bioihbjkbjnl/mcl2 huggingface dataset:
Metformin and Dietary Restriction to Prevent Age-related Morbid Events in People With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase III randomized controlled trial on men and women with Metabolic syndrome (MetS) to test
      the hypothesis that comprehensive life-style changes and/or metformin treatment prevent
      age-related chronic non-communicable diseases (ArCD).

      The aim of the present study is to evaluate the effect of a comprehensive life-style
      intervention (including moderate physical activity and Mediterranean/macrobiotic diet with
      moderate calorie and protein restriction), and of treatment with Metformin (a calorie
      restriction mimetic drug) for the prevention of ArCD.
    

Detailed description: 
      Phase III randomized controlled trial on men and women with MetS to test the hypothesis that
      comprehensive life-style changes and/or metformin treatment prevent ArCD.

      Design:

      2x2 factorial: 2,000 volunteers will be randomized in four equal groups of 500 each, and
      allocated to the following treatments: METFORMIN (1700MG/DAY) + ACTIVE LIFESTYLE INTERVENTION
      PLACEBO + ACTIVE LIFESTYLE INTERVENTION METFORMIN (1700 mg/day) alone PLACEBO alone The
      metformin /placebo component of the study will be double blind.
    

Intervention name(s): Metformin Hydrochloride 850 MG Oral Tablet [Glucophage]; Ludipress, mg stereate, micronized hydrated silica, talcum
Intervention type(s): Drug; Drug
Intervention description(s): Tablet
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a 26 week, randomized, parallel group, double blind comparison of PF-02545920 5
      mg, PF-02545920 20 mg, and placebo dosed BID in the treatment of motor impairment of subjects
      with Huntington's Disease. A total of approximately 260 subjects are planned to be randomized
      in the study. Primary endpoint is the change from baseline in the Total Motor Score (TMS)
      assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 26 weeks of
      treatment. secondary endpoints will include change from baseline in the Total Maximum Chorea
      (TMC) score of the UHDRS after 13 and 26 weeks of treatment and Clinical Global
      Impression-Improvement score after 13 and 26 weeks of treatment.
    


Intervention name(s): PF-02545920; PF-02545920; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): 20 mg twice a day (BID) for 26 weeks. Each 20 mg dose will be taken as 4 tablets of 5 mg. The 20mg dose will be titrated as follow: 5mg BID for 7 days, 10mg BID for 7 days, 15 mg BID for 7 days and 20 mg BID to week 26. Study drug will be provided in weekly blister cards.; 5 mg twice a day (BID) for 26 weeks. Each 5 mg dose will be taken as 4 tablets: one tablet of 5 mg and 3 tablets of matching placebo. The 5mg dose will not be titrated. Study drug will be provided in weekly blister cards.; Matching Placebo twice a day (BID) for 26 weeks. Each placebo dose will be taken as 4 tablets of matching Placebo. The placebo dose will not be titrated. Matching placebo will be provided in weekly blister cards.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Huntington; chorea; total motor score; CAG repeat: total functional capacity; motor cognitive and behavioral symptoms
Ketoacidosis in Individuals With Type I Diabetes Mellitus (T1DM)
Condition: Type 1 Diabetes
MeSH terms: Ketosis
Study type: Interventional

Summary: 
      The purpose of this study is to investigate individuals with type 1 diabetes who were
      disconnected from their insulin pump and insulin therapy was started again after positive
      ketones (U) in the urine or blood β-hydroxybutyrate.
    

Detailed description: 
      Individuals with type 1 diabetes were disconnected from their insulin pump and insulin
      therapy was started again after positive ketones (U) in the urine or blood β-hydroxybutyrate
      with different therapy regimens after positive blood ketones.
    

Intervention name(s): Different insulin therapy at different time points
Intervention type(s): Behavioral
Intervention description(s): different insulin therapy after positive blood ketones
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: therapy after positive ketone bodies in the blood; timepoint of diagnosis; timepoint of metabolic normalisation
A Study of Induction and Maintenance Treatment With MabThera (Rituximab) in Patients With Indolent B-Cell Nonfollicular Lymphomas
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of MabThera in combination chemotherapy,
      followed by maintenance treatment with MabThera. The anticipated time on study treatment is
      1-2 years, and the target sample size is <100 individuals.
    


Intervention name(s): rituximab
Intervention type(s): Drug
Intervention description(s): 1
Other intervention name(s): MabThera/Rituxan
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Recurrence Rate Comparison Between Esomeprazole and Lansoprazole in Eradicating Helicobacter Pylori Infection Among Children
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections; Recurrence
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study aims to compare the recurrence rates of Esomeprazole and Lansoprazole in triple
      combination therapy to eradicate H.pylori infection in children. The participants were
      divided into two groups, those who received Esomeprazole and those who received Lansoprazole
    

Detailed description: 
      H. pylori eradication therapy is still contentious. A treatment that is uncomplicated,
      well-tolerated, and boasts an efficiency rate of more than 80% is recommended.

      PPIs are a type of acid-sensitive drug which is most beneficial in preventing the degradation
      of drugs in the stomach. In developing countries, Esomeprazole and Lansoprazole were mainly
      selected as a drug of choice. Major influential factors such as Esomeprazole's additional
      antioxidant ability, are comparable to vitamin C. This is due to its ability to scavenge
      Diphenyl Picrylhydrazyl (DPPH) free radicals at low concentrations. Lansoprazole also possess
      similar ability, albeit needs a slightly higher concentration to reach a similar effect. In
      terms of IC50 values, both drugs have a substantial advantage over vitamin C, earning them
      the title of 'potentially ideal' agents in the treatment algorithm. Furthermore, numerous
      studies mention that children better tolerate PPIs.
    

Intervention name(s): Esomeprazole; Lansoprazole; Amoxicillin; Clarithromycin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered once a day per-oral (PO) with the dose of 0.4 mg/kg; Administered once a day per-oral (PO) with the dose of 15 mg if individual's body mass was <30 kg, and 30 mg if it was >30 kg; Administered thrice a day per-oral (PO) with the dose of 25 mg/kg; Administered twice a day per-oral with the dose of 7.5 mg/kg
Intervention MeSH terms: Amoxicillin; Clarithromycin; Esomeprazole; Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Triple therapy; Children; Esomeprazole; Lansoprazole
Study To Evaluate the Efficacy, Safety and Tolerability of E2027 (Hereinafter Referred to as Irsenontrine) in Participants With Dementia With Lewy Bodies
Condition: Dementia With Lewy Bodies
MeSH terms: Dementia; Lewy Body Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be conducted to compare Irsenontrine to placebo on the cognitive endpoint of
      Montreal Cognitive Assessment (MoCA) and the global clinical endpoint of Clinician's
      Interview Based Impression of Change Plus (CIBIC-Plus) Caregiver Input in participants with
      dementia with Lewy bodies after 12 weeks of treatment.
    


Intervention name(s): Irsenontrine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral hypromellose capsules.; Oral hypromellose capsules.
Other intervention name(s): E2027
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irsenontrine; Montreal Cognitive Assessment; Neuropsychiatric Inventory; Mini-Mental State Examination; Cognitive Fluctuation Inventory
Open-Label,Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC1004 in Subjects With Severe Plaque Type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      Open label study for patients with severe plaque type psoriasis. This study is looking to
      evaluate the pharmacodynamic effect of CC10004 when taken for 29 days in reducing the
      epidermal thickness in subjects with severe placque type psoriasis.
    


Intervention name(s): CC10004
Intervention type(s): Drug
Intervention description(s): 2 X 10 mg caps taken once daily for a daily dose of 20 mg. Must be taken upon awakening and fasted
Other intervention name(s): Apremilast
Intervention MeSH terms: Apremilast
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: psoriasis
Fractional Laser and Steroid Ointment to Improve the Old Scar After Thyroidectomy
Condition: Thyroid; Wound; Steroid Acne
Study type: Interventional

Summary: 
      This clinical study was conducted to assess the effects of LADD combined with a fractional
      ablative carbon dioxide laser and a topical steroid for the treatment of post-thyroidectomy
      hypertrophic scars.
    

Detailed description: 
      Thyroidectomy results in unsightly scarring at the anterior neck of the patient. A clinical
      study was conducted to assess the effectiveness of five courses, applied every 4 weeks, of
      laser-assisted drug delivery (LADD) combining a fractional ablative carbon dioxide laser and
      topical 0.05% clobetasol propionate to the treatment of post-thyroidectomy hypertrophic scars
      in patients. Assessments of the scars by the patient themselves according to the patient and
      observer scar assessment scale.
    

Intervention name(s): Laser-assisted drug delivery
Intervention type(s): Device
Intervention description(s): All patients received treatment using the same protocol with the same fractional ablative carbon dioxide laser (eCO2 PlusTM, manufactured by Lutronic, South Korea). Each patient was applied with Lidopin 5% cream (Panion & BF Biotech Inc.), which remained on the scar for 30 min for pain relief before each laser course. Later, the Lidopin 5% cream was gently removed using a normal saline-rinsed gauze, and the scar was treated with a fractional ablative carbon dioxide laser with two passes under a 10,600 nm wavelength, 120 mm spot size, pulse energy of 50 mJ, 30 W of power, and a density of 200. A topical steroid cream (clobetasol propionate, 0.05%) was evenly applied on the scar gently back and forth using a cotton swab immediately after the laser treatment. The patients underwent five full courses by the same doctor according to the same protocol, with each course given 4 weeks apart.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety of Tinted Soft Scleral Eye Shields When IPL is Applied on Eyelids
Condition: Dry Eye Disease; Meibomian Gland Dysfunction
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Meibomian Gland Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to verify the safety of tinted soft scleral eye shields when IPL
      is applied directly on eyelids.
    

Detailed description: 
      Patients with dry eye disease due to meibomian gland dysfunction will be treated with one
      session of IPL applied directly on upper and lower eyelids, when eyes are protected with
      tinted soft scleral eye shields which prevent IPL from penetrating into ocular structures.
      Ocular structures will be examined with various tests (including: biomicroscopy, OCT and
      specular microscopy) at baseline and at 10 minutes after IPL, 24 hours after IPL, and 7 days
      after IPL. In addition, visual acuity will be measured at each of these times, and the
      patient will report of any visual symptoms at each of these times. The primary objective is
      to verify that no morphological or functional changes occur between the baseline and the 7
      days follow-up visit.
    

Intervention name(s): Protection of eyes with tinted soft scleral eye shields
Intervention type(s): Combination Product
Intervention description(s): In subjects with dry eye disease due to meibomian gland dysfunction, protection of eyes with tinted soft scleral eye shields followed by IPL administration on eyelids
Other intervention name(s): IPL adminstration on eyelids
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Low Frequency TMS for Depression in Epilepsy
Condition: Epilepsy; Depressions, Refractory
MeSH terms: Epilepsy; Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional

Summary: 
      The purpose of this study is to determine if low-frequency transcranial magnetic stimulation
      (TMS) is safe and feasible for treating depressive symptoms in patients with epilepsy.
      Patients will receive an accelerated protocol of TMS consisting of three consecutive days of
      treatment. Patients will have in-person follow up visits after one month and again after six
      months.
    

Detailed description: 
      This is a pilot study designed primarily to assess whether patients with epilepsy can safely
      tolerate low-frequency transcranial magnetic stimulation in an accelerated protocol to treat
      depression. The investigators aim to treat 12 patients with epilepsy and comorbid depression
      to receive a total of 15 hours of transcranial magnetic stimulation over 3 days at
      Dartmouth-Hitchcock Medical Center (DHMC). The investigators will assess safety of this
      protocol with regards to seizure frequency and other side effects of TMS treatment and the
      feasibility of using an accelerated protocol in this patient population. In addition to these
      primary aims, our secondary goal is to determine if dense array EEG can provide a useful
      biomarker for depression and its treatment in focal epilepsy. A structural and functional MRI
      will be obtained before treatment and a dense array EEG before and after TMS treatment to
      assess for changes in specific dense array EEG based biomarkers.

      In addition to recruiting patients, the study staff will likewise request that family members
      or friends of the patient accompany the patient monitor him/her for increased seizure
      frequency. The recruited family member will bring the patient to the treatment and stay with
      the patient overnight at a local hotel and monitor for possible seizures or other adverse
      events of treatment. Family members will be instructed in seizure safety and be given
      emergency phone numbers to call if the patient is experiencing adverse effects of TMS.
    

Intervention name(s): Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): Repetitive transcranial magnetic stimulation (TMS) is a focal, nonpharmacological, noninvasive method for stimulating the brain and modulating neural network activity. To administer TMS, an electromagnetic coil is placed on the scalp, and uses electrical current to create magnetic fields that depolarize or hyperpolarize neurons in the brain.
Other intervention name(s): Mag-Venture Mag-pro; TMS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: epilepsy; depression; refractory; TMS
Screening of Athletes
Condition: Individual Differences; Motor Activities
Study type: Observational [Patient Registry]

Summary: 
      Athletes have to participate in screenings in order to reduce injuries. Up-to-now most
      screenings are purely clinically based. Literature, however, indicates the importance of
      knowledge on deviant movement patterns as possible risk factors for injuries. From this
      perspective, the current project aims to measure movement patterns, gait and running in young
      athletes to optimise training and prevent injuries.

      2D- and 3d registration methods, force plate data and pressure plate data will be used to
      document the performance of the athletes.
    


Intervention name(s): Advice
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Athletes will be selected from a list offered by the Flemish Atlethics League. This
        incorporates a group of athletes with potential to become Elite Athletes of the highest
        international level
      
Keywords: Athletes
Pain Control After Cardiac Surgery Using Intravenous Acetaminophen
Condition: Pain
Study type: Interventional

Summary: 
      Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid
      consumption and/or pain intensity scores after cardiac surgery.
    


Intervention name(s): IV Acetaminophen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.; Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Other intervention name(s): 1000mg IV Acetaminophen; inactive substance
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Keywords: Males or females; 18 years of age or older.; Non-emergency; cardiac surgery; midline sternotomy.
A Study To Evaluate The Safety, Tolerability And Pharmacokinetics of HS-10345 In Treatment-Resistant Depression
Condition: Treatment Resistant Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
      intranasal HS-10345 (84mg) compared with placebo in participants with treatment-resistant
      depression (TRD).
    

Detailed description: 
      This will be a randomized, double-blind, placebo-controlled, multicenter study. Approximately
      24 male and female adult participants diagnosed with TRD will participant in this study.
      There will be 4 study phases: a 4-week screening phase, a 1-day baseline phase, a
      double-blind treatment phase (Day 1 to Day 15), and a 1-week post-treatment (follow-up)
      phase. Firstly, 12 patients will be assigned to intranasal placebo or HS-10345 of 84mg. Extra
      12 patients may be enrolled depending on the pharmacokinetics analysis of 84mg. Safety
      assessments will be performed throughout the study. The maximum study duration for a
      participant will be 7 weeks.
    

Intervention name(s): HS-10345 84mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 6 sprays of HS-10345 84 mg self-administered as an intranasal formulation for 4 days (Days 1, 4, 8, 11) during the double-blind phase; 6 sprays of placebo self-administered as an intranasal formulation for 4 days (Days 1, 4, 8, 11) during the double-blind phase
Other intervention name(s): HS-10345; HS-10345 Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Treatment resistant depressive disorder; Intranasal; HS-10345
An Active Approach to Treat Amblyopia: Video Game Play
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional

Summary: 
      Amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of
      vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. This
      study uses psychophysical measures to study neural plasticity in adults with amblyopia.
    

Detailed description: 
      Amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of
      vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. Our
      previous findings (see CITATIONS) show that the adult amblyopic brain is still plastic and
      malleable, suggesting that active approach is potential useful in treating amblyopia. The
      goal of this project is to assess the limits and mechanisms of neural plasticity in amblyopic
      spatial vision. This study uses psychophysical measures to study neural plasticity in adults
      with amblyopia. Research participants will be asked to play video games with the amblyopic
      eye for a period of time. A range of visual functions will be monitored during the course of
      treatment.
    

Intervention name(s): Perceptual learning; Video Game; Crossover (Occlusion therapy + Video Game)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Research participants will be asked to practice a visual discrimination task (e.g. position acuity, contrast sensitivity, stereoacuity etc) in our laboratory for a period of time (2 hrs/day, 5 days/week).; Research participants will be asked to play "off-the-shelf" video games in our laboratory for a period of time (2 hrs/day, 5 days/week).; Phase 1. Research participants will be required to cover the good eye during the day in order to push the brain to use the amblyopic eye (2 hrs/day, 5 days/week for 2-4 weeks).
Phase 2. Research participants will be required to cover the good eye during the day in order to push the brain to use the amblyopic eye (2 hrs/day, 5 days/week for 2-4 weeks).
Other intervention name(s): vision therapy; vision training; vision therapy; vision training; vision therapy; vision training
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: amblyopia treatment; neural plasticity; perceptual learning; vision therapy; spatial vision; video games; occlusion therapy