bioihbjkbjnl/mcl2 huggingface dataset:
Periarticular Injection Versus Fascia Iliaca Block for Total Knee Arthroplasty
Condition: Total Knee Arthroplasty
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, the aim is to compare the efficacy of Periarticular multimodal drug
      injection(group PI) and Fascia Iliaca Compartment Block ( group FI)for total knee
      arthroplasty.
    

Detailed description: 
      Total knee arthroplasty is very painful surgical intervention.Patients were assigned to 2
      groups to receive either periarticular multimodal drug injection or fascia iliaca compartment
      block for postoperative pain.
    

Intervention name(s): periarticular injection; fascia iliaca block
Intervention type(s): Procedure; Procedure
Intervention description(s): patients were performed bupivacaine solution to the periarticular soft tissues during surgery by the surgeon.; patients were performed fascia iliaca block with bupivacaine solution before surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: periarticular drug injection; fascia iliaca block; knee arthroplasty
Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution
Condition: Healthy
Study type: Interventional

Summary: 
      This study involves comparison of the performance of two SpHb sensors in subjects that
      undergo a hemodilution procedure. The sensors' performance will be assessed by comparison of
      the measured hemoglobin values against reference values obtained by a laboratory hematology
      analyzer. Blood samples will be collected from healthy volunteers who undergo a hemodilution
      procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced
      by administering intravenous fluids to the volunteer in a controlled manner.
    


Intervention name(s): INVSENSOR00001; Control SpHb sensor; Hemodilution
Intervention type(s): Device; Device; Procedure
Intervention description(s): This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.; This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.; This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers while undergoing a hemodilution procedure.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Phase 1/1b Study of MEDI3726 in Adults Subjects With Metastatic Castration Resistant Prostate Cancer
Condition: Metastatic Castration Resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability, describe the
      dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum
      administered dose (MAD [in the absence of establishing the MTD]) for single agent MEDI3726 in
      subjects with mCRPC who have received prior treatment with abiraterone or enzalutamide, with
      or without a prior taxane-based chemotherapy in the mCRPC setting.
    


Intervention name(s): MEDI3726 Post-Chemo; MEDI3726 Pre-Chemo; MEDI3726 & Enzalutamide Combo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single agent MEDI3726 after abiraterone or enzalutatmide, with a prior taxane-based chemotherapy in the mCRPC setting; Single agent MEDI3726 after abiraterone or enzalutatmide, without a prior taxane-based chemotherapy in the mCRPC setting; MEDI3726 in combination with Enzalutatmide after prior treatment with abiraterone, with or without a prior taxane-based chemotherapy in the mCRPC setting
Intervention MeSH terms: MEDI3726
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metastatic, prostate cancer
Clinical Trial Testing Buzzy Bee vs Vapocoolant During IV Placement
Condition: Intravenous Administration
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the anxiety and pain levels of patients when using
      Buzzy with ice, Vapocoolant, and placebo when inserting IV's line for IV fluids and/or
      phlebotomy in pediatric patients in the pediatric emergency department.
    


Intervention name(s): Buzzy Bee; Vapocoolent; Placebo
Intervention type(s): Device; Drug; Other
Intervention description(s): The Buzzy is a vibrating palm-sized device with removable ice wings developed by MMJ Labs Atlanta, GA. It uses Melzack and Wall's Gait Control theorywhich asserts that activation of non-nociceptive fibers can interfere with signals from pain fibers thereby inhibiting pain.; Vapocoolent is a volatile refrigerated liquid, ie ethyl chloride, which is supposed to feel like the skin is numb before insertion of the IV.; A band will be placed on the arm before IV insertion for placebo effect.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: analgesic; anxiolytic; Buzzy Bee; Shot-blocker
Cerebellar rTMS for the Treatment of Schizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The primary aim of this protocol is to determine whether the use of repetitive transcranial
      magnetic stimulation (rTMS) over vermis of the cerebellum may be safe and therapeutically
      effective in patients with schizophrenia. Because this is the first evaluation of this
      treatment in this population, the focus of this study is safety.
    


Intervention name(s): Transcranial magnetic stimulation via MagPro x100 device
Intervention type(s): Device
Intervention description(s): Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.
Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Efficacy and Pharmacokinetics of BTA-C585 in a RSV Viral Challenge Study
Condition: Respiratory Syncytial Virus (RSV) Infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to evaluate the antiviral activity of oral BTA-C585
      compared to placebo in healthy volunteers after intranasal challenge with RSV-A Memphis 37b
      virus.
    


Intervention name(s): BTA-C585 oral capsule; Matching placebo capsules
Intervention type(s): Drug; Drug
Other intervention name(s): BTA585
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Viral diseases; Antiviral; Paramyxoviridae infections; RSV; Aviragen Therapeutics, Inc.; Aviragen Therapeutics; Aviragen
Kinesiotaping the Hand in Cerebral Palsy
Condition: Spasticity
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional

Summary: 
      BACKROUNDS: Thumb in palm deformity restricts hand function by prevent somatosensory input in
      the children with cerebral palsy who have spasticity in their hands.

      OBJECTİVES: To investigate the effects of thenar palmar kinesiotape application with and
      without pressure on hand function in children with cerebral palsy. METHOD: 45 children were
      randomly allocated to one of the thenar taping groups either with or without pressure or to
      the control group. Nine hole peg test and nine parts puzzle test were used to measure hand
      function. The two study groups were evaluated initially, with taping 20 minutes later and 20
      minutes after taping was removed.
    

Detailed description: 
      BACKROUNDS: Thumb in palm deformity restricts hand function by prevent somatosensory input in
      the children with cerebral palsy who have spasticity in their hands.

      OBJECTİVES: To investigate the effects of thenar palmar kinesiotape application with and
      without pressure on upper extremity function in children with cerebral palsy. METHOD: 45
      children were randomly allocated to one of the thenar taping groups either with or without
      pressure or to the control group. Nine hole peg test and nine parts puzzle test were used to
      measure upper extremity function. The two study groups were evaluated initially, with taping
      20 minutes later and 20 minutes after taping was removed.
    

Intervention name(s): Kinesiotape plus thenar pressure (PPTG); Taping Group (TG)
Intervention type(s): Device; Device
Intervention description(s): In the kinesiotape plus thenar pressure (PPTG). Kinesiotape was applied to control the cortical thumb sign. In addition a piece of plastazote aiming to give thenar pressure was also applied.
The amount of pressure was regulated so that the child felt the pressure without being irritated and without restriction in grasping functions.; In the taping group (TG) kinesiotape was applied to control the cortical thumb sign.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spasticity, Hand Function, Cerebral Palsy, Kinesiotape
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.
Condition: 13-valent Pneumococcal Vaccine; Premature Birth; Immunization; Safety
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to describe the safety, tolerability, and immunogenicity of a
      2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to
      preterm infants with concomitant vaccines, compared to infants born at term.There will be a
      follow-up phase to assess the persistence of the antibody response at 24 and 36 months of
      age.
    


Intervention name(s): 13-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.; 13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: 13-valent pneumococcal conjugate vaccine; premature; immunization; safety.
Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will evaluate the effectiveness and safety of the investigational drug SB683699 in
      treating patients with relapsing multiple sclerosis (MS), using data from magnetic resonance
      imaging (MRI) scans as the main measure.
    


Intervention name(s): SB683699
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: multiple sclerosis; relapsing; remitting; Relapsing-Remitting MS (RRMS)
Evaluation of the 755nm Alexandrite Laser for the Treatment of Tattoos
Condition: Tattoos
Study type: Interventional

Summary: 
      The purpose of this study is to collect further data on the safety and efficacy of removing
      unwanted non cosmetic tattoos (including recalcitrant) using the 755nm Alexandrite laser.
    


Intervention name(s): 755nm Alexandrite Laser; 755nm Alexandrite Laser with CAP Array
Intervention type(s): Device; Device
Intervention description(s): 755nm Alexandrite Laser; 755nm Alexandrite Laser with CAP Array
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Endoscopic Ultrasound-guided RadioFrequency Ablation for the Treatment Pancreatic NeuroEndocrine Neoplasms
Condition: Neuroendocrine Tumors; Neuroendocrine Carcinoma; Pancreas Neoplasm; Neuroendocrine Tumor Gastrointestinal, Hormone-Secreting
MeSH terms: Neoplasms; Neuroendocrine Tumors; Carcinoma, Neuroendocrine; Pancreatic Neoplasms
Study type: Interventional

Summary: 
      This study evaluates the possibility and the safety of performing local therapy for
      Pancreatic neuroendocrine neoplasms (PanNENs) using radiofrequency ablation of the tumor
      under ultrasonography (EUS) guidance.
    

Detailed description: 
      Pancreatic neuroendocrine neoplasms (PanNENs) are rare, but their incidence has significantly
      increased in the last decades. The mainstay treatment of PanNENs is surgery, which is
      associated with a significant benefit in term of survival but also with significant short-
      and long-term adverse events.

      Based on the above data, less invasive alternative therapeutic interventions to avoid short-
      and long-term adverse events of surgery are needed.

      In this context radiofrequency ablation has been reported to be effective in the treatment of
      these tumors in absence of major adverse events. However, the available studies on the matter
      are limited by small sample size and lack of standardized criteria for patient selection.
    

Intervention name(s): EUS guided radiofrequency ablation
Intervention type(s): Device
Intervention description(s): The EUS-RFA system (Taewoong, Seoul, Korea) utilized for EUS-RFA consists of an 19-gauge needle electrode (140-cm long), a radiofrequency generator, and an inner cooling system that circulates chilled saline solution during the RFA procedure. The inner metal part is insulated over its entire length, with the exception of the terminal 5 to 20mm for energy delivery. The needle electrode is attached to a radio frequency current generator (VIVA RF generator; Taewoong) and to a cooling pump. The generator, in addition to providing radio frequency current, allows the control of physical power and impedance parameters.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of HPN-07 and HPN-07 Plus NAC
Condition: Hearing Loss; Sensorineural Hearing Loss; Noise-Induced Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Loss, Noise-Induced
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, randomized, placebo-controlled, double-blind, single ascending
      dose escalation study to determine the safety, tolerability, and PK profile of oral
      administration of HPN-07 in single doses to approximately 32 healthy male and female subjects
      between 18 and 55 years of age.

      Subjects will receive single oral doses of the study drug. The primary endpoint of this trial
      is to establish the safety and tolerability of HPN-07 and HPN-07 plus N-acetylcysteine (NAC).
    

Detailed description: 
      This study is a single-center, randomized, placebo-controlled, double-blind, single ascending
      dose escalation study to determine the safety, tolerability, and PK profile of oral
      administration of HPN-07 in single doses to healthy male and female subjects between 18 and
      55 years of age.

      Approximately 32 subjects will be enrolled in a panel of 4 cohorts with approximately 8
      subjects per cohort. There will be approximately 3 sequential ascending dosing levels of
      HPN-07, with each cohort administered 1 dose of HPN-07 ranging from 500 mg to 1,500 mg and
      the fourth cohort administered the highest tolerated dose of HPN-07 plus 1,200 mg NAC.

      The primary endpoint of this trial is to establish the safety and tolerability of HPN-07 and
      HPN-07 plus N-acetylcysteine (NAC). Pharmacokinetics (PK) analysis of HPN-07 will enable a
      preliminary determination of the relationship between dose and the time course of the drug
      concentration in the body. Blood samples will be collected at regular intervals over the
      predicted time of HPN-07 systemic exposure.
    

Intervention name(s): HPN-07; NAC; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 500-1,500 mg oral capsules administered in a single dose; 1,200mg NAC administered via oral capsule in single dose; placebo oral capsule
Other intervention name(s): disufenton sodium; Disodium 4-[(tert-butylimino)methyl]benzene-1,3-disulfonate N-oxide; N-acetylcysteine; acetylcysteine; N-acetyl-L-cysteine
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine; Disufenton sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hearing Loss; Sensorineural Hearing Loss; Noise-Induced Hearing Loss; Antioxidant; NAC; N-acetylcysteine; HPN-07
Relative Bioavailability Trial of Oral Dispersible Praziquantel Tablets in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, open-label, randomized, 4 period, crossover, single-center trial. The
      purpose of this trial is to assess the relative bio-availability of racemate Oral Dispersible
      Tablet praziquantel (ODT-PQZ) (MSC1028703A) 150 milligram (mg) versus the current marketed
      praziquantel (PZQ) (Cysticide® 500 mg) formulation in healthy male volunteers.
    


Intervention name(s): Oral dispersible tablet of praziquantel (ODT-PZQ); Cysticide; ODT-PZQ; ODT-PZQ; ODT-PZQ; Cysticide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.; Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.; Treatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal.; Treatment C2 (test): ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal.; Treatment D1 (test): ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal.; Treatment D2 (reference): Cysticide crushed tablets at a single dose of 40 mg/kg will be given with water orally after a meal.
Other intervention name(s): MSC1028703A; PZQ; MSC1028703A; MSC1028703A; MSC1028703A; PZQ
Intervention MeSH terms: Praziquantel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ODT-PZQ; Bio-availability; Praziquantel; Cysticide; Pharmacokinetics
Open-Label Extension Study of Patients Previously Enrolled in Study CIN-107-124
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, multicenter, open-label extension (OLE) study to evaluate the long-term
      safety, tolerability, and effectiveness of CIN-107 for up to 52 weeks in patients with HTN
      who have completed Part 1 or Part 2 of Study CIN-107-124. The study will be conducted at
      clinical sites that have participated in the double-blind, Phase 2 Study CIN-107-124.
    


Intervention name(s): CIN-107
Intervention type(s): Drug
Intervention description(s): 2 mg of CIN-107, once a day for 52 weeks
Intervention model: Single Group Assignment
Intervention model description: Eligible patients from Study CIN-107-124 who elect to participate in this study will continue treatment with 2 mg CIN-107 tablets QD after enrollment, starting at Visit 1 and concluding at EOT (Visit 7)
Masking: None (Open Label)
Primary purpose: Treatment
Effect of External Heat on a Transdermal Granisetron Patch in Pharmacokinetics (PK) of Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of heat applied to a granisetron
      transdermal patch in healthy subjects.
    


Intervention name(s): granisetron IV; granisetron patch
Intervention type(s): Drug; Drug
Intervention description(s): IV; patch
Intervention MeSH terms: Granisetron
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sancuso; granisetron; Pharmacokinetics
Jaktinib Versus Hydroxycarbamide in Subjects With Intermediate-2 or High-risk Myelofibrosis
Condition: Myelofibrosis
MeSH terms: Primary Myelofibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to determine the efficacy of Jaktinib versus Hydroxycarbamid in participants
      with Intermediate-2 or High-risk myelofibrosis
    


Intervention name(s): Jaktinib; Placebo to match Hydroxycarbamide; Hydroxycarbamide Tablets; Placebo to match Jaktinib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Jaktinib Hydrochloride Tablets administered orally twice daily; Placebo to match Hydroxycarbamide Tablets administered orally twice daily; Hydroxycarbamide Tablets administered orally twice daily; Placebo to match Jaktinib Tablets administered orally twice daily
Intervention MeSH terms: Hydroxyurea
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment