bioihbjkbjnl/mcl2 huggingface dataset:
Immune-Related Trafficking and Signaling in Human Skin Associated With Low-Power, Infrared Laser Treatment
Condition: Vaccine Response Impaired
Study type: Interventional

Summary: 
      The purpose of this is that the researcher can use low power Near Infrared laser treatment
      non-painful and non-damaging dose to changes the skin properties.The researcher can prove
      that signaling and a significant increase in the number of skin cells in skin tissue exposed
      to the laser can improve the human skin immune system to help improve human body response to
      vaccines.
    

Detailed description: 
      The researcher can use low power laser light one-minute exposures delivered to the skin at
      non-painful and non-damaging dose. The resulted in significant immunologic changes in the
      skin that included up-regulation of specific skin tissue and skin genes and the activation
      and mobilization of specific skin cells.

      In the first part of the study, the researcher will make a determination of the laser
      irradiance that will be tolerated. The highest irradiance the subject tolerates for 1 minute
      will be identified as that subject's maximum tolerable irradiance. After all subjects are
      tested, researcher will select the highest irradiance that was tolerated and use this in the
      second phase of the study.

      Approximately 24 hours after the first test exposures, each subject will receive a one minute
      laser treatment at the maximum tolerable irradiance. Four hours later, two skin biopsies will
      be collected from laser treated site a untreated.

      One tissue sample will be test at UC Irvine Dept. of Dermatopathology to evaluate microscopic
      skin changes, one skin sample will be delivered to Massachusetts General Hospital to evaluate
      RNA and protein expression.
    

Intervention name(s): low power laser
Intervention type(s): Other
Intervention description(s): Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Tacrolimus Blood Levels After Topical Application of Tacrolimus on Healthy Skin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I trial to evaluate tacrolimus blood levels after topical application of
      tacrolimus twice daily on healthy skin.
    

Detailed description: 
      The purpose of this trial is to assess the safety of a topical formulation of tacrolimus.

      Tacrolimus is commonly used in T-cell medicated diseases. It is expected that 24 subjects
      will be enrolled in the trial and will be assigned to receive topical application of
      tacrolimus twice daily for 14 days.
    

Intervention name(s): topical formulation of tacrolimus
Intervention type(s): Drug
Intervention description(s): Topical application of tacrolimus twice daily for 14 days (one dose on Day 14).
Intervention MeSH terms: Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: open-label; multiple-dose; non-randomised; non-comparative
Short-Term Intensive Insulin Therapy Induction of Long-term Glycemic Control
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      We designed this prospective, randomized control study to compare the benefits between the
      insulin therapy and OADs after correction of the glucose toxicity with a short period of
      intensive insulin therapy.
    

Detailed description: 
      OBJECTIVE-Type 2 diabetes is associated with defects in insulin secretion and insulin action.
      Hyperglycemia may aggravate these defects, a feature known as glucose toxicity. Previous
      studies have shown that acute correction of hyperglycemia in subjects with long-standing type
      2 diabetes gives only short-term improvement in glycemic control after discontinuation of
      insulin. The current study attempts to identify any characteristics of patients with newly
      diagnosed type 2 diabetes (fasting glucose >300mg/dL) who would have a long-term benefit, in
      terms of glycemic control, from a brief course of insulin therapy.

      RESEARCH DESIGN AND METHODS-Newly diagnosed type 2 diabetic patients with severe
      hyperglycemia (fasting blood glucose >300 mg/dL or random blood glucose >400 mg/dL) will be
      hospitalized and treated with intensive insulin injection for 10 to 14 days. Oral glucose
      tolerance will be performed after one week of intensive insulin treatment. After discharge,
      patients will be randomized to receive insulin injection or oral anti-diabetic drug for
      further management. Patients will be followed in our clinics and adjust their medication
      according to their blood glucose levels. Oral glucose tolerance test will be repeated 6
      months later, whereas the insulin sensitivity and beta-cell function will be evaluated again.

      EXPECTED RESULTS-We will respect that short-term intensive insulin therapy can induce
      lone-term glycemic control in newly diagnosed type 2 diabetes with severe hyperglycemia.
    

Intervention name(s): Insulin; OAD
Intervention type(s): Drug; Drug
Intervention description(s): Gliclazide-MR, Metformin, Glimepiride
Other intervention name(s): Insulatard, Actrapid, Lantus, monotard; Diamicron-MR, Glucophage, Amaryl
Intervention MeSH terms: Gliclazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes; oral glucose tolerance test; insulin; oral anti-diabetic drug; ß-cell function
Fructose Consumption and Metabolic Dysregulation
Condition: Central Obesity; Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia; Obesity, Abdominal
Study type: Interventional

Summary: 
      High fructose intake is increasingly recognized as causative in development of prediabetes,
      metabolic syndrome and cardiovascular disease (CVD). The mechanisms underlying
      fructose-induced metabolic disturbances are unclear but are beginning to be unraveled. In
      contrast to metabolism of glucose, the breakdown of fructose leads to the generation of
      metabolites that stimulate hepatic de novo lipogenesis (DNL) and increased levels of both
      fasting and postprandial triglycerides. The key lipogenic transcription factor seems to be
      activated by fructose independently of insulin. However, it is still controversial whether
      fructose consumption increases DNL in man to the extent that it induces metabolic
      disturbances. Animal studies have shown that also the adipose tissue is responsive to
      fructose feeding fructose, and that high fructose-feeding induces insulin resistance and
      inflammation in the adipose tissue. The role of intestinal insulin resistance in
      fructose-induced dysmetabolism has not been studied in detail. The critical question is
      whether the metabolic disturbances are induced by calorie excess or by fructose per se.
    

Detailed description: 
      Detailed description: Study subjects will participate to studies 1-4 before and 3 m after
      fructose diet:

        1. An oral fat load or a kinetic study with stable isotopes combined with an oral fat load.

        2. Determination of liver, subcutaneous and intra-abdominal fat. (Proton magnetic resonance
           spectroscopy )

        3. Lipolytic enzymes, advanced lipid analysis, fat biopsies and genetic studies and gut
           microbiota profiling

        4. Oral glucose tolerance test and analysis of incretins and inflammatory biomarkers.
    

Intervention name(s): Fructose
Intervention type(s): Dietary Supplement
Intervention description(s): 3 month fructose diet 75 g/day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: fructose; hypertriglyceridemia; postprandial lipids; de novo lipogenesis; stable isotopes
Safety and Efficacy of MP-424 to Treat Chronic Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety after administration of MP-424
      to patients with chronic hepatitis C.
    


Intervention name(s): MP-424 (Telaprevir)
Intervention type(s): Drug
Intervention description(s): Three tablets of MP-424 250mg tablet at a time, every 8 hours, 24 weeks administration (dose in a day: 2250 mg)
Other intervention name(s): Telaprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis C; Protease Inhibitor
Inspiratory Muscle Strength Training and Incentive Spirometer on Postmenopausal Asthmatic Women
Condition: Asthmatic; Postmenopausal Symptoms
MeSH terms: Respiratory Aspiration; Asthma
Study type: Interventional

Summary: 
      Objective: To compare the effectiveness of inspiratory muscle training (IMT) and incentive
      spirometer on ventilatory functions in post-menopausal asthmatic women. Participants and
      methods: A total of forty postmenopausal women suffering from asthma, their ages ranged from
      50 to 60 years old, and their body mass index of the patient don't exceed 30kg/m2. They were
      recruited from patient chest clinic in Kasr -El- Ainy Teaching Hospital, Cairo University,
      Egypt.
    

Detailed description: 
      They signed a consent form, confidentiality was assured. They assigned into two groups (A)
      who received inspiratory muscle training in the form of: Inspiratory threshold muscle trainer
      in addition to traditional chest physical therapy intervention (Deep breath, cough training)
      while patients in group (B): received traditional chest physical therapy intervention and
      incentive spirometer, three sessions per week for six weeks. Patients in both groups were
      assessed before treatment (pre-training) then after treatment (post-training) (after 6 weeks)
      to measure lung functions using electronic spirometer. The training program was carried in
      the duration from January 2019 to July 2019.
    

Intervention name(s): incentive spirometer; Inspiratory muscle trainer device
Intervention type(s): Device; Other
Intervention description(s): Patient had to produce a high inspiratory pressure. The ball serves as visible feedback of the inspiratory flow and indicates the obtained flow on a calibrated scale on the transparent cylinder of the spirometer. If the patient flows greater than 300 milliliters per second, the float ball in first chamber will rise. As patient flow increases to 600 milliliters per second the second ball float will rise. If the patient flow exceeds 900 milliliters per second all three will be suspended. Patient should encourage holding the balls up for a few seconds; The threshold trainer is a small plastic handheld device supplied by respironics. It includes a mouthpiece and a calibrated spring loaded valve. The valve controls a constant inspiratory pressure training load and the patient must generate the inspiratory pressure in order for the inspiratory valve to be opened and allow inhalation of air.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: inspiratory muscle training in the form of: Inspiratory threshold muscle trainer in addition to traditional chest physical therapy intervention (Deep breath, cough training)
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inspiratory; Spirometer; Postmenopausal; asthma
Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Cat Allergic Subjects With Asthma
Condition: Allergic Asthma; Allergy; Allergy to Cats
MeSH terms: Asthma; Hypersensitivity
Study type: Interventional

Summary: 
      This is a randomized, double blind, cross-over study designed to determine the concentration
      of airborne cat allergen inducing bronchial response in asthmatic subjects allergic to cat,
      during allergen exposures in the Alyatec environmental exposure chamber (EEC).

      The study was also designed to validate the specificity of the asthmatic reaction induced by
      exposure to airborne cat allergen in Alyatec EEC.
    


Intervention name(s): Exposure to Placebo; Exposure to dose A and dose B of cat allergen; Exposure to a single dose of cat allergen
Intervention type(s): Other; Other; Other
Intervention description(s): Patients are exposed to placebo in the EEC; Patients are exposed to dose A and B for successive exposures in the EEC; Patients are exposed to a single dose of cat allergen in the EEC according to the dose selected to achieve the main objective (dose A or B)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double blind, cross-over study including two study groups
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Cat allergy; Allergic rhinitis; Allergy
The Extreme Significance of Bilateral Embolic Retinal Phenomena That Can be Life Saving
Condition: Life Threatening Diseases; Embolic Shower
Study type: Observational

Summary: 
      This study shows how careful ophthalmic examination of two patients showed signs of
      simultaneous bilateral retinal emboli. Starting from this point significant, life
      threatening, underlying reasons were found and treated.
    

Detailed description: 
      Two patients were found to have signs of simultaneous bilateral retinal emboli. One patient
      was asymptomatic and routine ophthalmic examination showed bilateral retinal hemorrhages and
      exudates close to both optic discs. This patient was on anti-coagulant treatment for atrial
      fibrillation. The finding of bilateral signs of retinal emboli necessitated immediate blood
      tests and dose adjustments of her medication.

      The second case did not have general symptoms other than mild evening chills and her eye
      examination again was the start point of intensive investigation to find the reason of her
      bilateral retinal emboli. Ultrasound studies revealed a life threatening reason that was
      urgently treated.
    

Intervention name(s): imaging
Intervention type(s): Diagnostic Test
Intervention description(s): imaging before and after treatment
Other intervention name(s): color fundus photos
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        any patient in which signs of bilateral retinal emboli are seen and documented (imaged).
Immunogenicity Study of the Influenza Vaccine in Adults
Condition: Orthomyxoviridae Infections; Influenza
MeSH terms: Infections; Influenza, Human; Orthomyxoviridae Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      All marketed influenza vaccines are injected by the intramuscular (IM) route. This study will
      test whether an influenza vaccine is effective when injected by a route other than into the
      muscle. In order to prove this, the amount of antibodies in the blood will be measured before
      and after vaccination. In addition, the safety of both influenza vaccines will be tested by
      evaluating all serious reactions occurring after vaccination. The vaccine injected in this
      study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip). In
      addition, the safety of both influenza vaccines administered by different routes will be
      tested by evaluating all adverse events and especially all serious reactions.

      Primary Objective: To demonstrate and compare the immune response of an influenza vaccine
      after a single dose when administered by different routes.

      Secondary Objectives: To describe the compliance of the immunogenicity of the vaccine with
      the European Medicine Agency (EMEA) after the first injection.
    


Intervention name(s): Inactivated, split-virion influenza vaccine; Inactivated, split-virion, influenza virus
Intervention type(s): Biological; Biological
Intervention description(s): 0.1 mL single annual dose; 0.5 mL single annual dose
Other intervention name(s): Vaxigrip®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Orthomyxoviruses; Inactivated; Split-virion influenza vaccine; adults; Myxovirus Infection; Orthomyxovirus Infection
Effect of Probiotics on Cardiometabolic Health
Condition: Cardiometabolic Risk Factors
Study type: Interventional

Summary: 
      Atherosclerosis is a major risk factor for cardiovascular diseases. Recently, dysbiosis of
      gut microbiota has been reported to play an important role in the pathogenesis of
      atherosclerosis. Animal studies have demonstrated that administration of probiotics help
      delay the progression of atherosclerosis through several mechanisms. This trial aims to
      examine its protective effect in humans.
    

Detailed description: 
      Atherosclerosis is a major risk factor for cardiovascular diseases. Recently, dysbiosis of
      gut microbiota has been reported to play an important role in the pathogenesis of
      atherosclerosis. Animal studies have demonstrated that administration of probiotics help
      delay the progression of atherosclerosis through several mechanisms such as reduction in
      endotoxemia, and enhanced production of short-chain fatty acids.

      However, whether administration of probiotics also has a protective effect in subjects with
      metabolic syndrome (MetS), who are at high risk for developing atherosclerosis, remain
      unknown.
    

Intervention name(s): Probiotics; Placebo control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): During the study period, subjects are instructed to take one capsule of probiotics daily for a total of 3 months. Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their habitual diet or exercise habits.; During the study period, subjects are instructed to take one capsule of placebo control daily for a total of 3 months. Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their habitual diet or exercise habits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to see if children and adolescents with poorly controlled type 1
      diabetes will benefit from using a continuous glucose monitor (CGM), a device that can be
      used to check blood sugars.
    

Detailed description: 
      Adolescents with type 1 diabetes, HbA1c ≥9% on insulin pumps were admitted to the clinical
      research center and a continuous glucose sensor was inserted. Sensor glucose (SG) values were
      compared to plasma glucose measured at least hourly using Yellow Springs Instrument's (YSI)
      glucose analyzer. SG rather than YSI was used for treatment decisions unless YSI was <70
      mg/dL or specific criteria indicating SG and YSI were very discordant were met.
    

Intervention name(s): Continuous Glucose Monitor (CGM)
Intervention type(s): Device
Intervention description(s): CGM during 24-hr CRC stay.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes; adolescents; poor control; CGM
Safety and Efficacy Study of Antiviral Local Application to Treat High Grade Cervical Intraepithelial Lesions (CIN2/3)
Condition: Uterine Cervical Neoplasia; Cervix Intraepithelial Neoplasia
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this phase-II study is to evaluate the efficacy and safety of an aqueous gel
      containing an antiviral, administered directly on cervix exhibiting high grade squamous or
      glandular intraepithelial lesion (CIN 2 and 3) in comparison with a placebo treatment.
    

Detailed description: 
      Human Papilloma Virus (HPV) infections induce cervical intraepithelial neoplasia (CIN) of
      cervix. To reduce incidence of invasive tumor associated with high grade CIN lesions, the
      standard treatment is the conisation of cervix (surgical act). A local treatment with
      antiviral would preserve the cervix of young subjects and reduce obstetrical morbidity
      induced by the conisation.

      This clinical study is aimed at:

        -  to evaluate the efficacy of a gel with antiviral directly applied on the cervix
           exhibiting high grade CIN lesions (CIN2/3): conisation is still indicated?

        -  to evaluate the safety and tolerance after local application.
    

Intervention name(s): C1
Intervention type(s): Drug
Intervention description(s): Local application of the experimental gel or placebo gel.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Trial of YYD701-2 for Treatment of Nasolabial Folds
Condition: Wrinkle Severity Rating Scale(WSRS) Grade 3 (Moderate) or 4 (Severe) of Nasolabial Folds
Study type: Interventional
Phase: Phase 3

Summary: 
      A multicenter, active-controlled, randomized, evaluator and subject blinded, split-face,
      comparative, non-inferiority, Medical device Clinical trial.

      This study is randomized, evaluator and subject blinded, split-face medical device Clinical
      trial. The Subjects are injected investigational device(YYD701-2 or Restylane Perlane
      Lidocaine) in right or left nasolabial folds.
    


Intervention name(s): YYD701-2; Restylane Perlane Lidocaine
Intervention type(s): Device; Device
Intervention description(s): HA Filler; HA Filler
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: The Subjects are injected investigational devide(YYD701-2 or Restylane Perlane Lidocaine) in right or left nasolabial folds
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effect of Conjugated Linoleic Acid on Body Fat in Overweight Children
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The prevalence of overweight children has increased dramatically over the last decade, and
      many overweight children will remain overweight as adults. Conjugated linoleic acid (CLA), a
      naturally occurring dietary fatty acid, has shown promising results in reducing body fat
      among adults, and we propose to test the efficacy of CLA supplementation on body fat
      accretion in 6 to 10 year old children who are overweight or at risk of overweight.
    


Intervention name(s): Conjugated linoleic acid
Intervention type(s): Dietary Supplement
Intervention description(s): 3 grams per day of 80% CLA in safflower oil (2.4 grams active CLA isomers in triglyceride form)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: conjugated linoleic acid, body fat, children, overweight