bioihbjkbjnl/mcl2 huggingface dataset:
12-Month Extension Study of Dialectical Behavior Therapy for Youth With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The overarching goal of this project is to evaluate the longer-term effects of implementing
      DBT for adolescents with BD in a subspecialty clinic. In collaboration with the University of
      Pittsburgh and continuing from the parent study (042-2018), this study will measure the
      longer-term effects of DBT in additional the the longer-term effects of DBT training on study
      therapist knowledge and performance.
    

Detailed description: 
      This is an extension study related to an ongoing implementation study of dialectical behavior
      therapy (DBT) for adolescents with bipolar disorder, in collaboration with investigators at
      the University of Pittsburgh. During the conduct of that initial study (the DITO study; REB
      PIN 042-2018), compelling questions have been raised by the investigators, study therapists,
      and participants/patients about what will happen following participation in the initial
      study: Which DBT outcomes are sustained over time? Will patients request and/or require
      additional booster sessions? Will study therapists remain adherent to the treatment model?
      There is sparse knowledge regarding what happens after a course of DBT is completed, and this
      study seeks to advance our understanding of what happens in the year after DBT by addressing
      these questions. This study provides a unique opportunity to examine the frequency, dose, and
      indications for ongoing DBT treatment for participants who have completed one year of DBT at
      the Centre for Youth Bipolar Disorder (CYBD). In the spirit of the original dissemination and
      implementation study, this study is focused on "real-world" issues routinely faced by study
      therapists and patients, and anticipated findings will inform future randomized controlled
      trials on this topic.
    

Intervention name(s): Dialectical behavioral therapy
Intervention type(s): Behavioral
Intervention description(s): Participants will be provided with the option to continue treatment with their study therapist. For those who elect to continue with DBT sessions, they will discuss frequency of sessions with their therapist, in addition to selecting type of sessions (individual and/or family skills). Participants who elect not to continue with DBT sessions at the time of enrollment will retain the option of being able to request additional sessions at any point during the 12-month study. Irrespective of participation in additional DBT sessions, all participants will be asked to complete follow-up interviews and questionnaires.
Other intervention name(s): DBT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dialectical behavior therapy
Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging
Condition: Infertility; Ovarian Aging; Diminished Ovarian Reserve (DOR); Predicted Poor-responders
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      -  To test the hypothesis that supplementation of DHEA for at least twelve weeks prior to
           and during ovarian stimulation increases oocyte quantity (number of oocytes retrieved)
           and oocyte quality (clinical pregnancy rates and molecular markers) following IVF and
           IVF/ICSI treatment.

        -  To evaluate the feasibility of conducting a large multicentre trial
    

Detailed description: 
      The purpose of this study is to evaluate the role of DHEA in counteracting the effects of
      ovarian ageing in an in-vitro fertilization (IVF) model. The study will examine whether the
      use of DHEA could improve clinical pregnancy rates following IVF treatment in women predicted
      to have aged ovaries by increasing oocyte quantity (ovarian response to gonadotrophins) and/
      or by improving oocyte quality. The oocyte quality will be assessed by morphological and
      molecular markers.

      This study will provide a mechanistic framework for translational research on mechanisms of
      ovarian ageing and drug interventions to slow down the ovarian ageing process and subsequent
      adverse physical and psychological consequences. Further, the data that will be produced from
      this research will have the potential to influence clinical practice in fertility clinics
      worldwide.
    

Intervention name(s): Dehydroepiandrosterone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dehydroepiandrosterone (DHEA)(St Mary's Pharmaceutical Unit Cardiff and Vale) DHEA 75 mg capsule. 1 capsule taken once daily for at least 12 weeks prior commencing ovarian stimulation protocol
: Stimulation protocol standard long down-regulation protocol, using human menopausal gonadotropin (HMG); Matched Placebo containing no active ingredient. 1 capsule taken once daily for at least 12 weeks prior commencing ovarian stimulation protocol
: Stimulation protocol standard long down-regulation protocol, using human menopausal gonadotropin (HMG)
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity After CYD Tetravalent Dengue Vaccine
Condition: Dengue; Dengue Fever; Dengue Hemorrhagic Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study was to evaluate a compressed dosing schedule and the immunologic effects
      of co-administration of a CYD dengue vaccine with a licensed flavivirus (FV) with Japanese
      encephalitis (JE) vaccine.

      Primary Objectives:

        -  To describe and compare the humoral immune response to each of the 4 parental dengue
           virus serotypes at baseline and 28 days after each CYD dengue vaccine dose.

        -  To describe the persistence of the humoral immune response to each of the 4 parental
           dengue virus serotypes 6 after CYD dengue vaccine Dose 3, irrespective of whether or not
           JE vaccine had been previously administered.

      Secondary Objectives:

        -  To describe the safety profile after each injection of CYD dengue vaccine.

        -  To describe the humoral immune response to each of the 4 parental dengue virus serotypes
           at baseline and 28 days after each CYD dengue vaccine dose when administered with or
           after JE virus vaccine in Groups 3 and 4.

        -  To describe the persistence of the humoral immune response to each of the 4 parental
           dengue virus serotypes at 6 months post-dose 3 in all four groups and at 12 months
           post-dose 3 in Groups 1 and 3 with the compressed schedule.

        -  To determine the level of viremia on Day (D)0, D3, D5, D7 and D14 following each CYD
           vaccine dose administered in Groups 1-4.

        -  To describe the JE humoral immune response at baseline and 28 days after each injection
           of CYD dengue vaccine in Groups 3 and 4.
    

Detailed description: 
      Study participants were randomly assigned to one of the four groups to receive assigned study
      vaccine and were evaluated for neutralizing antibody titers; markers of cell-mediated
      immunity.
    

Intervention name(s): CYD Dengue Vaccine; CYD Dengue Vaccine; Japanese Encephalitis Vaccine; Japanese Encephalitis Vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): IXIARO Japanese Encephalitis Vaccine; IXIARO Japanese Encephalitis Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dengue; Dengue fever; CYD dengue vaccine; IXIARO JE vaccine; Flavivirus
Lavender Oil on Preoperative Anxiety and Sedation Requirement in General Anaesthesia
Condition: Preoperative Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Assessment of how Lavender oil reduces preoperative anxiety and subsequently influences
      requirement of induction agents for general anesthesia.
    

Detailed description: 
      This study aims to use aromatherapy (Lavender oil) to reduce Preoperative Anxiety among
      Female patients coming for elective surgeries under General Anesthesia.

      As a consequence of that, the effect is also evaluated on how that influences the amount of
      intravenous sedation is required during induction for General Anesthesia.
    

Intervention name(s): Lavender Oil on Nasal Strip (Lx); Strip without Lavender Oil (Px); Propofol 1 % Injectable Suspension
Intervention type(s): Other; Other; Drug
Intervention description(s): Usage of Aromatherapy for Preoperative Anxiety; Strip without Lavender Oil (Px); Propofol 1% (10mg/mL)
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Lavender Oil,; Propofol
Clinical Outcomes, Nutritional Status, Exercise and Psychosocial Factors in Pediatric Hematopoietic Cell Transplant
Condition: Malnutrition; Obesity
MeSH terms: Malnutrition
Study type: Observational

Summary: 
      Children who receive hematopoietic cell transplants (HCT) are at high nutritional risk due to
      comorbidities and complications that are likely to develop before, during and after
      transplant. Prior to transplant, many children undergo multiple rounds of chemotherapy which
      affect appetite and cause gastrointestinal toxicities that limit food intake. During
      transplant, painful mucositis makes it difficult to consume adequate nutrients and often
      children will require nutrition support such as parenteral or enteral nutrition. Energy
      imbalance and physical deconditioning following transplant can result in loss of lean body
      mass and functional impairment; these nutritional side effects are exacerbated if the child
      develops graft-versus-host disease. After transplant, a substantial number of childhood
      cancer survivors become overweight and develop metabolic syndrome. However, little is known
      about the prevalence and distribution of pediatric malnutrition (under-nutrition as well as
      obesity), the psychosocial factors that affect dietary intake and how the quality of the
      child's food intake and physical activity level throughout the transplant process might
      affect body composition and clinical outcomes. In this exploratory study, we will monitor
      nutritional status in pediatric patients undergoing HCT. This study will test the feasibility
      of collecting patient-reported dietary intake data along with anthropometric, body
      composition, functional status and psychosocial measurements that may influence dietary
      intake in pediatric patients undergoing HCT. The data collected in this preliminary analysis
      will inform future interventional studies.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric hematopoietic cell transplant patients
The Human Metabolic Profile and Gut Microbiota Under Various Dietary Quality
Condition: Biomarkers
Study type: Interventional

Summary: 
      The goal of this food intervention study is to screen/validate the whole grain food intake
      biomarker in health Chinese's population.
    

Detailed description: 
      Although increased consumption of whole grains (WGs) is associated with improved health
      outcomes, the dietary intake assessment and health mechanisms for WGs or WG-containing food
      remain unresolved. In addition, information regarding its consumption and health effects in
      Chinese people is scarce. Biomarkers of WGs intake would allow a more accurate assessment of
      its consumption in nutrition studies. The investigators want to perform a crossover study
      where participants were subjected to a WG-wheat flour or a refine wheat-flour Chinese diet.
      Using a metabolomics approach, the investigators aimed to identify the WG-specific
      metabolites present in plasma/urine after consumption WG or WG foods, including new candidate
      biomarkers of WG intake.
    

Intervention name(s): whole grain-wheat flour food+standardized meals; refined wheat flour food+standardized meals
Intervention type(s): Other; Other
Intervention description(s): whole grain food made by 50 g whole grain wheat flour; refined grain food made by 50 g refined wheat flour
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Food biomarker; Whole grain; Chinese population
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and
      ivacaftor (IVA) in participants 1 to less than 2 years of age with cystic fibrosis (CF),
      homozygous for F508del (F/F).
    


Intervention name(s): LUM; IVA
Intervention type(s): Drug; Drug
Intervention description(s): Fixed Dose Combination (FDC) granules (LUM/IVA).; FDC granules (LUM/IVA).
Other intervention name(s): lumacaftor; VX-809; ivacaftor; VX-770
Intervention MeSH terms: Ivacaftor
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect Of Zoledronic Acid On Circulating And Bone Marrow-Residing Prostate Cancer Cells In Patients With Clinically Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to assess the effect Of zoledronic acid on circulating and
      bone marrow-residing prostate cancer cells in patients with clinically localized prostate
      cancer
    


Intervention name(s): Zoledronic acid
Intervention type(s): Drug
Intervention MeSH terms: Zoledronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostate cancer; molecular staging; antitumor potential
Textbook Outcome as a Composite Outcome Measure in Laparoscopic Pancreaticoduodenectomy
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Study type: Observational

Summary: 
      This is a multicenter, retrospective, observational study. Textbook outcome is a composite
      outcome measure for surgical quality assessment. The aim of this study was to assess textbook
      outcome following laparoscopic pancreaticoduodenectomy in China, identify factors
      independently associated with achieving textbook outcome and analyze hospital variations
      regarding the textbook outcome after case-mix adjustment.
    

Detailed description: 
      Laparoscopic pancreaticoduodenectomy (LPD) remains one of the most complex and technically
      challenging procedures in pancreatic surgery, although LPD has developed rapidly worldwide in
      recent years. Traditionally, quality assessment of LPD has mainly focused on individual
      outcome measures such as morbidity, mortality, operative time, operative blood transfusion,
      readmission rates and length of hospital stay. However, individual outcome parameters do not
      reflect the multiple facets of the whole surgical procedure and do not measure actual
      variations among different hospitals. In this context, several outcome experts have suggested
      that composite measures of surgical quality may be better than individual outcome parameters
      to compare hospital performance. Textbook outcome (TO) is such a composite outcome measure of
      multiple desirable outcome metrics, which was first proposed in 2013 by Dutch colorectal
      surgeons in order to give a comprehensive summary of hospital performance. TO is realized
      when all of the desired outcome parameters are achieved following surgery and represents the
      optimal ("textbook") hospitalization.

      Although several studies on TO in pancreatic surgery have been reported, relevant data on LPD
      are lacking, especially from China. The objective of this study was to assess TO among
      patients undergoing LPD in China, identify factors independently associated with achieving TO
      and analyze hospital variations regarding the TO after case-mix adjustment.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): This is an observational study without any intervention
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients underwent laparoscopic pancreaticoduodenectomy from 16 high-volume pancreatic
        centers in China from January 2010 and August 2016.
      
Keywords: textbook outcome; laparoscopic pancreaticoduodenectomy; composite outcome measure; hospital variation
Bioequivalence Study of CJ-30061 in Healthy Male Volunteers
Condition: Hypertension; Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the pharmacokinetics and safety after a single dose administration of CJ-30061 and
      co-administration of Exforge® 5/160mg, Lipitor® 20mg in healthy adult volunteers
    


Intervention name(s): CJ-30061; Exforge® 5/160mg & Lipitor® 20mg
Intervention type(s): Drug; Drug
Intervention description(s): Test: CJ-30061(Fixed-dose combination drug containing Amlodipine 5mg/Valsartan 160mg/Atorvastatin 20mg); Reference: Co-administration of Exforge® tab 5/160mg and Lipitor® tab 20mg
Intervention MeSH terms: Amlodipine, Valsartan Drug Combination; Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
An Open Label Positron Emission Tomography (PET) Study of GSK618334 in Healthy Male Subjects Using 11C-PHNO as PET Ligand
Condition: Substance Dependence
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the relationship between the plasma
      concentrations of the study drug and the amount of the study drug bound to the D3 receptors
      of the brain after dosing of a new compound GSK618334.
    

Detailed description: 
      This imaging study will be an open label, non-randomised PET receptor occupancy study using
      healthy male volunteers. The time course and degree of D3 receptor occupancy (RO) after
      single doses of GSK618334 will be determined using 11C-PHNO as a PET ligand labeling dopamine
      receptor. The PK/PD relationship between plasma concentrations of GSK618334 and D3 RO will be
      described. Potential relationships between D3 RO and functional magnetic resonance imaging
      (fMRI) endpoints will be assessed as an exploratory aim.
    

Intervention name(s): GSK618334
Intervention type(s): Drug
Intervention description(s): D3 receptor antagonist
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: positron emission tomography; addiction
Study of Bleeding With Extended Administration of an Oral Contraceptive
Condition: Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an non-comparative study. There is no statistical hypothesis. The effects of
      extension of treatment on bleeding will be recorded and described.
    


Intervention name(s): Norethindrone 1 mg / ethinyl estradiol 20 mcg
Intervention type(s): Drug
Intervention MeSH terms: Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Estradiol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Contraception
Transient Receptor Potential Vanilloid One (TRPV1) Receptor Expression in Children With Retrosternal Pain
Condition: Epigastric Pain; Retrosternal Pain; Esophagitis; Gastrointestinal Symptoms
MeSH terms: Esophagitis
Study type: Observational

Summary: 
      We would like to evaluate the changes in nerve innervation and TRPV1 receptor expression
      along with microscopic changes associated with heart burn and abdominal pain
    

Detailed description: 
      Approximately 5% of children between 10-17 years of age report symptoms of heart burn,
      epigastric pain or regurgitation. This study will evaluate the changes in nerve innervation
      and TRPV1 receptor expression in children having upper endoscopy for evaluation of heart burn
      and abdominal pain.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children undergoing an endoscopy procedure for gastrointestinal symptoms and chest pain or
        reasons other than those listed in the exclusion criteria.
      
Biospecimen description: 
      We are collecting a single mucosal biopsy during an endoscopy procedure.
    
Keywords: TRPV1; Nerve growth factor; Capsaicin; TrkA; Retrosternal pain; Epigastric pain; Esophagitis; Gastrointestinal symptoms
The Value of Short-term Pain Relief for the Prediction of Long-term Outcome After Cervical or Lumbar Nerve Root Infiltration
Condition: Cervical Disc Herniation; Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Interventional

Summary: 
      The purpose if this study is to assess the response to nerve root infiltration therapy in
      patients with cervical or lumbar disc herniations.
    

Detailed description: 
      This prospective, observational study examines the response to routine infiltration therapy
      in patients suffering from disc herniations of the spine. Using health-related quality of
      life questionnaires (SF-12 and Neck Pain and Disability Scale and Oswestry Disability Index)
      and the visual analogue scale the patients will be categorized into ultra-early-, early-,
      mid-term-, late-responders and non-responders. A two year follow-up of up to 250 patients is
      planned. With the anonymized participation of this study no patient will experience a change
      in his treatment plan. Valuable therapeutic management considerations might be drawn from the
      published results of this study for future patients.
    

Intervention name(s): Cervical nerve root infiltration; Lumbar nerve root infiltration; Mephamesone; 0.5% bupivacaine (Bupivacain®); Kenacort®
Intervention type(s): Procedure; Procedure; Drug; Drug; Drug
Intervention description(s): 4mg Mephamesone followed by 1ml of 0.5% bupivacaine (Bupivacain®) will be administered.; 40mg triamzinolone (Kenacort®) followed by 2ml of 0.5% bupivacaine (Bupivacain®) will be administered.
Intervention MeSH terms: Bupivacaine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: infiltrative therapy; cervical disc herniation; lumbar disc herniation