bioihbjkbjnl/mcl2 huggingface dataset:
Atelectasis During Delivery - Comparing Cesarian (c) -Section and Labor
Condition: Delivery, Obstetric; Cesarean Section; Labor; Respiration Disorders; Atelectasis
MeSH terms: Pulmonary Atelectasis; Respiration Disorders
Study type: Observational

Summary: 
      Pregnancy promotes respiratory system's restrictive component. This study observes the
      generation of atelectasis during labor.
    

Detailed description: 
      Pregnancy causes restriction of diaphragm movements as well as higher resistive component to
      the respiratory system. Spirometry studies have shown that the supine position increases
      risks of hypoxemia. There seems to be only casual observation regarding the generation of
      atelectasis during labor.
    

Intervention name(s): CT scan
Intervention type(s): Radiation
Intervention description(s): Thoracic CT scan
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hospital, obstetric division
      
Keywords: Delivery, obstetric; Atelectasis
A Phase I Study to Investigate the ADME of KD101
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male
      Subjects
    

Detailed description: 
      A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male
      Subjects
    

Intervention name(s): KD101
Intervention type(s): Drug
Intervention description(s): after 10 min KD101 administered, 14C KD101 3.52ug/1ml administrated. both of them will be administrate for oral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study to Evaluate the Efficacy of Optical Imaging to Evaluate the Anatomy of the Developing Pediatric Vocal Fold
Condition: Vocal Fold Development
Study type: Observational

Summary: 
      The specific aim of this study is to develop a growth and development chart (similar to a
      height or weight chart for children) that identifies the pattern of development of the
      pediatric vocal cord lamina propria from a single to a three layer structure. A secondary aim
      is to identify whether this growth chart shows a pattern of linear development or whether
      there are clear critical periods of development.
    

Detailed description: 
      The goal of this study is to identify critical periods of development when the lamina propria
      structure of the pediatric vocal fold matures. A Universal Modular Glottiscope will be
      utilized for adequate laryngeal exposure. An operating microscope will be used for
      magnification. This setup will allow for the Optical Coherence Tomography (OCT) imaging probe
      to be introduced using a laryngoscope to provide stability. The optical imaging probe will
      then be directed, or gently applied towards, the glottal surface, and an image field of 500
      microns x 500 microns x 350 microns will be obtained. As the probe is moved along the medial
      and superior mucosal surfaces of the vocal folds, "real-time" images will be obtained and
      digitally stored for review. The digitally stored images will be assessed and analyzed for
      their optical characteristics. The optical imaging probe will then be withdrawn from the
      patient and the original operative procedure will then be performed. Images can be attained
      in both "non-contact" mode (where the probe tip remains in the space between each vocal fold)
      and "contact" mode (where the probe tip is gently placed against the glottal tissue to
      compress it). The contact mode allows for deeper imaging (much like an ultrasound), which
      would be useful in situations involving larger (thicker) vocal folds. The study will end when
      images are acquired from a range of developmental ages to be able to refine the optical
      characteristics of the optical imaging system.

      Adults have also been included in this study for comparison as OCT imaging in adults may
      confirm the number of vocal fold layers compared to children.
    

Intervention name(s): Children Examined with the OCT Probe
Intervention type(s): Procedure
Intervention description(s): The child undergoing therapy will have the Optical Coherence Tomography (OCT) probe to examine the vocal fold.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children ages 1 month to 18 (and adults >18) undergoing laryngoscopy and bronchoscopy for
        airway evaluation where the patients will be already scheduled for general anesthesia with
        intravenous catheter placement as part of standard routine.
Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis
Condition: Chronic Kidney Disease Stage 5
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 single dose study conducted to evaluate the PK and PD of pegloticase
      administered to hemodialysis patients.

      A single dose of pegloticase will be administered intravenously to male or female
      hemodialysis patients (N = 12) starting 3 hour prior to dialysis.

      The study consists of a Screening Period, a Treatment Period, and Follow up Period.
    

Detailed description: 
      End stage renal disease (ESRD) patients that require hemodialysis typically undergo
      hemodialysis treatment 3 times per week. As such, medications can be dialyzed off, reducing
      their clinical effectiveness; this study is being conducted to understand how dialysis
      affects the pharmacokinetics (PK) and pharmacodynamics (PD) of pegloticase.
    

Intervention name(s): Pegloticase
Intervention type(s): Drug
Intervention description(s): a single 8 mg iv (in the vein) dose before hemodialysis session
Other intervention name(s): KRYSTEXXA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Chronic Kidney Disease Stage 5; Hemodialysis; pegloticase
Comparison of Respiratory Functions and Physical Fitness Parameters of Professional Basketball Players With Sedentary Controls
Condition: Physical Fitness, Basketball, Respiratory
Study type: Observational

Summary: 
      The aim of the study was to compare the professional basketball players and sedentary
      controls in terms of respiratory function and physical fitness parameters and to investigate
      the relationship between respiratory function and physical fitness parameters in basketball
      players.
    

Detailed description: 
      Basketball is one of the most common team sports in the world, where aerobic and anaerobic
      power is used together and taking into account the rising number of participants in
      non-professional leagues, it is especially popular among female athletes from various
      countries . Basketball players' muscular strength and endurance, power, speed, agility and
      physical properties such as reaction time are the main factors underlying the performance. In
      addition to this, respiratory functions are important as well as physical properties in
      basketball. Because during the maximal exercise, the blood flow to the inspiratory and
      expiratory muscles accounts for 15% of the total oxygen cost of the exercise. Assessment of
      the motor skills and physical characteristics of basketball players is very important for the
      positioning of the player, performance analysis and monitoring the effectiveness of the
      training. There are many studies examining the physical fitness characteristics of basketball
      players.However, no study evaluating respiratory muscle strength and endurance in female
      basketball players was found in the literature.therefore, this study was planned.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A team playing professional basketball in Turkey in Super League Basketball Women Study
        (mean age, 24.24 ± 4.96 years), basketball and sedentary individuals of the same age and
        sex were included on a voluntary basis. Permits were obtained from the necessary
        institutions before the studies to be made to the athletes. A total of 42 people from 21
        people were included in the study according to 5% Type1 error, two-way hypothesis test
        design and sample size calculation with at least 80% working power. Before the measurement
        protocols, the participants were informed about the study and informed consent form was
        obtained.
      
Keywords: basketball, respiratory, physical fitness
Trial of Adjuvant XELOX Chemotherapy and Concurrent Capecitabine and Radiotherapy for Resected Gastric Carcinoma
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the trial is to compare disease-free survival between adjuvant XELOX alone
      vs XELOX with concurrent capecitabine and radiotherapy in curatively resected gastric cancer
      patients with D2 dissection.
    

Detailed description: 
      Gastric cancer is one of the most common malignancies in China. Complete surgical resection
      is the only potentially curative therapy available to patients with gastric cancer. However,
      the overall survival results remain unsatisfactory. The main factor accounting for high
      mortality rate is the relapse after surgical resection. During the past few decades, the
      principle of combined modality treatment has been developed and applied in gastric cancer.
      Radiation therapy plus concurrent chemotherapy had demonstrated to be able to achieve a
      significant improvement in overall and disease-free survival according to Intergroup Trial
      0116/Southwest Oncology Group 9008. Nevertheless, the result from Intergroup Trial 0116 study
      had been challenged by the fact that the surgical treatment applied in the trial was
      gastrectomy with limited lymph node dissection (D0 or D1) in 90% of cases. Therefore, it is
      debatable whether adjuvant chemoradiation therapy can confer survival benefit in patients
      with extensive lymph node dissection. In ARTIST study, the addition of concurrent
      capecitabine and radiotherapy to capecitabine and cisplatin chemotherapy did not
      significantly reduce recurrence after curative resection and D2 lymph node dissection in
      gastric cancer. In subgroup analysis of patients with positive pathologic lymphnodes, there
      was a statistically significant prolongation in disease-free survival in the concurrent
      treatment arm when compared with the chemotherapy alone arm. Furthermore, CLASSIC study
      showed that XELOX (oxaliplatin/capecitabine) combination given as adjuvant chemotherapy for
      stage II or III patients after D2 surgery could achieve a significant survival benefit. The
      standard treatment modality in gastric cancer after D2 dissection is still disputable. Thus,
      the assessment of the effect of adjuvant sequence chemoradiotherapy in D2 resected gastric
      cancer is essential.
    

