bioihbjkbjnl/mcl2 huggingface dataset:
Pain Control in Children and Adolescent After Thoracic Surgery: The Effect of Gabapentin
Condition: Pain, Postoperative; Surgery, Thoracic
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is performed in patients aged 5-18 years after thoracic surgery. The primary aim of
      this trial is to determine whether the use of gabapentin as a component of multimodal
      analgesic regiments reduces pain scores following thoracic surgery in pediatric patients. The
      secondary objective of the trial are to evaluate whether the use of gabapentin reduces
      postoperative anxiety scores and consumption of ropivacaine with fentanyl, decreases
      side-effects, and improves patient satisfaction.
    

Detailed description: 
      The subjects are randomized to the Gabapentin or Placebo group. All patients receive
      preoperative gabapentin (15 mg/kg, treatment) or placebo, respectively and after surgery
      either gabapentin (7,5 mg/kg, treatment) or placebo 2 times per day for 3 days, respectively.

      Patients are subjected to the same anaesthesia protocol. Postoperative analgesia are achieved
      with either continuous ropivacaine 0.2%/fentanyl 5.0 μg/ml infusion through a thoracic
      epidural catheter (N=40; Gabapentin n=20, Placebo n=20), or intravenous infusion of morphine
      (N=40; Gabapentin n=20, Placebo n=20). All patients receive acetaminophen and non-steroidal
      anti-inflammatory drugs, and metamizol as a "rescue drug"

      The intravenous infusion of morphine grup was expanded on the basis of the bioethics
      commission's decision KB-125/2019 (N=64; Gabapentin n=32, Placebo n=32).
    

Intervention name(s): Gabapentin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients in this arm of the study receive identical capsules, containing 15 mg/kg of oral gabapentin.
Patients after surgery receive identical capsules, containing 7,5 mg/kg of oral gabapentin 2 times per day.; Patients in this arm of the study receive identical placebo capsules 1 hour before surgery.
Patients after surgery receive identical placebo capsules 2 times per day.
Other intervention name(s): Gabapentin TEVA, capsules
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative pain; Anxiety; Postoperative Complications; Patient Satisfaction
LANCGMS - Lantus Continuous Glucose Monitoring Subcutaneous
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of incidence of hypoglycaemic events and glycaemic fluctuations in diabetic
      patients with basal substitution with NPH insuline versus insuline glargine. Evaluation of
      HbA1c, FBG (Fasting Blood Glucose), BMI (Body Mass Index), dose of insulin, ratio of basal
      and prandial insulin, satisfaction with treatment, incidence of adverse events.
    


Intervention name(s): insulin glargine
Intervention type(s): Drug
Intervention MeSH terms: Insulin Glargine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intraosseous Transcutaneous Amputation Prosthesis
Condition: Traumatic Amputation of Lower Extremity
MeSH terms: Amputation, Traumatic
Study type: Interventional

Summary: 
      Direct Skeletal Fixation of Prosthetic Limbs Following Trans-Femoral Amputation - Study of an
      Intraosseous Transcutaneous Amputation Prosthesis (ITAPTM).
    

Detailed description: 
      The core ITAP™ design comprises of three discrete sections, the proximal section, which is
      the intramedullary stem secured into the medullary canal, the soft tissue integration flange
      and the transcutaneous component that passes through the skin. The device has been designed
      to be surgically implanted in a one stage procedure. In greater detail:

      Intra-medullary stem - this component is designed to match the natural shape of the canal and
      is designed using the same principles established and used for the fixation of massive
      endo-prosthetic replacements. In certain cases a hydroxyapatite ceramic (CaPO4) coating is
      used, providing enhanced uncemented fixation. In other cases, depending on the geometry of
      the intramedullary canal, the stem can be fixed in place using acrylic bone cement.
    

Intervention name(s): Direct skeletal fixation of ITAP to lower limb amputees.
Intervention type(s): Device
Intervention description(s): Intraosseous Transcutaneous Amputation Prosthesis (ITAPTM) fitting. The core ITAP™ design comprises of three discrete sections, the proximal section, which is the intramedullary stem secured into the medullary canal, the soft tissue integration flange and the transcutaneous component that passes through the skin.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osseointegration; Direct skeletal attachment
A Study to Analyze the Impact of Treatment With Paliperidone Palmitate on Clinical Outcomes and Hospital Resource Utilization in Adult Participants With Schizophrenia in Portugal
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The purpose of this study is to investigate the mean number of schizophrenia-related hospital
      admissions, in adult participants with schizophrenia, occurred during 12 months before and 12
      months after initiation of Paliperidone Palmitate 1-month formulation treatment.
    


Intervention name(s): Oral Antipsychotics (OAPs); Paliperidone Palmitate 1-Month Formulation (PP1M)
Intervention type(s): Drug; Drug
Intervention description(s): No study treatment will be administered as a part of this study. Participants will receive OAPs (such as olanzapine, risperidone, paliperidone, aripiprazole or quetiapine) as per their usual clinical practice.; No study treatment will be administered as a part of this study. Participants will receive PP1M as per their usual clinical practice.
Intervention MeSH terms: Paliperidone Palmitate; Antipsychotic Agents
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will include ambulatory participants diagnosed with schizophrenia that
        switched from oral antipsychotics (OAPs) to paliperidone palmitate 1-month formulation
        (PP1M), and with available information concerning the annual schizophrenia-related
        hospitalizations before and after initiation of PP1M treatment.
Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
Condition: Infections, Rotavirus
MeSH terms: Hepatitis B; Rotavirus Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess immunogenicity and safety of Rotarix TM when
      administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first
      vaccination) who received Hepatitis B immunoglobulin after birth.
    


Intervention name(s): Rotarix TM
Intervention type(s): Biological
Intervention description(s): Oral, 2 doses
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Human rotavirus vaccine
Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism
Condition: Secondary Hypogonadism
MeSH terms: Neoplasm Metastasis; Overweight; Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of ZA-302 is to determine the effects of Androxal on morning testosterone and
      reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism
      (confirmed morning T<300 ng/dL) and normal sperm concentration, compared to changes with
      placebo. Subjects must not have previously been treated with testosterone products within the
      last 6 months.
    

Detailed description: 
      Protocol ZA-302 is a randomized, double-blind, placebo-controlled multi-center Phase 3 study
      to evaluate normalization of morning testosterone levels in overweight men with acquired
      hypogonadotropic hypogonadism and normal baseline sperm concentrations. The study requires 10
      to 12 clinic visits (2 for eye exams), and is approximately 4 to 5½ months in duration.
      Subjects will be treated for 12-18 weeks. At Visit 3 (Week 6) subjects who do not achieve
      morning T values ≥300 ng/dL will be up-titrated to 25 mg. Placebo subjects may be sham
      titrated. Up-titrated subjects will receive an additional 6 weeks of treatment (18 weeks
      total). A schedule of procedures and assessments is displayed in Section 4. The study will
      enroll up to 152 male subjects, up to 114 randomized to treatment with Androxal and up to 38
      randomized to placebo, in a 3:1 ratio. Subjects must not have used any prior testosterone
      treatments within the last 6 months.

      Eligible subjects must have 2 consecutive assessments of morning T below 300 ng/dL and LH
      below 9.4 mIU/mL. They will provide 2 sperm samples at baseline, at least 2 days apart,
      another 2 after 12 weeks of treatment, and up-titrated subjects will provide an additional 2
      samples at the end of treatment. After 12 weeks of treatment (V5) all subjects will undergo
      serial T assessment for determination of the Cavg. Safety assessments will include collection
      of adverse events, eye examinations, physical examinations and clinical laboratory
      assessments.
    

Intervention name(s): enclomiphene citrate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral, capsules, taken one time daily, for 3 months; Oral capsule taken one time daily for 3 months
Other intervention name(s): Androxal; Dummy
Intervention MeSH terms: Enclomiphene; Clomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Different ARA Formulations of Infant Formula on Fatty Acid Status, Immune Markers and Infection Rates in Infants
Condition: Healthy Infants
MeSH terms: Infections
Study type: Interventional

Summary: 
      The clinical trial will investigate the effect of different formulations of ARA + 0.4% DHA in
      infant formula on plasma fatty acid status in healthy 6 months old infants supplemented for 6
      months. A 6-month follow on phase will provide additional efficacy (e.g. infection rates,
      immune markers) and safety information in these 12-18 month old infants.
    

Detailed description: 
      This study is a randomized, double-blind, parallel-group study of 0% ARA +0.4% DHA or 0.76%
      ARA +0.4% DHA supplemented infant formula provided to 6 months old healthy infants for 6
      months. Infants will have been breast-fed or formula-fed prior to enrollment. The difference
      in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation
      will be measured. Parents will be asked about the infant's current daily diet (fatty acid
      intakes calculated via 24 hour recalls). All completed infants will be enrolled into a 6
      month extension period (non-supplemented) to collect additional measures of efficacy (i.e.
      infections and illnesses, immune markers) and safety out to 18 months of age.
    

Intervention name(s): combination ARA + DHA; DHA
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): combination ARA + DHA supplemented infant formula; DHA supplemented infant formula
Other intervention name(s): infant formula; infant formula
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: arachidonic; docosahexaenoic acid; infant formula
A Clinical Study Evaluating Sedation of Intravenous Administration of HSK3486 in ICU Patients Undergoing Long-Term Mechanical Ventilation
Condition: Sedation in Intensive Care
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized, open-label, propofol-controlled exploratory clinical
      study. In this study, 20 ICU patients undergoing mechanical ventilation are expected to be
      enrolled and will be randomly assigned to the HSK3486 group and the propofol group in a 1:1
      ratio. This study is not blinded as it is open-label.
    


Intervention name(s): HSK3486; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Loading Dose：0.1 mg/kg，Maintenance Dose：Maintenance is started at 0.3 mg/kg/h, and the dose can be adjusted up and down by 0.05-0.1 mg/kg/h.; Loading Dose：0.5 mg/kg，Maintenance Dose：Maintenance is started at1.5 mg/kg/h, and the dose can be adjusted up and down by 0.25-0.5mg/kg/h.
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®
Condition: Diphtheria; Pertussis; Polio; Hepatitis B; Tetanus
MeSH terms: Hepatitis A; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of
      injections during the first 2 years of life while providing a complete course of immunization
      against infection caused by H. influenzae type b, hepatitis B virus, Corynebacterium
      diphtheriae, Clostridium tetani, Bordetella pertussis, and poliovirus types 1, 2, and 3.

      Primary Objective: To evaluate immunogenicity of PR5I with the adjuvant composition
      enhancement to the hepatitis B component when administered concomitantly with Prevnar®

      Secondary Objectives: To assess the safety and immunogenicity of PR5I when administered
      concomitantly, or one month apart with Prevnar® or separately with licensed vaccines used for
      routine infant vaccination in Canada.
    


Intervention name(s): Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC; Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC; Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, 4 doses, IM; 0.5 Ml, 4 doses, IM; 0.5 mL, 4 doses, IM with concommitant vaccines
Other intervention name(s): PR5I; PR5I; PR5I; PENTACEL™; NGERIX-B®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B; Pertussis; Diphtheria; Tetanus; H. influenzae type b; Polio
Dyslipidemia Prevalence, Perception, Treatment, and Awareness in the Tunisian Population
Condition: Dyslipidemias; Atherosclerosis; Households; Survey, Family Life
MeSH terms: Atherosclerosis; Dyslipidemias
Study type: Observational [Patient Registry]

Summary: 
      ATERA Survey is a national cross sectional observational study, aiming to determine the
      prevalence of dyslipidemia and other conventional risk factors for CHD (Coronary Heart
      Disease), the relationship between environmental and lifestyle factors with dyslipidemia, the
      perception and the knowledge of cardiovascular risk factors by the population, and above all,
      to strengthen the national strategy for primary and secondary prevention against coronary
      heart disease.
    

Detailed description: 
      ATERA Survey is carried on in a random sampling including 10 000 men and women from the seven
      regions of Tunisia (Great Tunis, North East, North West, central East, Central West, South
      East and South West. The screening is being assessed using surveys covering socioeconomic,
      nutritional and anthropometric measures in addition to biological assessments.

      The target population is being recruited by random sampling drown by the National Institute
      of Statistics (Tunisia). The estimated number of participants at the end of recruitment
      amount to 10 000. The frame sampling uses a two stage cluster sampling (district and
      household).

      Interview with each eligible participant will be conducted mainly during assessment visit and
      after consenting the subject, it will be notified all the demographic, behavioral history,
      family history, cardiovascular risk factors and medical history. During the assessment visit,
      Physical examination/anthropometry data and Diet survey will be filled up by the
      investigator.

      Data capture will be performed by the DACIMA Clinical Suite according to FDA 21 CFR part 11
      requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA
      specifications (Health Insurance Portability and Accountability Act), and the ICH standards
      (International Conference on Harmonisation)
    

Observational model: Family-Based
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All subjects aged between 25 and 75 years who accept to participate at the study
      
Biospecimen description: 
      Serum
    
Keywords: Coronary Heart Disease; Hypercholesterolemia; Triglycerides High; LDL Hyperlipoproteinemia; HDL Low; Diabetes; Cardiovascular Diseases; Hypertension; Risk Factor, Cardiovascular; Diet Habit; Smoking
Serum Proteomic Profiling for the Early Diagnosis of Colorectal Cancer
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      No ideal serum biomarker currently exists for the early diagnosis of colorectal cancer (CRC).
      Therefore, it is urgent that accurate and reliable serum biomarkers be identified.
    

Detailed description: 
      Magnetic bead-based fractionation coupled with matrix-assisted laser
      desorption/ionization-time-of-flight mass spectrometry (MALDI-TOF MS) was used to screen
      serum samples from CRC patients and healthy controls.
    

Intervention name(s): Serum proteomics
Intervention type(s): Other
Intervention description(s): magnetic bead-based fractionation coupled with matrix-assisted laser desorption/ionization-time-of-flight mass spectrometry
Other intervention name(s): MB coupled with MALDI-TOF MS
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All of the CRC serum samples were obtained from patients with histologically confirmed
        colorectal cancer in the Department of General Surgery, Zhongshan Hospital, Fudan
        University, China. The control samples were collected from healthy volunteers.
      
Biospecimen description: 
      All fasting blood samples were prepared without anticoagulant and left to clot at room
      temperature for 1.5 h. The serum was then isolated by centrifugation at 3000 g for 10 min at
      room temperature and stored at -80℃. All samples were subjected to one freeze-thaw cycle.
    
Keywords: proteomics; serum peptides; colorectal cancer; MALDI-TOF MS
Spinal Cord Injury Epidural Stimulation
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      This is a feasibility study to test the use of epidural stimulation to restore volitional
      function previously lost due to spinal cord injury.

      Previous studies conducted in animal models, performed elsewhere and here at Mayo Clinic,
      have shown that direct electrical stimulation of the spinal cord increases the excitability
      of spared neuronal connections within the site of injury, thereby enhancing signal
      transmission and allowing recovery of previously lost volitional function. Recently, epidural
      electrical stimulation of the lumbosacral spinal cord in four individuals with spinal cord
      injury (SCI) has restored motor and autonomic function below the level of injury. Despite
      positive results, further translational research is needed to validate these findings. The
      goal of this proposal is to perform epidural stimulation to restore volitional function in
      patients with SCI. In two patients, we will implant an epidural stimulator onto the dorsal
      aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program
      of daily physical rehabilitation, treadmill step training, and epidural stimulation to
      recover motor, sensory, and autonomic function.
    


Intervention name(s): Epidural Stimulator
Intervention type(s): Device
Intervention description(s): Subjects will be implanted with an epidural stimulator onto the dorsal aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program of daily physical rehabilitation, treadmill step training, and epidural stimulation to recover motor, sensory, and autonomic function.
Other intervention name(s): Medtronic Restore ULTRA 97712
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Study of the Effect of Calorie Supplementation on Growth in Young Children on ADHD Medication
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to see if supplementing calories with Pediasure is effective in
      maintaining height, weight, and BMI percentiles for young children during 2 years of
      treatment with ADHD medication.
    

Detailed description: 
      This is a pilot study evaluating the effect of caloric supplementation on maintenance of
      growth parameters during two years of open-label atomoxetine treatment in 5 and 6 year old
      children with ADHD. The study will assess the efficacy of caloric supplementation in
      maintaining baseline percentiles for height, weight, and body mass index (BMI). Patients will
      be randomly assigned to receive either PediaSure for caloric supplementation, or no
      supplementation.

      Secondary aims include assessing the tolerability and efficacy of long-term, open-label
      atomoxetine treatment in 5 and 6 year old children with ADHD, and obtaining adequate pilot
      data regarding the safety, efficacy, and potential effects of atomoxetine on growth
      parameters in order to submit a multisite R01 to more adequately assess atomoxetine treatment
      and its effects in young children with ADHD.
    

Intervention name(s): Pediasure; Nutritional counseling
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): 50% will be randomized to pediasure with nutritional counseling; 50% randomized to nutritional counseling only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Growth; Atomoxetine; Pediasure
The Contribution of Heels for Walking Quality Among Children With Muscular Dystrophy
Condition: Step Time and Length; Symmetry; Step Time and Length Variability; Heart Rate; Gait Velocity
Study type: Observational

Summary: 
      During the stand phase the DMD foot is too plantarflexed in addition patients adopt a higher
      flexion and abduction of the hip in order to advance the swinging limb. The aim of this work
      is to assess the immediate contribution of heels for these walking disturbance in children
      with muscular dystrophy disease.
    


Intervention name(s): adding a heel
Intervention type(s): Device
Intervention description(s): walking with and without heels on the gaitrite system
Observational model: Case-Only
Sampling method: Non-Probability Sample
Study population: 
        children with DMD age >6 yrs walk without heel strike