bioihbjkbjnl/mcl2 huggingface dataset:
A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches
      between Humira® and ABP 501 (new high concentration formulation) compared with continued use
      of Humira® in participants with moderate to severe plaque psoriasis. This multi-center study
      is composed of two periods: A lead-in period of treatment with Humira® followed by a
      randomized two parallel arm period.
    


Intervention name(s): Adalimumab; ABP 501
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive subcutaneous (SC) injection of adalimumab; Participants will receive SC injection of ABP 501
Other intervention name(s): Humira®
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Adalimumab; Biosimilars; Tumor necrosis factor; Psoriasis Area and Severity Index
Effect of Inverse Ratio Ventilation During Induction of General Anesthesia on Safe Apnea Time in Obese Patients
Condition: Obesity
MeSH terms: Apnea
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the clinical application value of inverse ratio
      ventilation in obese patients during induction of general anesthesia by studying the effect
      of inverse ratio ventilation on the safe apnea time.
    

Detailed description: 
      Inverse ratio ventilation(IRV) can produce mean airway pressure(Pmean)similar to external
      positive end expiratory pressure(Peep) by increasing inspiratory time. Moreover, the increase
      of Pmean was not accompanied by the further increase of peak airway pressure (Ppeak) and
      airway plateau pressure (Pplat), while the application of external peep accompanied with the
      increase of Pplat increased the risk of barotrauma . High level of Peep increased cardiac
      load and decreased cardiac output. A number of studies have found that the hemodynamic
      stability of patients can be achieved when IRV regulates the inspiratory / expiratory ratio
      in an appropriate range (I: E < 2:1). Therefore, the inverse ratio is considered to be
      superior to Peep in terms of gas exchange and respiratory mechanics.
    

Intervention name(s): Inspiratory-to-expiratory (I : E) ratio of 1:2; Inspiratory-to-expiratory (I : E) ratio of 2:1
Intervention type(s): Other; Other
Intervention description(s): After preoxygenation and induction of anesthesia, noninvasive positive pressure ventilation with inspiratory-to-expiratory (I : E) ratio of 1:2 for 5 min before endotracheal intubation.; After preoxygenation and induction of anesthesian, noninvasive positive pressure ventilation with inspiratory-to-expiratory (I : E) ratio of 2:1 for 5 min before endotracheal intubation.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: inverse ratio ventilation; safe apnea time
Effect of Precise Grip Strength Training on PICC Catheter-Related Thrombosis in Cancer Patients
Condition: Lung Cancer; Stomach Cancer; Breast Cancer; Liver Cancer; Colon Cancer; Rectal Cancer
MeSH terms: Stomach Neoplasms; Thrombosis
Study type: Interventional

Summary: 
      In this study, color Doppler ultrasound diagnostic instrument and electronic grip device were
      used to determine the best grip strength of patients with tumor PICC catheterization,
      formulate precise and standardized grip strength training guidance for them, provide
      personalized functional exercise health education, and observe the impact of precise grip
      strength training guidance on Peripheral central venous catheter-associated thrombosis. To
      provide a reference for clinical prevention of Peripheral central venous catheter-associated
      thrombosis in the future.
    


Intervention name(s): Precision grip training; Use maximum strength grip training; Health education on routine grip strength training
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): First determine patients for holding the ball movement should reach the effective blood flow velocity and best duration - relaxation, and USES the electronic grips and color doppler ultrasonic diagnostic apparatus, for individual patients to choose the best grip the efforts and training, to form the best grip the training plan, and observe the scheme for Peripheral central venous catheter-associated thrombosis prevention effect.; Patients were routinely implanted with PICC, and on the basis of health education in the control group, the best continuous-relaxation time, frequency and maximum grip strength of patients were used for grip strength training.; Patients were routinely implanted with PICC and received routine health education. The content of health education included face-to-face language explanation of the whole process of catheter knowledge, issuing catheter maintenance manual, issuing ordinary grip ball and telling how to use it, and follow-up.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: PICC；Cancer patients；Grip strength training
Comparison of Patient-Controlled Analgesia With Different Background Infusion
Condition: Patient-Controlled Analgesia
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      In this study, the investigators investigated the efficacy, usefulness and analgesic
      consumption of three different patient-controlled analgesia(PCA) programmes:bolus dose alone
      without background infusion, bolus dose with low background infusion and bolus dose with high
      background infusion to evaluate postoperative analgesia for patients after laparoscopic
      colorectal surgery.
    

Detailed description: 
      There have been many studies using patient-controlled analgesia (PCA) and opioids for
      postoperative analgesia.Patient-controlled analgesia with opioids is now widely used after
      surgery for the treatment of acute postoperative pain. This technique provides effective pain
      treatment, adjusts the dose according to personal need and keeps plasma analgesic levels at a
      constant level,but the incidence of opioid-induced side-effects still be reported
      frequently.A proper PCA programme may increase efficiency of analgesic and decrease incidence
      of analgesic-induced side-effects.

      In this study, 90 patients who is undergoing elective laparoscopic colorectal surgery will be
      randomly allocated into three groups (no background infusion group(Group B0),low background
      infusion group(Group B1) and high background infusion group(Group B2)). Patients in all
      groups will be given a patient-controlled analgesia (PCA) pump in post anesthetic recovery
      unit (PACU) after surgery.The PCA programme of Group B0 is dezocine 0.6mg/kg, flubiprofen
      3mg/kg, diluted into 120ml and administer at a background infusion of 0ml/h, and a bolus of
      4ml, with a lock-out of 15min. The PCA protocol of Group B1 is dezocine 0.6mg/kg,flubiprofen
      3mg/k diluted into 120ml and administer at a background infusion of 1ml/h, and a bolus of
      2ml, with a lock-out of 15min.The PCA protocol of Group B2 is dezocine 0.6mg/kg,flubiprofen
      3mg/k diluted into 120ml and administer at a background infusion of 2ml/h, and a bolus of
      2ml, with a lock-out of 15min.
    

Intervention name(s): Patient-Controlled Analgesia(PCA)
Intervention type(s): Device
Intervention description(s): Patients receive analgesic regimens using Patient-Controlled Analgesia(PCA) with different background infusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Analgesia; Colorectal Surgery; Background Infusion
Phase I Study to Investigate Safety, Tolerability, and Pharmacokinetics of VVZ-149 Injection
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      VVZ-149 is a novel analgesic drug candidate that shows a potential analgesic activity
      inhibiting GlyT2 and 5HT2A simultaneously. There have been many efforts to develop
      single-target selective drugs to treat pain, but usually unsuccessful due to the lack of
      efficacy or limitations of single-target approach for new drug discovery. VVZ-149 is expected
      to have a dual-target activity, demonstrated having a synergism between GlyT2 and 5HT2A
      antagonistic activities to maximize an antinociceptive effect in the in vivo animal models.
      Now the investigators are developing VVZ-149 as an IV injection to treat post-operative pain.

      The primary objective of this study is to evaluate a safety, tolerability and pharmacokinetic
      properties of VVZ-149 injection with placebo in healthy male volunteers. This Phase 1 study
      consists of a randomized, double-blind, placebo controlled, single and multiple ascending
      dose (SAD & MAD) escalation clinical trials.
    

Detailed description: 
      In this clinical study, the investigational drug product will be offered as an injectable
      form in a transparent glass vial that contains VVZ-149 dissolved by water for injection. When
      administered, the drug will be diluted by normal saline and will be given by intravenous
      infusion for 4 hours.

      SAD study is planned that maximal 7 cohorts of healthy male subjects are administrated single
      dose of VVZ-149 injection or placebo. The planned groups for dose escalations were 0.25, 0.5,
      1, 2, 4, 6, and 8 mg/kg groups. As a pilot study for safety in this first-in-human study,
      only 3 subjects received active drug are allocated to first two groups each, without subjects
      for placebo. For the following groups, 6 subjects for active drug and 2 for placebos are
      allocated after randomized.

      MAD study is planned that 2 cohorts of 10 healthy male subjects each were administered
      multiple doses of VVZ-149 injection or placebo. The final doses of VVZ-149 injection will be
      determined later based on the results of SAD study. In each group, 7 subjects for active drug
      and 3 for placebos are allocated after randomized
    

Intervention name(s): VVZ-149 Injection; placebo
Intervention type(s): Drug; Drug
Intervention description(s): VVZ-149 in water for injection; water for injection
Other intervention name(s): VVZ-149 Injection or Water for injection; VVZ-149 Injection or Water for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Phase I Study of GFH312 in Healthy Chinese Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study was to evaluate the pharmacokinetic profile and observe the safety of
      GFH312 after single and multiple administrations in healthy Chinese subjects.
    

Detailed description: 
      This study was planned to enroll about 26 healthy subjects, subjects were planned to receive
      single administration of 100 mg GFH312, single administration of 200 mg GFH312, or multiple
      administrations of 120 mg GFH312, as well as their matching placebo. Subjects were randomized
      in 3:1 ratio in the single dose cohorts and in 4:1 ratio in the multiple dose cohort.
    

Intervention name(s): GFH312 100 mg; GFH312 200 mg; GFH312 120mg; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Participants receive single dose of GFH312 100 mg orally; Participants receive single dose of GFH312 200 mg orally; Participants receive daily dose of GFH312 120mg orally for fourteen consecutive days; Participants receive placebo matching with GFH312
Other intervention name(s): GFH312; GFH312; GFH312
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison Of Doxycycline And Common Salt For Treatment Of Umbilical Granuloma: A Randomised Control Trial
Condition: Umbilical Granuloma
MeSH terms: Granuloma
Study type: Interventional

Summary: 
      it is the study for the disease called umbilical granuloma to look for the better treatment
      option which can be performed by healthcare physicians and local nurses and even parents
    

Detailed description: 
      umbilical granuloma is a condition for which multiple treatments are available those
      including interventional and non interventional, most of the treatments are performed by the
      health care physician like application of silver nitrate cryotherapy, electrocautery, double
      ligation.

      the main goal of this study is to prefer those method or drugs which could be safely used by
      the nurses the health care personal and even by parents at home with fewer side effects
    

Intervention name(s): Doxycyclin; COMMON SALT
Intervention type(s): Drug; Other
Intervention description(s): THE USE OF DOXYCYCLIN POWDER IN THE TREATMENT OF UMBILICAL GRANULOMA; THE USE OF COMMON SALT IN TREATMENT OF UMBILICAL GRANULOMA
Other intervention name(s): COMMON SALT
Intervention MeSH terms: Doxycycline
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Health Services Research
Transversus Abdominis Plane Block Versus Wound Infiltration for Postcesarean Analgesia
Condition: Postcesarean Analgesia
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      The study will compare the analgesic efficacy of transversus abdominis plane block and wound
      infiltration in parturients undergoing cesarean delivery under spinal anesthesia.
    

Detailed description: 
      This randomized, controlled, double-blind study will be conducted on ASA physical status II
      parturients with full-term singleton pregnancy undergoing elective cesarean delivery under
      spinal anesthesia. Patients will receive either ultrasound-guided transversus abdominis plane
      block or wound infiltration at the end of surgery. After delivery, all patients will receive
      standard analgesia (intravenous ketorolac and oral paracetamol) and patient-controlled
      analgesia with intravenous fentanyl. Total fentanyl consumption at 24 h, pain scores at 2, 4,
      6, 12, and 24 h, side effects, and patient satisfaction will be compared between the 2
      groups.
    

Intervention name(s): Spinal anesthesia; Intrathecal bupivacaine; Intrathecal fentanyl; Cesarean delivery; Wound infiltration; Sham procedure; Transversus abdominis plane block; Ketorolac; Paracetamol; Fentanyl patient-controlled analgesia
Intervention type(s): Procedure; Drug; Drug; Procedure; Procedure; Procedure; Procedure; Drug; Drug; Procedure
Intervention description(s): Performed at the L3-4 or L4-5 interspace using 27- or 25-gauge spinal needle.; Bupivacaine 12.5 mg will be administered in the subarachnoid space.; Fentanyl 15 µg will be administered in the subarachnoid space.; Lower segment cesarean section using the Pfannenstiel incision and exteriorization of the uterus.; 30 mL bupivacaine 0.25% will be injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing.; Sham procedure will be performed after surgery by moving the ultrasound probe and pressing a covered spinal needle on both sides of the patients' abdomen.; Bilateral ultrasound-guided TAP block using 20 mL bupivacaine 0.25% on each side. A 7-12 MHz linear array probe and 22-gauge needle will be used. The probe will be placed transversely above the iliac crest in the anterior axillary line and the needle will be introduced in-plane with the probe from medial to lateral.; IV ketorolac 30 mg/8 h starting at the end of surgery.; Oral paracetamol 1 gm/8 h starting 4 h after surgery.; Intravenous fentanyl: bolus dose = 20 µg, lockout interval = 7 min, 4-h dose limit = 200 µg, with no background infusion.
Intervention MeSH terms: Acetaminophen; Ketorolac; Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Ai Chi Versus Stretching in Fibromyalgia Management
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare the efficacy and tolerability of Ai Chi, an adaptation
      of Tai Chi exercise to water, with stretching on fibromyalgia symtomatology.
    

Detailed description: 
      Physical therapies have shown to be effective in the treatment of fibromyalgia and It is
      generally assumed that a multidisciplinary approach, combining both pharmacologic and
      non-pharmacologic measures, is probably the optimal treatment approach for most fibromyalgia
      patients. As these patients are usually physically deconditioned, low-intensity exercise has
      been recommended at least as initial treatment. At this respect, exercise in warm water is
      considered a good option as both temperature and water buoyancy minimize body weight's stress
      and help patients to minimize pain. In a previous study comparing short term physiotherapy
      with stretching and Ai Chi we found that Ai Chi was at least as effective as stretching and
      induced a significant reduction in fibromyalgia core symptomatology and in sleep parameters.
      The objective of the present randomized controlled study is to compare both physiotherapy
      techniques in a long term basis.
    

Intervention name(s): physical therapy; physical therapy
Intervention type(s): Other; Other
Intervention description(s): weekly pool physiotherapy with muscle stretching; weekly pool physiotherapy with Ai Chi movements during a 6 months period
Other intervention name(s): physiotherapy; physiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fibromyalgia; physical therapies; stretching; Ai Chi
Bayesian Estimation of Diagnostic Performance for Cardiovascular Autonomic Neuropathy
Condition: Diagnostic Performance of Cardiovascular Autonomic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Nervous System Diseases
Study type: Observational

Summary: 
      This study aimed to evaluate the reference values for the short-term heart rate variable
      (HRV), estimate the performance of cardiovascular autonomic neuropathy (CAN) diagnostic tests
      in the absence of a gold standard, and assess CAN prevalence in our cross-sectional dataset.
    

Detailed description: 
      The CAN prevalence is rapidly growing in all populations worldwide. No document has been
      reported about normal reference values for CAN using this test in the Chinese population.
      This study aimed to evaluate the reference values for the short-term HRV in a large
      cross-sectional dataset, and to estimate sensitivities and specificities of CAN diagnostic
      tests using the Bayesian approach, in the absence of a gold standard in another independence
      dataset. Finally, CAN prevalence was estimated in the investigators' cross-sectional dataset.
      Firstly, the reference the values for the short-term HRV were calculated in the
      investigators' previous study (including 371 healthy subjects). This study dataset contained
      88 subjects who completed both the short-term HRV test and Ewing's test. Simultaneous
      inferences about the population prevalence and the performance of each diagnostic test were
      possible using the Bayesian approach without a gold standard.
    

Intervention name(s): not intervention
Intervention type(s): Other
Intervention description(s): This is a cross-sectional study for estimation of diagnostic performance.
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Individuals with inclusion and exclusion criteria were recruited from healthy examination
        centres to assess cardiovascular autonomic function using both the short-term heart rate
        variability and Ewing's tests.
      
Keywords: Bayesian estimation; short-term heart rate variability; cardiovascular autonomic neuropathy; diagnostic performance
Effects of Coordinated Care for Disabled Medicaid Recipients
Condition: Chronic Conditions Faced by Medicaid Recipients With Disabilities
MeSH terms: Chronic Disease
Study type: Interventional

Summary: 
      The purpose of this study is to improve the quality of care for individuals with multiple
      chronic conditions, health care systems have begun turning to coordinated care. Although
      coordinated care can refer to many different things, it usually includes activities such as
      assessing patients' needs, referring them to the right doctors, helping them make and keep
      appointments, and helping them comply with medical or dietary recommendations. To understand
      the effects of coordinated care for high-needs Medicaid recipients, MDRC is conducting a
      randomized trial of a pilot coordinated care program run by Kaiser Permanente for blind and
      disabled Medicaid recipients in the Denver area.
    


Intervention name(s): Coordinated care
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: All conditions faced by disabled Medicaid recipients
Measuring Hydration Levels of Healthy and Heart Failure Patients Before, During, and After an Electrophysiology (EP) Procedure
Condition: Cardiac Arrhythmia
MeSH terms: Heart Failure; Arrhythmias, Cardiac
Study type: Interventional

Summary: 
      Subjects will be consented to wear the AleriTM sensor prior to, during, and after an
      Electrophysiology Procedure. During this time, the system will measure the following
      parameters from subjects: HR, temperature, saline volume/rate, urine production volume, USG,
      BPO. Data will be retrospectively analyzed to determine if the system effectively operates
      under these conditions, and can effectively monitor hydration levels of subjects compared to
      currently available methods.
    

Detailed description: 
      Study subjects scheduled for an EP procedure who have signed an informed consent form (ICF)
      will be admitted to the study. Prior to the EP procedure (e.g. in a hospital room or
      operating room at NYU Medical Center), either an employee of NYU or Hydrostasis will place
      sensor on subject's bicep, forearm, or wrist, start the sensor and connect the sensor to
      mobile app to start data collection.
    

Intervention name(s): AleriTM sensors
Intervention type(s): Device
Intervention description(s): AleriTM sensors are worn on the bicep or forearm and communicates through BLETM to a mobile App. The data is sent through the mobile App to web-based system processing where PHI is calculated and sent back to the mobile App.
The AleriTM sensor has a form factor similar to a conventional arm band, with a hockey puck shape of approximately 48mm in diameter and 15mm in thickness the AleriTM sensor is a non-significant risk (NSR) device as it does not meet the definition of significant risk device (21 CFR 812.3(m)) because it is: not an implant; is not purported or represented to support or sustain human life; its use is not of substantial importance in the diagnosis, cure, treatment, mitigation, or prevention of impairment of health; and it does not present a serious risk to the health, safety, or welfare of a subject.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic