bioihbjkbjnl/mcl2 huggingface dataset:
Sacubitril/Valsartan Versus Valsartan in Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study was to identify potential prognostic factors of
      sacubitril/valsartan vs Valsartan treatment response.
    

Detailed description: 
      Study will include 80 symptomatic patients with chronic HFrEF (left ventricular ejection
      fraction ≤35%) and New York Heart Association (NYHA) class II/III: Group 1 (N = 40) received
      sacubitril/valsartan (target dose, 100 mg twice daily) or group 2 received valsartan (target
      dose, 80 mg twice daily) in addition to recommended therapy according to physician's
      judgment. Analysis of biochemical parameters, cardiopulmonary exercise testing, and
      echocardiographic evaluation was performed at baseline and 6 months later. The primary
      outcome was the change in LVEF%, Lipo A, troponin I, NT-Pro BNP and neopterin levels. The
      secondary outcome is reporting efficacy and safety of sacubitril/valsartan vs Valsartan use
      and the relationship between NYHA and EF and biomarkers.
    

Intervention name(s): Sacubitril / Valsartan Oral Tablet; Valsartan 80 mg
Intervention type(s): Drug; Drug
Intervention description(s): Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) in addition to recommended therapy according to physician's judgment.; group 2 received valsartan (N=40, target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment.
Other intervention name(s): sacubitril / valsartan (100 mg twice daily); Valsartan
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) or group 2 received valsartan (target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: LVEF%,; Lipo A,; troponin I,; NT-Pro BNP,; neopterin
Single-Dose Islatravir in Moderate Hepatic Impairment (MK-8591-030)
Condition: Human Immunodeficiency Virus (HIV) Infection
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-dose study of the plasma pharmacokinetics (PK), safety, and
      tolerability of islatravir (ISL, MK-8591), and the intracellular PK of ISL triphosphate
      (ISL-TP) in male and female adult participants with moderate hepatic impairment and in
      healthy matched control participants.
    


Intervention name(s): Islatravir
Intervention type(s): Drug
Intervention description(s): Two ISL 30 mg capsules taken by mouth.
Other intervention name(s): MK-8591
Intervention MeSH terms: Islatravir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of OSE-127 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a first-in-human phase I randomised, double-blind, placebo-controlled,
      evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity
      of Single (IV and SC) and Multiple (IV only) Ascending Doses of OSE-127 in Healthy Subjects.
    


Intervention name(s): OSE-127; Placebo; OSE-127
Intervention type(s): Drug; Drug; Drug
Intervention description(s): mAb antagonist to CD127 receptor (or IL-7Rα)
Group 1-7
6 escalating dose level groups IV
SC; Vehicle study drug; mAb antagonist to CD127 receptor (or IL-7Rα)
Group 8-9
2 escalating dose level groups IV
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part 1 (SAD) primary objective : safety and tolerability profile of single ascending IV (Cohort A) and SC (Cohort B) doses given to healthy subjects, compared to placebo.
Part 2 (MAD) primary objective : safety and tolerability profile of two IV doses given on two separate occasions to healthy subjects, compared to placebo.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CD127/IL-7Rα Antagonist; Auto-Immune Diseases; inflammatory bowel diseases; Ulcerative Colitis
Evaluation of Post-Operative Recovery in ATTUNE® Total Knee Arthroplasty
Condition: Non-inflammatory Degenerative Joint Disease
MeSH terms: Joint Diseases; Osteoarthritis
Study type: Observational

Summary: 
      This post-marketing investigation will evaluate the rate of recovery of the ATTUNE knee from
      the time of surgery through the 6 month endpoint in patients with severely painful and/or
      severely disabling Non-inflammatory Degenerative Joint Disease (NIDJD).
    

Detailed description: 
      This study is designed as a prospective, multi-center, non-randomized, non-comparative,
      non-controlled study. A sample size of N=200 subjects will be implanted at up to 4 sites in
      the Netherlands. Each site is expected to implant approximately 50 Subjects (50 knees).

      This study allows the participating surgeon to choose the type of ATTUNE implant they would
      ordinarily use in standard practice. Both resurfaced patellae and non-resurfaced patellae are
      permitted in this investigation; consistent with the surgeons standard of care.

      Subjects will receive one of four available implants: cruciate retaining fixed bearing (CR
      FB), cruciate retaining rotating platform (CR RP), posterior stabilized fixed bearing (PS
      FB), and posterior stabilized rotating platform (PS RP).
    

Intervention name(s): ATTUNE Primary, Cemented Total Knee Replacement
Intervention type(s): Device
Intervention description(s): Patients will undergo a primary total knee replacement using one of the four implant configurations of the ATTUNE knee ( CR FB, CR RP, PS FB, PS RP).
Keywords: Osteoarthritis; Post-traumatic Arthritis
Aerosol Particle Concentrations Among Different Oxygen Devices for Spontaneous Breathing Patients With Tracheostomy
Condition: Transmission, Patient-Professional
Study type: Interventional

Summary: 
      For spontaneous breathing patients with tracheostomy, whose lower airway is directly opened
      to the room air, the aerosol particles generated by the patients would be directly dispersed
      into the room air, which might be an direct resource of virus transmission. However, the
      transmission risk has not been evaluated and the appropriate humidification therapy is
      unknown. Thus this study is aimed to investigate the aerosol particle concentrations among
      different oxygen devices for spontaneous breathing patients with tracheostomy, in order to
      reflect the transmission risk.
    

Detailed description: 
      The transmission route of the SARS-CoV-2 virus remains controversial, and concerns persist of
      potentially increased virus transmission when utilizing high-flow devices and aerosol devices
      among COVID-19 patients. For spontaneous breathing patients with tracheostomy, whose lower
      airway is directly opened to the room air, the aerosol particles generated by the patients
      would be directly dispersed into the room air, which might be an direct resource of virus
      transmission. However, the transmission risk of tracheostomy during spontaneous breathing has
      not been evaluated and the appropriate humidification therapy is unknown. Thus this study is
      aimed to investigate the aerosol particle concentrations among different oxygen devices for
      spontaneous breathing patients with tracheostomy, in order to reflect the transmission risk.
    

Intervention name(s): high-flow high humidity oxygen device with tracheostomy adapter
Intervention type(s): Device
Intervention description(s): This device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.
Other intervention name(s): Airvo2, Fisher & Paykel Healthcare Ltd
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: five oxygen and humidification different devices will be used for the enrolled patients, with 5 minutes each. Aerosol particle concentrations at 1 foot away from the patients will be measured.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: aerosol generating procedure; tracheostomy; oxygen therapy
A Comparison of Long-Term Effectiveness of Two Desensitizing Products
Condition: Dentin Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      This randomized, controlled, clinical trial aimed to compare the 6- month clinical
      performance of a desensitizer that contains calcium phosphate TM with a two-step self-etch
      adhesive SE and placebo (distilled water). At least 150 teeth wil be treated with
      desensitizing products and placebo randomly one third usig TM, one third using SE and one
      third using placebo. The efficiency of the materials will be evaluated at baseline, 1 week, 1
      month, 3 months and 6 months after treatment.
    

Detailed description: 
      The aim of this randomized, controlled, clinical trial is to compare the clinical efficacy of
      a desensitizer that contains calcium phosphate with a two-step self-etch adhesive and placebo
      through a long-term period (6 months). At least fifty patients with a sensitivity score of 6
      or higher, according to the Visual Analog Scale (VAS), with at least three teeth will
      participate in this study. Teethmate Desensitizer (TM), Clearfil SE Bond 2 (SE) and placebo
      (distilled water) will be applied randomly to three teeth of each patient. Recalls will be
      done at baseline, 1 week, 1 month, 3 months and 6 months after treatment by applying
      air-blast and the sensitivity scores will be determined according to VAS. The efficiency of
      the materials will be determined according to the VAS scores. Data will be analyzed using
      Paired t test and repeated measures of ANOVA.
    

Intervention name(s): Teethmate Desensitizer (TM); Clearfil SE Bond 2; Distilled water
Intervention type(s): Other; Other; Other
Intervention description(s): Desensitizing agent will be applied to sensitive teeth.; Desensitizing agent will be applied to sensitive teeth.; Placebo will be applied to sensitive teeth as a negative control.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: For each patient, selected teeth will be randomly assigned to TM, SE or placebo by the lottery method. The subjects will blind to the agent being used. All applications will be performed by the same examiner.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dentin hypersensitivity; Randomized clinical trial; Calcium phosphate desensitizer; Adhesive resin; VAS
FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of Response to Antiviral Therapy
Condition: Chronic Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Observational

Summary: 
      The main objective of this study is to assess whether a recently-developed bioassay for the
      protein FGL2 can be used to predict the progression and/or response to treatment of Hepatitis
      C Virus disease in patients with chronic HCV infection. The hypothesis is that increased
      levels of FGL2 and increased numbers of T regulatory cells are associated with a failure to
      respond to treatment.
    

Detailed description: 
      The current therapy for chronic Hepatitis C Virus infection leads to a sustained viral
      response in only 50% of treated patients. Evidence suggests that a poor response to treatment
      may be the result of a dysfunction of immunoregulatory mediators including T regulatory cells
      (Tregs) which secrete FGL2. The aim of this study is to test whether serum FGL2 levels can
      serve as a biomarker for clinical progress and treatment response in patients undergoing
      anti-viral therapy for chronic HCV infection.

      This study will measure the blood Treg and FGL2 levels of patients with chronic Hepatitis C
      as they undergo antiviral therapy and will compare those levels to their pre-treatment and
      post-treatment levels. Treg and FGL2 expression levels will also be measured in patients'
      liver biopsy tissue when available.

      Additionally, this study will examine the main form(s)of Fc Receptor expressed in these
      patients. The Fc receptor is the hypothesized binding partner of FGL2, and the form expressed
      in a given patient may determine the downstream effects of FGL2's binding. These data along
      with clinical, biochemical and virological data will be used to determine whether there is a
      correlation between FGL2 levels and disease outcome and/or treatment response.

      The study will also recruit a group of normal healthy volunteers to give blood samples on two
      occasions so that the baseline range of FGL2 levels in healthy individuals can be established
      for comparison.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): None. This is an observational study.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chronic HCV treatment-naive patients who are willing to begin antiviral therapy
      
Biospecimen description: 
      Whole Blood Plasma Liver tissue from biopsy
    
Keywords: Antiviral therapy
Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants
Condition: Infection, Viral, Enterovirus
MeSH terms: Virus Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, placebo-controlled, double-blind clinical trial is to evaluate the safety and
      immunogenicity of a new inactivated EV71 vaccine developed by Sinovac Biotech CO., LTD.
    


Intervention name(s): 100U EV71 vaccine with adjuvant; 200 U EV71 vaccine with adjuvant; 400U EV71 vaccine with adjuvant; 200U EV71 vaccine without adjuvant; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): inactivated vaccine (vero cell) against EV71 of 100U /0.5ml, two doses, 28 days interval; inactivated vaccine (vero cell) against EV71 of 200U /0.5ml, two doses, 28 days interval; inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval; inactivated vaccine (vero cell) against EV71 without adjuvant of 200U /0.5ml, two doses, 28 days interval; 0.5ml placebo, two doses, 28 days interval
Other intervention name(s): EV71 vaccine; EV71 vaccine; EV71 vaccine; EV71 vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Ascending Dose (SAD) of CAN106 Administered Intravenously (IV) in Healthy Subjects
Condition: PNH
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single site, single dose escalation study in healthy subject with CAN106. The study
      is to assess the safety and tolerability of single escalating doses of CAN106; to
      characterize the PK and PD profile of CAN106; and to evaluate the immunogenicity of CAN106
      injection.
    


Intervention name(s): CAN106; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CAN106 is a selective inhibitor of complement activation, which binds to the complement component C5.; placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Central European Society for Anticancer Research (CESAR) Study of Paclitaxel Therapeutic Drug Monitoring
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will be performed on grade IIIb and grade IV Non Small Cell Lung Cancer (NSCLC)
      chemotherapy naive patients with good performance status. In course of this study, patients
      will be treated with Paclitaxel in combination with either Cisplatin or Carboplatin in a
      maximum of six therapy cycles. The goal of this study is to determine, if a pharmakokinetic
      driven dose adaptation of paclitaxel leads to a reduction of of grade 4 neutropenia, compared
      to conventional Paclitaxel dosing, without affecting progression free survival and overall
      survival.

      This study includes a biomarker analysis and an optional genetic substudy.
    


Intervention name(s): Paclitaxel dosing according to SmPC; Individualized pharmacokinetically driven paclitaxel dosing
Intervention type(s): Drug; Drug
Intervention description(s): Paclitaxel i.V. Up to 6 cycles Dosing according to SmPC; Paclitaxel i.V. Up to 6 cycles Dosing based on patient age, gender, severity of neutropenia and Paclitaxel plasma concentration
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      -  To evaluate the safety and tolerability of escalating single doses of CAT-1004 relative
           to placebo in healthy adult volunteers.

        -  To evaluate the pharmacokinetics (PK) of escalating single doses of CAT-1004 in healthy
           adult volunteers.

        -  To evaluate the effect of a high-fat meal on single doses of CAT-1004 in healthy adult
           volunteers.
    


Intervention name(s): Drug; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.; Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
Other intervention name(s): CAT-1004
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Human healthy volunteers
Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy
Condition: Cerebral Palsy (CP)
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Phase 1

Summary: 
      A double-blind, placebo-controlled, crossover study in subjects with cerebral palsy (CP) to
      evaluate the safety and tolerability and the effect of dalfampridine extended release (ER)
      tablets on sensorimotor function
    


Intervention name(s): dalfampridine-ER 10mg; Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of repeated dosing of once-daily 25, 50
      and 75 mg opicapone (OPC, development code BIA 9-1067) on the levodopa pharmacokinetics (PK),
      in comparison to placebo and 200 mg entacapone (ENT).
    

Detailed description: 
      This study was a single-centre, randomized, double-blind, gender-balanced, placebo-controlled
      study in 4 groups of 20 healthy subjects each (10 male and 10 female). The clinical part
      included a screening examination within 3 weeks before the first institutionalization, an
      ambulatory period of 11 days (from Day 1 evening to Day 11 evening), during which the
      subjects returned to the clinical unit every evening, followed by an institutionalization of
      1.5 days (from Day 11 evening to Day 13 morning (i.e. 14 h after the third administration of
      levodopa/carbidopa). Then, a follow-up visit at 5 to 9 days after collection of the last PK
      blood sample (i.e. Day 13). The maximum total duration of the clinical study, including the
      21-day screening period and the post-study follow-up, was expected to be about 39 to 43 days.
    

Intervention name(s): BIA 9-1067; Entacapone; Placebo; Levodopa/carbidopa
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): BIA 9-1067 25 mg and 50 mg; Entacapone (ENT), over-encapsulated tablet 200 mg; PLC, placebo; Levodopa/carbidopa, tablet 100/25 mg
Other intervention name(s): Opicapone, OPC; Comtan®, ENT; PLC, placebo; Sinemet®
Intervention MeSH terms: Levodopa; Carbidopa; Opicapone; Entacapone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease (PD); BIA 9-1067; Opicapone
Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study in individuals with early Alzheimer's disease is designed to assess:(1) safety and
      tolerability (2) the capacity of ACC-001 and QS-21 adjuvant to reduce brain amyloid load as
      measured by positron emission tomography (PET) scans.
    


Intervention name(s): ACC-001 3 μg/ QS-21 50 μg; ACC-001 10 μg/ QS-21 50 μg; Placebo- Phosphate buffered saline (PBS)
Intervention type(s): Biological; Biological; Other
Intervention description(s): ACC-001 3 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18; ACC-001 10 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18; Phosphate buffered saline IM on day 1, month 1, month 3, month 6, month 12, and month 18
Other intervention name(s): Vanutide Cridificar; Vanutide Cridificar
Intervention MeSH terms: Saponin QA-21V1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Early Alzheimer's disease; active immunization; amyloid imaging