bioihbjkbjnl/mcl2 huggingface dataset:
Crystalloids Versus Colloids Versus Hypertonic Saline as a Co-load During Spinal Anesthesia.
Condition: Spinal Anaesthesia
Study type: Interventional

Summary: 
      Spinal anesthesia is commonly accompanied by hypotension due to vasodilation that follows
      sympathetic blockade and decreased systemic vascular resistance. Prevention of hypotension is
      usually achieved through administration of fluids and vasopressors .There is an ongoing
      debate concerning both the proper fluid timing, pre-load against co-load and fluid type
      crystalloids against colloids .This study aims at comparing the effectiveness of co-loading
      of crystalloids versus colloids versus hypertonic saline 3% in preventing hypotension induced
      by spinal anesthesia.
    

Detailed description: 
      Spinal anesthesia is commonly accompanied by hypotension due to vasodilation that follows
      sympathetic blockade and decreased systemic vascular resistance. Prevention of hypotension is
      usually achieved through administration of fluids and vasopressors . Fluids are either
      administrated before initiation of spinal anesthesia which is defined as fluid pre-loading or
      at time of initiation of spinal anesthesia which is defined as fluid co-loading .There is an
      ongoing debate concerning both the proper fluid timing, pre-load against co-load and fluid
      type crystalloids against colloids. Fluid preloading with colloids appears to have superior
      effect on that of crystalloids as the later shows a shorter intravascular half-life. While
      both colloid and crystalloid co-loading show comparable results .Although crystalloid
      preloading has been the traditional regimen for long time, it failed to reduce the incidence
      of hypotension. This is because crystalloids rapidly distribute out of the intravascular
      compartment to the interstitial space. Superiority of fluid co-loading might be explained by
      decrease of the extravascular crystalloid redistribution secondary to the simultaneous
      vasodilatation response to sympathetic block.This study aims at comparing the effectiveness
      of co-loading of crystalloids versus colloids versus hypertonic saline 3% in preventing
      hypotension induced by spinal anesthesia.
    

Intervention name(s): Normal saline; hydroxyethyl starch; Hypertonic saline
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): normal saline 0.9% 15 ml/kg over 15-20 minutes.; hydroxyethyl starch 130/0.4 in 0.9 % sodium chloride 5 ml/kg over 15-20 minutes.; hypertonic saline 3% (7ml/kg) over 15-20 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hypertonic saline; colloids; normal saline
The Mini-Screw as Orthodontic Anchoring: Survival, Clinical Efficiency and Experience of the Patient
Condition: Dental Implants
Study type: Interventional

Summary: 
      This is a clinical trial to evaluate the mini-screw as orthodontic anchoring. This trial will
      study implant survival, clinical efficiency and experience of the patient.
    


Intervention name(s): Placement of the mini-screw
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Burst Spinal Cord Stimulation for Neuropathic Pain.
Condition: Peripheral Neuropathic Pain; Radiculopathy; Lower Back Pain
MeSH terms: Neuralgia; Radiculopathy; Low Back Pain
Study type: Interventional

Summary: 
      This study will evaluate the effect of Burst spinal cord stimulation (SCS) in the treatment
      of painful radiculopathy in lower extremity(ies) with or without lower back pain. It is a
      multicenter double-blinded "n-of-1" RCT with repeated two-week periods of Burst SCS or sham
      in randomised order.
    

Detailed description: 
      SCS is a treatment offered to patients with peripheral neuropathic pain, and involves
      electrical stimulation of the spinal cord. The analgesic effect is possibly mediated via both
      spinal and supra-spinal mechanisms.

      Traditional "tonic" SCS causes paresthesia during treatment, but the newer burst technique
      (five electrical pulses at 500Hz delivered in intermittent packets of 40 Hz) can be performed
      below detection level. Thus, it is possible to do double-blinded sham-controlled studies.

      In this study, we will study the effect of burst SCS compared with sham on pain intensity and
      function (Patient-Specific Functional Scale). In addition, we will use several questionnaires
      (psychometric data, health-related quality of life, sleep, global impression of change, use
      of analgesics, blinding).
    

Intervention name(s): Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)
Intervention type(s): Device
Intervention description(s): Burst SCS implies high frequency SCS treatment in intermittent packets with stimulation below detection level. Abbott BurstDR at default setting: Pulse width 1000 microseconds, frequency 500 Hz/40 Hz, continuous stimulation (no cycling). Pulse amplitude at maximum 60% of sensory threshold
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: N-of-1-study.
Each patient will go through three treatment cycles each consisting of two weeks of active treatment and two weeks of sham in randomised order. In total the study period will be 12 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assess Efficacy and Safety of TachoComb H vs. Standard Surgical Treatment (i.e. Suturing) in Patients Undergoing Prostatectomy (TC-017-AU)
Condition: Control of Local Bleeding in Patients Undergoing Prostatectomy.
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall objective is to compare efficacy and safety of TachoComb H versus standard
      surgical treatment for the control of local bleeding in patients undergoing prostatectomy.
      Specific objectives include the comparison between test treatments for intraoperative
      haemostatic efficacy as well as for post-operative blood loss to be assessed by haemoglobin
      and haematocrit concentration of drainage fluid.
    


Intervention name(s): Human fibrinogen/thrombin and bovine aprotinin (TachoComb H)
Intervention type(s): Drug
Intervention MeSH terms: Thrombin; Aprotinin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Digital Health Nudging in Adolescents With Congenital Heart Disease
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      In adolescents with congenital heart disease physical activity level is reduced which is why
      promotion to a more active lifestyle with an age-appropriate and modern intervention is
      needed. In healthy subjects digital health nudging was shown to increase physical activity.
      However, in adolescents with congenital heart disease such studies have not been conducted
      yet. In this RCT participants receive daily, short smartphone messages with the primary
      purpose to increase daily physical activity, which is monitored with a "Garmin vivofit jr."
      wearable.
    


Intervention name(s): Digital Health Nudging
Intervention type(s): Behavioral
Intervention description(s): Short daily text messages with information and motivation concerning physical activity.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Physical Activity Promotion; Digital Health Nudging
Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)
Condition: Candidemia
MeSH terms: Candidemia
Study type: Observational

Summary: 
      The purpose of this study is to assure the uniform collection, handling, storage and
      transport of patient whole blood specimens and associated information to support validation
      of the T2 Candida Assay.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients who have undergone a diagnostic blood culture.
      
Biospecimen description: 
      Whole Blood specimens, in addition to bacterial and fungal species isolates
    
Keywords: Candida; Diagnostic Assay; Blood culture; Sepsis; T2 Magnetic Relaxation
Peritoneal Ropivacaine Infiltration on Postoperative Pain in Children Affected
Condition: Testicular; Colic
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study was to evaluate the analgesic effect of intraperitoneal infiltration of
      ropivacaine in children undergoing laparoscopic surgery.
    

Detailed description: 
      1. Quality assurance plan that addresses data validation and registry procedures, including
           any plans for site monitoring and auditing.

        2. Data checks to compare data entered into the registry against predefined rules for range
           or consistency with other data fields in the registry.

        3. Source data verification to assess the accuracy, completeness, or representativeness of
           registry data by comparing the data to external data sources .

        4. Data dictionary that contains detailed descriptions of each variable used by the
           registry, including the source of the variable, coding information .

        5. Standard Operating Procedures to address registry operations and analysis activities,
           such as patient recruitment, data collection, data management, data analysis, reporting
           for adverse events, and change management.

        6. Sample size assessment to specify the number of participants or participant years
           necessary to demonstrate an effect.

        7. Plan for missing data to address situations where variables are reported as missing,
           unavailable, "non-reported," uninterpretable, or considered missing because of data
           inconsistency or out-of-range results

        8. Statistical analysis plan describing the analytical principles and statistical
           techniques to be employed in order to address the primary and secondary objectives, as
           specified in the study protocol or plan
    

Intervention name(s): intraperitoneal infiltration of ropivacaine
Intervention type(s): Drug
Intervention description(s): intraperitoneal infiltration of ropivacaine by a special equipment
Intervention MeSH terms: Ropivacaine
Intervention model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: analgesia; pediatric; pain; laparoscopy; ropivacaine
Effect of Thermomechanical Stimulation Device and Virtual Reality Glasses During Peripheral Intravenous Catheterization
Condition: Catheterization
Study type: Interventional

Summary: 
      The study was conducted as a randomized controlled experimental study to determine the effect
      of Thermomechanical Stimulation Device (Buzzy®) and Virtual Reality Goggles (VRG) applied
      during peripheral intravenous catheterization (PIC) on pain and patient satisfaction in adult
      patients.
    

Detailed description: 
      The research was carried out at the Emergency Department of the Etimesgut Şehit Sait Ertürk
      State Hospital in Ankara from April 2021 to February 2022. The sample of the study consisted
      of 126 adult patients. The patients were divided into three groups by randomization method.
      VRG was applied to the first group, Buzzy to the second group and the control group which was
      the third group using the standard procedure. Before the procedure of PIC, "Introductory
      Characteristics Form for Patients" was prepared by the researcher containing the
      sociodemographic characteristics of the participants (gender, marital status, age,
      educational status, etc. as such). This form was filled out by asking the patient by
      face-to-face interview method. After catheterization, the "Visual Comparison Scale for Pain"
      was used by the nurse practitioner to determine the pain of the patients and the "Visual
      Comparison Scale for Satisfaction" was used to determine the satisfaction status of the
      patients regarding the application to be performed. It is expected that pain and patient
      satisfaction scores in groups where a VRG and Buzzy® were used during PIC in adult patients
      will result more positively than in the control group. It is thought that the results
      obtained from the research will contribute to the literature.
    

Intervention name(s): Virtual Reality Glasses; Thermomechanical Stimulation Device
Intervention type(s): Other; Other
Intervention description(s): Group 1; Group 2
Other intervention name(s): VRG; Buzzy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nursing; pain; patient satisfaction; peripheral intravenous catheterization; thermomechanical stimulation; virtual reality
Effect of Pharmacological Anti-lipolysis on FFA and VLDL-TG Metabolism Before and During Exercise
Condition: Diabetes; Obesity
Study type: Interventional

Summary: 
      This study will investigate free fatty acid and VLDL-TG metabolism before and during exercise
      with and without pharmacological antilipolysis by the niacin antagonist Acipimox. Main
      focuses will be VLDL-TG and free fatty acid metabolism as well as expression of membrane
      proteins in fat- and muscle biopsies.
    

Detailed description: 
      Insulin resistance in liver and skeletal muscle is of central pathogenic significance in the
      development of type 2 diabetes. The molecular connections are unresolved but high levels of
      free fatty acids and triglyceride is probably involved. Diabetic subjects and to a lesser
      extent obese subjects have increased triglyceride levels, this could be due to an abnormal
      turnover of VLDL-TG. It is not yet investigated whether VLDL-TG kinetics changes during
      pharmacological antilipolysis. Using the aseptic ex-vivo labeling technique (developed in our
      laboratories) we will investigate this issue in sedentary healthy men. After a 3 hour basal
      period subjects will exercise on a bike for 60 minutes at 60% of VO2max. In both basal and
      exercise period one muscle and one fat biopsy will be obtained, further blood samples will be
      drawn to examine FFA and VLDL-TG metabolism etc..

      This new knowledge will contribute to the understanding of metabolic disorders like type 2
      diabetes and obesity.
    

Intervention name(s): Acipimox
Intervention type(s): Drug
Intervention description(s): Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day
Intervention MeSH terms: Acipimox
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: VLDL-TG; Metabolism; Exercise; Free Fatty Acids
Intraoperative Retrolaminar Block as Opioid Free Anesthesia After Posterior Lumber Spine Discectomy
Condition: Opioid Free Anesthesia
Study type: Interventional

Summary: 
      Opioid-free intraoperative protocols have been successfully used in specific surgical
      populations with equal or superior results to classic general anesthetic approaches. In
      instances where opioid-free anesthesia may not be entirely feasible, there exists a
      continually growing body of evidence that the modern anesthesiologist has a potent
      pharmacologic and regional anesthetic arsenal that can reduce the amount of opioids required
      to effectively treat pain.

      Retrolaminar block is considered a new, easy and simple technique with decreasing incidence
      of complications such as hypotension, pleural and nerve injury. Its efficacy had been
      investigated in trauma patients
    

Detailed description: 
      -  Null hypothesis: Intraoperative retrolaminar block will not produce opioid sparing
           anesthetic effect and enhanced recovery after posterior lumber spine discectomy.

        -  Alternative hypothesis: Intraoperative retrolaminar block will produce opioid sparing
           anesthetic effect and enhanced recovery after posterior lumber spine discectomy.
    

Intervention name(s): Standard analgesia (paracetamol +fentanyl); Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv; Patients will receive intraopertative retrolaminar block: 15 ml of bupivacaine 0. 25 % plus 2ml magnesium sulfate 10% (200mg) plus 2ml (8mg) dexamethasone on each side by slipping the needle of injection on the bone of spinous process and lamina.
Intervention MeSH terms: Acetaminophen; Dexamethasone; Magnesium Sulfate; Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Pain is a major problem after TKA, especially in patients with high pain catastrophizing.
      Newer MR-scan studies indicate that Escitalopram may have an immediate cognitive and
      emotional effect. The investigators therefore investigate the effect of Escitalopram as a
      perioperative analgesic.
    

Detailed description: 
      Pain is a major problem after TKA, especially in patients with high pain catastrophizing.
      Newer MR-scan studies indicate that Escitalopram may have an immediate cognitive and
      emotional effect. Patients with high pain catastrophizing are mentally vulnerable and may be
      sensitive to the effects of Escitalopram.

      We therefore investigate the effect of Escitalopram as a perioperative analgesic in this
      group of patients where the pain problem is pronounced.
    

Intervention name(s): Escitalopram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tables with Escitalopram (10 mg), 1 tablet a day for 7 days, starting on the day of surgery; Placebo tablets, 1 tablet a day for 7 days, starting on the day of surgery
Other intervention name(s): Cipralex
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Recovery and Analgesia After Surgery for Gynecological Cancer
Condition: Gynecological Cancer
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare epidural analgesia and intrathecal analgesia for
      explorative laparotomy through a middle-line incision for gynecological cancer in a fast
      track program to se if there is any difference in recovery. Length of stay is analyzed
      together with self-rate quality of life.
    


Intervention name(s): Epidural; Intrathecal
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Halliwick Concept on Motor Functions in Spastic CP
Condition: Spastic Cerebral Palsy; Spastic Hemiplegic Cerebral Palsy
MeSH terms: Muscle Spasticity; Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      This randomized controlled trial will investigate the effect of hydrotherapy (halliwick
      concept) on motor functions in children with spastic cerebral palsy (CP). Minimum of 30
      Spastic CP children will be recruited for this study. Children will be randomly assigned into
      control group who will receive conventional selected exercise treatment or study group who
      will receive the same conventional program in addition to underwater exercise program. Motor
      function will be evaluated at baseline and after 3 months of treatment. No potential harms
      are expected during this study.
    


Intervention name(s): Aquatic Halliwick method; Conventional physical therapy
Intervention type(s): Other; Procedure
Intervention description(s): The Halliwick Concept is a detailed swimming programme based on the scientific principles of body mechanics and the properties of water intended to educate individuals with special needs to be water safe and to move independently in the water as much as possible (Lambeck & Stanat 2001a).The programme consists of 10 specific progressive stages that are achieved without the use of floatation devices (Lambeck & Stanat 2001b).; Conventional selected exercise program for 60 minutes ,3 session per week for 3 successive months aiming to improve the motor functions of the children in form of: (1) Neuro-developmental technique, (2) Back and abdominal exercises to improve postural control and correct spinal deformities (3) improving postural responses, (4) Flexibility exercises of the soft tissue (5) Strengthening exercise (particularly knee extensors, hip abductors and the ankle dorsi-flexors muscles and (6) Improving standing, weight transfer and shift and finally facilitation of normal walking pattern .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment