bioihbjkbjnl/mcl2 huggingface dataset:
ET1402L1-ARTEMIS™2 T Cells in Alpha Fetoprotein (AFP) Expressing Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma; Liver Cancer; Liver Neoplasms; Metastatic Liver Cancer
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Clinical study to evaluate safety (primary objectives) and efficacy (secondary objective) of
      ET1402L1-ARTEMIS™2 T cells in patients with alpha fetoprotein positive (AFP+ ) hepatocellular
      carcinoma (HCC).
    

Detailed description: 
      The molecular target for ET1402L1-ARTEMIS™2 is human leukocyte antigen (HLA) -A02 complexed
      with a HLA-A02-restricted peptide of alpha fetoprotein (AFP), which is expressed on 60-80
      percent of hepatocellular carcinoma (HCC). ARTEMIS™2 is a second generation ARTEMIS™ receptor
      engineered with a human antibody domain against the anti-HLA-A02/AFP complex. This clinical
      study evaluates the safety and pharmacokinetics of ET1402L1-ARTEMIS™2 T-cells in patients
      with HCC who have no available curative therapeutic options and a poor overall prognosis.

      Patients with lesion(s) localized in liver will be enrolled in the intra-hepatic artery (IA)
      arm or Intratumoral Injections arm, with the ET1402L1-ARTEMIS™2 T-cells administered via
      intrahepatic artery catheter. Patients with extrahepatic metastasis will be enrolled in the
      intravenous (IV) arm, with the ET1402L1-ARTEMIS™2 T-cells administered through intravenous
      infusion.
    

Intervention name(s): ET1402L1-ARTEMIS™ T cells -IV; ET1402L1-ARTEMIS™ T cells -intra-hepatic artery; ET1402L1-ARTEMIS™ T cells -Intratumoral Injections
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1) -ARTEMIS™2 expression construct -intravenous (i.v.) arm; Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1) -ARTEMIS™2 expression construct: intra-hepatic artery (i.a.) arm; Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1) -ARTEMIS™2 expression construct: Intratumoral Injections (i.t.) arm
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Iron Bioavailability of High Surface Area Ferric Phosphate
Condition: Iron-deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      The primary objective of this study is to compare iron absorption of high surface area ferric
      phosphate with that of ferrous sulfate and bulk ferric phosphate in a rice-based meal in
      non-pregnant women.
    


Intervention name(s): FeSO4 fortified rice test meal; FePO4 fortified rice test meal; HiFePO4 1 fortified rice test meal; HiFePO4 2 fortified rice test meal
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Rice test meal extrinsically labeled with 2 mg ferrous sulfate (58FeSO4); Rice test meal extrinsically labeled with 2 mg ferric phosphate (58FePO4); Rice test meal extrinsically labeled with 2 mg high surface ferric phosphate 1 (57FePO4); Rice test meal extrinsically labeled with 2 mg high surface ferric phosphate 2 (57FePO4)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Shockwave Therapy Versus LIPUS on Mandibular Fracture Bone Healing
Condition: Mandibular Fractures
MeSH terms: Mandibular Fractures; Fractures, Bone
Study type: Interventional

Summary: 
      compare between the effect of shockwave therapy and low-intensity pulsed ultrasound on
      healing process of fresh mandibular fractures
    

Detailed description: 
      The mandible is the commonest facial bone to fracture. Mandibular fractures represent more
      than 74% of all maxillofacial fractures.

      To compare between the effect of shockwave therapy and low-intensity pulsed ultrasound on
      healing process of fresh mandibular fractures.

      A total of 21 patients; aged between 20-40 years, who have mandibular fracture were selected
      for this study from the outpatient clinic of the Oral and Maxillofacial Surgery Department,
      Faculty of Dentistry, Alexandria University. In this study all patients were subjected to
      closed reduction and intermaxillary fixation. This will be followed by shockwave therapy in
      seven patients as a study group and by low-intensity pulsed ultrasound in seven patients as
      study group. Seven patients will receive neither and will constitute the control group.
    

Intervention name(s): inter maxillary fixation with shockwave therapy; Inter maxillary fixation and exposure to low intensity pulsed; Inter maxillary fixation
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Shockwave therapy device which give 1500-4000 pulses per session with or without anesthesia, and the treatment session takes approximately 5-10 minutes at the day after surgery.; Low-intensity pulsed ultra sound was applied three times weekly for six weeks from the second day after surgery.; Closed reduction will be done. Intermaxillary fixation (IMF) will be secured after proper reduction of the fractured segments to assure proper occlusion using upper and lower arch bars or eyelet wires for six weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human)
Condition: Anti-Hepatitis A Antibody Levels in Heathy Subjects
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a single center, open-label, single-arm study in which approximately 28 Hepatitis A
      virus (HAV)-seronegative healthy subjects were enrolled. There was a screening period of up
      to 28 days during which subjects were screened for enrollment in the study.

      Healthy subjects received a single intramuscular (IM) dose of GamaSTAN (0.2 mL/kg), followed
      by a pharmacokinetic (PK) sampling period of 150 days (approximately 5 half-lives). The
      protective levels of anti-HAV antibodies were assessed up to 60 days after the administration
      of GamaSTAN. A PK curve was obtained during the PK sampling period.
    

Detailed description: 
      This was a single center, open-label, single-arm study design, in which approximately 28
      subjects received the same study treatment (0.2 mL/kg dose via IM injection). There was no
      reference therapy in this study.

      The study was explained to each subject prior to the subject providing written informed
      consent. All subjects were screened to ensure that all the inclusion criteria and none of the
      exclusion criteria were met.

      A sufficient number of healthy male and female subjects were qualified by screening
      assessments and procedures for reporting to the clinical site on Day -1. The healthy subjects
      received a single IM dose of GamaSTAN (0.2 mL/kg) on Day 1. Subjects were discharged from the
      clinic on Day 2, following the scheduled assessments and procedures, and returned to the
      clinical site for the remaining ambulatory PK samples and safety monitoring, and again for
      the final visit (Day 150).

      The total duration of study participation for subjects who completed the study were
      approximately 178 days.
    

Intervention name(s): Immune Globulin (Human)
Intervention type(s): Biological
Intervention description(s): A single 0.2 mL/kg IM injection of Immune Globulin (Human) (GamaSTAN) was administered in healthy subjects.
Other intervention name(s): GamaSTAN
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effect of Distraction Technique on Children's Pain, Anxiety and Fear of Medical Procedure in Invasive Interventions
Condition: Child Behavior
Study type: Interventional

Summary: 
      This study was conducted on the effects of visual and/or auditory distraction techniques
      applied to children aged 7-12 years who applied to Çanakkale Mehmet Akif Ersoy State Hospital
      Gynecology and Pediatric Emergency Service during invasive procedures (blood sampling,
      intravenous access or intramuscular injection in the deltoid region). Kaleidoscope, music
      concert, virtual reality glasses) is a randomized controlled experimental study to determine
      the effect of children on pain, anxiety and fear of medical procedures.
    


Intervention name(s): Kaleidoscope; Music; Virtual reality glasses
Intervention type(s): Other; Other; Other
Intervention description(s): Kaleidoscope; Music; Virtual reality glasses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: music; Kaleidoscope; virtual reality glasses
The Superiority of Contralateral Oblique View for Mid-thoracic Epidural Assess
Condition: Herpes Zoster; Postherpetic Neuralgia; Cancer
MeSH terms: Herpes Zoster; Neuralgia; Neuralgia, Postherpetic
Study type: Interventional

Summary: 
      The aim of the present study is to compare contralateral oblique view with the lateral view
      for fluoroscopic guided mid-thoracic epidural assess.
    

Detailed description: 
      A thoracic epidural assess (block or catheter insertion) is a widely used intervention to
      reduce pain in patients with postherpetic neuralgia or who underwent chest and upper
      abdominal surgery.

      In order to achieve the correct procedure, accurate access to the thoracic epidural space is
      needed. However, a thoracic epidural assess is a relatively more difficult procedure than
      procedures used in other regions, because the spinous process of the thoracic vertebra is
      longer than that of the lumbar vertebra, and the area through which the needle can approach
      the epidural space is relatively smaller due to an acute angle and larger distance between
      the skin and the epidural space. The midthoracic region (T4-8) is the most difficult area
      when performing this procedure.

      To overcome this issue, a method of approaching the thoracic epidural space through the
      contralateral oblique view (CLO view) has been introduced, however, unlike the cervical or
      lumbar spine, advantages of the CLO view over the lateral view or the optimal angle of the
      CLO view have not yet been studied. Therefore, we planned this study to investigate the
      advantages of the CLO view compared with the lateral view and to determine the optimal angles
      of the CLO view when fluoroscopic guided mid-thoracic epidural assess.
    