Intervention name(s): Capecitabine; Oxaliplatin; Radiotherapy
Intervention type(s): Drug; Drug; Radiation
Intervention MeSH terms: Capecitabine; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: gastric cancer; radiotherapy; postoperative therapy; chemotherapy
Relative Bioavailability Study of a Pediatric Granule Formulation of Dolutegravir
Condition: Infections, Human Immunodeficiency Virus and Herpesviridae
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Dolutegravir (DTG, GSK1349572) is an integrase inhibitor currently in Phase 3 clinical trials
      for the treatment of human immunodeficiency virus (HIV) infection. A granule formulation has
      been developed as an alternative to the current tablet formulation for administration in
      pediatric populations.

      This is a single-center, randomized, open-label, 5-way crossover study in healthy adult
      subjects. The study will evaluate the relative bioavailability of a 50 mg granule formulation
      of dolutegravir when administered 1) directly to mouth; 2) with purified water; 3) with
      Contrex brand water; and 4) with milk-based infant formula compared to the current 50 mg
      tablet formulation administered with tap water. Safety evaluations and serial PK samples will
      be collected during each treatment period. A taste assessment of the granule will also be
      performed. A follow-up visit will occur 5-7 days after the last dose of study drug.

      Pharmacokinetic assessments during the study will include area under the concentration-time
      curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity)), area under
      the concentration-time curve from time zero (pre-dose) to last time of quantifiable
      concentration within a subject across all treatments (AUC(0-t)), maximum observed
      concentration (Cmax), terminal phase half-life (t½), lag time before observation of drug
      concentrations in sampled matrix (tlag), time of occurrence of Cmax (tmax), concentration at
      24 hours post-dose (C24), and apparent clearance following oral dosing (CL/F).
    

Detailed description: 
      ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
      updating systems to reflect the change in sponsorship
    

Intervention name(s): Dolutegravir 50 mg tablet; Dolutegravir 50 mg oral granules
Intervention type(s): Drug; Drug
Intervention description(s): Dolutegravir is an experimental drug in the integrase inhibitor class for the treatment of HIV.; Dolutegravir is an experimental drug in the integrase inhibitor class for the treatment of HIV.
Intervention MeSH terms: Dolutegravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: dolutegravir; pediatric; granule formulation; GSK1349572; HIV
Immunogenicity Bridge Between an Investigational Monovalent Vaccine and the Equivalent Component of Gardasil (V501) a Quadrivalent Vaccine (V501-012)(COMPLETED)
Condition: Cervical Cancer; Genital Warts
MeSH terms: Condylomata Acuminata
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine if an investigational vaccine with a single
      component develops an immune response that is similar to the equivalent investigational
      vaccine with four components to reduce cervical disease.
    


Intervention name(s): V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Demonstrate the Bioequivalence of Interferon Beta-1a (INFB) Manufactured by Two Different Processes in Healthy Volunteers
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Biogen Idec has developed a novel process to manufacture Interferon beta-1a (INFB), the
      active ingredient of Avonex®, that does not include fetal bovine serum (FBS). This
      bioequivalence study is being conducted to confirm the pharmacokinetic (PK) and
      pharmacodynamic (PD) comparability of Interferon beta-1a produced by the currently approved
      serum-containing process and Interferon beta-1a produced by the new serum-free manufacturing
      process.
    


Intervention name(s): Interferon beta-1a (current approved manufacturing process invloving FBS); Interferon beta-1a (new process, manufactured without FBS)
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 60 mcg given Intramuscularly (IM); Single dose of 60 mcg given Intramuscularly (IM)
Other intervention name(s): Avonex®)
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
First Trimester Placental Assessment in the Screening of Preeclampsia and Intrauterine Growth Restriction
Condition: Preeclampsia; Intrauterine Growth Restriction
MeSH terms: Pre-Eclampsia; Fetal Growth Retardation
Study type: Observational

Summary: 
      Preeclampsia (PE) and intrauterine growth restriction (IUGR) are clinical manifestations of
      placental insufficiency. These complications affect 5-15% of pregnancies, and are responsible
      for up to 20% of preterm births. Women who develop PE during pregnancy also have an increased
      risk for cardiovascular events, both at short and long term. This justifies the need to
      improve diagnostic tools to identify patients at risk for these complications. PE and IUGR
      are multifactorial entities. Screening algorithms should thus include several parameters to
      achieve high detection rates. Research has mainly focused in the analysis of biophysical and
      biochemical parameters, and the study of the placenta itself has not been included in current
      diagnostic strategies. Investigators hypothesize that detection rates of preeclampsia and
      intrauterine growth restriction could be improved by the study of placental characteristics
      in the first trimester of pregnancy.
    


Intervention name(s): Ultrasound study of the placenta; Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test
Intervention type(s): Other; Other
Intervention description(s): The placenta will be scanned to measure the placental volume, chorionic plate, basal plate and thickness.
Intervention MeSH terms: Angiogenesis Inhibitors; Angiogenesis Inducing Agents
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with singleton pregnancies and ultrasonographic evaluation between 11+0 and 13+6
        weeks of gestation
      
Biospecimen description: 
      Serum samples from the first blood test performed during pregnancy
    
Keywords: Placental volume; First-trimester screening; Ultrasound; Preeclampsia; Intrauterine growth restriction; Biochemical markers; Uterine artery doppler
The 24 Hour Effects of Remedial Exercises With and Without Compression Therapy on Breast Cancer-related Lymphedema
Condition: Lymphedema, Breast Cancer
MeSH terms: Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
Study type: Interventional

Summary: 
      The aim of this study to investigate 24 hours of effects of remedial exercises with and
      without compression therapy on severity of lymphedema and symptoms of the lymphedema The
      present study is designed as a non-drug clinical trial. The patients will complete two
      remedial exercise sessions, one without and one with compression in a randomized order
      separated by a 3-day wash-out period.The main questions it aims to answer are

        1. The 24 hour effects of remedial exercises with and without compression therapy on the
           severity of lymphedema are different in individuals with lymphedema associated with
           breast cancer surgery.

        2. The 24 hour effects of remedial exercises with and without compression therapy on the
           symptoms of lymphedema are different in individuals with lymphedema associated with
           breast cancer surgery.
    


Intervention name(s): Remedial exercise; Compression bandage
Intervention type(s): Other; Other
Intervention description(s): Remedial exercise program will be taught by qualified physiotherapist. Patients will be practiced to the exercise 3 sets of 15 repetitions without compression. Patients will be monitored telephonically in the washout period for remain the routine activities.; Multi-layered short stretch bandaging will be applied for 23 hour. Patients will be practiced to the exercise 3 sets of 15 repetitions with compression bandage. The bandage will be removed at the same time the next day. Patients will be monitored telephonically in the washout period for remain the routine activities.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: compression therapy; lymphedema; exercise
The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Injured Soldiers
Condition: Acute Compartment Syndrome
MeSH terms: Compartment Syndromes; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to define the reliability and accuracy of Near Infrared
      Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and
      noninjured extremities over time. The investigators hypothesize that this technology,
      combined with vital signs, intracompartmental pressures and clinical examinations, will be
      useful in diagnosing acute compartment syndrome (ACS), monitoring patients at risk for ACS,
      and evaluating the adequacy of fasciotomy in patients treated for ACS.
    


Intervention name(s): near-infrared spectroscopy
Intervention type(s): Device
Intervention description(s): Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Active duty OIF/OEF military personnel who have been air evacuated from theater to
        Landstuhl Regional Medical Center (LRMC). Ambulatory, self-care volunteers from the LRMC
        outpatient spine center will be identified to serve as controls for Cohort 1.
      
Keywords: near infrared spectroscopy; lower extremity injury
Study to Evaluate the Safety and Immunogenicity of Nimenrix (Registered) in Healthy Infants, Given at 3 and 12 Months of Age
Condition: Meningococcal Vaccine
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and immunogenicity of a single dose of Nimenrix in
      infants at 3 months of age, followed by a second dose at 12 months of age. Current posology
      allows for 2 doses of Nimenrix before 6 months of age, where the first dose is administered
      from 6 weeks onwards with a second dose at least 2 months later, with a booster at 12 months;
      and in infants from 6 months of age, a single dose at 6 months, with a booster dose at 12
      months. This study will provide valuable immunogenicity and safety data for a single dose in
      healthy infants <6 months of age, followed by the booster at 12 months
    


Intervention name(s): Nimenrix
Intervention type(s): Biological
Intervention description(s): MenACWY-TT vaccine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention