bioihbjkbjnl/mcl2 huggingface dataset:
My Health eSnapshot - A Preconception Health Research Study
Condition: Preconception Care; Health Information Technology; Primary Health Care; Risk Assessment
Study type: Interventional

Summary: 
      The purpose of the research is to identify the prevalence of preconception health (PCH) risk
      factors in the Wellington-Dufferin-Guelph (WDG) catchment area and to determine whether or
      not a client-driven electronic preconception health risk assessment tool "My Health
      eSnapshot", for use during healthcare visits, will increase preconception health knowledge
      and behaviour change among women of reproductive age (15-49 years).
    

Detailed description: 
      The purpose of the project is:

        1. To develop a client-driven electronic preconception health client risk assessment tool
           for use in a primary care setting.

        2. To develop a customized key message handout for patients based on their risk assessment
           results.

        3. To determine a successful and sustainable process for healthcare providers (HCPs) to
           administer the risk assessment tool and discuss results with patients within their
           primary care setting.

        4. To increase participants' knowledge of preconception health and their risk factors as a
           results of the risk assessment tool and discussion with their HCP.

        5. To modify participants' health behaviours as a result of the risk assessment tool and
           discussion with their HCP.

        6. To increase WDG Public Health's understanding of the most prevalent preconception health
           risk factors among reproductive women in WDG.
    

Intervention name(s): Risk Assessment, Counselling & Resources
Intervention type(s): Behavioral
Intervention description(s): A risk assessment tool is completed on a tablet. The results are scanned into the patient's electronic medical record. A healthcare provider gives behavioural counselling on identified risk factors. The patient is given a customized handout that includes health recommendations and resources based on the participant's identified risk factors.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Effect of Pistachio Intake on Insulin Resistance and Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      Hypothesis: Chronic intake of pistachios improves glucose metabolism and insulin resistance
      status thus contributing to decrease the risk of type 2 diabetes mellitus and its associated
      abnormalities.
    

Detailed description: 
      In free-living overweight or obese adult with impaired fasting glucose or impaired glucose
      tolerance we will compare the effects of a pistachio-rich diet or a Mediterranean Diet on:

        -  Fasting glucose levels, hemoglobin A1c, insulin, C peptide, HOMA IR, advanced glycation
           end products and soluble receptor of advanced glycation-end products.

        -  Peripheral haemostatic parameters.

        -  Plasma inflammatory markers.

        -  Lymphocyte expression of toll-like receptors, C peptide, resistin and interleukin-6 in
           peripheral leukocytes.

        -  Lymphocyte glucose transport and expression of glucose transporter 4 in peripheral blood
           leukocytes.

        -  Platelet function including platelet number, mean platelet volume, platelet factor 4
           levels and urinary 11-dehydro-thromboxane B2.
    

Intervention name(s): Pistachios; control diet
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Participants are randomised crossover clinical trial of 4-months trials separated by a 2-week washout period.
Total duration of intervention and follow-up is nine months.; Participants are randomised crossover clinical trial of 4-months trials separated by a 2-week washout period.
Total duration of intervention and follow-up is nine months.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: pistachio intake; insulin resistance; type 2 diabetes mellitus
Dose Tolerance Study in Healthy Male Volunteers After Intranasal Application of Epinastine Nasal
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety, tolerability and pharmacokinetics
    


Intervention name(s): Epinastine nasal; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Epinastine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Compare the Pharmacokinetic of K-877 Controlled Release (CR) and Immediate Release (IR) Tablets in Healthy Adults.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to compare the pharmacokinetics of 3 types of K-877 controlled release tablets with a
      current normal K-877 tablet in healthy adult subjects.
    


Intervention name(s): K-877 CR Tablet A; K-877 CR Tablet B; K-877 CR Tablet E; K-877 IR Tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): K-877 Controlled Release Tablet A; K-877 Controlled Release Tablet B; K-877 Controlled Release Tablet E; K-877 Immediate Release Tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Trial of Resistance and Endurance Exercise in Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The first questions asked by patients with a new diagnosis of Amyotrophic Lateral Sclerosis
      (ALS) often include: "Does exercise help slow the progression of the disease?", "Is there any
      harm in exercising?", or "What type of exercise (endurance or resistance) is most
      appropriate?" At this time, however, there is a lack of answers for people who suffer from an
      illness that affects their strength above all else. Yet the beneficial effects of exercise in
      both healthy people as well as people with other diseases have been extensively studied and
      resulted in recommendations about the types of exercise that are beneficial. In this study
      the investigators will ask participants with ALS to exercise in one of three ways:
      weightlifting (resistance exercise), stationary bicycling (endurance exercise), and range of
      motion exercise (the current "standard of care" for ALS patients). The investigators will use
      several different types of tests to determine whether one type of exercise is tolerated
      better and is safer than another. The investigators will also collect information about how
      the body responds to exercise in ALS. This study will help in the development of a larger
      national study to understand how exercise can be combined with other treatments to
      potentially improve strength and alter the course of the disease.
    


Intervention name(s): Resistance Exercise; Endurance Exercise; Stretching/Range-of-Motion
Intervention type(s): Other; Other; Other
Intervention description(s): Resistance will be administered using a series of adjustable cuff weights for the upper limbs and hip flexion. Knee flexion and extension will be administered with a weight bench using a leg exercise attachment and free weights.; Endurance will be administered using a minicycle. It can be used from a sitting position (chair or wheelchair) for lower limb exercise and then placed on a tabletop for upper limb use.; Stretching and range of motion exercise is widely accepted as a "standard of care" for ALS management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: ALS; Exercise; Resistance; Endurance
TQLB for Postoperative Pain After Laparoscopic Partial Nephrectomy
Condition: Laparoscopic Renal Surgery; Pain Management; Nerve Block
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This prospective, randomized study,control study aims to compare the analgesic effect,opioids
      consumption,quality of recovery,length of hospital stay，et al. between single-injection
      QLB(quadratus lumborum block)+ intravenous patient-controlled analgesia (IPCA) and
      intravenous patient-controlled analgesia (IPCA) alone in patients undergoing laparoscopic
      partial nephrectomy.
    


Intervention name(s): single-injection TQLB(transmuscular quadratus lumborum block); Morphine given as IPCA(intravenous patient controlled analgesia)
Intervention type(s): Procedure; Drug
Intervention description(s): Inject 0.6ml/kg local anesthetics in between quadratus lumborum and psoas major under ultrasound guidance; PCIA was initiated using a pump set to deliver boluses of 1.5-2 mg of morphine with a 5-minute lockout interval and no background infusion. The maximal permitted dosage of morphine was set at 8 mg/h.
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Anastomotic Leak Testing in Gastrectomy
Condition: Anastomotic Leak; Gastric Cancer; Surgery; Testing, Reality; Gastroscopy
MeSH terms: Stomach Neoplasms; Anastomotic Leak
Study type: Interventional

Summary: 
      Anastomotic leak after radical gastrectomy is a serious complication. Intraoperative leak
      testing was often used to assess the integrity of the anastomosis. However, the reliability,
      clinical benefits and safety of intraoperative leak testing are controversial. Our aim is to
      evaluate the effect and safety of intraoperative leak testing, and to compare the surgical
      complications of patients in intraoperative leak testing group with patients in
      non-intraoperative leak testing group.
    

Detailed description: 
      Anastomotic leak after radical gastrectomy is a serious complication. Intraoperative leak
      testing was often used to assess the integrity of the anastomosis. However, the reliability,
      clinical benefits and safety of intraoperative leak testing are controversial. Our aim is to
      evaluate the effect and safety of intraoperative leak testing, and to compare the surgical
      complications of patients in intraoperative leak testing group with patients in
      non-intraoperative leak testing group. patients underwent total gastrectomy for gastric
      cancer, with esophagojejunostomy reconstruction.
    

Intervention name(s): Introperative leak testing
Intervention type(s): Procedure
Intervention description(s): After anastomosis was completed. We test the integrity of anastomosis intraoperatively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Anastomotic leakage; Gastric cancer; Leakage testing; Total gastrectomy; Gastroscopy
First Research Study of the Possible New Medicine NNC0113-2023 in Healthy Men.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to assess how safe the study drug is and how well a participant
      tolerates it after a single oral (taken by mouth) dose. The study also aims to measure the
      concentration of the study drug and its breakdown products after a single dose. Participants
      will either get NNC0113-2023 (a new medicine) or placebo (a "dummy medicine similar to the
      study medicine but without active ingredients) - which treatment any participant gets is
      decided by chance. Participants will get one dose (can be one or two tablets) of study
      medicine. The study will last for about 65 days. Participants will have 10 scheduled site
      visits with the study physician or study staff at the study centre. For one of the visits,
      participants will stay at the research unit for 5 days. At all visits, except the first
      information visit, participants will have blood drawn along with other clinical assessments.
      Participants cannot take part in this study if participants have any disorder that the doctor
      thinks is a health problem. Only healthy men are allowed to take part.
    


Intervention name(s): NNC0113-2023; Placebo (NNC0113-2023)
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive dose levels of 1 mg, 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of NNC0113-2023 orally. Each participant will receive only one dose.; Participants will receive NNC0174-0833 matched placebo orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective

      • To assess the half-life of BIVV001, Standard Half-Life (SHL) rFVIII and Extended Half-Life
      (EHL) rFVIII after a single intravenous (IV) injection

      Secondary objectives

        -  To characterize additional pharmacokinetic (PK) parameters of BIVV001, SHL rFVIII and
           EHL rFVIII after a single IV injection

        -  To evaluate the safety and tolerability of a single IV injection of BIVV001
    

Detailed description: 
      This is a Phase 1, single center, open-label, sequential treatment, 3-period fixed sequence
      study to assess PK profiles of BIVV001, SHL and EHL rFVIII after a single IV injection in
      male, previously treated patients, 18-65 years of age, with severe hemophilia A (defined as
      <1 IU/dL [<1%] endogenous FVIII).

      The expected duration of the study is up to approximately 67 days including

        -  Screening and washout up to 28 days,

        -  Advate® dosing, PK sampling, including washout: approximately 4 days,

        -  Adynovi® dosing and PK sampling, including washout: approximately 7 days,

        -  BIVV001 dosing and PK sampling: approximately 14 days, Remainder of Safety Observation
           Period: approximately 14 days.
    

Intervention name(s): Efanesoctocog alfa; Octocog alfa; Rurioctocog alfa pegol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Solution for injection Intravenous; Solution for injection Intravenous; Solution for injection Intravenous
Other intervention name(s): BIVV001; Advate®; Adynovi®
Intervention MeSH terms: Factor VIII; BAX 855
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
18F-FDG Tomography and Labeled Leukocyte Scintigraphy
Condition: Malignant Otitis Externa
MeSH terms: Otitis; Otitis Externa
Study type: Observational

Summary: 
      The study will aim to show that there is a superiority of 18F-FDG PET/CT compared to labeled
      leukocyte scintigraphy in patients with a malignant otitis externa.
    

Detailed description: 
      The management of malignant otitis externa (MEO) is a major issue in patients who are often
      polypathological and fragile. Appropriate antibiotic therapy must be started quickly after
      the diagnosis is made and followed for a period of at least 6 weeks. Imaging plays a major
      role in assessing the extent of the infection and especially healing, after 6 weeks of
      antibiotic therapy. The persistence of an infection at the end of the treatment, observed in
      imaging, will allow a change of antibiotic line. This study consists in studying in a
      population affected by an OEM, the performance of PET/CT with 18F-FDG compared to
      scintigraphy with labeled leukocytes. The usefulness of the latter in the follow-up of the
      pathology after antibiotic therapy has already been proven in the literature. The study will
      aim to show that there is a superiority of 18F-FDG PET/CT compared to labeled leukocyte
      scintigraphy.
    

Intervention name(s): 18F-FDG PET/CT
Intervention type(s): Other
Intervention description(s): Patients who underwent an 18F-FDG PET/CT examination and a labeled leukocyte scintigraphy before and after antibiotic therapy in the case of management of an EO.
Other intervention name(s): scintigraphy with labeled leukocytes
Intervention MeSH terms: Fluorodeoxyglucose F18
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent an 18F-FDG positron emission tomography examination and a labeled
        leukocyte scintigraphy before and after antibiotic therapy in the case of management of an
        malignant otitis externa.
National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra
Condition: Breast Reconstruction After Mastectomy
Study type: Interventional

Summary: 
      This multicentre, non-randomised, observational clinical device investigation will be
      performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the
      improvement of the patients' quality of life as well as on the rate of complications of the
      device under investigation.

      The objective of this clinical investigation is to establish the feasibility, efficacy and
      safety of the TiLOOP® Bra.
    


Intervention name(s): TiLOOP Bra
Intervention type(s): Device
Intervention description(s): Titaniferously coated polypropylene mesh
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast reconstruction; mastectomy; mesh; breast cancer
Behavioral Economics of Human Drug Self-Administration
Condition: Drug Dependence
MeSH terms: Substance-Related Disorders
Study type: Observational

Summary: 
      The objective of this protocol is to examine the utility of behavioral economics for
      understanding reinforcer interactions as they pertain to drug self-administration. In a
      series of 6 experiments, the researchers will attempt to quantify the effects of
      qualitatively different reinforcers (money, cigarettes, alcohol, nicotine gum) and their
      interactions. This work represents a continuation of research by this investigator in the
      area of addiction and pharmacology.
    


Intervention name(s): nicotine; alcohol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nicotine
Observational model: Natural History
Time perspective: Cross-Sectional
Clinical Response to Rhinovirus Challenge
Condition: Asthma; Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      Rhinovirus (RV) infections represent the most common cause of asthma exacerbations in
      children and adolescents. The investigators hypothesize that the immune responses generated
      in the nose of allergic rhinitics and asthmatics underlie subsequent systemic modulation of
      the immune system, and that - in susceptible individuals (i.e., those with pre-existing
      asthma) - this modified nasal milieu is responsible for the asthma exacerbation.

      Open label single center study in asthmatics as well as allergic rhinitis (AR) and healthy
      controls. All subjects will undergo good manufacturing practice (GMP) RV16 inoculation and
      responses will be compared between the 3 cohorts.
    

Detailed description: 
      Primary objectives are:

      To determine whether RV increases expression of interleukin (IL)-25 transcripts by nasal
      epithelial cells in the asthma and AR but not control cohorts at the peak of infection (days
      3 and 4).

      To determine whether RV increases lower respiratory symptoms in the asthma but not AR and
      control cohorts.

      To determine whether asthmatics and allergic rhinitics will demonstrate an increased severity
      of infection in comparison to control subjects.

      Secondary objectives are:

        1. To determine whether asthmatic and AR cohorts demonstrate increased IL-25 transcript
           expression over the course of RV infection

        2. To determine whether asthmatic and AR cohorts demonstrate increased expression of mRNA
           transcripts of a type 2 cytokine-inducing profile (IL-33 and thymic stromal
           lymphopoietin (TSLP)).

        3. To determine whether increased transcript expression of this type 2 cytokine-inducing
           profile can be corroborated as increased expression of protein.

        4. To determine whether RV infection in the asthma cohort is associated with increases in
           biomarkers of inflammation.

        5. To determine whether increased severity of RV infection in the asthma and AR cohorts
           will be associated with more symptoms.

        6. To determine whether increased severity of RV infection in the asthma and AR cohorts is
           related to decreased innate immunity.
    

Intervention name(s): Rhinovirus (GMP RV16 HRV-16)
Intervention type(s): Biological
Intervention description(s): 300 tissue culture infectious dose (TCID)50 mg/ml intranasal one time only
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Adjunctive Local Sodium Hypochlorite Gel in Non Surgical Periodontal Debridement
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      The aim of this study was to assess the efficacy of minimally invasive nonsurgical
      debridement (MINSD) of periodontal pockets with or without local amino acid buffered sodium
      hypochlorite (NaOCl) gel application after 6 months follow-up.
    

Detailed description: 
      Forty periodontal compromised patients were randomly allocated in two groups. Periodontal
      pockets > 5 mm in patients of test group were treated by MINSD and NaOCl gel application,
      meanwhile in patients of control group MINSD alone was performed. Full-mouth plaque score
      (FMPS) , Full-mouth bleeding score (FMBS), probing depth (PD), clinical attachment level
      (CAL) and gingival recession (GR) were assessed at baseline and after 6 months follow-up.
    

Intervention name(s): Sodium hypochlorite gel application
Intervention type(s): Drug
Intervention description(s): Patients treated by scaling and root planing and Sodium hypochlorite gel application, meanwhile in patients of control group scaling and root planing alone was performed.
Other intervention name(s): Gel application
Intervention MeSH terms: Sodium Hypochlorite; Eusol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care