bioihbjkbjnl/mcl2 huggingface dataset:
Contact Lens Comfort Relative to Meibomian Gland Status
Condition: Meibomian Gland Dysfunction
MeSH terms: Meibomian Gland Dysfunction
Study type: Interventional

Summary: 
      This trial aims to establish a correlation between patient reported comfort while using soft
      contact lenses and meibomian gland dysfunction (MGD).
    


Intervention name(s): senofilcon A
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Achieving Energy Balance in Post Partum Teens
Condition: Obesity
Study type: Interventional

Summary: 
      This proposal will test Balance Adolescent Lifestyle Activities and Nutrition Choices for
      Energy (BALANCE), a multilevel intervention administered through Parents as Teachers (PAT)
      and designed to reduce overweight in postpartum teens. The intervention will focus on the
      replacement of 'obesogenic' patterns (such as high soda intake, excess portion size, and
      sedentary activity) with 'energy' patterns (such as water consumption, appropriate portion
      size, and walking).
    


Intervention name(s): BALANCE
Intervention type(s): Behavioral
Intervention description(s): The intervention will focus on the replacement of 'obesogenic' patterns (such as high soda intake, excess portion size, and sedentary activity) with 'energy' patterns (such as water consumption, appropriate portion size, and walking).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Intra-arterial Chemotherapy for the Treatment of Progressive Diffuse Intrinsic Pontine Gliomas (DIPG).
Condition: Diffuse Intrinsic Pontine Glioma (DIPG)
MeSH terms: Glioma; Diffuse Intrinsic Pontine Glioma
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this pilot study is to determine if intra-arterial (IA) chemotherapy is safe in
      the treatment of progressive diffuse intrinsic pontine gliomas (DIPG). IA administration of
      the chemotherapeutic agent enhances the regional distribution of the drug, thereby increasing
      the local delivered dose while minimizing systemic toxicity. It also provides a treatment
      option for these patients at the time of tumor recurrence.
    

Detailed description: 
      Delivering the chemotherapeutic agent directly to the tumor via the arterial system avoids
      the complications and adverse events associated with toxicity from systemic chemotherapy.
    

Intervention name(s): Melphalan hydrochloride
Intervention type(s): Drug
Intervention description(s): Drug administered intra-arterially (injection in the artery).
Standard dose: Cycle 1: 1 mg, intra-arterial (IA) delivery. Cycle 2: 2 mg, intra-arterial (IA) delivery.
Duration of treatment: Eight weeks total - two cycles of IA chemotherapy, separated by four weeks.
Other intervention name(s): Alkeran
Intervention MeSH terms: Melphalan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: diffuse intrinsic pontine glioma (DIPG); intra-arterial chemotherapy; angiography
A Study of LY3549492 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of LY3549492 in
      healthy participants. The blood tests will be performed to check how much LY3549492 gets into
      the bloodstream and how the body handles LY3549492. This study includes two parts and will
      last up to approximately 76 days for each participant, including screening.
    


Intervention name(s): LY3549492; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      -To test the hypothesis that higher initial dose of basal insulin (0.3 U/kg) is non inferior
      to standard initial dose (0.2 U/kg) based on the percentage of patients with at least one
      episode of hypoglycemia (≤3.9 mmol/L or severe) during the 16 weeks of treatment in
      overweight and obese type 2 diabetic patients uncontrolled with oral anti-diabetes drugs
      (OADs).

      Secondary Objective:

        -  To evaluate the percentage of patients achieving glycated hemoglobin (HbA1c) <7%.

        -  To evaluate the percentage and accumulated percentage of patients achieving fasting
           plasma glucose (FPG) target (<5.6, <6.1, and <7.0 mmol/L).

        -  To assess the changes in HbA1c, FPG, and postprandial glucose (PPG).

        -  To evaluate the insulin doses change.

        -  To evaluate the weight change.

        -  To evaluate overall hypoglycemia, nocturnal hypoglycemia and severe hypoglycemia
           occurrence.

        -  To descriptively evaluate the safety profile.

        -  To assess patient and physician satisfaction and adherence (drop-out rate and the
           percentage of patients who can follow the treatment and insulin titration).

        -  Subgroup analysis on efficacy (control rate, control rate without confirmed
           hypoglycemia, and changes in HbA1c, FPG and PPG) and safety data according to:

        -  Age

        -  Duration of diabetes

        -  Baseline treatment (OAD)

        -  Baseline HbA1c, FPG and PP
    

Detailed description: 
      The duration of study for each patient is approximately 20 weeks from screening visit to
      end-of-study follow-up phone call.
    

Intervention name(s): INSULIN GLARGINE; metformin; acarbose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: solution
Route of administration: subcutaneous injection; Pharmaceutical form: table or capsule
Route of administration: oral administration; Pharmaceutical form: table or capsule
Route of administration: oral administration
Other intervention name(s): HOE901
Intervention MeSH terms: Metformin; Insulin Glargine; Acarbose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Open-label, Non Significant Risk, Adhesive Wear Validation Study for the On Body Drug Delivery Device Component of the SQIN-01 Furosemide Infusor (Infusor Device)
Condition: Healthy Volunteer Study
Study type: Interventional

Summary: 
      The purpose of the present study is to test the adequacy, performance and skin reactivity of
      the adhesive tape to be utilized in the to-be-marketed Device.

      The present study will examine adhesive hold performance, re-use protection (i.e. adhesive
      re-application) and skin reactivity/tolerability of the proposed commercial adhesive tape
      (i.e. within the Test Infusor Device; TID). As the purpose of the study is to assess adhesive
      performance which does not require activation of the device. Hence in this study no canula
      will be deployed (no skin penetration) and no delivery of the drug or other fluids.
    

Detailed description: 
      An open-label, non significant risk, adhesive wear validation study with 60 adult subjects.

      Group A (30 subjects): Wearing of the Infusor for 5-9hrs followed by assessment and
      subsequent removal of the Infusor by study staff with photographic recording prior to and
      after removal.

      Group B (30 subjects): Wearing of the Infusor for 5-9hrs followed by assessment and
      photographic recording of the Infusor by study staff after which the subject will return home
      and removal of the Infusor by subject or caregiver approximately 12hrs after placement (±
      1hr), when another photograph will be taken. The subject must return the device to the site
      and transfer the photograph in accordance with the instructions.

      Until enrollment for Group B is complete, study candidates will be asked if prefer group A or
      B. Additional inclusion criteria apply for participation in group B.

      Consent, screening and enrollment may be performed on the same day (Day 1) Screening must be
      performed within 7 days of the Wear phase.

      Following signing of the ICF (A or B) each subject will complete Screening activities
      (height, weight, brief medical history). If the subject meets all inclusion criteria an none
      of the exclusion criteria the subject may enroll.

      The Wear Phase consists of one (1) wear period of five to twelve (5-12) hours.
    

Intervention name(s): 3M 1529 Adhesive Tape
Intervention type(s): Other
Intervention description(s): 5-12 hour adhesive wear
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adhesive; Attachment duarability; Assess possible skin reactions; Erythema; Edema
Optimized Peak VO2 in Predicting Advanced HF
Condition: Heart Failure; Morality; Transplant; Failure, Heart
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The ability and timely selection of severe heart failure (HF) patients for cardiac
      transplantation and advanced HF therapy is challenging. Peak VO2 by cardiopulmonary exercise
      test (CPET) was used for transplant listing. This study aimed to reassess the prognostic
      significance of peak VO2 and to compare that with the Heart Failure Survival Score in the
      current optimized novel guideline-directed medical therapy (GDMT).
    

Detailed description: 
      Investigators retrospectively collected acute HF patients discharged alive from the hospital.
      Investigators divided participants into more-GDMT (≥2 kinds) and few-GDMT (<2 kinds) groups
      and compared the prognostic significance of peak VO2 and HFSS for combined all-cause
      mortality and urgent cardiac transplantation.
    

Intervention name(s): cardiopulmonary exercise test
Intervention type(s): Diagnostic Test
Intervention description(s): CPET was performed in this HF cohort within one month after being discharged and interpreted as previously described. Patients underwent an upright graded cycle ergometer exercise using a personalized ramp protocol or a motorized treadmill using a modified Bruce or Cornell protocol. Peak VO2 data measured by cycle ergometer were increased by 10% to allow a comparison between the two different procedures. Peak VO2 was defined as the highest 30-second average value obtained during exercise. Submaximal CPET variables such as ventilatory efficiency were calculated by the slope of VE versus VCO2 below the ventilatory compensatory point (VCP). If the slope of VE/VCO2 can't be calculated, we used the nadir of VE/VCO2, or the ratio of VE/VCO2 at the anaerobic threshold (AT) as the variable of ventilatory efficiency. The AT was determined by the V-slope method.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Investigators retrospectively collected acute HF patients discharged alive from the
        hospital. Investigators divided participants into more-GDMT (>= 2 kinds) and few-GDMT (<2
        kinds) groups and compared the prognostic significance of peak VO2 and Heart Failure
        Survival Score for combined all-cause mortality and urgent cardiac transplantation.
      
Keywords: advance heart failure; cardiac transplantation; Peak oxygen consumption; Guideline-directed medical therapy; Risk score; Heart Failure Survival Score
Luminex-based Assay to Identify Major IgE-binding Episode Among IgE-mediated Wheat-allergic Patient
Condition: Wheat Allergy
MeSH terms: Wheat Hypersensitivity
Study type: Observational

Summary: 
      This study will be using Luminex-based peptide assay (LPA) to determine major IgE-binding
      epitope among wheat allergic children to differentiate clinical phenotype.
    

Detailed description: 
      Luminex-based peptide assay (LPA) is a novel tool using machine learning techniques,
      developed to predict different degrees of food allergy has been successfully reported among
      cow's milk protein allergy. This technique provide a more precise and advanced adaptation
      from microarray-based immunoassay (MIA). Using this technique will aid us for the
      differentiation of clinical phenotypes of wheat-allergic patients. This study will be the
      first study to date using this technique aim to determine major IgE-binding epitope among
      immediated-reaction of wheat allergic children to differentiate clinical phenotypes, and may
      lead to further study to develop the new therapeutic approach to wheat-allergic patients.
    

Intervention name(s): Blood drawing
Intervention type(s): Procedure
Intervention description(s): Blood drawn will be done once using 15 mL of blood volume (Serum or plasma samples will be collected during the routine follow up of level of sIgE to wheat or during the oral food challenge test which intravenous insertion routinely prepared in case of the emergency reaction occurred). The specimen will be transferred to the Icahn School of Medicine at Mount Sinai, New York, USA for Laboratory processing (Luminex-based peptide assay)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients between the aged of 1-18 years with confirmed IgE-mediated wheat allergy will be
        enrolled
      
Biospecimen description: 
      Blood serum or plasma (Blood drawn will be done using 15 cc of blood volume)
    
Keywords: Major allergen
The InsuPad in Daily Life Study - Effect of Local Heating on Postprandial Glucose Excursions Using the InsuPad Device
Condition: Type 1 Diabetes Mellitus With Diabetic Neuralgia
MeSH terms: Neuralgia; Diabetic Neuropathies; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomised, controlled, cross-over study with inpatient and outpatient phases. The
      inpatient phase length will be two days, which include a "Control" day without activating the
      InSuPad and a "Test" day where the InsuPad is activated. The outpatient phase length is 8
      weeks: 4 weeks without the device-"Control", and 4 weeks with the device-"Test".
    

Detailed description: 
      A randomised, controlled, cross-over study with inpatient and outpatient phases. The
      inpatient phase length will be two days, which include a "Control" day without activating the
      InSuPad and a "Test" day where the InsuPad is activated. The outpatient phase length is 8
      weeks: 4 weeks without the device-"Control", and 4 weeks with the device-"Test". Each subject
      will be randomly selected into one of two groups, group "A" and group "B". Forty (40) type I
      subjects who are meeting the inclusion/exclusion criteria as outlined below and who provide
      written Informed Consent will be enrolled in the study.

      During the inpatient phase subjects will have standardized breakfast and dinner and venous
      blood samples will be taken for insulin and blood glucose measurements. Comparison of the two
      days ("control" and "test") will enable us to evaluate the effect of the device on post
      prandial glucose levels and insulin levels.

      During the outpatient (daily life) phase subjects will be required to perform at least 5 self
      blood glucose measurements (SMBG), three before each meal and two at 90 minutes post
      breakfast and dinner. Comparing the SMBG measurement from the two periods will enable us to
      evaluate the effect of the device on post prandial glucose levels. The subjects will be
      contacted over the phone by the study staff to verify compliance with the protocol.
    

Intervention name(s): InsuPad
Intervention type(s): Device
Intervention description(s): Heating pad
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: insulin injection
Copeptin in Outcome Prediction of an Acute Psychotic Episode
Condition: Acute Psychotic Episode; Schizophrenia Spectrum and Other Psychotic Disorders; Affective Disorder; Bipolar Disorder
MeSH terms: Diabetes Insipidus; Schizophrenia; Bipolar Disorder; Mental Disorders; Psychotic Disorders; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
Study type: Observational

Summary: 
      An acute psychotic episode is a severe psychiatric syndrome which might occur in different
      psychiatric diagnoses.

      The outcome prediction of relapse rate of a psychotic episode within a certain time frame is
      difficult and depends on many factors. More and better predictors are required to improve the
      outcome prediction in order to adjust therapy and follow-up if patients suffer from this
      acute disease.

      Copeptin, a surrogate marker for vasopressin, has been proven helpful in the prediction of
      the outcome in serious somatic diseases. Additionally, a rise of copeptin due to
      psychological stress was shown.

      The aim of this study is to investigate the association of the neuroendocrine biomarker
      copeptin and the prediction of the onset of psychotic episode within one year.
    

Detailed description: 
      An acute psychotic episode is a severe psychiatric syndrome characterised by symptoms like
      delusions, hallucinations, and perceptual disturbances. A psychotic episode might occur in
      different psychiatric diagnoses, such as schizophrenia spectrum disorders and affective
      disorders (depression and bipolar).

      The outcome prediction of relapse rate of a psychotic episode within a certain time frame is
      difficult and depends on many factors. More and better predictors are required to improve the
      outcome prediction in order to adjust therapy and follow-up if patients suffer from this
      acute disease.

      Copeptin, a surrogate marker for vasopressin, has been proven helpful in the prediction of
      the outcome in serious somatic diseases such as stroke, myocardial infarction, and pneumonia.
      Additionally, a rise of copeptin due to psychological stress was shown.

      Some studies have shown an increase in vasopressin levels during acute psychosis, no study
      has been performed using copeptin.

      The aim of this study is to investigate the association of the neuroendocrine biomarker
      copeptin and the prediction of the onset of psychotic episode within one year.
    

Intervention name(s): Observation only
Intervention type(s): Other
Intervention description(s): Observation only
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are hospitalized with an acute psychotic episode within schizophrenia spectrum
        disorder, affective disorder and bipolar disorder.
      
Biospecimen description: 
      Copeptin, Cortisol, Serum Sodium, Urinary sodium and urinary osmolality in case
    
Keywords: Copeptin; Outcome prediction
The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients
Condition: Candidiasis, Oral; HIV Infections
MeSH terms: Infections; Candidiasis; Candidiasis, Oral
Study type: Interventional

Summary: 
      To evaluate the safety and effectiveness of Peridex (an oral rinse containing chlorhexidine
      gluconate) for preventing the occurrence of clinically-evident microbiologically-documented
      oral candidiasis in HIV-positive patients, who are at risk of the disease based on previous
      history of candidiasis.
    


Intervention name(s): Chlorhexidine gluconate
Intervention type(s): Drug
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Primary purpose: Treatment
Keywords: AIDS-Related Opportunistic Infections; chlorhexidine gluconate; Acquired Immunodeficiency Syndrome; Anti-Infective Agents, Local; AIDS-Related Complex; Candidiasis, Oral
Effects of Age and Obesity on Brain Insulin Sensitivity
Condition: Insulin Resistance; Obesity
MeSH terms: Obesity; Insulin Resistance
Study type: Interventional

Summary: 
      Obesity and especially type 2 diabetes (T2D) increases the risk of neurocognitive
      dysfunctions including adverse effects on brain structure and function. Recent evidence from
      clinical studies have shown that T2D almost doubles the risk for dementia. As the population
      gets older, age-related chronic diseases, as T2D, become more prevalent. Scientific evidence
      is emerging that there are several links between metabolic and neurocognitive functions.
      Impaired insulin action (i.e. insulin resistance), the main hallmark of T2D, has been
      suggested as a likely shared common pathophysiological mechanism. However, the neural
      processes that determine how insulin resistance is are connected to the onset and progression
      of T2D and dementia remain unclear. In this context, the overall aim is to study brain
      insulin resistance to disentangle age-related and obesity related brain insulin resistance in
      healthy normal and overweight/obese persons at the age of 20 to 70 years . To this end, the
      investigators will assess brain insulin action using intranasal insulin/placebo during
      functional Magnetic Resonance Imaging (fMRI). Additionally, structural changes and cognitive
      processes will be assessed as secondary variables.
    


Intervention name(s): Human nasal insulin; Placebo
Intervention type(s): Other; Other
Intervention description(s): single dose of 160 U of human insulin as nasal spray; Single dose of placebo solution as nasal spray
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science