bioihbjkbjnl/mcl2 huggingface dataset:
Video Distraction to Decrease Use of Sedation in Pediatric Participants During Radiation Therapy
Condition: Malignant Neoplasm
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I pilot trial studies how well video distraction works to decrease the use of
      sedation in pediatric participants during radiation therapy. Radiation treatment requires
      participants to lie very still (for accuracy). Many children cannot do this without sedation.
      Watching movies during radiation may distract children so they don't need sedation to
      complete treatment.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. To determine if the use of video distraction during radiation therapy (VidRT) during
      radiation for patients ages 3 to 13 decreases the rate of sedation use compared to patients
      previously treated without VidRT.

      SECONDARY OBJECTIVE:

      I. To determine which variables are associated with decreased need for sedation use.
      Variables will include patient age, length of treatment time (number of treatments and
      beam-on time), oncologic diagnosis, use of immobilization devices, pre-existing developmental
      or psychiatric diagnoses (attention deficit hyperactivity disorder [ADHD], dissociative
      disorders [DD], anxiety, depression, developmental delay, learning disability), pain scale
      ratings at time of first radiation treatment (0-10).

      EXPLORATORY OBJECTIVES:

      I. To determine the impact of VidRT on patient-reported quality of life prior to starting,
      during, and at the end of treatment using the pediatric quality of life inventory surveys
      including the Pediatric Quality of Life Inventory (PedsQL) - 4.0 Core and Peds QL- 3.0 brain
      tumor questionnaires.

      II. To determine the impact of VidRT on patient-reported anxiety throughout radiation
      treatment as monitored by Patient-Reported Outcomes Measurement Information System (PROMIS)
      pediatric item bank version (v) 2.0 anxiety questionnaire.

      III. To determine if workup assessment category for patient being low, medium, or high risk
      of needing sedation correlates to actual sedation use.

      OUTLINE:

      Participants undergo daily radiation therapy and watch videos/movies of their choice during
      treatments.
    

Intervention name(s): Quality-of-Life Assessment; Questionnaire Administration; Radiation Therapy; Video
Intervention type(s): Other; Other; Radiation; Other
Intervention description(s): Ancillary studies; Ancillary studies; Undergo RT; Watch video of choice during RT
Other intervention name(s): Quality of Life Assessment; Cancer Radiotherapy; Irradiate; Irradiated; Irradiation; Radiation; Radiation Therapy, NOS; Radiotherapeutics; RADIOTHERAPY; RT; Therapy, Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparison Between Two Techniques to Reposition the Maxilla After le Fort 1
Condition: Dentofacial Deformities; Le Fort; I
MeSH terms: Dentofacial Deformities
Study type: Interventional

Summary: 
      clinical and radiographic comparison between novel locating guide design with pre-bent
      titanium plates and 3d printed intermediate wafer to reposition the maxilla after Le Fort 1
      osteotomy in orthognathic surgery (randomized controlled clinical trial)
    

Detailed description: 
      Eligible patients will be allocated randomly into 2 equal groups with 7 patients in each
      group according to the method that will be used to reposition the maxilla by simple
      randomization using computer generated random numbers. Group 1 (Study group) will be treated
      with locating guides to reposition the maxilla with pre-bent plates on 3d model. Group 2
      (Control group) will be treated with Intermediate wafer.
    

Intervention name(s): Orthognathic surgery (lefort1)
Intervention type(s): Procedure
Intervention description(s): All patients will be treated under general anesthesia.
The surgical field will be scrubbed with povidone-iodine surgical scrub solution, followed by draping of the patient with sterile towels exposing only the area of surgery.
The surgical procedure of Le Fort I osteotomy will be performed which can be summarized as follows:
External reference marking
Incision and subperiosteal dissection
Maxillary osteotomy
Pterygomaxillary disjunction,
Septal, vomerine, and lateral nasal osteotomies
Down fracture
Mobilization of the maxilla
Application of stent in one group and the locating guide in the other group.
Maxillary fixation
Occlusal evaluation
Wound debridement and closure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: orthognathic; virtual planning
Prospective Study of Active Pain Management in Lung Cancer Outpatients (APM)
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is:

        -  A single-center, randomized, prospective controlled trial.

        -  To prove superiority of active pain management group compared to control group by the
           percent of pain intensity difference of outpatients with lung cancer pain.

        -  204 patients will be recruited.
    

Detailed description: 
      -  The recruited patients in both group will be provided the education about pain-killer,
           and received medicines including opioids according to their numeric rating scale (NRS)

        -  Active management group will be provided additional telephone counseling and dosage
           modification by specialized nurse for cancer pain.

        -  The percent of pain intensity difference (%PID)

             -  PID = (NRS of visit 1 - NRS of visit 3)/NRS of visit 1
    

Intervention name(s): Active pain management
Intervention type(s): Behavioral
Intervention description(s): Active pain management will be provided by specialized pain nurse, such as telephone counseling for toxicity control and opioid dose modification.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Lung cancer; Cancer pain; Opioid
Effect of Desflurane Versus Sevoflurane With Recent Bio-markers on Renal and Hepatic Functions
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Observational

Summary: 
      Studying the effects of both inhalational anesthetics desflurane and sevoflurane on hepatic
      integrity and renal function, guided by recent blood and urine biomarkers in patients
      undergoing laparoscopic cholecystectomy surgery.
    


Intervention name(s): Neutrophil Gelatinase-Associated Lipocalin (NGAL); Desflurane; Sevoflurane
Intervention type(s): Diagnostic Test; Drug; Drug
Intervention description(s): The evaluation of inhalational anesthetics (desflurane and sevoflurane) on NGAL levels in laparoscopic cholecystectomy patients.; Desflurane; Sevoflurane
Intervention MeSH terms: Sevoflurane; Desflurane
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        After informed written consents have been taken, this study will be conducted on 70
        patients scheduled for laparoscopic cholecystectomy. The patients will be randomly
        allocated into two groups (a desflurane (D) group and a sevoflurane (S) group) using a
        sealed envelope technique for each group.
Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg (T80/A5/H12.5 mg) Fixed-dose Combination (FDC) Tablet and T80/H12.5 mg Tab and A5 mg (Encap A2.5 mg Tab x2) Concomitant Use
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the steady state pharmacokinetics of different formulation of Telmisartan,
      Amlodipine, and Hydrochlorothiazide (HCTZ).
    


Intervention name(s): Amlodipine 5mg capsule; T80/H12.5 mg FDC tablet; T80/A5/H12.5 mg FDC tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Amlodipine 5mg capsule; Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg FDC tablet; Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg FDC tablet
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial to Evaluate Safety and Immunogenicity of an Ebola Zaire Vaccine in Healthy Adults
Condition: Ebola Virus Disease
MeSH terms: Virus Diseases; Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety profile of the Zaire Ebola vaccine and the
      strength of the immune response.
    

Detailed description: 
      Ebola Zaire is a filovirus that has caused devastating epidemics of hemorrhagic fever in
      South Africa. Research is underway to create a safe and effective vaccine to protect against
      Ebola disease, especially for the military and health care workers. Promising animal studies
      with this vaccine indicate safety and immunogenicity, and the vaccine platform used to
      deliver the Ebola protein antigen has been successful in creating a safe and protective
      immune response in people. Note that only one Ebola protein is used in this vaccine; since
      the entire intact Ebola virus is required for infection, it is impossible to get Ebola
      disease from this vaccine.

      The study targets enrollment of 39 healthy adults. These participants are divided into 3
      groups that will be administered one of three dose levels of the vaccine (low, medium, high).
      The study participants will receive two doses of vaccine: one on day 1 and the second on day
      28 (1 month). Three participants at each dose level will act as controls and receive a
      placebo instead of the active vaccine. A total of 13 visits to the clinic are required over a
      period of 26 weeks. The total study is expected to take 9 months.
    

Intervention name(s): Ebola Vaccine - low dose; Ebola Vaccine - mid dose; Ebola Vaccine - high dose; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 2 x 0.5ml vaccine will be given as intramuscular injections on each of day 1 and day 28; 2 x 0.5ml vaccine will be given as intramuscular injections on each of day 1 and day 28; 2 x 1.0ml vaccine will be given as intramuscular injections on each of day 1 and day 28; 2 x 0.5ml or 2 x 1.0ml placebo will be given as intramuscular injections on each of day 1 and day 28 depending on cohort
Other intervention name(s): Ebola Zaire Vaccine (2.5 x 10^4 pfu); Ebola Zaire Vaccine (2.5 x 10^5 pfu); High Dose Ebola Zaire Vaccine (2.0 x 10^6 pfu)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Ebola; VSV; Vesicular Stomatitis Virus; Vaccine; Zaire
Are Opioids Needed After ACL Reconstruction
Condition: Anterior Cruciate Ligament Rupture
MeSH terms: Rupture
Study type: Interventional
Phase: Phase 4

Summary: 
      As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons
      must revisit pain management protocols to reduce unnecessary opioid prescriptions. The
      long-term goal is to reduce opioid use and residual opioids in circulation.
    

Detailed description: 
      As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons
      must revisit pain management protocols to reduce unnecessary opioid prescriptions. The
      long-term goal is to reduce opioid use and residual opioids in circulation. The purposes are
      to 1) conduct a double-blinded randomized controlled trial to determine the effectiveness of
      opioid versus non-opioid medications on post-surgical pain, and 2) examine predictors of
      opioid usage in individuals following Anterior Cruciate ligament (ACL) reconstruction.
      Patients will use an innovative Smartphone application to track pain and medication usage.
      Additionally, patients will complete quality of life and pain catastrophizing questionnaires,
      as well as undergo pain threshold testing, to be used in a model to determine predictors of
      greater post-surgical opioid use. This study will provide information on non-opioid
      alternatives and specific predictors of post-surgical opioid use that can be used to develop
      prescribing protocols. These findings will help orthopaedic surgeons make informed decisions
      when tailoring individualized prescriptions for patients following ACL reconstruction.
      Importantly, findings will be readily translatable into research to reduce opioid use in
      other orthopaedic surgical cohorts as well. Our ultimate goal is to lessen the burden of the
      opioid epidemic on not only our orthopaedic patients, but also society, by minimizing the
      number of opioids left in circulation.
    

Intervention name(s): Oxycodone; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10; Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets.
Other intervention name(s): Xtampza ER, Oxaydo, Roxicodone, and Oxycontin
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, double-blind, randomized controlled clinical trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Opioids
Daily Physical Activity in Myelomeningocele
Condition: Physical Activity
MeSH terms: Meningomyelocele; Spina Bifida Cystica
Study type: Observational

Summary: 
      Obesity is getting more common and challenging to treat in children and adolescents with
      myelomeningocele. Therefore, it is becoming more important to determine daily physical
      activity in these patients. Daily walking performance and average steps per day in patients
      with low lumbar and sacral level myelomeningocele are shown to not differ from healthy
      controls. Step counts can not reflect all torsional accelerations associated with daily
      living activities. Omnidirectional accelerometers provide all types of body movement outputs
      and give detailed parameters of physical activity level and energy expenditure. There is no
      data about energy expenditure and physical activity level of the patients with
      myelomeningocele in daily routine. This study aims to quantify energy expenditure and
      physical activity of children and adolescents with low lumbar and sacral level
      myelomeningocele.
    

Detailed description: 
      Children and adolescents with low lumbar and sacral level myelomeningocele, and age-, sex-,
      and BMI-matched controls were included. Omnidirectional accelerometer monitor (Actical®) was
      used to assess activity energy expenditure and daily durations spent in sedentary, light
      activity and moderate to vigorous physical activity (MVPA).
    

Intervention name(s): Omnidirectional accelerometer monitor (3x3 cm and 16 g, Actical®, Philips Respironics)
Intervention type(s): Device
Intervention description(s): All participants were instructed to wear monitors for five consecutive days except during water-based activities. Data for each participant was collected to ensure included three valid weekdays. Daily activity energy expenditure (kcal/kg/min), and sedentary, light, moderate and vigorous levels (min) were examined using a software program.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children and adolescents with low lumbar and sacral level myelomeningocele and their age-,
        sex-, and body mass index (BMI)-matched healthy peers were included.
      
Keywords: Activity energy expenditure; Moderate to vigorous physical activity; Myelomeningocele
Influence of Metoclopramide on Ticagrelor Pharmacokinetics and Pharmacodynamics in Patients With Unstable Angina Pectoris on Concomitant Treatment With Morphine
Condition: Unstable Angina Pectoris
MeSH terms: Angina Pectoris; Angina, Unstable
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate differences in the pharmacokinetics and
      pharmacodynamics of ticagrelor and its active metabolite between patients who received
      ticagrelor and morphine followed by metoclopramide versus patients treated with ticagrelor
      and morphine alone for unstable angina pectoris.
    

Detailed description: 
      According to contemporary guidelines, ticagrelor is a recommended antiplatelet agent in acute
      coronary syndromes, including unstable angina pectoris. Quick platelet inhibition plays
      pivotal role in the treatment of acute coronary syndromes. As evidenced in the IMPRESSION
      study, analgesia with morphine delays platelet inhibition in patients with acute myocardial
      infarction. On the other hand, the results of the MOJITO study prove that administration of
      crushed ticagrelor tablets leads to quicker platelet blockage.

      Taking the above into consideration, we created a pharmacokinetic/pharmacodynamic study
      aiming to evaluate differences between patients who received crushed ticagrelor orally
      followed by either 1) a combination of intravenous morphine and metoclopramide or 2)
      intravenous morphine alone.

      The primary study outcome is time needed for ticagrelor and its active metabolite to reach
      their maximum plasma concentration in each study arm. Secondary outcomes include ticagrelor
      and AR-C124900XX maximum concentration and the area under the plasma concentration curve for
      both agents.

      Platelet reactivity will be assessed with the Multiplate Analyzer in all study participants
      at nine predefined time points.
    

Intervention name(s): Crushed ticagrelor followed by morphine; Crushed ticagrelor, morphine,metoclopramide
Intervention type(s): Drug; Drug
Intervention description(s): Crushed ticagrelor (180 mg) followed by morphine 5 mg intravenously; Crushed ticagrelor (180 mg) orally followed by morphine 5 mg and metoclopramide 10 mg intravenously
Other intervention name(s): Brilique; Brilique
Intervention MeSH terms: Morphine; Metoclopramide; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm
Condition: Trichuris Trichiura; Infection; Hookworm Infections
MeSH terms: Infections; Communicable Diseases; Hookworm Infections; Ancylostomiasis; Trichuriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The rationale of the study is to provide evidence on the efficacy and safety of Emodepside in
      adults infected with Trichuris trichiura and hookworm.
    


Intervention name(s): Emodepside
Intervention type(s): Drug
Intervention description(s): Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo.
Intervention MeSH terms: Emodepside
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Emodepside; Trichuris trichiura; Hookworm; Soil-transmitted helminths; Efficacy; Safety; Dose selection
Effect of Very-low Calorie Diet and Synbiotic Supplementation in Gut Microbiota (Pronokal Method)
Condition: Weight Loss; Inflammation
MeSH terms: Inflammation; Weight Loss
Study type: Interventional

Summary: 
      The present study aimed to investigate the changes produced in gut microbiota by a
      very-low-calorie-ketogenic diet followed by a low calorie diet, whether the use of synbiotics
      is able to modulate gut microbiota diversity and composition and its association with gut
      permeability and inflammation
    

Detailed description: 
      All participants followed a very-low-calorie ketogenic diet according to a commercial weight
      loss program (Pronokal method), which includes lifestyle and behavioural modification
      support. This method is based on high-biological-value protein preparations which contained
      15 g protein, 4 g carbohydrates, 3 g fat and 50 mg docosahexaenoic acid, and provided 90-110
      kcal. The study was divided in two phases. The first phase consists of a very-low-calorie
      ketogenic diet (600-800 kcal/day), low in carbohydrates and lipids. Throughout this ketogenic
      phase, supplements of vitamins and minerals such as K, Na, Mg, Ca and omega-3 fatty acids
      were provided. In this study the ketogenic step was maintained for 2 months. Then, the
      patients started a low-calorie diet (800-1500 kcal/day) which lasted two months.

      During the first phase consisting of a very-low-calorie ketogenic diet, subjects were
      randomly divided into two groups, the treatment group who received synbiotic supplementation
      as capsules, a complex of B. lactis, Lactobacillus rhamnosus, B. longum ES1 and prebiotics
      fiber (synbiotic 1) and the control group who received a placebo. During the second phase
      consisting of a low-calorie diet, the treatment group received synbiotic supplementation as
      capsules consisting of B. animalis subsp. lactis and prebiotics fiber (synbiotic 2)
      (synbiotic1 + synbiotic 2 group), while the control group was divided into two groups: one
      continued receiving a placebo (control group) whilst the other group received synbiotic 2
      (placebo + synbiotic2 group).
    

Intervention name(s): Diet; Synbiotic1; Synbiotic2
Intervention type(s): Other; Dietary Supplement; Dietary Supplement
Intervention description(s): Very low calorie ketogenic diet followed by low calorie diet; B. lactis, Lactobacillus rhamnosus, B. longum ES1 and prebiotics fiber; B. animalis subsp. lactis and prebiotics fiber
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: microbiota; obesity
Bioequivalence Study of Dr. Reddy's Divalproex Sodium Coated Particles in Capsules, 125 mg, Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, bioequivalence study of Divalproex Sodium coated particles in capsules 125 mg with
      Depakote® Sprinkle125 mg capsules in healthy, adult, human subjects under fed conditions.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, bioequivalence study of Divalproex Sodium Capsules (Sprinkle), 125 mg of
      Dr.Reddy's Laboratories Limited,comparing with that of Depakote® Sprinkle 125 mg capsules of
      Abbott Laboratories, USA in healthy, adult, human subjects under fed conditions with an
      adequate washout period of 10 days.
    

Intervention name(s): Divalproex Sodium
Intervention type(s): Drug
Intervention description(s): Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited
Other intervention name(s): Depakote Sprinkle
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment