bioihbjkbjnl/mcl2 huggingface dataset:
Thermal Micro-cautery for Painful Knee Osteoarthritis
Condition: Chronic Pain Syndrome
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Chronic Pain
Study type: Interventional

Summary: 
      To trial a traditional pain management technique from Ayurveda in a modern way - the
      technique involves micro - cautery to painful areas in knee osteoarthritis for patients on a
      waiting list for knee replacement. The Investigators will include a waiting list control
      series.
    

Detailed description: 
      The Research and Ethics Committee at Tallaght University Hospital approved the recruitment of
      patient into the study by invitation. Patients who accepted the invitation were enrolled into
      the intervention group and patients who declined the invitation were enrolled into the
      control group and both groups were followed up for 8 week period. Agnikarma is a traditional
      surgical technique (thermal cautery) described in ancient surgical manuscripts for the
      treatment of severe persistent pain.

      It applies intense heat to points of maximum pain agreed with the patient pre procedure. The
      heat is applied by a metal rod (Shalaka) heated in an open naked flame. The rod is applied to
      the skin at the agreed pain point in an even manner and generates a micro second degree burn.
      A traditional herbal cream is then applied which cools the application as reported by the
      patient. It is usual to allow skin healing to occur before the application of further heat
      (1-2 weeks). The pain points can move within a painful area and the technique best works with
      precise application to the current pain point. So before each application the precise points
      are agreed with the patient in advance by demarcating the painful area with a pen and
      searching for the points of maximum tenderness within that field.

      The purpose of this study was simply to define if indeed this technique delivers pain relief
      as observed in practice. The investigators chose one group to study - painful knee arthritis.
      In this condition patients often wait many years for the definitive procedure and run some
      risks with current pain relief treatment. As these patients were not the normal attendees at
      a pain clinic the investigators decided in advance to limit the study to 4 applications over
      a 4- 8 week period, the latter to allow for different speeds at which the skin might heal.
      The investigators recruited both our interventional group and waiting list control group from
      the same orthopedic waiting list.
    

Intervention name(s): Peripheral Nerve Field Stimulation by Thermal Micro-Cautery
Intervention type(s): Other
Intervention description(s): The most painful points over the knee received an intense heat by a metal rod for 0.5 seconds.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: intervention offered and those who decline are followed as a waiting list control
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Standard Treatments of Very-early Stage Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma; Very-early Stage
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      The aim of our study was to elucidate the difference in the rates of complication,
      hospitalization days, medical expenses, MRI showed that the degree of tumor necrosis, and
      overall survival rates of the therapies between PEI, MVA and RFA, and make the standard for
      minimally invasive treatment of very early stage HCC.
    


Intervention name(s): RFA; MWV; PEI
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Percutaneous ethanol injection
Other intervention name(s): Microwave ablation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: treatments; hepatocellular carcinoma
Safety and Immunogencity of H7N9 Influenza Antigen With 2 Adjuvant Formulations in Healthy Adults in Brazil
Condition: Influenza; H7N9 Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall aim of this study is to evaluate the safety, immunogenicity and dose sparing
      effects of H7N9 influenza antigen formulated with 2 different adjuvants .
    

Detailed description: 
      Following the emergence of avian influenza A/H7N9 influenza virus in humans in China in March
      2013, the WHO Essential Regulatory Laboratories prepared candidate vaccine viruses and
      reagents for further development and several manufacturers have developed various inactivated
      influenza vaccines with and without adjuvant against A/H7N9 and tested these candidates in
      trials in healthy adults. The overall aim of this study is to evaluate the safety,
      immunogenicity and dose sparing effects of H7N9 influenza antigen produced by Butantan
      Institute in combination with 2 different adjuvants.
    

Intervention name(s): H7N9 antigen + adjuvant IB160; H7N9 antigen + adjuvant SE; H7N9 antigen without adjuvant; Placebo (PBS)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): H7N9 monovalent (fragmented and inactivated); H7N9 monovalent (fragmented and inactivated); H7N9 monovalent (fragmented and inactivated); Placebo (Phosphate Buffered Saline -PBS)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
U/S Guided vs. Traditional Palpation for Radial Artery Cannulation
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy of ultrasound- guided with the
      traditional palpation radial artery cannulation in critically ill children.
    

Detailed description: 
      Arterial catheterization is often performed in critically ill patients for continuous
      hemodynamic monitoring and blood sampling. However, insertion of radial artery catheter with
      traditional palpation may be technically challenging, particularly in pediatric patients.
      There are few published studies on the use of ultrasound guidance for radial-artery catheter
      placement and mostly they were elective surgery children which received inhalation or deep
      sedative medication. Recently no setting published in pediatric intensive care unit.
    

Intervention name(s): Ultrasound; traditional method
Intervention type(s): Procedure; Procedure
Intervention description(s): ultrasound at radial site and measure the size and depth of radial artery and perform radial artery cannulation; Radial artery catheters will be placed by the palpation technique only.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Video-assisted Telephone CPR With the EmergencyEye-Software - a Pilot Study
Condition: Cardiac Arrest
MeSH terms: Heart Arrest
Study type: Interventional

Summary: 
      Technical advance as broad-bandwidth wireless internet coverage and the ubiquity utilization
      of smartphones has opened up new possibilities which surpass the normal audio-only telephony.
      High quality and real-time video-telephony is now feasible. However until now this technology
      hasn't been deployed in the emergency respond service.

      In the hope of helping the detection of the cardiac arrest, offer the possibility to evaluate
      and correct via a video-instructed CPR (V-CPR) and to facilitate a fast localization of the
      emergency site, a new software (EmergencyEye®/RAMSES®) was developed which enables the
      dispatcher a video-telephony with the callers mobile terminal (smartphone) if suitable.

      This technology hasn't been tested in a randomized controlled trail yet and no data exists
      that shows if V-CPR in comparison to T-CPR and non-instructed CPR leads to a better bystander
      CPR-performance.
    

Detailed description: 
      Technical advance as broad-bandwidth wireless internet coverage and the ubiquity utilization
      of smartphones has opened up new possibilities which surpass the normal audio-only telephony.
      High quality and real-time video-telephony is now feasible. However until now this technology
      hasn't been deployed in the emergency respond service.

      In the hope of helping the detection of the cardiac arrest, offer the possibility to evaluate
      and correct via a video-instructed CPR (V-CPR) and to facilitate a fast localization of the
      emergency site, a new software (EmergencyEye®/RAMSES®) was developed which enables the
      dispatcher a video-telephony with the callers mobile terminal (smartphone) if suitable.

      This technology hasn't been tested in a randomized controlled trail yet and no data exists
      that shows if V-CPR in comparison to T-CPR and non-instructed CPR leads to a better bystander
      CPR-performance.
    

Intervention name(s): Video-assisted CPR; telephone-assisted CPR
Intervention type(s): Device; Drug
Intervention description(s): Emergency call using a Software capable of video Transmission for Video assistance in CPR; Emergency call with telephone assistance in CPR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
GSK1278863 Effects on Eccentric Exercise-Induced Muscle Damage
Condition: Tendon Injuries
MeSH terms: Tendon Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      As per non-clinical studies, prolyl hydroxylase inhibitor GSK1278863 can protect muscle from
      unaccustomed exercise induced muscle damage and enhance functional muscle repair. This study
      is designed to investigate arm function, pain and other pharmacodynamic (PD) markers after
      unaccustomed maximal eccentric exercise with concurrent administration of GSK1278863 or
      placebo. Primary objective of the study is to evaluate the protective effects of GSK1278863
      on eccentric exercise induced muscle injury. Subjects will be randomized in a 1:1 ratio (1
      subject on GSK1278863 for every 1 subject on placebo). Each subject will be given five oral
      doses of GSK1278863/placebo in total. The first dose will be administered immediately after
      completion of eccentric exercise and then 4, 8, 24, and 48 hours later. Subjects will be
      housed till day 4 in unit and will return for a follow-up visit 7-10 days after discharge.
      After enrolment of approximately 30 subjects, enrolment will be paused and planned interim
      analysis will be performed to decide whether to terminate enrolment/study, continue dosing or
      to reduce the dose to 5 milligrams (mg).
    


Intervention name(s): GSK1278863; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK1278863 will be supplied as oral tablet of strength 100mg, 5mg(5mg if a low dose is elected for subjects enrolled after interim analysis) to be administered with 240 mL of water after end of eccentric exercise; GSK1278863 matching placebo will be supplied as oral tablets for administration with 240 mL of water after end of eccentric exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: muscle soreness; Muscle damage and recovery; muscle function; eccentric exercise
Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors, AZD3759 or AZD9291, in Patients Who Have Advanced Non-Small Cell Lung Cancer
Condition: EGFR Mutation Positive Advanced Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first time in patient study to assess the safety, tolerability and preliminary
      efficacy of AZD3759 in patients with advanced Non Small Cell Lung Cancer (NSCLC) In this
      study, patients with Leptomeningeal Metastasis and Brain Metastasis may also be enrolled to
      assess the anti-tumour efficacy, safety, pharmacokinetics and potential biological activity
      of AZD9291
    

Detailed description: 
      A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics
      and Preliminary Anti-Tumour Activity of AZD3759 or AZD9291 in Patients with EGFR Mutation
      Positive Advanced Stage Non Small Cell Lung Cancer (NSCLC) who failed standard treatment and
      developed brain or leptomeningeal diseases
    

Intervention name(s): AZD3759; AZD9291
Intervention type(s): Drug; Drug
Intervention description(s): Starting dose 50 mg, administered twice daily. If tolerated subsequent cohorts will test increasing doses of AZD3759, until a maximum tolerated dose or an effective dose is defined; AZD9291 160mg once daily
Intervention MeSH terms: Osimertinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non Small Cell Lung Cancer, EGFR, Tyrosine kinase inhibitor,EGFR mutation positive, Brain Metastasis, Leptomeningeal Metastasis
Assessment of Gait After Dysport Treatment
Condition: Equinovarus; Acquired
MeSH terms: Clubfoot
Study type: Interventional
Phase: Phase 4

Summary: 
      This pilot study will aim to understand the potential benefit of the assessment of walking
      using video slow motion for muscle selection and the development of an image catalogue guide
      of the potential results of injection of abobotulinumtoxinA by comparing foot postures before
      and after injection. The objective is to evaluate the use of video assessment to improve
      muscle selection for the injection of botulinum toxin A to improve walking outcomes. Primary
      outcomes include: self-selected velocity (SSV), maximal velocity (MV) and symmetry of
      walking. Secondary outcomes include: passive range of motion (PROM), Modified Ashworth Scale
      (MAS) and the Tardieu Scale (TS). Fifteen persons post stroke or TBI over age 18 with
      equinovarus foot deformity who are able to ambulate will be included in the study. Dysport
      1000 to 1500 units will be used to be distributed on the basis of clinical indication to
      ankle plantar flexors (gastrocnemius and soleus), tibialis posterior and long toe flexors.
      The duration of subjects' participation is 4-6 weeks.
    

Detailed description: 
      This is a prospective, single arm, non-randomized clinical study with pre-post assessment to
      include post-stroke and Traumatic Brain Injury (TBI) outpatients with spastic ankle / foot
      muscles amenable to botulinum toxin injection. Subjects must be able to walk without braces.

      AbobotulinumtoxinA injection in a dose range of 500 to 1500 units one time to be distributed
      on the basis of clinical indication to ankle plantar flexors (gastrocnemius and soleus), knee
      extensors, knee flexors, tibialis posterior and long toe flexors.
    

Intervention name(s): Dysport
Intervention type(s): Drug
Intervention description(s): Dysport 1000 to 1500 units to be distributed on the basis of clinical indication to ankle plantar flexors (gastrocnemius and soleus), knee extensors and flexors, tibialis posterior and long toe flexors.
Other intervention name(s): abobotulinumtoxinA
Intervention MeSH terms: abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Impact of Acupuncture on the Success Rates of IVF (In Vitro Fertilisation) Treatments
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The trial aims to investigate whether acupuncture has an effect in increasing clinical
      pregnancy (pregnancy that is confirmed by a scan) and live birth rates on women undergoing
      IVF treatment.
    

Detailed description: 
      Failing to conceive naturally poses significant stress to the infertile couple. It creates a
      feeling of failure and frustration. It has been found that the use of complementary therapies
      makes women feel empowered, with a sense of regaining control of the body.

      The popularity of acupuncture is increasing. A significant proportion of couples having
      fertility treatment, especially IVF (In-Vitro Fertilisation) ask their clinician about using
      acupuncture and some patients undergo acupuncture privately without reporting to their
      clinicians.

      The effectiveness of acupuncture on IVF has been extensively researched; however the results
      are varied and not conclusive. This is due to previous studies varying significantly in their
      study design, acupuncture timing and the final outcome measure. As a result of the difference
      in the studies it is not clear whether acupuncture is beneficial regarding IVF success rates
      and whether it should be offered to women undergoing IVF.
    

Intervention name(s): acupuncture
Intervention type(s): Procedure
Intervention description(s): patients received a Delphi acupuncture at least 3 times during their fertility treatment cycle.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
RAOLA Observational: Local Anesthesia During Cardiac Catheterization
Condition: Anesthesia, Local
Study type: Observational

Summary: 
      An open label observational clinical study to compare the efficacy of EMLA cream (lidocaine
      2.5% and prilocaine 2.5% in a ratio of 1:1 by weight) in comparison to the established local
      anesthesia (LA) protocol of lidocaine subcutaneous injection, in providing adequate
      peri-operative local anesthesia during transradial coronary angiography
    

Detailed description: 
      A total of 800 consecutive patients, who are referred for elective coronary angiography to
      1st Cardiology Department cathlab, with the suspicion of coronary artery disease (CAD) will
      be enrolled in this study. Exclusion criteria are acute coronary syndrome, previous
      ipsilateral transradial approach, Raynaud's syndrome, abnormal renal function with or without
      need for hemodialysis, known history of sensitivity to local anesthetics, non-palpable radial
      pulse, abnormal Barbeau's test and patient's refusal. Baseline clinical, demographic and
      procedural data of the study population will be recorded.

      The study will not involve any intervention but it will observe patients assigned to other
      EMLA cream or lidocaine injection for local anesthesia as part of their clinical routine
      treatment during transradial catherization.

      Primary end-point: the perception of radial pain assessed during artery puncture and 30
      minutes after sheath removal. Secondary end-point: The number of puncture attempts, the total
      time required before successful sheath insertion, and the occurrence of radial artery spasm
      will be also documented in each group Participants will be observed for 4 hours post
      angiography for development of local complications or side effects.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of 800 consecutive patients, referred for elective coronary angiography In
        1stCardiology Dpt Cath Lab with the suspicion of coronary artery disease (CAD) are enrolled
        in this study. All procedures will be undertaken by experienced and radial dedicated
        interventional cardiologists (i.e. more than 90% radial catheterizations). Exclusion
        criteria were acute coronary syndrome, previous ipsilateral transradial approach, Raynaud's
        syndrome, abnormal renal function with or without need for hemodialysis, known history of
        sensitivity to local anesthetics, non-palpable radial pulse, abnormal Barbeau's test and
        patient's refusal
      
Keywords: coronary; catheterization; transradial; anesthesia
Intrawound Administration of Vancomycin in TKA
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to determine the intra-articular and serum levels of vancomycin
      over the first 24 hours postoperatively after intra-articular administration of a standard
      dose of vancomycin in primary total knee arthroplasty.
    


Intervention name(s): Intrawound administration of vancomycin after closure of the arthrotomy
Intervention type(s): Procedure
Intervention description(s): After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle.
Intervention MeSH terms: Vancomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Lorcaserin in Combination With XR-Naltrexone for Relapse Prevention in Opioid Use Disorder
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study proposes to recruit patients with Opioid Use Disorder (OUD) seeking treatment into
      our program of outpatient detoxification and naltrexone induction followed by a
      relapse-prevention treatment with Extended release-naltrexone (XR-NTX) . Eligible
      participants will be randomly assigned to adjunctive treatment with lorcaserin (N = 40), or
      placebo (N = 20) with weekly therapy.
    

Detailed description: 
      The study proposes to recruit patients with Opioid Use Disorder (OUD) seeking treatment into
      our program of outpatient detoxification and naltrexone induction followed by a
      relapse-prevention treatment with Extended release-naltrexone (XR-NTX) . Eligible
      participants will be randomly assigned to adjunctive treatment with lorcaserin (N = 40), or
      placebo (N = 20) with weekly therapy. Lorcaserin or placebo 10 mg bid will be started on Day
      1 of the study to address acute withdrawal, then maintained over the next 5 weeks, and
      stopped after the second XR-naltrexone is administered. Patients will be seen twice weekly
      for monitoring and offered two injections of naltrexone; at the end of oral naltrexone
      induction (end of week 1) and four weeks later (week 5). The primary outcome measures will be
      the proportion of patients successfully inducted onto XR-naltrexone.
    

Intervention name(s): Lorcaserin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lorcaserin 10mg, twice daily; Matched placebo for lorcaserin condition dosed twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Alirocumab SAR236553 (REGN727)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      Injection Site Tolerability

      Secondary Objective:

        -  To assess the safety profile of alirocumab SAR236553 (REGN727)

        -  To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553
           (REGN727)
    

Detailed description: 
      The total duration of study for each subject is up to 15 weeks including a screening period
      up to 3 weeks.
    

Intervention name(s): alirocumab SAR236553 (REGN727)
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:Solution Route of administration: Subcutaneous
Intervention MeSH terms: Alirocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment