bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This parallel group, open label study will evaluate the safety and efficacy of Pegasys
      (peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at
      baseline) with HBeAg positive chronic hepatitis B. Children without advanced fibrosis and
      without cirrhosis will be randomized 2:1 to treatment Group A, receiving Pegasys 45-180 mcg
      subcutaneously weekly for 48 weeks, or to the untreated control Group B. Children with
      advanced fibrosis will be assigned to treatment group C and receive 48 weeks of treatment
      with Pegasys. Children in the untreated control Group B who have not experienced
      seroconversion 48 weeks after randomization may enter the Switch Arm to receive 48 weeks of
      Pegasys treatment. This offer will be available for 1 year following 48 weeks from
      randomization. Anticipated time on study treatment is 48 weeks. All subjects will be followed
      up for 5 years after the end of treatment (A,C,Switch)/principal observation (B) period.
    


Intervention name(s): peginterferon alfa-2a [Pegasys]; peginterferon alfa-2a [Pegasys]
Intervention type(s): Drug; Drug
Intervention description(s): Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48; Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, after Week 48 for Group B patients who have not experienced HBeAg seroconversion
Intervention MeSH terms: Peginterferon alfa-2a; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Occurrence and Trend of Pregnancies Growing Outside the Womb (Ectopic Pregnancy) 2009-2018. A Study on a Defined Group of Persons
Condition: Pregnancy, Ectopic
MeSH terms: Pregnancy, Ectopic; Cardiac Complexes, Premature
Study type: Observational

Summary: 
      In this trial researchers want to learn more about the occurrence of pregnancies growing
      outside the womb over the last decade (2009-2018) and the potential risk factors associated
      with pregnancies growing outside the womb. Electronic data in women who were age 15 to 44
      years abstracted from health care systems such as electronic health records (EHR), regional
      claims systems and administrative databases were used to address research questions on ...

        -  occurrence and trends of pregnancies growing outside the womb;

        -  influence of method of contraception used on occurrence and trends of pregnancies
           growing outside the womb;

        -  potential risk factors associated with pregnancies growing outside the womb;

        -  trends in management of pregnancies growing outside the womb over the last decade.
    

Detailed description: 
      The overall goal of this study is to assess the incidence rate of ectopic pregnancy over the
      last decade in a representative population of US women and potential risk factors associated
      with ectopic pregnancy.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention, epidemiological investigation
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Health-insured women of reproductive age from California (USA)
      
Keywords: Ectopic pregnancy; Electronic medical records; Chart Review; Intrauterine device (IUD)
Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the immunogenicity, safety, tolerability, and
      behavioral impact of an HPV-6, -11, -16, -18 vaccine in HIV-infected young women.
    


Intervention name(s): HPV vaccine for strains -6, -11, -16, and -18
Intervention type(s): Biological
Intervention description(s): All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Highly-active antiretroviral therapy; Human papillomavirus; HPV vaccine
The Acute Effects of Food Structure on Post Prandial Glucose and Subsequent Metabolic Responses
Condition: Obesity
Study type: Interventional

Summary: 
      Aims: To investigate the effects of different food structures on glucose concentrations and
      subsequent metabolic responses including insulin,GIP, GLP-1 DESIGN: A randomised, controlled,
      clinical trial.
    

Detailed description: 
      Rationale:

      There is very little evidence at the present time in the role of food structure in glucose
      homeostasis. There is circumstantial evidence that foods consumed intact have great effects
      on suppressing appetite.

      To test the effect of three structurally different meals with the same nutritional content
      and volume on appetite regulation. Each participant will receive the following meals:

      Solid meal group. Milled (intact-cell) meal group. Milled (destroyed-cell) meal group.

      All of which will contain the same macro and micro nutrients from the same food sources
    

Intervention name(s): chickpea
Intervention type(s): Dietary Supplement
Intervention description(s): all three meals are isocaloric but different in the chickpea structure( physical form):
• Whole chickpea, flour chickpea, intact cell flour chickpea
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to assess the effect of mild and moderate hepatic impairment on
      the pharmacokinetics (PK) of lemborexant after a single-dose administration.
    


