bioihbjkbjnl/mcl2 huggingface dataset:
Application of Monitoring and Intervention Technologies in Suboptimal Health Status
Condition: Suboptimal Health Status; Metabolic Abnormality
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      The purpose of this study is to use monitoring and intervention technologies in suboptimal
      health status in a general population in China and evaluate the effectiveness of these
      technologies in the improvement of suboptimal health status.
    

Detailed description: 
      The Suboptimal health status questionnaire (SHSQ-25) is used to evaluate the suboptimal
      health status. The SHSQ-25 includes 25 questions. The score of the SHSQ-25 is from 0 to 100.
      Suboptimal health status is defined as the SHSQ-25 score above than 35. The higher scores of
      the SHSQ-25 one gets, the more severity of suboptimal health status he/she has. All
      participants are asked to fill in the SHSQ-25 before and after the intervention. If the score
      decreases after the intervention, it means that the suboptimal health status has been
      improved.

      A monitoring device is used to monitor a person's blood pressure, blood glucose, oxygen
      saturation, body weight, and energy consumption by Bluetooth Wireless technology.
      Intervention technologies include a health information push technology and a field-effect
      meridian therapy instrument.
    

Intervention name(s): meridian therapy instrument; health information push technology; monitoring device
Intervention type(s): Device; Other; Device
Intervention description(s): The meridian therapy instrument are widely used to improve the physical and relieve fatigue and pain in many hospitals by the field-effect.; The health information push technology regularly send health information on the measurements of body weight control and the improvement of a healthy lifestyle.; The monitoring device is used to monitor a person's blood pressure, blood glucose, oxygen saturation, body weight, and energy consumption by Bluetooth Wireless technology.
Other intervention name(s): KangRu; Health Management System; BianQueFeiJiu
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Measuring Adherence in Subjects With Acne Vulgaris in a Clinic Population Subtitle: Topical Benzoyl Peroxide for Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to see how often benzoyl peroxide is applied for acne.
      Use of medication was monitored electronically.
    

Detailed description: 
      We give subjects topical benzoyl peroxide, a standard first line acne treatment, in a
      container that records when the container is opened and closed. Subjects will simply be asked
      to "return in six weeks to see how well benzoyl peroxide works for them." Subjects initially
      will not be told that they are participating in a formal study. When they return with their
      medication, we will seek their informed consent to participate in the study. Verbal consent
      will be obtained at the beginning of the study. There will be no written consent obtained
      until the end of the study. By doing this, subjects will not be aware that adherence is being
      measured. Subjects will not be aware that they are participating in a study. Only if they
      consent would we then collect the medication container and monitor and retrieve the adherence
      data. If they do not consent, we will not have collected any research data on them except
      baseline acne severity measures which may have been collected anyway as part of their clinic
      treatment.
    

Intervention name(s): Benzoyl Peroxide
Intervention type(s): Drug
Intervention description(s): Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks.
Other intervention name(s): Epiduo
Intervention MeSH terms: Benzoyl Peroxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intravenous Silibinin in Combination With Peg-interferon and Ribavirin in Nonresponders
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      By chance the investigators found that iv. silibinin has a potent antiviral effect against
      the hepatitis C virus. Based on the results of the dose finding study (published) te optima
      dosing schedule is explored.This study will be evaluate whether the highest active dose given
      for the optimal time combined with standard of care will result in a sustained virologic
      response (=cure of hepatitis C).
    

Detailed description: 
      Since the publication of the first data the optimal dosing schedule is investigated
    

Intervention name(s): Silibinin; Silibinin
Intervention type(s): Drug; Drug
Intervention description(s): comparison of different dosing schedule of Silibinin infusions (20 mg/kg/d infused over 2 hours) A: 3x5days B: 14 days C: 21 days D: 28 days
sequential the infusion duration will be shortened - 2 hours, then 1 hr and then 1/2 hr/infusion; 20 mg/kg Silibinin iv /d /21 days, antiviral combination therapy will be continued
Other intervention name(s): Silibinin infusions (20 mg/kg/d infused over 2 hours)given for 21 (either Monday -Friday or daily) or 28 days, continuation of antiviral combination therapy
Intervention MeSH terms: Silybin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: silibinin; chronic hepatitis C; peginterferon; ribavirin; nonresponders; efficacy of iv. silibinin; safety
Virtual Reality a Novel Screening and Treatment Aid in Attention Deficit Disorder
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Using a virtual reality program in screening and treatment of ADHD.
    

Detailed description: 
      Virtual Reality is a novel program designed to imitate a real classroom environment including
      various distractions. It includes a head monitor to track eye movements Children aged 10-20
      years with ADHD will use the program with and without methylphenidate(1 mg/kg). Their results
      will be compared to a control group.

      Parental consent will be obtained.
    

Intervention name(s): methylphenidate
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Virtual Reality; ADHD; Methylphenidate
Platelet Rich Fibrin Versus Melatonin Around Dental Implants
Condition: Patients With Missing Teeth
MeSH terms: Tooth Loss; Anodontia
Study type: Interventional
Phase: Phase 2

Summary: 
      Dental implant is a dental treatment that allow oral rehabilitation for partial and fully
      edentulous patients. Osteointegration is the factor that control success s or failure of
      dental implant that can be improved by addition of different adjunctive biological materials.
      Platelets Rich fibrin plays a significant role in tissue regeneration and wound healing.
      Melatonin is biological hormone that secreted from pineal gland and played an important role
      in human growth.
    


Intervention name(s): dental implants with melatonin gel
Intervention type(s): Biological
Intervention description(s): platelet rich fibrin membrane around dental implants
Other intervention name(s): dental implants with platelet rich fibrin
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Blood Pressure Monitor Clinical Test (Cuff Range: 22 cm-30 cm)
Condition: Blood Pressure
Study type: Observational

Summary: 
      The purpose of this study is to monitor the blood pressure level of the patient using a cuff
      ranged 22 cm-30 cm.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        People whose arm range is 22 cm-30 cm
Effects of Ginkgo (Gingko Biloba) on Retinal and Choroidal Ocular Tissue
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to understand the effect of Ginkgo Biloba oral supplements on
      retinal and choroidal ocular tissue.
    

Detailed description: 
      The study objectives are to:

      1. assess the changes from pre- to post- oral supplementation on retinal and choroidal
      thickness and blood flow, retinal oxygen saturation, ocular perfusion pressure, and retinal
      function
    

Intervention name(s): Gingko Biloba
Intervention type(s): Dietary Supplement
Intervention description(s): oral intake of Gingko Biloba, 240mg/day for 4 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Beef in an Optimal Lean Diet (BOLD) Effects on Cardiovascular Disease (CVD) Risk
Condition: Hypercholesterolemia; Hypertriglyceridemia
MeSH terms: Cardiovascular Diseases; Hypercholesterolemia; Hypertriglyceridemia
Study type: Interventional

Summary: 
      The study is designed to assess the effects of a heart-healthy diet that includes lean beef
      as the primary source of high quality protein on risk factors for cardiovascular disease.
    


Intervention name(s): BOLD+ Diet; BOLD diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Comparison of lean beef based, high protein diet to DASH diet and Average American diet on cardiovascular disease risk factors; Comparison of lean beef based diet to DASH diet and Average American diet on risk factors of cardiovascular disease
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: lean beef; cholesterol; lipids; diet intervention
Vascular Function and Biomarker Assessments in Healthy Volunteers and in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the vascular function and biomarkers in healthy
      volunteers and type 2 diabetic patients.
    

Detailed description: 
      The present interventional study will be performed in 3 groups of healthy volunteers of
      different ages and in type 2 diabetic patients without an investigational medicinal product
      administrated.
    

Intervention name(s): Other; Other
Intervention type(s): Drug; Drug
Intervention description(s): Healthy volunteers will be selected within 3 weeks before inclusion (Day 0). The investigations will be performed on 2 days (Day 1 (D1) and Day 2 (D2)): vascular endothelial function assessment and blood collection for biomarker investigation on Day 1 and Case Report Form (CFR) on Day 2.
Then, subjects will be discharged at the end of the last investigation day (Day 2).
All the participants have received two pharmacological agents (NIMP) :
Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function.
Adenosine : administered intravenously during MRI for the measurement of CFR.; Type 2 diabetic patients will be selected within 3 weeks before inclusion (Day 0).
The investigations will be performed on 2 days (Day 1 (D1) and Day 2 (D2)): vascular endothelial function assessment and blood collection for biomarker investigation on Day 1 and CFR on Day 2.
Then, subjects will be discharged at the end of the last investigation day (Day 2).
All the participants have received two pharmacological agents (NIMP):
Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function.
Adenosine : administered intravenously during MRI for the measurement of CFR.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Type 2 diabetes mellitus; Phase 1; Healthy volunteers; Clinical translational exploratory study; Target involvement; Exploratory biomarkers; Cardiovascular disease; Vascular function; Coronary flow reserve; Biopterins; Cutaneous blood flow
PGL2001 Proof of Concept Study in Symptomatic Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, multicentre, randomised, two-arm, parallel group ,double-blind, placebo
      controlled, study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics
      of the steroid sulfatase inhibitor PGL2001 with concomitant, continuous NETA administration
      for the treatment of pain symptoms suggestive of endometriosis. The target population will be
      women of reproductive age with symptoms suggestive of endometriosis.
    


Intervention name(s): PGL2001 + Primolut-Nor 5; Placebo + Primolut-Nor 5
Intervention type(s): Drug; Drug
Intervention description(s): PGL2001(estradiol sulfamate, E2MATE, ZK190628), Tablets, 1mg. 4 mg weekly for 4 weeks followed by 2mg weekly for 12 weeks.
Norethisterone acetate (NETA), Tablets, 5mg. Once daily for 16 weeks plus during follow-up.; Placebo, Tablets.4 tablets weekly for 4 weeks followed by 2 tablets weekly for 12 weeks.
Norethisterone acetate (NETA), Tablets, 5mg.Once daily for 16 weeks plus during follow-up.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Project Wellness Pilot Feasibility Randomized Controlled Trial
Condition: Diabetes, Gestational
MeSH terms: Diabetes, Gestational
Study type: Interventional

Summary: 
      This pilot feasibility randomized controlled trial will be conducted among women at risk for
      or diagnosed with gestational diabetes (GDM) at the University of Tennessee Medical Center
      Knoxville (UTMC). The trial will be called Project Wellness. It will compare a physical
      activity (behavior change) intervention (i.e., walking/stepping in place) versus a general
      wellness intervention (e.g., health education focusing on immunizations, contraceptive
      options following delivery, etc.) on physical activity levels, maternal glycemic profile in
      the third trimester, and infant size and anthropometric measurements soon after birth (i.e.,
      weight, length, circumference, skinfolds). It is hypothesized that the physical activity
      intervention will increase physical activity levels, and improve maternal glycemic profile
      and infant anthropometric measures at birth. It is also hypothesized that maternal glycemic
      profile in the third trimester will be associated with infant anthropometric measurements at
      birth.
    

Detailed description: 
      Participants will also be followed through 12 months postpartum: Maternal weight and
      device-based and self-reported measures of physical activity will be assessed at 3, 6, 9 and
      12 months postpartum, as well as the same infant size and anthropometric measurements
      assessed soon after delivery.
    

Intervention name(s): Physical Activity Intervention; Wellness Education
Intervention type(s): Behavioral; Other
Intervention description(s): Motivational interviewing techniques helped participants set reasonable, specific, and achievable individual goals at each session: a duration (i.e., minutes) and frequency (i.e., days of the week) of walking or stepping, and potentially, a step count (i.e., a proxy for intensity). Individual goals often differed from the program goal in an effort to meet the participants 'where they are'.; The following topics were addressed: postpartum contraception, maternal immunizations, infant immunizations, car seat safety and planning for your hospital stay, and safe sleep and skin to skin. No information on PA was provided to the control group (i.e., neither encouragement for PA nor instructions to limit PA).
Other intervention name(s): Step Up Program; Next Steps
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Exercise; Contraception; Vaccination
The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia
Condition: ESRD; Hyperkalemia; End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Hyperkalemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With
      Hyperkalemia (potassium greater than 5 milliequivalents per liter) is a non-randomized,
      crossover study. This is an open-label, pilot clinical trial with 3 sequential phases of (a)
      2 weeks of no intervention, (b) 12 weeks of Patiromer treatment, and (c) 6 weeks of no
      intervention. Treatment with Patiromer will be initiated at a dose of 8.4 grams, once daily
      and observed for a week, then uptitrated to 16.8 grams once daily. Eligible study subjects
      will collect stool samples and provide blood and urine samples.
    


Intervention name(s): Patiromer
Intervention type(s): Drug
Intervention description(s): Patiromer will be orally self-administered by participants.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: End Stage Renal Disease; ESRD; Hyperkalemia
Pilot Study to Assess the Efficacy and Safety of the Lubo Cervical Collar
Condition: Elective Surgical Procedure
Study type: Interventional
Phase: Phase 1

Summary: 
      The Lubo cervical collar is a device that simultaneously maintains cervical spine control and
      keeps an open airway in a non-invasive manner. The purpose of the device is to manage
      cervical spine control and airway protection in the trauma patient.
    

Detailed description: 
      Cervical spine stabilization is usually achieved by a semi-rigid collar. While these collars
      achieve the goal of supporting the cervical spine, they limit the possibilities for jaw
      thrust or other airway manipulations. Definitive airway protection usually must be achieved
      by orotracheal intubation. Thee Lubo collar is a device that simultaneously maintains
      cervical spine control and keeps an open airway in a non-invasive manner that is simple to
      operate. The objective of the study is to test the safety of the collar volunteers. The study
      is composed of two stages:1.healthy volunteers that will not undergo any intervention except
      testing the LCC.2. second group of patients scheduled to undergo an operation under general
      anesthesia with endotracheal intubation or laryngeal mask airway.
    

Intervention name(s): Lubo cervical collar
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Potentially Avoidable Hospitalisation in France
Condition: Heart Failure; COPD; Diabetes
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      Potentially Avoidable Hospitalizations (Pah) Are Studied As An Indirect Measure Of Access To
      Primary Care And Of The Interface Between Primary And Secondary Care. A Previous Work Unveils
      Considerable Geographic Variation In The Rate Of Pah In France And Suggest That Primary Care
      Organization Might Play A Role In This Variation. However, A Limitation Of This Work Lies In
      The Lack Of Data On Actual Primary Care Utilization.

      The Aim Of This Study Is To Analyze The Role Of Primary Care In The Variation Of Potentially
      Avoidable Hospitalizations At the Zip Code Level, In The French Region
      Languedoc-Roussillon-Midi-Pyrénées.

      The investigator will implement An Ecological Approach In Which The Geographic Variation In
      The Rate Of Pah Is Analyzed In The French Region Lrmp, Year 2014. Age- And Sex-Adjusted Rate
      Of Pah By Zip Codes (N=612) Is Modeled Using A Spatial Regression Model.
    


Intervention name(s): measure of access to primary care and of the Interface Between Primary ans Secondary Care
Intervention type(s): Other
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All patients with at least one hospital admission in the LRMP region in 2014.
      
Keywords: Avoidable hospitalizations; primary care; geographicvariation
The Effect of Simulated Obstructive Apnoea and Hypopnoea on Heart Rhythm in Patients With Paroxysmal Atrial Fibrillation
Condition: Patients With Paroxysmal Atrial Fibrillation
MeSH terms: Sleep Apnea, Obstructive; Atrial Fibrillation
Study type: Interventional

Summary: 
      In this randomised controlled cross-over study we will investigate whether intrathoracic
      pressure changes induced by simulated obstructive apnoea and hypopnoea trigger premature
      supraventricular and ventricular contractions as well as atrial fibrillation in patients with
      paroxysmal atrial fibrillation.
    


Intervention name(s): Mueller manoeuvre; Inspiratory threshold; Expiratory apnoea; Steady state normal breathing
Intervention type(s): Other; Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic