
      with bariatric surgery suggest that with the appropriate intervention, it should be possible
      to reverse diabetes and that the earlier the intervention occurs, the greater the chances of
      placing diabetes into remission. There is now a need to translate this knowledge into the
      medical care of younger patients with early diabetes who are overweight/obese. The aim of
      this study is to see if younger adult patients with overweight/obesity and type 2 diabetes
      who are participants in a programme incorporating a low energy diet and physical activity
      (lifestyle) will lower their weight, cardiovascular risk and improve their glycaemic control
      as compared to the usual care.
    

Detailed description: 
      The aim of the proposed study is to conduct a pragmatic randomised controlled clinical trial
      randomising young adult patients with obesity and type 2 diabetes to an intervention
      incorporating a low calorie diet and physical activity or usual care. The investigators
      hypothesise that patients in the low calorie intervention arm will have greater weight
      reduction leading to significant improvement in glycaemic control and cardiovascular risk.
      The primary outcome will be weight loss. The low calorie diet intervention arm is designed to
      achieve and maintain significant weight loss through decreased calorie intake, increased
      physical activity, and behaviour change. Usual care will include routine advice about diet
      and physical activity. Secondary outcomes include diabetes control, body composition, and
      quality of life.
    

Intervention name(s): Low Energy Diet
Intervention type(s): Dietary Supplement
Intervention description(s): Low Energy Diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Different Plasma Insulin Levels on the Accuracy of Continuous Subcutaneous Glucose Monitoring
Condition: Type 1 Diabetes; Continuous Glucose Monitoring; Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional

Summary: 
      Achieving near-normoglycaemia has been established as the main objective for most patients
      with diabetes. However, it is well known that intensification of treatment is associated with
      an increase in the frequency of hypoglycemia, especially in the context of insulin therapy.
      The burden of hypoglycemia in terms of psychological implications, morbidity and even
      mortality, explains why it has been defined as the main limiting factor to achievement of
      good metabolic control.

      Continuous subcutaneous glucose monitoring (CGM) devices have been claimed to be useful in
      hypoglycemia detection/prevention, allowing theoretically for safer intensification of
      therapy in diabetic patients. However, accuracy of CGM devices, especially in the
      hypoglycemic range, raises some concerns. In fact, commercially available CGM devices
      estimate plasma glucose from measurements in the interstitial fluid and not in plasma.
      However, the relationship between plasma and interstitial glucose is not fully understood,
      especially under dynamic conditions, and this may explain the poor CGM performance during
      rapid changes in blood glucose and hypoglycemia.

      In this project, the relationship between plasma and interstitial glucose will be evaluated
      under conditions of normal glucose concentrations and hypoglycemia. Experiments will be
      performed to assess the role, if any, of different plasma insulin concentrations on the
      accuracy of CGM.

      All the information obtained may be relevant to the improvement of the ability of CGM devices
      to detect hypoglycemia and hypoglycemic risk.
    


Intervention name(s): High insulin eu-hypoglycemic clamp; Low insulin eu-hypoglycemic clamp
Intervention type(s): Other; Other
Intervention description(s): Primed intravenous insulin infusion at a rate of 1mU/kg/min is given during the whole study duration. Glucose is infused at a variable rate to maintain plasma glucose concentrations 'clamped' at pre-specified levels. Plasma glucose levels will be the same in both study arms.; Primed intravenous insulin infusion at a rate of 0.3mU/kg/min is given during the whole study duration. Glucose is infused at a variable rate to maintain plasma glucose concentrations 'clamped' at pre-specified levels. Plasma glucose levels will be the same in both study arms.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Hypoglycemic Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Interstitial glucose dynamics; Accuracy of continuous glucose monitoring under hypoglycemia; Glucose clamp
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Chinese Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics properties of TNM002 following a single intramuscular dose in Chinese
      healthy adults.
    


Intervention name(s): TNM002; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TNM002, intramuscular injection; Placebo, intramuscular injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Clinic-based Intervention to Promote Cervical Cancer Prevention Behaviors
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The project is a clinical behavioral research project based at University of Pennsylvania.
      The goal of this research is to design a brief clinic-based, Nurse Practitioner-guided, and
      theory-based health promotion intervention to enhance cervical cancer prevention among young
      women ages 18-26 living in economically disadvantaged urban communities. The investigators
      will evaluate the intervention for feasibility, acceptability and preliminary efficacy.
    


Intervention name(s): Step Up to Prevention; Step Up to Prevention: knowledge; Step Up to Prevention:belief; Offered HPV vaccine only
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.; Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.; Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.; Participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Cervical cancer prevention
Small Airways Involvement in Smoker Asthmatic Patients: a Pilot Study
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Asthma is an inflammatory disease affecting the whole respiratory system, from central to
      peripheral airways. Anti-inflammatory treatment with inhaled corticosteroids (ICS), with or
      without long-acting β2-adrenoceptor agonists (LABA), is the cornerstone of asthma management
      [GINA Guideline - available at www.ginasthma.com]. Nevertheless, a considerable subset of
      asthmatic patients neither benefits from ICS nor gain optimal asthma control even with
      ICS/LABA combinations.

      The involvement of the distal lung, i.e. the peripheral membranous bronchioles < 2 mm in
      diameter (so-called small airways), in the pathogenesis of asthma has been extensively
      investigated and its significance debated. However, whether specifically targeting distal
      lung abnormalities can lead to further clinical benefit is still an open question. In this
      context, interest has been raised by hydrofluoroalkane (HFA) pressurised metered-dose
      inhalers, which can deliver compounds with a mass median aerodynamic diameter that is
      significantly smaller than other available devices, leading to increase peripheral airways
      drug deposition.

      Up to 30% of asthmatic patients smoke, mirroring the rate found in the general population.
      Several data document that smoking habit negatively affect corticosteroid efficacy in asthma.
      In particular, asthmatic patients who smoke experience faster lung function decline,
      increased frequency of exacerbations and reduced asthma control despite being regularly
      treated. Several molecular mechanisms have been proposed to address the issue of reduced
      corticosteroids responsiveness in smoker patients. However it has been never investigated
      whether reduced corticosteroid responsiveness in asthmatic patients who smoke can be related
      to more severe small airways involvement leading to impaired distribution or impaired
      peripheral deposition of inhaled corticosteroids. If this is the case, asthmatic patients who
      smoke might benefit from a pharmacological approach able to target and to reach small
      airways.
    


Intervention name(s): Extrafine treatment (Clenilexx(R) or Foster(R))
Intervention type(s): Drug
Intervention description(s): Following the initial evaluation (cross-sectional) patients will be switched to an extrafine equipotent dose of the same compound (extrafine beclomethasone dipropionate - Clenilexx(R) - if the patient was on ICS) or combination (extrafine beclomethasone dipropionate/formoterol - Foster(R) - if the patient was on ICS/LABA combination). After 3-months patients will be reassessed for lung function and asthma control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Asthma; Cigarette smoke; Small airways; Lung function; Asthma control
Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion
Condition: Urinary Tract Infections; Catheter Infection; Catheter-Related Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Catheter-Related Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Urinary Tract Infection (UTI) complications following catheter use in surgical patients
      remains high. Using an aseptic protocol has been shown to drastically reduce UTI incidence by
      50%. Reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use
      associated with this complication and improve cost-effectiveness of care. The investigators
      hypothesize that they can reduce the incidence of UTIs after catheter placement with the
      implementation of a Quality Improvement (QI) protocol to prevent excess exposure to the
      environment exposure of the catheter before, during and after insertion.
    


Intervention name(s): Catheter insertion with Povidone Iodine; Standard of care catheter insertion
Intervention type(s): Drug; Procedure
Intervention description(s): The catheter will be treated with Povidone Iodine prior to insertion.; Catheter inserted right out of package.
Other intervention name(s): Aseptic protocol for catheter insertion using Povidone Iodine treated catheter
Intervention MeSH terms: Iodine; Povidone-Iodine; Povidone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with normal urinary analysis (UA) pre-surgery will be randomized 1:1 to one of two arms prior to surgery:
Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter or
Standard of care (SOC) catheter insertion in which catheter is inserted right out of package/non-treated catheter.
Masking: None (Open Label)
Primary purpose: Prevention
Treatment of Larotaxel/Docetaxel, +/- Trastuzumab, After Anthracycline-cyclophosphamide in Breast Cancer Patients
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to assess the pathological Complete Response (pCR)
      rate by treatment arm (according to Chevallier criteria).

      The secondary objectives are:

        -  to assess in each treatment arm the clinical Response Rate (RR), the rate of breast
           conservation, the Progression-Free Survival (PFS), the Overall Survival (OS), the safety
           and tolerability profile, the pathological Complete Response rate (pCR) according to
           NSABP and Sataloff criteria,

        -  to rank docetaxel and larotaxel alone in Her2 -ve patients, or combined with trastuzumab
           in Her2 +ve patients, according to the pCR rate.
    


Intervention name(s): larotaxel (XRP9881); docetaxel; trastuzumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intravenous administration; intravenous administration; intravenous administration
Intervention MeSH terms: Docetaxel; Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; Neoadjuvant therapy
Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year Old Children Previously Vaccinated With Vaxelis® or INFANRIX® Hexa (V419-012)
Condition: Hepatitis B; Pertussis
MeSH terms: Hepatitis A; Hepatitis B; Whooping Cough; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter extension study of two European randomized, double-blind studies
      (V419-007 and V419-008). It describes long-term persistence of hepatitis B and pertussis
      antibody responses in healthy 4- to 5 year old children previously vaccinated with Vaxelis®
      or INFANRIX® hexa
    


Intervention name(s): Blood Sample
Intervention type(s): Other
Intervention description(s): Blood sample at approx. 4 years of age
Other intervention name(s): Vaxelis®; INFANRIX® hexa
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immune response
Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, randomized, double-blind, multicenter, parallel, placebo controlled study.
      Approximately 120 eligible patients with mild-to-moderate active ulcerative colitis will be
      randomized to double blind treatment of either 1,000 mg twice daily (b.i.d.) ASP3291 (2,000
      mg/d) or matching placebo in a 1:1 ratio for 8 weeks.

      The study hypothesis is that treatment with ASP3291 compared to placebo will improve a
      patient's ulcerative colitis endoscopic score from baseline to Week 8.
    


Intervention name(s): ASP3291; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet, 1,000 mg (four 250-mg tablets), twice a day, 8 weeks; Matching placebo tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ulcerative colitis
Double-blind, Randomized, Placebo-controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body Myositis
Condition: Inclusion Body Myositis
MeSH terms: Myositis; Myositis, Inclusion Body
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Inclusion body myositis (IBM) is the most common late onset acquired muscle disease. Patients
      develop progressive weakness that may result in the need for assistive devices including a
      wheelchair. IBM may be due to abnormal immune activation, due in part to overproduction of
      tumor necrosis factor (TNF)-alpha. Etanercept blocks the activity of TNF-alpha, thereby
      blunting immune overactivation. Previous unblinded studies and case reports suggest that
      etanercept may improve strength or slow the progressive weakness in IBM. We are conducting a
      double-blind, randomized, placebo-controlled study to test if Etanercept is beneficial in
      slowing the progressive weakness in patients with IBM.
    

Detailed description: 
      Travel expenses not covered by the study.
    

Intervention name(s): Etanercept
Intervention type(s): Drug
Intervention description(s): 50 milligrams subcutaneously every week
Other intervention name(s): Enbrel
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Investigate the Influence of CKD-519 on 24-h Ambulatory Blood Pressure in Healthy Adult Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine influence of CKD-519 on 24-h ambulatory blood
      pressure after oral administration in healthy adult volunteers.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled, multiple dosing, cross-over phase I clinical
      trial to investigate the effect of CKD-519 on 24-h ambulatory blood pressure after oral
      administration in healthy adult volunteers.
    

Intervention name(s): CKD-519 200mg; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): (formulation II) 200mg (100mg X 2tabs)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dyslipidemia; CKD-519; CETP inhibitor; ABPM
Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill
Condition: Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      Norgestrel 75 mcg is a progestin-only pill (POP), which is a kind of oral birth control pill.

      To be effective in preventing pregnancy, this kind of birth control pill is supposed to be
      taken every day at the same time, without delaying the intake for more than 3 hours.

      This study aims to find out if taking the pill 6 hours late or not taking it for one day will
      affect the way it works.
    

Detailed description: 
      This study is an exploratory, prospective, multi-center, randomized, cross-over study to
      assess the effect of norgestrel 75 mcg on cervical mucus and ovarian activity during reported
      perfect daily use, after a delayed intake of 6 hours and after a missed pill.

      After a screening period up to one month, depending on the menstrual cycle of the subject,
      the subjects will take norgestrel 75 mcg for three 28-day treatment periods, every day at the
      same time except for one day in the middle of treatment period 2 and treatment period 3 where
      they will either take it 6 hours late or not take it.

      In week 5 (1st visit of treatment period 2), they will be randomized to 2 sequences, either 6
      hours delayed intake in treatment period 2 and missed pill in treatment period 3 or the
      opposite.

      After the end of treatment period 3, a follow-up up to 12 days may be required to follow
      ovarian activities.

      Subjects will have visits twice a week and sometimes more often to assess the effects of the
      pill on:

        -  cervical mucus properties by a cervical mucus sampling

        -  ovarian activity by a vaginal ultrasound (TVUS)

        -  reproductive hormones levels by a blood sample (Progesterone (P4), Estradiol (E2),
           Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH))

        -  plasma drug level by a blood sample
    

Intervention name(s): Norgestrel 0.075 mg
Intervention type(s): Drug
Intervention description(s): Subjects will take norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for 1 specific day during treatment period 2 and treatment period 3
Other intervention name(s): Norgestrel 75 mcg
Intervention MeSH terms: Norgestrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Birth Control; Progestin Only Pill; Estrogen Free Pill; Norgestrel; Oral Contraception; Female Contraception; Cervical Mucus; Ovarian Activity
Feasibility of Ambulatory Surgery for Early Breast Cancer
Condition: Early Breast Cancer; Psychosocial Wellbeing; Ambulatory Surgery
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The aim was to assess the patient compliance and medical and psychosocial effects of same day
      hospital discharge after breast conserving surgery and sentinel node biopsy only.
    

Detailed description: 
      The patients with small breast tumours (<2 cm)and clinically node negative disease, were
      randomized to receive breast conserving surgery and sentinel node biopsy as ambulatory
      surgery or inpatient-surgery.Complication rate, patient satisfaction and psychosocial
      outcomes were compared. The psychosocial effects of the treatment mode on their spouses were
      recorded as well.
    

Intervention name(s): Ambulatory surgery
Intervention type(s): Other
Intervention description(s): Sentinel node mapping was done on the previous day and the patients were operated on first in the morning.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Early breast cancer surgery; Psychosocial wellbeing; Ambulatory surgery
The Role of Inflammation and Aging in HIV-Associated Cardiovascular Risk
Condition: HIV Infection; Cardiovascular Disease; Inflammation
MeSH terms: HIV Infections; Cardiovascular Diseases; Inflammation
Study type: Observational

Summary: 
      It is the central hypothesis of the investigators study that HIV disease is a
      pro-inflammatory condition, and that years of inflammation result in premature "aging' of the
      immune system ("immunosenescence"). Just as these changes are thought be causally associated
      with heart disease in the very old,the investigators postulate that these changes will be
      associated with early heart disease in the untreated and perhaps treated HIV disease. To
      address this hypothesis, the investigators will measure immunosenescence in a large cohort of
      patients who span the entire disease process.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Treated and untreated HIV-infected individuals and HIV-uninfected individuals.
      
Biospecimen description: 
      Serum, plasma, PBMCs
    
Keywords: HIV Infection; Endothelial function; Cardiovascular Disease; Inflammation; Antiretroviral medication; Treatment naive; Treatment experienced