Intervention name(s): Lemborexant
Intervention type(s): Drug
Intervention description(s): oral tablet
Intervention MeSH terms: Lemborexant
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mild hepatic impairment; moderate hepatic impairment; lemborexant; healthy participants; metabolites; E2006; pharmacokinetics
Brain Changes in Stimulant Dependent Subjects - 8
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to identify the neurophysiologic indicators of cocaine or
      methamphetamine use and withdrawal, to examine the relationship between subjects' reports of
      depression, craving, and stimulant use, and neurophysiologic measures, and to identify
      neurophysiologic measures which can be used to identify new treatments for stimulant
      dependence.
    

Detailed description: 
      By Incorporating QEEG into clinical trails, the plan is to develop physiologic markers of
      treatment efficacy, and to aid in the identification of effective treatments.
    

Intervention name(s): counseling
Intervention type(s): Behavioral
Primary purpose: Treatment
Keywords: stimulant dependence
Optical Trocar to Create the Pneumoperitoneum in Bariatric Patients
Condition: Obesity, Morbid; Bariatric Surgery Candidate; Surgery-Complications
MeSH terms: Pneumoperitoneum; Obesity, Morbid
Study type: Observational

Summary: 
      Laparoscopic bariatric surgery are becoming the most used procedure to treat the obesity. To
      facilitate safe initial access to the abdominal cavity, we insert an optical viewing trocar
      at the left hypocondrium. The aim of this study is to systematically evaluate all published
      data existing in the literature to analyze the safety of optical trocars in patients
      undergoing bariatric surgery and to compare these data with our experiences.
    

Detailed description: 
      In this study we analyze data existing in the literature about the use of the optical trocars
      in patients undergoing bariatric surgery and we compare these data with our experiences.

      Establishing pneumoperitoneum is classically performed using a Veress needle or the open
      Hasson technique, but obesity presents its own challenges when using these techniques,
      including thickened abdominal wall, variable anatomical landmarks, difficult and
      time-consuming dissection, air leak, inadequate pneumoperitoneum, subcutaneous emphysema, and
      difficulty with fascial closure
    

Intervention name(s): optical trocar to create the pneumoperitoneum for bariatric surgery
Intervention type(s): Procedure
Intervention description(s): The technique involves the use of 4 12 mm trocars. Pneumoperitoneum is induced by a 0° optical trocar and maintained at 15 mmHg. The first trocar is usually inserted along the left mid-clavicular line approximately 2 fingers from the costal arch, another trocar along the left axillary line, a third trocar 1 cm to the right of the midline, and the fourth trocar along the right mid-clavicular line. A 10 mm, 30 ° laparoscope is used.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Body mass index (BMI) ≥35-39 kg/m2 with one obesity- associated co-morbidity or
        BMI≥40kg/m2, age ≥ 18 years.
Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      To characterize the pharmacokinetics and safety of alpelisib in subjects with hepatic
      impairment compared to matched healthy control subjects.
    


Intervention name(s): Alpelisib
Intervention type(s): Drug
Intervention description(s): Subjects will receive a single dose of 300 mg alpelisib.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hepatic impairment; Healthy volunteers; Clinical pharmacology study; BYL719; alpelisib
Diabetes Virtual Trek: Obesity and Diabetes Prevention Through Science Enrichment
Condition: Type 2 Diabetes; Obesity
MeSH terms: Diabetes Mellitus; Obesity
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the effectiveness of a school-to-home education
      program for it's ability to increase knowledge about, and ability to prevent type two
      diabetes in children and parents.
    

Detailed description: 
      The study involved pre and post testing of parent's knowledge and behaviors relating to the
      prevention of type two diabetes, before and after a school based intervention designed to
      encourage school to home communication. Parents/Guardians and children, grades 2-6, from
      schools with high Hispanic enrollment during the 2001-2005 school year were used for both
      comparison and intervention groups.
    

Intervention name(s): DvtProgram ENERGY; DvtProgram ENERGY; DvtProgramENERGY
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 11 - weekly or biweekly newsletters about diabetes and its prevention and family challenges sent home with children; 6 - weekly or biweekly newsletters about diabetes and its prevention and family challenges sent home with children; Children participating in Program ENERGY but no newsletters or family challenges sent home to parents
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Parental; Parents; Prevention; Energy balance; Glucose regulation; Healthy lifestyles; Healthy families; Active living
Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan Syndrome
Condition: Genetic Disorder; Noonan Syndrome
MeSH terms: Dwarfism; Noonan Syndrome; Genetic Diseases, Inborn; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Asia. The aim of the trial is to investigate the long-term
      efficacy and safety of two doses of NN-220 (somatropin) in short stature due to Noonan
      syndrome.
    


Intervention name(s): somatropin
Intervention type(s): Drug
Intervention description(s): Administered subcutaneously (s.c., under the skin) in a daily regimen for at least 104 weeks. Subject will be offered to continue treatment for another 104 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Efficacy of Penile Rehabilitation Using Udenafil After Total Mesorectal Excision of Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Sexual dysfunctions are well-recognized complications after rectal cancer surgery. Damage to
      the pelvic plexus and pelvic splanchnic nerves results in ejaculatory dysfunction. The
      purpose of this study is to evaluate the efficacy of Udenafil(Zydena®, Dong-A Pharmaceutical
      co., Ltd, Seoul, Korea) in penile rehabilitation for patients who undertake total mesorectal
      excision.
    


Intervention name(s): Placebo drug; Udenafil
Intervention type(s): Drug; Drug
Intervention description(s): After total mesorectal excision for rectal cancer, patients take placebo drug five time per week for 12 weeks.; After total mesorectal excision, patients take 50mg udenafil five times per week for 12 weeks.
Intervention MeSH terms: Udenafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Udenafil; rectal cancer; penile rehabilitation; total mesorectal excision
Buprenorphine and Naloxone Combination Study - 10
Condition: Heroin Dependence; Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders; Heroin Dependence
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine pharmacokinetics and dose proportionality of
      sublingual tablets containing varying doses of buprenorphine and naloxone.
    

Detailed description: 
      The objective of this study is to examine pharmacokinetics and dose proportionality of
      sublingual tablets containing varying doses of buprenorphine and naloxone.
    

Intervention name(s): Buprenorphine/naloxone
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Masking: Double
Primary purpose: Treatment
Anxiety Reduction During Office Procedural Medicine Using Aromatherapy
Condition: Anxiety; Anxiety State; Procedural Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This goal of this study is to assess whether lavender aromatherapy during gynecologic and
      urogynecologic outpatient procedures is associated with a decrease in patient anxiety levels.
      Based on similar interventions in other specialties of medicine, the investigators
      hypothesize that patients exposed to lavender aromatherapy during their procedure will have
      less anxiety than those who are not exposed to lavender aromatherapy.
    

Detailed description: 
      Patients who present to the Loyola Urogynecology office for an outpatient procedure will be
      invited to participate. Patients who consent to participate will be asked to complete
      pre-procedure questionnaires including an assessment of their level of procedural anxiety.
      Subsequently, patients will be randomized to receive either lavender aromatherapy or saline
      aromatherapy (placebo) during their procedure. Post-procedural levels of anxiety will then be
      assessed. Changes between pre- and post-procedural anxiety will be compared between the
      treatment and placebo control groups.
    

Intervention name(s): Lavender Aromatherapy; Placebo Aromatherapy
Intervention type(s): Other; Other
Intervention description(s): Participants in the experimental group will be passively exposed to lavender essential oil; Participants in the control group will be passively exposed to saline water aromatherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are randomized to lavender aromatherapy or saline placebo aromatherapy using a 1:1 random block allocation
Masking: None (Open Label)
Primary purpose: Supportive Care
A Single and Multiple Dose Study of PF-05221304 in Healthy Japanese Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study is designed to evaluate the safety, tolerability and pharmacokinetics of
      PF-05221304 in healthy Japanese adult subjects following single and multiple dose
      administration.
    


Intervention name(s): PF-05221304; PF-05221304; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3, 10, 50 mg; 50 mg multiple dose; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: PF-05221304, PK, Japanese, NASH, ACC inhibitor
Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease
Condition: Advanced Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to provide continued access to levodopa-carbidopa
      intestinal gel (LCIG), to participants who have already participated in an open-label
      efficacy and safety study with the same treatment (Study S187.3.003 [NCT00360568] or Study
      S187.3.004 [NCT00335153]).
    


Intervention name(s): Levodopa-Carbidopa Intestinal Gel (LCIG); CADD-Legacy® 1400 ambulatory infusion pump; Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)
Intervention type(s): Drug; Device; Device
Intervention description(s): LCIG for upper-intestinal infusion is a suspension of levodopa (20 mg/mL) and carbidopa (5 mg/mL) in an aqueous gel that is dispensed in a medication cassette reservoir containing 100 mL of LCIG.; Portable infusion pump (CADD-Legacy Pump Model 1400) connected to the LCIG medication cassette reservoir.; All participants previously had a PEG-J placed in one of the prior LCIG studies.
Other intervention name(s): Carbidopa-Levodopa Enteral Suspension (CLES); Duopa®; Duodopa®
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: levodopa/carbidopa intestinal gel; Severe Motor Fluctuations; Levodopa; Carbidopa; Parkinson's Disease; Dyskinesia
Safety and Efficacy Trial of Olanzapine in Outpatients With Pathological Gambling
Condition: Pathological Gambling
MeSH terms: Gambling
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to evaluate the efficacy (effectiveness) and safety of
      olanzapine in treating pathological gambling.
    


Intervention name(s): olanzapine; sugar pill
Intervention type(s): Drug; Drug
Intervention description(s): 2.5mg to 15mg daily; matching placebo to olanzapine
Other intervention name(s): zyprexa; fake pill
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study on Genetically Affected Sporadic Thoracic Aortic Aneurysm and Dissection
Condition: Dissection of Aorta, Thoracic; Aneurysm of Aorta, Thoracic
MeSH terms: Aortic Dissection; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic
Study type: Observational

Summary: 
      Mortality of thoracic aortic aneurysm and dissection (TAAD) remains high because of the huge
      blood lost from the aorta. Questions about the potentially genetic effects on sporadic TAAD
      are raised by researchers to explore the possible mechanisms leading to sporadic TAAD and to
      establish new clinical approaches to prevent TAAD-caused adverse clinical outcomes. This
      study is intended to collect the gene information in sporadic TAAD patients and to explore
      the relationship between genetic variation and the incidence of sporadic TAAD for further
      study.
    

Detailed description: 
      Thoracic aortic dissection (TAD) is a critical clinical condition partly due to the rupture
      of aortic aneurysm. Mostly, surgical treatment can reduce the symptoms and extend life span
      of patients with thoracic aortic aneurysm and dissection (TAAD). However, mortality of TAAD
      remains high because of the huge blood lost from the aorta. Sporadic TAAD was considered to
      be a server consequence of hypertension, though most patients with hypertension won't have
      TAAD as their final outcomes. Previous studies have revealed the associations between genetic
      abnormalities and familial TAAD, and genetic tests have applied to assist the diagnosis of
      certain TAAD. Therefore, the potentially genetic effects on sporadic TAAD are explored by
      researchers to understand the possible mechanisms leading to sporadic TAAD and to establish
      new clinical approaches to prevent TAAD-caused adverse clinical outcomes. This study is
      intended to collect the gene information in sporadic TAAD patients and to explore the
      relationship between genetic variation and the incidence of sporadic TAAD for further study.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with thoracic aortic aneurysm and dissection.
      
Biospecimen description: 
      Peripheral whole blood is obtained from patients. Serum, blood cell and DNA are separated and
      stored for further study.
    
Keywords: dissection; aneurysm; thoracic aorta
A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to measure the safety and efficacy of three doses of varenicline
      for smoking cessation.
    


Intervention name(s): CP-526,555 (varenicline)
Intervention type(s): Drug
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment