bioihbjkbjnl/mcl2 huggingface dataset:
Rapid P2Y12 Receptor Inhibition Attenuates Inflammatory Cell Infiltration in Thrombus Aspirated From the STEMI Patients
Condition: Inflammation; Thrombosis
MeSH terms: Thrombosis; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, randomized, parallel design study to investigate that ticagrelor could
      attenuate inflammatory cell infiltration in thrombus aspirated from ST elevation myocardial
      infarction (STEMI) patients. The anticipated duration of the study is approximately 9 months,
      including an anticipated enrolment period of 8 months and follow-up period of 1 month.
      Patients within 12 hours of symptom onset were randomly assigned in a one-to-one ratio to
      receive ticagrelor or clopidogrel at time of STEMI diagnosis. The primary endpoint was the
      extent of inflammatory cell infiltration in thrombus aspirated from STEMI patients, expressed
      as number of total inflammatory cells per mm2 thrombus area.
    

Detailed description: 
      This is a prospective, randomized, parallel design study to investigate that ticagrelor could
      attenuate inflammatory cell infiltration in thrombus aspirated from STEMI patients. The
      anticipated duration of the study is approximately 9 months, including an anticipated
      enrolment period of 8 months and follow-up period of 1 month. Patients within 12 hours of
      symptom onset were randomly assigned in a one-to-one ratio to receive ticagrelor or
      clopidogrel at time of STEMI diagnosis. The primary endpoint was the extent of inflammatory
      cell infiltration in thrombus aspirated from STEMI patients, expressed as number of total
      inflammatory cells per mm2 thrombus area.

      Screening will be made to select eligible participants before intervention. Patients with
      documented STEMI and within 12 hours of symptom onset will be enrolled from the study site.
      For patients post percutaneous coronary intervention (PCI), they must be on dual-antiplatelet
      therapy for at least 12 months to be eligible for the study.

      After the enrollment period, patients were randomly assigned in a one-to-one ratio to receive
      ticagrelor (180 mg loading dose) or clopidogrel (600 mg loading dose) at time of STEMI
      diagnosis. In addition to randomized study medication all patients should receive concomitant
      Ace Salicylic Acid (ASA) 100 mg daily during the treatment period according to local
      practice, unless they are allergic or intolerant. For those not previously given aspirin, a
      loading dose of 300 mg was preferred. At the end of the study, data will be collected and
      analyzed.
    

Intervention name(s): ticagrelor; Clopidogrel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immune Response to HPV Vaccine Among HIV-1-infected Subjects in Brazil
Condition: Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      Besides the specific response to vaccine antigens, the investigators will analyze the
      anti-HPV immune response in HIV-1-infected men in different strata of immune deficiency. The
      hypothesis will be tested by stratification by T CD4 + lymphocytes in an attempt to assess
      the range of the count with the highest possibility of vaccine response. Thus, knowledge of
      vaccine response in HIV-infected patients, indicate which patients would have greater
      potential for vaccine response in vivo.
    

Detailed description: 
      The study will be divided into three groups. Patients with HIV-1 infection will be subdivided
      into groups according to T CD4 + lymphocytes at the time of vaccination: Over 500 CD4 T cells
      count and bellow 500 CD4 T cells count. A healthy control group will be also studied.
    

Intervention name(s): HPV vaccine
Intervention type(s): Biological
Intervention description(s): HPV vaccine
Other intervention name(s): cerverix
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; HPV; Clinical trial; outcome
FMS European Long-Term Study
Condition: Fibromyalgia Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the
      treatment of fibromyalgia syndrome.
    


Intervention name(s): milnacipran; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): hard capsule; hard capsule
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
TDF and LdT in Immune-tolerant CHB Patients Awaiting Assisted Reproduction
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Immune-tolerant patients with chronic hepatitis B (CHB) awaiting assisted reproduction (AR)
      are required to initiate antiviral therapy due to laboratory safety. Additionally, rapid
      virus elimination is suggested to faciliate timely performance of AR. However, no consensus
      is reached regarding the antiviral therapy in this group. This study aimed to explore the
      efficacy and safety of tenofovir (TDF) and telbivudine (LdT) in this population.
    


Intervention name(s): Tenofovir and telbivudine; Tenofovir
Intervention type(s): Drug; Drug
Intervention description(s): tenofovir and telbivudine administered at least 48 weeks; tenofovir administered at least 48 weeks
Other intervention name(s): combination therapy; single therapy
Intervention MeSH terms: Tenofovir; Telbivudine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw
Condition: Blood Loss; Healthy
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 1

Summary: 
      Zynex's blood volume monitor (BVM) is a non-invasive monitoring device to monitor blood
      volume and blood loss of a patient during surgery, post operatively and/or in recovery. This
      monitoring device will identify baseline blood volume and relative changes in blood volume
      using a specific algorithm to compare and review data already monitored during surgery,
      displaying blood volume and blood loss in real-time.
    


Intervention name(s): CM-1500
Intervention type(s): Device
Intervention description(s): Blood Volume Monitor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: blood; loss; healthy; volume; To evaluate the ability of the Zynex BVM to non-invasively detect blood loss in healthy subjects during a blood draw.
Mucosal Immunity of Ulcerative Colitis Patients Undergoing Therapy With Trichuris Suis Ova
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      The purpose of this study is to understand the immune response activated in the human
      gastrointestinal tract by Trichuris Suis Ova (TSO) in patients with ulcerative colitis.
    

Detailed description: 
      The concept of helminthic therapy (using worms to treat diseases) is supported by experiments
      in mouse models as well as several clinical studies. TSO, which are purified eggs from the
      porcine whipworm Trichuris suis, are being investigated in clinical trials as a potential
      therapeutic agent for the treatment of active Crohn's disease, relapsing multiple sclerosis,
      peanut and tree nut allergy, and adults with autistic disorders.

      The goal of this study is to understand the immune mechanisms activated in the human
      gastrointestinal tract by treatment with TSO, which may lead to improvements in the symptoms
      of ulcerative colitis (UC). TSO have been shown to have a clinical benefit on a subset of
      patients with UC in a previous randomized placebo-controlled trial (Summers et al. 2005).
      However, the mechanisms of action of TSO on the intestinal mucosa remain unclear.

      We propose an exploratory 24-week mechanistic randomized double-blind placebo-controlled
      crossover study of TSO in patients with established and active UC to better characterize
      similarities and differences in the immune mechanisms of the intestinal mucosa in response to
      TSO. We hypothesize that treatment with TSO will lead to an anti-inflammatory immune response
      in some individuals with UC through an increase in intestinal mucus production and modulation
      of Th1, Th2, Th17, and T-regulatory effector lymphocyte populations.
    

Intervention name(s): Trichuris suis ova
Intervention type(s): Drug
Intervention description(s): 2,500 eggs by mouth every two weeks for 12 weeks
Other intervention name(s): TSO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Ulcerative Colitis; Trichuris Suis Ova; Inflammatory Bowel Disease; Mucus
A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis (RE-SPECT CVT)
Condition: Thromboembolism
MeSH terms: Sinus Thrombosis, Intracranial; Thrombosis; Thromboembolism
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, prospective, international, randomized (1:1), open-label study with
      two parallel groups. This phase III study is planned to investigate the efficacy and safety
      of dabigatran etexilate versus dose-adjusted warfarin on a net clinical benefit endpoint of
      major bleeding (ISTH criteria) and new venous thrombotic event (VTE) (primary endpoint) with
      blinded endpoint adjudication.
    


Intervention name(s): Dabigatran etexilate; Warfarin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Warfarin; Dabigatran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Safety and Efficacy of Botox in Bruxism
Condition: Bruxism
MeSH terms: Bruxism
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether botulinum toxin helps patients with
      bruxism.
    

Detailed description: 
      Bruxism represents involuntary movements of the jaw muscles, resulting in tooth grinding and
      clenching. Generally it occurs during sleep, but occasionally can be present during the day,
      so called awake bruxism. Bruxism is a common condition, affecting approximately 8% of all
      people. It is not known what causes bruxism but it may result in tooth damage, jaw pain,
      headaches, poor quality sleep and may bother your partner's sleep at night due to the tooth
      grinding noise. There is no generally accepted treatment for bruxism. Mouth guards and
      several medications have been tried, but they generally did not work or caused side effects.

      Botulinum toxin "Botox" is a natural toxin, which weakens the muscles when injected in very
      small amounts. It is currently approved and used for the treatment of various conditions
      involving abnormal muscle spasms, such as neck twisting (torticollis), twitching of the face
      (hemifacial spasm) or eyes (blepharospasm), headaches, muscles stiffness following strokes,
      and it has also been used cosmetically for wrinkle removal.

      Since bruxism is caused by involuntary spasms of the jaw muscles, botulinum toxin has been
      tried, initial results showing that it is safe and effective. The injections generally take
      one week to start working and 2 weeks for a full effect, which lasts on average 12-16 weeks,
      and slowly wear off. The injections are generally repeated every 3-4 months.
    

Intervention name(s): Botulinum toxin type A; Placebo arm
Intervention type(s): Drug; Drug
Intervention description(s): Patients are injected with botulinum toxin type A (BOTOX) 60 units in each masseter muscle and 35 in each temporalis muscle, bilaterally.; Placebo comparator
Other intervention name(s): Botulinum toxin type A (Botox)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: bruxism, botulinum toxin, sleep study
Musculoskeletal Plasticity After Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      Patients with spinal cord injury (SCI) experience metabolic syndrome, diabetes, obesity,
      pressure ulcers, and cardiovascular disease at far greater rates than the general population.
      A rehabilitation method to prevent or reverse the systemic metabolic consequences of SCI is a
      pressing need. The purpose of this study is to determine the dose of muscle activity that can
      enhance an oxidative muscle phenotype and improve clinical markers of metabolic health and
      bone turnover in patients with SCI. The long-term goal of this research is to develop
      exercise-based interventions to prevent secondary health conditions such as diabetes and to
      ultimately protect health-related quality of life (QOL). Specific Aim 1: To compare changes
      in skeletal muscle gene regulation in individuals who receive high frequency (HF)
      active-resisted stance and low frequency (LF) active-resisted stance for 3 years. Hypothesis
      1: The expression of genes regulating skeletal muscle metabolism will support that HF and LF
      both instigate a shift toward an oxidative muscle phenotype. A novel finding will be that LF
      is a powerful regulator of oxidative pathways in skeletal muscle. Specific Aim 2: To compare
      changes in systemic markers of metabolic health and bone turnover in individuals with SCI who
      receive HF or LF for 3 years. Hypothesis 2: HF and LF will both reduce glucose/insulin levels
      and HOMA (homeostasis model assessment) score.

      Secondary Aim: To measure subject-reported QOL using the EQ-5D survey metric. Hypothesis 3:
      HF and LF subjects will show a trend toward improved self-reported QOL after 3 years. There
      will be an association between metabolic improvement and improved perception of QOL. These
      observations will support that this intervention has strong feasibility for future clinical
      translation.
    


Intervention name(s): Single-session electrically induced exercise; Electrically-induced exercise training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A single session of electrically induced exercise to the quadriceps and hamstring muscle groups of people with paralysis.; Multiple sessions of electrically induced exercise to the quadriceps and hamstring muscle groups for up to 3 years in people with paralysis.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: metabolism; glucose; osteoporosis; secondary health conditions; quality of life; standing; electrical stimulation; diabetes; insulin; skeletal muscle
Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      A Randomized, Blinded, Parallel Group, Placebo-Controlled, Multiple Dose, Multicenter Study
      to Compare the Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose
      Inhaler, 110 mcg, to Flovent® HFA 110 mcg, in Adult Subjects with Asthma.
    


Intervention name(s): Fluticasone propionate pressurized metered dose inhaler; Flovent HFA pressurized metered dose inhaler; Placebo pressurized metered dose inhaler
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 110 mcg per actuation; 110 mcg per actuation; no active content
Other intervention name(s): Fluticasone propionate pressurized metered dose inhaler
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bioequivalence
A Study of SHR6390 in Combination With Letrozole or Anastrozole or Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
Condition: Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase IB/II clinical trial to evaluate the efficacy and safety of SHR6390 in
      combination with Letrozole or Anastrozole or Fulvestrant. Patients who have HR positive and
      HER2 negative recurrent/metastatic breast cancer and have not received systemic anticancer
      therapy are eligible for study.
    


Intervention name(s): SHR6390; Letrozole or anastrozole or Fulvestrant
Intervention type(s): Drug; Drug
Intervention description(s): SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment; Letrozole 2.5mg or anastrozole 1mg, orally once daily (continuously)， or Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle until progressive disease
Intervention MeSH terms: Letrozole; Fulvestrant; Anastrozole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CDK4/6 inhibitor; Breast cancer; Postmenopausal women; Hormone-receptor positive; HER2 negative; Premenopausal women
Using a Motivational Interviewing (MI) Informed Text Messaging Program to Lower Blood Sugar in Diabetic Patients.
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Despite advances in medical therapy for diabetes, significant numbers of patients fail to
      achieve adequate blood glucose control. Diabetic patients who engage in more self-care
      behaviors have better glycemic control, as measured by HbA1C. Patient "activation", defined
      as the knowledge, skills, beliefs, and behaviors to manage a chronic disease, is key to the
      performance of these self-care behaviors.

      There is a growing literature on diabetes behavioral change interventions; however
      interventions are often developed and implemented without consideration of patients readiness
      to engage in lifestyle changes. Additionally, patient-tailored interventions require
      intensive clinical and financial resources, making them difficult to integrate into clinical
      practice. Mobile text messaging (SMS) programs have been successfully used to promote smoking
      cessation, alcohol cessation, and weight loss in diverse patient populations. SMS
      interventions for diabetes have also been developed, but they have been designed primarily to
      provide feedback on blood glucose management, rather than to motivate behavioral change. The
      few studies that included motivational content as a primary feature, did not tailor their
      intervention to a patient's readiness for change or rigorously describe their motivational
      intervention, and show limited efficacy.

      To address these concerns, we will perform a three-month randomized controlled pilot study to
      develop and test a Motivational Interviewing (MI)-informed SMS intervention tailored to
      patient level of activation for patients with poorly controlled type II diabetes.
    


Intervention name(s): MI- informed SMS program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Long Endotracheal Tube vs. Aintree Intubating Catheter for Fiberoptic-guided Intubation in Manikin
Condition: Intubation;Difficult
Study type: Interventional

Summary: 
      In difficult airway situation, fiberoptic-guided endotracheal intubation through laryngeal
      mask airway(LMA) is one of option. Aintree catheter is a device to help change LMA to
      endotracheal tube, but it needs complex and multiple process. Long endotracheal tube can
      solve this problem of Aintree catheter. The purpose of this study is proving the efficacy of
      long endotracheal tube compared to Aintree cathter in fiberoptic-guided intubation through
      LMA.
    

Detailed description: 
      In difficult aiway situation, fiberoptic-guided endotracheal intubation through laryngeal
      mask airway(LMA) is one of option according to Difficult intubation guidelines. First, insert
      LMA and insert fiberoptic through LMA. Second, insert endotracheal tube using fiberoptic as a
      guide. This process has several problem. Removal of LMA is impossible, so there is a risk of
      dislodging of endotracheal tube.

      Aintree catheter is developed to this problem. Insert Aintree catheter through LMA using
      fiberoptic, and remove LMA, finally insert endotracheal tube throug Aintree catheter. But the
      problem of this method is that the whole process is complex and takes long time. And there is
      a risk of impeding of endotracheal tube at glottis level because the difference of diameters
      between endotracheal tube and aintree catheter.

      Long endotracheal tube could solve the problems mentioned above. Through LMA, insert
      endotracheal tube using fiberoptic as a guide. Tube is long enough to remove LMA without a
      risk of dislodging. And after removal of LMA, tube can be cut for optimizing length.

      So the purpose of this study is comparing the efficacy of Aintree catheter method and Long
      tube method in manikin.
    

Intervention name(s): Using long tube; Aintree catheter
Intervention type(s): Device; Device
Intervention description(s): Fiberoptic-guided intubation through LMA, using long tube; Fiberoptic-guided intubation through LMA, using Aintree catheter
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Manikin model Intubators are residents of Anesthesiology
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intubation; Aintree; Laryngeal mask airway; fiberoptic