bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Type 2 Diabetic Patients With Dyslipidemia
Condition: Diabetes Mellitus; Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a phase IV, randomized, open-label, parallel-arm, comparative and forced- titration
      study to compare the efficacy and safety of rosuvastatin versus simvastatin in patients with
      type 2 DM and dyslipidemia. When comparing the efficacy of rosuvastatin 20 mg with
      simvastatin 40 mg for the treatment of type 2 DM with dyslipidemia, rosuvastatin 20 mg is
      superior to simvastatin 40 mg in achieving the combined goal of LDL-C (<100 mg/dL) and
      non-HDL-C (<130 mg/dL).
    

Detailed description: 
      The duration of patient participation will be 18 weeks consisting of a 1-week screening
      period, a 5-week lead-in period, followed by a 12-week treatment period.
    

Intervention name(s): Rosuvastatin; Simvastatin
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg rosuvastatin for 4 weeks followed by rosuvastatin or another 12 weeks; 20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks
Other intervention name(s): crestor; zocor
Intervention MeSH terms: Rosuvastatin Calcium; Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Clinical Pharmacist-led Discharge Education Service in Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional

Summary: 
      To evaluate the impact of clinical pharmacist-led discharge education service in patients
      with acute coronary syndrome.
    

Detailed description: 
      This prospective, randomized controlled study was conducted in patients with acute coronary
      syndrome in an cardiology service of tertiary training and research hospital. The clinical
      pharmacist, within the scope of the discharge education services, provided medication
      reconciliation, medication review, individually prepared patient medicine (pill) card,
      patient education (based on Health Belief Model by using written material and video, and
      verbally [by using Teach back method especially for patients with low health literacy]) and
      counseling (using behavior change techniques based on The Capability, Opportunity, and
      Motivation Behavior model). The control group received standard care.
    

Intervention name(s): Discharge Education Program
Intervention type(s): Behavioral
Intervention description(s): medication reconciliation, medication review, individually prepared patient medicine (pill) card, patient education (based on Health Belief Model by using written material and video, and verbally [by using Teach back method especially for patients with low health literacy]) and counseling (using behavior change techniques based on The Capability, Opportunity, and Motivation Behavior model).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants
Condition: Procedural Pain
MeSH terms: Pain, Procedural
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess whether an instrument, the Laser Doppler Imager, is
      able to measure the effect of pain related changes in skin blood flow in newborn infants. The
      study will also determine whether the use of sucrose (sugar water) when given by mouth has
      any effect on pain related skin blood flow changes.
    

Detailed description: 
      During the last 25 years evidence that newborns can experience pain has been increasing.
      Painful procedures (injections, heel lances, and circumcisions) are part of normal routine
      newborn care. Studies have demonstrated that newborns have increased sensitivity to pain when
      compared with older children and adults. Pain assessment and management is an important
      component in the overall care of the newborn infant and safe, effective analgesics are
      needed.

      Pain assessment is complicated by the infants' verbal and cognitive limitations. Heart rate,
      blood pressure and oxygen saturation are commonly monitored in the nursery in response to
      pain, yet these parameters are affected by handling, illness, medications, as well as by
      pain. Skin blood flow has been documented to increase in premature newborns undergoing
      painful procedures in the Newborn Intensive Care Nursery. In the present study, Laser Doppler
      Imager technology will be used to define changes in skin blood flow response to heel lance
      and oral sucrose administration in normal newborn infants.
    

Intervention name(s): sucrose 24% oral solution; sterile water
Intervention type(s): Drug; Drug
Intervention description(s): sucrose 24% oral solution 2 ml one time only dose administered by mouth prior to heel lance; sterile water 2 ml single dose to be administered orally one time prior to heel lance
Other intervention name(s): Oral sucrose solution; sterile water U.S.P.
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Procedural Pain in Newborn Infants; newborn infant; acute procedural pain; skin blood flow changes; sucrose analgesia; laser doppler imager; neonatal infant pain scale
Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to test the therapeutic benefit of the compound PYM50028, versus placebo, in treating
      early-stage Parkinson's disease. Therapeutic benefit will be assessed using the Unified
      Parkinson's Disease Rating Scale (UPDRS). It is hypothesised that PYM50028 will be safe and
      well tolerated in this study and demonstrate therapeutic benefit in this patient population.
    


Intervention name(s): PYM50028; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IMP; Matching placebo comprising identical vehicle to active doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Early-stage
Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis
Condition: Alcoholic Hepatitis; Control Patients
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Alcoholic
Study type: Observational

Summary: 
      Purpose: To improve the diagnosis and assessment of severity of acute alcoholic hepatitis
      Participants: Patients admitted to one of ten centers with acute alcoholic hepatitis
      Procedures (methods): Consecutive patients admitted with acute alcoholic hepatitis will be
      enrolled in an NIH U01 study of acute alcoholic hepatitis where liver tissue, blood and stool
      will be collected to discover and validate factors associated with diagnosis, severity of
      disease and survival.
    

Detailed description: 
      The development of new targeted therapies for alcoholic hepatitis (AH) is one of the more
      urgent needs in clinical hepatology. To reach this goal, large multidisciplinary networks are
      required. The proposed initiative "Integrated Approaches for Identifying Molecular Targets in
      Alcoholic Hepatitis" (InTeam) will coordinate a multidisciplinary group composed of
      clinicians, physician-scientists, basic scientists and bioinformatics experts. The
      overarching hypothesis of InTeam is that the most rational way to provide a useful framework
      for future clinical trials in (AH) consists of the (i) determination of key drivers of the
      disease process, (ii) classification of molecular profiles and subtypes of AH, and (iii)
      identification of "druggable" targets based on both key drivers and molecular classification.
      Moreover, mouse models for AH are lacking making it impossible to evaluate promising targets
      in preclinical mouse studies in a meaningful manner. For this purpose, InTeam will integrate
      data obtained from molecular pathology studies in human AH and functional studies of key
      pathways in animal models. The proposed InTeam consortium includes three research projects,
      ten clinical centers, a Human Biorepository and a Mouse Models Core. The Human Biorepository
      Core will generate the to-date largest collection of samples from patients with AH from 10
      academic liver centers and a comprehensive database that will serve as a basis for the
      proposed translational studies and be a valuable asset for the broader scientific community.
      The Mouse Models core will conduct murine studies after establishing and evaluating mouse
      models of AH based on the pathophysiology and molecular drivers of human AH determined by
      this consortium.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with an episode of alcoholic hepatitis fulfilling the inclusion criteria will be
        eligible to participate in the study. Those patients who meet one or more exclusion
        criteria will not be included.

        Control patients
      
Biospecimen description: 
      Serum, Plasma, Whole Blood DNA, PBMCs, Urine, Stool, Liver Biopsy
Representation of the Bladder Innervation Using Diffusion Tensor Imaging Fiber Tracking With MRI - a Pilot Study
Condition: Spinal Cord Injury; Neurogenic Lower Urinary Tract Dysfunction
MeSH terms: Spinal Cord Injuries
Study type: Observational

Summary: 
      The exact innervation of the bladder and the changes after a spinal cord injury have been not
      yet been illustrated.

      Diffusion tensor imaging with magnetic resonance imaging is a new technique which can be used
      to visualize single nerve fibers, and thus represent the neural supply of a region in vivo.
      There are studies in which both the sacral plexus and the lumbar nerve roots have been
      represented using diffusion tensor imaging. However, there is no study concerning the
      innervation of the bladder.

      The investigators are therefore using diffusion tensor imaging with magnetic resonance
      imaging to represent the bladder innervation of individuals with neurogenic lower urinary
      tract dysfunction and individuals with normal bladder function.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        individuals with and without neurogenic lower urinary trat dysfunction
      
Keywords: diffusion tensor imaging fiber tracking; magnetic resonance Imaging; spinal cord injury; neurogenic lower urinary tract dysfunction
Photobiomodulation On Muscle Recovery In Professional Soccer Players
Condition: Muscle Development
Study type: Interventional

Summary: 
      Background: Photobiomodulation with low-level laser therapy (LLLT) has been widely used in
      clinical practice for diverse purposes, such as modulation of the inflammatory process,
      acceleration of the tissue repair process, pain relief and the enhancement of post-exercise
      recovery. Studies have demonstrated a beneficial interaction between photobiomodulation and
      the production of creatine kinase, with a reduction in the release of this marker of muscle
      damage when laser and/or LEDs is administered prior to high-intensity physical activity. The
      aim of the proposed study is to determine the influence of pre-exercise phototherapy on
      post-exercise muscle recovery.

      Methods: A randomized, cross-over, sham-controlled, double-blind, clinical trial is proposed.
      The participants will be healthy professional soccer players aged 15 to 20 years from the
      same team with a body mass index within the ideal range (20 to 25 kg/m2) and no history of
      lower limb musculoskeletal injuries or surgery or back surgery in the previous six months.
      The athletes will be allocated to two groups based on the previously calculated sample size
      and will be blinded to allocation. Creatine kinase will be measured and the subjective
      perception of fatigue will be determined for each participant. The volunteers will then be
      randomly allocated to Group A, which will receive active phototherapy, and Group B, which
      will receive sham phototherapy. The athletes will undergo reevaluations immediately after as
      well as 48 hours after a football match. The data will be submitted to statistical analysis
      and the level of significance will be set to 5%.
    


Intervention name(s): phototherapy
Intervention type(s): Other
Intervention description(s): Phototherapy will be performed using clusters of 12 diodes (Table 1); four 905 nm diodes (mean power of 0.3125 mW and peak power of 12.5 W for each diode; 250 Hz), four 875 nm diodes (mean power of 17.5 mW for each diode) and four 640 nm diodes (mean power of 15 mW for each diode). The device manufactured by Multi Radiance Medical® (Solon, OH, USA) will be used due to its high quality, ample use in clinical practice and due to the fact that no national companies manufacture diode clusters with the characteristics required for the proposed project.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Photherapy; Photobiomodulation; Creatine Kinase; Soccer; Muscle Recovery
LMN-101 in a Campylobacter Human Challenge Model
Condition: Campylobacter Infections
MeSH terms: Campylobacter Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized, double-blind, placebo-controlled, single dose regimen study of LMN-101 followed
      by Campylobacter jejuni challenge. Subjects will initially, after documentation of informed
      consent, begin taking their assigned LMN-101 or placebo regimen three times daily. After two
      days, subjects will receive the C. jejuni challenge inoculum. Subjects will begin an
      appropriate antibiotic course upon meeting early treatment criteria or 144 hours following C.
      jejuni challenge, whichever is earlier. Subjects will be allowed to leave the clinical
      research facility 3 days after antibiotics, when all symptoms have resolved or are resolving,
      and have had ≥ 2 consecutive stool cultures ≥ 12 hours apart negative for C. jejuni and are
      afebrile > 24 hours prior to release and off antipyretics within 24 hours of discharge.
      Subjects will continue taking their LMN-101 or placebo regimen three times daily for a total
      of 14 days. Subjects will be provided a diary card/memory aid and thermometer for at-home
      monitoring of solicited adverse events through Day 24. Subjects will be seen at research
      facility for protocol-specified evaluations and will also be contacted by telephone 6 months
      after challenge.
    


Intervention name(s): LMN-101; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): VHH-derived binding protein designed to bind and inhibit FlaA, flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, spirulina biomass; Identical appearing placebo
Other intervention name(s): Variable heavy chain (VHH) binding protein against flagellin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Healthy adults are treated with LMN-101 or placebo followed by an oral challenge of campylobacter to measure protective efficacy against campylobacteriosis.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effects of Cranberry Juice on Cardiovascular Risk Factors
Condition: Cardiovascular Disease Risk Factors
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of cranberry juice on central and
      peripheral blood pressure, indices of arterial stiffness, lipid and lipoprotein
      concentrations and size characteristics, and HDL function. The investigators hypothesize that
      the bioactive compounds in cranberry juice may elicit beneficial effects on blood pressure
      and arterial health, as well as LDL-C and HDL function.
    

Detailed description: 
      The investigators propose to conduct a 2-period randomized, crossover, placebo-controlled
      study to evaluate the effect of cranberry juice on central and peripheral blood pressure,
      indices of arterial stiffness, lipid and lipoprotein concentrations and size characteristics,
      and HDL function. Eligibility requires non-smoking men and women to be 30 to 65 years of age
      with BMI greater than or equal to 18 and less than or equal to 39, total cholesterol below
      273 mg/dL for men and below 284 mg/dL for women, triglycerides below 350 mg/dL, and have
      systolic blood pressure of 120 to 159 mmHg and/or diastolic blood pressure of 80 to 99 mmHg.
      Subjects will undergo randomized treatments including 500 mL/d cranberry juice beverage and
      500 mL/d of a color and taste matched placebo beverage. The two 8 to 12 week treatment
      periods will be separated by an 8 week washout.
    

Intervention name(s): Cranberry Juice Beverage; Placebo Beverage
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 16 ounces of 54% cranberry juice cocktail; Color, calorie, and taste matched beverage without cranberry bioactives
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cranberries; blood pressure; cholesterol; SphygmoCor
An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury
Condition: Obesity; Over-weight; Hypothalamic Injury; Craniopharyngioma
MeSH terms: Craniopharyngioma; Adamantinoma; Overweight; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of
      beloranib in obese subjects with hypothalamic injury.
    


Intervention name(s): ZGN-440 sterile diluent; ZGN-440 for injectable suspension
Intervention type(s): Drug; Drug
Intervention description(s): ZGN-440 sterile diluent/placebo
Other intervention name(s): Placebo; ZGN-440; Beloranib
Intervention MeSH terms: CKD732
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Beloranib; ZGN-440; ZGN-440 for injectable suspension; ZGN-433
Clinical Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      • This is a single-center, open-label, single-arm study with a double-blind,
      placebo-controlled, randomized withdrawal extension. Patients are initiated on a DCCR dose of
      about 1.5 mg/kg (maximum starting dose of 145 mg) and are titrated every 14 days to about 2.4
      mg/kg, 3.3 mg/kg, 4.2 mg/kg, and 5.1 mg/kg (maximum dose of 507.5 mg). These DCCR doses are
      equivalent to diazoxide doses of 1.03, 1.66, 2.28, 2.9, and 3.52 mg/kg. The administered dose
      will be as close to the mg/kg dosing as can be achieved by the available dose strengths of
      DCCR. Patients will be up-titrated at each visit at the discretion of the investigator. All
      patients will be continued in the double-blind, placebo-controlled, randomized withdrawal
      extension. Any patient who showed an increase in resting energy expenditure and/or a
      reduction in hyperphagia from Baseline through Day 55 or Day 69 will be designated a
      responder, whereas all others will be designated non-responders. Responders will be
      randomized in a 1:1 ratio either to continue on active treatment at the dose they were
      treated with on Day 69 or to the placebo equivalent of that dose for an additional 4 weeks.
      Non-responders will continue open label treatment during the extension.
    


Intervention name(s): DCCR; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Diazoxide Choline Controlled-Release Tablet
Intervention MeSH terms: Diazoxide; Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prader-Willi syndrome
Study of Benznidazole Transfer Into Breastmilk in Lactating Women With Chagas Disease
Condition: Chagas Disease; Lactation
MeSH terms: Chagas Disease
Study type: Observational

Summary: 
      The investigators propose to study the transfer of benznidazole into breastmilk from the
      blood of lactating women who receive the drug for the treatment of Chagas disease. Breastmilk
      and blood samples will be obtained from these patients at given times after they take the
      clinically indicated medication, and the concentrations in both matrices will be compared to
      estimate degree of transfer, which in turn will be used to evaluate potential degree of
      exposure of infants breastfed by these women. This study will help clarify safety of
      continuing breastfeeding while receiving treatment with benznidazole for Chagas disease.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        population of young women with Chagas disease referred to our center for evaluation and
        treatment
      
Biospecimen description: 
      breastmilk; plasma
    
Keywords: Chagas disease; lactation; breastmilk; postpartum period; infants; pediatric clinical pharmacology; developmental clinical pharmacology; parasitology; trypanosoma cruzi
Effects of T-bet B Cells in Persistent Virus Control After Discontinuance of NAs in CHB Patients
Condition: Chronic HBV Infection; Drug Withdrawal
MeSH terms: Substance Withdrawal Syndrome
Study type: Observational

Summary: 
      The immune mechanism of the nucleos(t)ide analogs (NAs) in inhibiting HBV replication
      effectively while having a low sustained virus control rate after drug withdrawal is unclear.
      B cell immunity and antibody response are the keys to prevent HBV reinfection and keep the
      virus under control. T-bet+ B, which can be regulated by IL-21, is a newly discovered major
      effector B cell in protection of pathogens and it is a main subtype of HBsAg-specific B
      cells. Thus, we suspect that T-bet+ B may play a role in ongoing controlling of the virus
      after withdraw of NAs in CHB patient. Based on our previous studies on CHB immunity, we use
      the RNAseq analyse, flow cytometry, and Elispot assay to analyze the frequency, function, and
      phenotype of B cells in CHB patients with different profiles after withdraw of NAs.
    


Intervention name(s): T-bet B cell
Intervention type(s): Diagnostic Test
Intervention description(s): The frequency, function, and phenotype of T-bet B cells was tested
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        CHB patients on NAs therapy
      
Biospecimen description: 
      pbmc
    
Keywords: transcription factor bet; chronic hepatitis B; nucleotide analogs; function cure; B cell