bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Fentanyl on Emergence Delirium (ED) on Children Undergoing Adeno-tonsilectomy at Kenyatta National Hospital (KNH)
Condition: Emergence Delirium
MeSH terms: Delirium; Emergence Delirium
Study type: Interventional

Summary: 
      This study will be a randomized double blind placebo controlled clinical trial among children
      undergoing adeno-tonsillectomy in KNH. The intervention arm will comprise Fentanyl given at a
      dose of 1ug/while the placebo arm will be given normal saline at a volume equivalent to
      Fentanyl dose, treatment will be administered approximately ten minutes to the end of surgery
      determined by the time when the mouth gag will be removed. The main outcome will be incidence
      of ED at the recovery room using Watcha scale and secondary outcomes will be delay in
      emergence time from anaesthesia and effectiveness of fentanyl in preventing ED.
    


Intervention name(s): Fentanyl; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): The intervention arm will comprise Fentanyl given at a dose of one microgram per kilogramme body weight administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed.; the placebo arm will be given normal saline at a volume equivalent to Fentanyl dose per body weight,administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed
Other intervention name(s): treatment; placebo
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Phase 2 Study of BMN 111 to Evaluate Safety, Tolerability, and Efficacy in Children With Achondroplasia
Condition: Achondroplasia
MeSH terms: Achondroplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, open-label, sequential cohort dose-escalation study of BMN 111 in children
      with achondroplasia. The primary objective is to assess the safety and tolerability of daily
      BMN 111 administered to children with achondroplasia.
    


Intervention name(s): BMN 111
Intervention type(s): Drug
Intervention description(s): BMN 111 will be administered daily for 24 months in an open-label sequential dose adjustment fashion.
Other intervention name(s): Modified recombinant human C-type natriuretic peptide; Vosoritide
Intervention MeSH terms: Natriuretic Peptide, C-Type
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Achondroplasia; Dwarfism; Bone Diseases, Developmental; Bone Diseases
Muscle Status to Oral Nutritional Supplementation in Hemodialysis Patients With Protein Energy Wasting
Condition: Muscle Wasting; End Stage Renal Disease on Dialysis
MeSH terms: Muscular Atrophy; Kidney Failure, Chronic; Wasting Syndrome; Cachexia
Study type: Interventional

Summary: 
      This multi-centred randomized, open label-controlled trial consists of hemodialysis (HD)
      patients identified with protein energy wasting (PEW) using the International Society of
      Renal Nutrition and Metabolism criteria. Intervention provided was oral nutritional
      supplementation (ONS) for 6 months and changes in muscle status in response toward the
      treatment was measured using ultrasound imaging method pre- and post-intervention.
    

Detailed description: 
      This study is a multi-centred randomized, open label-controlled trial where a total of 54 HD
      patients (29 intervention; 27 control) with PEW were recruited from government, private and
      non-governmental organization settings. Patients were randomized to either the intervention
      or control group. The intervention group received ONS (475 kcal and 21.7 g of protein), daily
      for 6 months. Both intervention and control group received standard nutritional counseling
      during the study period.

      Patients who consented were subjected to a screening for identification of PEW and other
      eligibility criteria. Patients who fulfilled the inclusion criteria were randomized to either
      control or intervention group. During the 6 months of treatment period, patients in both
      control and intervention groups were assessed at baseline, 3rd months and 6th months for
      changes in muscle status using ultrasound imaging and bio-impedance spectroscopy method,
      malnutrition inflammation complex syndrome using Malnutrition-Inflammation Score, and other
      measures indicative of nutritional status including anthropometry, biochemistry, dietary
      intake and quality of life assessment. These parameters were compared at baseline and 6
      months for within and between group differences using general linear model test.
    

Intervention name(s): Oral nutritional supplementation (ONS)
Intervention type(s): Dietary Supplement
Intervention description(s): Patients received a renal specific ONS (Novasource Renal, Nestle) providing 475 kcal and 21.7g of protein per serving on a daily basis for 6 months. This was a ready-to- drink formula available in a tetrabrik pack. Patients consumed the product 30 minutes after commencing their dialysis session or at home after completion of dialysis.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were allocated to intervention and control group. The intervention group received commercial renal-specific ONS for six months. Both groups received standard nutritional counseling during the study period.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hemodialysis; protein energy wasting; oral nutritional supplementation; ultrasound imaging
Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body
      build an immune response to kill tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who
      have non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the safety and feasibility of immunization with autologous tumor lysate-pulsed
           dendritic cell vaccine in patients with non-small cell lung cancer.

        -  Determine the immunologic response in patients treated with this vaccine.

      OUTLINE: Patients undergo surgery to remove all or most of the gross evidence of tumor. Two
      months after surgery (or 4 months if chemotherapy and/or radiotherapy are required), patients
      undergo leukapheresis. Peripheral blood mononuclear cells are isolated and cultured with
      interleukin-4 and sargramostim (GM-CSF) to generate dendritic cells (DC). DC are then pulsed
      with tumor lysate prepared from previously removed tumor. Patients receive autologous tumor
      lysate-pulsed DC vaccine subcutaneously twice, 4 weeks apart.

      Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 2 years.
    

Intervention name(s): autologous tumor cell vaccine; therapeutic autologous dendritic cells; conventional surgery
Intervention type(s): Biological; Biological; Procedure
Primary purpose: Treatment
Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer
Vitamin D Levels and Survival in Cancer Patients
Condition: Neoplasms
Study type: Observational

Summary: 
      Using the population-based data sources in Iceland and the well-characterized AGES-Reykjavik
      cohort, our overarching aims are on exploring whether pre-diagnostic serum levels of
      25-hydroxyvitamin D (25(OH)D) among older individuals living in Iceland were associated with
      survival after cancer diagnosis. We also wanted to assess the risk of being diagnosed with
      cancer in association with 25(OH)D levels. In this population living just south of the arctic
      circle, vitamin D levels largely depend on dietary- and supplemental sources.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        In 1967, all 30,795 men and women living in the capital area of Iceland and born between
        1907 and 1935 were invited by the Icelandic Heart Association to join a prospective cohort
        study. Approximately 19,000 attended the clinic at least once and became participants of
        the Reykjavik Study. Subsequently, in 2002, a random sample of the cohort comprising 5,764
        men and women who were still alive in Iceland and aged 66 to 96 years entered the Ages
        Gene/Environment Susceptibility (AGES) - Reykjavik Study (20). Serum 25(OH)D was measured
        in 5,519 of all 5,764 (96%) participants at study entry in year 2002 through 2006.
      
Biospecimen description: 
      Serum
Evaluation of Triple Antibiotic Paste Pulp Therapy Compared to Vitapex in Primary Molars.
Condition: Dental Pulp Cavity
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study was to compare the clinical and radiographic success of triple
      antibiotic paste (TAP) which includes (metronidazole, ciprofloxacin, and minocycline) and
      Vitapex (calcium hydroxide/iodoform paste) for root canal treatment of pulpally involved
      teeth.
    

Detailed description: 
      This study evaluated and compared the clinical and radiographic efficacy of
      non-instrumentation triple antibiotic paste pulp therapy (TAP) versus Vitapex pulpectomy in
      non-vital primary molars. Healthy 5 to 9 years old children with at least one non-vital
      primary molar were included in the study. molars were divided based on the subject's
      cooperation level and parental preference into two groups. In the first group, molars
      received TAP and in the second group, they received Vitapex pulpectomy followed by a
      stainless-steel crown. The TAP was freshly prepared and proportioned in equal parts by volume
      (metronidazole, minocycline, and ciprofloxacin=1:1:1) before the scheduled treatment
      appointment. The clinical and radiographic examination was performed by two calibrated and
      trained pediatric dentists at the pre-operative baseline and at the six- and 12-months
      follow-up visits.
    

Intervention name(s): triple antibiotic paste (TAP); Vitapex (calcium hydroxide/iodoform paste)
Intervention type(s): Drug; Drug
Intervention description(s): root canal treatment of pulpally involved teeth.; root canal treatment of pulpally involved teeth.
Intervention MeSH terms: Anti-Bacterial Agents; Calcium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Deciduous teeth, endodontic treatment, primary molars, pulpectomy.
Evaluation of Regional Myocardial Dynamics at Physical Stress in Essential Hypertension
Condition: Hypertension; Left Ventricular Hypertrophy
MeSH terms: Hypertension; Essential Hypertension; Hypertrophy, Left Ventricular; Hypertrophy
Study type: Interventional

Summary: 
      The study hypothesis is stress-related regional tissue dynamics is related to left
      ventricular outflow tract blood flow.
    


Intervention name(s): stress echocardiography
Intervention type(s): Procedure
Intervention description(s): safety and efficacy of stress echocardiography
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Pharmacodynamics and Pharmacokinetics of Aspirin Inhalation Powder With Non-Enteric-Coated Chewable Aspirin
Condition: Platelet Aggregation Inhibitors
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      ASA inhalation powder is an inhaled nonsteroidal anti-inflammatory drug-device combination
      that has been developed to reduce the risk of vascular mortality in patients with suspected
      acute myocardial infarction (MI), an FDA approved indication for oral formulations of
      aspirin.

      The primary goal of study OTP-P0-926 is to collect pharmacokinetic (PK)and pharmacodynamics
      (PD) pilot data to determine onset and extent of aspirin response after administration of
      varying doses of inhaled ASA (50-100mg) and 162 mg Non-Enteric-Coated Chewable ASA. PD will
      be assessed using standard methods to measure platelet inhibition by aspirin including
      platelet aggregation, serum thromboxane,and urinary thromboxane. Furthermore, the
      pharmacokinetics (PK) of ASA will be determined and compared to PD measurements. Results of
      this pilot study will guide dosing in a subsequent larger Phase II study.
    


Intervention name(s): Aspirin
Intervention type(s): Drug
Intervention description(s): Oral and inhaled ASA formulations
Other intervention name(s): Bayer Aspirin
Intervention MeSH terms: Aspirin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Silymarin for Acute Hepatitis
Condition: Hepatitis
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall objective of this project is to assess whether Silymarin therapy shortens illness
      or prevents complications in patients with acute hepatitis. We will specifically compare
      responses in acute hepatitis patients treated with Silymarin to those given a control
      preparation of a vitamin supplements in a double blinded, randomized, placebo-controlled
      trial.
    

Detailed description: 
      The study is designed as a double-blinded placebo controlled trial. We compare a 4 week
      course of therapy with silymarin tablets and a low-dose vitamin preparation (placebo) and
      then follow-up for a total of 8 weeks to assess treatment response. Outcomes of our
      randomized controlled trial are improvement in symptoms and signs, normalization of liver
      functions, time to resuming normal activities, and and sense of well-being. This protocol
      follows the standard therapeutic care for acute hepatitis except that the patients will
      receive either a herbal supplement (silymarin), which many patients are taking anyway, or a
      vitamin placebo.

      Freshly collected serum will be tested for anti-HAV IgM, anti-HBc Igm, anti-HBs, HBs Ag,
      anti-HCV antibody, HCV-RNA, anti-HDV IgM, anti-HEV IgM, CMV and EBV and for alanine
      aminotransferase (ALT), AST, direct and total bilirubin.
    

Intervention name(s): Silymarin (Silybum marianum)
Intervention type(s): Drug
Intervention MeSH terms: Silymarin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Acute hepatitis; Acute viral hepatitis; Acute nonviral hepatitis; Silymarin; Milk Thistle
Biological Standardization of Chenopodium Album Allergen Extract
Condition: Allergy to Chenopodium Album
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to determine the biologic activity of a Chenopodium album
      allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house
      reference preparation (IHRP).
    

Detailed description: 
      This is an open, unblinded and non-randomized biological assay. The study design is a slight
      modification of the recommendations proposed by the Nordic Guidelines.

      Four concentrations of Chenopodium album allergen extract, together with a positive and
      negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol
      saline solution, respectively, will be tested in every patient in duplicate on the volar
      surface of the forearm.
    

Intervention name(s): Prick test Chenopodium album allergen extract
Intervention type(s): Biological
Intervention description(s): This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines.
Four concentrations of Chenopodium album allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. This test will be referred to as the Titrated Skin Prick test.
Other intervention name(s): Chenopodium album allergen extract,
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Standardization; Immunotherapy; Skin prick test
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC122505MsOH Tablets in Healthy Adult Subjects
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The Safety, Tolerability, Pharmacokinetic and Food Effect Study of HEC122505MsOH Tablets in
      Healthy Subjects
    


Intervention name(s): HEC122505MsOH
Intervention type(s): Drug
Intervention description(s): Part2：Mulltiple doses once daily, up to 8 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of 18F-DCFPyL, a Second Generation Low-molecular Weight PSMA-based PET Radiotracer, in Patients With Prostate Cancer
Condition: Metastatic Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being done to determine the safety, biodistribution, and radiation dosimetry of
      18F-DCFPyL, and to detect prostate cancer by visual analysis.
    

Detailed description: 
      To assess the hypothesis that this new 2nd generation positron emission tomography (PET)
      radiopharmaceutical, 18F-DCFPyL, may possess pharmacokinetic and pharmacodynamic properties
      that will represent an advance in imaging metastatic prostate cancer in ten patients
      diagnosed with metastatic prostate cancer.
    

Intervention name(s): 18F-DCFPyL
Intervention type(s): Drug
Other intervention name(s): 10.0 A bolus of less than or equal to 9 mCi (331 MBq) of 18F-DCFPyL will be injected into the IV line by slow push IV push.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Metastatic Prostate Cancer
Glycemic Control, Brain Structure and Cognition in Youth With Type 1 Diabetes (T1DM)
Condition: Type 1 Diabetes Mellitis; Cognition
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      LO5 study: The investigators are inviting a new group of youth (ages 7-16) who have been
      recently diagnosed with type 1 diabetes and their non-diabetic siblings. These youth will
      complete cognitive tests and a MRI scan of the brain. This scan uses strong magnets to obtain
      pictures and does not involve any radiation or injections. The investigators will recruit
      patients within three months of their diagnosis date. The study entails 1 study visit that
      lasts 3.5 hours. Evening and weekend times are available. The investigators plan to enroll
      135 participants.

      HY5 study: The investigators are inviting a cohort of youth and young adults (ages 9-21) with
      type 1 diabetes and their non-diabetic siblings for a follow-up to a study they have already
      completed. This group of people will complete several memory and thinking tests along with
      several MRI scans of their brain, just as they did at their previous visits. The
      investigators plan to enroll 150 participants.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        LO5: Youth with type 1 diabetes (T1DM) between the ages of 7-16 who have been diagnosed
        within the previous 3 months. Non-diabetic siblings of the participants with T1DM aged 7-16
        years old.

        HY5: Youth and young adults (ages 9-21) who have already completed an earlier study with
        the lab.
      
Keywords: Type 1 Diabetes Mellitis; Youth; Hypoglycemia; Hyperglycemia; Cognition; Memory; Brain Growth & Development; Magnetic Resonance Imaging
Teen Sleep Health Study
Condition: Sleep Disorders, Circadian Rhythm; Adolescent Behavior
MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
Study type: Interventional

Summary: 
      The objective of this project is to develop an effective, yet feasible strategy to extend
      school-night sleep duration of older adolescents.
    

Detailed description: 
      The investigators are developing and testing a feasible behavioral intervention to increase
      school-night sleep duration by shifting the circadian system earlier and providing a time
      management plan for after-school activities in youngsters between 14 and 17 years and
      enrolled in high school. This study tests morning bright light and a school-night time
      management plan to facilitate earlier bedtimes to increase sleep duration. Circadian phase,
      sleep, neurobehavioral functioning and mood are measured before and immediately after the
      2-week intervention and compared to a control group. Long-term effectiveness, adherence, and
      acceptability are also examined in a 3-week extension study. These data will provide
      evidence-based treatment strategies for delayed and sleep-restricted adolescents, and
      acceptability of and adherence to the treatment in this age group.
    

Intervention name(s): Weekend Morning Bright Light & Early Bedtime
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Circadian rhythms; Sleep; Adolescence