bioihbjkbjnl/mcl2 huggingface dataset:
Continuous Application of Lisuride in Parkinson's Disease by Subcutaneous Infusion
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to evaluate the long-term efficacy, local tolerability and safety of
      Lisuride applied as subcutaneous infusion compared to placebo in patients with advanced
      Parkinson's disease with motor fluctuations and "OFF" periods refractory to conventional
      treatment.
    

Detailed description: 
      The current CALIPSO study investigates the efficacy of a continuous lisuride infusion against
      the optimized previous oral therapy in patients experiencing motor fluctuations with OFF
      periods and/or strenuous dyskinesias of more than four hours per day.

      The controlled core study is scheduled to last six weeks. Within the study the previous oral
      therapy will either be continued in a capsule/blinded design (while a placebo infusion is
      going on concurrently) or the oral therapy is substituted by lisuride infusion (while placebo
      capsules are administered at the same time).

      After the controlled core study all patients whose condition has not worsened during the
      study (meaning those patients of the placebo infusion group as well, who were treated during
      the core study just as they were before), will be given the chance to continue with the
      infusion therapy with lisuride in an open extension phase.
    

Intervention name(s): Continuous Subcutaneous Lisuride Infusion
Intervention type(s): Drug
Intervention MeSH terms: Lisuride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Lisuride; Continuous Dopaminergic Stimulation; Motor Fluctuations; Off-Times; Troublesome Dyskinesia; Parkinson's Disease with motor fluctuations with OFF periods and/or troublesome dyskinesias of more than four hours per day
A Comparison of Early Mobilization Versus Traditional Treatment for Acute Ankle Sprains.
Condition: Ankle Sprain
MeSH terms: Sprains and Strains; Ankle Injuries
Study type: Interventional

Summary: 
      Acute ankle sprain is one of the most common musculoskeletal injuries, accounting for an
      estimated 2 million injuries per year and 20% of all sports injuries in the United States.
      Ankle sprains can lead to prolonged periods of pain, difficulty with mobility, and lost work
      or play time. Current best practice guidelines for treatment of an acute ankle sprain are
      protection, rest, ice, compression and elevation (PRICE). However recent systematic reviews
      for ankle sprains call into question this treatment. Two critical components; immobilization
      and ice, have little or no evidence of efficacy for ankle sprain. Interestingly, mobilization
      appears to be more effective at reducing the pain, swelling and stiffness of musculoskeletal
      injuries including ankle sprains. Historically the limitation to early mobilization has been
      pain. Recently developed stretch bands have been introduced to the therapy market as a tool
      that allows pain-free active and resisted ankle movement after acute ankle sprain.

      The investigators propose a double blind randomized controlled study to compare 2 ankle
      sprain treatments on their ability to speed recovery and reduce morbidities such as pain,
      swelling and weakness.
    


Intervention name(s): Jump Stretch
Intervention type(s): Other
Intervention description(s): distraction with early mobilization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute ankle sprain in children and young adults
A Study to Evaluate the Effect of Aleglitazar on Cardiac Energetics and Function in Patients With Type 2 Diabetes Mellitus and no History of Coronary Artery Disease
Condition: Diabetes Mellitus Type 2
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      A single center, double-blind, placebo-controlled, randomized, crossover, phase II study to
      assess the effect of aleglitazar on cardiac energetics and function in patients with
      uncomplicated type 2 diabetes mellitus and no history of coronary artery disease who are
      drug-naïve or treated with stable metformin. Eligible patients will receive either 150 mcg
      aleglitazar or placebo orally daily for 6 weeks. After a washout period of 6 weeks, patients
      will cross over to the treatment not yet received.
    


Intervention name(s): aleglitazar; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 150 mcg orally daily, 6 weeks; orally daily, 6 weeks
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Miniaturized Extracorporeal Circulation Study
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Rationale:

      Contemporary coronary artery bypass grafting (CABG) continues to be associated with a
      significant risk of postoperative bleeding. Utilization of miniaturized extracorporeal
      circulation (miECC) significantly reduces the risk of postoperative bleeding but the
      underlying mechanisms are poorly understood.

      Primary Objective:

      To assess the impact of miECC compared to conventional extracorporeal circulation (cECC) on
      thrombin generation as indicator of the overall haemostatic capacity after CABG.

      Secondary Objectives To evaluate the impact of miECC versus cECC on blood loss and
      transfusion requirement, coagulation and fbrinolysis, inflammatory response, haemodilution
      and haemolysis, endorgan protection, seasibility and safety

      Study design:

      Single-center, double-blind, parallel-group randomized controlled trial

      Study population:

      60 Patients undergoing non-emergent primary isolated CABG with ECC randomized 1:1 to receive
      either miECC or cECC
    

Detailed description: 
      Blood samples will be obtained at the following time points:

        -  T0; preoperative after induction of anaesthesia (after insertion of central venous line)

        -  T1; after weaning of the ECC prior to protaminization

        -  T2; 10 minutes after full protaminization

        -  T3; six hours after the end of the ECC

        -  T4; 1. postoperative day (16-20 hours following end of surgery)
    

Intervention name(s): CABG; Miniaturized extracorporeal circulation; Conventional extracorporeal circulation
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Cannulation: 24-F arterial cannula, 29/29 F dual-stage venous cannula, and aortic root vent-/cardioplegia cannula
Grafting: pedicled left internal mammary artery, and no-touch
saphenous vein graft Heparin and protamine doses assessed by HMS Plus® Hemostasis Management System
Target activated coagulation time of >400 seconds; Centrifugal pump to reduce mechanical stress
Circuit coated with biosurface to increase haemocompatibilty.
Ante- and retrograde autologous priming and low-volume cardioplegia solution (intermittend cold modified Calafiore) to minimize haemodilution
Collapsible soft-shell reservoir for blood volume management
Cell-saving device
Venous air removing device and electric clamp system to air embolism; Roller pump
Circuit uncoated
Hard-shell venous reservoir
Intermittend cold blood Harefield cardioplegia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coronary artery bypass grafting; Miniaturized extracorporeal circulation; Thrombin generation
Study of Acute Autoimmune Encephalitis With Positive Antibodies in Eastern France
Condition: Acute Autoimmune Encephalitis
MeSH terms: Encephalitis; Autoimmune Diseases of the Nervous System; Hashimoto Disease
Study type: Observational

Summary: 
      The number of acute encephalitides diagnosed each year is gradually increasing, reaching
      approximately 5 to 10/100,000 per year; more than 50% of etiologies currently remain unknown.
      The majority of them are acute encephalitis of infectious origin, but it is estimated that
      20% of encephalitis in northern Europe is related to an autoimmune mechanism with the
      majority of encephalitis with anti-NMDA Ac discovered recently in 2007. The study of a large
      American encephalitis cohort showed a death rate of 3% to 7% in cases of autoimmune
      encephalitis. Furthermore, delay in the initiation of effective treatment (tumor removal or
      immunotherapy) beyond 4 weeks is associated with a poor prognosis at 1 year.

      It is therefore necessary to better understand the signs of autoimmune encephalitis in order
      to recognize the disease quickly and to start a treatment quickly; in order to improve the
      management and the prognosis of these children.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Minor subject (≤17 years) diagnosed between 01/01/2006 and 31/12/2018 with autoimmune
        encephalitis
      
Keywords: Acute autoimmune encephalitis; encephalitis; autoimmune encephalitis
Evaluation of Efficacy and Safety of Highly Purified Urofollitropin in Chinese Females Undergoing an Assisted Reproductive Technology (ART) Program
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the efficacy and safety of of Highly Purified Urofollitropin for Injection Compared
      to Recombinant Human Follitropin Alfa for Injection in Chinese Females Undergoing an Assisted
      Reproductive Technology (ART) Program.
    


Intervention name(s): Highly Purified Urofollitropin; Recombinant Human Follitropin Alfa
Intervention type(s): Drug; Drug
Intervention description(s): for injection; for injection
Other intervention name(s): Bravelle®; Gonal-F®
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Investigation of TWK10 Administration on the Effects of Amino Acid Absorption
Condition: Amino Acid; Exercise; Probiotic; Body Composition
Study type: Interventional

Summary: 
      The most common problem among sports people is that no matter how much protein food or
      products they eat, their sports performance cannot be improved, resulting in failure to
      achieve breakthroughs in sports performance. The cause of the trouble is digestion and
      absorption problems. The key is intestinal problems. If gastrointestinal function is
      maintained in a healthy state, then exercise performance must be maintained at a considerable
      level. Therefore, how to choose the source of protein in the diet is one of the most
      concerned issues of the sports crowd. Although past studies have confirmed that the essential
      amino acids in animal protein can be absorbed and utilized better than plant protein, plant
      protein can be broken down into easily digestible peptides and amino acids by pepsin. Promote
      the metabolite pool in the large intestine and the amino acid balance of the host in the
      small intestine. Recent studies have pointed out that the proteases and peptidases in lactic
      acid bacteria can provide free amino acids for the best growth of bacteria, and can increase
      the distribution of amino acids in the blood, the speed of muscle synthesis and the content
      of branched chain amino acids. However, the mechanism of action of Lactobacillus plantarum on
      protein digestion and amino acid absorption in the host is still unclear. Therefore, the
      purpose of this study is to explore the effect of supplementing sports lactic acid bacteria
      TWK10 in human experiments to effectively improve the amino acid bioabsorption rate of plant
      protein supplements. 40 subjects were randomly divided into 2 groups, each with 20 people
      (male and female): (1) pea protein without TWK10 (placebo), (2) TWK10 group (TWK10). The two
      groups of subjects were supplemented with test samples for 28 consecutive days and performed
      paired sports training 3 times a week. Before and after the intervention, the samples were
      subjected to exercise testing, blood and fecal sample collection, body composition analysis,
      and muscle mass analysis.
    


Intervention name(s): TWK10; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 4 days without training: drink 2 hours before bedtime.
3 days of training: drink within 30 minutes after training (uniformly brewed in the laboratory).
To analyze the amino acid concentration in blood, drink it immediately before blood collection.; 4 days without training: drink 2 hours before bedtime.
3 days of training: drink within 30 minutes after training (uniformly brewed in the laboratory).
To analyze the amino acid concentration in blood, drink it immediately before blood collection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Vibration Training and Muscles Properties
Condition: Muscle Relaxation
Study type: Interventional

Summary: 
      Application dose standards have not yet been determined for Whole Body Vibration Training
      which is subject to studies with different frequencies and amplitudes. Our objective was to
      examine acute responses of two different vibration training doses on muscle tone, strength,
      and flexibility.
    

Detailed description: 
      Application dose standards have not yet been determined for Whole Body Vibration Training
      which is subject to studies with different frequencies and amplitudes. Our objective was to
      examine acute responses of two different vibration training doses on muscle tone, strength,
      and flexibility.
    

Intervention name(s): Whole body vibration training
Intervention type(s): Device
Intervention description(s): Intermittent whole-body vibration exposure is a training method providing physical stimulation effect on skeletal muscles by increasing gravitational acceleration on the vibration platform.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Muscle Power, Muscle Flexibility, Muscle Tone, Whole-Body Vibration Training.
Scalp Nerve Block and Opioid Consumption in Brain Surgery
Condition: Brain Tumour
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid
      consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared
      to those who receive 0.9% normal saline solution (placebo).
    

Detailed description: 
      Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid
      consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared
      to those who receive 0.9% normal saline solution (placebo).

      A Prospective Randomized Double Blind Control
    

Intervention name(s): Scalp block with 0.5% plain Marcaine; Scalp block with 0.9% normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Anterior scalp block will be done by using 0.5% plain Marcaine 20 ml.; Anterior scalp block will be done by using 0.9% normal saline 20 ml.
Other intervention name(s): Code 1; Code 2
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: supratentorial brain tumour; craniotomy
Comparison of Two Different Insulin Dose Calculation Algorithms in Type 1 Diabetes
Condition: Insulin-Dependent Diabetes Mellitus 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The aim of this study is to compare the impact of carbohydrate counting (CC) method which is
      standard insulin dose calculation algorithm and food insulin index (FII) method which is a
      new algorithm on postprandial glucose following a high fat and a high protein meal in
      adolescent with type 1 diabetes. A randomized, single-blind and crossover trial included 14
      adolescents aged 14-18 years with type 1 diabetes. All participants were sent to their homes
      for 4 consecutive days with a different glycemic index breakfast. The insulin doses of the
      meals were calculated according to CC and FII methods. Test breakfasts with different GIs and
      insulin requirements calculated with different algorithms are as follows: High GI calculated
      by CC (CHGI), low GI calculated by CC (CLGI), high GI calculated by FII (FHGI) and low GI
      calculated by FII (FLGI).
    


Intervention name(s): High GI calculated by CC (CHGI); Low GI calculated by CC (CLGI); High GI calculated by FII (FHGI); Low GI calculated by FII (FLGI)
Intervention type(s): Other; Other; Other; Other
Intervention description(s): This test meal with high GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.; This test meal with low GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.; This test meal with high GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.; This test meal with low GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Adolescent; Carbohydrate Counting; Food Insulin Index; Glycemic Index; Type 1 diabetes
Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain
Condition: Moderate-to-severe Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the analgesic efficacy of Egalet-002 twice daily
      (BID) in patients with moderate-to-severe chronic low back pain
    


Intervention name(s): Oxycodone extended-release; Placebo of oxycodone extended-release
Intervention type(s): Drug; Drug
Other intervention name(s): Egalet-002, Egalet ADER oxycodone
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Safety and Risk Assessment of Obese Parturient Underwent Cesarean Section(CS) Delivery Under Different Anesthesia Ways
Condition: Cesarean Section
Study type: Interventional

Summary: 
      900 parturient who underwent CS under general anesthesia(GA) , intraspinal anesthesia
      included epidural anesthesia(EA) and combined spinal-epidural anesthesia(CSEA), which were
      divided into 3 groups: Morbid Obesity group (n=300) with body mass index (BMI) >40 kg/m2 ,
      severe Obesity group (n=300) with 30 kg/m2≤BMI ≤40 kg/m2 and non-Obesity group(n=300) with
      BMI<30 kg/m2. Findings Between January 1, 2013 and September 30, 2016, a total of 1000 women
      met inclusion criteria and 900 women received allocated intervention. All patients were
      divided into three groups: Morbid Obesity group(n=300), Severe Obesity group(n=300) and
      non-Obesity group(n=300) according to body mass index (BMI) >40 kg/m2, 30 kg/m2≤BMI ≤40 kg/m2
      and BMI<30 kg/m2.900 patients completed the protocol and related data were analysed.
    

Detailed description: 
      900 parturient who underwent CS under general anesthesia(GA) , intraspinal anesthesia
      included epidural anesthesia(EA) and combined spinal-epidural anesthesia(CSEA), which were
      divided into 3 groups
    

Intervention name(s): anesthesia
Intervention type(s): Procedure
Intervention description(s): Anesthesia : (1) General Anesthesia (GA)(2) Epidural Anesthesia (EA) (3) Combined Spinal-Epidural Anesthesia (CSEA)
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Obesity; Anesthesia Complications; Body Mass Index (BMI)
Postoperative Pain After Caesarian Section
Condition: Pain, Postoperative; Pruritus; Nausea and Vomiting Following Administration of Anaesthetic Agent; Consumption
MeSH terms: Pruritus; Nausea; Vomiting; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      To examine if perioperative pain/nausea/pruritus is altered when current standard analgesia
      for caesarian section (CS) is replaced with new guideline recommended analgesia.
    

Detailed description: 
      Control group (current analgesia, elective CS) is compared to current analgesia for emergency
      CS, and guideline recommended analgesia.

      Current analgesia for CS:

      Spinal hyperbaric bupivacaine 5 mg/ml, 9-11 mg. Spinal fentanyl 10-15 ug. Postoperative:
      Paracetamol 1g x 4, ibuprofen 400 mg x 4 po, oxycodone 10 mg (<70 kg) or 20 mg (>70 kg) x 2
      po, additional oxycodone 2,5 mg iv/5 mg po when needed.

      Guideline recommended analgesia for CS:

      Spinal hyperbaric bupivacaine 5 mg/ml, 9-11 mg. Spinal fentanyl 12,5 ug. Spinal morphine 0,05
      mg. After delivery of baby: Dexamethasone 8 mg iv, paracetamol 1g iv, parecoxib 40 mg iv.

      Postoperative: Paracetamol 1g x 4, ibuprofen 600 mg x 4 po, oxycodone 2,5 mg iv/5 mg po when
      needed.
    

Intervention name(s): Bupivacaine-fentanyl-morphine elective group; Bupivacaine-fentanyl elective group; Bupivacaine-fentanyl emergency group
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Guideline recommended analgesia in elective caesarian section.; Current analgesia in elective caesarian section.; Current analgesia in emergency caesarian section.
Intervention MeSH terms: Fentanyl; Morphine; Bupivacaine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Current treatment: Patients receive elective or emergency CS. Guideline recommended treatment: Only elective CS included.
Masking: None (Open Label)
Primary purpose: Treatment
Furcation Treatment With L-PRF and aPDT
Condition: Furcation Defects
MeSH terms: Furcation Defects
Study type: Interventional

Summary: 
      To treat grade II periodontally diseased furcation areas Leukocyte-Platelet Rich Fibrin
      (L-PRF) combined with antimicrobial Photo-Dynamic Therapy (a-PDT) was used.
    

Detailed description: 
      randomized, triple-blinded study (patient, clinician and biostatistician). Twenty-four
      patients with Grade II furcation involvement were recruited in this study.

      Control group only received L-PRF, while study group used a combination of L-PRF and aPDT
      Attachment level, pocket depth, horizontal component and gingival recession, also
      radiographic Bone depth, width, height and volume were were recorded at baseline and
      postoperatively after 6 months
    

Intervention name(s): L-PRF with aPDT; L-PRF
Intervention type(s): Procedure; Procedure
Intervention description(s): surgical open flap debridement followed by L-PRF with aPDT; surgical open flap debridement followed by L-PRF alone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: platelet rich fibrin; photodynamic therapy