bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of Peginterferon Alfa-2b in Chinese Chronic Hepatitis C Patients
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b
      (40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of
      180μg/week, in combination with Ribavirin in Chinese chronic hepatitis C patients. The study
      will first group patients into two sub-study, genotype 2/3 and non-genotype 2/3, depending on
      the HCV genotype that infected. In the genotype 2/3 sub-study about 219 patients will be
      enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group
      or active control group (Pegasys), receiving 24 weeks of interferon therapy and oral daily
      Ribavirin at a dose of 800mg/d. In the non-genotype 2/3 sub-study about 507 patients will be
      enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group
      or active control group (Pegasys), receiving 48 weeks of interferon therapy and oral daily
      Ribavirin 1000-1200mg/day , basing on body weight. All patients will be followed for 24 weeks
      after the end of therapy.
    


Intervention name(s): Ypeginterferon alfa-2b; Pegasys; Ypeginterferon alfa-2b; Pegasys
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): sc, qw, 24 weeks.; sc, qw, 24 weeks.; sc, qw, 48 weeks.; sc, qw, 48 weeks.
Intervention MeSH terms: Peginterferon alfa-2a; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peginterferon; Pegasys; Sustained virus response; HCV
Pain Neuroscience Education in Diabetic Neuropathy
Condition: Pain, Neuropathic; Diabetic Nephropathy
MeSH terms: Diabetic Neuropathies; Neuralgia; Diabetic Nephropathies
Study type: Interventional

Summary: 
      To determine the effects of Pain Neuroscience Education in Diabetic Neuropathy
    

Detailed description: 
      Pain neuroscience education (PNE) has shown to have immediate effects on various clinical
      signs and symptoms associated with central sensitization. Using a model of (innocuous,
      noxious and allodynia) PNE can be used in combination with exercise therapy, especially
      treating patients in which the nervous system has become increasingly hypervigilant. Teaching
      patients about the neuroscience of pain and lead to healthier and more positive attitudes and
      beliefs regarding chronic pain. Pain in diabetic neuropathy restrict the activity
      participation and compromise their quality of life. PNE will be helpful in such patients so
      decreasing pain can improve their quality of life.
    

Intervention name(s): Pain Neuroscience Education; Conventional Physical therapy
Intervention type(s): Other; Other
Intervention description(s): In first part educational content will be designed to be given in group of patients in six sessions by PNE booklet. The six sessions are 1.5 hours long (9 hours) and will be given at a frequency of 1 session per week. Final session will be given to solve doubts, and to provide additional information to the educational program. Book for additional material will be delivered to participants.; Control group will be treated by Conventional Physical therapy like TENS, stretching and strengthening exercises. Intervention will be initiated with warm up period (joint mobility exercises) for the duration of 5 mins and ended up with cool down period (relaxing exercises i.e. deep breathing) for the duration of 5 mins.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Neuropathy; Diabetes
Acute Effects of Sildenafil on Endothelial Function in People With Diabetes
Condition: Type 2 Diabetes Mellitus; Endothelial Dysfunction
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a double-blind, placebo-controlled, cross-over trial using a single dose of 100 mg
      sildenafil or placebo in 40 subjects with T2DM without known cardiovascular disease. Effects
      on haemodynamic parameters, flow mediated dilatation (FMD) in brachial artery, cardiovascular
      autonomic function tests, and spontaneous baroreflex sensitivity (BRS) were investigated.
    


Intervention name(s): Sildenafil
Intervention type(s): Drug
Intervention description(s): Orally administered, Sildenafil 100mg, unique administration
Other intervention name(s): Viagra
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Dyssomnias; Parasomnias; Heartburn
Study type: Interventional
Phase: Phase 4

Summary: 
      This study includes patients with sleep disturbances associated with gastroesophageal reflux
      disease (GERD) and has 3 treatment arms. Patients will receive only one of the following
      treatment arms: esomeprazole 20 mg once daily, esomeprazole 40 mg once daily, matching
      placebo once daily. The relief to the sleep disturbances will be assessed.
    


Intervention name(s): Esomeprazole; Esomeprazole; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20mg Oral tablet once daily; 40mg Oral tablet once daily; Oral once daily
Other intervention name(s): Nexium; Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux Disease; GERD; Esomeprazole; Heartburn; Nexium
Proof-of-concept for the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary Hyperaldosteronism
Condition: Primary Hyperaldosteronism
MeSH terms: Hyperaldosteronism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if LCI699, thorough reductions in aldosterone, can
      lower BP in patients with Primary hyperaldosteronism.
    


Intervention name(s): LCI699
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: primary hyperaldosteronism; hypokalemia; hypertension; aldosterone synthase inhibitor
A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001)
Condition: Healthy
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A phase I/II, randomized, single-blind, placebo-controlled escalating double-dose safety
      study of an intramuscular universal influenza vaccine (Multimeric-001) injected to healthy
      volunteers.
    


Intervention name(s): Adjuvanted Multimeric-001 250 Mcg; Multimeric-001 250 Mcg; Phosphate Buffered saline; Adjuvanted PBS; Adjuvanted Multimeric-001 500 Mcg; Multimeric-001 500 Mcg; Multimeric-001 125 Mcg
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: INFLUENZA; VACCINE; UNIVERSAL; SAFETY
Single-Ascending-Dose Safety/Tolerability of NP001 in Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objectives: To assess the safety and tolerability of ascending doses of NP001
      compared to placebo in subjects with ALS.

      Secondary objective: To explore the effects of NP001 on biomarkers potentially relevant to
      ALS.
    

Detailed description: 
      This study is a double-blind, placebo-controlled single ascending dose safety and
      tolerability study. Approximately 32-56 subjects with clinical diagnosis of ALS according to
      modified El Escorial criteria are planned to receive a single dose of study drug, NP001.
    

Intervention name(s): NP001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cohort 1: 0.3 mg/kg NP001(6:2 active:placebo) Cohort 2: 1.1 mg/kg NP001(6:2 active:placebo) Cohort 3: 2.1 mg/kg NP001(6:2 active:placebo) Cohort 4: 4.3 mg/kg NP001(6:2 active:placebo); Cohort 1: placebo Cohort 2: placebo Cohort 3: placebo Cohort 4: placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The proposed study will evaluate the safety of the rMenB+OMV NZ in an adult population
      potentially at risk for meningococcal disease (e.g. lab workers).

      In the second part of the study additional blood samples of high responding vaccinated
      subjects will be collected for the purpose of generating a control serum panel for the human
      serum bactericidal assay (hSBA) tests.
    


Intervention name(s): Recombinant meningococcal B + OMV NZ
Intervention type(s): Biological
Intervention description(s): 2 injections 2 months apart
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Neisseria, Meningitis, Group B, Vaccine, At-risk, Adults
Determination of the Utility of Pfizer's Pneumococcal Urine Antigen Test in Children 5 Years of Age or Younger With Community Acquired Pneumonia in Guatemala
Condition: Community-acquired Pneumonia; Streptococcus Pneumoniae Infection
MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Pneumococcal Infections
Study type: Observational

Summary: 
      This prospective case-control study aims to evaluate the utility and establish laboratory
      thresholds for a multi-serotype urine antigen test for the diagnosis of pneumococcal
      community acquired pneumonia in children 5 years of age or younger in Guatemala.
    


Intervention name(s): Urinary antigen detection assay
Intervention type(s): Other
Intervention description(s): Screening for Ag level in S. pneumoniae urinary antigen detection assay.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children 5 years of age or younger with either community-acquired pneumonia (cases) or
        health children (controls).
      
Biospecimen description: 
      Urine Blood Nasopharyngeal swab samples
    
Keywords: Streptococcus pneumoniae; Pneumonia; Community-acquired; Pediatric; Urine antigen
The Copper T380A IUD vs. Oral Levonorgestrel for Emergency Contraception
Condition: Pregnancy
MeSH terms: Emergencies
Study type: Observational

Summary: 
      The purpose of this study is to see if women presenting for emergency contraception (EC) and
      choose the copper intrauterine device (IUD) will have fewer unplanned pregnancies in the next
      year compared to women who choose oral levonorgestrel for EC. The study will also compare use
      of an effective method of contraception in the year after they received EC.
    

Detailed description: 
      All women presenting to 2 Planned Parenthood Association of Utah clinics in Salt Lake City
      will be offered participation in this study. Women will select either the copper IUD or oral
      levonorgestrel for EC. The primary outcome is unplanned pregnancy in the year following
      presentation for EC.

      Secondary outcomes include use of an effective method of contraception over the next year,
      abortions, repeat use of EC, number of days to first bleeding episode and duration of that
      bleeding episode, use of a barrier method to prevent sexually transmitted infections, patient
      satisfaction with the chosen method of EC and contraception. Participants selecting the IUD
      will be assessed for IUD expulsion, perforation, and removal.
    

Intervention name(s): Copper T380 IUD; Oral levonorgestrel
Intervention type(s): Drug; Drug
Intervention description(s): copper T 380 IUD; 1.5 mg
Other intervention name(s): Paragard IUD; Plan B
Intervention MeSH terms: Copper; Levonorgestrel
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women presenting to family planning clinics for emergency contraception
      
Keywords: contraception; emergency contraception; pregnancy prevention after unprotected intercourse
The Predictors of the Neonatal Hyperbilirubinemia
Condition: Hyperbilirubinemia, Neonatal
MeSH terms: Hyperbilirubinemia, Neonatal; Hyperbilirubinemia
Study type: Observational

Summary: 
      The oxygen tension increases more than 3 times from fetus to neonate. The oxidant stress
      happens. And it will cause the destruction of RBC. So, we propose that the ROS may play an
      important role of neonatal hyperbilirubinemia. There is strong association between the
      bilirubin level and ROS levels at 3 days old in our pilot study.
    

Detailed description: 
      The incidence of neonatal jaundice is higher in Eastern population than western people. The
      bilirubin comes from the destruction of RBC which heme is released and catabolized. If the
      bilirubin enters into the brain and deposits in basal ganglion, it will cause apoptosis of
      the neuronal cells, that is so called kernictrus, which is the major complication of the
      neonatal jaundice. However, the bilirubin has its own antioxidant protective effect. Many
      clinical or basic studies tried to find out the relationship of bilirubin and reactive oxygen
      species (ROS) in recent years.

      The American Association of Pediatrics proposed the management principle of neonatal jaundice
      in 1994. It postponed the management criteria of neonatal jaundice Besides, early discharge
      (before 48 hour-old) was the trend in many countries. It may be dangerous because the
      neonatal jaundice appears after 48 hour-old. Whether the criteria and the trend will cause
      the elevation of the incidence of kernictrus, is always the major concern of clinicians. So,
      searching factors to predict neonatal hyperbilirubinemia causes the interest of many
      investigators. The predictors are divided into risk-factor based and normogram based. But
      they are still not suitable for all populations.
    

Observational model: Natural History
Time perspective: Prospective
Keywords: hyperbilirubinemia; free radicals; Health neonate
Novel Approach for Embryo Transfer Medium by Adding Cytokine to Hyaluronan Enriched Embryo Transfer Medium (Embryo Glue)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      It was proven that the Cytokine granulocyte-Macrophage clony stimulating factor had been
      found naturally in reproductive tract so our target is to test its effect if added to embryo
      transfer medium.
    

Detailed description: 
      The IVF embryo transfer media design and upgrade underwent many ideas during the last 3
      decades, we suppose that adding Cytokine GM-CSF as an endometrial modifier to already proven
      successful medium hyaluronan enriched medium to test the efficacy ipon pregnancy and
      implantation rate in vitro so we decide to design a trial to compare the clinical outcome by
      sibling embryo to be transferred into 2 groups and the same culture condition but with one
      arm with Cytokine and the other is traditional one and closely monitor the outcome within the
      2 arms and record the results.
    

Intervention name(s): Cytokine group
Intervention type(s): Other
Intervention description(s): Testing the efficacy of adding Cytokine to embryo transfer medium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pregnancy; implantation; Cytokine
Single and Repeated Dosing Study to Assess the Safety and the Concentration-time Profile of SAR228810 in Alzheimer's Patients
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      - To assess the safety and tolerability of escalating single and multiple doses of SAR228810
      in patients with Alzheimer's disease (AD)

      Secondary Objective:

      - To evaluate the pharmacokinetic properties of SAR228810 after escalating single and
      multiple doses of SAR228810 in AD patients
    

Detailed description: 
      14.5 to 22 months
    

Intervention name(s): SAR228810; SAR228810
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:solution
Route of administration: intravenous; Pharmaceutical form:solution
Route of administration: subcutaneous
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: mild to moderate Alzheimer's Disease
Pupillary Pain Index and Reaction to Skin Incision
Condition: Pain; Anesthesia; Surgery
MeSH terms: Surgical Wound
Study type: Observational

Summary: 
      During routine general anesthesia (not standardized, left to the discretion of the attending
      anesthesiologist), pupillary pain index was measured one minute before skin incision. Then,
      variations in heart rate, blood pressure and bispectral index during the three minutes
      following skin incision were recorded, as well as the occurrence of movements.
    


Intervention name(s): videopupillometer; skin incision
Intervention type(s): Device; Procedure
Intervention description(s): Measure of pupillary diameter and pupillary pain index via an infrared camera Each measure lasts approximately 20 seconds; performed under general anesthesia by the surgeon, at the beginning of an elective or emergency surgery.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children under general anesthesia for an elective or emergent surgery requiring a skin
        incision in a body area not covered by regional anesthesia
The Effect of Semi Fowler 30' Right Lateral on Cardiac Output in Acute Heart Failure
Condition: Cardiac Output, High; Heart Failure; Pulmonary Edema With Heart Failure; Dyspnea; Cardiac; Arrythmia
MeSH terms: Dyspnea; Pulmonary Edema; Heart Failure; Cardiac Output, High
Study type: Interventional

Summary: 
      Heart failure is a special clinical syndrome such as difficulty breathing, fatigue, and
      swollen legs characterized by increased JVP, crackle lung sounds, and peripheral edema caused
      by heart disorders both structural and/or functional, resulting in decreased cardiac output
      and increased intracardiac pressure at rest and activity. Body positioning has been shown to
      affect stroke volume and parasympathetic modulating activity. The right lateral 30"
      semifowler position is a very safe position in heart failure patients admitted to the ICU.
      Although body positioning can affect stroke volume, and parasympathetic modulation, it is not
      yet clear what effect it has on cardiac output
    


Intervention name(s): Semifowler 30' Right Lateral Body Position
Intervention type(s): Behavioral
Intervention description(s): Semifowler 30' Right Lateral Body Position Is a regulation of body position by placing the patient's body in a semi-fowler and lateral resting position of 30 degrees
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cardiac Output; Heart Failure; Body Positioning; Right Lateral Body Position; Semifowler
Gemcitabine and Imatinib Mesylate as First-Line Therapy in Patients With Locally Adv. or Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed
      for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor
      cells.

      PURPOSE: This phase II trial is studying how well giving gemcitabine together with imatinib
      mesylate works as first-line therapy in treating patients with locally advanced or metastatic
      pancreatic cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate the time to progression in patients with locally advanced or metastatic
           pancreatic cancer treated with gemcitabine hydrochloride and imatinib mesylate as
           first-line therapy.

      Secondary

        -  Assess the response rate in patients treated with this regimen.

        -  Assess the percentage of patients treated with this regimen who survive 1 year or more.

        -  Assess the toxicity of this regimen in these patients.

        -  Assess the overall survival of patients treated with this regimen.

      OUTLINE: This is a multicenter, nonrandomized, open-label, uncontrolled study.

      Patients receive gemcitabine hydrochloride IV over 120 minutes on days 3 and 10 and oral
      imatinib mesylate on days 1-5 and 8-12. Treatment repeats every 21 days in the absence of
      disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
    

Intervention name(s): gemcitabine hydrochloride; imatinib mesylate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gemcitabine; Imatinib Mesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent pancreatic cancer; stage IV pancreatic cancer; stage III pancreatic cancer; adenocarcinoma of the pancreas; stage II pancreatic cancer