bioihbjkbjnl/mcl2 huggingface dataset:
HCV Viral Hepatitis, Blood Sugar Level and Systolic Blood Pressure in Egypt
Condition: Hepatitis C, Acute; Diabetes; Hypertension
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      An observational double-blind cohort study that examined the association between HCV viral
      hepatitis, blood sugar level and systolic blood pressure in the Egyptian population
    

Detailed description: 
      a cohort study on greater than 70000 Egyptian patients had been conducted. for all
      patients,1- we detected the Hepatitis C Virus (HCV) RNA antigens ( hepatitis C virus)presence
      using BIOLINE HCV kits( qualitative test for diagnosis of hepatitis C virus in the blood),
      For all positive patients, confirmatory rapid screening test was performed and all patients
      who tested positive twice underwent a qPCR test using QIAampMinElute Virus Spin kit (Thermo
      Fisher Scientific, Waltham, MA, USA) performed according to the manufacturer's recommended
      protocol.

      2- Investigators measured blood sugar levels for each patient using ACCU-CHEK kits(finger
      stick sugar level measurement) 3- Measured systolic blood pressure for each patient was
      measured using mercury meters.

      4-for all patients investigators obtained full medical history regarding the presence or
      absence of chronic diabetes, chronic hypertension, coronary artery disease, kidney impairment
      with dialysis or chronic obstructive pulmonary disease.

      5- for all patients investigators listed age, gender, and body mass index. 66121 patients
      were negative for HCV and 4852 were positive for HCV. Investigators measured the association
      between HCV presence, high blood sugar levels and high systolic blood pressure.

      It is supposed that this is the largest study in the world that examined both associations.

      In a word, this study was responding to a specific question: is hepatitis c virus presence is
      associated with high blood pressure or high sugar level or both or not associated???
    

Intervention name(s): BIOLINE HCV kits; ACCU-CHEK kits; ErKameter 3000 mercury manometer
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): We used BIOLINE HCV kits to detect the presence of HCV antibodies in stick blood samples of all recruited patients.; For all patients, we measured random blood sugar levels by stick blood samples using ACCU-CHEK kits.; For all patients, we measured systolic blood pressure using ErKameter 3000 mercury manometer.
Other intervention name(s): diagnosis of viral hepatitis C; measurement of blood sugar level; blood pressure measurement
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Egyptian patients aged 18-80 years.
Field Trial of Maternal Influenza Immunization in Asia
Condition: Influenza Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This project is designed to assess the efficacy of immunizing women during pregnancy with
      influenza vaccine on the health of these women during their pregnancy and for 6 months
      post-partum as well as on the health of their newborn infants during the first 6 months of
      life. It will be conducted in Sarlahi District in southern Nepal, a rural area where a number
      of large scale randomized trials have been conducted over the past 20 years.
    

Detailed description: 
      This is a community-based, placebo-controlled, individually randomized trial in trial among
      women who are or who become pregnant in 9 Village Development Committees in Sarlahi District,
      Nepal. The study population for this trial will include all women who are identified as
      pregnant with gestational age between 17 and 34 weeks gestation during a 12-month period in 9
      Village Development Committees (VDC) of Sarlahi District, Nepal. The 9 VDCs include: Dhungre
      Khola, Karmaiya, Hariaun, Ghurkauli, Sasapur, Netraganj, Lalbandi, Jabdi, and Raniganj.

      The vaccine that will be given will be the most current vaccine at the time of subject
      enrollment. That is, for women enrolled after October in either study cohort, the vaccine
      will be switched to the newly available vaccine for that year.

      The control group will be placebo (saline injection). The justification for the use of a
      placebo injection in this trial is as follows: There is only one trial (Bangladesh) that
      demonstrates efficacy of influenza vaccination in pregnancy on perinatal outcomes and
      respiratory morbidity in early infancy. One of the issues with that study is that it was not
      placebo controlled. The "control" in that study was adult pneumococcal vaccine. It could be
      that the Bangladesh study underestimated the impact of influenza vaccine because the mothers
      and infants receive some indirect protection from the pneumococcal vaccine. In addition,
      influenza vaccine is not part of national policy or recommendations in Nepal at the current
      time and Ministry of Health officials are very interested in the results of our study as they
      consider their immunization program expansion over the next few years.
    

Intervention name(s): influenza vaccine; saline placebo
Intervention type(s): Biological; Biological
Intervention description(s): Pregnant women will receive FDA approved influenza vaccine.; Vaccination of pregnant women with saline placebo.
Other intervention name(s): "VAXIGRIP®; saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: influenza; immunization; pregnancy; efficacy; pertussis; hepatitis E
A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants
Condition: Central Precocious Puberty
MeSH terms: Puberty, Precocious
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess long-term safety and efficacy of leuprorelin in the
      treatment of Central Precocious Puberty (CPP).
    

Detailed description: 
      The drug in this study is called leuprorelin. It is administered as a 1 month subcutaneous
      depot injection. Leuprorelin is used to treat children who have CPP. This study will look at
      whether leuprorelin can stop early puberty in pre-pubertal children.

      The study will enroll approximately 300 participants. Participants with body weight >=20 kg
      will receive the recommended dose of leuprorelin 3.75 mg subcutaneous injection every 4 weeks
      for 96 weeks. Participants with body weight <20 kg will receive recommended dose of 1.88 mg
      subcutaneous injection every 4 weeks for 96 weeks.

      This trial will be conducted in China. The overall time to participate in this study is 104
      weeks. Participants will make 11 visits to the clinic, and will be followed-up by the
      physician on a long-term basis until stable puberty is reached.
    

Intervention name(s): Leuprorelin
Intervention type(s): Drug
Intervention description(s): Suspension for injection.
Other intervention name(s): Enantone
Intervention MeSH terms: Leuprolide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy
A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether ceasing sitagliptin and switching to
      exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in
      those patients with type 2 diabetes who are experiencing inadequate glycemic control with a
      combination of sitagliptin and metformin.
    


Intervention name(s): exenatide and sitagliptin; exenatide and placebo
Intervention type(s): Drug; Drug
Intervention description(s): exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; sitagliptin-100mg tablet orally once a day; exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; placebo-tablet orally once a day
Other intervention name(s): exenatide-Byetta; sitagliptin-Januvia; exenatide-Byetta
Intervention MeSH terms: Sitagliptin Phosphate; Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diabetes; exenatide; Byetta; sitagliptin; Januvia; Amylin; Lilly
Interventricular Cardiac Septal Thickness in Fetus of Diabetic Mother Correlated to Postnatal Outcome
Condition: Maternal Diabetes Mellites Effect on Fetus
MeSH terms: Diabetes, Gestational
Study type: Observational [Patient Registry]

Summary: 
      Good glycemic control is superior to poor glycemic control in reducing risk of
      interventricular septal thickness among fetuses of diabetic mothers.
    

Detailed description: 
      Thick Interventricular septum is thought to be related to poor glycemic control during
      pregnancy, and it causes variable degree of left ventricular outflow obstruction and
      hypertrophic cardiomyopathy.

      Hypertrophic cardiomyopathy requires specific management as digoxin and inotropic agents
      usually used in heart failure are contraindicated.

      So high index of suspicion is required in fetus of diabetic mother having thick Inter
      ventricular septum.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        pregnant women with diabetes mellites
      
Biospecimen description: 
      pregnant over 35 weeks. medically free.single intrauterine pregnancy
Evaluation of a Nutritional Product for People With Type 2 Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The objective of this trial is to evaluate a nutritional product for people with Diabetes.
    


Intervention name(s): Experimental Study Product; Control Study Product
Intervention type(s): Other; Other
Other intervention name(s): Oral nutritional supplement for people with Diabetes.; Water beverage.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A Phase I Study to Evaluate the Safety, Reactogenicity, and Humoral Immune Responses to an Inactivated H5N1 Influenza Vaccine
Condition: Bird Flu; Avian Influenza; Influenza A(H5N1)
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      The focus of this study is to evaluate the safety, reactogenicity and humoral immune
      responses of the study vaccine when administered at the dose of 7.5 µg HA, 15 µg HA, or 30 µg
      HA to human subjects.
    

Detailed description: 
      Since 1997, avian H5N1 influenza in Southeast Asia has caused several human infections and
      has a high mortality rate. Experts warn that the next influenza pandemic is imminent and
      could be severe and prevention and control will depend on the rapid production and worldwide
      distribution of specific pandemic influenza candidate vaccines. An H5N1 influenza vaccine was
      successfully produced from whole virus grown in MDCK (Madin-Darby canine kidney) cells. These
      purified inactivated vaccine antigens were safe and could induce immune responses in animal
      studies. Moreover, when formulated in aluminum phosphate a stronger response was generated
      even at low doses in animals (Chong et al., 2008; Hu et al., 2008). However, further
      investigations are necessary before their human safety and immunogenicity can be established.
      This human phase I clinical study, therefore, evaluates the safety and immunogenicity of
      adjuvanted H5N1 virion influenza vaccine.
    

Intervention name(s): AT-301
Intervention type(s): Biological
Intervention description(s): Inactivated H5N1 Influenza Virion Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Avian Influenza; Influenza A Virus Subtype H5N1; Inactivated H5N1 Influenza Virion Vaccine; Phase I; Preventive H5N1 vaccination
Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens in Subjects With Type 2 Diabetes: An Extension to Trial BIASP-3756
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Asia. The aim of the trial is to compare the effect on glycaemic
      control of biphasic insulin aspart 30 twice daily with two different dosage split regimens
      for Chinese subjects with type 2 diabetes who did not achieve the treatment target of a
      glycosylated haemoglobin A1c (HbA1c) below 7% in trial BIASP-3756 (NCT01123980).
    


Intervention name(s): biphasic insulin aspart 30; biphasic insulin aspart 30; metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered subcutaneously (under the skin), twice daily with a dosage of 2/3 and 1/3 total daily dose before breakfast and before dinner, in combination with metformin.; Administered subcutaneously (under the skin), twice daily with a split dosage of 1/2 and 1/2 total daily dose before breakfast and before dinner, in combination with metformin.; Tablets 500 mg administered orally with meals. Pre-trial dose and regimen unchanged
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin, Isophane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase I Study to Assess the Pharmacokinetics of GSK2798745 Tablets
Condition: Heart Failure, Congestive
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK2798745 is being developed as a novel therapeutic intervention for the treatment of
      pulmonary edema associated with heart failure (HF) and is currently under investigation in
      the form of a compounded capsule. This is an open-label, randomized, single-dose, crossover
      study with the purpose to determine the pharmacokinetics (PK) of three 2.4 milligrams (mg)
      tablet formulations of GSK2798745 in 12 healthy subjects. The three formulations developed
      for this study will be micronized GSK2798745 active pharmaceutical ingredient (API) (Tablet
      A), micronized GSK2798745 API with sodium lauryl sulfate (SLS) and hypromellose (Tablet B),
      milled GSK2798745 API with SLS and hypermellose (Tablet C), and Tablet D, which will be
      either A/B/C based on interim PK analysis of data from the first three treatment periods.

      Following a 30-day screening period, subjects will be randomized to one of the 6 treatment
      sequences: Treatment sequence 1: ABCD, 2=CABD, 3=ACBD, 4=BACD, 5=BCAD, 6=CBAD over three
      4-day treatment periods. For treatment period 4, the best formulation based on the interim
      analysis data from the three treatment periods will be evaluated under fed conditions. Each
      treatment period will be separated by a minimum of 7 (+14)-day washout period. The total
      duration of participation in the study will be approximately 11 weeks including the follow-up
      visit.
    


Intervention name(s): GSK2798745 Micronized API without SLS and hypermellose (Tablet A); GSK2798745 Micronized API with SLS and hypermellose (Tablet B); GSK2798745 milled API without SLS and hypermellose (Tablet C)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): This is an immediate release tablet containing 2.4 mg of micronized GSK2798745 API; to be administered orally with 240 mL of water under fasted/fed conditions; This is an immediate release tablet containing 2.4 mg of micronized GSK2798745 API with SLS and hypermellose; to be administered orally in fasted/fed conditions with 240 mL of water; This is an immediate release tablet containing 2.4 mg of milled GSK2798745 API with SLS and hypermellose; to be administered orally in fasted/fed conditions, with 240 mL of water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Pharmacokinetics; Phase I; GSK2798745; Tablet
Smart Phone Application for Enteral Nutrition
Condition: Nutritional and Metabolic Diseases
MeSH terms: Metabolic Diseases
Study type: Observational

Summary: 
      Internal medicine resident physicians were provided an ipod with the EN application to assist
      them in choosing EN formulas for patients during their ICU rotation. The primary outcome was
      improved initiation of EN within 24 hours of admission. Secondary outcomes include, time to
      initiate EN, goal calories reached, infections rates, length of stay, mortality, and
      concordance with clinical guidelines.
    

Detailed description: 
      Background: Resident physicians are frequently uncomfortable ordering enteral nutrition (EN)
      and are unaware of the variety of formulas and supplements available for different disease
      processes. Many depend on a clinical dietitian to assist with recommending EN formulas and
      patient energy requirements which may not be readily available upon patient admission. This
      creates a barrier to early initiation of EN and non-compliance with Society of Critical Care
      Medicine and American Society of Parenteral and Enteral Nutrition clinical guidelines.
      Objective: Internal medicine resident physicians were provided an ipod with the EN
      application to assist them in choosing EN formulas for patients during their ICU rotation.
      The primary outcome was improved initiation of EN within 24 hours of admission. Secondary
      outcomes include, time to initiate EN, goal calories reached. Design: This study is a
      retrospective chart review to evaluate the impact of a smart phone/device application (EN
      application) to assist resident physicians when ordering EN. The study is a single center
      trial conducted at an academic teaching facility. All patient data was obtained by a
      retrospective chart review of patients admitted to the intensive care unit (ICU) at The
      University of Oklahoma Medical Center.
    

Intervention name(s): Tube Feeding Application
Intervention type(s): Other
Intervention description(s): A smart device application was developed and used to help residents determine the best enteral nutrition prescription for patients admitted to the ICU
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Medical ICU patients who can tolerate enteral nutrition
Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      Dental implants are regarded as a standard of care in restoring missing teeth. Although there
      is a high prevalence of diabetics who receive dental implants, the relationship between
      dental implants and diabetes has not clearly been investigated.

      A total of 32 subjects (14 patients with type II diabetes and 18 non-diabetes subjects) who
      have dental implants were recruited. The purposes of this research study were: (1) to
      evaluate diabetes patients to determine risk factors for bone loss at dental implants and
      teeth; and (2) to evaluate bone-resorptive biomarkers (proteins related to bone loss) present
      in saliva and blood serum, comparing the two groups.
    

Detailed description: 
      OBJECTIVE:

      Regulators of peri-implant bone loss in patients with diabetes appear to involve multiple
      risk factors that have not been clearly elucidated. This study was conducted to explore
      putative local etiologic factors on implant bone loss in relation to type 2 diabetes
      mellitus, including clinical, microbial, salivary biomarker, and psychosocial factors.

      MATERIALS AND METHODS:

      Thirty-two subjects (divided into type 2 diabetes mellitus and non-diabetic controls), having
      at least one functional implant and six teeth, were enrolled in a 1-year longitudinal
      investigation. Analyses of clinical measurements and standardized intra-oral radiographs,
      saliva and serum biomarkers (via protein arrays for 20 selected markers), and plaque biofilm
      (via qPCR for eight periodontal pathogens) were performed at baseline and 1 year. In
      addition, the subjects were asked to respond to questionnaires to assess behavioral and
      psychosocial variables.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Type II diabetics and non diabetics with dental implants
      
Biospecimen description: 
      saliva and plaque biofilm
    
Keywords: healthy
20 Week Bridging Study in Type II DM
Condition: Diabetes Mellitus Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      A multicenter, non-comparative, one arm, open, phase III study to evaluate the efficacy and
      safety of insulin glargine on subjects with Type 2 Diabetes Mellitus
    


Intervention name(s): Insulin Glargine
Intervention type(s): Drug
Intervention description(s): Insulin glargine at the discretion of the investigator Subcutaneous, once daily injection (at bedtime)
Other intervention name(s): Lantus
Intervention MeSH terms: Insulin Glargine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment