bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate pharmacokinetic similarity, efficacy, safety and
      immunogenicity of multiple switches between ustekinumab and ABP 654 compared with continued
      use of ustekinumab in participants with moderate to severe plaque psoriasis.
    

Detailed description: 
      This is a multi-center study and will enroll approximately 480 participants.

      After eligibility confirmation, all participants will be randomized in a 1:1 ratio into 2
      treatment arms: continued use of ustekinumab or multiple switches between ustekinumab and ABP
      654 at Week 28. The randomization will be stratified by prior biologic use for psoriasis (yes
      versus [vs] no) at baseline (Week 0), geographic region, and baseline (Week 0) body weight.

      All participants will receive an initial 3 doses of ustekinumab on Day 1 (Week 0), Week 4 and
      Week 16. At Week 28, participants will be randomized to continue on ustekinumab or switching
      between ABP 654 and ustekinumab every 12 weeks.

      At Week 28, efficacy assessments will be conducted including evaluation of Psoriasis and Area
      Severity Index (PASI). Participants who do not achieve PASI 50 response or better improvement
      at Week 28 will be considered as run-in failures and will not be randomized at Week 28; these
      participants will complete End of Study procedures at Week 28. The run-in period will occur
      from Day 1 until randomization at Week 28. Those unable to complete the Week 28 visit or did
      not have a PASI assessment completed at Week 28 will be discontinued from the study.

      The total duration of study participation for each participant will be 68 weeks, with up to 4
      weeks for screening and 64 weeks after the first investigational product administration.
    

Intervention name(s): Ustekinumab; ABP 654
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive subcutaneous (SC) injection of ustekinumab.; Participants will receive SC injection of ABP 654.
Other intervention name(s): Stelara®
Intervention MeSH terms: Ustekinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Psoriasis; Biosimilar; Psoriasis area and severity index; Ustekinumab; Skin Diseases; Dermatologic Agents; Papulosquamous
Radiotherapy Alternates Human Epidermal Growth Factor 2 (Her2) Expression in Human Breast Cancer
Condition: Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Based on fundamental study （in Vitro and in Vivo, Pro. Jianjian Li）， Her2 expression would be
      changed from negative to positive by cancer irradiation with liner-accelerator at dose 6GY or
      up. The propose of this study is to reveal the irradiation result on Her2 expression in human
      breast cancer.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        study population is among advanced Chinese breast cancer patient.
      
Keywords: Breast; Cancer; Human Epidermal Growth Factor 2 (Her2); irradiation
Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane
Condition: Anaesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      We hypothesise that patients who receive propofol for maintenance of anaesthesia will report
      dreaming more often when they emerge from anaesthesia than patients who receive desflurane
      for maintenance of anaesthesia.
    

Detailed description: 
      Patients commonly report that they have been dreaming when they emerge from anaesthesia. Data
      from observational studies and small randomised trials suggests that reports of dreaming are
      more commonly made after anaesthesia maintained with propofol than anaesthesia maintained
      with inhaled anaesthetic agents. We propose to randomise 300 healthy patients to receive a
      standardised general anaesthetic for surgery that includes either propofol or desflurane for
      maintenance. We will measure the raw and processed electroencephalogram during and after
      anaesthesia and interview patients about dreaming as soon as they emerge from anaesthesia.
    

Intervention name(s): Propofol; desflurane
Intervention type(s): Drug; Drug
Intervention description(s): target controlled infusion of propofol; Anaesthetic maintenance with desflurane
Intervention MeSH terms: Propofol; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: anaesthesia; propofol; desflurane; dreaming; electroencephalography
Synergistic Effect of Ibuprofen and Hydromorphone for Postoperative Pain
Condition: Breast Cancer
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Intravenous form of ibuprofen is recently approved by FDA and reports are rare on the
      co-administration with opioids. The investigators searched whether intravenous
      ibuprofen-hydromorphone combination is synergistic, additive, or infra-additive on
      postoperative pain using combination index (CI), dose reduction index (DRI) and isobologram.
    

Detailed description: 
      Ninety patients, undergoing breast surgery, were included in one of the three groups
      (Ibuprofen, Hydromorphone, Ibuprofen+Hydromorphone groups). Positive analgesic efficacy was
      defined as a numeric rating scale (NRS) ≤3 on a 0-10 NRS, 30 min after the drug
      administration. Drug was administered by the Dixon and Mood up-and-down method. Starting
      doses were ibuprofen 50 mg, hydromorphone 0.25 mg, or ibuprofen 25 mg + hydromorphone 0.125
      mg. The maximum doses were ibuprofen 800 mg, hydromorphone 2 mg, or ibuprofen 400 mg +
      hydromorphone 1 mg. Combination index (CI) (additive: 0.9-1.1, synergism: <0.9, antagonism:
      >1.1), dose reduction index (DRI, a measure of how much the dose of each drug in a
      combination can be reduced), and isobologram were used to define the nature of their
      interaction.
    

Intervention name(s): Ibuprofen; Hydromorphone
Intervention type(s): Drug; Drug
Intervention description(s): Drug was administered by the Dixon and Mood up-and-down method. Starting doses was ibuprofen 50 mg. The maximum doses was ibuprofen 800 mg. Combination index (CI) (additive: 0.9-1.1, synergism: <0.9, antagonism: >1.1), dose reduction index (DRI, a measure of how much the dose of each drug in a combination can be reduced), and isobologram were used to define the nature of their interaction.; Drug was administered by the Dixon and Mood up-and-down method. Starting doses was hydromorphone 0.25 mg. The maximum doses was hydromorphone 2 mg. Combination index (CI) (additive: 0.9-1.1, synergism: <0.9, antagonism: >1.1), dose reduction index (DRI, a measure of how much the dose of each drug in a combination can be reduced), and isobologram were used to define the nature of their interaction.
Other intervention name(s): Caldolor; Dilid
Intervention MeSH terms: Ibuprofen; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ibuprofen; hydromorphone; drug interactions
Everolimus Stent in Patients With Coronary Artery Disease (CAD)
Condition: Coronary Artery Disease; Coronary Atherosclerosis
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atherosclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Aim of the study is to compare the everolimus eluting stent and sirolimus eluting stent in
      all comers PCI eligible patients
    

Detailed description: 
      Compared with the currently available first-generation drug-eluting stents (DES),
      second-generation DES have been designed with the goal of improving safety and efficacy.
      Everolimus, a sirolimus analogue, is released from a open cell, thin-strut, cobalt-chromium
      frame. A significant reduction in cardiac events was noted in patients with the
      everolimus-eluting stent compared with those who had a paclitaxel-eluting stent. Sirolimus
      eluting stent was the first available drug eluting stent and is the most tested. Therefore
      the investigators compared the safety and efficacy of the everolimus-eluting and sirolimus
      eluting stents in unselected patients in real world practice.
    

Intervention name(s): coronary stent; stent
Intervention type(s): Device; Device
Intervention description(s): coronary angioplasty with stent implantation; coronary angioplasty with stent implantation
Other intervention name(s): XIENCE V drug eluting stent; Abbot Vascular USA; CYPHER drug eluting stent; Johnson & Johnson USA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Eluting Stents; Everolimus Eluting Stent; Coronary Angioplasty
Screening of Specific Genes for Pigmented Villous Nodular Synovitis
Condition: Pigmented Villonodular Synovitis
MeSH terms: Synovitis, Pigmented Villonodular; Synovitis
Study type: Observational

Summary: 
      This study retrospectively analyzed the history of present illness of PVNS patients in our
      hospital. The enrolled patients were followed up by telephone to follow up their
      postoperative recovery and living conditions. Take the patient's pathological specimens for
      immunohistochemical testing, evaluate the relationship between the expression of different
      molecular targets, clinical manifestations and patient prognosis, and explore new molecular
      targets related to disease diagnosis and treatment.
    

Detailed description: 
      This study retrospectively analyzed the symptoms, time of onset, injury history, laboratory
      examinations, imaging examinations, and intraoperative conditions of PVNS patients in our
      hospital. The enrolled patients were followed up by telephone to follow up their
      postoperative recovery and living conditions (VAS score, SF-36 score). Take the patient's
      pathological specimens for immunohistochemical testing, evaluate the relationship between the
      expression of different molecular targets, clinical manifestations and patient prognosis, and
      explore new molecular targets related to disease diagnosis and treatment.
    

Intervention name(s): Arthroscopic synovectomy
Intervention type(s): Procedure
Intervention description(s): Arthroscopic synovectomy
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with "pigmented villonodular synovitis" and "giant cell tumor of tendon sheath"
Cycle Ergometer Training and Heart Failure on Heart Rate Recovery and Mind Fullness
Condition: Heart Failure NYHA Class I; Heart Failure NYHA Class II
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      To evaluate the effects of cycle ergometer training on heart rate recovery in Newyork Heart
      Association (NYHA) class I and II heart patients. To evaluate the effects of cycle ergometer
      training on mind fullness in NYHA class I and II heart patients. Previous studies were
      designed to target only cardiac functions and no psychological aspect was studied so this
      study cover this aspect as well so from the outcomes of this study we can determine both
      psychological satisfaction and cardiac function as well.
    

Detailed description: 
      A review stated that "clinical and experimental data shows that physical training is an
      important aspect in the management of chronic heart failure patients. Also, it stated that
      physical exercise training plays an important role to modulate peripheral immune responses if
      congestive heart failure (CHF) patients show high pro-inflammatory cytokines, soluble
      cellular adhesion molecules, which further resulted in an improvement in exercise capacity in
      CHF patients.

      Heart rate recovery (HRR) improved in patients who were enrolled in the cardiac
      rehabilitation stage 2 program while similar outcomes were not noted among the control group.
      It was concluded that cardiac rehabilitation exercise program improves heart rate recovery.
      Also, HRR may be used in a cardiac rehabilitation program to recognize high risk factors and
      also useful in evaluating the outcomes.

      a systematic review about the effects of exercise training in patients with CHF was published
      who concluded that short-term physical exercise training in selected subgroups of patients
      with CHF, has physiological benefits and positive effects on quality of life.

      A meta-analysis by the Collaborative Group concluded that there is no evidence that
      supervised medical training programs for patients with CHF are dangerous and indeed there is
      clear evidence of an overall reduction in mortality. The authors did not perform a
      quantitative analysis on the outcome of cardiac performance, exercise capacity, or quality of
      life.
    

Intervention name(s): Cycle ergometer training; Conventional therapy
Intervention type(s): Other; Other
Intervention description(s): Hospital-based ergometer cycling for 20 minutes (Including warm-up and cooldown), 3x/week on alternate days for 6 weeks at 40-60% of VO2max.; In bed activities (Active ankle and hand pumping exercise* 15 Rep* BD AROMS of extremities* 15 Rep* BD, Deep breathing exercises* 15 Rep* BD, Ambulation (walk 10-15 minutes below fatigue and onset of symptoms level* BD) for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cycle ergometer; Heart rate recovery; Mindfulness; Heart Failure
An Intervention Study to Assess the Role of the Built Environment on Physical Activity and Active Transportation to School in Children and Youth
Condition: Physical Activity
Study type: Observational

Summary: 
      The purpose of this study is to evaluate if changes to the built environment influence
      physical activity and active transport to school in children and youth.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants who attend school grades 4-10 at baseline (Fall 2012) will be invited to
        participate (intervention group). Participants (n-matched) who attend school grades 4-10 at
        baseline (Fall 2012) in a neighbouring catchment boundary will be invited to participate
        (comparison group).
      
Keywords: Physical Activity; Physical Fitness; Transportation; Environment Design; Child; Adolescent
Effects of Soft Ball Tissue Release Exercises on Low Back Pain Secondary to Tight Hip Muscles.
Condition: Low Back Pain; Tight Hip Muscles
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      It is also suggested that low back pain patients tend to have trigger point or tight muscles,
      i.e. Gluteus Maximus, Gluteus Medius, iliopsoas and Quardatus Lumborum, on at least one
      side.After approval from the university ethical committee, 23 (male, female) were enrolled in
      this study. All patients who presented nonspecific low back pain were included on the basis
      of inclusion and exclusion criteria. Demographic data of the patients were collected.
      Oswestry low back disability index was used to evaluate the disability level of low back.
      Piriformis muscle tightness was diagnosed among low back pain patients using FAIR (Flexion,
      abduction, internal rotation) and Freiberg's test. The FAIR test was performed on the patient
      in, side lying position, with the hip flexed at 60º and the knee flexed at 90º. With the hip
      being stabilized, a single examiner will internally rotate and adduct the hip by applying
      downward pressure onto the knee. Freiberg's test was performed on the patient in the supine
      position with the thigh extended. The leg and thigh are passively internally rotated by the
      examiner. If pain is registered, the test is positive. The effects of soft ball tissue
      release exercises on low back pain secondary to tight hip muscles
    


Intervention name(s): Soft ball tissue release exercises
Intervention type(s): Other
Intervention description(s): Exercise program were given to patients with low back pain secondary to hip muscle tightness using soft balls, i.e. tennis balls plus core stability exercises.
3 days a week for four weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low Back Pain,Tight hip pain
Comparison of PET Imaging Patterns With PSMA and AR Expression in Prostate Cancer and Bladder Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Patients suffering either from newly diagnosed very high risk locally advanced and/or
      oligometastatic prostate cancer (cohort A), metastatic castration-resistant prostate cancer
      (mCRPC, cohort B), newly diagnosed postate cancer with planned radical prostatectomy (cohort
      C) or primary bladder cancer with planned radical cystectomy (cohort D) as identified by a
      multidisciplinary team of specialists, will be included.

      PET imaging patterns using PSMA- and FDHT PET scans will be correlated with prostate-specific
      membrane antigen and androgen specific receptor expression patterns in prostate cancer and
      bladder cancer.
    


Intervention name(s): PSMA PET Scan; FDHT PET Scan
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): [68Ga]Ga-PSMAHBED-CC (Ga-PSMA) PET Scan; [18F]-fluoro-5α-dihydrotestosterone (18F-FDHT) PET Scan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Safety and Tolerability Study of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate how CP-690,550 is handled by the body in healthy
      volunteers who have mild and moderate hepatic impairment compared to healthy volunteers with
      normal hepatic function. This study will also evaluate the safety and tolerability of
      CP-690,550.
    


Intervention name(s): CP-690,550; CP-690,550; CP-690,550
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single 10 mg dose of CP-690,550; Single 10 mg dose of CP-690,550; Single 10 mg dose of CP-690,550
Intervention MeSH terms: Tofacitinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Hepatic impairment
Resveratrol and Midazolam Metabolism
Condition: Healthy
Study type: Interventional

Summary: 
      Adverse events due to drug-drug and/or herb-drug interactions are of serious concern and a
      major cause of morbidity and mortality. Resveratrol is a polyphenol antioxidant that has been
      identified in over 70 species and is suggested to be the constituent in red wine responsible
      for cardioprotective effects. The potential health benefits of resveratrol supplements are
      highly extolled in the alternative medicine industry and daily doses are up to 5 grams are
      being studied. While there are potential health benefits of high doses of resveratrol, for
      patients taking other drugs metabolized by CYP3A4, such as transplant medications,
      chemotherapies and HMG-CoA reductase inhibitors, there may be a clinically significant
      herb-drug interaction.

      We, the investigators, have shown in vitro that resveratrol is a mechanism-based inhibitor of
      cytochrome P450 3A4 (CYP3A4). Based on our in vitro evidence and literature reports of the
      pharmacokinetics of resveratrol, we hypothesize that resveratrol will be a potent in vivo
      mechanism-based inhibitor of intestinal CYP3A4 enzymes. To date, there are no clinical
      studies that address the potential for a resveratrol-drug interaction. We propose to test
      whether single and multiple doses of resveratrol alter the pharmacokinetics of midazolam, a
      prototypic CYP3A4 probe drug.
    


Intervention name(s): Midazolam; resveratrol (single dose); resveratrol (multiple dose)
Intervention type(s): Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): 2 mg oral dose; 1 g oral dose; 1 g oral dose for 8 days
Other intervention name(s): Versed
Intervention MeSH terms: Midazolam; Resveratrol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: drug interactions; midazolam; cytochrome P450; resveratrol; pharmacokinetics
A Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open-label, non-randomized, single oral dose study in healthy male subjects.

      All subjects will receive a single oral dose of 10 mL of [14C]-RPC1063 Solution (0.1 mg/mL),
      containing NMT 1.3 MBq (37 μCi) 14C.
    

Detailed description: 
      Subjects will be screened for eligibility to participate in the study up to 28 days before
      dosing. Subjects will be admitted to the clinical unit on the morning of Day -1 prior to IMP
      administration. Subjects will be dosed on the morning of Day 1 following a standard
      breakfast, and will remain resident in the clinic until up to 168 h after dosing. It is
      planned that subjects will be released as a group when all subjects have achieved a mass
      balance cumulative recovery of >90% or if <1% of the dose administered has been collected in
      urine and faeces within 2 separate, consecutive 24 h periods. This may be earlier than 168 h
      post-dose but no sooner than 96 h post-dose. In this case, collection of all samples (blood,
      urine and faeces) will be stopped and the subjects will undergo discharge assessments. If
      this criteria has not been met by all subjects on Day 8, home collections of urine and faeces
      may be requested at the discretion of the investigator for individual subjects. A follow-up
      phone call will take place 5 to 10 days after discharge.
    

Intervention name(s): RPC1063
Intervention type(s): Drug
Intervention MeSH terms: Ozanimod
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Male Adults; 14C; RPC1063