bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Patient Cost-Sharing on Antidepressant and Adjunctive Therapy Use
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Observational

Summary: 
      The primary objective of this study is to measure the effects of patient cost-sharing on the
      initiation of adjunctive treatment and subsequent healthcare utilization and expenditures
      among a population of commercially insured adults on antidepressant therapy.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be selected from the MarketScan Commercial Database between January 1, 2004
        and September 30, 2008 (the last month of data available)
Trial of AB-110 in Adults With Hematologic Malignancies Undergoing Cord Blood Transplantation
Condition: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia in Remission; Myelodysplastic Syndromes; Other Acute Leukemias
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Hematologic Neoplasms; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase 1b, open label, multi-center trial of AB-110 in adults with hematologic malignancies,
      including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and
      myelodysplasia (MDS) undergoing cord blood transplantation. Subjects will receive
      unmanipulated cord blood (UCB) and AB-110 expanded CD34 enriched hematopoietic progenitor
      cells (HSPC).
    


Intervention name(s): Unmanipulated Umbilical Cord Blood (UCB); AB-110
Intervention type(s): Biological; Biological
Intervention description(s): Human leukocyte antigen (HLA) matched umbilical cord blood; Expanded cord blood stem cells and engineered human endothelial cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Confocal Laser Endomicroscopy (CLE) in Patients With Diarrhea
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Observational

Summary: 
      The main objective of this study is to determine the frequency of different gastrointestinal
      disorders as the cause of diarrhea in patients at a tertiary referral center using confocal
      laser endomicroscopy.
    

Detailed description: 
      Background:

      Diarrhea is characterized by frequent, loose, and watery bowel movements. Common causes
      include various gastrointestinal infections (e.g. clostridium difficile, salmonella),
      inflammatory bowel disease (ulcerative colitis, Crohn´s disease), drugs (e.g. antibiotics)
      and malabsorption syndromes (e.g. celiac and Whipple's disease). Confocal laser
      endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic
      imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal
      mucosa during the endoscopic procedure.

      Scope:

      In patients with diarrhea.

      Methods:

      Patients were randomized in two groups. Group 1: Patients underwent standard video
      colonoscopy for the evaluation of their symptoms. Group 2: During the endoscopic procedure
      CLE will be performed additionally.

      Procedure:

      The patient underwent colonoscopy. In Group 2 patients´ will receive intravenous fluorescein
      or topical mucosal staining with acriflavin or cresyl violet during the procedure, followed
      by in-vivo CLE of the tissue. Confocal images are digitally saved and analyzed afterwards.
    

Intervention name(s): Colonoscopy; Confocal Laser Endomicroscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will undergo colonoscopy for evaluation of their symptoms.; Patients will undergo CLE during their endoscopy. Findings will be compared to group 1.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients of a tertiary referral hospital.
      
Keywords: Patients with diarrhea
Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK),
      target engagement (TE) and immunogenicity of GSK3858279 when administered to healthy
      Caucasian, Chinese and Japanese participants.
    


Intervention name(s): GSK3858279; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK3858279 will be administered; Placebo will be administered
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Safety; Tolerability; GSK3858279; Placebo; Caucasian; Chinese; Japanese
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based Therapy
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and RBV
      in patients with (Genotype 1) hepatitis C, who did not respond to previous treatment.
    


Intervention name(s): MP-424; Ribavirin; Peginterferon Alfa-2b
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 750 mg every 8 hours for 12 weeks; 600 - 1000 mg/day based on body weight for 24 weeks; 1.5 mcg/kg/week for 24 weeks
Other intervention name(s): Telaprevir
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Functional Restoration After Abdominal and Pelvic Laparoscopic Surgery: Effect of Perioperative Intravenous Lidocaine
Condition: Colon Cancer; Inflammatory Bowel Diseases; Diverticulitis
MeSH terms: Inflammatory Bowel Diseases; Diverticulitis
Study type: Interventional

Summary: 
      This is a blinded randomized controlled trial in patients undergoing laparoscopic colon
      surgery. The aim of this study is to assess whether perioperative intravenous lidocaine has
      an impact on the early post operative physical activity recovery of patients scheduled for
      laparoscopic colon surgery.

      Twenty patients will receive thoracic epidural analgesia, twenty patients will receive
      intravenous lidocaine plus patient-controlled analgesia (PCA) and twenty patients will
      receive only PCA.

      Hypothesis: patients receiving perioperative intravenous lidocaine, post operative recovery
      will be faster and decrease pain intensity, opioid consumption and side effects, length of
      hospital stay; probably as a result of a significant opioid sparing and attenuated
      inflammatory response.
    

Detailed description: 
      This is a blinded randomised study of patients undergoing major laparoscopic abdominal and
      pelvic surgery. The first group of patients will receive thoracic epidural analgesia, the
      second group will receive perioperative intravenous lidocaine, the third group will PCA alone
      and the last group will receive spinal analgesia. Functional restoration assessed by
      self-administered quality of Life questionnaires (SF-36, CHAMPS, ICFS) and 2 and 6 min
      walking test will be assessed in the two groups at 3 and 8 weeks after the surgery.
    

Intervention name(s): Lidocaine; Epidural Block; PCA Morphine
Intervention type(s): Drug; Procedure; Drug
Intervention description(s): 1% Lidocaine 1mg/kg/hr IV drip x 48hr; 0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr; PCA Morphine is set to the patient for 48 hours postoperative. 2 mg. of morphine is given to a patient as much as patient requires, maximum at every 7 minutes.
Other intervention name(s): Intravenous local anesthetic infusion; Thoracic epidural analgesia; Patient Control Analgesia Morphine.
Intervention MeSH terms: Lidocaine; Morphine; Anesthetics, Local; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Alogliptin Combined With Metformin in Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily
      (QD), combined with metformin in adults with type 2 diabetes mellitus.
    

Detailed description: 
      There are approximately 19 million people in the United States who have been diagnosed with
      diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies
      among racial and ethnic populations and has been shown to correlate with age, obesity, family
      history, history of gestational diabetes, and physical inactivity. Over the next decade, a
      marked increase in the number of adults with diabetes mellitus is expected.

      Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients
      with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV
      enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of
      2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition
      of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2
      diabetes.

      The aim of the current study is to evaluate the effectiveness of alogliptin in combination
      with metformin in individually who are inadequately controlled on metformin alone.

      Individuals who participate in this study will be required to commit to a screening visit and
      up to 14 additional visits at the study center. Study participation is anticipated to be
      about 34 weeks (or 8.5 months).
    

Intervention name(s): Alogliptin and metformin; Alogliptin and metformin; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.; Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.; Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
Other intervention name(s): alogliptin; SYR110322; Glucophage; SYR-322; alogliptin; SYR110322; Glucophage; SYR-322; Glucophage
Intervention MeSH terms: Metformin; Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus; Lipoatrophic; Dyslipidemia; Drug Therapy
CHOICES: Family Physicians Treat Overweight Children
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      CHOICES is a program to provide children and families with lifetime tools and lifestyle
      strategies to achieve and maintain a healthy body size. Both parents and children get active,
      learn about the food choices they can make, and about the roles of TV in their lives. Led by
      physicians and young adults, the 12 weekly 90 minute sessions provide hands on experiences
      that connect into the participants' daily lives. In the study, the families were divided into
      two groups, beginning their classes 6 months apart. Body measurements were taken at baseline
      and every 4 months to 16 months.
    

Detailed description: 
      The specific aim of this pilot study was to use the group office visit model to provide an
      obesity treatment intervention for children 8-11 years of age in gender-specific groups and
      their parents in a clinic setting. The targeted lifestyle components of the intervention are
      less TV viewing, less sweetened beverages, smaller food portions, less fast food/better
      choices away from home and more general physical activity. The psychosocial component was
      based in Resiliency; the Choices model focused on a non-judgmental approach to empowerment in
      relation to personal goals and knowledge of the basics of nutrition and physical activity.

      Our aim was to recruit 35-40 children (approximately equal boys and girls) ages 8-11 and
      their parents for a 12 weekly sessions group office visit program. Participants were
      randomized into 2 groups; one group starting in March 2006 and the lagged intervention
      control group starting in September 2006. Physical measurements and data collection were at
      baseline, 4, 8, 12, 16 months from randomization.

      We evaluated the acceptability and feasibility of the group office visit model and effect
      size (body mass index (BMI) and weight-for-age Z-scores). Feasibility and acceptability
      included ability to recruit within clinics, attendance, completion, follow-up rates, focus
      groups data and interviews of those who drop out. Evaluation of effect size included the
      patterns of growth over 15 months from baseline in relation to expected growth patterns and
      intervention exposure.
    

Intervention name(s): Choices
Intervention type(s): Behavioral
Intervention description(s): The 12-week intervention included 1.5 hour classes each week. Topics included nutrition, physical activity, and psychosocial skills based in Resiliency.
Other intervention name(s): Resiliency; Nutrition; Physical Activity
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric obesity; resiliency; physical activity; dietary patterns; children
Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus
Condition: Barrett's Esophagus
MeSH terms: Barrett Esophagus
Study type: Observational

Summary: 
      Barrett's esophagus can progress to esophageal cancer, but it doesn't always. Current
      treatment is frequent surveillance via upper endoscopy with multiple biopsies to look for
      changes (dysplasia). Pathologists vary dramatically in their interpretation of Barrett's
      Metaplasia versus dysplasia and consensus is very difficult to achieve. The investigators
      propose a longitudinal study of subjects with confirmed Barrett's intestinal metaplasia
      without dysplasia to look for predictive factors for transformation to dysplasia or cancer.
      Potential biomarkers can be found in serum, plasma, urine, frozen or fixed Barrett's and
      Normal esophageal mucosa. In addition, the investigators are testing a brushing technique
      from CDx, Inc. for predictive factors. Subjects must have pathologically confirmed Barrett's
      intestinal metaplasia without history of dysplasia to be on this longitudinal study.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects undergoing clinically-indicated upper endoscopy for surveillance of their
        pathologically-confirmed Barrett's intestinal metaplasia. Recruitment is from the Endoscopy
        schedules of the collaborating locations.
      
Biospecimen description: 
      Plasma,serum, DNA, urine, Barrett's tissue (Fixed and Frozen), Normal Esophagus tissue (Fixed
      and Frozen)
    
Keywords: Barrett's Intestinal Metaplasia
SOMEBODY, a Social Media-based Eating Disorder Prevention Program
Condition: Eating Disorder Symptom
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to develop and evaluate the feasibility, acceptability, and
      preliminary evidence of potential efficacy of a social-media based intervention to reduce
      risk factors for eating disorders in college women.
    

Detailed description: 
      Previous research supports an association between specific aspects of social media use and
      increased eating pathology in correlational designs and that specific aspects of social media
      use cause increases in risk factors for eating disorders. The aim of the current project is
      to determine whether social media use can be altered to cause decreases in eating disorder
      risk factors. To accomplish this, college women will be recruited to participate in an open
      trial of a pilot program that adapts activities used within evidence-based eating disorder
      prevention programs to be used on social media platforms. The intervention is designed to
      target internalization of the thin ideal.
    

Intervention name(s): SOMEBODY Eating Disorder Prevention Program
Intervention type(s): Behavioral
Intervention description(s): Participants will receive daily activities to complete on their most frequently used social media platform for 14 consecutive days. Daily activities have been adapted from the Body Project - an intervention that has been demonstrated to reduce internalization of the thin ideal and reduce risk for eating disorders. Examples of activities to be piloted include unfollowing social media accounts the participant perceives as reinforcing the thin-ideal and posting a selfie without makeup or editing. Based on feedback from participants, the intervention may be altered to improve acceptability, feasibility, and preliminary evidence of potential efficacy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Improving the Quality of Paediatric Hospital Care in the Kyrgyz Republic
Condition: Quality of Hospital Care for Children
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A cooperation agreement between the Ministry of Health (MOH) of Kyrgyz Republic and WHO-EURO
      was established, for the implementation of a WHO Project to improve the quality of pediatric
      care in the referral hospitals. The pilot regions selected for this intervention are the
      three northern regions of Thalas, Chiu and Issik-Kul Region in Kyrgyz Republic. The MOH
      project will be implemented at a first stage in a group of 10 pilot hospitals, randomly
      selected among the existing hospitals in the above cited regions. Pilot Hospitals will be
      compared to "control hospitals", which are the hospitals in the region not receiving the
      intervention, using a pre-defined set of indicators of quality of care. The results of the
      present evaluation on the pilot hospitals will provide data that will inform the MOH on how
      better to scale up this project at a national scale.
    


Intervention name(s): Quality Improvement intervention
Intervention type(s): Other
Intervention description(s): Training for local trainers and medical staff on the National Adaptation of the WHO guidelines "Pocket Book of Hospital Care for Children".
Regular supporting supervision and monitoring at hospital level aimed at a sustainable improvement of the quality of the paediatric hospital care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Quality of care; Hospital; Children; WHO guideline
A Randomized, Double-blind, Placebo-controlled Study on Immunogenicity and Safety of MVA-BN (IMVAMUNE™) Smallpox Vaccine in Healthy Subjects
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the immune response after a single
      vaccination of pre-immune subjects compared to two vaccinations in naive subjects.

      In addition the study further investigates the cardiac safety profile of MVA-BN® in a healthy
      population compared to placebo.
    

Detailed description: 
      The study consists of 4 groups, which receive either MVA-BN once, MVA-BN two times, MVA-BN
      followed by placebo, or two administrations of placebo.
    

Intervention name(s): MVA-BN® (IMVAMUNE); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 1x 10E8_TCID50; Tris-Buffer
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Smallpox; Vaccination; Prevention
Bioceramics Pain Control
Condition: Endodontically Treated Teeth; Post Operative Pain
MeSH terms: Tooth, Nonvital; Pain, Postoperative
Study type: Interventional

Summary: 
      Postoperative pain in endodontic retreatment cases presents a challenge to any endodontist.
      Tricalcium silicate materials as mineral trioxide aggregate (MTA) and bioceramics have shown
      favorable periapical tissue reactions and healing when used as part of the root canal filling
      material. This study was conducted to compare the difference in the postoperative pain when
      resin cements are used versus bioceramic cements in the obturation of root canals.
    

Detailed description: 
      The Faculty of Dentistry Ain Shams University's Research Ethics Committee reviewed the
      current proposal for ethical approval. One hundred patients with permanent molar teeth
      requiring endodontic non-surgical retreatment were treated in this study. Teeth with
      fractured instruments were excluded. Patient ages ranged from twenty to fifty years, both men
      and women were treated in the current study. Infants, children, people unable to take
      decisions, university students, orphans, mentally or physically disabled patients were
      excluded from the current study.

      Preoperative assessment of the degree of the patient's pain was done using the visual analog
      scale. Fifty teeth were obturated with gutta percha using the epoxy resin-based sealer (AH
      Plus) as the control group, and in the other fifty bioceramic based cement (Endosequence) was
      used. All teeth were prepared by the protaper next rotary files (Dentsply Sirona) under
      copious irrigation with 30ml of 2.6 % sodium hypochlorite throughout the procedure.
      Ethylamine diamine tetracetic acid (EDTA) 17% was used to remove the smear layer before the
      obturation commenced. Obturation was done using the cold lateral compaction technique in the
      resin group and single cone technique in the bioceramic group. Postoperative pain assessment
      was done for each patient after six hours, twenty-four hours, four days and one week.
    

Intervention name(s): obturation
Intervention type(s): Procedure
Intervention description(s): obturation using different types of sealers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bio-ceramic postoperative pain sealer
The PK/PD Study of Multiple Dose of SHR3824 in Healthy Volunteers
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an
      insulin-independent approach to improve type 2 diabetes hyperglycemia. In this multiple-dose
      study the investigators evaluated the safety, tolerability and PK/PD profiles of SHR3824 in
      healthy subjects.
    


Intervention name(s): SHR3824; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Henagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SHR3824 Type 2 diabetes mellitus SGLT2