bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study of Protein Profiling of the Human Epidermal Cells After Ultraviolet Irradiation
Condition: Proteomics
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The main focus of this pilot study is to construct a fairly complete protein profile of the
      epidermis. This will allow us to study how the epidermis responds to external stressors such
      as ultra-violet. We hypothesize that by using the cutting edge technology, proteomics, we
      will be able to construct a fairly complete profile of different epidermal cells
      (keratinocytes, epidermal nerve fibers (ENFs), melanocytes, Langerhans cell,...etc) of normal
      and ultraviolet (UV) irradiated skin.
    

Detailed description: 
      We will investigate the changes of the epidermal cell proteome after UV irradiation to the
      forearms of healthy young male volunteers. Knowledge of specific molecular markers may
      provide knowledge of basic biological systems and possibly targeted therapy of inflammation.

      By using combined proteomic methodologies we will be able to quantify protein changes at
      cytoplasmic and membrane protein levels of epidermal cells in normal vs. irradiated skins.

      This study may allow us to obtain fairly comprehensive profile of membrane integrated and
      cytoplasmic proteins of epidermal cell populations which will facilitate our understand of
      biological responses to UV irradiation.
    

Intervention name(s): UV Irradiation
Intervention type(s): Procedure
Intervention description(s): UV irradiation
Other intervention name(s): UV irradiation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Combination of Fimasartan/Amlodipine/Rosuvastatin in Patients With Essential Hypertension and Dyslipidemia
Condition: Essential Hypertension; Dyslipidemia
MeSH terms: Hypertension; Essential Hypertension; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this clinical study is to evaluate the efficacy and safety by comparing the
      fimasartan/amlodipine/rosuvastatin treatment group to the fimasartan/amlodipine treatment
      group and the fimasartan/rosuvastatin treatment group respectively at Week 8 in patients with
      essential hypertension and dyslipidemia who fail to respond to the fimasartan monotherapy.
    


Intervention name(s): Fimasartan/Amlodipine, Rosuvastatin; Fimasartan/Amlodipine; Fimasartan, Rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): "A fixed dose combination tablet of Fimasartan and Amlodipine" and "Rosuvastatin" will be administrated once daily on treatment period.; "A fixed dose combination tablet of Fimasartan and Amlodipine" will be administrated once daily on treatment period.; "Fimasartan" and "Rosuvastatin" will be administrated once daily on treatment period.
Intervention MeSH terms: Amlodipine; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hypertension; Dyslipidemia; Fimasartan; Rosuvastatin
the Potential Immunomodulatory Effects of Spirulina on Thalassemic Children
Condition: Beta Thalassemia Major
MeSH terms: Thalassemia; beta-Thalassemia
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the possible immunologic effects of spirulina in
      children with beta thalassemia.
    


Intervention name(s): Spirulina
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
A Phase I, Multicenter, Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules
Condition: HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Vaccinia
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety and immunogenicity of 200 mcg MN rgp160 vaccine (Immuno-AG) versus
      placebo, administered on two immunization schedules to healthy volunteers. Per 06/15/94
      amendment, to determine the safety and immunogenicity of 800 versus 200 mcg given as a fourth
      immunization at 9 or 11 months after the third injection (i.e., at month 17).

      A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and
      immunogenic in healthy adults. Since the MN strain of HIV-1 is representative of a larger
      proportion of HIV-1 isolates in the United States than is the IIIB strain, evaluation of a
      gp160 vaccine derived from the MN strain is important.
    

Detailed description: 
      A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and
      immunogenic in healthy adults. Since the MN strain of HIV-1 is representative of a larger
      proportion of HIV-1 isolates in the United States than is the IIIB strain, evaluation of a
      gp160 vaccine derived from the MN strain is important.

      Volunteers are randomized to receive 200 mcg MN rgp160 or placebo at months 0, 1, and 6 or at
      months 0, 2, and 8. For each immunization schedule, ten volunteers receive vaccine and two
      volunteers receive placebo. Per amendment, volunteers receive a fourth immunization of 800 or
      200 mcg (or placebo) at 9 or 11 months after the third injection (i.e., at month 17) and are
      followed for 6 months afterward.
    

