bioihbjkbjnl/mcl2 huggingface dataset:
The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients
Condition: Hepatitis C, Chronic; DIABETES MELLITUS Type 2
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate if nitazoxanide used in combination with
      interferon alfa and ribavirin is effective in treating Hepatitis c infected type 2 Diabetic
      patients by improving their sustained viral response by more than 80%.Considering that the
      study is being conducted in a third world country like Pakistan, the standard treatment of
      hepatitis C is not cost effective. The aim is to introduce a new treatment comparable in
      efficacy to peginterferon and also cost effective.
    

Detailed description: 
      After taking proper informed consent from patients, patients who fulfill the research
      criteria are randomized into 2 groups (control/study). Patients in both groups will be
      treated with conventional interferon alfa and Ribavirin.Those in study group will be given
      tab nitazoxanide 500mg twice daily in addition to conventional treatment. The patients will
      be followed up at regular intervals: 0,4,12,24,48 week.At each visit Hepatitis C
      Virus(PCR)RNA, Liver function tests, complete blood count will be done.
    

Intervention name(s): nitazoxanide; conventional interferon alfa; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): nitazoxanide 500mg twice daily; Inj interferon 3 Million International Units thrice weekly; ribazole
Other intervention name(s): tablet nizonide500mg; tablet atizox500mg; Inj uniferon 3 Million International Units; Ribavirin 400mg-1200mg
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Nitazoxanide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nitazoxanide,; Sustained viral response; Type 2 DIABETICS
Proprioceptive Postural Control and Chronic Obstructive Pulmonary Disease (COPD)
Condition: Proprioceptive Postural Control; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Proprioceptive weighting changes may explain differences in postural control performance. In
      addition, the respiratory movement has a disturbing effect on postural balance. Postural
      balance seems to be impaired in individuals with respiratory disorders. Increased risk of
      falling is reported in individuals with chronic obstructive pulmonary disease. Besides the
      essential role of respiration, the diaphragm may also play an important role in the control
      of the trunk and postural balance.

      The aim of the study is to clarify whether proprioceptive postural control is impaired in
      individuals with chronic obstructive pulmonary disease.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        patients from the University Hospital Leuven - Respiratory Disvision
Exertional Heat Illness: Biomarkers for Prediction and Return to Duty
Condition: Heat Illness
MeSH terms: Heat Stress Disorders
Study type: Observational

Summary: 
      The investigators goal is to monitor and quantify the differential physiologic and biomarker
      responses of controls to standardized exercise under thermoneutral and thermally challenged
      conditions and responses of exertional heat stroke (EHS) subjects under a thermal-challenged
      environment to develop unique bio-signature panels to predict those at risk for exertional
      heat illness (EHI) and guide return to duty following an episode of EHS.
    

Detailed description: 
      Purpose: Our goal is to monitor and quantify the differential physiologic and biomarker
      responses of controls to standardized exercise under thermoneutral and thermally challenged
      conditions and responses of exertional heat stroke (EHS) subjects under a thermal-challenged
      environment to develop unique biosignature panels to predict those at risk for exertional
      heat illness (EHI) and guide return to duty following an episode of EHS.

      Research Design: This is a prospective cross-sectional study.

      Methodology/Technical Approach: The proposed study will examine multiple biomarkers in a
      group of 100 individuals who have not had an episode of EHS and a prospective study of 50
      persons who have had an EHS event. Control subjects will have biomarker assessments before
      and after an exercise challenge under thermoneutral (TTT) and thermally challenged conditions
      (heat tolerance test/HTT); differences in the responses to the two tests will be attributed
      to the heat. In EHS subjects, blood will be obtained at time of injury and then followed up
      at 6 weeks according to non-EHS controls. In addition, EHS cases will be prospectively
      followed at 3, 6, 12, and 18 months after the 6-week post assessment. If they are heat
      tolerant at 6-weeks as determined by a HTT, subsequent measures will include only blood
      samples and questionnaires, whereas if they are heat intolerant (HIT) at 6-weeks, subsequent
      measures will include additional HTTs, along with blood samples and questionnaires. As our
      previous data indicate, approximately 20% of non-EHS persons are HIT; we will test 100
      non-EHS and 50 EHI persons in this study. Thus, data will be evaluated with regard to
      thermotolerance. Importantly, all control participants will undergo two test sessions (HTT
      and TTT); to control for an order effect, we will randomize the tests.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The target population will include both civilian DOD beneficiary and active duty military
        men and women, of any race or ethnicity, between the ages of 18 and 45 years.
Pizza-Salami Study in Children and Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The Pizza-Salami-Study aims to investigate the efficacy of carbohydrate plus fat/protein
      (CFP) counting compared with carbohydrate (CARB) counting using normal and dual-wave bolus in
      sensor-augmented pump therapy in children and adolescents with type 1 diabetes. For
      fat/protein counting the model used by Pankowska et al. will be applied.
    

Detailed description: 
      This is a prospective, international multi-centre, open randomized clinical trial to assess
      whether the use of Paradigm REAL-Time System from the onset of Type 1 Diabetes (T1D) leads to
      a better glycaemic control after 12 months of T1D compared with the use of Paradigm 515/715
      insulin pump combined with conventional Self-Monitoring Blood Glucose finger-sticks in
      paediatric patients. Total randomized treatment duration of the study for a patient will be
      12 months with an optional phase of follow-up of 3 months.Patients eligible according to
      inclusion and exclusion criteria will be randomized to one of the two treatment groups. A
      total of 160 patients will be recruited. Each subject will participate in the study for 15
      months, which includes 12 months of treatment and 3 months of follow-up. Each patient is
      asked to use either the Paradigm REAL-Time System that provides a combination of insulin pump
      and the Real-Time continuous glucose monitoring or Paradigm 515/715 insulin pump combined to
      conventional SMBG finger-sticks. Main time-points of assessments are at baseline (within one
      month after T1D onset) and 12 months thereafter. In total, there will be 6 study visits at
      the local site. During study, patients will regularly attend the outpatient clinic according
      to local Standard care, i.e. every 8±2 weeks.
    

Intervention name(s): CFP counting; CARB counting
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients receive a standardized test meal at lunch time. The required insulin dose is calculated by CFP counting. Insulin is given as bolus and basal rate using an insulin pump. Continuous glucose monitoring is performed by sensor-augmented pump system for 6 hours after the meal. The intervention is taking part under in-patient clinical conditions.; Patients receive a standardized test meal at lunch time. The required insulin dose is calculated by CARB counting. Insulin is given as bolus and basal rate using an insulin pump. Continuous glucose monitoring is performed by sensor-augmented pump system for 6 hours after the meal. The intervention is taking part under in-patient clinical conditions.
Other intervention name(s): CFP algorithm according to Pankowska et al.; CARB algorithm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CSII; prandial insulin requirements; bolus calculation; dual-wave bolus
Beta Cell Function and Related Pharmacodynamics of HMS5552 in T2DM Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the beta cell function, pharmacodynamics, pharmacokinetics, safety and
      tolerability after 4 weeks treatment of 75mgBID or 75mgQD of HMS5552.
    


Intervention name(s): HMS5552
Intervention type(s): Drug
Other intervention name(s): Sinogliatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Safety and Precursors of Efficacy
Condition: Subcutaneous Fat
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate and compare the safety and pre-cursors of efficacy
      of a non-invasive 1064nm laser and 940nm diode, for the disruption of subcutaneous adipose
      tissue and skin tightening.
    

Detailed description: 
      The purpose of the biopsies is to assess if the device causes an inflammatory response in the
      abdominoplasty tissue that will be excised.
    

Intervention name(s): 1064nm Laser; 940nm Laser
Intervention type(s): Device; Device
Intervention description(s): Patient will be treated with 1064nm Laser prior to abdominoplasty; Patient will be treated with 940nm Laser prior to abdominoplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With COVID-19
Condition: Severe COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this Phase 2 study is to test safety, efficacy, and tolerability of an oral
      preparation of VB-201 in patients with severe COVID-19
    


Intervention name(s): VB-201 + Standard of care; Standard of care
Intervention type(s): Drug; Drug
Intervention description(s): Daily oral administration of VB-201- 160 mg (80 mg BID) with standard of care; Standard of care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; Severe
A Study to Evaluate a New Jaundice Stick Test
Condition: Jaundice; Serum Bilirubin
MeSH terms: Jaundice
Study type: Observational

Summary: 
      This is an observational prospective study. The main purpose is to evaluate the stability of
      the Bilistick system in a humid and hot climate compared to the quantitative test for serum
      bilirubin (SBR) measurement currently used, the BR-501 total bilirubin meter, kept in a
      controlled environment.

      The secondary aim is to assess the operational feasibility of the Bilistick system in a
      tropical limited-resource setting, when used by locally trained nurses.
    

Detailed description: 
      Study procedure:

        1. SBR will be measured in parallel with two tests during three distinct seasons. (Cold,
           hot, rainy). The Blood is from an extra capillary sample taken from a single heel prick
           done for routine SBR) BR-501 total bilirubin meter, the quantitative test for SBR
           currently used, will be kept in a controlled environment while the new bilirubin test
           (Bilistick system) will be exposed to tropical conditions.

        2. Trained nurses will use the Bilistick system observed by a qualified laboratory
           technician; Usability of the Bilistick system by the trained nurses will be evaluated
           via a 5-point Likert scale questionnaire and focus groups discussions.
    

Intervention name(s): Blood sampling
Intervention type(s): Other
Intervention description(s): One full capillary tube (50µl blood) will be used to measure the Hct level and the routine SBR using the BR-501 bilirubin meter machine (non-study procedure).
An additional half- filled capillary tube (25µl blood) will be used for the SBR measurement with the Bilistick system
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infant seen in WPA clinic during the neonatal period (birth to 28 days of life).
      
Biospecimen description: 
      Blood
    
Keywords: stick test
BABY SMART (Study of Massage Therapy, Sleep And neurodevelopMenT)
Condition: Sleep; Neurodevelopmental Disorders
MeSH terms: Neurodevelopmental Disorders
Study type: Interventional

Summary: 
      It is well known that sleep is essential for brain development and learning. Infants require
      extensive sleep for development of the hippocampus, pons, brainstem, and midbrain and for
      optimizing physical growth. It is also essential for brain plasticity; the genetically
      determined ability of the infant brain to change its structure and function in response to
      the environment. Studies in young animals have shown that sleep deprivation leads to
      increased programmed cell death, smaller brain size, and loss of brain plasticity, all of
      which have negative long-term impact on behaviour and learning ability.

      Infant massage, a form of systematic tactile stimulation by human hands, improves sleep
      hygiene. Very little is known about how massage influences early brain development but it is
      certainly linked to the theory of environmental enrichment, which has been well established
      in animal models.

      The aim of this project is to optimise the infant's sensory experience through a
      multi-sensory enrichment programme, including massage (a massage utilising a scented lotion
      before sleep each day), to encourage more structured sleep and ultimately show improved
      developmental and cognitive outcomes.
    

Detailed description: 
      See study protocol attached.
    

Intervention name(s): Baby Massage
Intervention type(s): Procedure
Intervention description(s): Structured massage of the baby
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single centre, unblinded, randomised, controlled study to evaluate whether a multi-sensory enrichment programme in the first 4 months of life will improve sleep architecture and neurodevelopment in healthy infants.
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Infant Sleep; Baby Massage; Neurodevelopmental Disorders
Validity of Turkish Version of PROMIS-29 Measure
Condition: Musculoskeletal Diseases
MeSH terms: Musculoskeletal Diseases
Study type: Observational

Summary: 
      This study will be carried out on 100 patients with chronic musculoskeletal disorders who
      applied to Acıbadem Maslak Hospital Orthopedics and Traumatology Department. Demographic
      information (age, education level, occupation, marital status) will be obtained from the
      patients, they will be asked whether they have a chronic musculoskeletal disease diagnosed by
      the doctor, and they will be asked to fill in the PROMIS 29 and SF-36 v2 questionnaires.

      The PROMIS 29 questionnaire contains 4 questions from each of the seven contents of PROMIS
      (physical function, depression, anxiety, fatigue, sleep disorder, participation in social
      activities and pain interaction) and 1 question from the intensity of pain. Each item has 5
      answer options (from 1 to 5), only pain intensity has 11 answer options (from 0 to 10). From
      the sum of the answers to each question in the domain, the total raw score for each domain is
      calculated, resulting in seven domain scores, each between 4 and 20. SF-36 is the most widely
      used scale to assess general health status, and 36 items question 8 content (physical
      function, physical role, pain, general health, social function, energy / fitness, social
      function, emotional role, mental health). The Turkish translation of the PROMIS 29
      questionnaire is presented in ANNEX-2.

      The translation of the PROMIS 29 questionnaire into Turkish was made by Northwestern
      University according to the FACIT translation method. Its Turkish translation was obtained
      from Northwestern University by signing a license agreement for use in scientific research.

      Participants will first be asked to sign the informed consent form electronically. PROMIS 29
      and SF-36 v2 forms will be sent to the volunteers via e-mail and will be asked to respond via
      an internet-based questionnaire platform.

      The external validity of the PROMIS 29 questionnaire will be evaluated by its correlation
      with the SF-36 v2, a similar general health profile questionnaire.

      To evaluate inter-rater test-retest reliability, both scales will be filled in by patients a
      second time between 7-14 days.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Persons who applied to the Acibadem Maslak Hospital Orthopedics and Traumatology department
        and were diagnosed with a chronic musculoskeletal disease by orthopedists will be included
        in the study.
Anti-Cytokine Therapy for Hemodialysis InflammatION
Condition: End-Stage Renal Disease
MeSH terms: Kidney Failure, Chronic; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      Anti-Cytokine Therapy for Hemodialysis InflammatION (ACTION) is a phase II multi-center study
      to evaluate the safety and tolerability of anakinra, an IL-1 receptor antagonist, for
      patients treated with maintenance hemodialysis.
    

Detailed description: 
      The ACTION Trial will enroll 80 participants being treated with maintenance hemodialysis for
      end-stage renal disease. Participants will be randomized to receive Anakinra, 100 mg
      administered intravenously 3 times per week at the end of the hemodialysis session, or
      matched placebo. The duration of study drug administration is 24 weeks. There will be an
      additional 24 weeks of follow-up after study drug administration has been completed.
    

Intervention name(s): Anakinra; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Anakinra (Kineret®) is a therapeutic agent that blocks the effects of IL-1α and IL-1β by competitively binding to the interleukin-1 type I receptor (IL-1RI). It is a recombinant, non-glycosylated form of the naturally occurring human interleukin-1 receptor antagonist (IL-1Ra) but differs from human IL-1Ra in that it has the addition of a single methionine residue at the amino terminus. It is supplied commercially in single use 1 ml prefilled glass syringes as a sterile, clear, colorless-to-white, preservative free solution. Each syringe contains: 0.67 ml (100 mg) of anakinra in a solution (pH 6.5) containing sodium citrate (1.29 mg), sodium chloride (5.48 mg), disodium EDTA (0.12 mg) and polysorbate 80 (0.70 mg) in Water for Injection, USP.; Saline (0.9%) will be used as the placebo, in single use 1 ml prefilled glass syringes as a sterile, clear, colorless-to-white, preservative free solution.
Other intervention name(s): Kineret®
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ESRD; End-Stage Kidney Disease
A Study of LY2623091 in Participants With High Blood Pressure
Condition: Primary Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to evaluate the safety and effectiveness of the study drug
      known as LY2623091 in participants with high blood pressure.
    


Intervention name(s): LY2623091; Tadalafil; Spironolactone; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally; Administered orally
Other intervention name(s): Mineralocorticoid Receptor Antagonist; LY450190
Intervention MeSH terms: Spironolactone; Tadalafil; Mineralocorticoid Receptor Antagonists; Mineralocorticoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis
Condition: Lymphocytic Colitis
MeSH terms: Colitis; Colitis, Lymphocytic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether budesonide or mesalazine is more active in
      the treatment of lymphocytic colitis.
    


Intervention name(s): Budesonide; Mesalamine; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): 9 mg per day; 3 g per day; 0 g per day
Intervention MeSH terms: Budesonide; Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment