bioihbjkbjnl/mcl2 huggingface dataset:
Maternal Voice on Anesthetic Emergence Period
Condition: Anesthesia, General
Study type: Interventional

Summary: 
      Mother spend a large amount of time with their children. It is assumed that mother
      contributes to their neurological development not only with visual stimuli, but also with
      auditory stimuli. A recent study revealed that prefrontal cortex can be activated in response
      to the self-name being spoken by the mother than by a stranger. Therefore, investigators
      suppose that recorded maternal voice can stimulate the pediatric patients and thereby fasten
      the emergence from general anesthesia.
    


Intervention name(s): recorded maternal voice; recorded stranger's voice
Intervention type(s): Procedure; Procedure
Intervention description(s): A voice recording will be performed before the operation. At a preoperative visit or preoperative clinic, informed consent was obtained before the recording. On a calm environment, the mother was asked to speak following sentences.
" OO (first name of child), wake up~. Let's go home with mommy. OO, wake up~. Open your eyes. Take a deep breath. "
At the end of surgery, the recorded maternal voice was delivered to the child every 15 seconds until he/she wakes up.; A voice recording will be performed before the operation. On a calm environment, a blinded female investigator was asked to speak following sentences.
" OO (first name of child), wake up~. Let's go home with mommy. OO, wake up~. Open your eyes. Take a deep breath. "
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: emergence agitation; emergence time; pediatric
Wound Infections Following Implant Removal
Condition: Surgical Wound Infection
MeSH terms: Infections; Communicable Diseases; Wound Infection; Surgical Wound Infection; Wounds and Injuries; Surgical Wound
Study type: Interventional
Phase: Phase 4

Summary: 
      In the Netherlands about 18,000 surgical procedures with implant removal are annually
      performed after fracture healing, of which 30-80% concern the foot, ankle and lower leg
      region. For clean surgical procedures, the rate of postoperative wound infections (POWIs)
      should be less than 5%. However, rates of 10-12% following implant removal, specifically
      after foot, ankle and lower leg fractures are reported. Currently, surgeons decide
      individually if antibiotics prophylaxis is given, since no guideline exists. This leads to
      undesirable practice variation.

      Therefore, the investigators propose a double-blind randomized controlled trial (RCT) in
      patients scheduled for implant removal following a foot, ankle or lower leg fracture, to
      assess the (cost-)effectiveness of a single gift of antibiotic prophylaxis. Primary outcome
      is a POWI within 30 days after implant removal. Secondary outcomes are quality of life,
      functional outcome at 30 days and 6 months after implant removal and costs.

      With 2 x 250 patients a decrease in POWI from 10% to 3.3% (expected rate in
      clean-contaminated elective orthopedic trauma procedures) can be detected (Power=80%, 2-sided
      alpha=5%, including 15% lost to follow up).

      If the assumption of the investigators, that prophylactic antibiotics prior to implant
      removal reduces the infectious complication rate, is confirmed by this RCT, this will offer a
      strong argument to adopt a single gift of antibiotic prophylaxis as standard practice of
      care. This will reduce the incidence of POWIs and consequently will lead to less physical and
      social disabilities and health care use. In addition, it will decrease the rate of use of
      empiric broad-spectrum antibiotics (and antibiotic resistance) prescribed upon suspicion or
      diagnosis of a POWI. A preliminary, conservative estimation suggests yearly cost savings in
      the Netherlands of €3.5 million per year.
    

Detailed description: 
      See study protocol
    

Intervention name(s): Cephalozin; Sodium chloride
Intervention type(s): Drug; Other
Intervention description(s): 1000 mg Cephalozin; 10 cc of NaCl 0.9%
Other intervention name(s): Kefzol; NaCl 0.9%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Implant Removal; Antibiotic Prophylaxis; Postoperative wound infection; Orthopedics
Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma
Condition: Kidney Cancer; Melanoma (Skin); Metastatic Cancer; Ovarian Cancer; Sarcoma
MeSH terms: Melanoma; Sarcoma; Brain Neoplasms; Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients
      with newly diagnosed brain metastases from kidney cancer, melanoma, or sarcoma.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluate whether the delivery of stereotactic radiosurgery without conventional whole
           brain radiotherapy is feasible in patients with 1-3 newly diagnosed brain metastases
           from renal cell carcinoma, melanoma, or sarcoma.

        -  Determine the 3-, 6-, and 12-month radiographic and neurologic intracranial patterns of
           progression (i.e., original lesions vs new lesions) in patients treated with this
           regimen.

      OUTLINE: This is a multicenter study. Patients are stratified according to maximum tumor
      diameter (2 cm vs greater than 2 cm to 3 cm vs greater than 3 cm to 4 cm).

      Patients undergo stereotactic radiosurgery at an assigned dose according to tumor diameter.
      Patients undergo MRI or CT scan at 3, 6, and 12 months after treatment or until disease
      progression.

      All other therapies are allowed after stereotactic radiosurgery except external beam whole
      brain radiotherapy or resection of brain metastases, unless there is documented progression
      or unrelenting mass effect that necessitates craniotomy.

      Patients are followed every 3 months for 2 years.

      PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 7.2 months.
    

Intervention name(s): stereotactic radiosurgery
Intervention type(s): Radiation
Primary purpose: Treatment
Keywords: metastatic osteosarcoma; chondrosarcoma; stage IV renal cell cancer; stage IV melanoma; tumors metastatic to brain; stage IV uterine sarcoma; ovarian sarcoma; metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor; stage IV adult soft tissue sarcoma
Effect of Intracervical on the Pain Associated With the Insertion of the LNG-IUS
Condition: Pain
Study type: Interventional

Summary: 
      This study has the objective to evaluate the effect of Injectable intracervical anesthesia in
      comparison with a non-steroidal anti-inflammatory drug (NSAID) on the pain scores immediately
      after insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) in women
      without previous vaginal delivery.

      H0: There is no difference in terms of pain score between the treatments H1: There will be
      difference in terms of pain score between treatments
    

Detailed description: 
      Objective: To evaluate the effect of Injectable intracervical anesthesia in comparison with a
      non-steroidal anti-inflammatory drug (NSAID) on the pain scores immediately after insertion
      of the levonorgestrel-releasing intrauterine system (LNG-IUS) in women without previous
      vaginal delivery. As secondary objectives, the effects of the interventions on the pain
      scores assessed 2 and 6 hours after the LNG-IUS insertion, the level of discomfort associated
      with the insertion procedure and the ease of insertion of the LNG-IUS will be evaluated.

      Design: open randomized controlled trial Setting: Outpatient contraceptive services Patients:
      100 women who want to use the LNG-IUS Interventions: 100 women will be randomized into two
      groups: a) use of a NSAID (ibuprofen, 400 mg) 1 hour before the LNG-IUS insertion; and b) 2%
      lidocaine intracervical injection. These women will be evaluated immediately after the
      LNG-IUS insertion, and then 2 hours and 6 hours after it.

      Main outcome measures: Two pain scales will be used (the visual analogue scale and the facial
      pain scale) in addition to assessing the ease of insertion (as rated by the provider) and the
      level of discomfort from the procedure (as rated by the patient). Multivariate logistic
      regression will be performed to analyze the predictors associated with moderate/severe pain.
    

Intervention name(s): Intracervical anesthesia with lidocaine 2%; ibuprofen 400 mg
Intervention type(s): Drug; Drug
Intervention description(s): 5 min before LNG-IUS placemen; 1 hour prior to the LNG-IUS insertion
Intervention MeSH terms: Ibuprofen; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Levonorgestrel-releasing intrauterine system; anesthesia; pain; nulliparous
Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Out of the 13 identified serogroups of Neisseria meningitidis (Nm) the six serogroups (A, B,
      C, W, Y and X) are responsible for majority of infections. Presently available vaccines
      effectively protect against A, B, C, W and Y serogroups; but no vaccine that is protective
      against serogroup X is available yet.

      Serum Institute of India Private Limited (SIIPL) has developed a conjugate vaccine against
      serogroups A, C, Y, W and X (NmCV-5).

      The first-in-human Phase 1 study was among 60 healthy adults in USA did not show no any
      safety issues.

      This phase 2 study is designed to evaluate safety and immunogenicity of the non-adjuvanted
      and adjuvanted formulations of NmCV-5 in healthy children 12-16 months of age, in comparison
      with the licensed quadrivalent meningococcal conjugate vaccine (Menactra®).

      Both vaccines will be administered in two dose schedule 3 months apart. among vaccine-naïve
      healthy subjects in Mali. Safety will be assessed by collecting solicited reactions till day
      7 post each dose whereas adverse events will be collected throughout the study. Each subject
      will be followed up for 84 days post each vaccine dose.

      The vaccine immunogenicity will measured using a rabbit complement serum bactericidal
      activity assay (rSBA).
    


Intervention name(s): Non-adjuvanted study formulation NmCV-5; Adjuvanted study formulation NmCV-5; Menactra
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.; Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine; Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
Other intervention name(s): MenACYWX; Adj MenACYWX; MenACYW-D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Neisseria meningitidis; conjugate meningococcal vaccine; meningococcal serogroup X
A Mobile App for Medication Adherence in Persons With Hypertension: a Pilot Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      A development and pilot test of an app targeting persons with hypertension. Content in the
      app was based on persons with hypertensions experiences and a literature review. The
      participants experience of using the app as well as testing a instrument for medication
      adherence.
    


Intervention name(s): Adaptive digital intervention
Intervention type(s): Other
Intervention description(s): Participants received reminder for medication intake on daily basis. Also, short message regarding hypertension, medication and lifestyle changes
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with hypertension, more than one year, were enrolled. From primary care.
      
Keywords: artificial intelligence; focus group; adherence, medication; pilot study
A Study Exploring Efficacy of SIBP04 in Subjects With Non-squamous Non-small Cell Lung Cancer
Condition: Non-squamous Non-small-cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is a randomized, double-blind, parallel-controlled, multicenter phase III clinical
      study. To evaluate the clinical efficacy of SIBP04 in patients with locally advanced,
      metastatic or recurrent non-squamous non-small cell lung cancer.
    

Detailed description: 
      This trial is a randomized, double-blind, parallel-controlled, multicenter phase III clinical
      study. The study was divided into three stages: screening stage, treatment stage (combined
      chemotherapy stage, single drug maintenance treatment stage, visit after treatment) and
      follow-up stage (survival follow-up after disease progression). To evaluate the safety,
      tolerability, pharmacokinetics and clinical efficacy of SIBP04 in patients with locally
      advanced, metastatic or recurrent non-squamous non-small cell lung cancer.
    

Intervention name(s): SIBP04; Avastin; Paclitaxel; Carboplatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): SIBP04, 15mg/kg, intravenous infusion, the first intravenous infusion 90min (+10min), 3 weeks/cycle, administered on the first day of each treatment cycle.; Avastin, 15mg/kg, intravenous infusion, the first intravenous infusion 90min (+10min), 3 weeks/cycle, administered on the first day of each treatment cycle.; Paclitaxel, 175mg/m2, intravenous infusion, every 3 weeks/cycle, administered on the first day of each treatment cycle.; Carboplatin, AUC=5.0, (upper limit 800mg), intravenous infusion, 3 weeks/cycle, administered on the first day of each treatment cycle.
Intervention MeSH terms: Paclitaxel; Carboplatin; Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, double-blind, parallel-controlled, multicenter Phase III clinical study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-squamous Non-small-cell Lung Cancer; Efficacy; Safety; Tolerability; Pharmacokinetics
Prospective Comparison of Indirect Pulp Therapy and Mineral Trioxide Aggregate Pulpotomy in Decayed Primary Molars
Condition: Dental Pulp Capping
Study type: Interventional

Summary: 
      This prospective study compares the use of indirect pulp therapy and mineral trioxide
      aggregate pulpotomy for pulp therapy of the primary molar with dental caries approaching the
      pulp.
    


Intervention name(s): Indirect pulp therapy; Pulpotomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Decayed dentin is lined with a resin-modified glass ionomer (Vitrebond Plus); A cervical pulpotomy is done and the radicular pulp is lined with Mineral Trioxide Aggregate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Tegoprazan Versus Esomeprazole-containing Bismuth Quadruple Therapy for Eradication of Helicobacter Pylori
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a multicenter, randomized, double-blind, double-dummy, phase III study to
      evaluate the efficacy and safety of tegoprazan versus esomeprazole-containing bismuth
      quadruple therapy in patients infected with Helicobacter pylori in China.

      Screening phase: After signing the informed consent form, subjects will be determined for
      Helicobacter pylori infection by 13^C-urea breath test (UBT),histological testing and
      bacterial culture during the screening period. Subjects who meet all screening criteria will
      be randomized in a 1:1 ratio to receive the tegoprazan-containing bismuth quadruple therapy
      (hereinafter referred to as the tegoprazan group) or esomeprazole-containing bismuth
      quadruple therapy (hereinafter referred to as the esomeprazole group).

      Treatment phase: Subjects will receive relevant study medication starting on Day 1 of the
      treatment period for 14 days.

      Follow-up phase: Within 29+7 days after the last study drug treatment, subjects will return
      to the study site for efficacy and safety assessments. 13^C-UBT detection will be performed
      in this follow-up visit to determine the Hp infection status of the subjects after treatment.
    


Intervention name(s): Tegoprazan
Intervention type(s): Drug
Intervention description(s): tegoprazan-containing bismuth quadruple therapy or Esomeprazole-containing bismuth quadruple therapy; Route of administration: oral;
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
BPD Saturation TARgeting
Condition: Bronchopulmonary Dysplasia; Chronic Lung Disease of Prematurity; Chronic Lung Disease
MeSH terms: Lung Diseases; Bronchopulmonary Dysplasia; Premature Birth
Study type: Interventional

Summary: 
      Bronchopulmonary dysplasia (BPD), or chronic lung disease of prematurity, affects nearly half
      of extremely preterm infants.This study evaluates the use of supplemental oxygen to manage
      infants with established BPD. Participants will be randomly placed in either a higher oxygen
      saturation group or a lower oxygen saturation target group.
    

Detailed description: 
      Bronchopulmonary Dysplasia is diagnosed only in babies who are born prematurely, and affects
      about half of extremely preterm infants. The incidence of BPD has increased over time. It is
      most commonly defined as oxygen dependence at 36 weeks postmenstrual age (PMA).

      Infants with BPD face more than doubled odds of death after 36 weeks PMA or disability at 5
      years compared to preterm infants without BPD. BPD is associated with abnormal lung function
      throughout childhood and significantly increases health care costs. Cognitive and respiratory
      outcomes are closely linked throughout the life course; thus, optimal long--term management
      of BPD during infancy may ultimately improve cognitive outcomes of this high--risk
      population.

      Supplemental oxygen is a lifesaving therapy for premature infants; yet, there is limited
      evidence about the safety or efficacy of using supplemental oxygen to target higher versus
      lower oxygen saturations in infants with established BPD.

      Infants between the ages of 34-44 weeks post-menstrual age with moderate or severe BPD will
      be randomly assigned to higher or lower oxygen saturation target ranges. The study
      intervention will begin in the hospital and will continue at home until 6 months corrected
      age. When infants are discharged with supplemental oxygen, this will be titrated according to
      a study algorithm in order to ensure that the target saturations are maintained throughout
      the study period.
    

Intervention name(s): LOWER oxygen saturation target group; HIGHER oxygen saturation target group
Intervention type(s): Other; Other
Intervention description(s): We will randomize infants with moderate or severe BPD to lower SpO2 target ranges. The study team will then use novel technology to monitor infants starting at randomization, continuing after discharge and until 6 months corrected age, titrating supplemental oxygen to achieve these target SpO2 ranges.; We will randomize infants with moderate or severe BPD to higher SpO2 target ranges. The study team will then use novel technology to monitor infants starting at randomization, continuing after discharge and until 6 months corrected age, titrating supplemental oxygen to achieve these target SpO2 ranges.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BPD; Prematurity; Supplemental Oxygen; Oximetry; Infants
Laser Treatment of Tattoos With Pico Laser
Condition: Unwanted Tattoos
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Pico laser is effective and safe in the
      treatment of unwanted tattoos.
    

Detailed description: 
      The Investigational device is a dual wavelength laser system developed for treatment of
      pigmented lesions and for tattoo removal. The base unit is a GentleMax Pro laser system
      modified to emit light at wavelengths of 532 and 1064 nm and deliver pulse energy up to
      400mJ, and pulse duration of 700 ps.

      A multicenter study.
    

Intervention name(s): Picosecond Laser system
Intervention type(s): Device
Intervention description(s): Picosecond Laser System for the Treatment of Unwanted Tattoos
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tattoos, Picosecond Laser, Syneron