bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of ProSeal Laryngeal Mask Airway, LTS-D and I-gel in Mechanically Ventilated Patients
Condition: Airway Morbidity
Study type: Interventional

Summary: 
      The Aim of the study is to compare the clinical performance of p-LMA, i-gel and LTS-D in
      terms of the efficacy and safety in anaesthetized patient on Mechanical ventilation
      undergoing elective surgical procedure.
    

Detailed description: 
      The study aims to draw a comparison between ProSeal LMA, i-gel and LTS-D supraglottic airway
      devices in terms of the efficacy and safety in anaesthetised patient on Mechanical
      ventilation undergoing elective surgical procedure.

      Methodology: A prospective randomized control study conducted on 150 patients undergoing
      elective surgical procedure under general anaesthesia at Dr Sushila Tiwari Hospital and
      Government medical college, Haldwani.

      Following detailed pre-anaesthetic check-up, informed written consent was taken from patient
      fulfilling the required criteria. Patients were randomly allocated into 3 groups namely Group
      I (i-gel, n=50), Group P (p-LMA, n=50) and Group L (LTS-D, n=50) by online generated
      randomization.

      Standard general anaesthesia protocol was followed and once adequate depth was achieved i-gel
      or p-LMA or LTS-D appropriate for weight or / and height was selected and inserted. An
      effective airway was confirmed and device was fixed from maxilla to maxilla.

      The three groups were compared with respect to number of Insertion attempts, ease of
      insertion of device, time taken for placement of device, airway sealing pressure, ease and
      number of attempts of gastric tube placement and complications noted if any.
    

Intervention name(s): ProSeal Laryngeal mask airway; Laryngeal Tube Suction- Disposable; i-gel
Intervention type(s): Device; Device; Device
Intervention description(s): ProSeal was inserted in mechanically ventilated patients undergoing elective surgeries.; LTS-D was inserted in mechanically ventilated patients undergoing elective surgeries.; i-gel was inserted in mechanically ventilated patients undergoing elective surgeries.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ProSeal LMA; LTS-D; i-gel
Teleneurorehabilitation for the Continuity of Care Post-stroke: a Multicentric Pilot Study
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The main aim of this longitudinal, pilot study is to evaluate the feasibility of a
      multi-domain (i.e., motor, language and cognitive domains) telerehabilitation system using
      the Virtual Reality Rehabilitation System (VRRS, Khymeia) in patients with stroke.
      Furthermore, data on patients' needs and clinical data will be collected before and after
      treatment and then analyzed.
    


Intervention name(s): Telerehabilitation - VRRS Khymeia
Intervention type(s): Behavioral
Intervention description(s): Participants will receive an individualized, multidomain exercise program set up by the therapist, based on their needs. The intervention applied will consist of 20 sessions of motor, language and/or cognitive training distributed in five sessions for week, each lasting 1 hour. Remotely, the therapist will supervise the participant's exercise program.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Telerehabilitation; Feasibility; Virtual reality
Accuracy of MRI-based Patients Matched Instruments vs Jig-based Instruments in Total Knee Arthroplasty (TKA)
Condition: Osteoarthritis of Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Total knee arthroplasty (TKA) is the common and effective procedure for treatment of
      end-staged knee osteoarthritis. Postoperative alignment of TKA is one of the important
      factors which effects on survival of prosthesis. High percentage of misalignment has been
      reported in conventional technique with using the jig based instruments. Several methods and
      devices were established to solve this problem. Customized or patient matched instruments
      were the novel technology that made from magnetic resonance imaging (MRI) of lower limb. With
      using special software to calculate the alignment axis, it was thought that accurate
      alignment can be achieved by using this instruments. Therefore, the study aimed to compare
      the accuracy of MRI based patient matched instruments and jig based instruments in TKA.
    


Intervention name(s): Patient matched instruments; Jig based instruments
Intervention type(s): Device; Device
Intervention description(s): The patients undergo TKA with using patient matched instruments; The patients undergo TKA with using jig based instruments
Other intervention name(s): The Zimmer Patient Specific Instruments System; Zimmer Nexgen LPS MIS system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Impact of Dural Puncture Epidural Versus Traditional Lumbar Epidural on Onset of Labor Analgesia
Condition: Labor Pain; Labor Analgesia
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      This study is to examine the onset of pain relief with two different methods of labor
      epidural. The traditional labor epidural involves the placement of numbing and anti-pain
      medicine in the epidural space which surrounds the spinal cord. In order to take effect, the
      medication has to cross a layer of tissue called the dura. In the current study, the same
      medications are placed in the epidural space after the dura is punctured with a fine needle.
      This research, will help evaluate whether this technique will result in earlier onset of pain
      relief.
    


Intervention name(s): Lumbar Epidural; Dural Puncture Epidural
Intervention type(s): Procedure; Procedure
Intervention description(s): control group will receive lumbar puncture epidural; intervention group will receive a dural puncture epidural
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Extubation Under Deep Anesthesia on Emergence Agitation of Nasal Surgery
Condition: Emergence Agitation
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional

Summary: 
      This study analyzed the relationship between extubation timing and Emergence agitation in
      18-60 years old adults undergoing nasal surgery, such as nasal septum correction, endoscopic
      sinus surgery, and nasal bone fracture reduction. The number of agitation, sedation score,
      pain score, operation method, analgesic drugs and other data were recorded to analyze the
      effect of deep anesthesia extubation on agitation in patients with nasal surgery. It also
      provides a clinical basis for the prevention and treatment of agitation during the recovery
      period of such operations in adults.
    

Detailed description: 
      Nasal surgery is an operation with a high proportion of pain and agitation found in the
      clinical medical treatment of our hospital. Although the operation time is short, the
      operation trauma is small, and it does not involve important organs and blood vessels, the
      clinical observation shows that the incidence of agitation in such patients after operation
      is high, and the degree of pain varies greatly. Many studies have analyzed the related risk
      factors of agitation in the wake-up period of adult nasal surgery, and believe that the
      existence of postoperative endotracheal tube is the main risk factor. However, there is a
      lack of prospective randomized controlled study on the timing of postoperative extubation in
      patients with nasal surgery. Therefore, this study analyzes the impact of extubation timing
      on postoperative agitation, so as to clarify the correlation between postoperative agitation
      and extubation timing and possible protective factors, which is helpful to early prediction,
      prevention and treatment, and reduce the incidence of postoperative EA in patients with nasal
      surgery.
    

Intervention name(s): Extubation under deep anesthesia
Intervention type(s): Other
Intervention description(s): When the patient in sedation or anesthesia state, no body movement, bispectral index 60-70, spontaneous breathing recovery, VT ≥ 5ml / kg, respiratory rate 10-20 times / min, regular rhythm, PetCO2 < 45mmhg, regular waveform, stable circulation, the patient is in deep anesthesia state, and the endotracheal tube is removed.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
The Effect of Power Posing on Timed Up and Go Test Score
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This study determines the effects of posture on time up and go test. Half of the subjects
      will assume a high-power posture, while the other half will assume a low-power posture.
    

Detailed description: 
      Subjects in the experimental group were instructed to stand with hands on their hips, elbows
      pointing out and feet approximately one foot apart for 20 seconds. Subjects in the control
      group were instructed to stand with hands and arms wrapping around the torso and feet
      together for 20 seconds. Timed Up and Go test was administered using an OmniVR™ Virtual
      Rehabilitation System before and after the postural intervention
    

Intervention name(s): high-power; low-power
Intervention type(s): Other; Other
Intervention description(s): Subjects will stand with hands on their hips, elbows pointing out and feet approximately one foot apart (high-power) for 20 seconds.; Subjects will stand with hands and arms wrapping around the torso and feet together (low-power) for 20 seconds.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial
Condition: Vaso-occlusive Pain Episodes
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Vaso-occlusion contributes significantly to morbidity in sickle cell disease (SCD).
      Vaso-occlusive painful episodes (VOE) are common and debilitating, causing the majority of
      emergency department visits. Currently efforts to treat painful episodes with use of
      non-steroidal pain relievers and intravenous narcotics offer symptomatic relief only, without
      targeting the underlying mechanisms of vaso-occlusion.Investigators have found that an
      arginine deficiency and low NO bioavailability occurs during painful events in SCD. Since
      arginine is the obligate substrate for NO production, and an acute deficiency is associated
      with VOE, investigators hypothesized that arginine supplementation may be a safe and
      beneficial treatment for sickle cell pain.
    


Intervention name(s): Arginine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Saline or Sugar pill was given as placebo
Other intervention name(s): L-arginine, L-arginine-HCL
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: sickle cell disease; vaso-occlusive pain episodes; arginine; nitric oxide
The Effect of High vs. Moderate Protein Consumption on Human Health
Condition: Weight Loss; Metabolism and Nutrition Disorder; Obesity
MeSH terms: Nutrition Disorders; Weight Loss
Study type: Interventional

Summary: 
      The study will be conducted as a parallel randomized controlled intervention trial, initiated
      by eight weeks rapid weight loss with one of two VLCDs, one week of reintroducing regular
      foods, and 12 weeks with one of two different ad libitum diets; in total 21 weeks. The study
      will be blinded for the statistician. Due to obvious different dietary intakes in the two
      diets, subjects cannot be blinded and neither the study personnel. As the study includes
      different dietary recommendations the registered clinical dietician advising the subjects
      cannot be blinded either.

      In total 110 overweight and obese volunteers will be included.
    


Intervention name(s): VLCD-Active; Maintenance-Active; VLCD-Control; Maintenance-Control
Intervention type(s): Dietary Supplement; Other; Dietary Supplement; Other
Intervention description(s): Lighter life formula products supplied to subjects, four sachets pr day. Dietetic advise given regularly.; Weight loss maintenance diet with high protein and low glycemic index and load, high in fiber and whole grain, daily including 150 g minced beef.; Lighter life VLCD products; Weight loss maintenance diet with moderate protein and low glycemic index and load, high in fiber and whole grain, daily including 25 g minced beef.
Other intervention name(s): High protein VLCD; High protein diet; Moderat protein VLCD; Moderate protein diet
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: 2x2 factorial intervention trial with two and two arms
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Body composition; Metabolism
Effects of Whole-body Vibration Training on Body Composition in Adolescents With and Without Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      The main aims of the present project include 1) to study the longitudinal effects of
      whole-body vibratory exercise on bone metabolism in adolescents with and without DS and 2) to
      evaluate whether a low frequency vibratory training program consisting of 3 sessions per week
      for 9 months (each vibratory session last approximately 10 minutes and includes 5-6 bouts of
      1 min with 1 min rest between bouts) can improve bone development in these populations.
      Finally, and additional aim of the project is 3) to determine how long these effects may last
      after the end of the intervention.
    


Intervention name(s): Whole-body vibration training (Power Plate®) on bone mass and bone metabolism in adolescents with and without Down syndrome.
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if a flexible dose of Symbicort has a similar
      effect on the airways of patients with asthma as a higher fixed-dose of Symbicort with
      additional glucocorticosteroids added.
    


Intervention name(s): Budesonide/Formoterol Turbuhaler; Budesonide Turbuhaler (Pulmicort); Terbutaline Turbuhaler
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Symbicort
Intervention MeSH terms: Budesonide; Terbutaline; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Pharmacokinetic Substudy of the TDE-PH-304 Protocol
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      A sub-study to the TDE-PH-304 protocol to assess the pharmacokinetics of patients
      transitioning from a twice daily dosing regimen of oral treprostinil to a three times daily
      dosing regimen.
    

Detailed description: 
      As noted above in "Brief Summary".
    

Intervention name(s): UT-15C SR; treprostinil diethanolamine
Intervention type(s): Drug; Drug
Intervention description(s): Open label study drug.
Other intervention name(s): UT-15C Sustained Release (SR)
Intervention MeSH terms: Treprostinil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of Octagam (Intravenous Immunoglobulin [IVIG]) 10% on the Treatment of Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluated the effect of 6 or 12 infusions of different doses of octagam
      (intravenous immunoglobulin [IVIG]) 10% on the reduction of amyloid beta peptide (Aβ) in
      cerebral spinal fluid (CSF) and on the increase of Aβ in blood plasma in patients with mild
      to moderate Alzheimer's disease.
    

Detailed description: 
      Participants received 12 infusions of 0.1 g/kg, 0.25 g/kg, or 0.4 g/kg body weight octagam
      10% at 2-week intervals (±3 days) or 6 infusions of 0.2 g/kg, 0.5 g/kg, or 0.8 g/kg body
      weight octagam 10% at 4-week intervals (±5 days). The effect of the infusions on the
      reduction of Aβ peptide in CSF and the increase of Aβ peptide in blood plasma was evaluated.
    

Intervention name(s): Placebo; octagam 10%
Intervention type(s): Drug; Biological
Intervention description(s): Commercially available 0.9% isotonic sodium chloride solution.; octagam 10% was supplied as ready-to-use solutions of human immunoglobulin.
Other intervention name(s): IVIG
Intervention MeSH terms: gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Noninvasive Electrical Brain Stimulation on Memory at Different Times of Day in Younger and Older Adults
Condition: Effect of tDCS on Memory in Older and Younger Adults
Study type: Interventional

Summary: 
      This study will investigate the extent to which tDCS to dorsolateral prefrontal cortex (or
      dlPFC) impacts memory performance as a function of time-of-day in younger and older adults.
    

Detailed description: 
      Transcranial Direct Current Stimulation (tDCS) is the safest and most accessible,
      non-invasive brain stimulation technique available for testing causal links between different
      brain regions and functions, by manipulating cognitive abilities. By identifying key
      experimental factors that can improve the reliability and robustness of stimulation effects
      on cognitive performance in different age groups, this project should lead to the widespread
      adoption of these design features in future applications. This study will investigate the
      extent to which tDCS to dorsolateral prefrontal cortex (or dlPFC) impacts recollection
      accuracy and working memory performance as a function of time-of-day in younger and older
      adults. Moreover, this study will test the extent that tDCS to dlPFC impacts memory
      performance by impacting information-specific processes and/or cognitive control processes
      that operate across different types of information, thereby informing basic theories of how
      dlPFC contributes to memory in younger and older adults.
    

Intervention name(s): Active tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): The brain is stimulated for 20 minutes with mild electrical current (maximum 2 mA) with two 7 cm x 5 cm electrodes placed on the scalp, using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.; The brain is not stimulated for 20 minutes with mild electrical current, but instead a sham procedure is administered using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Transcranial Direct Current Stimulation; Memory; Prefrontal Cortex
Pharmacokinetic and Glucodynamic Crossover Study of Subcutaneously (SC) Administered Insulin Lispro + Recombinant Human Hyaluronidase (rHuPH20) and Regular Human Insulin + rHuPH20 Compared to Insulin Lispro Alone
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      Insulin lispro and regular human insulin are Food and Drug Administration (FDA)-approved
      medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase (rHuPH20)
      is approved by the FDA as an aid to the absorption and dispersion of other injectable drugs.
      In this study, rHuPH20 will be co-administered with both insulin lispro and regular human
      insulin in order to determine if it improves the absorption of these insulins to more closely
      mimic the body's natural increase in insulin in response to a meal.
    

Detailed description: 
      The purpose of this study is to compare the pharmacokinetics (absorption, distribution,
      breakdown and elimination) of regular human insulin + recombinant human hyaluronidase
      (rHuPH20) versus insulin lispro alone, and to compare the pharmacokinetics of insulin lispro
      + rHuPH20 versus insulin lispro alone. The effects of regular human insulin + rHuPH20,
      insulin lispro + rHuPH20, and insulin lispro alone on the body will be evaluated by blood
      glucose measurements and by calculating the rate at which a glucose solution is infused to
      maintain blood glucose within a certain range. The safety and tolerability of insulin lispro
      with and without rHuPH20 and regular human insulin with rHuPH20 will be studied. The study
      drugs will be administered by subcutaneous (under the skin) injection.
    

Intervention name(s): Insulin Lispro; Regular Human Insulin; rHuPH20
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Humalog; RHI; Humulin R; recombinant human hyaluronidase; HYLENEX
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: rHuPH20; Recombinant Human Hyaluronidase; Insulin Lispro; Regular Human Insulin
Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
Condition: Hepatitis B Vaccine
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune
      persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three
      injections at months 0, 1, and 6 in methadone maintenance treatment patients.
    

Detailed description: 
      Comparison of 2 vaccination strategy against Hepatitis B in patients with Methadone
      Maintenance Treatment

      Intervention:

      Arm 1 : 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6;

      Arm 2 : 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6.
    

Intervention name(s): 60 µg dose hepatitis B vaccine; 20 µg dose hepatitis B vaccine
Intervention type(s): Biological; Biological
Intervention description(s): three-dose, 60 µg per dose; three-dose, 20 µg per dose
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hepatitis B, Vaccine; Immunogenicity; methadone maintenance treatment; Randomized Controlled Trial