bioihbjkbjnl/mcl2 huggingface dataset:
Apabetalone for Pulmonary Arterial Hypertension: a Pilot Study
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The main OBJECTIVE of this proposal is to extend the investigator's preclinical findings on
      the role of epigenetics and DNA damage and Bromodomain-Containing Protein 4 (BRD4) inhibition
      as a therapy for a devastating disease, pulmonary arterial hypertension (PAH).

      There is strong evidence that BRD4 plays a key role in the pathological phenotype in PAH
      accounting for disease progression and that BRD4 inhibition can reverse PAH in several animal
      models. Intriguingly, coronary artery disease (CAD) and metabolic syndrome are more prevalent
      in PAH compared with the global population, suggesting a link between these diseases.
      Interestingly, BRD4 is also a trigger for calcification and remodeling processes and
      regulates transcription of lipoprotein and inflammatory factors, all of which are important
      in PAH and CAD. Apabetalone, an orally available BRD4 inhibitor, is now in a clinical
      development stage with a good safety profile.

      At this stage, the investigators propose a pilot study to assess the feasibility of a Phase 2
      clinical trial assessing apabetalone in the PAH population. The overall HYPOTHESIS is that
      BRD4 inhibition with apabetalone is a safe and effective therapy for PAH.
    

Detailed description: 
      In line with most pilot and safety studies, this is a two-centre (Quebec and Calgary)
      open-label trial. A 4-week pre-treatment phase will allow ensuring that patients are on
      stable doses of medication. Patients will be given doses of apabetalone 100mg BID for 16
      weeks. Patients will be regularly followed. At baseline and week 16, a cardiac
      catheterization and MRI will assess changes in pulmonary hemodynamics and RV function.
    

Intervention name(s): Apabetalone
Intervention type(s): Drug
Intervention description(s): A 4-week pre-treatment phase will allow ensuring that patients are on stable doses of medication. Patients will be given doses of apabetalone 100mg BID for 16 weeks. Patients will be regularly followed (Fig.1). At baseline and week 16, a cardiac catheterization and MRI will assess changes in pulmonary hemodynamics and RV function.
Other intervention name(s): BRD4 inhibitor
Intervention model: Single Group Assignment
Intervention model description: Pilot study to assess the feasibility of a Phase 2 clinical trial assessing apabetalone in 10 PAH patients
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Pulmonary Arterial Hypertension; Apabetalone; Bromodomain-Containing Protein 4 (BRD4); BRD4 inhibitor; Feasibility pilot study; Phase 2 clinical trial; Open-label; Two-centre
Simple Breath Test to Examine Phenylalanine Metabolism
Condition: Phenylketonuria (PKU)
MeSH terms: Phenylketonurias
Study type: Observational

Summary: 
      Phenylketonuria(PKU)is a rare condition caused by the body's inability to properly breakdown
      an amino acid called phenylalanine(PHE), due to a missing enzyme, phenylalanine
      hydroxylase(PAH). When the enzyme is missing and/or not functioning properly, it increases
      the level of PHE in the body. High levels of PHE can cause severe brain damage or nerve
      damage unless the children are on a strict low PHE diet. A low PHE diet restricts the intake
      of protein rich foods and can pose a significant burden to both the patient and the family.

      Investigators at the University of British Columbia and British Columbia Children's Hospital
      will examine the phenylalanine metabolism in children with PKU using a simple breath test.

      Patients (5-18y) receiving standard clinical care at the BC Children's Hospital's Biochemical
      Diseases Clinic will be enrolled.The study will be conducted twice on each patient. Baseline
      measurements will be performed at the beginning of each study for each patient.The Physician
      in charge will then prescribe the standard dose of sapropterin dihydrochloride (Kuvan®)
      (20mg/kg/d) or otherwise as deemed appropriate by the physician-in-charge. The test will be
      repeated a week (minimum) after the beginning of treatment with the prescribed dose.

      The investigators propose that children who are responsive to sapropterin dihydrochloride
      (Kuvan®) will have increased 13CO2 in breath after treatment, and those who do not respond
      will have no change in the 13CO2 in the breath before and after treatment.

