bioihbjkbjnl/mcl2 huggingface dataset:
Simons Variation in Individuals Project, Functional Common Acquisition Protocol
Condition: Healthy
Study type: Observational

Summary: 
      The University of California, San Francisco (UCSF) Simons Variation in Individuals Project
      (Simons VIP) is currently recruiting healthy controls for a study aimed at better
      understanding autism spectrum disorder. The UCSF site of the Simons VIP is conducting
      functional and structural imaging, neuropsychological evaluation, genetic testing, and
      neurologic exams in healthy individuals to compare with findings in autism spectrum disorder.
    

Detailed description: 
      To better understand autism spectrum disorders, the UCSF Simons VIP team is recruiting
      healthy controls to participate in a study involving brain imaging and psychological
      assessments and questionnaires. The study will involve phone interviews, cognitive testing
      and questionnaires, genetic testing, physical exam, photographs, non-invasive brain imaging
      sessions (MRI and MEG). The study can take up to 17 hours to complete, and there may be up to
      5 study visits to UCSF and UC Berkeley.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy individuals ages 7 through 60.
      
Keywords: Healthy children; Healthy adults; individuals ages 7-60
Effects of Phenolic Acids on Endothelial Function
Condition: Healthy
Study type: Interventional

Summary: 
      Epidemiological studies suggest dietary (poly) phenols decrease the risk of death from
      cardiovascular diseases. (Poly)phenol-rich foods include fruits and vegetables as well as
      tea, coffee, red wine, and chocolate. The aim of the present study is to investigate whether
      endothelial function is altered by ingestion of phenolic acids. Moreover, the investigators
      will evaluate the effect of phenolic acids on blood pressure and platelet adhesion.
    


Intervention name(s): Phenolic acids
Intervention type(s): Other
Intervention description(s): Phenolic acids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: subjects
A Neurocognitive Model of Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Observational

Summary: 
      The purpose of this study is to investigate thought processes and neural mechanisms that may
      contribute to the development of habitual behaviors. The investigators hypothesize that
      patients with AN will perform differently than people without eating disorders on a series of
      neuropsychological tasks and will show different neural activation patterns in functional
      neuroimaging scans.
    

Detailed description: 
      Patients with Anorexia Nervosa (AN) have extreme difficulty changing their eating behavior,
      even when they express desire for change. These behaviors seem to override all other
      potential responses, and can appear perseverative, or habitual. The purpose of this study is
      to investigate thought processes and neural mechanisms that may contribute to the development
      of habitual behaviors. The investigators hypothesize that patients with AN will perform
      differently than people without eating disorders on a series of neuropsychological tasks and
      will show different neural activation patterns in functional neuroimaging scans.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Anorexia Nervosa or Healthy Volunteers
Anti-LPS Antibody Treatment for Pediatric NAFLD
Condition: Nonalcoholic Fatty Liver Disease (NAFLD)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this pilot study is to evaluate whether 12 weeks of IMM-124E in
      children with nonalcoholic fatty liver disease (NAFLD) in combination with standard of care
      treatment will decrease inflammation in the liver as measured by alanine transaminase (ALT).
      Specifically, investigators will measure percent change in ALT from Week 0 to Week 12 in
      treatment compared to placebo.
    

Detailed description: 
      This is a randomized, double blind, placebo controlled, three month treatment trial of
      children aged 6-19 years. Participants will be recruited from the Children's Healthcare of
      Atlanta pediatric liver clinical practice.The purpose of this study is to evaluate if a three
      month treatment with IMM-124E (a bovine colostrum enriched with anti-LPS antibodies) in
      combination with standard of care lifestyle advice is safe and leads to greater improvement
      in hepatic inflammation, insulin sensitivity, and blood lipids in children with nonalcoholic
      fatty liver disease (NAFLD) compared to placebo with standard of care treatment.
      Investigators also seek to define the mechanism of action in response to three months of
      treatment with IMM-124E.
    

Intervention name(s): IMM-124E; Placebo
Intervention type(s): Biological; Other
Intervention description(s): IMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring.; Matched Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Adapting and Adopting Highly Specialized Pediatric Eating Disorder Treatment to Virtual Care: Implementation Research for the COVID-19 Context and Beyond
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Feeding and Eating Disorders; Anorexia Nervosa
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The COVID-19 pandemic has had detrimental effects on mental health. Individuals with eating
      disorders (EDs) are no exception, exhibiting increased symptoms and exacerbated feelings of
      isolation and anxiety. Across Canada, in-person outpatient services have been quickly
      replaced with virtual care, yet practitioners and patients have noted substantial challenges
      in adapting ED-related care virtually. Given the success of our previous research on
      Family-Based Treatment (FBT) for EDs, as well as the rapid transition to virtual care during
      COVID-19, there is an urgent need to adapt FBT to virtual formats and adopt it in the ED
      network. Using a multi-site case study with a mixed method pre/post design, this study aims
      to examine the implementation of virtual FBT (vFBT) as well as its impact within six ED
      programs in Ontario, building on the investigator's previous work, and further developing
      capacity in the system. The investigator will develop implementation teams at each site and
      provide a virtual training workshop on vFBT, with ongoing consultation during initial
      implementation. The investigator proposes to examine implementation success by studying
      fidelity to vFBT, as well as team and patient/family experience with virtual care, and
      patient outcomes. These findings for virtual care will not only be important in the COVID-19
      context but are also vital in the North, where access to specialized services is extremely
      limited.
    


Intervention name(s): Virtual Family-Based Treatment
Intervention type(s): Behavioral
Intervention description(s): Treatment involving the youth/adolescent who has been diagnosed with anorexia nervosa and their family, delivered virtually via videoconferencing.
Intervention model: Single Group Assignment
Intervention model description: We study a blended implementation approach for Family-Based Treatment delivered via videoconferencing (FBT-V)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anorexia nervosa; youth; adolescents; eating disorders; family-based treatment
HIPEC in Ovarian Cancer, Case-Controls Study With 10-years Follow up
Condition: Ovarian Cancer; HIPEC
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Observational

Summary: 
      Objectives:

      Compare overall survival (OS) and progression-free survival (PFS) among ovarian cancer
      patients who underwent into cytoreduction and HIPEC procedure vs patients who only received
      systemic chemotherapy in a 10-years follow up of a case-control study

      Methods:

      Cases were defined as patients treated by cytoreduction and HIPEC, and were matched (1:2)
      with patients treated with chemotherapy only, defined as controls. PFS and OS in the two
      groups were measured and compared. PFS was calculated from initiation of treatment to
      progression, death or to the last known follow-up. OS was calculated from initiation of
      treatment to death or to the last known follow-up.
    

Detailed description: 
      Epithelial ovarian cancer has the highest mortality of all gynecologic tumors in the world
      wide. Patients are diagnosed with International Federation of Gynecology and Obstetrics
      (FIGO) stage III to IV disease in 75%. The 10-year survival of women with advanced-stage
      ovarian cancer is 10% to 15% and has not improve in the past 20 years. Despite treatment with
      maximal cytoreductive surgery (CRS) and platinum-based chemotherapy, approximately 70% of
      patients with advanced-stage disease relapse within 18 months. Given this high number of
      recurrences, new approaches are needed to improve outcomes for these patients. Historically,
      peritoneal carcinomatosis represents a devastating form of cancer progression with a very
      poor prognosis.

      Objectives:

      Compare overall survival (OS) and progression-free survival (PFS) among ovarian cancer
      patients who underwent into cytoreduction and HIPEC procedure vs patients who only received
      systemic chemotherapy in a 10-years follow up of a case-control study

      Methods:

      Cases were defined as patients treated by cytoreduction and HIPEC, and were matched (1:2)
      with patients treated with chemotherapy only, defined as controls. PFS and OS in the two
      groups were measured and compared. PFS was calculated from initiation of treatment to
      progression, death or to the last known follow-up. OS was calculated from initiation of
      treatment to death or to the last known follow-up.
    

Intervention name(s): cytoreduction and HIPEC
Intervention type(s): Procedure
Intervention description(s): cytoreduction CCR 0-1, and HIPEC close technique
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        HIPEC population: 46 patients No HIPEC population : 92 patients
      
Keywords: HIPEC
Different Treatment Modality in Necrotic Primary Molars
Condition: Primary Teeth; Dental Pulp Regeneration
MeSH terms: Necrosis
Study type: Interventional

Summary: 
      Necrotic primary molars in preschool children will be treated with the regeneration concept
      to provide a healthy biological environment within the root canal system and regression in
      clinical signs and symptoms which are the primary outcomes of regeneration treatment.
    

Detailed description: 
      A convenient sample of preschool children have a necrotic primary second molar randomly
      allocated to one of the 3 study groups which are: group A (control) treated by the
      conventional treatment ( pulpectomy followed by stainless steel crown SSC), group B: treated
      by regeneration using triple antibiotic paste followed by SSC), group 3:(treated by
      regeneration using calcium hydroxide with iodoform(metapex) followed by SSC.

      the 3 groups were evaluated at baseline, 6 months and 12 months for clinical and radiographic
      success.
    

Intervention name(s): pulp regeneration for necrotic primary teeth
Intervention type(s): Other
Intervention description(s): a pulp regeneration procedure will be applied for necrotic primary teeth with different intracanal medication compared to conventional pulpectomy used in treatment for necrotic primary teeth
Other intervention name(s): different treatment options for necrotic primary teeth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: triple antibiotic paste
Autonomic Effects of T4 Mobilization in Asymptomatic Subjects
Condition: Other Disorders of the Autonomic Nervous System; Vertebra; Degeneration
MeSH terms: Autonomic Nervous System Diseases; Primary Dysautonomias
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether passive accessory intervertebral
      mobilization applied to the fourth thoracic vertebra produces autonomic effects.
    

Detailed description: 
      Asymptomatic subjects will be recruited to this study. Pressure pain threshold, heart rate,
      heart rate variability and skin conductance will be measured before, immediately after and
      fifteen minutes after the intervention.

      Subjects will be randomized into three groups: Passive accessory intervertebral mobilization
      one, passive accessory intervertebral mobilization two and placebo group.

      The researcher that will do the intervention will be blinded to the outcomes measures, and
      the researcher that will do the measurements will be blind to the intervention.
    

Intervention name(s): Spinal mobilization; Spinal Mobilization II; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): Experimental group; Active comparator group; Placebo group
Other intervention name(s): Postero-anterior spinal mobilization in prone; Postero-anterior spinal mobilization in seated position; Placebo technique, olny manual contact
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autonomic effects; spinal mobilization; clinical trial
IQP-CL-101 in IBS Management
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      After 2 weeks of run-in period, subjects are randomized to either IQP-CL-101 or a matching
      placebo. Over 8 weeks, the subjects are monitored for improvements in IBS symptoms
    


Intervention name(s): IQP-CL-101; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 2 softgels twice a day; 2 softgels twice a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Irritable bowel syndrome; IBS
Effect of Glucagon-like Peptide 1 (GLP-1) on Microvascular Myocardial Function in Patients With Type 2 Diabetes.
Condition: Type 2 Diabetes; Microvascular Dysfunction
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine if a GLP-1 agonist improves microvascular perfusion
      in the heart of patients with type 2 diabetes
    


Intervention name(s): Victoza
Intervention type(s): Drug
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: diabetes, GLP-1, Victoza, CFR, microvascular dysfunction
A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether duloxetine is safe and effective in the
      treatment of adolescents with Juvenile Primary Fibromyalgia Syndrome (JPFS).

      This trial consists of two distinct study periods. A blinded treatment period of 13 weeks and
      an open label extension period of 26 weeks.
    


Intervention name(s): Duloxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY248686
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescents; Juvenile Primary Fibromyalgia Syndrome
Contrast-induced Nephropathy: Incidence,Risk Factors,Effective Prevention and Management Method
Condition: Cardio-Renal Syndrome
MeSH terms: Cardio-Renal Syndrome
Study type: Observational

Summary: 
      This review article have included about ten thousand patients undergoing percutaneous
      coronary intervention (PCI), aim to identify the incidence of CIN in actual, find some new
      risk factors and the protecting methods for these factors.
    

Detailed description: 
      About ten thousand patients undergoing percutaneous coronary intervention (PCI) from 2010 to
      2015 are included in this study. We collect the data about the SCr of the patients before and
      after percutaneous coronary intervention, and define CIN as an increase in SCr of 0.5 mg/dl
      or 25% from baseline between 48 and 72 h after contrast medium exposure. Besides we obtain
      the data including clinical characteristics, laboratory data (blood and urine tests) for all
      the patients. The statistical analysis will find some new risk factors.
    

Intervention name(s): percutaneous coronary intervention
Intervention type(s): Device
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients undergoing percutaneous coronary intervention (PCI) from 2010 to 2015
      
Keywords: contrast-induced nephropathy; Percutaneous coronary intervention; risk factors; incidence
Biobehavioral Intervention in Gynecologic Oncology Patients
Condition: Neoplasms; Ovarian Neoplasms; Uterine Neoplasms; Vulva
MeSH terms: Neoplasms; Ovarian Neoplasms; Uterine Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Baseline self-report outcome measures will be completed and additional assessments will occur
      mid-treatment , post-treatment , 3 months following completion of all sessions, and 6 months
      following completion of all sessions. Patients and therapists will complete the evaluation
      measures in private (at home, in an office).

      At the University of Kentucky Markey Cancer Center, BBI treatment is offered in group and
      individual formats. The course of individual treatment varies and group treatment consists of
      10 1.5-hour weekly sessions in the "intensive" phase, followed by 2 1.5-hour bi-weekly
      maintenance sessions. Individual treatment is one-on-one. In group treatment, there are
      typically 6-12 patients per group and 1 or 2 therapists. The intervention helps patients to
      learn adaptive coping strategies and how to apply them to daily stressors. Additional content
      discusses use of seeking information, enhancing social support, enhancing body esteem and
      intimacy, and maintaining positive changes.
    


Intervention name(s): BBI intervention
Intervention type(s): Behavioral
Intervention description(s): Psychological intervention designed to reduce stress and enhance quality of life
Other intervention name(s): Biobehavioral Intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Assessment of UTI Symptoms and Quality of Life According to Antibiotics Treatment in Acute Uncomplicated Cystitis
Condition: Acute Cystitis
MeSH terms: Cystitis
Study type: Observational

Summary: 
      Although Cystitis includes a clinical syndrome characterized by various combinations of
      dysuria (painful urination), frequency, urgency, gross haematuria, lower back and/or
      abdominal/suprapubic discomfort with pyuria and bacteriuria. An acute uncomplicated UTI
      (referred to as cystitis) has been focused microorganisms and drug-resistance. There has been
      little research on Clinical aspects on cystitis treatment such as bothersomeness, or the
      impact of symptoms on patients' quality of life (QoL). The investigators want to study for
      Assessment of UTI Symptoms and Quality of Life According to Antibiotics Treatment(Ciprobay)
      in Acute Uncomplicated Cystitis in Korean Women.
    


Intervention name(s): Ciprobay
Intervention type(s): Drug
Intervention description(s): Ciprobay (250mg, bid, oral)
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Outpatient
      
Keywords: Acute cystitis; Antibiotics; Quality of life
Y 90 Ibritumomab Tiuxetan &Rituximab Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab,
      can locate cancer cells and either kill them or deliver radioactive cancer-killing substances
      to them without harming normal cells. Combining yttrium Y 90 ibritumomab tiuxetan with
      rituximab may kill more cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab
      tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large
      B-cell non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the best overall response in patients with relapsed or refractory diffuse
           large B-cell non-Hodgkin's lymphoma treated with yttrium Y 90 ibritumomab tiuxetan and
           rituximab.

        -  Determine the event-free survival of patients treated with this regimen.

        -  Determine the toxicity of this regimen in these patients.

      OUTLINE: This is an open-label, multicenter study.

        -  Radioimmunotherapy: Patients receive indium In 111 ibritumomab tiuxetan IV over 10
           minutes on day 1 (for imaging only); yttrium Y 90 ibritumomab tiuxetan IV over 10
           minutes on day 8; and rituximab IV over 3-4 hours on days 1, 8, 15, 22, 29, and 36.

        -  CNS ( central nervous system)prophylaxis: Patients receive CNS prophylaxis comprising
           intrathecal (IT) methotrexate or IT cytarabine on days 15, 22, 29, and 36 OR IT
           cytarabine (liposomal) on days 15 and 29.

        -  Maintenance rituximab: Patients are assessed for response at week 14. Beginning at month
           6, patients with stable or responding disease receive maintenance therapy comprising
           rituximab IV over 3-4 hours once weekly for 4 weeks. Maintenance therapy repeats every 6
           months for 2 years (total of 4 courses) in the absence of disease progression or
           unacceptable toxicity.

      Patients are followed every 3 months for 2 years and then every 6 months for 2 years.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
    

Intervention name(s): rituximab; cytarabine; liposomal cytarabine; yttrium Y 90 ibritumomab tiuxetan
Intervention type(s): Biological; Drug; Drug; Radiation
Intervention description(s): to be used for CNS prophylaxis; to be used as CNS prophylaxis
Other intervention name(s): Rituxan; cytosine arabinoside; Depocyte; Zevalin
Intervention MeSH terms: Cytarabine; Rituximab
Intervention model: Single Group Assignment
Intervention model description: Standard Phase 2
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; anaplastic large cell lymphoma