bioihbjkbjnl/mcl2 huggingface dataset:
Time Outside Target Oxygen Saturation Range in Preterm Infants and Long Term Outcomes and Preterm Infants
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Observational

Summary: 
      The purpose of this study is to determine if there is a relationship between time spent out
      the targeted oxygen saturation range in preterm infants is associated with long-term outcomes
      such as Retinopathy of Prematurity.
    

Detailed description: 
      All infants who had a birth weight of less than 1500 grams or less than 32 weeks gestation
      admitted to our neonatal intensive care unit (NICU) were eligible for the study. All infants
      were placed on Nellcor N600 pulsoximetry. Saturation data in two-second sampling from N600
      OXIMAX pulse oximeters (Covidian, CA) was collected using a modified Nellcor® Oxinet® III
      system (Covidian, CA and Cardiopulmonary, Milford, CT) Alarm limits were set at 83% and 93%
      while infants required oxygen supplementation and 85% to 100% when neonates were in room air.
      Desaturation events were defined as number of times the saturation fell below the low
      saturation limit set on the monitor (83% if oxygen requirement >21%, 85% if patient on room
      air). High saturation events were defined as the number of times the patient's saturation was
      above the upper saturation limit (93% if oxygen requirement >21%)

      The data collection system summarized each day in tabular form including average SPO2, number
      of low and high SPO2 events, duration of events in minutes, and the percentage of time
      infants spent outside of the intended saturation range. Primary outcome was threshold ROP
      requiring laser ablation. Data on ROP was collected during hospitalization and after
      discharge until resolution of ROP by pediatric ophthalmologist blinded to the study results.
      Secondary outcomes included bronchopulmonary dysplasia, length of hospitalization, sepsis,
      focal bowel perforation, necrotizing enterocolitis (stage 2 or greater), patent ductus
      ligation, intracranial hemorrhage, and number of red blood cell and platelet transfusions.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        NICU patients at risk for ROP
      
Keywords: oxygen saturation; retinopathy of prematurity; long term outcomes; hypoxia; hyperoxia
A Study to Assess the Relative Bioavailability and to Assess the Effect of Food on the Bioavailability of a TAK-648 Tablet in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the relative bioavailability of a TAK-648 tablet
      compared with a TAK-648 oral solution, and to assess the effect of food on the
      bioavailability of a TAK-648 tablet in healthy participants.
    

Detailed description: 
      This study will assess the relative Bioavailability (BA) of TAK-648 tablet compared with that
      of TAK-648 solution and the effect of food on the BA of the TAK-648 tablet.

      The study will enroll approximately 24 healthy participants. Participants will be randomly
      assigned to one of the three treatment sequences:

        -  TAK-648 tablet in fed state, followed by TAK-648 tablet in fasted state, followed by
           TAK-648 oral solution in fasted state

        -  TAK-648 tablet in fasted state, followed by TAK-648 oral solution in fasted state,
           followed by TAK-648 tablet in fed state

        -  TAK-648 oral solution in fasted state, TAK-648 tablet in fed state, TAK-648 tablet in
           fasted state The dosing in a period and the subsequent period will be separated by a
           minimum 7-day washout interval. Participants will be asked to take single dose of
           TAK-648 tablet or oral solution on Day 1 of each period.

      This single-center trial will be conducted in the United States. Participants will make 4
      visits to the clinic including three 4-day periods of confinement to the clinic, and will be
      contacted by telephone 30 days after last dose of study drug for a follow-up assessment.
    

Intervention name(s): TAK-648 Tablet; TAK-648 Oral Solution
Intervention type(s): Drug; Drug
Intervention description(s): Tak-648 tablet; TAK-648 oral solution
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy
Cardio- and Renoprotective Effect of Remote Ischemic Preconditioning in Patients Undergoing Percutaneous Coronary Intervention
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Myocyte necrosis occurs frequently in elective percutanious percutaneous coronary
      intervention (PCI) and is associated with subsequent cardiovascular events. This study
      assessed the cardio- and reno-protective effect of remote ischemic preconditioning (RIPC) in
      patients undergoing elective PCI. 200 patients were randomized into 2 groups: 100 patients
      received RIPC (created by three 5-minute inflations of a blood pressure cuff to 200 mm Hg
      around the upper arm, separated by 5-minute intervals of reperfusion) < 2 hours before the
      PCI procedure, and the control group (n = 100).
    


Intervention name(s): Remote Ischemic Pre-Conditioning
Intervention type(s): Other
Intervention description(s): The blood pressure cuff was inflated to a pressure of 200 mm Hg for 5 minutes, followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated 3 times by the resident doctors in the pre-cath room
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: remote ischemic preconditioning
High Dosage Vitamin D and Osteoporosis
Condition: Osteoporosis; Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 4

Summary: 
      Vitamin D and calcium are essential in the treatment and prevention of osteoporosis. What
      dosage of vitamin D which is the ideal one, is not yet clear. We want to test the hypothesis
      that high dosage of vitamin D (i.e. 6500 IU/d) is better than standard dosage (800 IU/d) in a
      randomized double-blind trial. We will include 400 postmenopausal otherwise healthy women
      with T-score <= -2.0 in L2-4 or mean total hip. Everybody will receive calcium 1000 mg and
      vitamin D 800 IU every day. Half of the group will also receive vitamin D 40 000 IU/week,
      while the other half will have placebo. The study period is one year.
    


Intervention name(s): cholecalciferol (Vitamin D3); placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 000 Iu x2/week
+ calcium 500 mg/cholecalciferol 400 IU x2/d; Calcium 500 mg/Cholecalciferol 400 IU x2/d and placebo 2/w
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteoporosis; bone mineral density; vitamin D
Comparison of Vaginal Axis on MRI in Alternative Apical Prolapse Surgeries to Sacrocolpopexy
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      Sacrocolpopexy remains the preeminent modality in addressing apical prolapse surgically.
      Nevertheless, amplified morbidity rates within cohorts characterized by obesity and advanced
      age constrain the advantages conferred by the procedure. Recent years have witnessed a
      proliferation of inquiries appraising the efficacy of laparoscopic lateral suspension,
      pectopexy, and sacrospinous ligament fixation interventions, which have, over time, garnered
      extensive clinical application, in relation to recurrence rates. A multitude of
      investigations have been undertaken to delineate the optimal vaginal axis. In the present
      investigation, we have delineated a research protocol aimed at scrutinizing these alternative
      surgical modalities with regard to their impact on the vaginal axis.
    

Detailed description: 
      The study objective pertains to the assessment of vaginal axis in patients undergoing apical
      prolapse surgery, whether they have undergone hysterectomy or not. The investigation is
      designed to test the null hypothesis by means of a comparative analysis of preoperative and
      postoperative Magnetic Resonance Imaging images capturing the vaginal axis. This examination
      will be conducted on patients slated to receive lateral mesh suspension, pectopexy, and
      sacrospinous ligament fixation procedures for the correction of apical prolapse.
    

Intervention name(s): laparoscopic lateral suspension; laparoscopic pectopexy; Sacrospinous ligament fixation
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Lateral suspension involves the lateral attachment or suspension of vaginal tissue to a stable structure, often using mesh or sutures, to provide support and stability to the pelvic organs. Control groups consist of hysterectomized women without cuff prolapse and nulliparous women.; Pectopexy involves attaching or suspending the vaginal vault to the pectineal ligament, which is a strong ligament in the pelvis. Control groups consist of hysterectomized women without cuff prolapse and nulliparous women.; Sacrospinous ligament fixation entails the attachment or fixation of the vaginal vault to the sacrospinous ligament, which is a strong fibrous band located in the pelvis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: pelvic organ prolapse; apical prolapse; pectopexy; sacrospinous ligament fixation; Lateral suspension
A Phase IIa Study of KHK4563
Condition: Uncontrolled and Suspected Eosinophilic Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, placebo-controlled dose-ranging study of KHK4563 to evaluate the
      effect of multiple-dose subcutaneous administration of KHK4563 on the annual asthma
      exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma.
    


Intervention name(s): KHK4563; KHK4563; KHK4563; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.; every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.; every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.; every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Quantifying the Venous Congestion Curve of a Tissue Oximetry Device
Condition: Post-Op Complication; Skin Flap Necrosis
MeSH terms: Hyperemia; Necrosis; Postoperative Complications
Study type: Interventional

Summary: 
      The purpose of this research study is to measure rate of decline and pattern of tissue
      oxygenation using the device, ViOptix T.Ox.

      ViOptix probes will be secured to the arm and hand. The recording process on the ViOptix
      machine will begin and obtain baseline StO2 levels for 5 minutes. After 5 minutes, a blood
      pressure cuff will be inflated on one arm. This blood pressure cuff will be left inflated for
      10-20 minutes. Every 2 minutes a pulse check or doppler exam will be performed at your wrist.
      Last, the cuff will be deflated and the you will be free to leave the study room.
    

Detailed description: 
      The rate of decline and pattern seen in tissue oxygenation as quantified by a NIRS device
      (ViOptiox T.Ox) can be quantified and described by a mathematical model which will allow
      earlier detection and identification of venous congestion in tissue. The vascular occlusion
      test has been established as a safe and accurate model to induce various states of vascular
      insufficiency and occlusion. Specifically the vascular occlusion test has been demonstrated
      to be an accurate model for inducing venous insufficiency on awake and aware patients. This
      study will aim to analyze the StO2 data output of the ViOptix in order to establish the
      earliest signs of tissue failure in various states of vascular compromise.

      The purpose of this research study is to measure rate of decline and pattern of tissue
      oxygenation using the device, ViOptix T.Ox. The data collected will be used to formulate a
      mathematical model which will allow earlier detection and identification of venous congestion
      in tissue. Identifying these specific patterns will help to establish an evidence-based
      approach in recognizing specific problems and patterns associated with tissue compromise that
      can guide physicians to consider earlier flap salvage measures.
    

Intervention name(s): ViOptix
Intervention type(s): Device
Intervention description(s): ViOptix machine
Intervention model: Single Group Assignment
Intervention model description: The ViOptix machine will be used to measure the oxygenation of composite tissue.
Masking: None (Open Label)
Primary purpose: Other
Spinal Versus Caudal Analgesia After Pediatric Infra-umbilical Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Caudal analgesia along with general anesthesia is a very popular regional technique for
      prolonged postoperative analgesia in different pediatric surgical procedures where the
      surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for
      approximately 4-6 hours.

      Recently, the use of spinal anesthesia in infants and children requiring surgeries of
      sub-umbilical region is gaining considerable popularity worldwide.

      - The ease of performance and the safety regarding cardio-respiratory functions makes spinal
      anesthesia as an alternative to general anesthesia in infants and children undergoing
      surgeries of sub-umbilical regions.
    

Detailed description: 
      The historic view that young children neither respond to, nor remember, painful experiences
      to the same degree as adults is no longer thought to be true. About 40% of pediatric surgical
      patients experienced moderate or severe postoperative pain and 75% had insufficient
      analgesia.

      -Pediatric acute pain services use techniques of concurrent or co-analgesia based on four
      classes of analgesics, namely local anesthetics, opioids, non-steroidal anti-inflammatory
      drugs (NSAIDs), and acetaminophen (paracetamol).

      Caudal analgesia along with general anesthesia is a very popular regional technique for
      prolonged postoperative analgesia in different pediatric surgical procedures where the
      surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for
      approximately 4-6 hours.

      Recently, the use of spinal anesthesia in infants and children requiring surgeries of
      sub-umbilical region is gaining considerable popularity worldwide.

      - The ease of performance and the safety regarding cardio-respiratory functions makes spinal
      anesthesia as an alternative to general anesthesia in infants and children undergoing
      surgeries of sub-umbilical regions.
    

Intervention name(s): Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5%; caudal plain bupivacaine 2.5mg/kg 0.25%
Intervention type(s): Drug; Drug
Intervention description(s): The lumber puncture will be made in the lateral position at the L4-5 or L5-S1 interspace with a 25 G pencil point Quincke spinal needle with a short bevel and the orifice of the spinal needle will be turned cephalad.; The sacral hiatus between the sacral conru will be palpated. While inserting the 23-G needle at 45° to the skin in the midline, a distance "give" or "pop" will be felt as the needle passes the sacral ligament into the caudal space, the needle will be tilted more toward the skin surface and inserted 2-3mm deeper.
Other intervention name(s): Marcain; Bucain
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Study of Guselkumab and Ustekinumab Following a Single Intravenous or Subcutaneous Administration in Healthy Chinese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK) of guselkumab following a
      single intravenous (IV) or subcutaneous (SC) administration in healthy Chinese participants;
      to evaluate the PK of ustekinumab following a single IV administration in healthy
      participants.
    


Intervention name(s): Guselkumab (SC): Dose 1; Guselkumab (SC): Dose 2; Guselkumab (IV): Dose 1; Guselkumab (IV): Dose 2; Ustekinumab 6 mg/mL
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive a single dose of guselkumab (dose 1) subcutaneously.; Participants will receive a single dose of guselkumab (dose 2) subcutaneously.; Participants will receive a single IV infusion of guselkumab (dose 1).; Participants will receive a single IV infusion of guselkumab (dose 2).; Participants will receive a single IV infusion of ustekinumab 6 mg/mL solution.
Other intervention name(s): CNTO 1959; CNTO 1959; CNTO 1959; CNTO 1959; Stelara
Intervention MeSH terms: Ustekinumab; Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy
Condition: Narcolepsy
MeSH terms: Narcolepsy; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to determine whether treatment with Armodafinil
      (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness
      associated with narcolepsy by measuring mean sleep latency from the Maintenance of
      Wakefulness Test (MWT) (20-minute version)(average of 4 naps at 0900, 1100, 1300, and 1500)
      and by the Clinical Global Impressions of Change (CGI-C) ratings (as related to general
      condition) at week 12 (or last postbaseline observation)
    


Intervention name(s): Armodafinil; Armodafinil; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Armodafinil 250 mg once daily in the morning; Armodafinil 150 mg once daily in the morning; Matching placebo tablets once daily
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Narcolepsy; Excessive Sleepiness; Cataplexy; Sleep Attacks; Excessive Sleepiness associated with Narcolepsy; Cephalon; Cephalon, Inc; Nuvigil
Thoracic Paravertebral Block Using Ropivacaine and Dexmedetomidine
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The hypothesis of the study is whether dexmedetomidine plus local anesthetic ropivacaine
      could extend the pain relieve time compared with only ropivacaine when thoracic paravertebral
      block is performed at the end of video-assisted pneumonectomy.
    

Detailed description: 
      The investigators aim to recruit 60 patients undergoing video-assisted pneumonectomy. All
      patients ASA physical status I-II grade, aged within 20-70 years, are randomly allocated into
      two groups: 75mg/20ml ropivacaine only group (Group R, n=30) and 75mg/20ml ropivacaine +
      1μg/kg dexmedetomidine (Group RD, n=30). At the end of surgery, the investigators perform
      four points thoracic paravertebral block guided by ultrasound combined with nerve stimulator
      at T3-4, T4-5, T5-6, T6-7 of surgical side where 5ml solution is injected to each point. The
      characteristics of patients are analyzed to confirm whether they are comparable in both
      groups. Pain was assessed according to a numerical rating scale (NRS) (0 = no pain; 10 =
      worst pain imaginable). Patients were asked to evaluate the maximal degree of pain. Pain
      scores were recorded in post anesthesia care unit(PACU), and1, 2,4, 8, 12, 24, 36 and 48
      hours after surgery. The study endpoints are evaluated by an anesthesiologist who does not
      know the group allocation. The postoperative rescue analgesic administration, adverse
      outcomes and patient satisfaction are also recorded.

      All data were processed in SPSS 18.0 (SPSS Inc., Chicago, IL USA). Normality was tested by
      the Kolmogorov-Smirnov analysis. Comparisons of continuous outcomes among groups were
      examined using Kruskal-Wallis test. Chi-square analysis or Fisher's exact test was used to
      assess categorical outcomes between groups. A P-value<0.05 was considered statistically
      significant.
    

Intervention name(s): Video-assisted Pneumonectomy; Thoracic paravertebral block
Intervention type(s): Procedure; Procedure
Intervention description(s): Video-assisted Pneumonectomy under general anesthesia.; The procedure is guided by ultrasound combined with nerve stimulator at T3-4, T4-5, T5-6, T6-7 of surgical side.
Other intervention name(s): Thoracic paravertebral nerve block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Thoracic paravertebral block; Dexmedetomidine; Video-assisted Pneumonectomy; Ropivacaine; Pain, Postoperative
Safety, Tolerability, and Pharmacokinetics of BI 201335 NA in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this trial was to investigate safety, tolerability, and pharmacokinetics of
      BI 201335 ZW after administration of single rising doses from 40 mg to 480 mg of BI 201335 NA
      in healthy Japanese male volunteers.
    


Intervention name(s): BI 201335 NA in single rising doses; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Esophageal Stump Washout
Condition: Esophageal Cancer; Gastrooesophageal Cancer
Study type: Interventional

Summary: 
      Intraluminally shed viable tumor cells might contribute to local recurrence in cancer of the
      esophagus and the cardia. The aim of the the study was to establish a method of mechanical
      lavage of the remaining part of the esophagus and, hence, to reduce the intraluminal cancer
      cells before doing the esophageal anastomosis.
    

Detailed description: 
      See study protocol!
    

Intervention name(s): Esophageal Stump Washout
Intervention type(s): Procedure
Intervention description(s): a washout of the closed esophageal stump with Ringer-solution (10 times 30ml) is performed by means of a transorally inserted 24F-Foley catheter. The first, fifth and tenth portion of the lavage fluid are collected and sent to cytological examination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: esophagus; gastro-esophegeal junction; cancer; tumor seeding; free viable tumor cells; surgery; intraluminal tumor cells; stump washout