Intervention name(s): Fluoroscopic-guided TEB
Intervention type(s): Procedure
Intervention description(s): When performing a fluoroscopic-guided thoracic epidural block (TEB), an 18-gauge Tuohy needle will be used for interlaminar epidural access. If the epidural space was accessed under fluoroscopic guidance and using the loss of resistance technique with air. All procedures will be performed with a paramedian approach under the true AP and lateral view at first, If the interlaminar space is not visible, the CLO view will be used. If the needle is deemed to be in the epidural space when the loss occurred, six fluoroscopic views will be obtained: true AP, CLO at 40 degrees, 50 degrees, 60 degrees, CLO measured, and lateral. The CLO measured angle will be determined by measuring the angle between the superior lamina and spinous process on the midsagittal plane on thoracic MRI or CT.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Fluoroscopy; Contralateral Oblique View; Thoracic epidural block; Mid thoracic epidural space
A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1283 and mRNA-1273 Vaccines in Healthy Adults Between 18 Years and 55 Years of Age to Prevent COVID-19
Condition: SARS-CoV-2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary goal for this study is to evaluate the safety and reactogenicity of 3 dose levels
      of mRNA-1283 and 1 dose level of mRNA-1273 vaccine given to healthy adults in 2 doses, 28
      days apart, and 1 dose level of mRNA-1283 administered as a single dose to healthy adults.
    


Intervention name(s): mRNA-1283; mRNA-1273; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Sterile liquid for injection; Sterile liquid for injection; 0.9% sodium chloride (normal saline) injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: mRNA-1283 vaccine; mRNA-1273; mRNA-1273 vaccine; SARS-CoV-2; SARS-CoV-2 Vaccine; Coronavirus; Virus Diseases; Messenger RNA; COVID-19; COVID-19 Vaccine; Moderna
The Efficacy of Zoledronic Acid in Modic Changes-related Low Back Pain (LBP)
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Modic changes are associated with low back pain (LBP) both in clinical and general
      population-based samples. Type I changes are regarded as more likely to be painful than type
      II changes. Several studies suggest that type I changes are inflammatory in nature.
    

Detailed description: 
      So far, no treatment exists for LBP due to Modic changes. Bisphosphonates could be effective
      in this specific low back disorder through two mechanisms: 1) they could consolidate
      vertebral bodies thereby improving the tolerance for mechanical load and 2) they could
      diminish inflammation as observed recently in case of ibandronate in an experimental model.
    

Intervention name(s): Zoledronic acid vs. placebo
Intervention type(s): Drug
Intervention description(s): Single infusion of zoledronic acid or placebo
Other intervention name(s): Aclasta; Zometa
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low back pain; Modic changes; Vertebral endplate signal changes; Efficacy; Zoledronic acid; Bisphosphonates; RCT
A Study of LY2541546 in Healthy Postmenopausal Women
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if a single dose of LY2541546 has any side effects
      on the body and to determine how long and how much LY2541546 stays in the bloodstream of the
      body.
    


Intervention name(s): LY2541546 - IV; LY2541546 - SC; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered IV; Administered SC; Administered IV or SC
Other intervention name(s): Blosozumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Postmenopausal females; Volunteers
A Multi-Center, Open-label Study Evaluate the Efficacy and Tolerability of a Dual Skincare Regimen Treatment for Facial Hyperpigmentation and Photodamaged Skin in Patients Exposed to Extrinsic Factors of Aging
Condition: Hyperpigmentation; Photodamaged Skin; Wrinkle; Fine Lines
MeSH terms: Hyperpigmentation
Study type: Interventional

Summary: 
      This open-label, multi-center clinical trial was conducted to evaluate the dual skincare
      regimen of vitamin C serum and moisturizing sunscreen SPF 45 to improve facial
      hyperpigmentation and photodamage after 12 weeks of twice daily use in healthy female
      subjects between 35 - 60 years old. A total of 33 subjects completed study participation.
    

Detailed description: 
      This open-label, multi-center clinical trial was conducted to evaluate the dual skincare
      regimen of vitamin C serum and moisturizing sunscreen SPF 45 to improve facial
      hyperpigmentation and photodamage when used twice daily over the course of 12 weeks by
      healthy women with Fitzpatrick skin type I - V, moderate to severe global face
      hyperpigmentation and moderate global face photodamage.

      Efficacy and tolerability will be assessed through clinical grading at baseline, weeks 4, 8
      and 12. Efficacy evaluation for hyperpigmentation (mottled), hyperpigmentation (discrete),
      overall photodamage, clarity/brightness, overall appearance, skin tone evenness (redness),
      fine lines and wrinkles. Investigator and subject tolerability, self-assessment questionnaire
      and clinical VISIA photography will be completed at baseline, weeks 4, 8 and 12. Subject
      testimonials will be completed at week 12.

      A total of 33 subjects completed study participation.
    

Intervention name(s): Gentle Cleansing Lotion, Revision Skincare
Intervention type(s): Other
Intervention description(s): Gentle cleansing lotion to be used by study participants twice daily
Intervention model: Single Group Assignment
Intervention model description: Prospective, Multi-Center, Open-Label 33 female subjects between 35 to 60 years old with Fitzpatrick skin type I-V, moderate to severe global face hyperpigmentation, and moderate global face photodamage.
Washout period of 2 weeks refraining from active antiaging topical products, including vitamin C, retinoids, peptides, and growth factors.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Vitamin C; Sunscreen; Pollution; Solar Radiation
Aminophylline on Recovery in Functional Endoscopic Sinus Surgery Under Dexmedetomidine Hypotensive Anesthesia
Condition: Aminophylline; Dexmedetomidine; Functional Endoscopic Sinus Surgery
Study type: Interventional

Summary: 
      This study will be conducted to evaluate the effect of intravenous aminophylline on
      hemodynamics and recovery of patients receiving dexmedetomidine infusion during functional
      endoscopic sinus surgery.
    

Detailed description: 
      Aminophylline is a nonselective adenosine receptor antagonist used for the treatment of
      asthma and chronic obstructive pulmonary disease. It has been used to antagonize the effects
      of anaesthetic and analgesic agents
    

Intervention name(s): Aminophylline group; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive 4 mg/kg aminophylline diluted in 50 ml normal saline over 30 minutes.; Patients will receive 50 ml normal saline over 30 minutes.
Intervention MeSH terms: Aminophylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aminophylline; Dexmedetomidine; Hemodynamics; Recovery; Functional Endoscopic Sinus Surgery
Multidirectional Yoga for Cognition
Condition: Standard Yoga; Multi-directional Yoga; Educational Control
Study type: Interventional

Summary: 
      Older individuals, 60-90, will be provided regular or cognitively based yoga training. They
      will then be evaluated using standard cognitive testing devices.
    

Detailed description: 
      Reductions in executive function are common with age. Along with these declines come
      reductions in simple functional patterns of daily living such as crossing a street, walking
      in a crowded area, or performing any functions that occurs in an open (changing) environment.
      This study will use a newly developed yoga program incorporating multi-directional movements,
      cognitive challenges and visuomotor disturbances to improve executive function and associated
      movements in persons over 60 years of age.
    

Intervention name(s): Standard Yoga; Multi-directional Yoga; Educational Control
Intervention type(s): Other; Other; Other
Intervention description(s): Yoga using standard poses and linear movements; The multidirectional yoga training program will use both simple and complex movement sequences (asana or postures) that include a cognitive component. For example, participants will be taught a movement sequence that includes 16-20 yoga postures that increase in difficulty as the training progresses.; Lectures on health and fitness
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparison of Yoga Interventions
Masking: Single (Investigator)
Primary purpose: Treatment
A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the
      cutaneous manifestations in subjects with systemic lupus erythematosus.
    


Intervention name(s): RSLV-132; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): RNase-Fc fusion protein; Saline placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Caudal Block and Sacral Erector Spinae Block for Postoperative Analgesia
Condition: Postoperative Pain; Children, Only
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Caudal block (CB) has been the method used for years to achieve adequate postoperative
      analgesia in pediatric patients, which is one of the main responsibilities of an anesthetist.
      CB, which has been proven to provide effective analgesia for many different indications, is
      the most commonly performed neuraxial block technique for postoperative pain control in
      urogenital surgeries. However, in the following years, truncal nerve blocks are recommended
      for postoperative analgesia by the literature both for more effective analgesia and for
      preventing complications of CB that may prevent early mobilization and prolong hospital
      discharge
    

Detailed description: 
      Circumcision, which is widely performed in male children for cultural and religious reasons
      in our country, is one of the daily urological surgical procedures with painful postoperative
      period. However, in the following years, truncal nerve blocks are recommended for
      postoperative analgesia by the literature both for more effective analgesia and for
      preventing complications of CB that may prevent early mobilization and prolong hospital
      discharge. Based on this knowledge, in order to provide postoperative analgesia in urogenital
      surgeries in male children sacral ESP (SESP) block can be used as an alternative to CB due to
      its undesirable effects
    

Intervention name(s): Regional anesthesia intervention
Intervention type(s): Procedure
Intervention description(s): Ultrasound-guided caudal and sacral erector spinae blocks were administered
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ultrasound; Pain; Sacral erector spinae block; Caudal block