bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic Study in Children and Adolescents Aged 6 to 17 Years Who Have Been Diagnosed With ADHD
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1

Summary: 
      To provide additional, required information on the pharmacokinetic profile of SHP465 in the
      targeted population (children and adolescents aged 6-17 years of age with ADHD).
    


Intervention name(s): SHP465 12.5mg; SHP465 25mg
Intervention type(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fascia Lata Allograft Versus Subepithelial Connective Tissue Grafts in the Peri-Implant Mucosal Thickness Enhancement.
Condition: Implant Tissue Failure
Study type: Interventional

Summary: 
      The aim of this, randomized clinical trial is to determine the clinical efficacy of fascia
      lata allograft in terms of peri-implant mucosal augmentation, as compared to autologous sub
      epithelial connective tissue graft, clinically and histologically in human adults .
    

Detailed description: 
      The aim of this, randomized clinical trial is to determine the clinical efficacy of fascia
      lata allograft in terms of peri-implant mucosal augmentation, as compared to autologous sub
      epithelial connective tissue graft, clinically and histologically in human adults .

      The hypothesis of the study is that a similar gain in peri implant mucosal thicknesses will
      be obtained in sites treated by either a sub epithelial connective tissue graft or a newly
      developed fascia lata allograft in clinically and histologically in human.

      The objective of this study will be to evaluate the efficacy of the peri-implant mucosal
      thickness enhancement following either subepithelial connective tissue grafts or human Fascia
      Lata Allograft placed simultaneously with dental implant placement.

      Sixteen sites that are indicated for peri-implant mucosal augmentation at the time of implant
      placement will be selected. Participants will be randomized to the control (simultaneous
      SCTGs) or test (simultaneous FLA) group.
    

Intervention name(s): Soft Tissue Enhancement around dental implant
Intervention type(s): Procedure
Intervention description(s): Sixteen sites that are indicated for peri-implant mucosal augmentation at the time of implant placement will be selected. Sixteen sites that were met the subsequent inclusion criteria were eligible to contribute in our study were classified randomly by the sealed envelope technique into two treatment groups, 8 sites in each group. Group I (Control Group): Autogenous SCTGs harvested from the palate +dental implants *. Group II (Experimental Group): FLA **+dental implants. The allocation was withheld from the surgeon (M.H.) until just before the surgical appointment. The clinical examiner (M.S.) was masked to the treatment group for the extent of the study.Three months after implantation, the sites were located, and the thickness of the mucosa will be evaluated using the customized stent. The operculectomy will be performed following the method of Flatebo et al.,22 collecting biopsy specimens of almost constant quality and evaluating clinical thickness without mucosal distortions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the trial is to assess the relative bioavailability of fixed dose combination
      tablets of linagliptin and metformin compared to the administration of two single tablets
      (linagliptin and metformin ) in Chinese subjects. The availability of a fixed dose
      combination tablet is expected to significantly enhance patients' compliance with
      antidiabetic treatment., in particular with concern to the frequent polypharmacy in diabetic
      patients.
    


Intervention name(s): linagliptin/metformin(high dose); Linagliptin/metformin(low dose)
Intervention type(s): Drug; Drug
Intervention description(s): patient would take fixed dose combination tablets of linagliptin /metformin (high dose) and single linagliptin and metformin (High dose) tablets single dose in random order, and each dosage will be separated in 42 days interval.; patient would take fixed dose combination tablets of linagliptin /metformin (low dose) and single linagliptin and metformin (Low dose) tablets single dose in random order, and each dosage will be separated in 42 days interval.
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Pharmacokinetics of Single Oral Doses of MBX-400 in Healthy Volunteers
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and pharmacokinetics following a single
      oral dose of MBX-400.
    

Detailed description: 
      Cytomegalovirus (CMV; herpesvirus 5), a member of the betaherpesvirus subgroup, occurs as a
      benign infection in the majority of humans, with a 90% prevalence in the adult population1.
      However, CMV infection continues to be a major cause of morbidity and mortality in
      immunosuppressed patients, particularly recipients of solid organ or bone marrow transplants.
      CMV is also known for its association with severe blinding retinitis, pneumonia and
      gastrointestinal inflammation in AIDS patients. However, with the successful introduction of
      HAART (highly active anti-retroviral therapy), the problem of CMV infection in AIDS patients
      has decreased substantially. CMV remains the most important cause of congenital viral
      infection in the United States, and CMV infection of neonates is associated with deafness,
      mental retardation and mortality. In addition, CMV is a suspected pathogenic agent in
      cardiovascular disease and can persist in large-vessel endothelial cells and infect all cell
      types involved in cardiovascular lesions. CMV has been implicated in the restenosis of
      diseased coronary arteries following angioplasty and has been associated with myocarditis. In
      severely immunocompromised patients with CMV infection, prolonged antiviral therapy is often
      necessary, which increases the risk of resistant viruses. Currently available therapy has
      limitations that preclude their long-term use including toxicity, poor oral bioavailability
      and the development of drug-resistant strains. MBX-400 is a nucleoside analog that is
      structurally related to ganciclovir and acyclovir and is being developed for the possible use
      in the prevention and/or treatment of CMV. MBX-400, has been shown to be a potent inhibitor
      of viral DNA synthesis and therefore may be useful in treating and/or preventing CMV
      infection.
    

Intervention name(s): MBX-400; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Capsule(s) for oral administration as a single dose. Planned doses include: 35, 100, 350, 700, 1000 and 1350 mg.; Capsule(s) for oral administration as a single dose. Planned doses include: 35, 100, 350, 700, 1000 and 1350 mg.
Other intervention name(s): ZSM-I-62; NSC D745998; Cyclopropavir (CPV); (Z)-9-{[2,2-bis-(hydroxymethyl)cyclopropylidene] methyl}guanine; microcrystalline cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cytomegalovirus; Antiviral; Safety; Healthy
Comparing the Efficacy of King Vision in Infants
Condition: Orotracheal Intubation in Infants Requiring General Anaesthesia for Surgery
Study type: Interventional

Summary: 
      The primary objective of this study is to find out whether the intubation success rates of
      Kingvision video laryngoscope is better than that of the conventional laryngoscopes in
      children < 1 year of age?
    

Detailed description: 
      Securing the airway by tracheal intubation is one of the most critical steps during
      administration of general anesthesia to infants. Failure or a delay in tracheal intubation
      leads to severe hypoxic insult to infants as the oxygen consumption is high in them when
      compared to adults.Smaller caliber of the pediatric airway, relatively large tongue,
      anteriorly located larynx, floppy and relatively large epiglottis predispose young children
      to airway obstruction during Anaesthesia. In addition, the large occiput of the infant places
      the head and neck in the flexed position when the patient is placed recumbent, further
      exacerbating airway obstruction

      Direct laryngoscopy requires a direct line of sight for proper glottis visualization which is
      achieved by proper alignment of airway axes (oral-pharyngeal-laryngeal). These manipulations
      can lead to significant hemodynamic disturbance, cervical instability, injury to oral and
      pharyngeal tissues and dental damage. In contrast to direct laryngoscopy, video laryngoscope
      utilizes indirect laryngoscopy via its camera and helps improve glottic visualization,
      thereby minimizing complications

      New age videolaryngoscopes with their unique design provide better glottis visualization
      without the requirement of proper alignment of oral-pharyngeal-laryngeal axes, thereby
      minimizing the complications associated with excessive manipulation and hence provide a
      decent edge over the conventional indirect laryngoscopes routinely used. With the above
      mentioned advantages these videolaryngoscopes can be efficiently used in both elective as
      well as emergencysettings in infants for intubation The investigators in this study will be
      evaluating the efficacy of King vision video laryngoscope when compared to the conventional
      laryngoscopes in routine use for infants.
    

Intervention name(s): Orotracheal intubation in infants with Macintosh; Orotracheal intubation in infants with King vision
Intervention type(s): Procedure; Procedure
Intervention description(s): Orotracheal intubation in infants using Macintosh laryngoscope; Orotracheal intubation in infants with King vision videolaryngoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: King vision; Difficult airway; Videolaryngoscope; Paediatric intubation
Project Healthy Eating in Adults. A Study on the Health Effects of Fish Intake in Overweight Adults (FINS)
Condition: Overweight or Obese Adults; Healthy
MeSH terms: Overweight
Study type: Interventional

Summary: 
      It has previously been observed that increased fish intake improves the metabolic health of
      overweight and obese adults, and animal protein improved metabolic health of obese rats. In
      this project the investigators will investigate whether increased intake of fish or meat
      improves metabolic health in overweight/obese adults aged 20-55 years when replacing
      processed food. The hypothesis is that increased intake of unprocessed fish or meat will
      improve metabolic health in adults as measured by glucose tolerance, lipid metabolism and
      inflammatory markers.
    


Intervention name(s): Salmon Group; Cod Group; Meat Group
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Prediction Model Based on Computed Tomography Liver Volume for the Short-term Mortality in Hepatitis B Related Acute-on-Chronic
Condition: Acute-on-Chronic Liver Failure; Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure
Study type: Observational

Summary: 
      HBV-related acute-on-chronic liver failure (HBV-ACLF) deteriorates rapidly with a high
      short-term mortality. Early identification and accurate prognostic prediction was critical to
      improve survival rate. This study was sought to determine the liver volumetry as predictor
      for short-term mortality in HBV-ACLF and develop a simpler prognostic model based on liver
      morphology. Liver volumetry were determined from CT at admission. Univariate and multivariate
      logistic regression were used to identify the optimum prognostic indicators and develop
      prognostic model. Additionally, receiver operating characteristic curves were analyzed to
      evaluate the predictive ability of the model.
    

Detailed description: 
      HBV-ACLF deteriorates rapidly with a high short-term mortality and early identification and
      accurate prognostic prediction may be the key to make clinical decision and improve survival
      rate. Liver volume, non-invasively reflects the balance of structural collapse with hepatic
      regeneration, predicting the prognosis of liver diseases. However, there is no idea whether
      the liver volume is an indicator to predict the mortality of HBV-ACLF patients. The present
      study evaluated the difference of liver volume between 28-day survival group and
      non-survivals and developed a new prognostic model based on liver volume . This study
      highlighted the significance of liver morphology in predicting the outcome of HBV-ACLF for
      the first time.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All the patients were diagnosed with hepatitis B virus-related acute-on-chronic liver
        failure who met with the inclusion criteria and exclusion criteria. Two cohorts of subjects
        were enrolled in several liver centers. In the modeling cohort, subjects were identified
        retrospectively from patients with acute exacerbation of chronic hepatitis B manifesting as
        hepatic encephalopathy (HE), upper gastrointestinal bleeding, ascites, acute jaundice and
        coagulopathy, referred from January 1, 2015 to December 31,2019. In the validation cohort,
        subjects were enrolled from external liver centers for validating the model.
      
Keywords: Hepatitis B; Acute-on-Chronic liver failure; liver volume; prognostic model
The Effectiveness of Chewing Gum in Influencing Capsule Endoscopy Transit Time
Condition: Gastric Transit Time; Small-bowel Transit Time
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of chewing gum, during the first one
      hour of examination in patients undergoing CE for GTT and SBTT time and the proportion of
      cases with complete small bowel examination and gastroscopy intervention.
    

Detailed description: 
      The participants will include patients who need to a capsule endoscopy (CE) in this unit. The
      investigators will include 200 participants who had a CE at our centre based on the gastric
      transit times. These will be randomly divided into two groups. The participants (chew chewing
      gum) and the controls (do not chew chewing gum).
    

Intervention name(s): Chewing Gum; Control
Intervention type(s): Other; Other
Intervention description(s): Patients of CG group chewed one piece of sugarless gum for approximately 15 min every 30 min at the first hour of the examination.; The control group will not chew chewing gum while undergoing capsule endoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients aged 16-80 years who were scheduled to undergo the small bowel capsule endoscopy(SBCE).
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Study of Evaluating Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this study was to evaluate the safety and immunogenicity of 10µg/0.5ml
      and 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in
      saccharomyces cereviside yeast for infants and other age groups.
    


Intervention name(s): 3 dose of 10µg/0.5ml hepatitis B vaccine; 3 dose of 5µg/0.5ml hepatitis B vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 3 dose of 10µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside were administered intramuscular injection at 0, 1, 6 momth interval.; 3 dose of 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside were administered intramuscular injection at 0, 1, 6 momth interval.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Safety; Immunogenicity; Vaccine; Hepatitis B
Efficacy and Safety of ALGRX 4975 in the Treatment of Postoperative Pain After Gall Bladder Removal
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      Postoperative pain after gall bladder removal can be significant, mobility limiting and
      extend hospital stay. ALGRX 4975 is an ultra-pure form of capsaicin, which is a pain medicine
      that has the potential for long-term pain relief following a single administration. This
      study will determine whether ALGRX 4975 can provide pain relief following gall bladder
      removal.
    

Detailed description: 
      Postoperative pain after open cholecystectomy can be significant and mobility limiting,
      causing increased risk of deep venous thrombosis, pulmonary complications, and extended
      hospital stay. With increasing emphasis on early postoperative mobilization, adequate
      postoperative pain control is essential. Acute postoperative pain is currently managed
      largely with opioids and co-administration of nonsteroidal anti-inflammatory drugs (NSAIDS).
      Opioids are highly effective in managing acute postoperative pain, however dosing is often
      limited by side effects such as respiratory depression, nausea and vomiting, and sedation.
      NSAIDS are administered to reduce opioid use, but may also have limiting side effects, such
      as gastrointestinal toxicity and platelet dysfunction. New strategies to manage acute
      postoperative pain would provide clinical benefit. ALGRX 4975 is an ultra-pure form of
      capsaicin, which is a pain medicine that has the potential for long-term pain relief
      following a single administration. This study will determine whether ALGRX 4975 can provide
      pain relief following open cholecystectomy.
    

Intervention name(s): ALGRX 4975
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Postoperative pain; Open cholecystectomy; Capsaicin
Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether early intervention with neuromuscular
      electrical stimulation (NMES) for muscle strengthening immediately after total knee
      arthroplasty (TKA) is more effective than voluntary exercise alone in countering changes in
      quadriceps muscle activation, force production, and function in older adults.
    

Detailed description: 
      Osteoarthritis (OA) is a chronic degenerative joint disease that disables about 10% of people
      over the age of 60 and compromises the quality of life of more than 20 million Americans. To
      alleviate pain and disability associated with knee OA, over 400,000 total knee arthroplasty
      (TKA) are performed each year in the United States, and future projections indicate that by
      the year 2030, more than 750,000 TKAs will be performed per year. While TKA reliably reduces
      pain and improves function, the recovery of force and function to normal levels is rare,
      which predisposes patients to future disability with increasing age. A month after TKA,
      impairments in quadriceps force are predominantly due to reflex inhibition, but are also
      influenced, to a lesser degree, by muscle atrophy. Neuromuscular electrical stimulation
      (NMES) may offer a promising alternative approach to override quadriceps reflex inhibition
      and prevent muscle atrophy to restore normal quadriceps muscle function more effectively than
      voluntary exercise alone, especially when applied within the first days after surgery.

      The overall goal of this study is to evaluate the efficacy of NMES initiated 48hrs after TKA
      as an adjunct to standard rehabilitation. NMES is expected to more effectively restore normal
      quadriceps muscle function to produce greater quadriceps force by decreasing reflex
      inhibition. Patients will be randomized into one of two rehabilitation groups: 1) the
      standard rehabilitation group or 2) standard rehabilitation + NMES.
    

Intervention name(s): Neuromuscular Electrical Stimulation (NMES); Standard Rehabilitation Protocol
Intervention type(s): Device; Other
Intervention description(s): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy; Standard physical therapy for 8 weeks after surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: electrical stimulation; total knee arthroplasty; quadriceps; muscle; arthroscopy
Study of the Effectiveness of Breakfast Recommendations On Reducing Body Weight
Condition: Obesity; Food Habits
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This is an experiment that will compare the effect of recommending breakfast consumption, or
      breakfast skipping, on body weight. Our objective is to determine if breakfast consumption
      recommendations can produce weight loss, and if that weight loss is dependent on typical
      breakfast eating habits.
    


Intervention name(s): General Nutrition Recommendations; Breakfast Recommendation; No Breakfast Recommendation
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Obesity; Weight Loss; Breakfast