bioihbjkbjnl/mcl2 huggingface dataset:
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in South Korea
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      This is a National, Multicentre, Observational Registry to study Adherence and Long Term
      Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth
      hormone treatment from hospital in Korea in order to assess the level of adherence of
      subjects receiving SAIZEN® via easypod™.
    

Detailed description: 
      Subjects will be enrolled in a multicenter, longitudinal, observational registry.
      Parents/subjects will provide their Informed Consent/assent to upload their data for
      population-based analyses and optionally to adhere to a patient adherence support program
      designed to improve their adherence and, ultimately, clinical outcomes. Adherence data will
      be primarily derived from the easypod™ device combined with physician data entry of outcome
      measures. Data will be collected retrospectively and prospectively. This will allow the
      establishment of adherence profiles and explore the hypothesis that patient adherence support
      programs improve adherence and subsequent clinical outcomes. Collected data will be also
      analyzed in a multinational pooled analysis of comparable national studies.

      Primary Objective:

      To assess the level of adherence of subjects receiving SAIZEN via easypod™

      Secondary Objectives:

        -  To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN
           via easypod™

        -  To identify adherence subject profiling

        -  To assess the impact of adherence on Insulin-like growth factor 1 (IGF-1) (i.e. above,
           below or within normal ranges)

        -  Temporal profile of IGF-1 and IGFBP-3 levels
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the
        easypod™ electromechanical device.
      
Keywords: Growth disorders; Saizen; easypod™; Growth hormone; Pediatric subject
Connectome Characterization With Aging
Condition: Healthy
Study type: Interventional

Summary: 
      The main aim of this project is to develop a new model to characterize brain connectivity and
      its changes with aging. This characterization will be based on new sensitive and specific
      markers, allowing a better understanding of structural and functional brain networks. To this
      end, two complementary MRI methods will be developed: 1) Resting-state functional MRI
      (rs-fMRI) which allows the measurement of cerebral activity in different cortical gray matter
      regions, and 2) high angular resolution diffusion imaging (HARDI) MRI, which allows to
      characterize brain tissue microarchitecture. HARDI sequences will be developed to acquire and
      reconstruct fiber tractography of patient's brains. In combination with conventional MRI,
      both HARDI and rs-fMRI will be used to estimate the connection degree between each pair of
      cortical regions, so- called "Connectome". Once generated, brain networks will be quantified
      through numerous graph metrics, such as graph density, global efficiency and assortativity
      (etc.), reflecting the organization and topology of subjects' connectivity with aging.
    


Intervention name(s): Single complete MRI intervention
Intervention type(s): Other
Intervention description(s): MRI examination will comprise conventional T1 and FLAIR sequences, and advanced sequences such as rs-fMRI and High angular resolution MRI (HARDI).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Improving Therapeutic Outcomes in the Tongue Carcinoma Patient: Assessment of Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging
Condition: Tongue Carcinoma
MeSH terms: Carcinoma; Tongue Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to see how the brain re-learns to control the tongue in speaking
      and swallowing when either portions of the tongue have been removed, or when the tongue has
      been treated with radiation, in order to treat cancer. We hope the results of this study will
      help us to improve healing for patients who are being treated for cancer of the tongue.

      When patients with cancer of the tongue are treated by removing parts of the tongue (surgery)
      or by destroying the cancer with radiation to the tongue, they have significant difficulty
      speaking and swallowing after such treatments. At this time, patients who have been treated
      for cancer of the tongue re-learn speaking and swallowing through exercises taught by a
      speech pathologist.

      What is needed is information on how the brain re-learns to control speaking and swallowing
      so that we can help these patients re-learn faster after their treatments.
    

Detailed description: 
      The purpose of this investigation is to determine cortical mechanisms of adaptation to
      surgical or radiation treatment to the tongue. This study will use a non-invasive imaging
      technique, Functional Magnetic Resonance Imaging (fMRI), to investigate cortical responses to
      partial glossectomy or radiation therapy for treatment of a tongue malignancy. Patients with
      Stage I-IV (AJCC) malignancies of the tongue who are treated with surgery and or radiation
      therapy will be imaged using fMRI pre-operatively and at approximately six months
      postoperatively.

      Patterns of brain activity from the fMRI studies will be compared with matched healthy
      control subjects. The results of this investigation will provide needed information on both
      central and peripheral mechanisms of adaptation.
    

Intervention name(s): MRI
Intervention type(s): Procedure
Intervention description(s): Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Tongue; Carcinoma; Cancer; 02-093
Short or Long High Intensity Training
Condition: Sports Performance; Cycling; Well-trained Athletes
Study type: Interventional

Summary: 
      To compare the effects of short and long high intensity interval training (HIT) conducted
      with the same total accumulated duration on physiological- and performance parameters during
      a 4-week training period.
    

Detailed description: 
      Studies among elite athletes have documented the importance of large amounts of training
      volume in order to perform at a high level in endurance sports. It is also well documented
      that both low intensity training (LIT), moderate intensity training (MIT) and high intensity
      training (HIT) should be included in the overall training efforts. It is well documented that
      HIT has a positive effect on the aerobic endurance among both elite athletes and recreational
      athletes.

      Despite the fact that there is general agreement that HIT is an important part of the overall
      training, it is unclear how this part of the training should be organized in order to
      optimize the training effects. The adaptions of endurance performance seem to depend on both
      the intensity and the accumulated duration of the HIT sessions. Therefore, the aim of this
      study was to compare the effects of SI and LI training, including equal accumulated HIT
      duration, during a 4-week intervention period, conducted as 4x8-min with 2-min recovery
      periods, 4x(12x40/20-sec) with 2-min recovery periods and 4x(8x40/20-sec) with 2-min recovery
      periods, in different physiological- and performance parameters among well-trained cyclists.
    

Intervention name(s): Training effects on aerobic output
Intervention type(s): Other
Intervention description(s): The cyclists were allowed to perform ad libitum low intensity (LIT) in addition to high intensity (HIT) sessions that were determined to each group. The cyclists completed 12 supervised HIT sessions during the intervention period, three HIT sessions per week with at least 48 hours between each HIT-session. All HIT sessions were performed as supervised group training sessions. Each HIT session started with an individual 30 minutes' warm up at low intensity (55-70% HRmax) interspersed by freely chosen progressive sprints. For all groups the power output during the recovery periods was 50 % of the power output used during work intervals. The cyclists in all groups were instructed to perform each interval session at their maximal sustainable intensity. Each session ended with 15-20 minutes' cool down (55-70% HRmax). All HIT sessions were supervised and performed in groups on the University of Agder's (UiA) premises at Spicheren fitness center in Kristiansand.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Cycling; endurance performance; intermittent exercise; maximal oxygen consumption; physiological adaptions; well-trained athletes
Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy for Unexplained Infertility
Condition: Subfertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 4

Summary: 
      . This study aimed to determine and compare the effect of vaginal sildenafil citrate and
      estradiol valerate on endometrial thickness, blood flow and pregnancy rates in infertile
      women.
    

Detailed description: 
      The study is a randomized controlled trial that was carried on 148 infertile women with
      unexplained infertility. Patients were divided into 3 groups. Group 1 included 48 patients
      who received oral estradiol valerate (Cyclo-Progynova 2mg, from day 8th till triggering of
      ovulation), another 50 patients in group 2 received oral Sildenafil (Respatio 20mg/12hr film
      coated tablets for 5 days starting from last day of menstruation till ovulation), while group
      3 was the control one who included 50 patients were given ovulation induction with CC
      50mg/12hr from 2nd to 7th day of cycle. Every patient underwent a transvaginal ultrasound to
      determine ovulation, number of follicles, and pregnancy rates. Miscarriage, ectopic
      pregnancy, and multiple pregnancies were tracked for 3 months, as were any adverse
      consequences.
    

Intervention name(s): estrogen therapy; Sildenafil; Clomiphene Citrate 50mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral estradiol valerate; PDE5 inhibitor; used for ovulation induction
Other intervention name(s): white tablet of cycloprogynova; Respatio; Technovula
Intervention MeSH terms: Sildenafil Citrate; Clomiphene; Enclomiphene; Zuclomiphene; Estrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain
Condition: Weight Gain
MeSH terms: Body Weight; Weight Gain
Study type: Interventional
Phase: Phase 4

Summary: 
      Lifestyle intervention and certain medications have been shown to be effective for
      antipsychotic-induced weight gain, but no controlled studies have compared psychological and
      pharmacological therapies. We conducted a randomized, placebo-controlled study to test the
      efficacy of lifestyle intervention and metformin alone and in combination for
      antipsychotic-induced weight gain.
    

Detailed description: 
      The study was designed as a double-blind randomized controlled trial, with research assessors
      and patients intended to be blind to the intervention status. The staff members performing
      the assessment were not involved in implementing any aspect of the intervention.128 patients
      were randomized to one of four 12-week individual treatments: metformin (750mg/day), placebo,
      lifestyle intervention plus metformin (750mg/day) or lifestyle intervention plus placebo.
      Medications were provided in double-blind fashion.The assessments include body weight, body
      mass index, waist circumference, fasting glucose, fasting insulin and insulin resistance
      index.
    

Intervention name(s): metformin; lifestyle intervention
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Weight gain; antipsychotic; lifestyle interventions; metformin; antipsychotic-induced weight gain.
Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia
Condition: Schizophrenia; Iloperidone; Efficacy
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether iloperidone is effective in the treatment
      of Schizophrenia.
    


Intervention name(s): iloperidone; Risperidone
Intervention type(s): Drug; Drug
Intervention description(s): Iloperidone is being development as a treatment of schizophrenia. This trial will verify the safety and efficacy of iloperidone in patients with schizophrenia.; Risperidone is used for the treatment of schizophrenia.Risperidone is unique among most other atypicals in that it has high affinity for the D2 receptor whereas most other atypicals have 'loose binding' of the D2 receptor. It has actions at several 5-HT (serotonin) receptor subtypes.
Intervention MeSH terms: Risperidone; Iloperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: schizophrenia; iloperidone; Risperidone; Efficacy; Safety
Targeted Intensification With ZBEAM and Autologous Stem Cell Transplantation in Patients With High-grade B-Cell Lymphoma
Condition: Lymphoma, Large Cell, Diffuse
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and the safety of a preparative regimen
      utilizing standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy combined
      with high-dose BEAM followed by ASCT after first line treatment in patients aged from 18 to
      65 years with poor prognosis CD 20 Diffuse Large B-Cell lymphoma
    


Intervention name(s): ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan); ASCT; Rituximab
Intervention type(s): Drug; Procedure; Drug
Intervention description(s): Zevalin 0.4 mCi/kg: D-14 BCNU 300 mg/m² : D-6 Etoposide 100 mg/m²/12h : D-6 D-5 D-4 D-3 Aracytine 200 mg/m²/12h : D-6 D-5 D-4 D-3 Melphalan 140 mg/m²: D-2; ASCT : D0; Rituximab 250 mg/m² :D-21 D-14
Intervention MeSH terms: Cytarabine; Rituximab; Etoposide; Melphalan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lymphoma; Lymphoma Diffuse; B-Cell lymphoma; Aggressive lymphoma
An Observational Study to Investigate the Efficacy, Safety, Tolerability and the Effect on Quality of Life of Telmisartan (Micardis) and Telmisartan With HCTZ (Micardis Plus) in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      An observational study to investigate the efficacy, safety, tolerability and the effect on
      quality of life of Telmisartan (Micardis) and Telmisartan with HCTZ (Micardis Plus) in
      patients with hypertension
    


Intervention name(s): telmisartan/telmisartan + HCTZ (Hydrochlorothiazide)
Intervention type(s): Drug
Intervention MeSH terms: Hydrochlorothiazide; Telmisartan
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients from clinics and hospitals in Korea
An Investigation Of The Relationship Between Temporomandibular Disorder With Posture And Pedobarographic Analysis
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      The aim of the study is, to evaluate the whole body posture and plantar pressure
      distributions in individuals with Temporomandibular Disorder and also in people with healthy
      temporomandibular joints. A study group aged between 18-35 years, 30 patients, who were
      diagnosed with Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) who
      applied us with jaw pain and 30 healthy people at the same age range as a control group were
      included in the study. Both groups received global postural assessments by using
      PostureScreen Mobile® (PSM) program which is using four side photographs and the New York
      Posture Scale (NYPS). Static pedobarographic measurements were taken.
    


Intervention name(s): Postural Analysis; plantar pressure analysis
Intervention type(s): Other; Other
Intervention description(s): posture and plantar pressure analysis; posture and plantar pressure analysis
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Plantar Pressure Distribution; Posture; Posturescreen Mobile; RDC/TMD; TMD
A Study to Evaluate the Safety, Tolerance, and Pharmacokinetic and Pharmacodynamic Profile Of 1 SR Formulation of EB-1020
Condition: Normal, Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate whether there is a food-effect with oral administration with EB-1020 as well
      as to obtain information on the safety, and tolerability of EB-1020 in a range of doses.
    

Detailed description: 
      -  To investigate the safety and tolerance of single doses of EB-1020 immediate release
           (IR) versus three sustained release (SR) formulations.

        -  To investigate the safety and tolerance of a single oral dose of a SR formulation of
           EB-1020 in the fed and fasted state.

        -  To investigate the safety, tolerance, and cognitive effects of multiple oral rising
           doses of a SR formulation of EB-1020.

      Secondary Objectives

        -  To characterize the single dose and steady state pharmacokinetic profiles of EB-1020 SR
           formulations.

        -  To investigate the effect of food on the pharmacokinetic profile of EB-1020 SR following
           single oral doses.
    

Intervention name(s): EB-1020 IR; EB-1020 SR1; EB-1020 SR2; EB-1020 SR3; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): Immediate release; sustained release; Sustained release; Sustained release; Placebo formulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy; Normal
neuroQWERTY: a Transparent Patient-centered Outcome Method to Quantify Parkinsonian Motor Signs for Drug Trials
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The motor impairment produced by Parkinson's disease (PD) is a significant and debilitating
      part of the condition. Current methods to evaluate this impairment rely on subjective
      examinations. The investigators seek to develop an objective assessment of motor deficits by
      monitoring the participants natural interactions with a keyboard (on a computer or smart
      device). This approach provides a window to how the brain behaves during typical daily use of
      these devices, i.e. writing a report, sending an email or any other task performed on a
      digital device and thus has the potential to be used easily and regularly. (Importantly, the
      data gathered are non-sensitive and based only on timing information).

      PD participants will be recruited during outpatient visits to PD clinics throughout the
      Madrid metropolitan region. General entry criteria will be those patients who are scheduled
      to begin dopaminergic therapy, and own a home computer or laptop. The study will not impact
      on participants' standard clinical management other than by asking the participants to type
      for 15 minutes at each of the clinic visits, and installing the investigators proprietary
      software on their home computer. This software will collect keystroke data alone. (None of
      the actual information about what is being typed will be collected.) The keystroke data
      collected will be analyzed and compared with standard clinical metrics of therapeutic
      response, as well as the in-clinic typing data.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A group of early Parkinson's disease participants who are going to be prescribed
        dopaminergic agents and a group of healthy volunteers will be recruited at the different
        collaborating institutions.
      
Keywords: Hypokinesia; Patient Outcome Assessment
A Study to Evaluate the Efficacy of ELAPR in Women With Striae Distensae Alba
Condition: Striae Distensae
MeSH terms: Striae Distensae
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to evaluate the efficacy of two formulations of a cross-linked
      tropoelastin matrix given the product codes ELAPR002f and ELAPR002g (collectively referred to
      as ELAPR or ELAPR002) for the treatment of Striae Distensae (SD) alba when administered as
      intradermal implants.
    

Detailed description: 
      The study will consist of six study visits. There will be a screening visit to confirm
      eligibility and to assess baseline parameters (Day -28 to Day -1). For enrolled subjects
      there will be three intradermal (i.d.) treatment sessions of ELAPR002f or ELAPR002g and
      placebo, given at one-monthly intervals (approximately Day 0, Day 28 and Day 56). There will
      be a safety assessment visit 7 days after the first treatment session (Day 7) to review any
      adverse events and assess the implant sites. ELAPR002f or ELAPR002g will be administered
      alone vs. placebo. Subjects will be followed for a total of 12 weeks (to Day 84) following
      the first treatment, with efficacy and safety assessments undertaken at each study visit. At
      the final follow-up visit (Day 84) a biopsy sample will be taken from each of the treated SDs
      (active and placebo treated), together with a control biopsy of normal skin collected from an
      area of the lateral aspect of the abdomen, hip or thigh without an SD alba. Each study
      subject will act as their own control with active and placebo treatments given single-blind
      to contralateral sides of the abdomen, hip or thigh, into matched and paired SD. Prior to
      administration the selected injection sites along the length of SD alba to be treated will be
      identified and marked with a semi-permanent mark to ensure consistency of anatomic sites for
      treatment and biopsy. Follow-up period extended to D168, D336 and D504.
    

Intervention name(s): ELAPR002f; ELAPR002g; Saline
Intervention type(s): Device; Device; Device
Intervention description(s): Intradermal implant; Intradermal implant; Intradermal implant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alba