bioihbjkbjnl/mcl2 huggingface dataset:
Study of Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab in Subjects With Recurrent or Progressive Glioblastoma
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex
      for production of human IL-12. IL-12 is a protein that can improve the body's natural
      response to disease by enhancing the ability of the immune system to kill tumor cells and may
      interfere with blood flow to the tumor.

      Cemiplimab-rwlc (Libtayo) is an antibody (a kind of human protein) that is being tested to
      see if it will allow the body's immune system to work against glioblastoma tumors. Libtayo
      (cemiplimab-rwlc) is currently FDA approved in the United States for metastatic cutaneous
      cell carcinoma (CSCC), but is not approved in glioblastoma. Cemiplimab-rwlc may help your
      immune system detect and attack cancer cells. Ad-RTS-hIL-12 and veledimex will be given in
      combination with cemiplimab-rwlc to enhance the IL-12 mediated effect observed to date.

      The main purpose of this study is to evaluate the safety and efficacy of a single tumoral
      injection of Ad-RTS-hIL-12 given with oral veledimex in combination with cemiplimab-rwlc.
    

Detailed description: 
      Eligible patients will receive one dose of cemiplimab-rwlc, via infusion, one week prior to
      standard of care craniotomy and tumor resection (subtotal or total). On the day of surgery,
      patients will receive one dose of veledimex before the resection procedure. Ad-RTS-hIL-12
      will be administered by free-hand injection. Patients will continue on oral veledimex for 14
      days. Following veledimex, patients will receive cemiplimab-rwlc via infusion every three
      weeks.

      The study is divided into three periods: the screening period, the treatment period and the
      follow-up period.
    

Intervention name(s): Ad-RTS-hIL-12; Veledimex; Cemiplimab-Rwlc
Intervention type(s): Biological; Drug; Drug
Intervention description(s): intratumoral injection of Ad-RTS-hIL-12
2.0 x 10^11 viral particles (vp) per injection; 20mg/day 15 oral daily doses of veledimex; Infusion every 3 weeks (350mg)
Other intervention name(s): Libtayo; REGN2810
Intervention MeSH terms: Cemiplimab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Physical Performance and Functional Asymmetries in Female Football
Condition: Resistance Training; Inter-limb Asymmetries; Athletic Performance
Study type: Interventional

Summary: 
      Worldwide, soccer has grown increasingly popular among female players. According to the
      Women´s Football Survey of the Fédération Internationale de Football Association (FIFA),
      there were more than 30 million registered women soccer players in 2014. Elite female soccer
      players cover approximately a total distance of 10 km with 1.7 km completed at high-speed
      (>18 km/h-1), between 1350 and 1650 changes of activity like passing, dribbling, tackling and
      trapping and 5.1 and 31.2 repeated sprinting and high intensity bouts, respectively. Thus, it
      seems that those strategies addressed to improve such high-intensity activities should be
      considered a priority for female soccer players.

      Different training methods to improve soccer specific variables have been developed such as,
      high-intensity interval training, resisted sprint training, strength training or plyometric
      training. Whilst individual training interventions have been shown to produce enhancements in
      measures of athletic performance for soccer players, there is a paucity of studies looking at
      the effectiveness of strength and power training specifically on performance measures in
      female soccer populations.

      Unilateral strength asymmetry can be a risk factor of musculoskeletal injuries. In recent
      years, inter-limb asymmetries have been included in battery tests performed by different
      soccer clubs due to their relation with lower-limb injuries. Few studies have analysed the
      change of an intervention on inter-limb asymmetry in female soccer players, hence, more
      studies for this population are warranted.

      The main aim of this research project is therefore, to evaluate the effect of a physical
      intervention on the performance and inter-limb asymmetries of female soccer players.
    


Intervention name(s): Strength training program
Intervention type(s): Other
Intervention description(s): Strength training program in female soccer players
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Soccer; Female; Lower limb asymmetries; Strength
TAP vs Caudal Block Using Dexmedetomidine/ Bupivacaine for Post Operative Analgesia
Condition: Analgesia, Epidural
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      Caudal epidural block is a well-established and commonly performed regional neuraxial
      technique for providing intraoperative and postoperative analgesia in children scheduled for
      lower abdomen/perineal surgical interventions. Although the efficacy and safety of Caudal
      epidural block are fairly high, the associated complications, such as inadvertent dural
      puncture, unwarranted motor blockade of the lower limbs, and disturbance of bladder function,
      limit its use. Furthermore, a major limitation of an uncomplicated Caudal epidural block when
      administered as a "single-shot" technique is its brief duration of action (up to 6 hours),
      which makes administration of additional analgesics necessary .
    

Detailed description: 
      Ultrasonography guidance, by virtue of real-time visualization of the muscle layers and
      fascial planes, has significantly facilitated practice of regional nerve blockade for it
      offers confirmation of the spread of the local anesthetic drug in the correct space.
      Interestingly, there has been a reinvigoration of interest in ultrasonography-guided
      transversus abdominis plane block in children since its emergence as a valid postoperative
      analgesia alternative in adults undergoing abdominal surgery. transversus abdominis plane
      block involves blockade of spinal afferent nerves in the neurofascial plane between the
      internal oblique and transversus abdominis muscle. Whereas the advantages (reduction in pain
      intensity/analgesic requirements) of ultrasonography-guided transversus abdominis plane block
      have been well documented in adults in the first 48 hours post surgery, in children, its use
      as a primary postoperative analgesia technique remains limited. Caudal anesthesia is easy to
      perform in younger children; however, its main disadvantage is the short duration of action.
      Even bupivacaine, along-acting local anesthetic drug, can provide only4-8 h of analgesia.
      Dexmedetomidine is a highly selective alfa2 agonist with sedative and analgesic properties.
      It has an alfa1/2 selectivity ratio of 1600 : 1, which is eight times more potent than
      clonidine (200 : 1)[16]. DEX has been used effectively in intensive care to aid weaning from
      mechanical ventilation and is being used increasingly in children
    

Intervention name(s): ultrasonography-guided TAP block; Caudal epidural block
Intervention type(s): Drug; Drug
Intervention description(s): (1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine).; (1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Dexmedetomidine; pediatrics; postoperative;; Analgesia; caudal
A Trial of Pentoxifylline for the Treatment of Recurrent Aphthous Stomatitis
Condition: Recurrent Aphthous Stomatitis
MeSH terms: Stomatitis; Stomatitis, Aphthous; Recurrence
Study type: Interventional

Summary: 
      This is a randomized, double blind, placebo controlled trial of the use of pentoxifylline
      (oxpentifylline) for the treatment of recurrent mouth ulcers.
    

Detailed description: 
      There are few effective treatments for recurrent aphthous stomatitis (cancer sores, recurrent
      mouth ulcers). Most existing treatments are palliative topical treatments. Some systemic
      drugs e.g. steroids and thalidomide can suppress the recurrence of mouth ulcers but have
      serious long term side effects. Pentoxifylline (also known as oxpentifylline) has been used
      systemically for many years to treat peripheral vascular disease and has a good side effect
      profile. It shares several actions with thalidomide but does not share its serious side
      effects. Furthermore, some small scale, open label clinical studies have indicated it may be
      very effective in treating recurrent aphthous stomatitis (RAS). This study enrolled patients
      with RAS for which no underlying cause could be identified. Patients kept a diary of the
      pattern of their mouth ulcers for 60 days to confirm the pattern of ulceration and provide
      baseline data. Those still qualified for the study were then randomized to treatment with
      pentoxifylline 400mg three times daily or an identical placebo tablet three times daily for a
      further 60 days during which they continued to keep a daily ulcer diary. At the end of this
      period, treatment was stopped and they kept the daily ulcer diary for a further 60 days to
      identify if any benefit from the treatment was continued after ceasing treatment.
    

Intervention name(s): Pentoxifylline (also known as oxpentifylline)
Intervention type(s): Drug
Intervention MeSH terms: Pentoxifylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: recurrent aphthous stomatitis; recurrent mouth ulcers; pentoxifylline; clinical trial; double blind; placebo controlled; randomized
Double Pet Project : A Comparison Between 11C-Acetate and 11C-acetoacetate Heart and Kidney Uptake
Condition: Ketoses, Metabolic
MeSH terms: Ketosis
Study type: Interventional

Summary: 
      The objective of this study is to make a comparison between 11C-acetate and 11C-Acetoacetate
      heart and kidney metabolism
    

Detailed description: 
      Healthy people will have two positron emission tomography scan to perform. One, with a
      11C-Acetate Tracer and the other with 11C-Acetoacetate. The results will allow to determine
      if both tracers are used in a similar way but the organs and see if the investigators can use
      the already validated analyse method for acetate to make acetoacetate analysis
    

Intervention name(s): Observational heart and kidney on siemens TEP scan
Intervention type(s): Radiation
Intervention description(s): Same as arm description
Intervention model: Sequential Assignment
Intervention model description: Participants will have to perform 2 scans one after the other
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: ketones; heart metabolism; kidney metabolism
Comparison Between Etview Tracheoscopic Ventilation Tube - TVT to Standard Endotracheal Intubation
Condition: Endotracheal Intubation
Study type: Interventional

Summary: 
      Airway management is one of the most important tasks facing the physician, especially the
      anesthesiologist. Fast and correct performance of endotracheal intubations done as normal
      routine in the operating room, but can save life everywhere.

      To make intubation easier, several newly designed tubes and laryngoscopes are developed and
      tested every year. Their performance is evaluated subjectively by the acting
      anesthesiologist, and by using objective parameters such as speed of intubation, the force
      applied during laryngoscopy , or catecholamines secretion during intubation as a stress
      parameter . The studies set for testing these parameters lead to establish accepted
      indications for the treatment of the airway in cases of anticipated and unanticipated
      difficult airway.

      In the present study we will compare the performance parameters of intubation using Etview
      Tracheoscopic Ventilation Tube - TVT to the standard tube, of which most of daily intubations
      are carried with. The Etview TVT is similar to the standard endotracheal tube; its outer
      dimensions and material is exactly as the standard tube, the difference is only the inner
      fiber of the camera.
    


Intervention name(s): ETview TVT endotracheal tube; Endotracheal tube
Intervention type(s): Device; Device
Intervention description(s): intubation; Intubation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Endotracheal intubation and its outcomes
Glutamatergic Modulation of Disordered Alcohol Use
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Alcohol use disorders remain a significant public health problem. The pharmacological
      facilitation of behavioral treatment represents a promising strategy for addressing
      disordered drinking. Alcohol use disorders are recognized to be associated with various
      vulnerabilities that complicate the course of treatment and that may be amenable to glutamate
      modulators. The purpose of this randomized, double-blind, controlled trial is to test various
      glutamate modulators in conjunction with motivational enhancement therapy (MET) for alcohol
      use disorders.
    

Detailed description: 
      Individuals diagnosed with alcohol dependence will be randomized to receive a single infusion
      of glutamate modulators during week 2 while engaged in a 5-week course of MET. They will meet
      with staff twice weekly, except for week 2 during which they will present to the clinic three
      times. Clinic visits include MET sessions, psychiatric monitoring, assessments, and study
      procedures (e.g., medication administration).
    

Intervention name(s): CI-581a; CI-581b; Motivational Enhancement Therapy (MET)
Intervention type(s): Drug; Drug; Behavioral
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the
      anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the
      development of neurological deficits remains the most feared complication of spine surgery.
      During scoliosis surgery it is very important to monitor the spinal cord to detect spinal
      cord injury with surgical manipulation. Continuous or intermittent intraoperative
      electrophysiological monitoring (neuron-monitoring) is used routinely during these procedures
      to provide the surgeon with information concerning the integrity of neurological structures
      at risk. All neuron-monitoring modalities are affected by the anesthetic regimen used. Of the
      various intravenous anesthetic drugs, the combination of propofol, remifentanil and
      dexmedetomidine appear to impact neuron-monitoring the least. The current anesthetic practice
      is to use the three drugs in combination at doses that do not depress the signals but there
      is no data relating targeted dexmedetomidine and propofol blood levels to neuron-monitoring
      signals. The lack of data results in wide variability in dosing with consequent variability
      in patient response.

      Hypothesis: Clinically relevant blood levels of dexmedetomidine will affect the amplitude of
      transcranial motor-evoked potentials (TcMEP) either independently or by interaction with
      propofol in a dose dependent manner.
    


Intervention name(s): low dexmedetomidine, low propofol; high dexmedetomidine, low propofol; Dexmedetomidine; Dexmedetomidin; Dexmedetomidine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 100 MCG/KG/M; Dexmedetomidine loading dose 1.1 MCG/KG ,Propofol infusion 100 MCG/KG/M; Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 200 MCG/KG/M; Dexmedetomidine loading dose 1.1 MCG/KG.Propofol infusion 200 MCG/KG/M; Dexmedetomidine loading dose 0.9 mcg/kg,Propofol infusion 140 mcg/kg/min
Intervention MeSH terms: Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Keywords: dexmedetomidine; neuromonitoring; spine procedures; safe dose; 1- safe dose of dexmedetomidine when used in total intravenous anesthesia for procedures require neuromonitoring; 2- safe dose of propofol when uses in comination with dexmedetomidine in neuromontoring; 3effect of dexmedetomidine on somatosensory evoked potential and motor evoked potentials
Bioequivalence Study in Healthy Volunteers for Empagliflozin/Metformin Fixed Dose Combination Compared to Separate Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed
      dose combination tablets compared to tablets administered together in healthy male and female
      volunteers under fed conditions.
    


Intervention name(s): Empagliflozin 2.5 mg; Empagliflozin 10 mg; Metformin 500 mg; Empagliflozin/Metformin FDC
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Empagliflozin 2.5 mg tablet; Empagliflozin 10 mg tablet; Metformin 500 mg tablet; 12.5 mg Empagliflozin / 500 mg Metformin
Intervention MeSH terms: Metformin; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Third Generation Cognitive Behavioural Therapy vs Treatment-as-usual for ADHD
Condition: Adhd
Study type: Observational

Summary: 
      The investigators hypothesize that the mindfulness Cognitive Behavioral Therapy program will
      lead to a reduction in attention deficit and hyperactivity disorder symptoms, anxiety and
      depression, and improve self-confidence, emotional control, social integration and school
      results.
    


Intervention name(s): Mindfulness Cognitive Behavioral Therapy program
Intervention type(s): Behavioral
Intervention description(s): 16 simultaneous-but-separate therapy sessions for parents and children.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Families consulting for attention deficit and hyperactivity disorder
Trial of IW-1973, A Stimulator of Soluble Guanylate Cyclase (sGC) in Patients With Stable Type 2 Diabetes and Hypertension
Condition: Diabetes Mellitus, Type 2; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD)
      effects of 2 treatment regimens of IW-1973 tablet (40 mg per day) administered orally for 2
      weeks to patients with stable type 2 diabetes mellitus and hypertension.
    


Intervention name(s): IW-1973; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Tablet; Oral Tablet
Intervention MeSH terms: Praliciguat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Aqualase Versus Torsional ip. A Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity
Condition: Cataract
MeSH terms: Cataract; Corneal Edema; Hypersensitivity
Study type: Interventional

Summary: 
      Objective of this study is the comparative assessment of the impact of torsional and
      liquefaction technologies on endothelial cells (ECC), corneal edema (CCT) and corneal
      sensitivity (CCS) in a sample of cataract patients.

      Participants were recruited from the Cataract Service of the UHA in a consecutive-if-eligible
      basis. Eligibility criteria included diagnosis of senile cataract with stage 2 nuclear
      opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale
      [10]. By means of a custom computer randomization program all participants randomly populated
      two study groups according to the cataract-extraction technology used: a) Torsional group
      (TG) and b) Liquefaction group (LG).
    


Intervention name(s): liquefaction; Torsional ip
Intervention type(s): Procedure; Procedure
Intervention description(s): Cataract extraction surgery type; A type cataract surgery using torsional ip technology
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: cataract; phacoemulsification; liquefaction; torsional ip; endothelial cell count; central corneal edema; central corneal sensitivity
Assessing Cost and Effectiveness of Training and Supervision of Front Line Workers on Early Breastfeeding Practices
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this operational research is to compare the cost-effectiveness of two methods for
      capacity building of existing TBAs/CVs to improve rates of delayed cord clamping, early skin
      to skin contact and infant-led initiation of breastfeeding, to reduce prelacteal feeding and
      increase early exclusive breastfeeding in research areas of rural Bangladesh.
    

Detailed description: 
      Suboptimal early infant feeding practices are the norm in Bangladesh, and contribute to its
      poor infant health and nutrition. However, the modern health services are unable to help
      because approximately 85% of births take place at home. The Government has begun the huge
      process of training the informal community traditional birth attendants (TBAs) who, along
      with community volunteers (CVs), deliver the majority of babies, especially in the rural
      areas. The proposed operations research will take place in one of the poorest rural
      districts. It will compare the cost effectiveness of practical training of these relatively
      uneducated community members, with or without supportive supervision in improving early
      infant feeding practices, using a cluster-randomized study design. The practices to be
      measured before and after on probability samples include: 1) delayed cord clamping, 2) early
      skin to skin contact and 3) newborn-led initiation of breastfeeding within one hour of birth,
      4) avoidance of the traditional prelacteal feeds, and 5) exclusive breastfeeding, at least
      for the early months. Costs will be carefully monitored so as to compare the cost per
      behavior improved per infant.
    

Intervention name(s): Improve Early Breastfeeding
Intervention type(s): Behavioral
Intervention description(s): One arm got only training, another arm training and supervision and third arm without any intervention as control.
Other intervention name(s): IYCFCH
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Health Services Research
Keywords: Exclusive Breastfeeding; Skin to skin contact; Cord Clumping; Prelactial feeding