bioihbjkbjnl/mcl2 huggingface dataset:
Study of Standard Maintenance Method of Intravenous Port and Post-operation Pain Analysis
Condition: Cancer
Study type: Interventional

Summary: 
      Investigators deconstructed the port that removed from patients and identified there were
      structural weakness, old blood clot and fibrin deposits. Investigators consider the problem
      may be exist in maintenance. After thoroughly examination the maintenance protocol,
      Investigators identified the problem and try to remodel the maintenance protocol. The Goal of
      this study was to testify the clinical value of standard maintenance protocol.
    

Detailed description: 
      A secure and easily feasible vascular access is crucial for oncology patients because of the
      therapeutic need. Although intravenous port has been utilized for 3 decades, catheter-related
      complication still remain and had to deal with. According to investigators clinical
      experience, investigators summarized a standard algorithm as a recommendation for intravenous
      sport implantation. The complication before and after standard algorithm was 20 % and 3.5 %,
      respectively. However, catheter related infection and malfunction still could not be avoided.
      If patient was identified with these 2 complications, re-intervention is needed and
      cancer-related therapy has to be postpone. Investigators deconstructed the port that removed
      from patients and identified there were structural weakness, old blood clot and fibrin
      deposits. Investigators consider the problem may be exist in maintenance. After thoroughly
      examination the maintenance protocol, investigators identified the problem and try to remodel
      the maintenance protocol. The Goal of this study was to testify the clinical value of
      standard maintenance protocol.
    

Intervention name(s): normal saline; normal saline+heparin
Intervention type(s): Other; Other
Intervention description(s): experimental group use normal saline sealing tube; normal saline+heparin(Currently, Regular used in hospital)
Intervention MeSH terms: Heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cancer patients in need of chemotherapy
Newly accepted Port-A Implant
port maintenance:Catheter irrigation with 20 ml N/S,10 ml N/S sealing tube
Masking: None (Open Label)
Primary purpose: Other
Keywords: intravenous port; port maintenancem
Dynamics of Human PApilloma Virus Interactions; Internet-based Students HeAlth Research Enterprise
Condition: Infection by Human Papilloma Virus
MeSH terms: Infections; Papilloma
Study type: Interventional

Summary: 
      Human papillomavirus (HPV) infection is the most common sexually transmitted infection. The
      high risk oncogenic types, HPV-16 and -18 are responsible for 70% of cervical cancers. The
      introduction of vaccination against two major oncogenic genotypes of HPV raises questions
      about genotype replacement because of the existence of other oncogenic types not targeted by
      the vaccine. A better understanding of natural history of HPV infection and interaction
      (competition, synergy) between genotypes are required in order to anticipate this phenomenon.

      The aims of this study are to characterize HPV infection in young female students and to
      follow up HPV infection and co-infection dynamics with different genotypes, taking into
      account both vaccination status and immunity to HPV 16 and 18. The study also focuses on the
      determination of factors influencing the development of persistent cervical HPV infections.

      The DyPAVIR-ISHARE study is based on the participation of 5000 young female students, from 18
      to 20 years-old, all registered at the Universities of Bordeaux or Versailles Saint-Quentin
      (UVSQ). The 3-years follow-up includes completion of a self-administrated questionnaire
      regarding sexual behaviour, socio-demographic characteristics, access to health-care services
      and, for a sub-group of 1000 students, the taking of genital and oral self-taken samples for
      the detection and genotyping of HPV (every 3 months). Previously, a pilot phase study (2
      visits in 3 months of interval) is set up on 50 young female students from UVSQ in order to
      test feasibility.

      This study will provide data to gain insight into the possibility of type replacement.
      Moreover, this study would provide an overview of HPV vaccine coverage and effectiveness HPV
      incidence and factors associated with HPV infection and co-infection ; Partners recruitment
      would allow us to follow HPV transmission dynamics among couples, and in particular, HPV
      exposure in young adult women. The HPV research won't be limited to virus detection in
      samples but will indicate the presence or absence of HPV infection.

      Finally, additional genetic studies could be conducted in order to study genetic
      susceptibility to HPV infection, to chronic HPV infection and to co-infection.

      This research project is part of the i-Share program funded by the "Investissement d'Avenir"
      cohort call.
    


Intervention name(s): Various biological sampling
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Human papilloma virus; Young women; I-Share
Fontan Circulation and Cardiopulmonary Function: Prognostic Factors, Hemodynamics and Long-term Effects
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      Cross-sectional study of a national cohort of adolescents with univentricular congenital
      heart defects and Fontan type palliation.
    

Detailed description: 
      A study group of 40-50 individuals will be investigated by non-invasive and invasive methods,
      including echocardiography at rest and during exercise, heart catheterization with advanced
      hemodynamic studies, cardiac and abdominal MRI, abdominal ultrasound and transient
      elastography, quality of life assessment and cardiopulmonary exercise testing. A selection of
      tests will be performed in a healthy control group as well.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All adolescents i Norway with univentricular heart defects and Fontan type palliation
      
Biospecimen description: 
      EDTA, citrate and serum samples for analysis for vitamin status, biochemical analysis,
      inflammation markers and organ specific markers.
    
Keywords: Univentricular heart defect; Fontan circulation
Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation - Froedtert
Condition: Stroke Rehabilitation; Ischemic Preconditioning; Physical and Rehabilitation Medicine
MeSH terms: Stroke; Ischemia
Study type: Interventional

Summary: 
      This study will be the first study to use ischemic preconditioning (IPC) as an intervention
      to improve stroke rehabilitation. IPC is a well studied, well tolerated intervention which
      has been shown to improve regional blood flow, motor neuron excitability and muscle function
      in multiple patient groups and in young, healthy subjects. Because IPC targets three
      physiological systems which are all affected by stroke, we hypothesize that repeated bouts of
      IPC during the first days to months following stroke (when the majority of recovery occurs)
      will make traditional rehabilitation strategies more effective.
    


Intervention name(s): Ischemic Preconditioning; Sham
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study to Determine the Effects of Nebivolol and Hydrochlorothiazide in African Americans With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The main purpose of this study is to evaluate the effects of Nebivolol and
      Hydrochlorothiazide on blood pressure in African Americans with high blood pressure.
    

Detailed description: 
      Many blood pressure medications are not effective in African American men and women. The two
      lower chambers of the heart contract to pump blood to the body. The lower chambers have to
      relax so they can refill with blood to pump out again. Many patients with high blood pressure
      have stiffness in the lower chambers which prevents the heart from relaxing so it can
      properly fill with blood. Some patients with the stiffness in the lower chambers of the heart
      will develop heart failure.

      The study is to test whether or not Nebivolol (Bystolic)and a diuretic Hydrochlorothiazide
      (HCTZ) will help the heart relax so the heart can properly fill and prevent stiffness of the
      lower heart chambers.
    

Intervention name(s): Nebivolol; Hydrochlorothiazide
Intervention type(s): Drug; Drug
Intervention description(s): 5mg/day with increase to 10 mg/day to reach blood pressure <140/90; Hydrochlorothiazide 25 mg/day
Other intervention name(s): Bystolic; HCTZ
Intervention MeSH terms: Hydrochlorothiazide; Nebivolol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hypertension; African Americans; Arterial Stiffness; Vascular Resistance
A Study To Determine Any Effect Of Tafamidis On Electrocardiographic Intervals, Specifically The Rate Corrected QT Interval (QTc)
Condition: TTR Cardiomyopathy
MeSH terms: Cardiomyopathies
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effects of tafamidis on the intervals of the
      electrocardiogram, specifically the rate corrected QT interval (QTc) in healthy volunteers.
    


Intervention name(s): Period 1; Period 2; Period 3
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.; A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.; A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.
Other intervention name(s): tafamidis (Vyndaqel); moxifloxacin
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: Thorough QTc evaluation of tafamidis compared to the effects of moxifloxacin and placebo in healthy volunteers.
A Study of the Pharmacokinetics and Safety of SM03 in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This was an open phase I trial to evaluate the pharmacokinetic, pharmacodynamic, safety and
      clinical activity profiles of anti-CD22 monoclonal antibody SM03 in patients with active RA.
    

Detailed description: 
      This was an open phase I trial to evaluate the PK, PD, safety,tolerability, efficacy, and
      immunogenicity of SM03 in patients with RA. The total study duration was approximately 16
      weeks for each participant, including a screening period of maximally 4 weeks, a
      multiple-dose period of 2 weeks (day 0 ~ day 14), and a post-treatment follow-up period of 10
      weeks (day 15 ~ day 84).
    

Intervention name(s): Biological: SM03
Intervention type(s): Drug
Intervention description(s): Biological: SM03 600 mg or 900 mg intravenous (IV) on week 0,2
Other intervention name(s): SM03
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LOXO-305) and Digoxin (P-Glycoprotein Substrate) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the effect of Pirtobrutinib (LOXO-305) on
      multiple oral doses of digoxin (P-gp substrate) when administered as single and multiple
      doses by collecting the blood samples and conducting the blood tests to measure how much
      digoxin is in the bloodstream and how the body handles and eliminates it in healthy
      participants. The study will also evaluate the safety and tolerability of Pirtobrutinib.
      Participants will stay in this study for up to 58 days, including screening.
    


Intervention name(s): Pirtobrutinib; Digoxin
Intervention type(s): Drug; Drug
Intervention description(s): Administered Orally.; Administered Orally.
Other intervention name(s): LOXO-305; LY3527727
Intervention MeSH terms: Digoxin; Pirtobrutinib
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effects of Physical Training and GLP-1 Receptor Agonist Liraglutide Treatment in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to investigate the effects of physical training in patients
      with type 2 diabetes during treatment with the GLP-1 receptor agonist liraglutide (Victoza®)
      in a 16-weeks double-blinded, randomized placebo-controlled clinical trial.

      Hypothesis: Physical training leads to better metabolic control in type 2 diabetic patients
      when training is combined with liraglutide (Victoza®) treatment.
    


Intervention name(s): Training and liraglutide; Training and placebo
Intervention type(s): Other; Other
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GLP-1; Training; Exercise; Type 2 Diabetes
Effect of Food on the Pharmacokinetics of AQW051 in Japanese Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate safety, tolerability and pharmacokinetics of individual oral doses
      of AQW051 in Japanese healthy male subjects, and will also evaluate the effect of food on the
      pharmacokinetics of AQW051.
    


Intervention name(s): AQW051
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Safety, tolerability, pharmacokinetics, AQW051, food, Japanese, healthy male subjects; Healthy volunteers study
Ability of Cardio Q for Prediction of Hypotension
Condition: Prostate Cancer
MeSH terms: Hypotension
Study type: Observational

Summary: 
      Evaluation the ability of each indicator of Cardio Q in predicting hypotension after position
      changes in robot-assisted laparoscopic radical prostatectomy
    

Detailed description: 
      Hypotension is common in patients who undergo general anesthesia. Hypotension may cause
      hypoperfusion in the organs of the body, resulting in ischemia and increased mortality within
      one year. Hypotension may occur at any time during general anesthesia but may also occur with
      changes in posture. In robot-assisted laparoscopic radical prostatectomy, hypotension often
      occurs when posture is changed from a Trendelenburg position to a supine position. However
      there is no data regarding which hemodynamic parameters can predict hypotension induced by
      position change.

      Excessive administration of the fluid in steep Trendelenburg position may lead to fluid
      overload and lead to complications such as pulmonary edema. Thus, the predictors are should
      be identified to manage patients without fluid overload. Therefore, the aim of this study is
      to investigate the parameters of Cardio Q which are useful for predicting hypotension after
      position change.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ASA 1-3 Patient undergoing robot-assisted laparoscopic radical prostatectomy
      
Keywords: Robotic surgery; Position; Cardio Q; hypotension
Anti-inflammatory Effect of Aerobic Exercise in Individual With Increased Cardiovascular Risk
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      Aerobic physical activity attenuates systemic inflammatory activity in individuals with
      cardiovascular risk.
    

Detailed description: 
      Background: Observational studies suggest that exercise has anti-inflammatory effect, however
      this idea has not been definitively confirmed by randomized clinical trials.

      Objective: To test the hypothesis that aerobic exercise attenuates systemic inflammatory
      activity in individuals with cardiovascular risk.

      Methods: Randomized controlled trial, which included 68 sedentary individuals, with at least
      two risk factors for coronary heart disease or established cardiovascular disease. The
      volunteers were randomized to 3 months of supervised aerobic training or just advice when
      healthy lifestyles. C-reactive protein (CRP) was measured by the method of high sensitivity
      before and after 3 months of intervention.
    

Intervention name(s): Aerobic Exercise; Only Counseling
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise
Glossopharyngeal Nerve Block for Post -Tonsillectomy Pain Relief
Condition: Analgesia
Study type: Interventional

Summary: 
      The aim of the present study is to evaluate the efficacy and safety of Ultra-sound guided
      submandibular parapharyngeal glossopharyngeal nerve block as regards time for first need of
      analgesic as a primary outcome as well as pain score, total postoperative analgesic
      requirement, and incidence of complications as secondary outcomes
    

Detailed description: 
      Tonsillectomy is one of the most frequent surgical procedures performed all over the world
      that has been identified as being severely painful especially in the adult population.
      Management of post tonsillectomy pain is of paramount importance in order to improve
      swallowing and enhance oral intake as well as to decrease the risk of dehydration, infection
      and secondary hemorrhage with a subsequent hastening of recovery.

      A variety of analgesic regimens have been implemented to alleviate post-tonsillectomy pain,
      however; no consensus on the ideal analgesic regimen has been yet identified.

      The Ultrasound (US)-guided glossopharyngeal nerve (GPN) block has been acknowledged as a
      feasible option for providing perioperative analgesia in tonsillectomy patients. It blocks
      sensory impulses from the posterior third of the tongue, palatine tonsil, and mucous
      membranes of the mouth and pharynx. Conventional techniques for blocking the GPN carry the
      risk of vascular puncture, inadvertent block of closely adjacent other cranial nerves, with
      increased probability of local anesthetic toxicity and even upper airway obstruction.
      Recently, a novel, safe, and reproducible US-guided GPN block technique has been introduced
      by Azman et al, which would block the GPN distally, in the tissue plane just next to the
      pharyngeal wall and relatively far from high risk nearby structures.
    

Intervention name(s): bilateral ultrasound guided GPN block
Intervention type(s): Procedure
Intervention description(s): a linear high frequency ultrasound probe will be initially positioned over the hyoid bone in the transverse plane, then the probe will be rotated to keep in line with the mandibular angle and the pharyngeal wall is identified by US. Using an in plane approach, a 22 G ,5 cm needle will be advanced till it reaches just superficial to the pharyngeal wall and 2.2 ml of 0.25% bupivacaine will be injected.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
The Effectiveness and Safety of Low-intensity Single-wavelength Red Light in Controlling High Myopia in Children and Adolescents：A Randomized, Controlled, Multicenter Clinical Trial
Condition: Age 3 to 16 Years (Inclusive), Male or Female; Clinical Diagnosis Confirming That Myopia Has Occurred in at Least One Eye; The Guardian Voluntarily Signed the Subject's Informed Consent Form
MeSH terms: Myopia
Study type: Interventional

Summary: 
      Objective: To study the effectiveness and safety of low-intensity single wavelength red light
      in controlling high myopia in children and adolescents.

      Methods: Subject population: Children aged 3-16 years who have high myopia. Sample size: 190
      subjects were planned to be enrolled and assigned to the test or control group in a 1:1
      ratio.
    

Detailed description: 
      Design: The trial was a randomized, controlled, multicenter clinical trial. A total of 190
      children aged 3-16 years with high myopia were selected and divided into 95 cases in the test
      group and 95 cases in the control group. The test group was treated with the Eyesing
      Instrument developed by Suzhou Industrial Park Zoguan Medical Equipment Co. and conventional
      optometry. The safety and efficacy of the low-energy laser device in the test group were
      evaluated by comparing the changes in myopia between the two groups during the observation
      period. Subjects were screened after signing the informed consent form (performed as early as
      7 days before the randomization), and the examination used for screening could use the
      results of eye examinations performed within 1 week at our hospital, and they were enrolled
      after confirming that they met the inclusion criteria. On the same day, the grouping was done
      by randomization, and the glasses were prescribed or the glasses were prescribed in
      combination with the device according to the grouping results. Visits were performed at 30±
      14 days, 90± 14 days, 180± 14 days, 270± 14 days, and 365± 14 days
    

Intervention name(s): Eyesing Redlight Instrument
Intervention type(s): Other
Intervention description(s): Eyesing Instrument developed by Suzhou Industrial Park Zoguan Medical Equipment Co. and conventional optometry.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Main efficacy indicators. Axial length changes in the left and right eyes (30± 14 days, 90± 14 days, 180± 14 days, 270± 14 days, and 365± 14 days).Secondary efficacy indicator: change in equivalent spherical lens after astigmatism (day 365±14)
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: high myopia; red light; children and adolescents
Comparison of HES 130 in Balanced and in Unbalanced Solution
Condition: Decreased and Nonspecific Blood Pressure Disorders and Shock
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of HES 130/0.42 in an electrolyte
      infusion in comparison to HES 130/0.4 in a sodium chloride infusion.
    


Intervention name(s): 6% HES 130/0.42 in plasma adapted Ringer's solution; 6% HES 130/0.4 in a saline solution
Intervention type(s): Drug; Drug
Intervention description(s): 60 g/l hydroxyethyl starch 130 dissolved in plasma adapted Ringer's solution (balanced solution); 60 g/l Hydroxyethyl starch (HES) with a mean molecular weight of 130 kDalton which is dissolved in a saline solution
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment