bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1, Pharmacokinetics of the MMP-12 Inhibitor FP-025 After Multiple Oral Ascending Doses in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, phase I study consisting of 2 parts. The first part is a multiple
      ascending dose (MAD) part with a randomized, double-blind, placebo-controlled design in 3
      treatment groups of 8 subjects (6 active; 2 placebo). The second part is a food effect (FE)
      part with a randomized, open-label, 2-period, 2-way crossover, single dose design in 8
      subjects.
    

Detailed description: 
      MAD part (Part 1)

      After assessing eligibility during a 4-week screening period, subjects will be randomized to
      1 of the 3 treatments as follows:

        -  Treatment A: 14 oral doses of 100 mg FP-025 (n=6) or placebo (n=2) in 8 days.

        -  Treatment B: 14 oral doses of 200 mg FP-025 (n=6) or placebo (n=2) in 8 days.

        -  Treatment C: 14 oral doses of 400 mg FP-025 (n=6) or placebo (n=2) in 8 days.

      FE part (Part 2)

      After assessing eligibility during a 4-week screening period, 1 treatment group of 8 subjects
      (8 active; 0 placebo) will be randomized to a treatment sequence (D followed by E, or E
      followed by D):

        -  Treatment D: single oral dose of 200 mg FP-025 under fasted conditions, and

        -  Treatment E: single oral dose of 200 mg FP-025 after intake of a high-fat, high-calorie
           breakfast (fed condition).

      The total study planned duration for each part, Part 1 and Part 2 of the study, is
      approximately 6 weeks, including screening period.
    

Intervention name(s): FP-025 (MMP-12 inhibitor); FP-025 (MMP-12 inhibitor); FP-025 (MMP-12 inhibitor); FP-025 (MMP-12 inhibitor); FP-025 (MMP-12 inhibitor)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Treatment A: 14 oral doses of 100 mg FP-025 (n=6) or placebo (n=2) in 8 days.; Treatment B: 14 oral doses of 200 mg FP-025 (n=6) or placebo (n=2) in 8 days.; Treatment C: 14 oral doses of 400 mg FP-025 (n=6) or placebo (n=2) in 8 days.; Treatment D: single oral dose of 200 mg FP-025 under fasted conditions.; Treatment E: single oral dose of 200 mg FP-025 after intake of a high-fat, high-calorie breakfast (fed condition).
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: MAD part (Part 1) - sequential multiple ascending doses; FE part (Part 2) - crossover food effect after single dose administration
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: FP-025, MMP-12 inhibitor
Representations and Prevention of Cancers in Schools
Condition: Healthy
Study type: Observational

Summary: 
      The main objective is to develop an educational program and to measure the impact on social
      representations identified as acting in the prevention of cancer. Child should write, draw
      and speak about cancer signifiance to identify individual conceptions and representations of
      health and cancer in children aged 9 to 12 years in school.
    

Detailed description: 
      The stages are :

        -  Selection of forms

        -  Technique of write and draw and interview by a school nurse

        -  Data analysis
    

Intervention name(s): Write, draw and interview
Intervention type(s): Other
Intervention description(s): Child should write, draw cancer signifiance and after, they were interview by a school nurse about cancer signifiance.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        students aged 9 to 12 years and enrolled in classes CM1, CM2 and 6th
Study of Melphalan HCl for Injection (Propylene Glycol-free), Carmustine, Etoposide, Cytarabine (BEAM Regimen) and Autologous Stem Cell Transplantation for Lymphoma
Condition: Hodgkin Disease; Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Hodgkin Disease; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II study is being conducted to confirm the safety and efficacy of high-dose Melphalan
      HCl for Injection (Propylene Glycol-Free) when included in the BEAM regimen for myeloablative
      conditioning in lymphoma patients undergoing ASCT
    


Intervention name(s): Carmustine; Etoposide phosphate; Cytarabine; Melphalan HCl (propylene glycol-free)
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): BCNU; BiCNU®; VP-16; Vepesid; Cytosar-U ®; 1-β-Arabinofuranosylcytosine; Arabinosylcytosine; Cytosine arabinoside; Ara-C
Intervention MeSH terms: Cytarabine; Etoposide; Melphalan; Carmustine; Etoposide phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered
      with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response
      (RVR) i.e., undetectable hepatitis C virus [HCV] viral ribonucleic acid [RNA] at Week 4 in
      participants with chronic HCV infection. The primary hypothesis was that the proportion of
      participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater
      than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were
      co-administered with Peg-IFN/Ribavirin.
    


Intervention name(s): Comparator: Vaniprevir; Comparator: Pegylated-Interferon (Peg-IFN); Comparator: Ribavirin; Comparator: placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days; Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks; Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks; Matching placebo to vaniprevir; duration of treatment: 28 days
Other intervention name(s): MK-7009
Intervention MeSH terms: Interferons; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Fenofibrate on Kidney Function: a Six-week Randomized Cross-over Trial in Healthy People
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to test the effect of fenofibrate treatment on glomerular
      filtration rate (GFR), kidney hemodynamics and tubular function in middle-aged subjects with
      normal kidney function to further investigate the increase in creatinine levels observed in
      fenofibrate-treated subjects.
    


Intervention name(s): Fenofibrate 160 mg tablet; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fenofibrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fenofibrate; Glomerular filtration rate; inulin clearance; creatinine; healthy volunteers; cross-over
Impact of Different Types of Physical Activity in Patients With Chronic Inflammatory Bowel Disease
Condition: Inflammatory Bowel Diseases; Exercise Therapy
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      This is a prospective interventional study. The investigators will include patients in
      clinical remission who are on stable treatment. These IBD patients will be followed to
      analyze the effects of physical activity on their inflammatory disease. Different exercises
      will be offered to two separate groups of randomly distributed patients: the first group will
      perform muscle building exercises while the other group will be offered aerobic
      exercises.There will also be a control group that does not initially benefit from a specific
      physical activity program. However, this group will be integrated into one of the other two
      groups after the 10-week follow-up. All three groups will perform the same baseline tests.
      These will be of different types: physical tests, biological tests and quality of life
      questionnaires.
    


Intervention name(s): Endurance training; Resistance training
Intervention type(s): Other; Other
Intervention description(s): This group will perform aerobic type exercises. Initially, patients will perform continuous exercises of progressive intensity in order to adapt to this kind of effort. Next, we will introduce interval exercises.; Patients in this group will perform lower limb strengthening exercises to improve the maximum strength of different muscle groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Diabetes Dietary Study- Low Carbohydrate and Low-Fat Diets in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of a low-carbohydrate diet compared to
      a low-fat/high-carbohydrate diet on glucose control in patients who have Type 2 Diabetes.
    

Detailed description: 
      Obesity is not only a risk factor for type 2 diabetes but it also frequently increases the
      need for insulin requirement in people with type 2 diabetes who are overweight or obese.
      However, since insulin is a lipogenic hormone, insulin or sulfonylurea therapy that increases
      circulating insulin levels often results in additional weight gain. Controlled-carbohydrate
      "ketogenic" diets have been popular as an alternative way of losing weight, but little is
      known about the safety and efficacy of using a ketogenic approach in the management of
      overweight/obese patients with type 2 diabetes.

      The proposed study will randomize a group of 126 overweight or obese (BMI > 25 and < 40)
      adults with type 2 diabetes to either a low-carbohydrate or a low-fat weight loss diet. The
      primary study endpoint will be six and twelve month changes in glycemic control as measured
      by hemoglobin A1c (HbA1c). Secondary endpoints include adiposity (BMI, body composition and
      fat distribution); blood glucose patterns (from self-monitoring records); change in
      antidiabetic medications (potential decrease in number and dosage), lipids, insulin
      sensitivity from a meal tolerance test, other metabolic markers (C-reactive protein, leptin)
      and participants' lifestyle (physical activity and diet) and perceptions of satiety, quality
      of life, mood, and well-being.
    

Intervention name(s): low-carbohydrate diet; low-fat diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): ketogenic low-carbohydrate diet in patients with type 2 diabetes; low-fat diet in patients with type 2 diabetes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; low-carbohydrate diet; weight loss; obesity; dietary intervention
ImPACT Online Clinical Study
Condition: Brain Concussion
MeSH terms: Brain Concussion
Study type: Interventional

Summary: 
      The researchers want to find out more about a standalone software application, ImPACT Online
      and how it relates to other commonly used tests of memory, attention and reaction time.
      ImPACT Online is a computer-based neurocognitive test for concussion management. The test was
      designed to help measure the effects of concussion on cognitive processes (for example,
      memory, attention, brain speed) and visual functioning.
    


Intervention name(s): ImPACT Online/Paper Pencil Tests; ImPACT Online
Intervention type(s): Device; Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
PEACH Questionnaire Study
Condition: Deafness
MeSH terms: Deafness; Hearing Loss
Study type: Observational

Summary: 
      There are few or no questionnaires in French on the hearing quality of life of children with
      hearing aids.

      The objectives of the study are to measure the hearing quality of life of children with
      hearing aid and / or cochlear implants and to compare the hearing quality of life according
      to the type of hearing aid (hearing aid and / or cochlear implant).
    

Detailed description: 
      There are few or no questionnaires in French on the hearing quality of life of children with
      hearing aids.

      The study will allow an evaluation of the quality of life benefit of hearing rehabilitation
      at different ages and with varying levels of deafness.

      The translated questionnaire for the study will be given to the parents of the child after a
      sure diagnosis of the child's degree of deafness and at least 1 month of hearing aids. The
      translated is proposed by Necker Hospital Pediatric ENT department.

      The objectives of the study are to measure the hearing quality of life of children with
      hearing aid and / or cochlear implants and to compare the hearing quality of life according
      to the type of hearing aid (hearing aid and / or cochlear implant).
    

Intervention name(s): The Parents' Evaluation of Aural/Oral Performance of Children (PEACH)
Intervention type(s): Other
Intervention description(s): The Parents' Evaluation of Aural/Oral Performance of Children (PEACH) will be completed once.
Other intervention name(s): Questionnaire
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients followed by the Pediatric ENT department of Necker-Enfants Malades hospital.
      
Keywords: Deafness in children; The Parents' Evaluation of Aural/Oral Performance of Children (PEACH) in french
A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty
Condition: Puberty, Precocious
MeSH terms: Puberty, Precocious
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if 11.25 and 30 mg formulations of leuprolide are
      effective in treating children with Central Precocious Puberty (CPP).
    

Detailed description: 
      Study Design:

      A total of 80 children with confirmed CPP were planned to be enrolled and randomized in a 1:1
      ratio to receive 2 injections of either leuprolide acetate 11.25 mg or 30 mg depot
      formulation, each injection administered 3 mo apart (6 mo of treatment):

      This study includes a 4-week Screening Period, two 3-mo treatment cycles, and a posttreatment
      follow-up period (12 weeks following the Mo 6 visit). Study visits will occur at Screening,
      Day 1, Week 2 (only for subjects participating in the pharmacokinetic subset), Mo 1, 2, 3, Mo
      6/Early Termination, and 12 weeks later, for the Posttreatment Follow-up Visit.

      This study was conducted at 18 sites in the United States and 4 sites in Puerto Rico.
    

Intervention name(s): Leuprolide acetate 11.25 mg; Leuprolide acetate 30 mg
Intervention type(s): Drug; Drug
Intervention description(s): Two intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 mo apart.; Two intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 mo apart.
Other intervention name(s): ABT-818; leuprolide acetate; Lupron; ABT-818; leuprolide acetate; Lupron
Intervention MeSH terms: Leuprolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CPP; central precocious puberty; pediatrics; suppression of luteinizing hormone; Lupron; leuprolide acetate; depot formulation; GnRHa; GnRH agonist; GnRH analog; luteinizing hormone
Safety of and Immune Response to a Hepatitis B Virus Vaccine Given With a Booster (CpG7909 ODN) in HIV Infected and HIV Uninfected People
Condition: HIV Infections; Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to determine the safety of and immune response to a hepatitis B
      virus vaccine series given with a boosting agent, CpG7909 oligodeoxynucleotides (ODN), in HIV
      infected and HIV uninfected individuals who previously failed to develop a response to
      hepatitis B vaccine.

      Study hypothesis: Administration of CpG7909 ODN together with recombinant hepatitis B vaccine
      will result in increased frequency and magnitude of response to vaccine in individuals who
      have previously failed to mount a response to vaccination, and that in HIV infected subjects
      with detectable plasma viremia, it will lead to the enhancement of HIV-specific responses.
    

Detailed description: 
      As HIV disease progresses in HIV infected people, their immune responses to infectious and
      other foreign invaders becomes weaker; in particular, the cellular (T-cell) immune response
      is particularly affected by HIV. A boosting agent called CpG7909 ODN may be an ideal adjuvant
      for vaccines given to HIV infected people, because it may help elicit an increased CD8 T-cell
      response. This study will evaluate the safety of and immune response to a hepatitis B virus
      vaccine series given with CpG7909 ODN in HIV infected and uninfected people.

      There will be three groups in this study; participants will be stratified by baseline CD4
      counts and viral load. Within each group, participants will be randomly assigned to receive 3
      injections of hepatitis B vaccine with CpG7909 ODN or 3 injections of hepatitis B vaccine
      alone. Injections will be given at study entry and Months 1 and 6. There will be 10 study
      visits; a physical exam and blood collection will occur at each visit.
    

Intervention name(s): CpG7909 oligodeoxynucleotides (ODN); Hepatitis B virus vaccine
Intervention type(s): Drug; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Hepatitis B Vaccine; Treatment Experienced; Treatment Naive
Machine Learning Model for Perioperative Transfusion Prediction
Condition: Surgery; Blood Transfusion
Study type: Observational

Summary: 
      This study aimed to develop and interpret a machine learning model to predict red blood cell
      (RBC) transfusion.
    

Detailed description: 
      A dataset from a multicenter study involving 6121 patients underwent elective major surgery
      was analysed. Data concerning patients who received inappropriate RBC transfusion were
      excluded. Twenty one perioperative features were used to predict RBC transfusion. The data
      set was randomly split into train and validation sets (70-30). Decision tree, random forest,
      k-nearest neighbors, logistic regression, and eXtreme garadient boosting (XGBoost) methods
      were used for prediction. The area under the curves (AUC) of the receiver operating
      characteristics curves for the machine learning models used for RBC transfusion prediction
      were compared.
    

Intervention name(s): Perioperative blood transfusion
Intervention type(s): Other
Intervention description(s): Perioperative blood transfusion
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing major elective surgical procedures were considered eligible. All age
        groups and both genders were included. The surgical procedures were predefined according to
        the Classification of Diagnostic, Therapeutic, and Surgical Procedures of the National
        Social Insurance Institution, in which every procedure has a unique cod
      
Keywords: Decision tree; eXtreme garadient boosting; k-nearest neighbors; Logistic regression; Machine learning; Prediction model; Random forest; Red blood cell transfusion; Surgery
Study of rADAMTS-13 (SHP655) in the Treatment of Participants With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
Condition: Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombotic Thrombocytopenic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of
      rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment of acquired
      thrombotic thrombocytopenic purpura (aTTP) participants.
    


Intervention name(s): Placebo; SHP655; Standard of Care
Intervention type(s): Other; Drug; Other
Intervention description(s): Participants will receive injection of placebo matched to SHP655.; Participants will receive injection of SHP655.; Participants will receive PEX as Standard of Care (SOC).
Other intervention name(s): rADAMTS-13; PEX
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Gingival Health Parameters in Hybrid CAD / CAM Crowns Produced After Different Retraction Processes
Condition: Periodontal Disease; Gingival Disease
MeSH terms: Periodontal Diseases; Gingival Diseases
Study type: Interventional

Summary: 
      Clinically, the gingival retraction dentistry itself has found wide uses. It has achieved the
      use of subgingival and gingival crowns in fixed prostheses, cervical abrasion in restorative
      dentistry, management of root caries and root sensitivity, and recently in the use of
      appropriate measurements to improve the marginal fit of implant prostheses.There are three
      different retraction procedures described in the literature: mechanical, mechanical-chemical
      (chemically impregnated cords or matrix in injectable form) and surgery (electrosurgical,
      laser, cauterization, etc.)The mechanical method of retraction cords is not always suitable
      for patients' existing pocket depth, the necessity of using different combinations in shallow
      or deep pockets, the potential for limited bleeding control in chemically impregnated cords
      and the toxicity values in those who interact with chemical have led researchers to search
      for alternative methods. Especially inflammed gingiva is very sensitive to mechanical and
      chemical trauma. Studies have reported that gingival inflammation, pain, pocket formation,
      gingival withdrawal, increased bleeding and wound contamination occurred following retraction
      cord application. However, it is a known fact that the impression material is distorted or
      the accuracy of the measurement is decreased with the measurements taken without retraction.
      Nowadays, CAD / CAM (computer-aided design / computer-aided manufacturing) devices, which are
      designed to overcome these problems and eliminate the errors related to the measurement
      material, are the first step to be taken with a clear measure.Gingival retraction is
      recommended to improve the success of scanners in all restorations performed at the gingival
      or subgingival endpoint. Therefore, in our study, crown restorations will be produced from
      hybrid blocks by means of CAD / CAM device in order to evaluate the interaction of gingival
      health with hybrid blocks and to provide the latest technology and standardization.
    


Intervention name(s): mechanical cord usage
Intervention type(s): Procedure
Intervention description(s): Due to the retraction procedures, same preparation conditions will be obtained.
Other intervention name(s): Chemical contained retraction usage; MZ-6 laser tip used throughing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: CAD/CAM; Gingival retraction