bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive,
      interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following
      48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The
      anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
      individuals.
    


Intervention name(s): Peginterferon alfa-2a
Intervention type(s): Drug
Intervention description(s): Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks.
Other intervention name(s): Pegasys
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation on Differences in Skin Sodium Content Between Normal Subjects and ICU-patients
Condition: Hypernatremia
MeSH terms: Hypernatremia
Study type: Observational

Summary: 
      This study investigates the differens in sodium storage in skin between normal subjects,
      patients after cardiac surgery and septic patients.
    

Detailed description: 
      According to the current paradigm ICU-acquired hypernatremia is mainly an iatrogenic problem,
      caused by sodium overload or water deficit. In spite of several interventions to reduce
      sodium intake and optimize fluid balance, critically ill patients still develop
      hypernatremia. These patients also seem to have an inability to excrete sodium, hence develop
      a positive sodium balance. In animals sodium storage in the third compartment was found. Our
      hypothesis is that sodium storage in the third compartment is different in critically ill
      patients and this difference could play a role in the development of ICU-acquired
      hypernatremia.
    

Intervention name(s): Skin biopsies; Blood and urine analysis; Blood collection for RNA-investigation
Intervention type(s): Procedure; Other; Other
Intervention description(s): 2 3mm skin biopsies will be taken; Measurement of sodium, potassium and kidneyfunction in blood and urine.; A blood sample that, in case of relevant differences between groups, could be used for RNA-profiling.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        -  15 patients admitted to the ICU with systemic inflammatory response syndrom in the
             presence of a(n expected) new infection

          -  15 patients admitted to the ICU after coronary artery bypass surgery, matched by
             gender and age (+/- 10 years) to the septic patients

          -  15 patients undergoing a hip replacement for arthrosis, matched by gender and age (+/-
             10 years) to the septic patients
      
Biospecimen description: 
      Slides for microscopic investigations, containing slices of the skin biopsies. These biopsies
      are only diagnostic and these are specific and only for study properties. Study involvement
      will not influence diagnostic or therapeutic interventions that are due to common treatment.
Combination Chemotherapy Followed by Surgery in Treating Patients With Non-small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug with surgery may kill more tumor
      cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with docetaxel
      and cisplatin followed by surgery in treating patients with stage IIIA non-small cell lung
      cancer.
    

Detailed description: 
      OBJECTIVES: I. Assess the efficacy and toxic effects of docetaxel plus cisplatin in patients
      with stage IIIA non-small cell lung cancer. II. Assess the clinical and pathological response
      rate to this therapy in this patient population. III. Compare the benefit of surgery in terms
      of overall survival of responding and nonresponding patients.

      OUTLINE: Patients receive infusions of docetaxel over 1 hour on day 1, followed by infusions
      of cisplatin over 1 hour on days 1-2. Treatment is repeated for three 21 day courses.
      Patients undergo tumor resection and mediastinal lymph node dissection. Patients are to
      receive postoperative radiotherapy within 4 weeks of resection if the tumor reaches the
      resection margins and/or the first mediastinal lymph node levels are involved. Patients will
      be followed until death.

      PROJECTED ACCRUAL: Approximately 5-40 patients will be accrued within 3 years.
    

Intervention name(s): cisplatin; docetaxel; surgical procedure; radiation therapy
Intervention type(s): Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Docetaxel
Primary purpose: Treatment
Keywords: squamous cell lung cancer; large cell lung cancer; stage IIIA non-small cell lung cancer; adenocarcinoma of the lung
Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is expected to demonstrate the anti-diabetic efficacy of 3-months treatment with
      GFT505 (80 mg/d) on Glycosylated Haemoglobin A1c (HbA1C) and fasting plasma glucose.

      And to assess the tolerability and safety of once-a-day administrations of oral doses of
      GFT505 for 12 weeks in patients with type 2 diabetes mellitus.
    

Detailed description: 
      The study period per patient is 16-20 weeks maximum and is conducted as follows :

        -  Run-in period: 2 weeks or 6 weeks for patients under fibrate treatment at screening (4
           weeks fibrate wash-out + 2 weeks placebo run-in);

        -  Treatment period: 12 weeks;

        -  Follow-up period: 2 weeks.
    

Intervention name(s): GFT505 80mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): hard gelatin capsules dosed at 20mg,oral administration,4 capsules per day before breakfast; hard gelatin capsules,oral administration,4 capsules per day before breakfast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Cardiovascular Diseases; PPARs; OGTT
Survey: Clinical Outcome After Bowel Resection in Women Due to Endometriosis
Condition: Bowel Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      Endometriosis is one of the most frequent benign diseases that can affect women in their
      reproductive age. In severe form, the colon or rectum may be involved. It has been shown that
      the surgical treatment improve typical symptoms like pain and dyspareunia. The investigators
      evaluated the functional results and quality of life after laparoscopic colonic resection for
      endometriosis
    

Detailed description: 
      A clinical analysis of thirty women with typical symptoms including pelvic pain, infertility
      and endometriotic bowel lesions who underwent laparoscopic surgery including colonic
      resection performed from 2009 to 2012. Quality of life and pain was documented
      postoperatively. We conduct a telephone survey, which starts at May 2014.
    

Intervention name(s): laparoscopic colonic surgery
Intervention type(s): Procedure
Intervention description(s): women with typical symptoms including pelvic pain, infertility and endometriotic bowel lesions who underwent laparoscopic surgery including colonic resection performed from 2009 to 2012
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        women with typical symptoms including pelvic pain, infertility and endometriotic bowel
        lesions who underwent laparoscopic surgery including colonic resection performed from 2009
        to 2012
      
Keywords: pain; quality of life
Evaluation of the Effects of the New Program for Cognitive Enhancement and Improvement in the Elderly
Condition: Aging
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of cognitive rehabilitation program on
      the improvement of cognitive functions in normal elderly subjects.
    

Detailed description: 
      The cognitive rehabilitation program was developed to improve cognitive functions of the
      elderly or patients with cognitive impairments. The study will enroll 40 healthy subjects
      with a normal cognitive function between 55 and 85 years of age. Forty subjects will be
      randomly assigned into two groups. Subjects in the intervention group will receive four weeks
      of cognitive rehabilitation training, three times per week and 30 minutes per day. The
      control group will not receive any intervention. The investigator will measure their
      cognitive and brain functions three times at pre-intervention, post-intervention and four
      weeks after intervention to assess the effectiveness of the cognitive training program.
    

Intervention name(s): Cognitive rehabilitation program
Intervention type(s): Other
Intervention description(s): Cognitive rehabilitation programs have been developed to improve the cognitive functions of the elderly or patients with cognitive impairments. The program includes sub-categories such as attention, working memory, memory and executive functions with various levels of difficulty.
Other intervention name(s): Computer-aided Cognitive Rehabilitation Training System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: aging, computerized cognitive training
Comparative Anti-Reflux Procedures in Neurologically Impaired Children
Condition: Gastroesophageal Reflux; Nervous System Diseases; Fundoplication; Enteral Nutrition
MeSH terms: Gastroesophageal Reflux; Nervous System Diseases
Study type: Interventional

Summary: 
      This trial is a randomized controlled trial of two standard anti-reflux procedures, Nissen
      fundoplication versus gastrojejunal feeding tubes (GJ tubes), in children and adolescents
      with functional and intellectual impairment who have gastrostomy feeding tubes and medically
      refractory or severe gastroesophageal reflux disease (GERD). This is a pilot study to
      establish feasibility before initiating a multi-centered study.
    


Intervention name(s): Fundoplication; Gastrojejunal (GJ) feeding tube
Intervention type(s): Procedure; Procedure
Intervention description(s): During fundoplication surgery, the upper curve of the stomach (the fundus) is wrapped around the esophagus and sewn into place so that the lower portion of the esophagus passes through a small tunnel of stomach muscle. This surgery strengthens the valve between the esophagus and stomach (lower esophageal sphincter), which stops acid from backing up into the esophagus as easily.; Gastrojejunal (GJ) tube placement is an image guided technique in which a special soft feeding catheter is placed through an existing hole in the stomach (gastrostomy) into the small bowel (jejunum).
Other intervention name(s): Nissen Fundoplication; GJ tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux; Nervous System Diseases; Fundoplication; Enteral Nutrition
Rapamune Improves Outcomes of Severe H1N1 Pneumonia
Condition: H1N1 Pneumonia; Hypoxemia
MeSH terms: Pneumonia; Hypoxia
Study type: Interventional
Phase: Phase 2

Summary: 
      Severe H1N1 pneumonia with acute respiratory failure shows hyperactive immune cells
      infiltration of lung. Rapamune, a mTOR inhibitor, modulates the immune response by blocking
      activation of T- and B-cells. To investigate the clinical efficiency of rapamune in severe
      H1N1 pneumonia with respiratory failure, this study was conducted.
    

Detailed description: 
      From 2009 winter to 2011 spring, patients with flu-like symptoms in Chang Gung Memorial
      Hospital were screened by rapid antigen test and influenza subtype was confirmed by
      polymerization chain reaction (PCR). 38 H1N1 patients with severe hypoxemia
      [alveolar-arterial oxygen gradient, (A-a) O2 gradient, > 200 mmHg] requiring ventilator
      support were randomized to receive Rapamune (2mg/day) or not. Patients were then randomized
      to receive either Sirolimus (Rapamune 2mg/day, Pfizer) or not for a course of 14 days. The
      outcome variables include liberation of ventilator, ICU mortality, necessity of ECMO,
      Sequential Organ Failure Assessment (SOFA) score and complications after admission to ICU
      were recorded. SOFA score composed of scores from six organ systems, graded from 0 to 4
      according to the degree of dysfunction/failure.
    

Intervention name(s): Sirolimus (Rapamune 2mg/day, Pfizer)
Intervention type(s): Drug
Intervention description(s): Sirolimus (Rapamune 2mg/day, Pfizer) or not for a course of 14 days.
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: H1N1 patients with severe hypoxemia requiring ventilator support
The Effect of Anesthetic Technique on VEGF-C and PGE2
Condition: Uterine Leiomyomas
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      The purpose of this study is to verify the effect of anesthetic technique on the change of
      postoperative serum vascular endothelial growth factor C and prostaglandin E2, and to explore
      the potential impact of the anesthetic technique on leiomyomas recurrence and growth after
      the surgery of abdominal myomectomy.
    

Detailed description: 
      Uterine leiomyomas is the most common benign tumor of uterus, the most common tumor in women
      as well. Like many other forms of tumor, it requires an independent blood supply to enlarge.
      This process, angiogenesis, is mediated by vascular endothelial growth factor C (VEGF-C) and
      prostaglandin E2 (PGE2). Several studies have confirmed that VEGF-C has a high level in
      patients with uterine leiomyomas, which has also been demonstrated that it was related to
      occurrence and growth of uterine leiomyomas because it's capable of promoting angiogenesis,
      mitogenic, and vascular permeability-enhancing activities. Also, some researchers suggested
      that suppression of prostaglandin synthesis (including PGE2) via cyclooxygenase type-2
      (COX-2) enzyme inhibition may reduce the incidence of some tumor. The aim of this study is to
      verify the effect of anesthetic technique on the change of postoperative serum VEGF-C and
      PGE2, and to explore the potential impact of the anesthetic technique on leiomyomas
      recurrence and growth after the surgery of abdominal myomectomy.
    

Intervention name(s): general anesthesia and patient controlled intravenous analgesia; spinal anesthesia and continuous postoperative epidural analgesia
Intervention type(s): Other; Other
Intervention description(s): Patients receive general anesthesia intraoperative period and continuous intravenous analgesia postoperation; Patients receive spinal anesthesia intraoperative period and continuous epidural analgesia postoperation
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: analgesia; anesthesia; leiomyomas; tumor; vascular endothelial growth factor; anesthesia technique on tumor
Long-term Study on Anti-HBV Effect of Tenofovir and Resistance Surveillance in Asian-American Adult Patients
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Observational

Summary: 
      This is a Phase IV, open-label, single-arm, 96 week community-based observational study
      evaluating the antiviral efficacy, safety, and tolerability of TDF in HBV mono-infected
      Asian-American adults who had completed 48 week treatment with Tenofovir in Gilead 174-0123
      study. The primary objective of this study is to evaluate the long-term antiviral efficacy of
      tenofovir DF 300 mg once daily in these patients. The secondary objectives are to evaluate
      the safety and tolerability of TDF including the biochemical and virological responses to
      TDF, the incidence of drug resistance mutations in these patients The duration of treatment
      in this study is total of three Years (144 weeks) on TDF.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adult infected with chronic hepatitis B
      
Keywords: CHB
Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy
Condition: Hip Arthroscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this proposed study is to evaluate the efficacy of a multimodal approach to
      analgesia for patient's pain after hip arthroscopy and to also assess if this new approach
      will result in a reduction in post-operative narcotic use.

      This study is a single-center, randomized prospective study comparing post-operative pain
      scores and narcotic consumption between individuals receiving acetaminophen along with a
      reduced quantity of Percocet (to be used as needed for breakthrough pain) and individuals
      receiving Percocet only. Both pain management options are considered to be standard of care.
      Both cohorts will receive aspirin for DVT prophylaxis and celecoxib for heterotopic
      ossification prophylaxis.

      The primary objective of the study are to compare patients' narcotic consumption and reported
      pain following arthroscopic hip surgery, and determine if acetaminophen can provide adequate
      pain relief compared to a narcotic medication.
    


Intervention name(s): Acetaminophen; Percocet
Intervention type(s): Drug; Drug
Intervention description(s): acetaminophen 600 mg to be taken every 8 hours (TID); Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group.
Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics of Rivaroxaban After Bariatric Surgery
Condition: Bariatric Surgery; Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional
Phase: Phase 1

Summary: 
      Data on pharmacokinetics of rivaroxaban after bariatric surgery and in morbid obesity are
      sparse. The aim of this study is to assess the pharmacokinetic and pharmacodynamic parameters
      of rivaroxaban, used at a therapeutic anticoagulant dose, in patients with previous bariatric
      surgery, with sleeve gastrectomy or gastric bypass, and in morbid obese subjects.

      Four groups of 16 subjects per group are studied: Morbid obese subjects / Subjects who have
      undergone gastric bypass surgery / Subjects who have undergone sleeve gastrectomy surgery /
      Non-operated control subjects matched for age and BMI with operated subjects.

      All patients (obese, surgical patients, and controls) will receive rivaroxaban 20mg once
      daily during 8 days. Blood samples will be taken predose (Baseline) and 0.5, 1, 2, 3, 6, 9,
      12 and 24h post rivaroxaban administration at day1 and day8. PK and PD parameters will be
      compared between groups in order to explore the impact of bariatric surgery, type of surgery
      and body mass index on the pharmacological profile of rivaroxaban.
    


Intervention name(s): rivaroxaban 20 mg once daily 8 days
Intervention type(s): Drug
Intervention description(s): Blood samples for the measurement of rivaroxaban PK parameters
Intervention MeSH terms: Rivaroxaban
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sleeve gastrectomy; gastric bypass; morbid obesity
Investigation of Psychophysiological Correlation of Aggression and Response to Aversive Stimuli
Condition: Conduct Disorder; ADHD; Oppositional Defiant Disorder
MeSH terms: Aggression; Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders
Study type: Observational [Patient Registry]

Summary: 
      This study investigates the psychophysiological correlations of aggression and response to
      aversive stimuli in a population of 133 children clinically diagnosed with conduct disorder
      (CD) and/or attention-deficit/hyperactivity disorder (ADHD). Data was gathered about
      participants' level of aggression through the Reactive-Proactive Aggression Questionnaire
      (RPQ). The stimuli that were presented to the participants included 1) a loud sound, 2)
      threatening photographs from the International Affective Picture System (IAPS), and 3) the
      Trier Social Stress Task (TSST). Participants' psychophysiological features of heart rate and
      galvanic skin conductance were measured and analyzed in relation to their RPQ scores and
      clinical diagnosis.
    


Intervention name(s): No intervention was administered for the purpose of this study.
Intervention type(s): Other
Intervention description(s): No intervention was administered for the purpose of this study. Observations were carried out for all participants.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study involves children and adolescents diagnosed with disruptive behaviour disorder
        (DBD, i.e. conduct disorder or oppositional defiant disorder) or attention deficit /
        hyperactivity disorder (ADHD, i.e. combined type or ADHD predominantly inattentive type or
        ADHD predominantly hyperactive-impulsive type).
To Investigate the Role of Upstream High Dose Statin in STEMI
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a double-blinded randomized placebo controlled trial investigating the role of
      upstream 80mg Atorvastastin-calcium in patients undergoing percutaneous intervention for
      acute STEMI.
    


Intervention name(s): Atorvastatin calcium; Inactive Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Eligible patients will receive 80mgs of atorvastatin orally upon admission to hospital prior to percutaneous intervention of the affected artery. Dose of post-procedural statin will be at the discretion of the cardiologist.; Eligible patients will receive a placebo orally upon admission to hospital prior to percutaneous intervention of the affected artery.
Other intervention name(s): Lipitor; Placebo, Sugar Pill
Intervention MeSH terms: Atorvastatin; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment