bioihbjkbjnl/mcl2 huggingface dataset:
RELEVANCE - RWE Study in Unresectable Non-Small Cell Lung Cancer (Stage III) in Canada
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      In the RELEVANCE study, we will develop a scalable electronic medical report data capture
      platform to collect and analyse real-world data in the stage III NSCLC population in Canada
      across several Canadian cancer centres. Subsequent analyses will examine treatment patterns
      and clinical outcomes, including overall survival, for these patients, stratified by
      durvalumab regimen or non-durvalumab regimen during the time of the PACIFIC Patient Support
      Program.
    


Intervention name(s): Durvalumab
Intervention type(s): Drug
Intervention description(s): Chemoradiotherapy plus durvalumab
Other intervention name(s): Imfinzi
Intervention MeSH terms: Durvalumab
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients diagnosed with stage III NSCLC who received treatment at one of the
        participating clinical centres across Canada from November 1, 2017 until December 31, 2019
      
Keywords: real-world evidence, treatment patterns, clinical outcomes, durvalumab, chemoradiotherapy
Efficacy Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy Patients
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to assess the efficacy, safety, tolerability, and pharmacokinetics
      (PK) of AVI-4658 (eteplirsen) in both 50.0 mg/kg and 30.0 mg/kg doses administered over 24
      weeks in subjects diagnosed with Duchenne muscular dystrophy (DMD).
    

Detailed description: 
      For details regarding the roll-over extension study 4658-us-202, please refer to NCT01540409.
    

Intervention name(s): AVI-4658 (Eteplirsen); Placebo
Intervention type(s): Drug; Other
Intervention description(s): Treatment group 1 (n=4): 50.0 mg/kg eteplirsen once weekly x 24 weeks via a 60-minute i.v. infusion Treatment group 2 (n=4): 30.0 mg/kg eteplirsen once weekly x 24 weeks via a 60-minute i.v. infusion Treatment group 3 (n=4): matching placebo once weekly x 24 weeks via a 60-minute i.v. infusion; treatment group 3a will match two placebo subjects to 50.0 mg/kg eteplirsen; treatment group 3b will match two placebo subjects to 30.0 mg/kg eteplirsen; sterile, isotonic, clear, colorless phosphate buffered saline solution of eteplirsen at a concentration of 100 mg/mL in single-use vials containing a nominal volume of 1.0 mL without preservatives.
Other intervention name(s): Eteplirsen- Phosphorodiamidate Morphilino Oligomer; Phosphate buffered saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: DMD
Combination of PD-1 and VEGFR-2 Blockade for Advanced Hepatocellular Carcinoma
Condition: Progress Free Survival (PFS) and Overall Survival (OS)
MeSH terms: Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      The aie of this clinical study is the safety and efficacy of combination therapy for HCC
      patients.
    

Detailed description: 
      Activation of anti-tumor immune response using programmed death receptor-1 (PD-1)blockade
      showed benefit only in a fraction of hepatocellular carcinoma (HCC) patients. Specific
      blockade of vascular endothelial receptor 2 (VEGFR-2) using a murine antibody significantly
      delayed primary tumor growth but failed to prolong survival. Combining PD-1 blockade with
      antiangiogenesis has shown promise in substantially increasing the fraction of HCC patients
      who respond to treatment in vitro. Based on these clinical data, we are aimed to
      investigation the safety and efficacy of combination therapy for HCC patients.
    

Intervention name(s): Bevacizumab Injection; Nivolumab
Intervention type(s): Drug; Drug
Intervention description(s): 15mg/kg (Q3W); nivolumab 480 mg IV infusions for 30 minutes q4w
Intervention MeSH terms: Bevacizumab; Nivolumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Instrument Assisted Soft Tissue Mobilization and Myofascial Gun in Upper Cross Syndrome
Condition: Postural; Defect
Study type: Interventional

Summary: 
      To compare the effects of Instrument Assisted Soft Tissue Mobilization and Myofascial gun in
      Upper Cross Syndrome
    

Detailed description: 
      Upper Cross Syndrome is a very common postural abnormality developed due to prolong slouched
      postures in desk jobs and also in students. Janda explained it that it is simultaneous
      presence of Forward Head Posture and protracted shoulders.

      This includes weakness of lower and middle trapezius, deep neck flexors, rhomboids and
      serratus anterior. It also includes tightness of upper trapezius, Sternocleidomastoid,
      Pectoralis major and minor. The simultaneous occurrence of FHP and rounded shoulder is
      nothing but upper crossed syndrome.

      Upper Trapezius is the primary muscle that is involved in Upper Cross Syndrome. Instrument
      Assisted Soft Tissue Mobilization is applied over the tight muscles to improve muscle length
      to its normal length. It is applied from origin to insertion with some pressure to apply
      compression on the muscle.

      Myofascial gun is a recent technology that can be applied by the clinician and also by the
      affected person for self mobilization. They provide varying amount of frequencies through
      various shaped heads according to the area they are used,
    

Intervention name(s): Myofascial gun with conventional therapy; Instrument Assisted Soft Tissue Mobilization with Conventional therapy
Intervention type(s): Other; Other
Intervention description(s): MYofascial gun was applied for the duration of 5 minutes over upper trapezius muscle. every week, on first two sessions frequency was set to 1-2 then for next two 3-4 and so on conventional therapy Hot Pack applied at the beginning of session for 10 minutes Muscle stretching of Upper Trapezius, Levator Scapulae and Pectoralis Major applied with holding time 20 seconds and 4 repetitions.
Cold pack was applied at the end of the session for few minutes; Graston's tool was applied over upper trapezius muscle from its origin to insertion kept at the angle of 45 Conventional Therapy Hot pack 10mins Upper Trapezius, Levator scapule and Pectoralis major muscle stretching(20s hold and 4 reps) Cold pack for few minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 30 participants were recruited in study and divided into two groups. Group A was given intervention with Instrument Assisted Soft Tissue Mobilization and Group B with Myofascial gun
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Upper Cross Syndrome; Instrument Assisted Soft Tissue Mobilization; Myofascial gun
Supporting Patient Provider Communication in Paediatric Care
Condition: Cancer; Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      Children with Cancer or congenital heart disease (CHD) experience complex, physical,
      psychosocial and behavioural symptoms and problems due to the illness, treatment, and medical
      procedures. To help children cope with their problems and prevent psychological distress, the
      investigators developed SiSom, a support system to help children with cancer or CHD report
      their symptoms and problems in an age-adjusted manner on a touch-pad, portable computer.

      This quasi-experimental study with 202 children age 7-12 with CHD or cancer will test the
      following hypotheses: When children use SiSom to report their symptoms and problems, and this
      information is provided to their clinicians in their outpatient consultations:

        -  Children and parents will experience less anxiety.

        -  Children and parents will be more satisfied with the outpatient visit.

        -  There will be greater congruence between children's reported symptoms and problems and
           those addressed by their clinicians as evidenced in documented patient care.

      To better understand the mechanisms by which these effects may occur, the investigators will
      also explore:

        -  Differences between control and experimental groups in patient-provider communication in
           terms of instrumental and affective behaviour, participation, initiative and person
           addressed;

        -  The relationships among outcomes of patient-provider communication, congruence between
           patients' reported symptoms and those addressed by their clinicians and children's and
           parents' anxiety and satisfaction; and how these relationships differ between treatment
           and control conditions.

      Finally, the investigators will investigate time requirements, ease of use and usefulness of
      SiSom by children and clinicians.

      For analyses the investigators will use inferential statistics and qualitative analyses of
      the video-taped consultation sessions. This study will contribute to improving
      patient-centred care for a particularly vulnerable population, and to a better understanding
      of the triadic communication and interactions among child-parent and clinician.
    


Intervention name(s): SiSom
Intervention type(s): Behavioral
Intervention description(s): SiSom is a symptom assessment tool designed to help the child report disease specific problems.The child also report the severity of their problems. After using the tool a report is printed and given to the clinician.
Other intervention name(s): Symptom assessment tool
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Symptom management; Symptom assessment; Patient satisfaction; Patient-provider communication
Celecoxib, Ibuprofen and the Antiplatelet Effect of Aspirin
Condition: Ischemic Heart Disease; Osteoarthritis
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Study design: Single center, placebo-controlled, double blind, parallel groups. To evaluate
      the potential interaction between aspirin and ibuprofen or celecoxib in patients with
      osteoarthritis (OA) and documented stable ischemic heart disease, a total of 24 patients
      chronically treated with aspirin will be randomly assigned to one of the 3 treatment groups:
      1) celecoxib 200 mg bid; 2) ibuprofen 600 mg tid; 3) placebo.
    

Detailed description: 
      Patients with arthritis and vascular disease may receive both NSAIDs and lowdose aspirin for
      the secondary prevention of important vascular events. The use of COX-2 inhibitors may have
      the potential advantage vs. nonselective NSAIDs in reducing the probability of interfering
      with permanent inactivation of COX-1 platelet by low-dose aspirin, in this setting. In fact,
      recent studies suggest that the likelihood of COX-inhibitors to present this pharmacodynamic
      interaction is inversely related to their COX-2 selectivity. Thus, differently from the
      non-selective NSAID ibuprofen, prior administration of the selective COX-2 inhibitor
      rofecoxib, does not antagonize the irreversible inhibition induced by aspirin in healthy
      subjects. Aim of this study is to determine whether celecoxib given at therapeutic dose at
      steady state alters the antiplatelet activity of low-dose aspirin, in comparison with
      ibuprofen.
    

Intervention name(s): celecoxib; ibuprofen; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): celecoxib capsules 200 mg bid for 1 week; ibuprofen tablets 600 mg tid for 1 week; placebo capsules tid for 1 week
Intervention MeSH terms: Ibuprofen; Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
This Study Tests in Healthy Korean Women Which Effects BI 409306 and a Birth-control Pill Have on Each Other
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the effect of multiple doses of
      ethinylestradiol / levonorgestrel (Microgynon®) on single dose pharmacokinetics of BI 409306
      and the effect of single dose of BI 409306 on multiple dose pharmacokinetics of
      ethinylestradiol / levonorgestrel (Microgynon®)
    


Intervention name(s): Microgynon; BI 409306
Intervention type(s): Drug; Drug
Intervention description(s): Run in period & Treatment Period; Day 18 & 29 (Treatment Period)
Intervention MeSH terms: Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination; BI 409306
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Anesthesia Methods on Percutaneous Kyphoplasty
Condition: Vertebral Fracture
MeSH terms: Spinal Fractures
Study type: Observational [Patient Registry]

Summary: 
      The aim of this research is to examine the effects of the anesthesia method and preoperative
      characteristics on postoperative results and complications in patients who underwent
      percutaneous kyphoplasty (PKP).

      Method: Patients were split into three groups according to anesthesia methods: (1) General
      Anesthesia (Sedation), (2) Central Block (Spinal and Epidural Anesthesia), (3) Peripheral
      Block [Erector Spina Plane Block (ESPB), and Paravertebral Block (PVB)]. Patients' pain
      values, hemodynamic parameters, additional need for sedation, and perioperative and
      postoperative complications were recorded prospectively together with Visual Pain Scales
      (VAS).
    

Detailed description: 
      Demographic characteristics (body mass index [BMI], gender, age, ASA use, pain values [VAS]
      before surgery, analgesic use habits, anesthesia technique chosen by anesthesiologist blind
      to the study, perioperative hemodynamic parameters, additional opioid during surgery, parol?
      or anesthetic need, perioperative complications [patients who willingly stopped the procedure
      during the intervention, moaning, hypotension, hypertension, bradycardia, respiratory
      depression, desaturation and need for mask ventilation] were taken from the records of the
      individuals with the treatment of PKP between 01/22-07/22 after the approval of the SBÜ Bursa
      Yüksek İhtisas EAH Ethics Committee (2021-KAEK-25 2021/12-09) and the patient's consent. In
      addition, the first mobilization time, additional analgesic need, total amount of analgesic
      used in 24 hours, discharge time, VAS values at 2, 6,12, and 18 hours, complications (nausea,
      vomiting, pain, delirium, respiratory insufficiency, infection, deep vein thrombosis,
      pulmonary embolus, need for re-operation, need for intensive care or mechanic ventilator)
      were also recorded.
    

Intervention name(s): Analgesic consumption
Intervention type(s): Procedure
Intervention description(s): 1 gr iv paracetamol for all patients with a VAS value of 2 or 3; for 4 and over, 1.5 mg/kg iv tramadol was administered additionally.
Intervention MeSH terms: Analgesics
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        18-100 aged kyphoplasty patients
      
Keywords: percutan kyphoplasty; Vertebroplasty
Analgesic Efficacy of Serratus Anterior Plane Block in The Rib Fractures Pain
Condition: Serratus Plane Block
MeSH terms: Rib Fractures
Study type: Interventional

Summary: 
      Serratus Anterior Plane Block (SAPB) is a facial plane block that was first described by
      Blanco in 2013 and that blocks the lateral cutaneous branches of the T2-T9 intercostal
      nerves, the intercostobrachial nerve, n. thoracic longus, n. thoracodorsalis nerves. Case and
      case series have been reported in the literature on the use of SAPB in rib fractures, and it
      has been reported as an effective analgesia method. We apply SAPB to patients with rib
      fractures with pain in our clinic.

      Our aim is to evaluate SAPB for patients with rib fractures pain and to compare them with the
      control group in terms of total analgesic consumption and pain scores.
    

Detailed description: 
      After Ethics Committee approval patients with rib fracture pain and have a Numerical Rating
      Scale (NRS) score of ≥ 4, included the study. The patients were randomized by the closed
      envelope method. The patients were divided into two groups as the SAPB-performed group (Group
      S) and the Control group (Group K). Intravenous patient-controlled analgesia (PCA) device
      prepared with tramadol was applied to all patients.
    

Intervention name(s): Serratus Plane Block; Control
Intervention type(s): Procedure; Procedure
Intervention description(s): Serratus Plane Block was performed; No block was performed
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Halliwick and Aquatic Exercises in Spastic Cerebral Palsy
Condition: Spastic Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional

Summary: 
      The aim of this research is to find and compare the effects of halliwick exercises and
      aquatic exercises on gross motor function, trunk stability and hand function in spastic
      cerebral palsy.
    

Detailed description: 
      Randomized controlled trials done at Dream Child institute and Children hospital complex
      Multan. The sample size was 32. The subjects were divided in two groups, 16 subjects in
      halliwick exercise group and 20 in aquatic exercise group. Study duration was of 6 months.
      Sampling technique applied was convenient non probability sampling technique. Only 13-16
      years diagnosed spastic cerebral pals individuals were included. Tools used in the study are
      Gross motor function measure (GMFM-66), Trunk impairment scale (TIS) and Nine-hole peg test
      (NHPT). Data was being analyzed through SPSS 22.
    

Intervention name(s): aquatic exercises; halliwick exercise programme
Intervention type(s): Other; Other
Intervention description(s): aquatic polymetric exercises for 30 min including hip abduction/adduction, knee flexion/extension, hip flexion/extension, holding pool from sides, bending forward and picking up objects, shoulder flexion/extension kangroo jumpes, jumping to sides.; Halliwick exercise programme for 30 min include sagittal rotations, transversal rotations, longitudnal rotations and combined rotations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Halliwick exercises; Aquatic exercises; Gross Motor Function measurment; Trunk control
Analgesic Effect of Ropivacaine Combined With Hydromorphone for CSEA After Total Knee Arthroplasty
Condition: Postoperative Analgesia
Study type: Interventional

Summary: 
      The aim of this study is to investigate the continuous analgesic effect and side effects of
      ropivacaine combined with hydromorphone for combined spinal-epidural anesthesia(CSEA) after
      total knee arthroplasty and to explore its clinical application value. To observe whether
      hydromorphone combined with ropivacaine can promote the rapid recovery of patients.
    

Detailed description: 
      For patients undergoing total knee arthroplasty, different spinal anesthesia drugs were
      injected in the two groups. The spinal anesthetic drugs injected in the hydromorphone group
      were hydromorphone 50 μg and ropivacaine 15 mg. In the control group, the spinal anesthetic
      was ropivacaine 15 mg.The differences in analgesia, sedation, and side effects between the
      hydromorphone group and the control group were analyzed by collecting various data at
      different times after anesthesia.
    

Intervention name(s): Hydromorphone was injected into the subarachnoid space
Intervention type(s): Drug
Intervention description(s): The dose of hydromorphone is 50 micrograms
Intervention MeSH terms: Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Effect of a New Infant Cereal on Weight Gain
Condition: Infant Development
MeSH terms: Weight Gain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a new infant cereal has an effect on weight
      gain and intestinal microbiota compared to a standard cereal in healthy infants .
    

Detailed description: 
      This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind
      study to evaluate the effect of a new infant cereal supplemented with prebiotics, probiotics,
      vegetable proteins and a special blend of starches on weight gain and intestinal microbiota
      in healthy infants from 6 to 12 moths of age. Patients will be randomized to receive either
      the new infant cereal or a standard cereal.
    

Intervention name(s): New Infant Cereal; Standard Infant Cereal
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): New Infant Cereal; Standard Infant Cereal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Cereals; Obesity; Complementary Feeding
Characteristic of Play: Comparison Between Children With Development Coordination Disorder ( DCD) and Children With Typical Development
Condition: Development Coordination Disorder
MeSH terms: Motor Skills Disorders
Study type: Observational

Summary: 
      There will be found differences in the issue of characteristic of play between Children with
      Development Coordination Disorder and Children with Typical Development.
    


Sampling method: Probability Sample
Study population: 
        Children aged 4-6 years with Development Coordination Disorder ( DCD) and Children with
        Typical Development (controlled group)
      
Keywords: Characteristic of play; DCD; children; Typical Development; Whether there are any differences in the issue of Characteristic of play between Children with DCD and Children with Typical Development
Safety Evaluation of Sericin-chitosan Cream in Healthy Volunteers
Condition: Pressure Sore; Safety Issues
MeSH terms: Pressure Ulcer
Study type: Interventional

Summary: 
      A prospective, randomized, active-controlled clinical trial was conducted to evaluate safety
      of sericin-chitosan cream in healthy volunteers.
    

Detailed description: 
      A prospective, randomized, active-controlled clinical trial was conducted to initially
      evaluate safety of sericin-chitosan cream in comparison with a commercially available cream
      containing dimethicone for pressure sore treatment in healthy volunteers. The results of this
      study provided preliminary safety profile of sericin-chitosan cream before conducting the
      further clinical trial in specific population (pateints with early-stage pressure sore).
    

Intervention name(s): Sericin and chitosan cream
Intervention type(s): Device
Intervention description(s): A novel film-forming cream containing sericin and chitosan
Intervention MeSH terms: Chitosan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention