bioihbjkbjnl/mcl2 huggingface dataset:
CTC Pancreatic Adenocarcinoma
Condition: Adenocarcinoma; Circulating Tumor Cells; Pancreatic Neoplasms
MeSH terms: Adenocarcinoma; Neoplastic Cells, Circulating; Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Proportion of circulating tumor cells (CTC) in the postoperative phase after curative tumor
      removal of pancreatic cancer will be determined and correlated to the accordance of
      anesthesia (desflurane versus propofol)
    

Detailed description: 
      This prospective, randomized study will be conducted over a 36-month period to investigate
      whether commonly used anesthetics (volatile versus intravenous) have an effect on the changes
      or occurrence of CTC in patients suffering from primary pancreatic cancer undergoing curative
      surgery. The specific research question is if there are changes of the CTC count in the
      postoperative phase in the desflurane group (intervention) compared to the propofol one
      (control). A secondary question is if these changes can be correlated to tumor outcome.
    

Intervention name(s): Desflurane
Intervention type(s): Drug
Intervention description(s): Apply desflurane as anesthetic
Other intervention name(s): Suprane
Intervention MeSH terms: Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Circulating Tumor Cells; Anesthesia and immunity; Cell Search System
A Single-blind, Placebo-controlled, Outpatient Trial to Assess the Effects of Single Oral Tablet Dose of OPC-214870
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Despite availability of several antiepileptic drugs (AEDs), in one-third of patients,
      epilepsy remains uncontrolled with AEDs. There is a need to develop new approaches to improve
      the existing medications to relieve patients' epilepsy, and OPC-214870 is being studied for
      this purpose.
    


Intervention name(s): OPC-214870; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Tablet(s); Tablet(s)
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This study is conducted in Europe. The intention of this health service research study is to
      obtain data from daily routine to evaluate the quality of life and the costs of the disease
      for patients with type 2 diabetes mellitus.
    


Intervention name(s): liraglutide; insulin
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be treated according to routine clinical practice at the discretion of the treating physician according to current labelling.; Any insulin in any device available on the market may be used by patients as part of routine clinical practice according to current labelling.
Intervention MeSH terms: Liraglutide
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with type 2 diabetes mellitus, currently treated with oral antidiabetics
        (OADs), who need treatment intensification with insulin or liraglutide due to inadequate
        blood glucose control.
The Role of Bleeding at Implant Placement
Condition: Bleeding; Angiogenesis; Peri-Implantitis
MeSH terms: Peri-Implantitis; Hemorrhage
Study type: Observational

Summary: 
      Angiogenesis is inherently associated to bone formation and healing. During implant
      osseointegration, a successive and successful angiogenic processes has to occur to promote
      bone formation. In 1969, Branemark et al. demonstrated that direct contact between bone and
      titanium implant surface was possible, defining osseointegration as "the direct, structural,
      and functional contact between live bone and the surface of a functionally loaded implant".
      Consequently, the need of an empirical measurement appeared. With the introduction of
      resonance frequency analysis (RFA), it is now possible to measure the degree of implant
      stability at any time during the course of implant treatment and loading. In this way,
      changes in implant stability can be monitored over the time and it is likely possible to find
      implants at risk of failure before they become loose. The rationale of this study is to
      analyse how important a good vascularization is for the future bone formation around dental
      implants.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who come to the Unit of Periodontology (UZ Leuven, St. Rafaël), in need of implant
        rehabilitation, will be evaluated for initial study eligibility during a screening visit.
        Patients shall be advised of the need to attend follow-up visits: 3 months after implant
        placement (at abutment placement visit) and 1 year, the latter to analyse the early bone
        remodelling.
      
Keywords: Dental Implants
Nasal Human Abuse Potential of PTI-821
Condition: Opioid Abuse Nondependent
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the human abuse liability of PTI-821 (oxycodone extended-release
      capsules) when administered nasally compared to crushed oxycodone IR tablets and crushed
      OxyContin tablets, also administered nasally.
    

Detailed description: 
      The nasal human abuse liability of PTI-821 will be compared to oxycodone IR using
      pharmacokinetic and pharmacodynamic assessments. A comparison to OxyContin will be dose using
      pharmacokinetic assessments.
    

Intervention name(s): PTI-821 capsule Manipulated; PTI-821 Non-manipulated; OxyContin; Placebo; Oxycodone
Intervention type(s): Drug; Drug; Drug; Other; Drug
Intervention description(s): PTI-821 (oxycodone) 40 mg extended release capsule; PTI-821 (oxycodone) 40 mg capsule extended release capsule; Crushed OxyContin (oxycodone) extended-release 40 mg tablet; Matching placebos for PTI-821 and oxycodone IR; Crushed oxycodone 40 mg immediate release tablet
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 4-way single-dose crossover with an exploratory 5th treatment arm
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue Regeneration
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate Gintuit as a safe and effective alternative to
      palatal tissue in the treatment of subjects (with recession-type defects) who have an
      insufficient zone of attached gingiva associated with at least two nonadjacent teeth.
    


Intervention name(s): Gintuit; Autologous palatal tissue
Intervention type(s): Device; Other
Intervention description(s): Application of Gintuit at Day 0 to the gingival bed; Tissue will be harvested from the subject's palate and placed on the gingival bed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults
Condition: Impaired Liver Function
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and pharmacokinetics of two doses of orally administered
      Proellex® in female patients with impaired hepatic function and healthy volunteers with
      normal hepatic function.
    

Detailed description: 
      16 subjects will be allocated to 2 groups. The test group will consist of 8 female patients
      with moderately impaired hepatic function meeting the Child-Pugh Class B severity criteria,
      while the control group will consist of 8 healthy female adult volunteers. During Stage I,
      all subjects will receive a single oral dose of 25mg of Proellex® (fasting state) and be
      followed in a Clinical Research Unit (CRU) for about three days. Only subjects who do not
      experience serious adverse events (SAEs) or adverse events (AEs) that are determined by
      Investigator to be possibly, probably or definitely related to the treatment will participate
      in Stage II. The dose will be increased to a single dose of 50mg of Proellex® (fasting state)
      and subjects will be followed in a Clinical Research Unit (CRU) for about three days.
      Subjects will undergo blood draws at several time points.
    

Intervention name(s): Proellex
Intervention type(s): Drug
Intervention description(s): Proellex 25 mg capsule, single dose
Other intervention name(s): Telapristone acetate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Cupping and Serkangabin Versus Conventional Migraine Treatment
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      Migraine is the most common recurrent headache. Current therapy of migraine headache consists
      of multiple drug groups for control of attack and prophylaxis against recurrent attacks.
      Emerging alternative medicine worldwide led investigators to evaluate the efficacy of cupping
      therapy plus SERKANGABIN syrup in treatment of migraine headache. Severity, duration and
      frequency of attacks of migraine headache evaluated in two groups during six months from
      presentation.
    

Detailed description: 
      In a randomized controlled trial investigators randomly assigned 76 patients with migraine to
      cupping therapy plus SERKANGABIN or to receive conventional medical treatment. The use of CAM
      in migraine is a growing phenomenon. Migraine patients seek and explore both conventional and
      CAM approaches. Wet cupping is an ancient medical technique still used in several
      contemporary societies. It is being used in management of hypertension, diabetes mellitus,
      and headaches, renal and biliary stones and for maintaining health. Little experimental study
      has been devoted to test its efficacy to treat migraine headache. Investigators planned this
      study for evaluation of therapeutic efficacy of wet cupping and an Iranian traditional
      medicine preparation, SERKANGABIN in treatment of migraine headache compared with current
      medicine protocols. SERKANGABIN is a preparation of honey, vinegar and distilled mint water
      that in traditional Iranian medicine is believed to have therapeutic effects in many diseases
      (diabetes mellitus, hypertension, hyperlipidemia, osteoarthritis, chronic obstructive airway
      disease, interstitial lung disease, hepatitis, fatty liver, ischemic heart disease, migraine,
      cerebrovascular diseases)
    

Intervention name(s): cupping and serkangabin syrup; conventional migraine drug treatment
Intervention type(s): Procedure; Drug
Intervention description(s): wet cupping serkangabin syrup; nortriptyline ,propranolol ,ergotamine , sumatriptan tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: migraine; prophylactic treatment; cupping; serkangabin
Computational Anatomy in Surgery for Childhood Tumours and Malformations
Condition: Malformation; Tumor; Paediatric Surgery; 3D Imaging
MeSH terms: Congenital Abnormalities
Study type: Observational

Summary: 
      This study is part of the launch of a multidisciplinary project called IMAG2, for
      image-guided minimally invasive surgery. It involves collaboration between the radiology and
      surgery teams at Necker Hospital and the Image Processing and Interpretation (TII) team at
      the LTCI at Télécom ParisTech.

      To make a decision, surgeons need access to a 3D model reflecting the anatomy of the specific
      patient and its pathological variations. Patient-specific 3D reconstruction provides a
      significant improvement, leading to a precise assessment of the malformation or tumour and
      its relationship with surrounding organs, nerves and vessels. It allows the surgeon to
      simulate a pre-operative procedure, which is a definite advantage in terms of safe, effective
      and curative surgery, particularly in oncology. MRI has been chosen as the basic imaging
      technique because of its non-irradiating nature and the current lack of 3D MRI reconstruction
      technology.

      The study aims to provide an aid to diagnosis and surgical planning by developing dedicated
      methods and algorithms for segmenting not only the tumour but also the main anatomical
      components surrounding the tumour from 3D MRI imaging data. The imaging will be performed on
      a 3 Tesla MRI. The data will be that required for diagnosis and surgical planning, acquired
      on a routine clinical basis with an expected benefit for patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients included in the three groups are followed in the visceral surgery department of
        Necker-Enfants Malades Hospital in Paris (France) for whose an MRI is required as part of
        diagnosis, extension assessment or monitoring.
A Single Dose Study About the Influence of Food on the Oral Bioavailability of Ladarixin Capsule in Healthy Volunteers
Condition: no Condition
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:

      - to investigate the effect of food on the bioavailability of DF 2156Y after single dose
      administration of 400 mg of ladarixin to healthy male and female volunteers under fed and
      fasting conditions.

      Secondary objectives:

        -  to investigate the effect of gender on the bioavailability of DF 2156Y and its
           metabolites (DF 2108Y and DF 2227Y) after single dose administration of 400 mg of
           ladarixin to healthy male and female volunteers

        -  to evaluate safety and tolerability of a single dose administration of ladarixin 400 mg
           to healthy male and female volunteers.
    

Detailed description: 
      This is a Single center, single dose, open label, randomized, two-way, crossover, food effect
      on bioavailability study.

      More precisely, a single oral dose of 400 mg of ladarixin (two 200 mg capsules) was
      administered to healthy male and female volunteers under fed (Test treatment) and fasting
      (Reference treatment) conditions in two consecutive study periods, according to a two-way
      crossover design, with a wash-out interval of at least 14 days between the two
      administrations.
    

Intervention name(s): Ladarixin
Intervention type(s): Drug
Intervention description(s): A single oral dose of 400 mg of ladarixin (two 200 mg capsules) was administered to healthy male and female volunteers under fed (Test treatment) and fasting (Reference treatment) conditions in two consecutive study periods, according to a two-way crossover design, with a wash-out interval of at least 14 days between the two administrations.
Other intervention name(s): LDX
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Fenofibrate and Niacin in Patients With Hypertriglyceridemia and Low High-Density Lipoprotein (HDL)-Cholesterol
Condition: Hypertriglyceridemia With Low HDL-cholesterol
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare the efficacy and tolerability of fenofibrate 160 mg
      and niacin 1500 mg in patients with hypertriglyceridemia and low HDL-cholesterol. The primary
      end point is the percent change of apoB/A1 and the secondary end points are other lipid
      parameters and biomarkers.
    


Intervention name(s): lipid modification
Intervention type(s): Drug
Intervention description(s): 1) fenofibrate 160 mg po for 16 weeks, 2) niacin 500 mg po for 4 weeks, niacin 1000 mg po for 4 weeks, niacin 1500 mg po for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
HELP Therapy for Dry AMD
Condition: Non-exudative (Dry) Age-related Macular Degeneration (AMD)
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      This is an open-label, single center clinical investigation to evaluate the efficacy and
      safety of Heparin-induced Extracorporeal Lipoprotein Precipitation (H.E.L.P.) Therapy as a
      treatment for non-exudative (dry) Age-related Macular Degeneration (AMD). A total of 14
      clinic visits are scheduled, one baseline visit, 8 visits for H.E.L.P. therapy treatments (to
      be performed over a period of 12 weeks for each patient) and 5 follow-up visits to be
      performed one week following the 4th H.E.L.P. therapy session and 12 weeks, 24 weeks, 36
      weeks and 52 weeks after the final H.E.L.P. therapy session.
    


Intervention name(s): H.E.L.P. therapy (H.E.L.P. Plasmat Futura System)
Intervention type(s): Device
Other intervention name(s): Heparin-Induced Extracorporeal LDL-Cholesterol Precipitation
Intervention MeSH terms: Heparin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Age-Related Macular Degeneration (AMD); Age Related Eye Disease Study (AREDS); Best-Corrected Visual Acuity (BCVA); Early Treatment Diabetic Retinopathy Study (ETDRS); Heparin-Induced Extracorporeal LDL-Cholesterol Precipitation (HELP); Visual Function Questionnaire (VFQ)
Effects of Online Training Aimed at Increasing Participation in Everyday Life During a Pandemic (SCD Online).
Condition: Subjective Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study evaluates the efficacy of Real-World Strategy Training (RWST) compared to a
      psycho-education workshop for improving everyday life performance in older adults with
      subjective cognitive decline (SCD). Participants will be randomly assigned to receive one of
      these approaches. Additionally, this study will provide insight into the benefits of the
      program while people are not able to meet in person during a pandemic.
    

Detailed description: 
      Evidence suggests that 25-50% of community-dwelling older adults report SCD and that these
      individuals have an elevated risk for developing Mild Cognitive Impairment and/or dementia.
      Many of these individuals report difficulties with complex activities of daily living.

      RWST aims to reduce these difficulties in everyday life by providing a meta-cognitive
      training approach that compensates for age-related executive changes. The approach is
      provided within the context of individually identified everyday-life difficulties.

      The psycho-education approach is a Brain-Health Workshop supplemented by intellectually
      stimulating activities such as doing Sudoku and/or word searches. This approach provides
      information people may use to inform health behaviour changes.
    

Intervention name(s): Real World Strategy Training; Brain Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.; The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sodoku puzzles. Homework will consist of reading assignments related to the session topics.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Age-related cognitive changes
A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this two-part study is to evaluate the safety and tolerability of the study
      drug known as LY3202328 in healthy overweight participants in Part A, and those with
      dyslipidemia (abnormal blood fats) in Part B.
    


Intervention name(s): LY3202328; Placebo; Atorvastatin; Simvastatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Atorvastatin; Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part A is a crossover. Part B is a parallel assignment.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Safety of a Second Dose of Biken's Varicella Vaccine
Condition: Varicella
MeSH terms: Chickenpox; Herpes Zoster
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the present study is to assess and document the safety of a second dose of
      Varicella Biken vaccine administered at 4 to 6 years of age in healthy children having
      previously received a first dose of Varicella Biken vaccine.

      All subjects will receive a second dose of Varicella vaccine (Varicella Biken) at 4 to 6
      years of age.

      The expected total duration of follow-up (first visit to last visit) for each subject will be
      one month.
    


Intervention name(s): Live Attenuated Varicella Virus Vaccine
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Subcutaneous
Other intervention name(s): Varicela Biken
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: varicella-zoster virus; varicella