bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Concomitant Administration of Cilostazol and Probucol on Biomarkers, Endothelial Function and Safety
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Based upon evidence of efficacy and safety of both cilostazol and probucol administration in
      independent randomized controlled trials in PAD and CAD, the present trial seeks to
      investigate the effect of concomitant administration of cilostazol and probucol on FMD
      compared to each drug individually, as well as to evaluate biomarker measures and safety
      indices in this context.
    

Detailed description: 
      Primary:

        1. To evaluate the effect of concomitant administration of cilostazol and probucol on the
           12-week change in FMD from baseline compared, with individual drugs alone.

        2. To assess the safety of concomitant administration of cilostazol and probucol in
           peripheral artery disease (PAD) subjects complicated with coronary artery disease (CAD)
           as determined by physical examination, vital signs, adverse events (AEs), laboratory
           tests, ECGs.

      Secondary:

        1. To evaluate the effect of cilostazol and probucol administered concomitantly and as
           individual drugs, compared with control, on changes in FMD from baseline to Weeks 6 and
           12.

        2. To evaluate the effect of cilostazol and probucol administered concomitantly and as
           individual drugs, compared with control, on changes in metabolic, inflammatory,
           oxidative, and platelet biomarkers from baseline to Weeks 6 and 12.

        3. To evaluate the effect of cilostazol and probucol administered concomitantly and as
           individual drugs, compared with control, on the time course (over the 12-week treatment
           period) of changes in FMD and biomarkers levels.

        4. To assess the effect of drug withdrawal on these endpoints at follow-up (from Week 12 to
           Week 16).

        5. To explore the relationship between changes in FMD and changes in the biomarker levels
           at Week 12.
    

Intervention name(s): Cilostazol, Probucol
Intervention type(s): Drug
Intervention description(s): Treatment Group 1 (control) No cilostazol or probucol
Treatment Group 2 (cilostazol alone) 1 tablet cilostazol 100 mg PO BID
Treatment Group 3 (probucol alone) 1 tablet probucol 250 mg PO BID
Treatment Group 4 (concomitant cilostazol and probucol) 1 tablet cilostazol 100 mg PO BID, and 1 tablet probucol 250 mg PO BID
Intervention MeSH terms: Cilostazol; Probucol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Biomarker; Endothelial Function; Peripheral Artery Disease; Coronary Artery Disease; Flow Mediated Dilation; Cilostazol; Probucol
Physiological Effects of Gastric Sleeve Operation
Condition: Obesity, Morbid; Bariatric Surgery
MeSH terms: Obesity, Morbid
Study type: Observational

Summary: 
      After gastric sleeve patients undergo a substantial weight loss, but the physiological
      mechanisms behind the weight loss is not fully elucidated. Studies suggest that gut-hormone
      secretion is altered comparable to what is also seen after Roux-en-Y gastric bypass, however
      to which extent is not fully established and furthermore, the mechanisms behind an altered
      secretion are unclear. The purpose of this study is to investigate absorption and
      postprandial metabolism of glucose and protein in addition to gut hormonal responses after
      gastric sleeve compared with a group of un-operated subjects machted on sex, age and BMI.
      Furter, a group of Roux-en-Y gastric bypass operated patients matched on pre-operative BMI,
      current BMI, sex and age will be included for comparison.
    


Intervention name(s): Mixed meal test with double tracer technique
Intervention type(s): Diagnostic Test
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients, who have undergone Roux-en-Y gastric bypass OR gastric sleeve operation > 12
        month prior to inclusion.

        Matched un-operated control subjects.
      
Biospecimen description: 
      Blood and urine samples during mixed meal test with double tracer tecnique using iv tracers
      ([D2] Phenylalanine, [ring-D4]Tyrosine, [6,6-2H2]Glucose, [1,1,2,3,3-2H5]Glycerol, [15N2]Urea
      and labelled oral tracers ([U13C6]glucose, intrinsically [ring-D5]Phenylalanine).
    
Keywords: Gastric sleeve; Gastric bypass
Microwave Ablation for Pulmonary Metastases From Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      (MWA) is the most recent development in the field of local ablative therapies. The aim of
      this study was to evaluate CT-guided percutaneous microwave (MW) ablation safety and efficacy
      in pulmonary metastases from colorectal cancer.
    

Detailed description: 
      From June 2010 to June 2015, 48 unresectable lesions in 32 patients with pulmonary metastases
      from colorectal cancer were selected for CT-guided microwave ablation. Patients were
      scheduled for a 1 and 3 month CT follow-up to evaluate lesion diameter.We retrospectively
      evaluated CT-guided percutaneous microwave (MW) ablation safety and efficacy in pulmonary
      metastases from colorectal cancer.
    

Intervention name(s): microwave ablation
Intervention type(s): Device
Intervention description(s): pulmonary metastases from colorectal cancer are destructed/ablated using microwave ablation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool
Condition: Breast Cancer Screening; Oncology; Preventative Medicine; Mammography
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this investigation is to conduct a feasibility study to evaluate the potential
      for implementing the developed decision support tool with Latina, Black, and non-Latina White
      women. The investigators will collect feasibility data and assess the use of the decision
      support tool with end-users. The aim is to determine if women using the decision support tool
      make more informed choices measured by knowledge, attitudes, and intentions.
    


Intervention name(s): Breast Cancer Screening Decision Support Tool; National Cancer Institute Breast Cancer Screening PDQ
Intervention type(s): Other; Other
Intervention description(s): -Provides a description of screening mammography, current screening recommendations, benefits and downsides, narratives, and questions for the participant's physician.; -Provides current information about breast cancer screening and is meant to inform and help patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Health Literacy; Health Disparities; Shared Decision Making
Additive Beneficial Effects of Atorvastatin Combined With Amlodipine In Treatment of Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesized combination therapy would be superior to monotherapy.
    


Intervention name(s): statin, amlodipine
Intervention type(s): Drug
Intervention MeSH terms: Amlodipine
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: endothelial; function; insulin; sensitivity
Oxytocin, Trauma Disclosure and Intrusions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Severe traumatic experiences such as falling victim to assault, torture, or rape have
      deleterious effects. Clinical manifestations include intrusions, avoidance behavior, and
      hyperarousal, which are associated, at a circuit level, with hyperfunction of the amygdala
      and hypofunction of prefrontal cortex (PFC) subregions. In up to 50 % of the cases,
      resilience is not sufficient and trauma-exposed individuals develop posttraumatic stress
      disorder (PTSD). Oxytocin (OXT) is a hypothalamic peptide hormone that exerts anxiolytic
      effects. Recent clinical trials provide preliminary evidence that post-trauma administration
      of OXT could be effective as a preventive intervention for PTSD in a subsample of individuals
      exhibiting early PTSD symptoms prior to the onset of the disorder. However, the underlying
      neurobiological mechanisms are unclear. Therefore, the rationale of the present project is to
      expose a sample of healthy participants to experimental trauma in order to explore the
      circuit mechanisms by which OXT influences, and interferes with, traumatic experience.
      Functional magnetic resonance imaging (fMRI) will be employed in order to elucidate the
      long-term effects of intranasal OXT on trauma-induced intrusions, amygdala and PFC responses
      during an emotional face matching task and resting state functional connectivity.
    

Detailed description: 
      Participants will be exposed to an experimental trauma (i.e. a highly aversive movie) at days
      1 and 4 of the study. After the first experimental trauma and after the first functional
      magnetic resonance imaging (fMRI) measurement, the participants will receive intranasal OXT
      or placebo in three different groups (1. OXT for six days, 2. OXT for three days and then
      placebo for three days, 3. placebo for six days). The same fMRI tasks will be used after the
      first and second trauma exposure (i.e. one measurement before the treatment and one
      measurement after three days of treatment).
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intranasal administration, 24 international units (IU) oxytocin.; The placebo nasal sprays contain identical ingredients except for the peptide itself.
Other intervention name(s): syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: amygdala, fear, intrusion, oxytocin, trauma disclosure
Safety and Immunogenicity Study of Ad26-ENVA and Ad35-ENV HIV Vaccines in Healthy HIV-uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of Ad26.ENVA.01 and
      Ad35-ENV in low-risk for HIV-uninfected healthy adults administered in heterologous and
      homologous prime-boost regimens at different time intervals.
    

Detailed description: 
      The study is a randomized, double-blind placebo-controlled trial assessing the order of
      vector priming and boosting (Ad26 versus Ad35), the timing of boost (3 versus 6 months) and
      the homologous versus heterologous regimen at the 3-month time interval. Groups A-D will be
      enrolled in Boston, MA, USA, Groups E-H will be enrolled at the East African Clinical
      Research Centres and Groups I-L will be enrolled at the South African Clinical Research
      Centres.

      Volunteers will be screened up to 56 days before vaccination and will be followed for 12
      months after the second vaccination.

      Approximately 212 volunteers will be randomized to receive either vaccine or placebo within a
      group (A-L); Groups A-D, Groups E-H and Groups I-L will be randomized separately. Up to 7%
      over-enrolment (approximately 15 volunteers) will be allowed to facilitate enrolment.
    

Intervention name(s): Ad35-ENV vaccine; Ad26.ENVA.01 vaccine; Placebo Control
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Recombinant adenovirus serotype 35 vector vaccine 5x10^10 vp, delivered IM; Recombinant adenovirus serotype 26 vector vaccine, 5x10^10 vp delivered IM; Colorless 10mm Tris/HCl buffer
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV
A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This 2 arm study will investigate the pharmacokinetics of simvastatin and methotrexate in
      combination with tocilizumab to assess any potential drug interactions. Patients will be
      randomized to receive either tocilizumab (10mg/kg iv infusion on day 8) + methotrexate
      (10-25mg po /week) or tocilizumab + methotrexate + simvastatin (40mg po on days 1, 15 and
      43). Blood samples will be taken for analysis at intervals up to day 44. The anticipated time
      on study treatment is <3 months, and the target sample size is <100 individuals.
    


Intervention name(s): tocilizumab [RoActemra/Actemra]; Methotrexate; Simvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10mg/kg iv on day 8; 10-25mg po/week; 40mg po on days 1, 15 and 43
Intervention MeSH terms: Methotrexate; Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Noradrenalin vs Terlipressin in Hepatorenal Syndrome
Condition: Hepatorenal Syndrome
MeSH terms: Hepatorenal Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether noradrenalin is as effective and safe as
      terlipressin in the treatment of hepatorenal syndrome
    

Detailed description: 
      Hepatorenal syndrome (HRS) is a major complication of cirrhosis; it is characterized by
      functional renal failure and poor prognosis. Arterial dilation is a key pathogenic event of
      HRS, leading to reduction of the effective blood volume, homeostatic activation of vasoactive
      systems and renal vasoconstriction with decrease in renal blood flow. The clinical signs of
      HRS vary depending on the clinical pattern. HRS type 1 is characterized by a rapidly
      progressive renal failure; HRS type 2 by a moderate and more stable renal failure. HRS type 1
      has a very poor short term prognosis, with a median survival of only about 2 weeks; patients
      with HRS type 2 have a median survival of about 6 months. The management of HRS still
      constitutes a major challenge. Liver transplantation is the ideal treatment, but it has
      important inherent drawbacks, such as the organ shortage and the time needed to perform the
      transplant, that is too long to consent the survival of these patients. The management of HRS
      has focused on improving renal function, thus extending patients survival and allowing the
      performance of the liver transplant. In the last years, remarkable results have been obtained
      using vasoconstrictor drugs. By improving the effective blood volume, vasoconstrictors induce
      the suppression of homeostatic vasoactive systems and increase renal blood flow and
      glomerular filtration rate.Among vasoconstrictors, terlipressin, a V1 vasopressin agonist,
      has currently the best efficacy pedigree. However, it is expensive and is not available in
      many countries, including North America. More recently, it was suggested that
      alpha-adrenergic drugs such noradrenalin and midodrine may be also effective in HRS.
      Noradrenalin would have the potential advantage of wider availability and of lower cost. The
      current prospective randomized study was undertaken to assess the efficacy and safety of
      noradrenalin vs terlipressin in patients with HRS.
    

Intervention name(s): Terlipressin; Noradrenalin
Intervention type(s): Drug; Drug
Intervention description(s): 1mg/4 h per day; 0,1 mcg/kg/min
Intervention MeSH terms: Terlipressin; Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatorenal syndrome; ascites; portal hypertension; cirrhosis
Functional MRI Study in Healthy Children Engaged in Aggressive Behaviors
Condition: Impulsive Aggression
MeSH terms: Aggression
Study type: Observational

Summary: 
      The purpose of this non-interventional study is to optimize the point subtraction aggression
      paradigms (PSAP) task in typically developing children (TDC).
    

Detailed description: 
      The PSAP is a behavioral aggression test used to evaluate behavioral response related to
      impulsive aggression. The task will be combined with functional MRI to establish a reliable
      BOLD signal during testing in developing healthy subjects (8-12 years old) and, to determine
      the feasibility to perform the task.

      Additionally, the levels of neurotransmitters Glutamate and GABA will be measured using
      magnetic resonance spectroscopy (MRS).
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Healthy Volunteers
Testing a New Therapy for Trichotillomania
Condition: Trichotillomania
MeSH terms: Trichotillomania
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will test the effectiveness of a new behavioral therapy for adults with
      trichotillomania (compulsive hair pulling).
    

Detailed description: 
      Trichotillomania (TTM) is a disorder in which people compulsively pull out their own hair.
      Treatments for TTM sometimes do not have long-term effectiveness. Acceptance and commitment
      therapy (ACT) is a therapeutic approach thought to have longer lasting effects than standard
      cognitive behavioral therapy (CBT) approaches, because ACT focuses on accepting thoughts and
      behaviors as opposed to changing them. Previous research indicates that a combination of ACT
      and habit reversal behavioral therapy is more effective than no treatment. This study will
      test whether a combination of ACT and behavioral therapy, called acceptance enhanced
      behavioral therapy (AEBT), is more effective than the current standard treatment for TTM.

      Participation in this study will last 12 weeks, and follow-up assessments will last for 6
      months. At study entry, participants will complete a brief intelligence test and an in-person
      interview about their medical history, psychiatric history, and hair pulling. At their second
      visit, participants will have digital pictures taken of their hair-pulling sites and complete
      two computer tasks measuring their response inhibition and cognitive flexibility. After the
      second visit, participants will be randomly assigned to receive either AEBT or
      psychoeducation and supportive therapy (PST)-a standard treatment for TTM. Both treatments
      will involve ten 1-hour sessions completed over 12 weeks. Assessments of participants will
      occur after 6 weeks of treatment, at treatment completion, and after 6 months. These
      assessments will measure treatment effectiveness, based on several clinical scales and
      measures of TTM symptoms. Participants who receive PST during this study will be offered AEBT
      afterward.
    

Intervention name(s): Acceptance enhanced behavior therapy (AEBT); Psychoeducation and supportive therapy (PST)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Ten 1-hour sessions over 12 weeks, enhancing awareness of hair-pulling behavior and teaching strategies to deal with hair pulling; Ten 1-hour sessions over 12 weeks, teaching the participant about hair pulling and discussing how hair pulling affects those who do it
Other intervention name(s): Acceptance and Commitment Therapy; ACT; Habit Reversal; Behavior Therapy; Supportive Therapy; Psychoeducation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Impulse Control Disorders; Behavior Therapy; Acceptance; Habit Reversal
User Acceptability of a Nicotine Lactate Delivery System (P3L)
Condition: Smoking
Study type: Interventional

Summary: 
      This study will provide an initial assessment of the acceptability of the Nicotine Lactate
      Delivery System (P3L) after ad libitum use and the ability of combustible cigarette (CC)
      smokers to use P3L to maintain their customary nicotine intake, in a manner comparable with
      their own brand of CC or the VUSE e-cigarette system.
    

Detailed description: 
      The total duration of the study for an individual subject will be between 3 and 8 weeks,
      including 1 day for the screening visit, 3 days for the ad libitum use sessions (P3L, VUSE
      e-cigarette system and subjects' own commercially available non-menthol CC), 1 day for the
      preference evaluation session (subjects will be given the choice of using ad libitum the P3L
      or the VUSE), the 2 to 10 days of interval between each visit, and 7 days for the passive
      safety follow-up period.

      The pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, will
      be evaluated as well as the safety and tolerability of the P3L.
    

Intervention name(s): P3L; VUSE; CC
Intervention type(s): Other; Other; Other
Intervention description(s): Ad libitum use for a maximum of three hours.
P3L delivers, on average, 80 µg of nicotine per puff under Health Canada Intense smoking regime.; Ad libitum use for a maximum of three hours.
VUSE delivers, on average, 80 µg of nicotine per puff based on the CORESTA e-cigarette recommended smoking regime.; Ad libitum use of the subject's own brand of non-menthol CC for a maximum of three hours.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Conventional cigarette; Nicotine lactate delivery system; e-cigarette; VUSE; Combustible cigarette
Opioid Free and Therapy Minimized Advantages Using HANA Table for Total Hip Arthroplasty
Condition: Arthropathy of Hip Joint; Osteoarthritis, Hip
MeSH terms: Osteoarthritis, Hip
Study type: Observational

Summary: 
      To prove that anterior approach total hip arthroplasty using the HANA table can be performed
      with little, if any, need for opioids using a combination of education, optimized pre op and
      post op pain protocols and optimized recovery tools.
    

Detailed description: 
      Methods:

      Data Collection:

        -  pre-op assessment/physical therapy evaluation

        -  post op assessment - PACU, phase II (Prior to discharge)

        -  phone calls after discharge (post op day 1, 2, 3)

        -  follow up assessment in surgeon's office (3 and 6 weeks post op)

        -  Ortech

        -  Swiftpath

        -  HOOS jr

      Pre-optimization:

        -  All patients enroll in SwiftPath education program

        -  Optimized BMI, hemoglobin, albumin, glucose control, A1C and blood pressure control

      Total Joint procedure:

      -anterior approach using the HANA table THA preformed with intra-articular block

      Pain Management regimen:

        -  Pre op PT teaching

        -  post op multimodal pain regimen
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Males and females presenting seeking elective unilateral total hip arthoplasty that fall
        within inclusion criteria listed above