bioihbjkbjnl/mcl2 huggingface dataset:
The Development of Tolerance to α1-Adrenoceptor Blockade With Chronic Carvedilol Treatment
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      There is now strong evidence from clinical trials that carvedilol therapy in heart failure is
      superior to therapy with metoprolol. Not only does carvedilol have superior effects on lipid
      profiles, insulin sensitivity, renal blood flow, and reversal of pathologic remodeling but
      also its use is associated with fewer deaths compared to metoprolol. These facts make it
      important to carefully define how metoprolol and carvedilol are pharmacologically different.
      One potential difference is α1-AR antagonism. If we demonstrate that these α1-AR effects are
      preserved with chronic therapy, then α1-AR blockade may have an important role in carvedilol
      favorably altering the natural history of heart failure. On the other hand, if we demonstrate
      that tolerance to the α1-AR blockade effect of carvedilol decreases with time, then it would
      be unlikely that this pharmacologic property contributes to the efficacy of carvedilol. In
      such a case other pharmacologic properties, such as antioxidant activity, would appear to be
      important. These results will help guide future studies into CHF and AR blockade.
    


Intervention name(s): phenylephrine
Intervention type(s): Drug
Intervention description(s): All patients undergo repeated phenylephrine infusions during standard up-titration and maintenance of carvedilol treatment.
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment Insulin Resistence in HCV G-1 Patient
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the effect of treatment of insulin resistance in the response of chronic
      hepatitis C treatment, mesure as HCV-RNA negative at week 72.

      4.3.2 Objetivos secundarios To evaluate the efficacy and safety of treatment with metformine
      to erradicate the insulin resistance of patients with chornic hepatitis C genotype 1 measure
      as HOMA-IR < 2.
    

Detailed description: 
      Differents studies show that infection by virus hepatitis C have a relevant rol in the
      development of insulin resistance. The insulin resistence is associated with a progression of
      fibrosis and the development of steatosis. The insulin resistence is frecuently associated
      with very difficult to cure patients as cirrhotics, afro-american patients, overweight
      patients and co-infected HCV-HIV patients. Recently is repported that sustained virological
      (SVR) response in genotype 1 patients is different according the insulin resistance. The SVR
      was 60% in patients without insulin resistance versus 20% in patients with strong insulin
      resistance (HOMA > 4.

      The present trial desire to analyze the effect that the treatment of insulin resistance
      produce in higher range of RVS.
    

Intervention name(s): Metformine; Placebo of metformine
Intervention type(s): Drug; Other
Intervention description(s): 850-2550 mg/daily for 48 weeks; 850-2550 mg/daily for 48 weeks
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: insulin resistance; chronic hepatitis C; genotype 1
Use of Wearable Digital Sensors After mRNA Vaccination in Adults
Condition: Healthy Participants
Study type: Observational

Summary: 
      The purpose of this study is to explore the physiological and behavioral impact of the immune
      response to vaccines after receipt of investigational or approved messenger ribonucleic acid
      (mRNA) vaccines using wearable medical sensors, with the potential of establishing a digital
      biomarker of vaccine response due to stimulation of the immune system.
    

Detailed description: 
      Participants will be provided wearable medical sensor equipment and instructions at the start
      of the study. Participants will have access to device support throughout the study period.
      The wireless medical devices will be applied prior to vaccination in the concurrent
      Moderna-sponsored vaccine trial in order to establish an initial baseline of participants'
      daily physiological patterns.
    

Intervention name(s): Wireless wearable digital devices
Intervention type(s): Device
Intervention description(s): Wireless wearable digital devices (including a small patch, modified watch, and datahub smartphone with electronic Patient Reported Outcomes [ePRO] capability) will be provided to each participant enrolled in the study.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants enrolled in the multi-center, concurrent Moderna-sponsored vaccine trial will
        be provided the opportunity to enroll in this study. Participants will be screened for
        eligibility based on their concurrent enrollment in the vaccine trial.
The Value of High-resolution Ultrasound in the Detection of Lymph Node Metastasis: a Proposal of NI-RADS
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms; Lymphatic Metastasis
Study type: Observational

Summary: 
      The status of axillary lymph node (ALN) is an important reference indicator for breast cancer
      surgery and systemic treatment, which is also an important prognostic indicator for breast
      cancer. Therefore, it is extremely important for surgeons to accurately determine whether
      axillary lymph nodes have metastasis and the number of metastatic lymph nodes. The value of
      ultrasound diagnosing the status of axillary lymph nodes was controversial in recent
      publications. Therefore, there is a high need to prove the accuracy and precision of
      ultrasound for axillary lymph node metastasis in breast cancer patients. The aim of this
      study is to assess the usefulness of ultrasound in the diagnosis of axillary lymph node
      status in breast cancer patients by gathering in vivo and vitro ultrasonographic parameters
      to build a clinical useful categorization system
    

Detailed description: 
      To facilitate the non-invasive assessment of lymph node status preoperatively, we use
      ultrasound to detect lymph node metastasis. We designed this study to obtain in vivo and
      vitro ultrasound features and parameters. Before surgery, the detailed ultrasound features
      are collected during routine ultrasound examination. After the completion of the axillary
      surgery, fresh lymph node specimens are collected for in vitro ultrasound evaluation one by
      one in a specially-designed detection system. Statistical models are built to categorize the
      probability of metastasis of lymph node according to a proposed categorization system similar
      as BI-RADS(Breast Imaging Reporting and Data System), which is named NI-RADS (Node Imaging
      Reporting and Data System).
    

Intervention name(s): Ultrasound evaluation
Intervention type(s): Diagnostic Test
Intervention description(s): High-frequency ultrasound is used to detected the lymph node metastasis in vivo and vitro. The lymph node number, morphology and elastographic parameters are collected in the patients and in fresh lymph node specimens.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients with invasive breast cancer planned to receive surgical axillary lymph node
        staging are eligible.
      
Biospecimen description: 
      Fresh lymph node specimens from breast cancer patients were detected using ultrasound.
    
Keywords: breast neoplasms; Ultrasonography, Interventional; Biopsy, Large-Core Needle; Biopsy, Fine-Needle
Liraglutide 3 mg for Knee Osteoarthritis
Condition: Osteoarthritis; Obesity
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomised, double blind, placebo-controlled, parallel group, and single-centre trial
      investigating the effect of liraglutide on body weight and pain in overweight or obese
      patients with knee osteoarthritis.

      Patients will be subjected to a run-in diet intervention phase (week -8 to 0) including a
      low-calorie diet and dietetic counselling. At week 0 patients will be randomised to receive
      either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on
      re-introducing regular foods and a focus on continued motivation to engage in a healthy
      lifestyle.
    


Intervention name(s): Liraglutide 3 mg (Saxenda); Liraglutide 3 mg placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Liraglutide; Liraglutide 3 mg; Osteoarthritis; Obesity
Reversal of General Anesthesia With Methylphenidate
Condition: Post Operative Cognitive Dysfunction; Emergence From Anesthesia
MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is to investigate whether methylphenidate (Ritalin) can actively induce
      emergence from general anesthesia in patients having a pancreaticoduodenectomy (Whipple
      procedure), a pancreatectomy, or a prostatectomy.
    


Intervention name(s): Methylphenidate; Saline
Intervention type(s): Drug; Other
Other intervention name(s): ritalin
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study of TAVO103A in Healthy Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single ascending dose study designed to investigate TAVO103A, administered
      as an IV infusion up to 60 minutes in length to healthy adult subjects. This study is
      designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of
      TAVO103A.
    

Detailed description: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD),
      single site study. There will be up to 5 SAD cohorts with 6 subjects enrolled into each.
      Subjects will be randomized at a ratio of 2:1 to receive TAVO103A or placebo. Subjects will
      be evaluated for safety throughout the study up through day 196.
    

Intervention name(s): TAVO103A; Placebo
Intervention type(s): Drug; Other
Intervention description(s): TAVO103A single ascending dose IV infusion.; Placebo single ascending dose IV infusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like
      medicine tablet or capsule, but contains no active medicine) is safe and effective when taken
      together with another antidepressant.
    

Detailed description: 
      A multicenter, randomized, double-blind, parallel group, placebo-controlled, phase III
      efficacy and safety study of TC-5214 (S-mecamylamine) in flexible doses as an adjunct to an
      antidepressant in patients with major depressive disorder with an inadequate response to
      antidepressant therapy.
    

Intervention name(s): TC-5214; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet, oral, twice daily for 8 weeks; Tablet, oral, twice daily for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; MDD; Depression; Safety; add-on therapy
The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery
Condition: Chlorzoxazone; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Chlorzoxazone is a centrally acting muscle relaxant used to treat muscle spasm and the
      resulting pain or discomfort. It acts on the spinal cord by depressing reflexes. Our purpose
      is to investigate the effect of chlorzoxazone on moderate to severe postoperative pain after
      spine surgery. Our hypothesis is that chlorzoxazone can reduce postoperative pain and reduce
      opioidconsumption and side effects compared to placebo.
    


Intervention name(s): Placebo; Chlorzoxazone; Morphine; Zofran
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Two placebo tablets identical to the chlorzoxazone tablets.; Two 250 mg chlorzoxazone tablets; Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.; Zofran 4 mg iv. in case of moderate to severe nausea, supplemented by Zofran 1 mg iv. if needed
Intervention MeSH terms: Morphine; Chlorzoxazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chlorzoxazone; Postoperative pain; Spine surgery; Opioid consumption
Effect on Teeth and Gum Cleaning in Patients With Gum and Kidney Disease
Condition: Renal Insufficiency Chronic; Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis; Renal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The main aim and objective of this study was to evaluate the effects of Non- surgical
      periodontal therapy on the subgingival microbiota and biochemical parameters in patients with
      chronic kidney disease and chronic periodontitis.
    

Detailed description: 
      The study was designed as a Non randomized prospective, interventional clinical trial. The
      sample size for the study was 40 individuals aged between 35-75 years, equally divided into
      two groups.

      Group I--- Patients with Chronic kidney disease and chronic periodontitis (Test) Group II---
      Patients with Chronic periodontitis only (Controls) At baseline both the groups were analyzed
      for clinical, microbiological and also biochemical parameters and underwent Non-surgical
      Periodontal treatment (i.e. scaling and root planning). All parameters were reassessed again
      after 3 months.

      A total of 20 patients attending the outpatient wing of Hyderabad Kidney Centre ,
      Malakpet,Hyderabad who were diagnosed clinically with Chronic Kidney disease and willing to
      participate in the study were included in the study.

      Another 20 patients attending the outpatient wing of Department of periodontics, Panineeya
      Mahavidyalaya Institute of Dental Sciences & Hospital, Hyderabad, diagnosed with Chronic
      Periodontitis and willing to participate in the study were taken.

      Biochemical parameters considered included -serum creatin & urinary albumin: creatin ratio.

      Microbiological assay was done by Polymerase chain reaction test (PCR) i.e., pooled plaque
      samples were taken from both predialysis as well as chronic periodontitis patients.
    

Intervention name(s): Scaling and Root planing
Intervention type(s): Other
Intervention description(s): All the patients were asked to use a preprocedural mouthrinse and scaling and rootplaning was done using ultrasonic scalers.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles Versus 12 Cycles
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate which oxaliplatie based adjuvant method (8 cycles
      or 12 cycles) is better for patients receiving curative colorectal cancer resection.
    

Detailed description: 
      We administered 5-FU, lv and Oxaliplatin as adjuvant chemotherapy (3 weeks per cycle) to
      patients with Stage II or Stage III colorectal cancer. The study endpoints were disease-free
      survival, overall survival, and liver metastasis-free survival as evaluated by
      intent-to-treat analysis.
    

Intervention name(s): 12 cycles of oxaliplatine based adjuvant chemotherapy; 8 cycles of oxaliplatine based adjuvant chemotherapy
Intervention type(s): Drug; Drug
Intervention description(s): oxaliplatine 85 mg/㎡ d1, lv 200 mg/㎡ d1, 5-fu 1300 mg/㎡ ivgtt maintain for 48hr, every 3 weeks/cycle, 12 cycles; oxaliplatine 85 mg/㎡ d1, lv 200mg/㎡ d1, 5-fu 1300 mg/㎡ ivgtt maintain for 48hr, every 3 weeks/cycle, 8 cycles
Intervention MeSH terms: Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oxaliplatine; colorectal cancer; chemotherapy
Clinical Study of the Endotracheal Tube Used in Prone Position Ventilation Condition
Condition: Mechanical Ventilation Complication
Study type: Interventional

Summary: 
      In this study, the investigators adopt the special endotracheal tube to those patients at
      prone posture during the operation,or those with acute respiratory distress syndrome in the
      intensive care unit(ICU), so that the investigators can reduce, or even avoid some severe
      complications during perianesthesia, and that the investigators can provide strong safeguard
      measures for the respiratory therapy of critical patients in ICU.
    

Detailed description: 
      The investigators apply some technical proposals to make it come true:one kind of special
      endotracheal tube, including traditional endotracheal tube,fixed device,fixed rope,two
      through holes.With this tube ,the investigators can keep away shifting and falling off of
      traditional air tube,so that the investigators can try to avoid disaster events.And for the
      patients with acute respiratory disease syndrome(ARDS),they are always given ventilation in
      prone position,so it may be beneficial.
    

Intervention name(s): prone position endotracheal tube(PPT)
Intervention type(s): Device
Intervention description(s): some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prone position ventilation; Endotracheal intubation; Displacement
Effect of Inulin-type Fructose Extracted From Jerusalem Artichoke on Improving Prediabetic State of Type 2 Diabetes
Condition: Prediabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The trial was a multicenter, randomized, double-blind, placebo-controlled,
      parallel-controlled, exploratory clinical study.Through the intervention of soluble dietary
      fiber in the pre-type 2 diabetic population, the change of blood glucose spectrum before and
      after intervention can show the effect of this intervention on the outcome, and further
      elucidate the effect of soluble dietary fiber intervention on the level of insulin resistance
      and its effect on outcome. Helps to prevent the more scientific and effective prevention of
      type 2 diabetes from pre-diabetes.

      Subjects who met the criteria were randomly divided into the experimental group and the
      control group, after 24 weeks of intervention, the incidence of blood sugar reversion to
      normal was main observed.The main purpose of this study was to investigate the effect of
      soluble dietary fiber treatment regimens on the conversion rate of pre-type 2 diabetes
      (converted to normal blood glucose, type 2 diabetes, or stable in the stage of impaired
      glucose tolerance). The secondary objective was to study the improvement of insulin
      resistance and changes in intestinal flora after intervention.
    

Detailed description: 
      The soluble dietary fiber (NIUCHANG®) and placebo used in the trial were exclusively produced
      by Inuling (Beijing) Technology Co., Ltd. and provided free of charge. During the treatment
      period, the treatment group was given oral "NIUCHANG®" (once 15g,once a day)and the control
      group was given oral placebo (once15 g, once a day) for 24 weeks.

      The test was performed for 12 weeks as a course of treatment。At the end of one course of
      treatment, if the glucose tolerance was changed to normal or the blood glucose was stable in
      the pre-diabetes phase, the original dose was maintained and continued for 12 weeks. At 24
      weeks, patients with normal blood glucose and glucose tolerance tests were followed up for 48
      weeks. At the end of one course of treatment, if the blood glucose progresses to the stage of
      diabetes, the test is withdrawn and treated according to clinical routine.
    

Intervention name(s): NIUCHANG; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Inulin; Soluble dietary fiber; Prediabetes