      As a comparison to the experimental group, age and gender matched healthy controls will also
      be studied. The test in healthy controls will be performed once without any intervention, and
      is only used as a comparative value.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with PKU will be enrolled from the Biochemical Diseases clinic at the British
        Columbia Children's Hospital.

        Healthy controls will be enrolled from the community and will undergo screening for age and
        gender match.
      
Biospecimen description: 
      Breath samples from both groups (children with PKU and healthy controls)
    
Keywords: PKU; Phenylketonuria; Phenylalanine; Children; Stable isotopes; Sapropterin dihydrochloride responsiveness
Lay Health Coaches for Weight Loss: Peers Versus Mentors
Condition: Obesity
MeSH terms: Obesity; Weight Loss
Study type: Interventional

Summary: 
      The primary aim of this study is to determine whether reduced intensity behavioral weight
      loss treatment (rBWL) + Peer Health Coaches yields significantly greater weight loss than
      rBWL + Mentor Health Coaches and rBWL alone.
    


Intervention name(s): Reduced Intensity Behavioral Weight Loss + Peer Health Coach; Reduced Intensity Behavioral Weight Loss + Mentor Health Coach; Reduced Intensity Behavioral Weight Loss
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will receive a 12-month reduced intensity group behavioral weight loss program. During weeks that there are no group meetings, participants will be coached by peers (i.e., other members of their weight loss group).; Participants will receive a 12-month reduced intensity group behavioral weight loss program. During weeks that there are no group meetings, participants will be coached by a mentor (i.e., successful weight loser).; Participants will receive 12 months of a reduced intensity group behavioral weight loss program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; weight loss; lay health coach; peer coach; mentor coach; reduced intensity weight loss program
da Vinci SP Robotic Gastrectomy
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      Laparoscopic surgery revolutionized the surgical treatment of gastric cancer saving large
      incsion and associated pain. Robotic surgical system was introduced to enhance the minimally
      invasive surgery using articulating robotic arm. The da vinci SP system, which enables
      single-port surgery, can allow surgeon to provide radical gastrectomy with minimal scar and
      associated pain.
    

Detailed description: 
      This study is a phase 1/2, single-arm surgical clinical trial. The primary endpoint is the
      safety of da vinci robotic gastrectomy. The secondary endpoint is operative time, bleeding,
      bowel recovery, and hospital stay. In the clinic, informed consent is received from patient
      who is scheduled to undergo radical gastrectomy. After the general anesthesia, low midline
      transverse incision is made at suprapubic area. After inserting SP port into the peritoneal
      cavity, additional port is inserted via right flank that would be used for assistant's energy
      device and suction devices. Radical subtotal gastrectomy is perfromed using cardiere-forceps,
      monopolar scissors, and maryland forceps. Reconstruction after gastrectomy is decided
      according to surgeon's preference. three days after gastrectomy, if the diet build up is
      complete and the patients has no evidence of complication, the patient is discharged from the
      hospital. Four weeks after gastrectomy, the patient will be followed up at the clinic. Major
      complication event within 30days after gastrectomy will be analyzed as primary endpoint as
      well as other secondary endpoints.
    

Intervention name(s): da vinc SP gastrectomy
Intervention type(s): Procedure
Intervention description(s): radical subtotal gastrectomy performed by da vinci SP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: da vinci SP; robotic surgery; gastrectomy; gastric cancer
Evaluation of Efficacy and Safety of Gynomax® XL Ovule
Condition: Trichomonal Vaginitis; Bacterial Vaginosis; Candidal Vulvovaginitis; Mixed Vaginal Infections
MeSH terms: Infections; Vaginosis, Bacterial; Candidiasis, Vulvovaginal; Trichomonas Vaginitis; Vaginal Diseases; Vaginitis; Vulvovaginitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Efficacy and safety of Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial
      vaginosis, candidal vulvovaginitis and mixed vaginal infections will be evaluated in this
      open label, single-arm, multicentral study.
    


Intervention name(s): Gynomax® XL Vaginal Ovule
Intervention type(s): Drug
Intervention description(s): tioconazole, tinidazole, lidocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Outcome Following Antidepressant Treatment on Possible Endo-Phenotypes for Major Depression
Condition: Healthy
MeSH terms: Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether outcome following antidepressant treatment
      can be used as a tool to evaluate endo-phenotypes for depression.
    

Detailed description: 
      The research in depression has for some years focused at the identification of
      endo-phenotypes. Endo-phenotypes are heritable biological or psychological markers, which are
      more commonly found in patients and their healthy relatives than in the general population.

      Recent studies point at disturbed regulation of the hypothalamic-pituitary-adrenocortical
      (HPA) system as a possible endo-phenotype for depression.

      The hypothesis of AGENDA are that endo-phenotypes are affected by treatment with
      antidepressants in healthy first degree relatives.

      AGENDA is a four week randomized, placebo-controlled, double-blind trial in which first
      degree relatives of patients with the diagnosis of depression are randomised in to two
      groups, which are treated with either placebo or antidepressant medicine (Cipralex). We
      expect to include 80 healthy subjects, with the predisposition for depression, since one of
      their parents or siblings recently was treated for depression.

      The subjects will be examined before and after four weeks of treatment by a thorough
      interview concerning psychiatric symptoms (SCAN), including depressive symptoms, personality,
      perceived stress and cognitive function. The effect of antidepressant on stress is measured
      with saliva-cortisol and by the response to the combined dexamethasone
      corticotropin-releasing (CRH) hormone test. Additionally, MR and PET scans of the 5-HT4
      receptor function will be conducted before and after 4 weeks of treatment.
    

Intervention name(s): Escitalopram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Escitalopram 10 mg p.o. per day; Placebo
Other intervention name(s): cipralex
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Major depression; First degree relatives; Escitalopram; Cortisol; Cognition; Personality; Endo-phenotype
Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Patients
Condition: Pediatric Cancer
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to evaluate the effectiveness and safety of fosaprepitant plus ondansetron
      with dexamethasone or placebo plus ondansetron with dexamethasone in preventing
      chemotherapy-induced nausea and vomiting (CINV) with MEC/HE multi-day chemotherapy in
      children with solid tumors.
    

Detailed description: 
      Participants will randomly assigned 1:1 to receive double-blind study drug ( fosaprepitant
      plus ondansetron with dexamethasone OR placebo to fosaprepitant plus ondansetron with
      dexamethasone). Fosaprepitant or placebo to fosaprepitant were supplied and administered in a
      blinded manner.

      Experimental:

      Participants received a single dose of fosaprepitant (age-based adjustment) administered
      intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron (weight based) IV with
      dexamethasone (weight based) iv/po prior to chemotherapy and up to 72 hours after
      chemotherapy.

      Placebo Comparator:

      Participants received a single dose of matched placebo for fosaprepitant administered
      intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron (weight based) IV with
      dexamethasone (weight based) iv/po prior to chemotherapy and up to 72 hours after
      chemotherapy.
    

Intervention name(s): Fosaprepitant,ondansetron, dexamethasone; placebo ondansetron with dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): Participants will randomly assigned 1:1 to receive double-blind study drug ( fosaprepitant plus ondansetron with dexamethasone OR placebo plus ondansetron with dexamethasone). Fosaprepitant or placebo to fosaprepitant were supplied and administered in a blinded manner.; placebo plus ondansetron with dexamethasone
Other intervention name(s): ondansetron, dexamethasone; ondansetron, dexamethasone
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ondansetron; Fosaprepitant; Aprepitant; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Short Daily Hemodialysis and Online HDF: Which One is Better?
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      1. To compare the efficacy of

        1. Short Daily Hemodialysis

        2. Online HDF in term of adequacy of dialysis.
    

Detailed description: 
      The investigators intend to compare the efficacy between these modalities of treatment in
      terms of adequacy and also other parameters such as calcium-phosphorus balance and hematocrit
    

Intervention name(s): Online HDF; Short Daily Hemodialysis
Intervention type(s): Procedure; Procedure
Intervention description(s): Online HDF; Short Daily Hemodialysis
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection
Condition: Temporomandibular Joint Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      Dysfunction of the jaw, associated with pain in the jaw or about the jaw in the face can be
      quite long lasting and debilitating. Dextrose injection with a small needle has be notably
      helpful in preliminary studies in reducing pain and improving jaw function. This randomized
      trial will compare dextrose injection with saline injection for temporomandibular(jaw)
      dysfunction, also known as TMD.
    

Detailed description: 
      Longitudinal studies of subjects with temporomandibular dysfunction show a general pattern of
      symptom diminishment, especially in the elderly. However studies out to 2-8 years show
      residual symptoms in many and nearly 25% with unabated symptoms. Dextrose injection has been
      utilized empirically for many years and a marked reduction in pain and luxation after
      intraarticular and pericapsular dextrose injection has been reported in a recent RCT.
      However, small study size and lack of a non injection control have prevented any definitive
      conclusions as the additional efficacy of including dextrose in the injectate. The mechanism
      of action of dextrose injection was originally thought to be via a brief stimulation of the
      inflammatory cascade with resultant production of growth factors. However, non-inflammatory
      dextrose effects on growth factor production have been demonstrated, and, more recently,
      dextrose has been found to treat neurogenic inflammation (pain from upregulation of the TRPV1
      receptor on peptidergic nerves). This has the theoretical benefit of reducing pain,
      regardless of the status and position of the intraarticular cartilage or degree of
      degenerative change of the TMD. The primary goal of this study is to evaluate the ability of
      dextrose injection versus saline injection to reduce pain and improve functional complaints
      referable to the temporomandibular joint.
    

Intervention name(s): Injection of 20% dextrose/ 0.2% lidocaine; Injection of 1 ml of 0.8 SW/0.2% lidocaine
Intervention type(s): Other; Other
Intervention description(s): Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 0.2% lidocaine.; Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 0.8 sterile water and 0.2% lidocaine.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TMD; temporomandibular; dextrose; prolotherapy
Caudal Epidural Steroid Injections for Low Back Pain/Sciatic Lumbar Pain
Condition: Pain; Disability
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The study hypothesis is that caudal epidural steroid injections provides short term relief to
      patients with persistent low back pain and sciatica due degenerative disc disease or lumbar
      spinal stenosis. Patients will be evaluated wiht clinical examination and radiological
      examinations before injections. They will be followed up with questionnaires on pain and
      disability up to 6 months postinjection.
    


Intervention name(s): caudal epidural steroid injection
Intervention type(s): Procedure
Intervention description(s): injecting steroids in the epidural space via caudal route
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PRESENCE 2: Predicting Sedentary Entertainment Choices and Effects
Condition: Obesity; Physical Activity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether playing motion-controlled video games
      produces low caloric intake and higher caloric expenditure than watching TV or playing
      traditional video games.
    

Detailed description: 
      The purpose of this study is to investigate differences in behaviors and emotions during TV
      watching and video game playing. Participants will be randomized to either watch TV, play
      traditional button-based video games, or play motion-based video games for one hour while
      palatable snack foods and sugar-sweetened beverages are provided within easy reaching
      distance. Both energy intake as well as energy expenditure during a one-hour period will be
      measured. All three conditions will be optimized to resemble typical in-home conditions as
      much as possible.

      An additional goal of this study is to provide insight into the possible pathways by which TV
      and video games differentially affect intake and expenditure. Distraction from the real world
      (also called presence or engagement) will be analyzed to determine if a) these variables
      differ across groups and b) if these variables explain differences in energy intake and/or
      expenditure. The TV group will watch TV shows using Netflix streaming service, which will
      allow them to choose from a variety of popular shows without viewing commercials. As the
      investigators are primarily interested in satiety and hand occupation effects, the lack of
      commercials will allow us to eliminate food advertisements as a causal factor.

      Finally, the third major goal of the study is to investigate how young adults choose
      screen-based media. In the two video game arms, participants will be allowed to choose to
      play any of 10 provided games, and in the TV group, participants will be able to choose from
      hundreds of options. Choices of game/program, time spent on each game/program, and
      psychological reactions to each game will be measured and analyzed.
    

Intervention name(s): Motion-controlled video gaming; Traditional video gaming; Television watching
Intervention type(s): Other; Other; Other
Intervention description(s): Play of motion-controlled video games for one hour; Participants played traditional video games for one hour; Participants watched television for one hour
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Energy intake; Video games; Television; Physical activity; Obesity