bioihbjkbjnl/mcl2 huggingface dataset:
Resveratrol in Patients With Non-alcoholic Fatty Liver Disease
Condition: Fatty Liver
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Non-alcoholic fatty liver disease (NAFLD) and fatty liver hepatitis (NASH) are very common in
      the Western world and strongly associated with obesity. No known effective treatment is
      known. From animal studies, it is known that the compound resveratrol perhaps has the
      potential to neutralize obesity-induced diseases. Resveratrol is already widely used as a
      food supplement though the precise effects are unknown. This project focuses on the effect of
      Resveratrol on fatty liver disease. The researchers plan to investigate the effects of
      Resveratrol or placebo treatment for 6 months on NAFLD/NASH in obese patients.
    

Detailed description: 
      Obesity is associated with non-alcoholic fatty liver disease (NAFLD) and steatohepatitis
      (NASH) and recently, low-grade inflammation has been hypothesized to be the causative link.
      From animal studies, it is known that the compound resveratrol (RES) has strong
      anti-inflammatory and antioxidant effects and perhaps the potential to neutralize
      obesity-induced diseases. RES is already widely used as a food supplement though the precise
      effects are unknown. This project focuses on the effect of RES on fatty liver disease. In a
      double-blind controlled clinical trial, the researchers investigate the effects of RES 500 mg
      or placebo treatment x 3 daily for 6 months on NAFLD/NASH in 48 obese patients in a
      double-blind, randomised, controlled clinical trial. The researchers hypothesize that RES
      improves the ALT levels and reduces liver fat and inflammation assessed by MR spectroscopy
      and histological evaluation.
    

Intervention name(s): Resveratrol; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Tablet Resveratrol 500 mg 3 times daily for 6 months; Tablet Placebo 3 times daily for 6 months
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; Resveratrol; Human study
A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-Resminostat
Condition: Cutaneous T Cell Lymphoma; Mycosis Fungoides; Sezary Syndrome
MeSH terms: Mycoses; Mycosis Fungoides; Sezary Syndrome; Lymphoma, T-Cell, Cutaneous
Study type: Interventional
Phase: Phase 1

Summary: 
      Resminostat is a potent, orally available inhibitor of Class I, IIb and IV histone
      deacetylases (HDACs), including a pronounced activity against HDAC6. Resminostat targets
      epigenetic changes observed in tumour cells and has the potential to provide significant
      benefit to patients with advanced malignancies by inhibiting tumour progression and
      metastasis or even inducing tumour regression.

      This will be a Phase 1, open-label, non-randomized, single dose study of the absorption,
      metabolism, excretion of [14C] resminostat following a single oral dose in healthy male
      participants.

      The purpose of this study is to determine the absorption, metabolism, and excretion (AME) of
      [14C] resminostat and to characterize and determine the metabolites present in plasma, urine,
      and, where possible, faeces in healthy male participants following a single oral
      administration. Knowledge of the metabolism and excretion of parent drug and its metabolites
      is useful for evaluating the Metabolites in Safety Testing requirements elucidated in the
      International Conference on Harmonisation (ICH) M3, and the likelihood of effects of renal or
      hepatic impairment on the disposition of resminostat, and the likelihood for drug-drug
      interactions with resminostat. The results from this study may guide future study designs
      using special populations or evaluating the potential for drug-drug interactions.
    


Intervention name(s): [14C]-resminostat
Intervention type(s): Drug
Intervention description(s): 1 single dose of 400 mg [14C]-resminostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Personalized Treatment for Refractory H Pylori Infection
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases
Study type: Interventional

Summary: 
      In this study, the investigators develop a personalized treatment according to culture-guided
      antibiotics plus high-dose proton-pump inhibitor and bismuth to treat refractory H pylori
      infection.
    

Detailed description: 
      They are categorized into three groups: (1) patients who have positive result of culture with
      equal to or more than three susceptible antibiotics are treated by non-bismuth quadruple
      therapy (rabeprazole 20 mg q.d.s. and three effective antibiotics), (2) patients who have
      positive result of culture with one or two susceptible antibiotics are treated by
      bismuth-containing therapy (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and
      all the effective antibiotics), and (3) patients who have negative result of culture or whose
      culture data are unavailable will be treated by (rabeprazole 20 mg q.d.s, amoxicillin 500 mg
      q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days.
    

Intervention name(s): rabeprazole+3 antibiotics; rabeprazole+bismuth+2 antibiotics; rabeprazole+amox+tetr+levo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): (rabeprazole 20 mg q.d.s. and three effective antibiotics) for 14 days.; (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics) for 14 days.; (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days.
Other intervention name(s): rabeprazole 20 mg; amoxicillin 1g; clarithromycin 500mg; metrondazole 250mg; tetracycline 500mg; levofloxacin 500mg; rabeprazole 20 mg; bismuth subcitrate 120 mg; amoxicillin 1g; clarithromycin 500mg; metrondazole 250mg; tetracycline 500mg; levofloxacin 500mg; rabeprazole 20 mg; bismuth subcitrate 120 mg; tetracycline 500mg; levofloxacin 500mg
Intervention MeSH terms: Anti-Bacterial Agents; Amoxicillin; Clarithromycin; Levofloxacin; Ofloxacin; Tetracycline; Antibiotics, Antitubercular; Bismuth tripotassium dicitrate; Rabeprazole; Bismuth
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; third-line therapy; antibiotic susceptibility; Eradication
Managing Dry Eye in Patients Using Glaucoma Drops
Condition: Dry Eye
MeSH terms: Glaucoma; Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      A single center randomized controlled trial on managing dry eye signs and symptoms in
      patients using anti-glaucoma eye drops.
    

Detailed description: 
      To compare the safety and efficacy of IPL therapy on drug-induced dry eye caused by long-term
      use of anti glaucoma drugs;
    

Intervention name(s): IPL
Intervention type(s): Device
Intervention description(s): Intense pulse light (IPL) therapy is used for the treatment of drug-related dry eye in glaucoma patients.
Other intervention name(s): Intense pulsed light
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, comparative pilot study
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glaucoma; IPL; Diquafosol; Drug-induced Dry Eye
Electrical Stimulation to Accelerate Wound Healing
Condition: Diabetes; Diabetic Foot Ulcer; Peripheral Neuropathy; Peripheral Arterial Disease
MeSH terms: Peripheral Nervous System Diseases; Diabetic Foot; Peripheral Arterial Disease; Peripheral Vascular Diseases; Foot Ulcer; Ulcer
Study type: Interventional

Summary: 
      A clinical study at the Baylor College of Medicine, Division of Vascular Surgery and
      Endovascular Therapy, is being proposed to test the efficacy of a novel electrical
      stimulation platform named the Tennant Biomodulator designed by AVAZZIA to accelerate wound
      healing, relieve pain and improve mobility in patients with diabetic foot ulcers.
    

Detailed description: 
      Electrical stimulation may offer a unique treatment option to heal complicated and
      recalcitrant wounds, improve flap and graft survival, and even reduce the likelihood of
      ulceration. Electrical stimulation has been suggested to reduce infection, improve cellular
      immunity, increase perfusion, relieve pain, improve plantar sensation, and accelerate wound
      healing.

      Electrical stimulation could have positive effect on not only increasing skin perfusion in
      patients with diabetes but also could improve mobility and balance via enhancing plantar
      sensation as demonstrated in our recent study. Thus, plantar stimulation not only may be
      beneficial to accelerate wound healing in diabetic foot ulcer (DFU) patients but also may
      assist to improve mobility and reduce the likelihood of recurrence of ulcers.

      This study is proposed to examine the effectiveness of an innovative portable electrical
      stimulation platform (Tennant Biomodulator by AVAZZIA) to accelerate wound healing in DFU
      patients. It is hypothesized that 1) electrical stimulation will have an immediate effect on
      increasing skin perfusion (immediate benefit) and 2) daily use of the Tennant Biomodulator
      for 4 consecutive weeks is effective to speed up wound healing, increase skin perfusion,
      reduce pain, and improve balance and mobility in DFU patients (long term benefit)
    

Intervention name(s): Electrical Stimulation - Active; Electrical Stimulation - Sham
Intervention type(s): Device; Device
Intervention description(s): Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.; Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: electrical stimulation; wound healing; skin perfusion; home based therapy; diabetic foot; Foot ulcer
Yoga, Mindfulness and Cognitive Psychotherapy as Treatment for Stress and Burnout
Condition: Stress, Psychological; Burnout, Professional; Anxiety; Depression
MeSH terms: Burnout, Professional; Depression; Burnout, Psychological; Stress, Psychological
Study type: Interventional

Summary: 
      The purpose of this study is to investigate if treatment with yoga or mindfulness has a more
      profound and longstanding effect on stress and burnout than treatment with cognitive
      psychotherapy alone.
    


Intervention name(s): Yoga; Mindfulness based cog psychotherapy; Cognitive psychotherapy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants in this intervention arm will practice yoga (physical postures, breathing exercises, and meditation) >= 5 times a week (twice in a supervised group and the rest on their own). Additionally, participants in this arm will practice various practical skills, such as how to plan a satisfactory day using their own definition of a satisfactory day. They will follow this schedule for 20 weeks.; Participants in this arm will attend a weekly group meeting to practice mindfulness based cognitive psychotherapy. They will also practice >= 4 time a week on their own. Additionally, participants in this arm will practice various practical skills, such as how to plan a satisfactory day using their own definition of a satisfactory day. Participants will follow this schedule for 20 weeks.; Participants in this arm will attend a weekly group meeting to practice cognitive psychotherapy. They will also practice >= 4 time a week on their own. Additionally, participants in this arm will practice various practical skills, such as how to plan a satisfactory day using their own definition of a satisfactory day. Participants will follow this schedule for 20 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stress; Burnout; Anxiety; Depression
Reliability of Dynamic Contour Tonometry (DCT)
Condition: Intraocular Pressure; Central Corneal Thickness
Study type: Interventional
Phase: Phase 4

Summary: 
      Study wants to test reliability Dynamic Contour Tonometry (DCT) in measuring intraocular
      pressure (IOP) and Ocular Pulse Amplitude (OPA). IOP values obtained with DCT will then be
      compared with IOP values obtained with Goldmann Applanation Tonometry (GAT), actually the
      gold standard technique.
    

Detailed description: 
      Healthy volunteers recruited among subjects who underwent a routine ophthalmologic evaluation
      or among students and workers both at our clinic, will undergo a series of 5 DCT to evaluate
      eventual differences among the measurements.

      A diurnal IOP curve performed though GAT, composed of 3 measurements (9am, noon, 4pm) will be
      taken 1 to 7 days before the DCT.

      At the end of the DCT measurements a last GAT will be taken to control eventual IOP changes
      versus previous GAT values obtained through the diurnal curve.

      After 3 weeks observers will contact patients to record eventual adverse events. If examiners
      consider it as necessary, a safety ophthalmological evaluation will then be performed.
    

Intervention name(s): DCT (PASCAL© Tonometer) IOP and OPA measurement
Intervention type(s): Device
Intervention description(s): Healthy volunteers recruited among subject that underwent a routine ophthalmologic evaluation or among both students and workers at our clinic, will undergo a series of 5 Dynamic contour tonometries to evaluate eventual differences among measurements.
Patients will be controlled for 30 days. A diurnal IOP curve performed though GAT, composed of 3 measurements (9am, noon, 4pm) will be taken 1 to 7 days before the DCT. At the end of the DCT measurements a last GAT will be taken to control eventual IOP changes versus previous GAT values obtained through the diurnal curve.
Other intervention name(s): Goldmann Applanation Tonometry (AT900© - Haag-Streit AG, Koeniz, Switzerland); Dynamic Contour Tonometry (PASCAL© Tonometer - Ziemer Ophthalmic Systems AG, Port, Switzerland); Ultrasound pachymeter (Pacline© - Optikon ind., Rome, Italy).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: IOP; Tonometry; Pascal; Goldmann; DCT; Dynamic Contour
RSA Study of Sirius Stem and Exceed Cup
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of the Sirius Cemented Stem
      used in conjunction with the Exceed ABT Cemented Acetabular Cup, either with E1 or Arcom
      polyethylene, and OptiPac/OptiVac bone cement mixing systems.
    

Detailed description: 
      This is a comparative, prospective randomized Radiostereometry (RSA) study, lead on 48
      patients in a single site.

      All 48 patients will be pooled in a single group for the evaluation of the primary criterion
      for evaluation, but randomized into four groups for the evaluation of the secondary criteria
      for evaluation

      The objectives of the study are to:

        1. Demonstrate a comparable migration pattern as is described in published literature on
           other double tapered polished cemented stems

        2. Measure wear pattern in the cup made of vitamin-E doped polyethylene or conventional
           Arcom polyethylene

      2)Demonstrate non-inferiority of Optipac vs. Optivac cement mixing systems on the stem side
      3)Evaluate the clinical outcome and survivorship of the implant
    

Intervention name(s): Optivac; Optipac; Arcom (Exceed cup); E1 (Exceed cup); Sirius stem
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): A vacuum mixing system for cement with mixing and collection under vacuum but open initial mixture of powder and monomer. Has been used since 1993 with excellent results; A vacuum mixing system for cement with mixing and collection under vacuum but with a pre-packed mixing system allowing for an all closed system minimizing exposure for monomer fumes. This is a relatively new mixing system; The Exceed cup is available in two type of advanced bearing polyethylene material: The first is the 'classic', long term proven ArCom, a conventional polyethylene; The Exceed cup is available in two type of advanced bearing polyethylene material: The new is a highly cross linked polyethylene with infusion of vitamin E1 to remove free radicals in order to reduce wear.; A polished tapered stem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Total Hip Replacement
Sun Protection Factor Assay (SPF Assay 105/2016)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987517
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z44-040)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide
Condition: Primary Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare intraocular pressure lowering effectiveness of a new fixed combination drug.
    

Detailed description: 
      This is a multicentric, double blind and prospective clinical study. We will include patients
      with confirmed diagnosis of primary open-angle glaucoma and/or ocular hypertension, with
      intraocular pressure (IOP) ranging between 21 and 31 mm Hg. Patients will be randomly divided
      into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2%
      dorzolamide in fixed combination (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the
      other one treated with 0.5% timolol-2% dorzolamide fixed combination (Cosopt®, MSD
      Laboratories, USA). Patients will receive 1 drop twice a day of either formulations and were
      examined at days 2, 7, 15, 30, 60, and 90 after initiation of treatment. The primary
      objective is to compare the efficacy of both formulations, estimated as a decrease in IOP. A
      Goldmann applanation tonometer will be used for IOP determination.
    

Intervention name(s): dorzolamide-timolol-brimonidine
Intervention type(s): Drug
Intervention description(s): Patients will be randomly divided into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2% dorzolamide in fixed combination (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with 0.5% timolol-2% dorzolamide fixed combination (Cosopt®, MSD Laboratories, USA). Patients will received 1 drop twice a day of either formulations.
Other intervention name(s): Krytantek Ofteno; Cosopt
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Dorzolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Open-angle glaucoma; Ocular hypertension; POAG; Treatment
Gait Parameters of Persons With Down Syndrome With and Without Orthotics Using GaitRite
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Observational

Summary: 
      This is a research study of persons with Down Syndrome between 2 and 80 years old who are
      independently walking. The purpose of this study is to see what effect orthotics have on how
      people with Down Syndrome walk.
    


Intervention name(s): custom orthotics
Intervention type(s): Procedure
Intervention description(s): Orthotics are fabricated uniquely for each patient and use molds or casts of their foot as the template. They are fabricated by a licensed orthotist. There is no device or brand name other than custom orthotics.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Persons with Down Syndrome followed in Down Syndrome clinic Persons with Down Syndrome
        recruited in the community
      
Keywords: Down Syndrome; Orthotics; Gait Analysis
The Effect of Selecting Treatment With Desmopressin or Alarm to Children With Enuresis Based on Home Recordings.
Condition: Enuresis, Nocturnal
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to investigate the importance of clinical characterization of
      children with monosymptomatic nocturnal enuresis (MNE) in order to improve treatment
      efficacy.

      The hypothesis is that clinical characterization by measurement of nocturnal urine production
      and maximal voided volumes in children with MNE and subsequent treatment tailoring improves
      the response to first-line treatment approach.
    

Detailed description: 
      This is a randomized, controlled study.

      This study will be performed at Aarhus University Hospital (Denmark), Ghent University
      Hospital (Belgium) and Hospital of Zhengzhou University (China) following the same protocol.

      According to the initial randomization, children will be allocated to treatment without
      (group A) or with (group B) prior clinical characterization based on home recordings.

      Group A: The children will be randomized to either an enuresis alarm or desmopressin without
      evaluating the home recordings.

      Group B: The home recordings will be evaluated and treatment will be based on the recordings.
      Desmopressin will be administered to the children with nocturnal polyuria and the conditional
      alarm to the children with reduced bladder capacity. Children with nocturnal polyuria and
      reduced bladder capacity will be treated with both desmopressin and conditional alarm.
      Children with neither nocturnal polyuria nor reduced bladder capacity will again be
      randomized to either desmopressin or alarm treatment.
    

Intervention name(s): Desmopressin; Conditional alarm
Intervention type(s): Drug; Device
Intervention description(s): The children will be treated with 120 microgram/day the first two weeks. If the child is not completely dry, the dose will be increased to 240 microgram/day the rest of the study period (maximum eight weeks of treatment).; Eight weeks of treatment.
Other intervention name(s): Minirin, melt
Intervention MeSH terms: Deamino Arginine Vasopressin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled study
Masking: Single (Participant)
Primary purpose: Treatment