bioihbjkbjnl/mcl2 huggingface dataset:
Oxygen Saturation and Perfusion Index ın Neonates at High Altitude
Condition: Critical Congenital Heart Disease; High Altitude
MeSH terms: Altitude Sickness; Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      Congenital heart diseases are among the most common congenital anomalies and occur with an
      incidence of approximately 8ınd12 / 1,000 live births worldwide. This figure does not cover
      minor lesions such as bicuspid aortic valves and small atrial or ventricular septal defects.
      Most of these defects do not need treatment or treatment is needed after infancy. Other
      defects are severe and usually require early treatment in the neonatal period. Critical
      congenital heart disease is defined as structural heart defects that are associated with
      hypoxia in the neonatal period and have significant morbidity and mortality potential in
      early life. Critical congenital heart disease is estimated to be ~3 in 1000 live births. It
      is estimated that 50% of congenital heart diseases are detected by prenatal ultrasound. Even
      if a standard neonatal examination is performed, 13 to 55% of patients with critical
      congenital heart disease can be discharged from the hospital without being diagnosed.

      Screening of infants with non-invasive oxygen saturation measurement has been proposed as an
      adjunct to early detection of critical congenital heart disease.

      The American Academy of Pediatrics, the American Cardiology Foundation and the American Heart
      Association have targeted 7 specific lesions for the pulse oximetry screening protocol:
      truncus arteriosus, transposition of the great arteries, tricuspid atresia, tetralogy of
      Fallot, total pulmonary venous return anomaly, hypoplastic left heart syndrome and pulmonary
      atresia.

      The reference values of peripheral perfusion (PPI) index has been established for normal
      newborns between 1 and 120 h of age.

      Lower PPI values than 0.70 may indicate illness. Including cut-off values for PPI in
      pulse-oximetry screening for duct dependent congenital heart disease is a promising tool for
      improving the detection of critical congenital heart disease with duct-dependent systemic
      circulation.

      We aimed to investigate screening critical congenital heart disease and also to establish
      normal values of oxygen saturation and perfusion index at high altitude.
    


Intervention name(s): oxygen saturation and perfusion index screening
Intervention type(s): Other
Intervention description(s): Oxygen saturation and perfusion index values that are measured by pulse oximeter is used for screening critical congenital heart disease.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Newborns with ≥34 weeks of gestational age
Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults
Condition: Influenza; Healthy
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective annual release study is designed to evaluate the safety on new influenza
      virus vaccine strains to be included in FluMist Quadrivalent for the 2013-2014 influenza
      season.
    

Detailed description: 
      This prospective, randomized, double-blind, placebo-controlled release study will enroll
      approximately 300 healthy adults 18 to 49 years of age. Eligible subjects will be randomly
      assigned in a 4:1 fashion to receive a single dose of trivalent vaccine or placebo by
      intranasal spray. Randomization will be stratified by site. This study will be conducted at 3
      sites in the United States of America. Each subject will receive 1 dose of investigational
      product on Day 1. The duration of study participation for each subject is the time from study
      vaccination through 180 days after study vaccination.
    

Intervention name(s): Trivalent Influenza Vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): A single dose of 10^(7.0 ± 0.5) FFU of trivalent influenza vaccine will be administered as intranasal spray on Day 1.; A single dose of placebo matched to trivalent influenza vaccine will be administered as intranasal spray on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Trivalent; Influenza; FluMist Quadrivalent; Vaccine; Prevention; Healthy
Evaluation of Software Generated Customized Foot Orthoses
Condition: Arthropathy of Ankle or Foot
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether custom-made foot orthoses generate a
      significant decrease in the perception of pain among individuals with foot pain and/or ankle
      pain.
    

Detailed description: 
      The investigators aim to enroll up to 60 participants over the course of 1-3 months. Each
      participant will be evaluated at baseline, when the customized foot orthoses will be made,
      and the corresponding tests will be conducted. Subsequently, consecutive surveys will be
      carried out at 0, 7, 30, 120, and 360 days from the first day of foot orthoses use to measure
      the change in pain and comfort with use of the foot orthoses. An interim analysis will be
      conducted after all subjects have completed the 30-day time point. This interim analysis will
      allow the sponsor to determine whether subjects are using the foot orthoses that the subjects
      have been provided. Complete primary analysis is estimated to be completed within 3 months
      after the termination of the study.
    

Intervention name(s): custom foot orthotic
Intervention type(s): Device
Intervention description(s): The goal of this study is to find out whether the use of software generated custom-made orthopedic foot orthoses improves pain in the long term.
Intervention model: Single Group Assignment
Intervention model description: Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted
Masking: None (Open Label)
Primary purpose: Supportive Care
Changes in Inflammatory Biomarkers When Symptomatic Contact Lens Wearers Are Refit in Acuvue Oasys 1-Day Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a 5-Visit, single-arm, single-site, subject masked, dispensing trial to evaluate
      contact lens discomfort and inflammatory biomarker expression.
    

Detailed description: 
      The study will assess device feasibility for up to 10 habitual wearers of 4 different types
      of marketed contact lens.
    

Intervention name(s): Acuvue® Oasys 1-Day
Intervention type(s): Device
Intervention description(s): TEST Lens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
High Dose Ascorbic Acid Treatment of CMT1A
Condition: Charcot-Marie-Tooth Disease, Type Ia
MeSH terms: Tooth Diseases; Charcot-Marie-Tooth Disease; Nerve Compression Syndromes; Hereditary Sensory and Motor Neuropathy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will look at the impact of ascorbic acid (Vitamin C) on the progression of disease
      in people with CMT1A as compared to volunteers receiving a placebo. This study will assess
      whether is it futile to proceed with a larger, longer-term, placebo-controlled study.
    

Detailed description: 
      Charcot Marie Tooth disease (CMT), or inherited peripheral neuropathies, are among the most
      frequent heritable disorders, affecting approximately 1 in 2500 people. The most frequent
      genetic form of CMT is CMT1A. CMT1A is caused by a 1.4 Mb duplication within chromosome
      17p11.2 in the region containing the PMP22 gene. Most subjects with CMT1A have a "typical"
      phenotype characterized by onset in childhood or early adulthood, distal weakness, sensory
      loss, foot deformities and absent reflexes. How increased expression of PMP22 causes these
      disabilities is unknown but is currently being investigated in both animal and tissue culture
      systems. In this study, researchers will evaluate whether ascorbic acid (Vitamin C),
      administered orally, slows clinical progression of CMT1A and affects the PMP22 mRNA levels of
      myelinated peripheral nerve fibers obtained from biopsies of glabrous skin.
    

Intervention name(s): Ascorbic acid (Vitamin C); placebo
Intervention type(s): Drug; Drug
Intervention description(s): Eight 500 mg capsules/day of ascorbic acid. Subjects will take four (4)capsules each morning and four (4) capsules each evening for 24 months. (Total 4 gr/day).; Eight 500 mg capsules/day of placebo. Subjects will take four (4)capsules each morning and four (4) capsules each evening for 24 months.
Intervention MeSH terms: Ascorbic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Ascorbic Acid; Vitamin C; Charcot Marie Tooth; CMT; CMT1a
Effects of S. Boulardii and Amoxicillin/Clavulanate on Gut Microbiota
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this study is to compare and contrast the effects of the probiotic
      Saccharomyces boulardii, the antibiotic amoxicillin/clavulanate and the combination on the
      gut microbiota of healthy volunteers.
    


Intervention name(s): Saccharomyces boulardii; Amoxicillin Clavulanate
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): 500 mg, 2 times daily for 14 days; 875/125 mg 2 times daily at least 1 hour before meals for 7 days
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: human Gut Microbiota; gut microbiota; gut microbiome; probiotic; antibiotic; antibiotic-associated diarrhea; intestinal bacterial overgrowth
Superior Trunk Block Catheter Versus Single-shot Superior Trunk Block With Intravenous Dexmedetomidine for Shoulder Arthroplasty
Condition: Shoulder Arthroplasty; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Shoulder arthroplasty is associated with significant postoperative pain. Appropriate pain
      control after shoulder arthroplasty is crucial for postoperative rehabilitation and patient
      satisfaction. Superior trunk block is a commonly employed regional anesthetic technique for
      shouler arthroplasty, and a continuous catheter is often placed to extend the analgesic
      benefit of the block. However, continuous peripheral nervel block (PNB) is more costly and
      time-consuming than sigle-shot PNB. Recent evidence suggests that intravenous (IV)
      dexmedetomidine (DEX) prolong the analgesic duration after sigle-shot PNB. The investigators
      will compare continuous superior trunk block with single-shot superior trunk block with IV
      DEX in patients undergoing shoulder arthroplasty.
    


Intervention name(s): Single-shot superior trunk block with intravenous dexmedetomidine; Continuous superior trunk block
Intervention type(s): Procedure; Procedure
Intervention description(s): During surgery, dexmedetomidine will be administered. After intravenous administration of 2 mcg/kg for 30 minutes, 0.5 mcg/kg/hr will be administered until the end of surgery. After surgery, a single-shot superior trunk block will be performed under ultrasound guidance. 15 mL of 0.5% ropivacaine with 1:200,000 epinephrine will be administered.; During surgery, an equivalent volume of the placebo solution was administered in a similar manner as dexmedetomidine. The superior trunk block catheter will be inserted under ultrasound guidance using 15 mL of 0.5% ropivacaine after the operation and utilize patient-controlled analgesia infusion pump with a 300 mL reservoir of ropivacaine 0.2%, and programmed the pump to deliver 5 mL per hour with an optional patient-controlled analgesia bolus of 4 mL at 30-minute lockout intervals. Patients were typically discharged home on POD 1, and block was continued until reservoir completion.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Reduction of Abdominal Obesity and Insulin Resistance in Women
Condition: Obesity
MeSH terms: Obesity; Insulin Resistance; Obesity, Abdominal
Study type: Interventional

Summary: 
      The purpose of the study was to assess the effects of equivalent diet- or exercise-induced
      weight loss and related insulin resistance in abdominally obese women.
    


Intervention name(s): Diet Weight Loss; Exercise Weight Loss; Exercise Without Weight Loss
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Obesity, exercise, diet, insulin resistance
Deep Brain Stimulation in HUCH Region Between 2006 and 2014
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational [Patient Registry]

Summary: 
      This study reviews the outcome of deep brain stimulation treated patients in Helsinki and
      Uusimaa University Hospital between 2006 and 2014. The aim of the study is to investigate the
      outcome and possible side effects of deep brain stimulation treatment.
    

Detailed description: 
      Deep brain stimulation is a FDA approved method in treating patients with advanced
      Parkinson's disease when the best medical treatment is insufficient. In this study the aim is
      to investigate the outcome of deep brain stimulation treated patients in Helsinki and Uusimaa
      University hospital between 2006 and 2014. This study is a retrospective study based on
      existing patients' medical records and does not include an intervention in the treatment of
      an individual patient.

      Deep brain stimulation carries the risks of major surgery. A complication risk for a
      hemorrhage is 1-2 % and for an infection is 3-10%. The aim of this study is to evaluate the
      complications that have occurred and the possible benefit of deep brain stimulation in deep
      brain stimulation treated patients with advanced Parkinson's disease.

      The gathered data will be processed anonymously and an individual patient cannot be
      identified. The data will be processed with an appropriate statistical program (SPSS). No
      data will be given to external parties.
    

Observational model: Case-Only
Sampling method: Probability Sample
Study population: 
        The study population consist of the patients who have received deep brain stimulation
        treatment. The patient selection for deep brain stimulation has been done according to a
        clinical protocol.
      
Keywords: Advanced; Deep brain stimulation
Effect of Pupilometer Guided Analgesia on Postoperative Pain
Condition: Cholecystectomy, Laparoscopic; Anesthesia, General; Reflex, Pupillary
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      In this study, the investigators measure a pupil size every 5 minutes during the operation in
      patients undergoing laparoscopic cholecystectomy under general anesthesia. The investigators
      would compare the postoperative pain intensity between the group adjusted the anesthetic drug
      concentration based on the changes of the pupil (Pupil group) and the group based on the
      changes of a surgical pleth index (SPI group).
    


Intervention name(s): Pupilometer guided anesthesia; SPI guided anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): At least 10 min after anesthesia induction by target-controlled infusion of propofol and remifentanil, baseline values for pupillary diameter is recorded before any surgical procedure.
During the operation, propofol effect-site target concentration (Ce) is adjusted to maintain the bispectral index (BIS) value between 40 and 60. Remifentanil Ce is adapted every 5 min based on the changes of pupillary diameter. If the pupillary diameter is increased by more than 30% compared to baseline value, remifentanil concentration is increased by 0.5 ng/ml. If the pupillary diameter is maintained between 5 and 30 % change compared with baseline, remifentanil is not modified. In a case of pupillary diameter is decreased less than 5 % change of baseline, remifentanil concentration is decreased by 0.5 ng/ml.; During the operation, SPI value should be maintained between 20 and 50 by changing the infusion rate of remifentanil. Even if the SPI is maintained within the target range, the remifentanil infusion rate is increased by 0.5 ng/ml in a case of the SPI value suddenly arises by more than 10.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
A Study in Healthy Men to Test How the Body Takes up and Tolerates Different Doses of BI 474121, and Whether it Makes a Difference if BI 474121 is Taken as a Tablet or a Drink.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this trial are to investigate safety, tolerability and
      pharmacokinetics (PK) of BI 474121 in healthy male subjects following oral administration of
      single rising doses.
    


Intervention name(s): BI 474121; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose; Single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Efficacy of Facial Cleanser
Condition: Healthy
Study type: Interventional

Summary: 
      This study is conducted to evaluate the safety and effectiveness of facial cleanser X
      containing combination of olive oil, virgin coconut oil, butylene glycol and hyaluronic acid
      on skin hydration and skin elasticity. The study duration is 5 weeks and the skin assessment
      will be carried out at baseline, week 3 and week 5.The main questions this study aims to
      answer are:

        1. The effect of product on skin hydration.

        2. The effect of product on skin elasticity.

        3. To observe any adverse effect occurrence with the usage of the product.
    


Intervention name(s): Other: Product X facial cleanser
Intervention type(s): Other
Intervention description(s): Product X facial cleanser contain olive oil, virgin coconut oil, butylene glycol and hyaluronic acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Aesthetic; Cosmetic
Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables
Condition: Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      During major surgical procedures, intravascular volume is maintained with the administration
      of isotonic fluids such as Lactated Ringers (LR), Normal Saline (NS) or Normosol-R. All three
      of these fluids are in common clinical use for this purpose. As large volumes of NS may
      result in a dilutional acidosis and an increasing base deficit, it may cloud clinical
      decision making when resuscitative efforts are guided by acid-base status on routine arterial
      blood gas analysis. This is a prospective, randomized study to evaluate changes in acid-base
      and electrolyte (sodium, potassium, calcium) status with the use of various isotonic fluids
      for intraoperative resuscitation.
    


Intervention name(s): Normal Saline; Lactated Ringer; Normosol-R Inj
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV infusion of 0.9% NaCl throughout surgery.; IV infusion of lactated ringer throughout surgery.; IV infusion of Normosol throughout surgery.
Other intervention name(s): 0.9% NaCl
Intervention MeSH terms: Plasma-lyte 148
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Non-Drug Study of The Suitability of Neurocognitive Tests And Functioning Scales For The Measurement of Cognitive And Functioning Changes in Individuals With Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Observational

Summary: 
      This non-drug, longitudinal, multi-center, multi-national study will evaluate the suitability
      of neurocognitive tests and functioning scales for the measurement of cognitive and
      functioning changes in individuals with Down Syndrome. Tests will be administered at clinic
      visits in Weeks 1, (4) and 24. The duration of the study for each individual will be between
      24 and 27 weeks.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Individuals with Down Syndrome
Safety, Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test in adults with Down Syndrome the safety, tolerability
      and immunogenicity of a vaccine, ACI-24.
    

Detailed description: 
      This is a prospective multi-center, placebo controlled, double-blind and randomized dose
      escalation study of 2 doses of ACI-24 versus Placebo over 24 months with a total of 21
      visits.

      All subjects will receive the study medication (ACI-24 or Placebo) 7 times via s.c. injection
      (12 months) and will be followed up for 12 months after the last dose with a final safety and
      efficacy assessment.
    

Intervention name(s): ACI-24 low dose; ACI-24 high dose; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): ACI-24 administered as a sterile suspension in PBS via s.c. injection.; ACI-24 administered as a sterile suspension in PBS via s.c. injection.; Placebo is a standard PBS sterile solution administrated via s.c. injection.
Other intervention name(s): PBS
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cognitive decline