bioihbjkbjnl/mcl2 huggingface dataset:
Senolytic Drugs Attenuate Osteoarthritis-Related Articular Cartilage Degeneration: A Clinical Trial
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase I/II randomized, double-blind, placebo-controlled clinical trial to test the safety and
      efficacy of Fisetin for treating mild to moderate osteoarthritis
    

Detailed description: 
      This is a Phase I/II randomized, double-blind, placebo-controlled clinical trial that will be
      conducted at The Steadman Clinic (TSC) and Steadman Philippon Research Institute (SPRI). The
      purpose of this study is to evaluate the clinical efficacy of Fisetin (FIS), a dietary
      supplement, in symptomatic knee osteoarthritis (OA) patients. Key aspects of this proposal
      include the investigator's well-developed methodologies to measure and compare systemic
      senescence-associated secretory phenotype (SASP) including inflammatory biomarkers and
      senescent cells, and collect magnetic resonance images, self-reported outcomes, physical
      performance and other objective clinical data. Given the drug FIS has been empirically
      demonstrated to reduce senescent cell burden, the main objective(s) are to determine 1) the
      safety of FIS during dosing and 2) whether FIS reduces senescent cells, pro-inflammatory and
      cartilage degenerating SASP markers, and reduces OA-symptoms leading to improved joint health
      and function.
    

Intervention name(s): Fisetin; Placebo oral capsule
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Fisetin will be administered orally at 20 mg/kg for two consecutive days, followed by 28 days off, then 2 more consecutive days.; Placebo will be administered orally for two consecutive days, followed by 28 days off, then 2 more consecutive days.
Other intervention name(s): Novusetin; 7,3',4'-flavon-3-ol; 3,3',4',7-tetrahydroxyflavone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fisetin; Inflammation; Osteoarthritis
A Randomized Phase 1 of of MZE001 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, single (SAD) / multiple
      (MAD) ascending dose and food effect study.
    

Detailed description: 
      Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and
      pharmacodynamics (PD) of orally administered MZE001 in healthy subjects, in fasted and fed
      states. Each SAD and MAD cohort will enroll 8 subjects randomized 6 active: 2 placebo to
      receive single or multiple doses of MZE001.
    

Intervention name(s): MZE001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Small molecule inhibitor of muscle glycogen synthase; Product containing excipients with no active ingredients
Other intervention name(s): MZ1449348; mannitol, silicified microcrystalline cellulose, magnesium stearate
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Metal on Metal Versus Ceramic on Metal Hip Replacement
Condition: Non-inflammatory Joint Diseases
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to compare the performance of artificial hips with metal heads
      and metal sockets to artificial hips with ceramic heads articulating with metal socket
      components. The success of the total hip arthroplasty (THA) will be based upon all of the
      following clinical and radiographic criteria being met at the two-year evaluation: (1) the
      patient's clinical results as measured using modified Harris Hip evaluation rating system,
      and the absence of a complication that requires the surgical removal or replacement of a
      component; and (2) radiographic findings at study endpoint (i.e., two years follow-up).
      Clinical and radiographic success at two (2) years postoperative is required for the study
      hip to be deemed successful.
    

Detailed description: 
      This study is a prospective, multi-center, randomized, single blind, controlled clinical
      investigation comparing the safety and efficacy of the cementless Ceramic on Metal total hip
      prostheses versus the cementless Metal on Metal total hip prostheses.
    

Intervention name(s): Total Hip Replacement; Total hip replacement
Intervention type(s): Device; Device
Intervention description(s): Total hip replacement; Total hip replacement
Other intervention name(s): Biolox Delta head; Ultamet insert; Pinnacle Acetabular shell; CoCr M-head, Ultamet insert, Pinnacle Acetabular shell
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Non-Inflammatory Degenerative Joint Disease
Effect of Omega-3 Fatty Acids on Insulin Sensitivity in Chinese Type 2 Diabetic Patients
Condition: Type 2 Diabetes; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      This study is to examine the change of fasting insulin, glucose, insulin sensitivity and
      related traits in response to the six month treatment of omega-3 fatty acids, including fish
      oil and flaxseed oil, in Chinese type 2 diabetic patients. Corn oil, rich in omega-6 fatty
      acids, will be selected as a controlled oil. The investigators hypothesize that omega-3 fatty
      acids could improve insulin sensitivity and glucose metabolism in Chinese type 2 diabetic
      patients.
    

Detailed description: 
      The insulin resistance will be estimated by a homeostatic model assessment model of insulin
      resistance (HOMA-IR)
    

Intervention name(s): Fish Oil Supplementation; Flaxseed Oil Supplementation; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: omega-3 fatty acids; randomized controlled trial
Adhesive Tape Trauma Evaluation of a New Gentle Tape in Healthy Infant Subjects
Condition: Skin (FLACC Scores of Test Subjects) After Tape Removal
Study type: Interventional

Summary: 
      The objective of this study is to determine the relative gentleness of a new medical tape.
    

Detailed description: 
      The objective of this study is to determine the relative gentleness of a new medical tape. A
      three-prong multidimensional evaluation consisting of expert grader, subject discomfort
      assessment, and laboratory assessments was used. One pre-study visit took place up to 7 days
      prior to the start of the study. The study was conducted over two days with one tape sample
      applied and removed. Assessments were taken on the final day. This was to mimic a normal tape
      application in health care practice.
    

Intervention name(s): Multi-Purpose Gentle Tape
Intervention type(s): Device
Intervention description(s): The Multi-Purpose Gentle Tape is a general purpose medical adhesive tape for medical applications used primarily to secure dressings, lightweight tubing, and devices to skin.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Hemodynamic Response in Surgery of Circumcision in Children
Condition: Children Who Need Circumcision
Study type: Interventional
Phase: Phase 4

Summary: 
      The surgery stress relives systemic inflammatory response by hormones and adrenergic
      receptors. When the pro-inflammatory mediator is higher than anti-inflammatory response, the
      physiologic status is impaired and the patient is more susceptible an infection and
      cardiovascular collapse. The anesthesia can abolish or minimize the surgery stress, improved
      more safety to the patient.

      This study is a double blind controlled trial with 40 patients divided in two groups (EMLA
      and Dorsal Penile Nerve Block - DPNB) submitted a standard inhalator anesthesia and
      postectomy surgery by Plastbell®. The investigators will be observe heart rate, respiratory
      rate, arterial pressure, involuntary movements during the surgery and pain in the
      pos-operatory.

      With this study, the investigators can define what tactic (EMLA or DPNB) associated a general
      anesthesia is more effective to relive the pain when children are submitted a postectomy by
      Plastbell®.
    


Intervention name(s): circumcision
Intervention type(s): Procedure
Intervention description(s): circumcision by plastbell
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: DPNB, pain, hemodynamics effects, circumcision
Development and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma
Condition: Asthma; Biomarkers
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Serum samples of asthmatic patients will be screened for serum biomarkers
    


Intervention name(s): Serum biomarker testing
Intervention type(s): Diagnostic Test
Intervention description(s): Serum and sputum samples will be collected and biomarkers will be evaluated using ELISA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Assessment of Central Sensitization, Neuropathic Pain, Sleep Quality and Daily Life Activities in Behcet's Disease
Condition: Behcet's Disease; Central Sensitisation
MeSH terms: Behcet Syndrome; Neuralgia
Study type: Observational [Patient Registry]

Summary: 
      There are few studies in the literature regarding increased frequency of neuropathic pain and
      sleep disturbance and decreased quality of life in Behçet's disease. Frequency of central
      sensitization was not investigated in patients with Behçet's disease before. In this study,
      it is aimed to investigate the frequency of central sensitization, neuropathic pain, sleep
      disorder and quality of life and their relation to each other in Behcet's disease.
    

Detailed description: 
      Central sensitization reduces the pain threshold in the pain pathways of the nervous system,
      causing pain sensation to be perceived with lower stimuli and often causing chronic pain.
      Central sensitization can be seen with many conditions such as neuropathic pain and sleep
      disorders, as well as with inflammatory diseases such as rheumatoid arthritis. There are few
      studies in the literature regarding increased frequency of neuropathic pain and sleep
      disturbance and decreased quality of life in Behçet's disease. Frequency of central
      sensitization was not investigated in patients with Behçet's disease before. In this study,
      it is aimed to investigate the frequency of central sensitization, neuropathic pain, sleep
      disorder and quality of life and their relation to each other in patients with Behcet's
      disease and healthy controls.
    

Intervention name(s): Central sensitisation; Neuropathic pain; Sleep disturbance; Quality of life
Intervention type(s): Diagnostic Test; Diagnostic Test; Other; Other
Intervention description(s): Central Sensitization Inventory, which is a comprehensive self-report inventory to assess the overlapping symptom dimensions of central sensitisation syndrome will be used to identify participants with central sensitisation.; Frequency of neuropatic pain will be investigated using Pain Detect Questionnaire; Assessment of sleep disturbance will be assessed by Pittsburgh Sleep Quality Index; Quality of life will be assessed by the Nottingham Health Profile
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population consists of participants who are between age 18-75, not pregnant and who
        were not diagnosed previously with diabetes mellitus or chronic renal failure
      
Keywords: Behcet's disease; Central sensitisation; Neuropathic pain; Sleep disturbance
Trial to Evaluate Safety and Immunogenicity of Trivalent Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant)
Condition: Seasonal Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2A randomized, double blind, placebo controlled trial to evaluate the safety
      and immunogenicity of a trivalent seasonal influenza virus-like particle (VLP) vaccine
      (recombinant) in healthy adults.
    

Detailed description: 
      The primary study objectives are:

        -  To assess the tolerability and safety of the Influenza VLP Vaccine

        -  To assess the immunogenicity of the Influenza VLP Vaccine as measured by
           hemagglutination inhibition (HAI) antibody titers to each of the component viral strains
    

Intervention name(s): Influenza VLP Vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): phosphate-buffered saline (PBS)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Compare the Quadriceps Function of Adductor Canal Block Versus Femoral Nerve Block With Electromyography Following Total Knee Arthroplasty
Condition: Quadriceps Function Monitored With Electromyography
Study type: Interventional

Summary: 
      Adductor canal block and femoral nerve block are the most commonly used nerve blocks for pain
      control after total knee arthroplasty. The block area for adductor canal is a sensory branch
      near the knee area, which can potentially reduce the effect of motor blockage of quadriceps
      muscle. We try to proof adductor canal block can reduce the pain level after surgery
      effectively and preserve the muscle power of quadriceps muscle. Therefore, the rehabilitation
      course can be reduced and further lowering the risks of falling and complications.
    


Intervention name(s): Nerve block
Intervention type(s): Procedure
Intervention description(s): Two different nerve block types, Adductor canal block group and Femoral nerve block group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Antihypertensive Response to Losartan and Genetic Polymorphisms
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the antihypertensive response of treatment with
      losartan with reference to genetic polymorphisms.
    


Intervention name(s): losartan potassium; Comparator: Hydrochlorothiazide
Intervention type(s): Drug; Drug
Intervention description(s): Losartan 50 mg/day for 4 weeks, then doubled to losartan 100 mg/day (in case of BP more than 140/90 mm Hg.) Continued until the end of the study (visit 9-week 48).; Hydrochlorothiazide 25 mg will be added at week 8 if BP is more than 140/90 mm Hg. This last regimen will be continued until the end of the study (visit 9-week 48).
Intervention MeSH terms: Losartan; Hydrochlorothiazide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Patients With Trophic Ulcers Using Mesenchymal Stem Cells
Condition: Trophic Ulcer
MeSH terms: Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Treatment of patients with trophic ulcers using injection of autologous adipose-derived
      mesenchymal stem cells around and inside the wound
    

Detailed description: 
      During the implementation of the project, it was planned to develop a method for the
      treatment of trophic ulcers using injection of autologous adipose-derived mesenchymal stem
      cells in the wound. The positive outlook for the effectiveness of MSCs is due to the
      following:

        -  the ability of MSCs to stimulate tissue regeneration

        -  positive results of preclinical studies of the method of treatment of trophic ulcers in
           animals (rats).

      In study were included 18 patients (28 trophic ulcers treated). MSCs will be isolated from
      adipose tissue, cultured and then transplanted back to the wound. From 1 to 10 million MSCs
      in 4 ml were injected depending on the area of the wound. Follow up patients monitoring will
      occur at 1，2 and 3, 6, 12, 22 months after injection.
    

Intervention name(s): Autologous adipose-derived mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): Autologous adipose-derived mesenchymal stem cells
Intervention model: Single Group Assignment
Intervention model description: Patients with trophic ulcers received standard treatment and mesenchymal stem cells
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Trophic Ulcer; Mesenchymal stem cells
Relative Bioavailability Study of Two Montelukast Sodium (GW483100) 5 Milligrams (mg) Chewable Tablets and One Reference Montelukast Sodium 5 mg Chewable Tablet in Healthy Adult Subjects
Condition: Respiratory Disorders
MeSH terms: Respiration Disorders; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to estimate the bioavailability of montelukast from the 5 milligrams
      (mg) montelukast sodium (GW483100) test formulations relative to 5 mg montelukast sodium
      reference chewable tablets (innovator product). It is an open-label, randomized, single dose,
      three-way cross over, six sequence study in 18 healthy human subjects. Each subject will
      participate in all three treatment periods. Subjects will be randomized to one of six
      sequences and administered one of the three treatments A, B or C in each treatment period,
      where Treatment A is 5mg chewable tablet of reference 5 mg montelukast sodium reference
      chewable tablets (innovator product), Treatment B is test formulation 1: 5mg montelukast
      sodium (GW483100) chewable tablet and Treatment C is test formulation 2: 5mg montelukast
      sodium (GW483100) chewable tablet. The treatment periods will be separated by a washout
      period of 7 to 14 days. Total duration in the study for each subject will be approximately 8
      weeks from screening to the follow-up visit.
    


Intervention name(s): Reference Montelukast; Test 1 Montelukast; Test 2 Montelukast
Intervention type(s): Drug; Drug; Drug
Intervention description(s): It is available as pink, round, bi-convex-shaped chewable tablet of reference 5 mg montelukast sodium (innovator product). that has to be placed on the tongue and chewed immediately.; It will be provided as pink, round, bi-convex-shaped chewable tablet of test formulation 1: 5mg montelukast sodium (GW483100) that has to be placed on the tongue and chewed immediately.; It will be provided as pink, round, bi-convex-shaped chewable tablet of test formulation 2: 5mg montelukast sodium (GW483100) that has to be placed on the tongue and chewed immediately.
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chewable tablet; montelukast sodium; healthy adult subjects; relative bioavailability; GW483100
Examining Perceptions of the 24-Hr Movement Guidelines
Condition: Health Behavior; Self Efficacy
Study type: Interventional

Summary: 
      The main objective of the proposed research is to experimentally test and inform the most
      effective brand attributes that is to be featured in the forthcoming Canadian 24-Hour
      Movement Guidelines for Adults. Specifically, there are two main objectives. The first
      objective is to determine the most preferred tagline associated with the new Guidelines among
      a sample of Canadian adults. The second objective is to experimentally test if this new
      attribute fosters stronger perceptions of self-efficacy among an adult sample, when compared
      to previous threshold-based approaches.
    


Intervention name(s): Generic Message
Intervention type(s): Other
Intervention description(s): Exposed to four sets of promotional materials hypothesized to increase perceptions of self-efficacy to meet Guidelines.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Movement Behaviors; Physical Activity; Sedentary Behaviour; Sleep; Knowledge Translation
Withdrawal of Steroids, Cyclosporine A Dose Reduction and Switch to Mycophenolatmofetile After Heart Transplantation
Condition: Heart Transplantation
Study type: Interventional

Summary: 
      The purpose of this study is first to improve or save renal function and second to decrease
      cardiac risk factors by optimising the immunosuppressive regimen by withdrawing steroids and
      reducing the Cyclosporine A dose. The concomitant administration of Mycophenolatmofetile, an
      effective immunosuppressive agent, will minimize the risk of acute rejection episodes.
    

Detailed description: 
      The decrease of quality of life in patients after heart transplantation in the long-term is
      determined by an increasing incidence of transplant vasculopathy and by
      immunosuppression-related side effects. Calcineurin inhibitors are associated with chronic
      nephrotoxicity, while long-term administration of steroids results in an increased incidence
      of cardiovascular risk factors (e.g. hypertension, lipometabolic disorders, steroid induced
      diabetes, adipositas)and therefore, carries the potential of graft disfunction.
    

Intervention name(s): prednisolon; Mycophenolatmofetile; Cyclosporin A
Intervention type(s): Drug; Drug; Drug
Intervention description(s): prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal; Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily; Cyclosporin A reduction: 8 weeks after starting prednisolon withdrawal and Mycophenolatmofetile administration reduction of Cyclosporin A trough level till a range from 50 to 90 ng/ml
Other intervention name(s): Decortin; steroid withdrawal; MMF; Cellcept; Sandimmun optoral
Intervention MeSH terms: Cyclosporine; Prednisolone; Cyclosporins
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cyclosporine; Glucocorticoids; renal insufficiency, chronic; long-term care