bioihbjkbjnl/mcl2 huggingface dataset:
Benefit of Assistive Listening Device for Lateralization
Condition: Hearing Loss, Sensorineural
MeSH terms: Hearing Loss; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe
      sensorineural hearing loss using a Phonak Roger microphone and hearing aid with compatible
      Phonak Roger receiver. Target speech will be presented from multiple directions while
      competing diffuse background noise is presented simultaneously. Participants will repeat back
      words and percent correct is calculated.
    


Intervention name(s): Roger On microphone; Roger Select microphone
Intervention type(s): Device; Device
Intervention description(s): Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids; Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Therapeutic Time Window of Mannitol During Craniotomy for Optimal Brain Relaxation in Patients With Supratentorial Tumours
Condition: Supratentorial Tumors
MeSH terms: Supratentorial Neoplasms
Study type: Interventional

Summary: 
      Although mannitol is used for brain relaxation during neurosurgery and in the treatment of
      raised intracranial pressure; there is not a consensus on its safe, effective dose and the
      duration of its administration. This study aimed to compare the effects of the mannitol in
      different use times, on the brain relaxation, electrolyte, lactate levels of the blood,
      peroperative fluid balance and the volume of the urine in supratentorial mass resection
      surgeries.
    


Intervention name(s): Mannitol
Intervention type(s): Drug
Intervention description(s): This drug is in our routine use of neuroanesthesia, are given for facilitate brain relaxation
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: brain relaxation; mannitol; supratentorial tumours
Early Ambulation to Reduce Hospital Length of Stay
Condition: Ambulation; Wearable Devices
Study type: Interventional

Summary: 
      Early ambulation of inpatients has been shown to be a key driver of decreased LOS and also
      reduced adverse events such as venous thromboembolism (VTE). We will test if a patient
      wearable device (pedometer) measuring steps and ambulation sessions decreases hospital LOS
      (primary outcome), decreases hospital LOS index (LOSI), decreases time to first ambulation,
      decreases time to first bowel movement (BM), decreases incidence of VTEs, and decreases costs
      (secondary outcomes). In a pilot randomized control trial, we will randomize 150 total adult
      patients admitted to UF Health Jacksonville in a 1:1 fashion to usual care and wearable
      pedometer or usual care. Patients randomized to the study intervention will receive a
      wearable pedometer upon admission, to be worn for the duration of their inpatient stay. Study
      outcome measures to be compared between the pedometer and no pedometer group include hospital
      LOS (primary outcome), hospital LOSI, time to first ambulation, time to first BM, incidence
      of VTEs, patient experience, and costs (secondary outcomes).
    


Intervention name(s): Wearable Pedometer
Intervention type(s): Device
Intervention description(s): Pedometer worn on wrist
Other intervention name(s): Pedometer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: length of stay; hospitalization
Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab
Condition: Inflammatory Bowel Disease
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine the rates of seroconversion to a hepatitis
      B vaccine series after a single 750 mg intravenous (IV) dose of vedolizumab or placebo.
      Secondary objectives are to determine the rates of seroconversion to an oral cholera vaccine
      series, assess change in anti-hepatitis B surface antibodies and assess the safety and
      tolerability of a single 750-mg IV dose of vedolizumab.
    


Intervention name(s): Vedolizumab; Placebo; Hepatitis B vaccine; Oral cholera vaccine
Intervention type(s): Drug; Drug; Biological; Biological
Intervention description(s): Vedolizumab for intravenous infusion; Placebo intravenous infusion
Other intervention name(s): Entyvio; MLN0002; MLN02; LDP-02; HBVAXPRO; Dukoral
Intervention MeSH terms: Vedolizumab; Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Drug therapy
Effectiveness of Menthol Chewing Gum in the Management of Thirst
Condition: Thirst
Study type: Interventional

Summary: 
      The objective of this study was to compare the effectiveness of menthol chewing gum compared
      to maintained fasting (usual care) in reducing the intensity of the surgical patient's thirst
      during the preoperative period. The hypothesis of the study was that the use of menthol
      chewing gum in surgical patients in the preoperative period would be more effective than the
      maintenance of fasting with regard to the decrease in thirst and its discomforts.
    

Detailed description: 
      There is evidence that chewing gum is effective in relieving thirst in the surgical patient
      in the preoperative period as it stimulates the salivary glands by means of mechano and
      chemoreceptors, increasing the salivary pH and flow, lubricating the oral cavity, acting in
      this way on peripheral thirst, which is triggered by dehydration of the oral mucosa.
      Furthermore, menthol gum stimulates the cold receptors, known as TRPM8, which are responsible
      for deactivating centers of thirst. Thus, the risk of bronchoaspiration due to gastric
      fullness is avoided and the discomfort of a dry mouth is reduced.Preliminary evidence
      indicates that the chewing gum strategy assists in the relief of a dry mouth and thirst in
      patients undergoing dialysis and head and neck radiotherapy. However, there is no scientific
      evidence of controlled studies with results that can be generalized regarding the use of
      chewing gum to reduce thirst and its discomforts in surgical patients in the preoperative
      period when they remain in a fasted state.
    

Intervention name(s): Menthol chewing gum; Usual care (fasting)
Intervention type(s): Other; Other
Intervention description(s): The experimental group received one unit of mentholated chewing gum, chewing and swallowing the saliva in a natural rhythm for 10 minutes. The menthol chewing gum used is called TRÍDENT®and is composed as follows: base gum, hydrogenated vegetable oil, vegetable oil, sweeteners: sorbitol, xylitol, mannitol, maltitol, aspartame, acesulfame potassium, and sucralose, humectants: glycerin and triacetin, flavorings (contains wheat derivatives), anti-humectant talc, emulsifiers: esters of mono- and diglycerides of fatty acids with acetic acid, soy lectin and mono and diglycerides of fatty acids and colorings: tartrazine and brilliant blue FCF, presenting a weight of 1.8g per unit.; The control group received the usual care given at the hospitalization units, that is, when the patient reported thirst, the need to maintain fasting for 10 minutes was reaffirmed.
Intervention MeSH terms: Menthol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chewing gum; Artificial saliva; Saliva; Mastication; Salivary glands; Xerostomia
Intravenous Immunoglobulin (IVIG) in Lung Transplantation
Condition: Hypogammaglobulinemia; Lung Transplantation
MeSH terms: Agammaglobulinemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent
      bacterial infections in lung transplant patients with low serum levels of immunoglobulin.
    

Detailed description: 
      An increased risk of infection despite intensive antimicrobial prophylaxis is a
      well-recognized complication of lung transplantation. Recent evidence suggests that
      immunosuppressive therapy after solid organ transplantation may lead to humoral
      immunodeficiency due to hypogammaglobulinemia (HGG). In lung transplant recipients with HGG,
      IVIG therapy offers the potential to significantly decrease the incidence and severity of
      infections, thereby reducing morbidity and potentially mortality.

      Comparison: The investigators are conducting a randomized clinical trial of IVIG versus
      placebo for lung transplant patients with severe HGG to see if IVIG decreases the number of
      bacterial infections in these patients.
    

Intervention name(s): IVIG; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks; 0.1% Albumin in an equal volume to the investigational product
Other intervention name(s): Immune globulin intravenous; Gamunex; Intravenous immunoglobulin
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hypogammaglobulinemia; Lung Transplantation
Therapeutic Individualization for Patients With Locally Advanced Gastric and Gastroesophageal Cancer
Condition: Gastric Cancer; Effects of Chemotherapy; Surgery
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to evaluate whether the R0 rate, pathological response degree,
      patterns of recurrence and long-term outcomes may be initially predicted in patients with
      locally advanced gastroesophageal junction and gastric cancer treated with a neoadjuvant
      approach and salvage surgery.
    

Detailed description: 
      Patients with locally advanced gastroesophageal junction and gastric cancer with T3-4 and/or
      N+ are included. Initially, patients are diagnosed by computerized tomography scan and
      endoscopic ultrasound. The neoadjuvant strategy consisted of 3-4 cycles of preoperative
      chemotherapy (group A) or 3-4 courses of induction chemotherapy followed by concurrent
      chemoradiotherapy (group B). Chemoradiotherapy comprised weekly chemotherapy concurrently
      with daily external beam radiotherapy up to 45 Gy). Surgery is scheduled 4 to 6 weeks after
      the end of CRT. Pathological response is graded according to the Becker criteria. Statistical
      analysis is performed IBM SPSS v20. Nonlinear mixed effects (NLME) modelling is applied to
      evaluate the impact of dynamic changes in tumor size, neutrophil lymphocyte ratio (NLR) and
      platelet lymphocyte ratio (PLR) on the clinical outcome of these patients.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with locally advanced adenocarcinoma gastric cancer for a neoadjuvant protocol
        consisting of preoperative chemotherapy or induction chemotherapy, chemoradiotherapy and
        salvage surgery. Patients must have a medically fit condition to complete the protocol.

        Initial staging comprises a thoracic and abdominal computerised tomography scan, endoscopic
        ultrasound endoscopy (EUS), biopsy and blood test including blood cell count, hepatic and
        renal function.

        Radiological and endoscopic evaluations are performed at baseline and at the completion of
        chemotherapy and chemoradiotherapy.

        Blood tests are acquired at baseline, before each chemotherapy course and concurrently with
        evaluations. Blood tests are also obtained during follow-up and at the time progression.
      
Biospecimen description: 
      Surgical specimen with potential for extraction of DNA.
    
Keywords: Radiotherapy; Neoadjuvant therapy; Pharmacodynamics; Pharmacokinetics; Nonlinear Dynamics
Lung Perfusion With Oxygenated Blood During Aortic Clamping
Condition: Postoperative Pulmonary Dysfunction
Study type: Interventional

Summary: 
      Pulmonary dysfunction presumably linked to an inflammatory response is frequent after cardiac
      operations using cardiopulmonary bypass (CPB) and pulmonary hypoperfusion.

      Aim of the study: To evaluate the protective effect of continuous pulmonary perfusion with
      oxygenated blood during aortic crossclamping on the inflammatory response.
    


Intervention name(s): lung perfusion; no lung perfusion
Intervention type(s): Procedure; Procedure
Intervention description(s): see literature of proceeding; see literature of proceeding
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I Study to Determine the Absorption, Distribution, Metabolism and Excretion of Esreboxetine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to learn more about how esreboxetine is handled by the body i.e.
      the absorption, metabolism and excretion of esreboxetine.
    


Intervention name(s): [14C]-esreboxetine
Intervention type(s): Drug
Intervention description(s): Single oral dose of 6mg esreboxetine in solution containing approximately 100uCi [14C]-esreboxetine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Radiolabel ADME study Healthy volunteers
Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to establish bioequivalence of two fixed dose
      combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin [Test 1] and
      low dose empagliflozin/500 mg metformin [Test 2]) and of the single tablets (medium dose
      empagliflozin tablets + Glucophage® 500 mg tablet [Reference 1] and low dose empagliflozin
      tablet + Glucophage® 500 mg tablet [Reference 2]) when administered together after a high
      fat, high caloric meal.

      The assessment of safety and tolerability will be an additional objective of this trial.
    


Intervention name(s): empagliflozin; metformin (Glucophage®); metformin (Glucophage®); empagliflozin; empagliflozin and metformin; empagliflozin and metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single tablet empagliflozin; single tablet metformin; single tablet metformin; single tablet empagliflozin; FDC tablet empagliflozin and metformin; FDC tablet empagliflozin and metformin
Intervention MeSH terms: Metformin; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Desmopressin on Blood Loss and the Quality of the Surgical Field During Endoscopic Sinus Surgery
Condition: Patients Undergoing Endoscopic Sinus Surgery
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      Bleeding during functional endoscopic sinus surgery (FESS) is a challenge for both surgeons
      and anesthesiologists despite several measures available for improving the surgical field.
      This study was conducted to evaluate the effect of desmopressin on blood loss and the quality
      of the surgical field in FESS.
    

Detailed description: 
      Desmopressin, a synthetic analogue of vasopressin, has been employed as a non-transfusional
      treatment for hemophilia and von Willebrand's disease. Hemostatic effects of desmopressin
      include: 1) an increase in plasma factors through endogenous release of coagulation factor
      VIII, von Willebrand factor and tissue plasminogen activator; 2) an increase in platelet
      adhesiveness; and 3) a reduction in bleeding time. Randomized, double-blind studies have been
      performed on patients undergoing various types of surgical procedures. A study in patients
      undergoing orthognathic surgery showed a significant reduction in intraoperative blood loss
      and a study in patients undergoing lumbar fusion concluded that desmopressin was effective in
      reducing intraoperative blood loss. The purpose of this study was to investigate the effect
      of administration of desmopressin on intraoperative blood loss in patients undergoing FESS.
    

Intervention name(s): Desmopressin; saline
Intervention type(s): Drug; Drug
Intervention description(s): Desmopressin 3ug/kg ivdrip before surgery; saline 100ml ivdrip before surgery
Intervention MeSH terms: Deamino Arginine Vasopressin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Evaluation Study of Web-based Resource for Youth
Condition: Chronic Disease; Healthy
MeSH terms: Chronic Disease
Study type: Interventional

Summary: 
      This study will evaluate DigiKnowIt News, a web-based resource to educate youth about
      pediatric clinical research. Youth will be randomly assigned to one of three groups (1.
      Intervention Version A; 2) Intervention Version B; 3) Wait-list control).
    

Detailed description: 
      Compared to the high numbers of clinical trials with adults, there are far fewer clinical
      trials with children and adolescents; highlighting the need for more clinical trials with
      pediatric populations. Lacking in the area of pediatric clinical research are resources to
      educate children and adolescents about clinical research in fun, interactive, and
      developmentally appropriate ways. Thus, a web-based resource, DigiKnowIt News, was developed
      for youth aged 8 to 14 years to educate youth about participating in pediatric clinical
      trials. The web-based resource includes video spotlights, investigations, and electronic
      comic books. The purpose of this study is to conduct a randomized controlled trial to
      determine the effectiveness of the web-based resource and examine its impact on youths'
      knowledge about pediatric clinical trials, self-efficacy about making decisions about
      participation in clinical research, and positive attitudes towards participation.
    

Intervention name(s): DigiKnowIt News
Intervention type(s): Behavioral
Intervention description(s): DigiKnowIt News is an online, interactive, multimedia web-based resource designed to educate youth about participating in clinical trials. Youth will learn general information about clinical trials, their rights in a clinical trial, the good and not so good of participating in clinical trials, communication with others during a clinical trial, and specific types of procedures used in clinical trials (i.e., needles, scans). DigiKnowIt News is web-based and youth can complete it at home, on their own time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Impact of Fitbit Plus Weight Management Program on Physical Activity and Metabolic Disease in Obese Adolescents
Condition: Obesity
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      This study is evaluating the feasibility and efficacy of using Fitbit Charge HR devices to
      remotely track the physical activity of obese pediatric patients who are concurrently
      enrolled in a comprehensive weight loss intervention program. Patients will receive Fitbit
      devices and will be called weekly to review their average daily steps and heart rates.
      Patients will receive the Fitbit either at the beginning of classes or upon completion of
      classes. Patients will then be followed remotely and called weekly for 12 additional weeks
      after completing classes. The two groups will be compared to examine for differences.
    

Detailed description: 
      Patients will be randomly assigned into one of two groups. In the first group, patients will
      undergo an already established multidisciplinary weight loss intervention program and will
      also wear Fitbit Charge HR devices. Their data will be regularly uploaded to their Fitbit
      Dashboard, and this information will be reviewed by the study team.
    

Intervention name(s): Fitbit Charge HR plus weekly phone calls to review physical activity data
Intervention type(s): Other
Intervention description(s): Patients during weekly Healthy Kids, Healthy Weight classes will also upload their Fitbit data, which will be remotely accessed by the study team and weekly phone calls will be implemented to discuss activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fitbit; Obesity; Pediatrics