bioihbjkbjnl/mcl2 huggingface dataset:
Study of Long-term Peg Intron vs. Colchicine in Non-responders.
Condition: Hepatitis C Virus; Advanced Fibrosis; Cirrhosis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study Peg-Intron will be tested to see if it will give better results than
      Colchicine. At this time, there is currently no recommended maintenance treatment for
      patients who have failed to respond to Interferon/Rebetron/Peg Intron and have advanced
      fibrosis. The purpose of this study is to compare two treatments to slow down the progression
      of liver disease and to prevent liver failure and liver cancer. The treatment will not cure
      Hepatitis C, but is being evaluated to see if it can slow down disease progression.
    

Detailed description: 
      We are proposing a randomized trial of Peg-Intron 0.5mcg per kg weekly versus colchicine
      0.6mg bid in prior non-responders to Interferon, Rebetron, PegIntron, or PegIntron &
      Ribavirin or any third agent such as Pegasys, CellCept, Amantadine with advanced
      fibrosis/cirrhosis. The specific aims of this proposal are to evaluate the role of long term
      Peg-Intron therapy on the natural history of patients with advanced chronic HCV infection
      with a primary focus on prevention of hepatic decompensation, progression of fibrosis and
      hepatoma development.

      The study design will focus on 3 monthly clinical evaluation for decompensation of liver
      function, rigorous clinical screening for development of hepatocellular cancer and liver
      biopsies for determination of progression of liver fibrosis every second year.
    

Intervention name(s): PEG -Intron; Colchicine
Intervention type(s): Drug; Drug
Intervention description(s): 0.6mg twice a day
Other intervention name(s): PEG interferon Alfa-2b 0.5mcg/kg weekly
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b; Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hepatitis C; cirrhosis; interferon; colchicine
Modified Atkins Diet and Type 2 Diabetic Patients
Condition: Obese Type 2 Diabetic Patients
Study type: Interventional

Summary: 
      This randomized control trial compared the influence of an Atkins diet to that of the ADA
      recommended diet on Type 2 diabetic obese patients during a one-year follow-up period
    


Intervention name(s): modified Atkins diet; ADA recommended diet
Intervention type(s): Other; Other
Intervention description(s): subjects assigned to follow modified Atkins diet for 1 year; subjects assigned to follow ADA recommended diet for period of 1 year
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: obesity; atkins; weight reduction; kidney function
Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry
      Syrup" in Children With Perennial Allergic Rhinitis: Double Blinded, Randomized, Placebo
      Controlled, Parallel Designed, Multi-centered, Phase III Study.
    


Intervention name(s): CITUS Dry Syrup; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pranlukast 10% dry syrup, b.i.d.; Placebo dry syrup, b.i.d
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Comparison of the Time to the First Rescue Analgesic Among Parturients Receiving Intrathecal Additive Fentanyl or Intrathecal Fentanyl With TAP Block or TAP Block Alone for Elective Cesarean Sections Under Hyperbaric Bupivacaine Spinal Anesthesia
Condition: Postoperative Pain; Cesarean Section
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The postoperative pain management after cesarean section under spinal anestheisa is done
      using various modalities. The commonly used regimens are systemic NSAIDs/Opioids, USG guided
      TAP block or Intrathecal additive Fentanyl or combined intrathecal fentanyl and USG guided
      TAP block.

      Investigators aim to compare the postoperative analgesia in terms of time to the first rescue
      analgesic in parturients receiving intrathecal additive fentanyl only, or intrathecal
      fentanyl with USG guided TAP block or USG guided TAP block alone for elective CS done under
      hyperbaric bupivacaine spinal anesthesia.
    

Detailed description: 
      Investigators will enroll 93 parturients planned for elective CS under hyperbaric bupivacaine
      spinal anesthesia and allocate them into three groups comprising intrathecal additive
      fentanyl only, or intrathecal fentanyl with USG guided TAP block or USG guided TAP block
      alone.

      The primary outcome will be time to the first rescue analgesics.
    

Intervention name(s): Fentanyl HCl; Bupivacaine 0.25% Injectable Solution
Intervention type(s): Drug; Drug
Intervention description(s): Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia; Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia Ultrasound-guided Transversus Abdominal plane block using Bupivacaine 0.25% Injectable Solution
Other intervention name(s): Intrathecal Fentanyl
Intervention MeSH terms: Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of a Lifestyle Intervention in Preschool Children on Physiological and Psychological Parameters
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Childhood obesity and low fitness tracks into adulthood and carries significant
      co-morbidities. The investigators test the hypothesis that a multidisciplinary multilevel
      lifestyle intervention in preschool children in the French and German speaking part of
      Switzerland during one school-year results in a smaller increase in body mass index (BMI) and
      a larger increase in aerobic fitness.
    

Detailed description: 
      We will assess the effect of this multidisciplinary intervention in a multicenter cluster
      randomized controlled trial including a total of 40 kindergarten classes in the French
      (canton Vaud) and in the German (canton St. Gallen) speaking part of Switzerland. Health
      promoters, trained in physical education, will receive further postgraduate training (in
      nutrition, education, psychology) and will then in reward teach several kindergarten teachers
      hands-on. These trained health promoters will intervene on the level of the kindergarten
      teacher, the parents, the local community and also on the level of the children following a
      professional pre-specified curriculum in the kindergarten that focuses primarily on physical
      activity, healthy nutrition, media use and sleep duration. The curriculum also includes
      information evenings, workshops and fun weekly homework packages. Special attention will be
      paid to establish a curriculum that reaches also socio-cultural high risk groups living in
      Switzerland. Measurements will be performed before and after the intervention.
    

Intervention name(s): Lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): Kindergarten and homebased increases in physical activity, healthy nutrition, sleep duration and decrease in media use: Involvement of parents and siblings
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: childhood; children; obesity; physical activity; nutrition; fitness; family
Video Assisted Education Before ERCP
Condition: Patient Compliance
Study type: Interventional

Summary: 
      It was aimed to study the effect of video assisted education about endoscopic retrograde
      cholangiopancreaticography (ERCP) on anxiety levels of patients who planned to undergo ERCP
      for any reason.Video revealing the ERCP procedure was shown to the patients in one group and
      not shown to the other. Then anxiety levels and pain scores have been obtained before and
      after the procedure in both groups
    

Detailed description: 
      The study was conducted to determine the effect of video education on anxiety level before
      the ERCP procedure and satisfaction degree after the ERCP procedure between September 1st
      2017 and December 31st 2018 at Bagcilar Medipol Mega University Hospital. Patients were
      grouped into two in a randomized manner. In control arm, patients underwent ERCP procedure
      with the information provided by the gastroenterologist who recommended the procedure.
      Patients in experimental arm, besides the information provided by the gastroenterologist,
      watched video of ERCP procedure and answered all the questions about the procedure by an
      experienced nurse. A total of 70 patients (35 in each arms) was planned to enroll to the
      study. State-Trait Anxiety Inventory (STAI) form was applied to measure anxiety level and
      visual analog score (VAS) was applied to measure the satisfaction about the procedure.
    

Intervention name(s): Video education
Intervention type(s): Behavioral
Intervention description(s): Procedure was presented to the cases via a video showing the steps in ERCP and questions had been answered by an experienced nurse
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: video education; ERCP; anxiety level; pain score
A Safety and Efficacy Study Comparing Naltrexone SR/Bupropion SR and Placebo in Obese Subjects With Type 2 Diabetes
Condition: Obesity; Overweight; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Overweight; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is determine whether the combination of naltrexone SR and bupropion
      SR is safe and effective in treating obesity in subjects with type 2 diabetes.
    

Detailed description: 
      Optimal care of patients with diabetes mellitus includes vigorous and persistent efforts to
      achieve physiologic control of blood glucose as well as other often associated conditions
      including hypertension, dyslipidemia and excess weight. Pharmacologic interventions for the
      treatment of obesity in type 2 diabetes have shown significant reductions in HbA1c. Two Phase
      II clinical trials demonstrated that a combination of bupropion SR and naltrexone is
      associated with greater weight loss than bupropion SR alone, naltrexone alone, or placebo in
      subjects with uncomplicated obesity. The current study investigated the safety and efficacy
      of the combination of naltrexone SR and bupropion SR compared to placebo in obese subjects
      with type 2 diabetes mellitus.
    

Intervention name(s): Naltrexone SR 32 mg/bupropion SR 360 mg/ day; Placebo; Ancillary therapy
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling
Other intervention name(s): NB32
Intervention MeSH terms: Naltrexone; Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Overweight; Diabetes Mellitus, Type 2
Alexander Technique Neck Pain
Condition: Chronic Non-specific Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This study aimed to test the efficacy of five Alexander Technique lessons compared to the
      same period of heat pad application and guided imagery in patients with chronic non-specific
      neck pain.
    

Detailed description: 
      see above
    

Intervention name(s): Alexander Technique; Heat pad application; guided imagery
Intervention type(s): Behavioral; Device; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
Condition: Subjective Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in
      the treatment of subjective tinnitus in comparison to placebo.
    


Intervention name(s): Neramexane mesylate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day; Double-blind treatment period of 17 weeks placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection
Condition: Respiratory Syncytial Virus Lower Respiratory Tract Infection
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to evaluate the anti-viral effect and safety of different doses of
      inhaled ALX-0171 in subjects hospitalized for Respiratory Syncytial Virus Lower Respiratory
      Tract Infection (RSV LRTI). The secondary objective is to evaluate the clinical activity,
      pharmacokinetic (PK) properties, pharmacodynamic (PD) effect and immunogenicity of different
      doses of inhaled ALX-0171.
    

Detailed description: 
      This was a Phase 2b, randomized, double-blind, placebo-controlled, international, multicenter
      dose-ranging study in infants and toddlers hospitalized for RSV LRTI. The study evaluated 3
      dose levels of ALX-0171 in a sequential part (safety Cohorts 1-3) followed by a parallel part
      (Cohort 4).

      An Independent Data Monitoring Committee (IDMC) was assigned to review study data and provide
      recommendations on proceeding to the next safety cohort and on which dose levels could be
      taken forward in the parallel part.

      Three dose levels of ALX-0171 were evaluated:

        -  Dose 1: target dose of 3.0 mg/kg

        -  Dose 2: target dose of 6.0 mg/kg

        -  Dose 3: target dose of 9.0 mg/kg

      The study drug was administered by inhalation once daily for 3 consecutive days along with
      standard of care treatment, which was determined by the Investigator (or his/her designee)
      according to institutional practice.
    

Intervention name(s): ALX-0171 3.0 mg/kg; ALX-0171 6.0 mg/kg; ALX-0171 9.0 mg/kg; Placebo
Intervention type(s): Biological; Biological; Biological; Other
Other intervention name(s): Matching Placebo
Intervention MeSH terms: Gontivimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: RSV, Lower Respiratory Tract Infection, pediattric patients
Intraoperative Radiation Therapy for Resectable Pancreatic Cancer
Condition: Resectable Pancreatic Adenocarcinoma
Study type: Interventional

Summary: 
      This phase II study is designed to investigate the efficacy of IORT for patients with
      resectable pancreatic adenocarcinoma. The purpose of the study is to show the local
      recurrence rate after surgical resection and IORT is superior to that of surgical resection
      alone from the historical control. A total of 42 patients will be enrolled, and these
      patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed, followed by 6
      cycles of adjuvant gemcitabine chemotherapy.
    

Detailed description: 
      Treatment outcomes of pancreatic cancer are poor even after surgical resection, thus patients
      may receive adjuvant chemotherapy or chemoradiotherapy. Intraoperative radiotherapy (IORT)
      with low energy (50 kV) x-ray allows delivery of a high dose radiation to the tumor bed
      during surgery while effectively sparing adjacent critical organs. Another advantage of IORT
      is that delivery of IORT does not interfere with the scheduled administration of adjuvant
      chemotherapy or chemoradiotherapy. Here we investigate the efficacy of IORT for patients with
      resectable pancreatic adenocarcinoma by comparing the local recurrence rate after surical
      resection and IORT with that of surgical resection alone from the historical control. A total
      of 42 patients will be enrolled in this phase II trial, and these patients will receive IORT
      of 10 Gy at 5 millimeter depth of the tumor bed, followed by 6 cycles of adjuvant gemcitabine
      chemotherapy.
    

Intervention name(s): Intraoperative radiation therapy (IORT)
Intervention type(s): Device
Intervention description(s): IORT with 50 kV x-ray will be delivered during surgery as a single dose of 10 Gy at 5 millimeter depths of the tumor bed, followed by gemcitabine chemotherapy (1000 mg/m2) every 4 weeks for a total of 6 cycles
Intervention model: Single Group Assignment
Intervention model description: Intervention: intraoperative radiotherapy
Masking: None (Open Label)
Primary purpose: Treatment
Factors Contributing to the Pressure Wave Form Changes
Condition: Analysis, Event History
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the decrease pattern of lumbar epidural pressure
      from ligamentum flavum to epidural space and analyzing factors contributing this pressure
      change pattern.
    

Detailed description: 
      Loss of resistance (LOR) is the most commonly used method to confirm the epidural space. The
      advantage of LOR is its simplicity; only saline or air filled syringe is required. LOR is
      felt through the sudden decrease of pressure and this pressure gradient is generated when the
      needle is within the passage of interspinous ligament, ligamentum flavum and epidural space.
      The presence of ligamentum flavum is crucial for the identification of epidural space by LOR.
      However, gaps in ligamentum flavum, paravertebral muscle and cyst in interspinous ligament
      can modify this passage and a false LOR is generated consequentially. The false positive rate
      of the lumbar and cervical area was reported to be 8.3~17% and 30~68%, respectively. If the
      false positive rate is high, repeated attempts of epidural steroid injection (ESI) are
      required, with additional discomfort or pain to the patient.

      The high rate of false LOR has prompted the design of adjunctive modalities. Among these,
      epidural pressure waveform analysis (EPWA) using pressure transducer has been reported. If
      the epidural needle or catheter is positioned accurately in the epidural space, a pulsatile
      wave coinciding with arterial pulsations can be seen through the monitor.

      Recent study suggested that significant abrupt pressure decrease occurs when cervical
      epidural injection was done via paramedian approach rather than midline.
    

Intervention name(s): lumbar epidural injection
Intervention type(s): Procedure
Intervention description(s): the pattern of pressure decrease from ligamentum flavum to epidural space
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: cervical epidural space; abrupt pressure decrease
Follow-up of Extreme Neonatal Hyperbilirubinemia in 5-10 Year Old Children: a Danish Population Based Study
Condition: Neonatal Hyperbilirubinemia
MeSH terms: Hyperbilirubinemia, Neonatal; Hyperbilirubinemia
Study type: Observational

Summary: 
      The objective of this study was to investigate whether infants with total serum bilirubin >
      450 umol/L in the neonatal period and no symptoms or no more than early acute bilirubin
      encephalopathy develop long term sequelae with impairment of motor development, hearing and
      executive function compared with a control group.
    

Detailed description: 
      Children in both the exposed and the non-exposed group were examined by use of the MABC-2 and
      pure tone audiometry by the responsible examiner for the study, Pernille Vandborg, MD. The
      aim was to see whether the exposed group suffered any long term sequelae to the extreme
      neonatal hyperbilirubinemia, i.e. impaired motor development or hearing impairment, compared
      to a control group. The examinations took place at the local hospital.
    

Intervention name(s): Movement assessment battery for children - 2
Intervention type(s): Procedure
Intervention description(s): A standardised test developed to identify developmental difficulties in children.
Other intervention name(s): MABC-2
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All children born in Denmark in the period 01.01.2000 - 31.12.2005 with a gestational age
        >= 35 weeks and a total serum bilirubin > 450 umol/L and a matched control group of
        children
      
Keywords: Neonatal hyperbilirubinemia; Follow-up; Motor development; Hearing; Executive function
The Efficacy of a Dentifrice in Providing Relief From the Pain of Dentinal Hypersensitivity
Condition: Dentine Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing
      dentinal hypersensitivity over an eight week treatment period.
    


Intervention name(s): Stannous Fluoride; Sodium Monofluorophosphate
Intervention type(s): Drug; Drug
Intervention description(s): dentifice; dentifrice
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453
Condition: Hypertension; Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the tolerability of BIA 5-453 after six multiple
      rising dose regimens of BIA 5-453.
    

Detailed description: 
      Two centres, double-blind, randomised, placebo-controlled study of six dosage regimens of BIA
      5-453 in six groups of healthy male subjects.

      In each group, the study consisted of a 10-day multiple-dose period. Progression to the next
      dose level only occurred if the previous dose level was considered to be safe and well
      tolerated. An appropriate interval separated the investigation of doses to permit a timely
      review and evaluation of safety data (including plasma exploratory pharmacokinetics) prior to
      proceeding to a higher dose level.
    

Intervention name(s): BIA 5-453; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration; The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
Other intervention name(s): Etamicastat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment