bioihbjkbjnl/mcl2 huggingface dataset:
Umbilical Cord Milking in Non-Vigorous Infants
Condition: Birth Asphyxia
MeSH terms: Asphyxia Neonatorum; Asphyxia
Study type: Interventional

Summary: 
      The investigators will conduct a study of non-vigorous term infants to determine if umbilical
      cord milking (UCM) results in a lower rate of NICU admissions than early clamping and cutting
      of the umbilical cord at birth for infants who need resuscitation.
    

Detailed description: 
      At birth, it is critical that an infant begins breathing quickly. The infant has to switch
      from relying on the placenta for oxygen to using its lungs for the first time. The currently
      recommended practice for infants who need resuscitation is to immediately clamp the umbilical
      cord. Animal studies show that clamping the cord before the baby breathes can cause the heart
      beat to slow and can decrease the amount of blood being pumped out of the heart each minute.
      This study will test whether infants will benefit from UCM. The cord will be quickly milked
      four times before cutting and will not delay the resuscitation procedures. This study is
      important because when there is need for resuscitation, neither UCM or delayed cord clamping,
      are recommended by national and international organizations due to lack of evidence. Yet,
      several large studies from around the world have identified that infants needing
      resuscitation are more likely to develop conditions such as cerebral palsy, autism and other
      developmental problems.

      The trial is a cluster crossover design in which each hospital will be randomly assigned to
      use either early cord clamping or UCM for any infant needing resuscitation over a period of
      12 months. Then sites will change to the other method for an additional 12 months.
    

Intervention name(s): Umbilical Cord Milking; Early Cord Clamping
Intervention type(s): Procedure; Procedure
Intervention description(s): At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds.; The umbilical cord is clamped within 30 seconds of delivery.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Cluster Randomized Crossover
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Umbilical Cord Milking; Immediate Cord Clamping; Resuscitation
Parenteral Artesunate Compared to Quinine as a Cause of Late Anaemia in African Children With Malaria
Condition: Anaemia
MeSH terms: Malaria; Anemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Delayed anaemia has been reported in European travellers with malaria cured by artesunate.
      Although no deaths related to this delayed anaemia have been reported so far, blood
      transfusion has been necessary in some affected patients. Recent observations suggest that
      this episodes of anaemia also occurs in endemic countries. The aim of this trial is to assess
      the incidence of late onset anaemia after treatment with intravenous artesunate compared to
      intravenous quinine, to identify patients at risk and to clarify the causes of this delayed
      anaemia.
    


Intervention name(s): artesunate; quinine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Artesunate; Quinine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malaria; anaemia; artesunate
Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive
Condition: Partial Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate whether multiple-dose administration of
      eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics
      and tolerability of the components of a combined oral contraceptive (ethinyloestradiol and
      levonorgestrel).
    


Intervention name(s): eslicarbazepine acetate and Microginon®; Microginon®
Intervention type(s): Drug; Drug
Intervention description(s): eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.
Microginon®: single oral dose on day 14 of treatment period; Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)
Other intervention name(s): ESL; BIA 2-093
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Partial; Epilepsy; Eslicarbazepine acetate; Combined oral contraceptive; Pharmacokinetics; Tolerability
A Bioequivalence Study Between Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 250/50 Inhalation Powder/GSK in Healthy Volunteers
Condition: Bioequivalence
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence study between two inhaler products of fixed dose combination of fluticasone
      propionate and salmeterol xinafoate inhalation powder
    

Detailed description: 
      A bioequivalence study of a single dose of the fixed-dose combination of fluticasone
      propionate and salmeterol xinafoate inhalation powder administered from Fluticasone
      propionate 250 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent
      Pharmaceuticals (test-Τ) as 2 inhalations and ADVAIR DISKUS® 250/50 mcg inhalation powder/GSK
      (reference-R) in healthy volunteers under fasting conditions. The study will be one-center
      crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded.
    

Intervention name(s): Test Product; Reference Product
Intervention type(s): Drug; Drug
Intervention description(s): 2 inhalations of Test and Reference product in each study period; 2 inhalations of Test and Reference product in each study period
Other intervention name(s): Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals; ADVAIR DISKUS 250/50
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: One-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded study
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: bioequivalence; fluticasone propionate; salmeterol xinafoate; ADVAIR
Phase 2, Safety & Microbiology Study of C16G2 in Multiple Oral Gel &/or Mouth Rinse Doses to Healthy Adults
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      The focus of the study is to evaluate the safety of multiple study drug administrations and
      the study drug selectively reducing or eliminating a specific bacteria in the mouth. It will
      compare a liquid and gel product applied in different modes.
    

Detailed description: 
      The study will evaluate the safety of multiple study drug administrations as assessed by
      adverse event monitoring, oral cavity assessments, targeted physical exams and vital signs.
      The study will also assess the study drug's ability to selectively reduce or eliminate
      specific bacteria in the mouth by comparing a liquid and gel product applied in different
      modes, such as mouth rinse administration and gel application using a dental tray, electric
      toothbrush or manual toothbrush administered over 7 consecutive days. Subjects will be
      followed for approximately 8 days after the last study drug administration for safety and
      microbiology.
    

Intervention name(s): C16G2 Rinse; Placebo; C16G2 Gel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Active rinses are 1.6 mg/mL C16G2.; Placebo is the vehicle without C16G2; Active C16G2 Gel is 3.2 mg/mL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Usage of Tramadol With Levobupivacaine for Pain Treatment After Cesarean Section
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients experience considerable amount of pain after cesarean section. The aim of this study
      is to investigate the effect of tramadol (an opioid pain killer) added to levobupivacaine (a
      local anesthetic) in continuous wound infusion (which is done by placing a catheter in the
      incision) after cesarean sections.
    


Intervention name(s): Tramadol infusion via wound catheter; Levobupivacaine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tramadol; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of the Blood Levels and Effects of ATL-962 on Fat Excretion in Obese Subjects
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the amount of metabolites of ATL-962 in the blood
      and to investigate the effect of ATL-962 on the amount of fat that is excreted in the faeces
      in subjects who are obese
    

Detailed description: 
      Obesity is a significant and increasing clinical problem. There is a need for effective
      therapeutic agents to help people reduce weight. ATL-962 is a lipase inhibitor which could
      reduce the amount of fat absorbed from a person's diet, leading to weight reduction.
    

Intervention name(s): ATL-962
Intervention type(s): Drug
Intervention MeSH terms: Cetilistat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Obesity; Pharmacokinetics; Pharmacodynamics
Total Knee Replacement Component Alignment Using Manual Versus Custom Instrumentation
Condition: Osteoarthritis of Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      1. To determine whether the low-dose, biplanar x-ray imaging (EOS) has the same accuracy as
           computed axial tomography (CT)

        2. To validate low-dose, biplanar x-ray imaging (EOS) as a tool to evaluate 3-dimensional
           alignment of Total Knee Replacement implants.

        3. To evaluate differences in total knee replacement implant alignment in patients whose
           arthroplasty is performed using manual or custom instrumentation derived from
           preoperative CT
    

Detailed description: 
      Achieving optimal prosthetic alignment of the femoral, tibial and patellar components during
      Total Knee Replacement (TKR) is of great importance as it contributes to better function,
      less pain and improved quality of life.TKR requires accuracy in the execution of bone cuts in
      the correct orientation to the coronal, sagittal and axial planes. Malposition potentially
      leads to increased mechanical stress on the bearing surfaces and inevitably to earlier
      loosening.

      Computed Axial Tomography (CT) is the gold standard technique to evaluate implant alignment
      in the coronal, sagittal and axial planes. As such, CT has imaging has been used to create
      custom instrumentation with purported likely improvement in surgical outcomes. Customized
      instrumentation created from a preoperative CT has been shown to be safe and effective, with
      no reported difference in patient outcomes and similar total knee arthroplasty component
      alignment. However, taking into consideration CT's high levels of radiation, cost expenses
      and its inability to obtain images of the limb in weight-bearing position, CT scan cannot be
      used routinely as a postoperative tool to evaluate TKR implant positioning.

      The imaging system manufactured by EOS Imaging (formerly Biospace Med, Paris) is a biplanar,
      low-dose radiation, full body, high resolution, radiological imaging system allowing
      simultaneous acquisition in the coronal and sagittal planes and in standing position.EOS'
      main benefits are the considerable reduction in radiation dose (up to 1000 times less than
      for CT and ten times less than the plain radiography) by using a gaseous detector. George
      Charpak, the inventor, was awarded the Nobel Prize in 1992 for this work. Moreover, the EOS
      system can provide 3D images by using the appropriate software algorithms, thus providing a
      low-radiation alternative to CT.
    

Intervention name(s): Medacta GMK Sphere
Intervention type(s): Device
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Post-Operative Pain Evaluation After Using Different Single-file Root Canal Preparation System: A Randomized Clinical Study
Condition: Root Canal Treatment
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The goal of this clinical trial is to assess post-operative pain following root canal
      preparation using various single-file systems
    

Detailed description: 
      The goal of this clinical trial is to assess post-operative pain following root canal
      preparation using various single-file systems.Postoperative pain assessment was done by an
      independent evaluator with no knowledge of the group under investigation. The visual Analogue
      Scale (VAS) was employed. Patients could put a mark anywhere on the VAS sheet with values
      ranging from 0 to 100 mm [10].

        -  Score 0: No pain (between 0 and 4 mm) the tooth after treatment felt normal, and no
           discomfort was reported by the patients.

        -  Score 1: Recognizable, mild pain (between 5 and 44 mm), not requiring analgesics.

        -  Score 2: Moderate pain (between 45 and 74 mm) that is uncomfortable but bearable (when
           analgesics were taken, the pain was successfully reduced).

        -  Score 3: Severe pain (between 75 and 100 mm) painful to endure (pain was not relieved by
           taking analgesics).

      The patients in this study were not aware of the preparation system used during treatment.
      Following treatment, three readings were taken at 24, 72, and 7 days. Each patient carried a
      VAS form, and reminder calls were made to record pain levels and return the form filled out
      completely
    

Intervention name(s): Hyflex EDM , The XP-endo Shaper, Primary WaveOne Gold
Intervention type(s): Device
Intervention description(s): rotary single files
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Hyflex/EDM; Post-operative pain; Single-file systems; Wave One Gold; XP-endo shaper.
Impact of Infant Formula on Caregiver-perceived Intolerance
Condition: Healthy Infants
Study type: Interventional

Summary: 
      Understand the impact of switching to a commercially available infant formula on
      gastrointestinal symptoms
    


Intervention name(s): Routine infant formula
Intervention type(s): Other
Intervention description(s): Routine infant formula with probiotic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PK Study to Evaluate the Effect of PLC on Healthy Chinese Subjects by Multiple-doses
Condition: Peripheral Arterial Diseases
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective is to evaluate the effect of Propionyl-L-Carnitine Hydrochloride on
      clinical pharmacokinetic characteristics and its effect of clinical pharmacokinetic
      characteristics and safety on healthy Chinese subjects to provide a basis for market
      authorization registration
    

Detailed description: 
      This is a single group subject, open-label, self-controlled, 3 periods, multi-doses
      administration trial. 12 Healthy Chinese volunteers satisfying inclusion criteria were
      enrolled with equal number of male and female. Each subject goes through a 7-day Run-in
      period to eliminate the remaining L-carnitine like substance in the food to ensure the
      baseline level of endougenous L-Carnitien is stable；In period III, during the first 4
      days，all healthy subjects take oral Propionyl-L-Carnitine 1g twice daily; on day 5, all
      healthy subjects take oral Propionyl-L-Carnitine 1g during fasting.
    

Intervention name(s): Propionyl-L-Carnitine Hydrochloride
Intervention type(s): Drug
Intervention description(s): 1g twice a day on first 4 days and 1g/ day on day 5 during Phase III
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Healthy Volunteer Study to Evaluate Reversibility of Induced Impairment of Cognition
Condition: Cognition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if cognitive impairment induced by scopolamine is
      reversed using donepezil and/or AZD1446 as compared to placebo, as assessed by
      electroencephalogram (EEG) measures.
    


Intervention name(s): AZD1446; AZD1446; donepezil; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): capsule; single oral dose; capsule, single oral dose; capsule, single oral dose; capsule, single oral dose
Other intervention name(s): Aricept
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy Volunteers; EEG
Exercise Perceptions and Preferences Among Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      The purpose of the study is to analyse exercise behaviour of rheumatoid arthritis patients.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients will be selected in the Rheumatology Department of the Centre Hospitalier
        universitaire Vaudois in Lausanne.
      
Keywords: Exercise; Barriers; Benefits; Preferences; Stages of change
Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the safety, efficacy/pharmacodynamics (PD) and
      pharmacokinetics (PK) of teduglutide treatment in infants with short bowel syndrome (SBS)
      dependent on parenteral (PN) support.
    


Intervention name(s): Teduglutide; Standard Medical Therapy; Syringe; Needle
Intervention type(s): Drug; Other; Device; Device
Intervention description(s): SC injection of 0.05 mg/kg teduglutide will be administered QD into abdomen or into either the thigh or arm for 24 weeks.; Standard medical therapy will be administered for 24 weeks.; Teduglutide will be administered using syringe (510k number: K980987).; Teduglutide will be administered using needle (510k number: K021475).
Intervention MeSH terms: Teduglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Short bowel syndrome; Teduglutide
Effect of Laughter Therapy on Surgical Stress, Oxygen Saturation, Pain and Comfort Level
Condition: Bariatric Surgery Pateints; Lauhgter Therapy; Laughter Yoga
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to examine the effect of laughter therapy based on Kolcaba comfort
      theory, on surgical stress, oxygen saturation, pain and comfort level in bariatric surgery
      patients. The main questions it aims to answer are:

        1. Is there a significant difference between salivary cortisol levels of patients with and
           without laughter yoga before surgical intervention?

        2. Is there a significant difference between the blood glucose levels of patients who were
           and were not treated with laughter yoga before surgical intervention?

        3. Is there a significant difference between the mean scores on the perceived stress scale
           of patients who were and were not treated with laughter yoga before surgical
           intervention?

        4. Is there a significant difference between the oxygen saturation levels of patients with
           and without laughter yoga before surgical intervention?

        5. Is there a significant difference between the mean scores on the comfort level scale of
           patients who were and were not treated with laughter yoga before surgical intervention?

        6. Is there a significant difference between the mean scores on the pain scale of patients
           who were and were not treated with laughter yoga before surgical intervention?

      The study population will consist of patients who will apply to the general surgery clinic of
      Düzce University Research and Application Center between June 2023 and April 2024, who will
      undergo bariatric surgery and agree to participate in the study. The data collected from
      these patients will be analyzed.

      From the patients who meet the inclusion criteria and agree to participate in the study;
      experimental and control groups will be determined by simple randomization. They will be
      informed about the research (a 15-minute presentation prepared by the researcher explaining
      what laughter therapy is) and their verbal and written permission will be obtained.

      The laughter yoga will be applied to experimanetal group. Every laughter yoga practice is 45
      minutes long and is planned 3 times a week for a total of 6 sessions. Control group patients
      will take only routine nursing care.
    


Intervention name(s): Laughter Therapy Based on Kolcaba Comfort Theory
Intervention type(s): Other
Intervention description(s): The laughter yoga will be applied to experimanetal group. Every laughter yoga practice is 45 minutes long and is planned 3 times a week for a total of 6 sessions. Control group patients will take only routine nursing care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: bariatric surgery patients; laughter therapy; laughter yoga