bioihbjkbjnl/mcl2 huggingface dataset:
Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy
Condition: Nausea and Vomiting, Postoperative
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is a randomized placebo controlled trial to determine whether repeated
      postoperative prophylactic ondansetron ("Zofran") administration will prevent postoperative
      and/or postdischarge nausea and vomiting in patients undergoing ambulatory hip arthroscopy.
      Ondansetron will be administered in the intra- and post-operative period. These individuals
      will be followed on postoperative days 1, 2, and 3. It is hypothesized that the incidence of
      postdischarge nausea and vomiting (PDNV) will be significantly decreased by postoperative
      prophylactic administration of multiple doses of ondansetron (Zofran).
    


Intervention name(s): Ondansetron; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The study group will receive 4 mg of IV ondansetron perioperatively and also postoperative oral ondansetron tablets (8 mg each day for two days). The tablets will be concealed in generic capsules prepared by the pharmacy at the Hospital for Special Surgery to make the ondansetron tablets indistinguishable from the placebos.; The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days). These placebo tablets will contain lactose and be indistinguishable from the study medication.
Other intervention name(s): Zofran
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Immediate Effect Analysis of Vocal Techniques
Condition: Voice Disorders
MeSH terms: Voice Disorders
Study type: Observational

Summary: 
      The objective of this clinical and experimental study was to verify the immediate effect of
      vocal techniques: vibration, nasal sound and articulation in women without vocal complaints.
    

Detailed description: 
      Vocal techniques have been used, but few studies had as their aim to effectively verify its
      use and effect produced in voice and the larynx. The objective of this clinical and
      experimental study was to verify the immediate effect of vocal techniques: vibration, nasal
      sound and articulation. Material and method: 32 female subjects with normal to mild dysphonia
      participated in the research, with ages from 20 to 45 years. All subjects were submitted to
      realization of vocal techniques of vibration of the lips, articulation and nasal sounds for
      twenty minutes. The subjects were submitted to record the voice and laryngostroboscopic exams
      for perceptual analysis and laryngostroboscopic exams before and after the use of vocal
      techniques.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Were included in the study, female subjects with normal voices evidenced by the slightly
        altered auditory-perceptual analysis, without vocal complaints, aged between 20 and 45
        years.
      
Keywords: Voice; Voice Quality; Voice Training; Evaluation
Safety and Effect of Oral Doses of 5mg or 10mg of SLx-2101 for 14 Days in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to determine the effect of SLx-2101 dosed at 5mg or 10mg for 14 days on
      systolic, diastolic pressures and heart rate in patients with hypertension.
    

Detailed description: 
      1. Placebo-corrected supine peripheral systolic, diastolic blood pressures and heart rate

        2. 24 hour ambulatory blood pressure and heart rate

        3. Safety and tolerability
    

Intervention name(s): SLx-2101
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
WAVE. Wearable-based COVID-19 Markers for Prediction of Clinical Trajectories
Condition: COVID; COVID 19; SARS-CoV 2
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The aim is to develop a wearable-based ICU (intensive care unit) prediction algorithm for
      inpatients contracted with SARS-CoV-2. Inpatients with suspicion of COVID-19 or with
      confirmed SARS-CoV-2 infection will be included. The participants will be equipped with a
      smartwatch, which gathers physiological data throughout hospitalisation.
    

Detailed description: 
      The SARS-CoV-2 pandemic puts an unprecedented burden on the healthcare system, specifically
      its healthcare providers and the resource demands for intensive care units (ICUs). To support
      effective care despite large case numbers, hospital operations urgently need improved
      decision support in early identification of patients at risk of an acute COVID-19
      deterioration that requires ICU.

      The investigators aim at developing a wearable-based ICU algorithm for inpatients contracted
      with SARS-CoV-2. Inpatients on the general ward with suspicion of COVID-19 or with confirmed
      SARS-CoV-2 infection will be included. The participant will be equipped with a smartwatch and
      wear the device throughout the hospital stay until the patient (1) is discharged home, (2) is
      transferred to the ICU, or (3) palliative care is initiated. The smartwatch collects several
      physiological parameters (e.g. heart rate, heart rate variability, respiration rate, oxygen
      saturation). The collected data will be used to develop an ICU prediction algorithm to detect
      patients at risk of an acute COVID-19 deterioration that requires ICU.
    

Intervention name(s): Equipment with smartwatch throughout hospital stay on the general ward
Intervention type(s): Other
Intervention description(s): Participants with confirmed SARS-CoV-2 infection or suspicion of COVID-19 will be equipped with a smartwatch and wear the device throughout the hospital stay on the general ward.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with suspicion of COVID-19 or tested positive for SARS-CoV-2 that are or will be
        hospitalized on the general ward
      
Keywords: Smartwatch; Intensive care; Intensive care unit; Prediction; Artificial intelligence; Clinical trajectories
Platelet Rich Fibrin With 1% Metformin Gel for Treatment of Intrabony Defects
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 2

Summary: 
      ABSTRACT:

      Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which
      releases various growth factors that promote tissue regeneration. Metformin (MF), a member of
      biguanide group has been shown to facilitate osteoblast differentiation and thus may exhibit
      a favourable effect on alveolar bone . Current study was designed to evaluate the combined
      efficacy of PRF and 1% MF gel with open flap debridement (OFD) in treatment of intrabony
      defects in chronic periodontitis (CP) subjects.

      Methods: One hundred and twenty subjects with single defects were categorized into four
      treatment groups: OFD alone, OFD with PRF, OFD with 1% MF and OFD + PRF+1% MF. Clinical
      parameters like site specific plaque index (PI), modified sulcus bleeding index (mSBI),
      probing depth (PD), relative attachment level (RAL) and gingival marginal level (GML) were
      recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic
      intra-bony defect depth reduction was evaluated using computer-aided software at baseline and
      9 months.
    


Intervention name(s): open flap debridement (OFD); Platelet rich fibrin (PRF); Metformin
Intervention type(s): Procedure; Other; Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Periodontal Surgery; Periodontal Regeneration; Growth factors; Clinical trials
SR-BI and Antiviral Treatment Response in HCV
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      The scavenger receptor type B class I (SR-BI) is a receptor for high-density lipoproteins
      (HDL) and one of entry factors for hepatitis C virus (HCV). The investigators aimed to
      examine the association of single nucleotide polymorphisms (SNPs) of the SCARB1 gene, which
      encodes SR-BI, with virologic responses to pegylated interferon-based treatment in Asian
      chronic hepatitis C (CHC) patients.
    

Detailed description: 
      1. Purpose of study: To examine the impacts of single nucleotide polymorphisms (SNPs)
           relevant to SR-BI on CHC patients.

        2. Study Design To enroll 400 CHC patients during a 3-year period

        3. Specify objectives of study when collecting extra specimen from participants Collect
           blood samples for genomic DNA to examine the SR-BI gene polymorphisms.

        4. Expected Endpoints of Treatment Sustained virologic response (SVR) means undetectable
           serum HCV RNA levels 24 weeks after completion of antiviral therapy.
    

Intervention name(s): Peginterferon alfa-2a
Intervention type(s): Drug
Intervention description(s): Peginterferon alfa-2a 180μg plus daily oral weight-based ribavirin (1,000 mg for body weight 75 kg or less, 1,200 mg for body weight greater than 75 kg) for 24 or 48 weeks
Other intervention name(s): Pegsys
Intervention MeSH terms: Peginterferon alfa-2a
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        HCV genotype 1 or 2 patients who received pegylated interferon alfa-2a (Peg-IFN alfa-2a)
        plus ribavirin therapy were consecutively enrolled from the gastroenterological clinics
      
Biospecimen description: 
      All enrolled subjects were genotyped for the SNPs of the SCARB1 gene and IL28B gene. All
      their blood specimens were collected into EDTA tubes. Human genomic DNA was extracted by
      standard protocols with blood RBC lysis, cell lysis, DNA binding, wash and elution. Extracted
      DNA normalized to 50 ng/µl was obtained. DNA quality was assessed by calculating the
      absorbance ratio OD260 nm/280 nm using NanoDrop model ND-1000 (Thermo Scientific, Wilmington,
      DE, USA). The SNP was genotyped by using the ABI TaqMan allelic discrimination kit and the
      ABI7900HT Sequence Detection System (Applied Biosystems, Foster City, CA, USA)
A Phase I Study to Investigate the Absorption, Metabolism and Excretion in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the absorption and excretion kinetics of
      bardoxolone methyl and to determine and characterize metabolites present in plasma, urine and
      feces in men following a single oral does or 20 mg of [14C]-bardoxolone methyl.
    

Detailed description: 
      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): bardoxolone methyl
Intervention type(s): Drug
Intervention description(s): oral, single dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pain, Exercise and Psychological Well-being in Pectus Excavatum
Condition: Pectus Excavatum
MeSH terms: Funnel Chest
Study type: Observational

Summary: 
      Recovery following major surgical procedures can be influenced by both physical (optimization
      of cardiopulmonary function, pain control, activity) and psychological factors. Physical
      activity recommendations for post-operative patients is difficult, in part because little is
      known about the short- and long-term benefits of exercise and mobility on post-operative pain
      and return to normal functioning.
    

Detailed description: 
      Major surgery has a drastic impact on the lives of patients and their families. Often,
      patients undergoing the Nuss procedure have lingering pain which can complicate recovery.
      Depending on the nature of the surgery and the severity of disease, this recovery period can
      be as short as a few days, or it can take several weeks and even months. Few studies have
      demonstrated the benefit of physical activity and exercise postoperatively on returning to
      normal function. Additionally, research has suggested that pain and recovery can be
      influenced by psychological factors.

      The investigators will use wireless activity monitors to assess the activity levels of
      children who undergo major musculoskeletal surgery, specifically the Nuss procedure. The
      investigators will also evaluate this population for psychological well-being. In this pilot
      study, the investigators identify goals and objectives which will provide preliminary
      evidence for physical and psychological recommendations to reduce post-operative pain and
      improve recovery.

      Families will be asked to complete questionnaires at different phases in the surgery
      (pre-surgery, post bar insertion, post bar removal). Children will be instructed to record
      any pain they are experiencing as a result of their condition or the surgery at various time
      points. The activity levels will also be followed over the course of the recovery period.
    

Intervention name(s): No intervention
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children who are scheduled to undergo surgical correction for pectus excavatum (Nuss
        procedure)
      
Keywords: sunken chest; caved-in chest; chest deformity; sunken sternum
Glucose Monitoring During Threatening Preterm Birth in Patients With and Without Gestational Diabetes Mellitus
Condition: Diabetes, Gestational; Insulin Sensitivity; PreTerm Birth; Glucose Intolerance During Pregnancy; Glucocorticoids
MeSH terms: Premature Birth; Diabetes, Gestational; Diabetes Mellitus; Insulin Resistance; Glucose Intolerance; Hypersensitivity
Study type: Observational

Summary: 
      This study aims to show whether the hyperglycaemic phases following a treatment with
      glucocorticoids, as well as blood measurements correlated to high blood glucose levels and
      insulin resistance, vary significantly between patients with and without gestational diabetes
      mellitus.
    

Detailed description: 
      BACKGROUND:

      The therapy with glucocorticoids for fetal lung maturation in the case of threatening preterm
      birth is an long existing part of the obstetric routine procedures. Under this therapy it
      should not be forgotten, that glucocorticoids can lead to a decrease of the maternal insulin
      sensitivity as well as they can cause an impaired maternal glucose tolerance.

      Therefore a threatening preterm birth as well as the including medical therapy do challenge
      the glucose metabolism of mother and child.

      Gestational diabetes mellitus (GDM) is one of the most common complications during pregnancy,
      and the numbers are on the rise. GDM is characterized through an insulin resistance during
      the pregnancy.

      High blood glucose level during pregnancy or labour can cause complications like a fetal
      hypoglycaemia right after birth.

      METHODS:

      This study includes pregnant women with and without gestational diabetes who are medicated
      with betamethasone due to threatening preterm birth.

      In this study the blood glucose measurements of one week, as well as the measurements of
      HbA1C, Insulin and Blood Glucose from a blood draw one week after the lung maturation therapy
      will be considered.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All participating patients will be pregnant women with a threatening preterm birth admitted
        to the department of feto-maternal health and obstetrics of the AKH Vienna.
      
Keywords: Blood glucose monitoring; Glucose tolerance; HbA1C; Insulin; Betamethasone
Ropivacaine Volume for Ultrasound-guided Retrograde Infraclavicular Brachial Plexus Block
Condition: Upper Extremity Injury Trauma
MeSH terms: Arm Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The retrograde infraclavicular brachial plexus block has been proved an effective and safe
      approach. Realtime ultrasound guide will facilitate a successful peripheral nerve block. The
      purpose of this study was to determine the medium effective volume required to produce an
      effective retrograde infraclavicular block using an ultrasound (US)-guided technique.
    

Detailed description: 
      Thirty adults undergoing elective upper limb surgery received an US-guided retrograde
      infraclavicular block. The initial concentration of 0.5% ropivacaine injected was 30 ml,
      which was subsequently varied at a ratio of 1: 1.2 for each consecutive patient according to
      the response of the previous patient. The medium effective volume (EV50) was determined using
      the Dixon and Massey up-and-down method. The effective volume in 95% of patients (EV95) was
      calculated using probit regression.
    

Intervention name(s): appropriate volume of 0.5% ropivacaine
Intervention type(s): Procedure
Intervention description(s): initial concentration: 30 ml, subsequently varied at a ratio of 1: 1.2 for each consecutive patient according to the response of the previous patient, until 5 up-and-down cycles completed.
Other intervention name(s): Naropin
Intervention MeSH terms: Ropivacaine
Intervention model: Single Group Assignment
Masking: Single (Participant)
Keywords: Anesthetic techniques,regional; Drug delivery,volume; Anesthetic, local: ropivacaine
Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery
Condition: Anesthesia, Spinal; Cesarean Section
Study type: Interventional

Summary: 
      The study will compare one technique of fluid administration (combined colloid preload and
      crystalloid colaod) with another one (crystalloid coload) during elective cesarean delivery
      performed under spinal anesthesia.
    

Detailed description: 
      This randomized, controlled, double-blind study will be conducted on ASA physical status II
      parturients with full-term singleton pregnancy undergoing elective cesarean delivery under
      spinal anesthesia. Participants will receive either 500 mL colloid preload and 500 mL
      crystalloid coload (Combination group) or 1000 mL crystalloid coload (Coload group). Systolic
      blood pressure will be recorded every minute and ephedrine will be administered when
      hypotension occurs according to a predefined protocol. The total ephedrine dose, time to the
      first ephedrine dose, heart rate, inferior vena cava diameter, nausea/vomiting, and neonatal
      Apgar scores will be recorded.
    

Intervention name(s): 500 mL Colloid Preload; Spinal Anesthesia; Intrathecal Bupivacaine; Intrathecal Fentanyl; 500 mL Crystalloid Coload; 1000 mL Crystalloid Coload; Cesarean Delivery; Ultrasound Assessment of the Inferior Vena Cava; Intravenous Ephedrine
Intervention type(s): Drug; Procedure; Drug; Drug; Drug; Drug; Procedure; Radiation; Drug
Intervention description(s): 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 500 mL will be rapidly infused before spinal anesthesia; Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle; Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space; Fentanyl 15 µg will be administered in the subarachnoid space; Ringer acetate 500 mL will be rapidly infused immediately after intrathecal injection; Ringer acetate 1000 mL will be rapidly infused immediately after intrathecal injection; Lower segment cesarean section using the Pfannenstiel incision; The inferior vena cava largest and smallest diameters will be measured proximal to the opening of the hepatic veins in the longitudinal axis with the M-mode using a 5-2 MHz curved array ultrasound probe placed longitudinally in the subxiphoid region; Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 90%, 80%, and 70% of baseline, respectively.
Intervention MeSH terms: Ephedrine; Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium
Condition: Delirium
MeSH terms: Delirium; Dyssomnias; Parasomnias; Emergence Delirium
Study type: Observational

Summary: 
      The investigators are performing this research study to understand the role of sleep
      disturbance on the incidence/severity of delirium after surgery. The investigators will study
      the brain using a polysomnography device (PSG), which records the brain's electrical activity
      during sleep.
    

Detailed description: 
      During this study, PSG recordings will be collected and a sleep questionnaire will be
      administered to participants on the night before surgery in order to establish level of
      preexisting sleep disturbance. Delirium assessments will be conducted during the
      postoperative period. On postoperative days 0 and 1, blood will be collected for analysis.
      Further cognitive, quality of life and pain questionnaires will be administered
      perioperatively.
    

Intervention name(s): PSG
Intervention type(s): Device
Intervention description(s): PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Inpatients over the age of 60 scheduled for a surgical procedure at MGH
The Effects of an Antioxidant Formulation on Ocular Blood Flow
Condition: Primary Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      The objective is to evaluate the effects of an antioxidant formula versus placebo on ocular
      blood flow in a randomized double-blind, crossover design.

      Based upon preliminary data, it is hypothesized that a dietary supplement containing a
      variety of ingredients with antioxidant properties will, compared to placebo, increase ocular
      perfusion pressure, retrobulbar, retinal capillary and choroidal blood flow, and maintain
      these effects over the course of the treatment period.
    


Intervention name(s): dietary supplement with antioxidants; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids; Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants
Other intervention name(s): Optic Nerve Formula
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Primary open angle glaucoma; intraocular pressure; ocular perfusion pressure; retrobulbar blood flow; retinal capillary blood flow; choroidal blood flow