bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Ankle Propriocement and Stability
Condition: Ankle Sprains; Instability, Joint
MeSH terms: Joint Instability; Ankle Injuries
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the postural control and proprioception before and
      after external capsulo-ligament reconstruction for ankle instability.
    

Detailed description: 
      The objective of the study is to evaluate the postural control and proprioception before and
      after external capsulo-ligament reconstruction for ankle instability using differents tests,
      questionnaires and instrument:

        -  Delos system (computerized oscillating platform)

        -  Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score
           (AOFAs), SF12 questionnaires

        -  modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery
           (SPPB)
    

Intervention name(s): Preoperative evaluation; Postoperative evaluation
Intervention type(s): Procedure; Procedure
Intervention description(s): Preoperative evaluation using differents clinical evaluation tests, questionnaires, and instrument:
Delos system (computerized oscillating platform)
Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires
modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB); Postoperative evaluation at 4 months of follow up after surgery using differents clinical evaluation tests, questionnaires, and instrument:
Delos system (computerized oscillating platform)
Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires
modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB)
Other intervention name(s): Questionnaires: "FAAM", "AOFAs", "SF12"; Instrument: "Delos computerized oscillating platform"; Tests: "mSEBT", "SPPB"; Questionnaires: "FAAM", "AOFAs", "SF12"; Instrument: "Delos computerized oscillating platform"; Tests: "mSEBT", "SPPB"
Intervention MeSH terms: Benzoyl Peroxide
Intervention model: Single Group Assignment
Intervention model description: All patients who undergo surgery for a ankle lateral ligament reconstruction from 4th Febbruary 2019 till to the end of the study on 4th August 2020
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: sprain; Brostrom; ankle instability
Evaluating the Performance of the KODEX-EPD CRyOballoon Occlusion Feature in Patients With Atrial Fibrillation
Condition: Atrium; Fibrillation; Ablation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      Prospective, multi-center, non-randomized, open label, double arm study to assess the
      performance of the KODEX-EPD PV occlusion viewer. This study includes patients with atrial
      fibrillation who are scheduled to undergo a cryo balloon ablation procedure for their atrial
      fibrillation.
    

Detailed description: 
      The study is designed to evaluate the performance of the KODEX-EPD occlusion viewer using a
      standardized workflow in a blinded setting in a homogenous patient group. Furthermore, in an
      effort to minimize therapy, a direct comparison between the success of the freeze when
      initiating therapy based on the occlusion viewer vs the assessment of occlusion assessed with
      fluoroscopy will be evaluated. The study design indicates a post-market interventional
      clinical investigation to evaluate the endpoints of the study. No follow-up is foreseen
      ensuring a minimal burden to the subjects participating in the study.
    

Intervention name(s): KODEX-EPD System; Fluoroscopy with contrast dye
Intervention type(s): Device; Device
Intervention description(s): The KODEX - EPD system is an open platform that uses any validated EP catheter to create real-time 3D images of the human heart. The KODEX occlusion viewer provides an indication of the occlusion status of the PV during cryoballoon PVI procedure; Fluoroscopy with contrast dye is used to determine occlusion status during cryoballoon PVI procedures
Other intervention name(s): KODEX Occlusion Viewer
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Arrhythmia patients scheduled to undergo a cryo balloon ablation procedure for their atrium
        fibrillation. Both male and female subjects who meet all eligibility criteria and give
        written informed consent will be enrolled in the study
      
Keywords: Atrial Fibrillation; AF; Cryoballoon; Ablation; KODEX-EPD
Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers
Condition: Ocular Pain; Dry Eye
MeSH terms: Dry Eye Syndromes; Eye Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether SYL1001 is safe for the prevention and
      treatment of ocular pain and dry eye syndrome.
    


Intervention name(s): SYL1001
Intervention type(s): Drug
Intervention description(s): SYL1001 eye drops. topical administration
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: ocular pain; dry eye; siRNA
Effect of Itopride, on Symptoms of Functional Dyspepsia, Such as Indigestion, Bloating, Inability to Finish a Meal
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 3

Summary: 
      Itopride is a new compound that is already marketed in Japan and in some countries of Eastern
      Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia.
      Patients suffering from this condition have difficulties digesting food. They feel full after
      eating a few bites; they feel bloated and their stomachs hurt. The goal of this study is to
      see if itopride helps to relieve the symptoms of functional dyspepsia.
    

Detailed description: 
      The study lasts approximately 10 weeks. Patients may either receive the real itopride, or a
      sugar pill called placebo. They have equal chances of receiving either treatment. After
      having completed this study, patients may be eligible to continue treatment for a longer
      period. At that point, all patients receive itopride.

      Patients need to come to the clinic for evaluations 4 times during the trial. Various
      evaluations are done at these visits, such as a physical exam, lab tests, evaluation of the
      heart condition, and questionnaires need to be completed by the patient to see if the drug
      helps them in relieving their symptoms.
    

Intervention name(s): Itopride Hydrochloride
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Functional dyspepsia; Abdominal Symptom relief; Fullness; Bloating; Indigestion
The Application of Balanced Propofol Sedation in Fiberoptic Bronchoscopy
Condition: Bronchoscopy
Study type: Observational

Summary: 
      The purpose of this study is to investigate the feasibility of using balanced propofol
      sedation for bronchoscopy. And screen out the optimal balanced propofol sedation
      compatibility plan.
    

Detailed description: 
      Balanced propofol sedation (BPS) is a technique proposed and developed by
      gastroenterologists. In recent years, multiple studies have confirmed that the use of BPS in
      gastrointestinal endoscopy can not only ensure patient comfort, but also reduce the incidence
      of respiratory and circulatory suppression. Moreover, the postoperative recovery time is
      short. Even for non-anesthesiologists applying BPS in gastrointestinal endoscopy , it has
      high safety.

      Compared with gastrointestinal endoscopy, bronchoscopy occupies the respiratory tract and
      most patients have respiratory system diseases. Therefore, it is more necessary for strict
      respiratory management and control of patient sedation depth. Traditional midazolam combined
      with opioid drugs or propofol monosedation cannot effectively meet clinical needs. The
      excellent sedative and analgesic effects of BPS, as well as its maintenance of respiratory
      and circulatory functions, make it theoretically very suitable for application in
      bronchoscopy. However, there is currently a lack of evidence to support the application of
      BPS in bronchoscopy.
    

Intervention name(s): Midazolam and sufentanil; Midazolam, sufentanil and propofol; Remazolam and sufentanil.; Remazolam, sufentanil and propofol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with midazolam combined with sufentani.; Patients undergoing bronchoscopic diagnosis and treatment under deep sedation with midazolam and sufentani combined with propofol.; Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with remazolam combined with sufentani.; Patients undergoing bronchoscopic diagnosis and treatment under deep sedation with remazolam and sufentani combined with propofol.
Intervention MeSH terms: Midazolam; Sufentanil; Dsuvia; Propofol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Population undergoing bronchoscopy examination at Qingdao University Affiliated Hospital
        from December 2023 to January 2014.
      
Keywords: Propofol; Balanced propofol sedation; Remazolam; Bronchoscopy
Local Infiltration Analgesia After Abdominal Hysterectomy
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to evaluate traditional analgesic therapy after abdominal
      hysterectomy with single infiltration of local anesthetics in the surgical area at the end of
      surgery.
    

Detailed description: 
      The study is a controlled, double blind, prospective, randomized and performed at Sahlgrenska
      University Hospital in Goteborg, Sweden. The injectant mixture consists of 300 mg ropivacaine
      mixed with 30 mg ketorolac and 0.5 mg epinephrine. Total volume of the solution is 156 ml.
      The normal saline injection is used in the control group in the same manner as in the LIA
      group. The parameters which would be evaluated are consumption of morphine, pain intensity
      and side effects.

      The primary objective is to evaluate whether local infiltration analgesia (LIA) into the
      operating field will reduce morphine consumption during the first 24 postoperative hours in
      patients undergoing abdominal hysterectomy (AH).

      Secondary end-points are pain intensity, incidence of nausea and vomiting, sedation
      intensity.
    

Intervention name(s): ropivacaine, ketorelac and epinephrine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active group; Placebo group
Other intervention name(s): Narop, Toradol and adrenaline; Saline
Intervention MeSH terms: Epinephrine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Analgesia; Local infiltration analgesia; Pain, relief; Pain, Postoperative; Ropivacaine; Ketorolac; Epinephrine; Adrenergic Agonists; Sympathomimetics; Therapeutic Uses; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Opioids; Morphine; Pain; Postoperative Complications; Physiological Effects of Drugs; Anesthetics, Local; Anesthetics
Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects
Condition: Venous Thrombosis; Pediatrics
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The first study with rivaroxaban in pediatric subjects is a Phase I study, where the
      pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to
      confirm that the exposure is comparable to adults. This study is a single dose study with
      multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism
      (VTE) treatment.
    


Intervention name(s): Rivaroxaban (Xarelto, BAY59-7939)
Intervention type(s): Drug
Intervention description(s): Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults
Intervention MeSH terms: Rivaroxaban
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Venous Thrombosis; Pediatrics
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection
Condition: HSIL; HSIL of Cervix; High-Grade Squamous Intraepithelial Lesions; High-grade Cervical Intraepithelial Neoplasia; Human Papilloma Virus; Cervical Cancer; Cervical Intraepithelial Neoplasia; Cervical Neoplasm; Cervical Dysplasia; CIN
MeSH terms: Uterine Cervical Neoplasms; Neoplasms; Carcinoma in Situ; Papilloma; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical
      precancerous lesions in adult women.
    


Intervention name(s): ABI-1968
Intervention type(s): Drug
Intervention description(s): Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Up to two ascending dose cohorts (8 subjects per cohort) may receive multiple doses in 2 ascending dose strengths of ABI-1968 Topical Cream. After completing the multiple ascending dose portion a Cohort Expansion group of 32 to 40 subjects will be initiated.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Exelon Patch and Combination With Memantine Comparative Trial
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to compare the tolerability between rivastigmine patch monotherapy
      and combination therapy with memantine in patients with Alzheimer's disease (AD). The
      secondary objective is to compare the efficacy and safety between rivastigmine patch
      monotherapy and combination therapy with memantine in patients with AD. The study hypothesis
      is that the tolerability of the combination therapy with memantine is not inferior to that of
      rivastigmine patch monotherapy in AD patients.
    

Detailed description: 
      Recently, the rivastigmine patch demonstrated efficacy comparable to the highest doses of
      rivastigmine capsules, with markedly improved tolerability profile. We hypothesized that
      combination of memantine and rivastigmine patch will be safe and well tolerated and result in
      more clinical benefit in patients with AD in comparison with rivastigmine patch monotherapy,
      for the mechanisms of the drugs are different.
    

Intervention name(s): Rivastigmine transdermal patch (Exelon patch), memantine; Rivastigmine transdermal patch
Intervention type(s): Drug; Drug
Intervention description(s): All patients start on a 5-cm2 rivastigmine patch and their dose is increased to a 10-cm2 patch after 4 weeks. Patients will be randomly allocated to 1 of 2 treatment groups of rivastigmine patch monotherapy and combination therapy with memantine at the baseline visit (week 9)and treated with the drugs for 16 weeks.; All patients start on a 5-cm2 rivastigmine patch and their dose is increased to a 10-cm2 patch after 4 weeks. Patients will be randomly allocated to 1 of 2 treatment groups of rivastigmine patch monotherapy and combination therapy with memantine at the baseline visit (week 9)and treated with the drugs for 16 weeks.
Other intervention name(s): exelon patch, ebixa; exelon patch
Intervention MeSH terms: Memantine; Rivastigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of 2% Lidocaine Gel for Intrauterine Device (IUD) Insertion
Condition: Pain
Study type: Interventional

Summary: 
      The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive
      that may be underutilized due to fear of pain during insertion. Although providers frequently
      prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no
      evidence for any pain reduction. In fact, no interventions evaluated in randomized controlled
      trials have been shown to be effective in reducing pain during IUD insertion. While many
      women tolerate IUD insertion well, others have moderate to severe pain. This double-blind
      randomized controlled trial of 150 women aims to estimate the efficacy of intracervical 2%
      lidocaine gel compared to placebo (KY jelly) to reduce IUD insertion pain. Our hypothesis is
      that women who are treated with 2% lidocaine gel prior to IUD insertion will have reduced
      pain as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). We will be able to detect a
      15 mm difference on the VAS with our sample size. Other data to be collected include
      information regarding age, BMI, obstetric history, lactation status, time since pregnancy or
      delivery, last menstrual period, history of cervical conization, anxiety levels, anticipated
      pain levels, insertion characteristics (time, difficulty, complications), side effects, and
      satisfaction with pain control. If 2% lidocaine gel is effective, then a viable, easily
      administered option for pain control will be available to providers and patients.
    


Intervention name(s): 2% lidocaine gel; Placebo gel
Intervention type(s): Drug; Drug
Intervention description(s): 120mg lidocaine x 1; Inert gel x 1
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Pain measurement; Intrauterine devices; Lidocaine
Patient-Provider Tools to Improve the Transition to Adult Care in Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      The purpose of the study is to develop patient-provider clinical support tools to improve
      clinical practice, patient self-management, and disease outcomes in sickle cell disease
      during transition to adult care. The investigators hypothesize that these clinical support
      tools (patient tool, provider tool, and patient/parent web-based portal) will be feasible,
      user friendly, and beneficial. The investigators hypothesize that participants will
      demonstrate better disease self-efficacy at the end of the 6 week intervention and maintain
      these gains during the follow-up period (up to 1 year post-intervention).
    

Detailed description: 
      The purpose of the study is to develop patient-provider clinical support tools to improve
      clinical practice, patient self-management, and disease outcomes in sickle cell disease
      during transition to adult care.
    

Intervention name(s): Self-management intervention for Adolescents with SCD; Patient Portal Intervention for Adolescents with SCD
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Chronic Disease Self-Management Program; MyChart for SCD intervention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anemia, Sickle Cell; Transition to Adult Care; Self Care; Personal Electronic Health Records; Adolescent; Young Adult; Disease Management; Physician-Patient Relations
Disturbed Structural Connectivity of Frontostriatal and Frontoparietal Networks in Adults With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      Attention deficit/hyperactivity disorder (ADHD) is a common, impairing, childhood onset
      neuropsychiatric disorder with executive dysfunctions. The ADHD symptoms and executive
      deficits may last to adulthood. Our previous studies, like western results, have shown that
      children with ADHD have disrupted microstructural integrity of frontostriatal fiber pathways
      and impaired brain activity in frontoparietal network. However, there is lack of data with
      regards to whether adults with ADHD also demonstrate structural and functional
      disconnectivity of frontostriatal and frontoparietal networks as compared to healthy controls
      without ADHD in Asian population and no study has been done to correlate a wide range of
      executive functions with the connectivity of these two networks.

      Specific Aims:

        1. to compare the executive functions, and structural and functional connectivity in
           frontostriatal and frontoparietal circuitries between adults with ADHD and healthy
           controls without ADHD;

        2. to correlate the data from structural and functional connectivity, executive functions,
           and ADHD core symptoms stratifying by the ADHD and controls; and

        3. to explore other circuitries that may involve in ADHD by using whole brain tractography
           analyses.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The sample consists of 50 adults (ages 18-45) with clinical diagnosis of ADHD according to
        the DSM-IV criteria and 50 age-, sex-, and IQ-matched healthy controls without lifetime
        diagnosis with ADHD.
      
Keywords: Adult ADHD; diffusion spectrum imaging; resting-state fMRI; frontostriatal circuitries; frontoparietal circuitries; executive function