Intervention name(s): gp160 Vaccine (Immuno-AG)
Intervention type(s): Biological
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; HIV-1; HIV Envelope Protein gp160; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
Ketamine for Reduction of Alcoholic Relapse
Condition: Primary Alcohol Use Disorder
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      96 recently detoxified alcoholics will be randomized to receive either 3 sessions ketamine
      (0.8 mg/kg IV over 45 minutes) or placebo plus manualised psychological therapy, or 3
      sessions of ketamine or placebo plus simple psychoeducation. Patients will be assessed at 3
      and 6 months on a range of psychological and biological variables. Primary endpoints will be
      % days abstinent at 6 months and relapse rates at 6 months. Secondary endpoints include
      depressive symptoms, craving, quality of life.
    


Intervention name(s): Ketamine; Placebo; Psychological Therapy; Alcohol Education
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Intervention description(s): 0.8 mg/kg ketamine; 0.9% saline; Manualised relapse prevention based CBT; Simple education about alcohol effects
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Stellate Ganglion Block on Intracranial Pressure Predicted by Ultrasonographic Assessment of Optic Nerve Sheath Diameter
Condition: Pain; Intracranial Pressure
Study type: Observational

Summary: 
      The stellate ganglion block increase cerebral blood flow, as the consequence of that, it has
      the potential to cause an increase of intracranial pressure (ICP). Previous studies have
      proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD)
      correlate with signs of increased ICP. Therefore, this study is aim to confirm the increased
      ICP by ultrasonographic measurement of ONSD after the stellate ganglion block.
    


Intervention name(s): ultrasonographic measurement of optic nerve sheath diameter
Intervention type(s): Procedure
Intervention description(s): A thick layer of gel is applied on the upper closed eyelid. The linear 13- to 6-MHz ultrasound probe is then placed in the gel, without exerting pressure on the eye. Two measurements are taken for each optic nerve: one in the transverse plane, with the probe being horizontal, and one in the sagittal plane, with the probe being vertical. The final ONSD is the mean of these measurements.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who were scheduled to receive stellate ganglion block at our pain management
        clinic
      
Keywords: stellate ganglion block
Effect of Liraglutide on Absorption of Paracetamol in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to to investigate if there is a
      drug-drug interaction between liraglutide and paracetamol (Benuron®) and to investigate the
      effect of liraglutide on post prandial glucose.
    


Intervention name(s): liraglutide; placebo; paracetamol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered as a subcutaneous injection. Initial dose 0.6 mg daily, adjusted to 1.2 mg daily in week 2 and escalated to 1.8 mg daily in week 3; Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively; One single dose of 1 g. Tablet
Intervention MeSH terms: Acetaminophen; Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation on the Safety of Ticagrelor Among Chinese ACS Patients
Condition: Acute Coronary Syndrome (ACS)
MeSH terms: Acute Coronary Syndrome
Study type: Observational [Patient Registry]

Summary: 
      The primary objective is to describe the safety and tolerability of ticagrelor, by assessment
      of adverse events (characteristics, reporting rate, severity, relationship and risk factors),
      especially the bleeding events as defined in 8.1 and other serious adverse events (SAEs)
      during 1-year follow up in Chinese acute coronary syndrome (ACS) patients.
    

Detailed description: 
      The trial is a multi-centre, prospective cohort, non-interventional study to be conducted in
      the department of cardiology from approximately 20 tier-2 or 3 hospitals, China. The study
      requires Chinese subjects aged over 18, diagnosed as ACS and treated with ticagrelor at least
      one tablet from the department of cardiology in the around 20 tier-2 or 3 hospitals. The
      subjects will be tracked up to 1 month after the discontinuation of ticagrelor for AE events
      and 1 year after enrollment for major cardiovascular events. This is an observational study.
      The prescribing doctor is in charge of prescribing or discontinuation ticagrelor. The
      investigator in an observational study may not intervene in the treatment. All 1000 subjects'
      related data will be collected
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Chinese subjects aged over 18, diagnosed as ACS and treated with ticagrelor at least one
        tablet from the department of cardiology in the around 20 tier-2 or 3 hospitals.
      
Keywords: ACS
Evaluation of Clinical Success of Restorations Using Different Magnification Aids
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study aimed to investigate the effect of using a loupe and dental operating microscope
      with different magnifications on the success of class II direct composite restorations.
    

Detailed description: 
      A total of 130 class II, D2 deep caries teeth of 85 patients were randomly distributed to the
      naked eye, 3x magnification loupe, 5x magnification loupe, 8.5x magnification dental
      operating microscope (DOM) groups, and direct composite restorations were made with these
      magnification aids. carried out. Clearfil SE Bond 2 and Clearfil Majesty Posterior composite
      were used in all restorations. The restorations were evaluated using FDI criteria at 1,6 and
      12-month periods, and restorations were scored between 1 and 5 for all criteria.
    

Intervention name(s): Dental Loupe; Dental Operation Microscope
Intervention type(s): Device; Device
Intervention description(s): Magnification aid; Magnification aid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It has 4 groups in total. The treatments were carried out
with no magnification aid
with x2 loupe
with x5 loupe
with Dental operation microscope
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dental loupe; restoration success; FDI criteria
Progressive Exercise After Operation of Rotator Cuff Rupture and Anterior Labrum Rupture
Condition: Rotator Cuff Disease; Shoulder Joint
MeSH terms: Rupture
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of progressive strength training
      after rotator cuff and labrum operation of the shoulder joint.
    


Intervention name(s): Progressive exercise
Intervention type(s): Behavioral
Intervention description(s): home-based exercise program, 2 to 3 exercise sessions per week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: shoulder joint; recovery of function; effectiveness of rehabilitation; rehabilitation
A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy and safety of two different neoadjuvant treatment
      approaches including bevacizumab in newly diagnosed participants with high risk locally
      advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A
      or Arm B).
    


Intervention name(s): Bevacizumab; Oxaliplatin; Folinic Acid; 5-fluorouracil; Preoperative Radiotherapy; Surgery
Intervention type(s): Drug; Drug; Drug; Drug; Radiation; Procedure
Intervention description(s): Bevacizumab will be administered at the fixed dose of 5 milligrams per kilogram (mg/kg) as an IV infusion over 30 to 90 minutes.; Oxaliplatin will be administered at a dose of 85 milligrams per square meter (mg/m^2) as a 2-hour IV infusion.; Folinic acid will be administered at a dose of 200 mg/m^2 as a 2-hour infusion.; 5-fluorouracil will be administered at a dose of 400 mg/m^2 as an IV bolus, then at a dose of 600 mg/m^2 as a continuous infusion for 22 hours in Phase 1, and will be administered at a dose of 225 mg/m^2 as a 24-hour infusion, 5 days a week, for 5 weeks in Phase 2.; Radiotherapy will be delivered in fraction of 1.8 gray per day (Gy/day), 5 days a week for 5 weeks, i.e., a total dose of 45 Gy will be administered in 25 fractions over a period of 33 days.; Radical rectal excision based on the TME technique.
Other intervention name(s): Avastin
Intervention MeSH terms: Leucovorin; Folic Acid; Bevacizumab; Fluorouracil; Oxaliplatin; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Non-Interventional Interview Study of Phenylketonuria (PKU) Adults
Condition: Phenylketonuria (PKU)
MeSH terms: Phenylketonurias
Study type: Observational

Summary: 
      The 165-901 study is designed to identify the appropriate tools for use in future
      interventional studies on the neurocognitive effects of pegvaliase on adults with PKU.
    

Detailed description: 
      Clinical studies have suggested that treatment with pegvaliase results in lowering of blood
      Phenylalanine levels in adults with Phenylketonuria (PKU). Because these individuals often
      exhibit inattention and mood difficulties, and blood Phe concentration affects cognition and
      mood, life-long blood Phe control with pegvaliase may improve cognitive abilities and
      emotional and mental health in patients with PKU. In order to adequately quantify potential
      pegvaliase treatment impact on cognition and mood, it is necessary to employ clinical outcome
      assessments (COAs) that are fit for purpose and that comprehensively address concepts
      important, relevant, and meaningful to PKU patients. This is an observational study to
      identify symptom, function, and health-related quality of life (HRQoL) concepts of interest
      (COIs) to patients with PKU and to seek additional patient, observer, and expert input on the
      appropriateness of concepts of BioMarin's proposed COAs for use in future efficacy trials in
      PKU.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        1. Individuals with PKU ≥18 years to ≤ 70 years of age who are naïve to pegvaliase

          2. Observers ≥18 years of an individual with PKU ≥18 years to ≤ 70 years of age who are
             naïve to pegvaliase

          3. Clinical experts currently treating PKU adults
Anti-Secretory Drug in Treatment of Acute Watery Diarrhea
Condition: Acute Watery Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      In conclusion, racecadotril is an anti-secretory drug that exerts its antidiarrheal effect by
      inhibiting intestinal enkephalinase. It is effective in reducing the volume and frequency of
      stool output. racecadotril is well tolerated and safe by providing symptomatic relief and
      reducing the severity of diarrhea as an adjuvant therapy during the acute attack of
      gastroenteritis. It is recommended that the new generations of already discovered drugs for
      control of secretory diarrhea should be studied to discover the ones with fewer side effects
      to other systems in the body.
    

Detailed description: 
      Background: Previous studies have shown that racecadotril is a safe and effective drug in
      treating children with acute diarrhea. Study Aim: to evaluate the effect of racecadotril as
      an adjunct to oral rehydration solution in the treatment of acute watery diarrhea among
      children under 5 years of age. Subjects and methods: This RCT trial included 50 children with
      acute watery diarrhea for 5 days or less with a frequency of three or more diarrheic stools
      in the past 24 hours before admission to the hospital, with no/mild to moderate dehydration.
    

Intervention name(s): Racecadotril
Intervention type(s): Drug
Intervention description(s): racecadotril (dose of 1.5 mg/kg/day, an oral single daily dose for three days
Other intervention name(s): Acetorphan
Intervention MeSH terms: Racecadotril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Online Grammatical Reasoning Training for Older Adults
Condition: Healthy Aging
Study type: Interventional

Summary: 
      The START study will investigate the impact of playing a Grammatical Reasoning brain training
      task on overall brain function (cognition) and day-to-day function in people over 50.

      The study builds on existing work that has shown very promising results with brain training
      approaches in older adults. There is good evidence that playing brain training games leads to
      improvements in brain functions including memory and reasoning. There is also a suggestion
      that regular involvement in brain training games might help reduce the risk of cognitive
      decline and dementia later in life. It appears that reasoning, or problem-solving, is
      particularly important as it is one of the first abilities to decline with age. This study
      will use this evidence to target reasoning in a specific brain training task. It will also
      explore the potential role of genetic factors in how people perform in the task.

      The study will compare the impact of a Grammatical Reasoning Task (START) with a control task
      consisting of simple picture-matching. Over 7000 participants will be randomly allocated to
      either START or the control and will be asked to play the task as often as they wish for a
      period of six weeks. Both tasks will be delivered entirely online so people will access the
      study from home on their computers. This will be achieved through our dedicated online
      research platform, PROTECT, which hosts a cohort of over 20,000 older adults who have
      provided DNA samples as part of a longitudinal study.

      This study will measure the impact of the training on cognition and Instrumental Activities
      of Daily Living. Assessments will be completed online at baseline, two/six weeks and six
      months. Overall, this study aims to generate exciting new data about how brain training could
      be included in guidance on healthy ageing.
    


Intervention name(s): Grammatical Reasoning; Card Pairs
Intervention type(s): Other; Other
Intervention description(s): START measures the ability to determine the relationships among different shape combinations which are assigned to grammatical statements about them which can be either correct or incorrect. It is a measure of attention, working memory and executive control.; A basic picture-matching task.
Other intervention name(s): START
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Study to Evaluate Tezepelumab on Airway Inflammation in Adults With Uncontrolled Asthma (CASCADE)
Condition: Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases
MeSH terms: Asthma; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to
      evaluate the effect of tezepelumab on airway inflammation in adults with inadequately
      controlled asthma.
    

Detailed description: 
      This is a multicentre, randomized, double-blind, placebo-controlled, parallel group study to
      evaluate the effect of tezepelumab on airway inflammation in adults with inadequately
      controlled moderate-to-severe asthma, taking inhaled corticosteroids and at least one
      additional asthma controller. Approximately 110 subjects will be randomized globally.
      Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection at the
      study site, over a 28-week treatment period. Although, due to the Covid-19 pandemic this may
      be an extended time frame for some subject visits. The study also includes a post-treatment
      follow-up period of 12 weeks.
    

Intervention name(s): Tezepelumab; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Tezepelumab subcutaneous injection; Placebo subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized in a 1:1 ratio to either tezepelumab or matching placebo both administered subcutaneously.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Uncontrolled asthma; Severe uncontrolled asthma