bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating the Efficacy of Aflibercept for the Treatment of NVCI in Young Patients
Condition: Idiopathic Choroidal Neovascularization
MeSH terms: Choroidal Neovascularization; Neovascularization, Pathologic
Study type: Interventional
Phase: Phase 2

Summary: 
      After myopia, the second etiology of choroidal neovascularization (CNV) in young adults (<50
      years old) is idiopathic choroidal neovascularization (ICNV) whose etiology remains unknown.
      This is a rare and severe disease, which can lead to blindness.

      ICNV is treated at the moment with off-label anti-VEGF (Vascular Endothelial Growth Factor)
      therapy and could also benefit from aflibercept (EYLEA), a new anti-VEGF currently indicated
      in Age-related Macular Degeneration (AMD). Case reports suggest that such patients would not
      need as many injections as in AMD.

      INTUITION is an open-label, single arm, prospective, multicenter, phase II study. The main
      objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment
      with aflibercept on the visual acuity of patients affected by ICNV. A specific dosage regimen
      is designed to achieve maximum efficiency. The patients are followed on a monthly basis until
      52 weeks. Intravitreal injections of aflibercept are initiated with a Treat & Extend (TAE)
      regimen until 20 weeks (3 mandatory injections with reinjection only in case of CNV
      activity). Then, a pro re nata (PRN) regimen is considered until 52 weeks (reinjection in
      case of CNV activity).
    


Intervention name(s): aflibercept
Intervention type(s): Drug
Intervention description(s): The patients are followed on a monthly basis until 52 weeks. Intravitreal injections of aflibercept at a dosage of 2 mg are initiated with a TAE regimen until 20 weeks (3 mandatory injections at inclusion, week 8 and 20 with reinjection at week 4, 12 and 16 only in case of CNV activity). Then, a PRN regimen is considered until 52 weeks (reinjection in case of CNV activity). Therefore, each patient receives between 3 and 13 injections in the whole study.
Intervention MeSH terms: Aflibercept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aflibercept; iodiopathic choroidal neovascularization; young patient
Comparison of Enteral Versus Parenteral Feeding in Healthy Human Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Literature suggests that route of feeding and/or certain nutrients may cause alterations in
      the body's immune cells. Immune cells help protect the body and fight infection/disease. Tube
      feeding (TF) is a method of delivering nutrition directly to the stomach/intestines via a
      small tube. The immune system may respond differently when receiving continuous TF as
      compared to receiving intermittent TF. Heart rate variability (HRV, the intervals between
      heartbeats) is a measurement of the nervous system's response to a stress/illness. The
      differences in immune cells and/or HRV may influence how the body reacts to complications
      such as infection.
    


Intervention name(s): Enteral Continuous; Enteral Intermittent; Parenteral Continuous
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Continuous Tube Feeding for 72 hours; Intermittent Tube Feedings; Parenteral Continuously for 72 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Immune System
Dietary Fatty Acids, PPAR Activated Genes, and CHD
Condition: Coronary Disease; Cardiovascular Diseases; Heart Diseases; Myocardial Infarction
MeSH terms: Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Coronary Disease; Infarction
Study type: Observational

Summary: 
      To examine the relationship between genetic and dietary factors that modify the risk of
      coronary heart disease (CHD).
    

Detailed description: 
      BACKGROUND:

      Coronary heart disease (CHD) is the major cause of death in most industrialized and
      developing countries. Links between genetic and dietary factors that modify the risk of CHD
      should give fundamental insight into its causes and improve population-based CHD prevention
      strategies.

      DESIGN NARRATIVE:

      The study will identify genes that modulate the association between dietary fatty acids (FAs)
      and myocardial infarction (MI). The study uses DNA samples obtained during a
      population-based, case-control study in Costa Rica of 2,150 subjects who experienced
      myocardial infarctions and 2,150 matched controls. Biochemical measurements, dietary data,
      and general information are available for this population. One unique aspect of the study is
      that adipose tissue biomarkers of polyunsaturated FAs will be used to evaluate dietary
      exposure variables. Adipose tissue biomarkers (i.e., alpha-linolenic and linoleic acid) are
      very good indicators of intake in this population. Furthermore, this study showed that
      increased levels of these biomarkers in adipose tissue are strongly associated with decreased
      risk of MI, whereas an increase in 18:2 trans FAs increase the risk of MI. Gene-diet
      association studies and a "candidate pathway" approach will be used to elucidate genetic
      mechanisms that link risk of MI with exposure to polyunsaturated FAs [including cis and trans
      isomers of linoleic acid (n-6), and alpha-linolenic acid (n-3)]. The focus will be on
      peroxisome proliferator-activated receptor (PPAR) genes, and PPAR-regulated genes, that are
      involved in vascular inflammation. Among controls, the investigators will examine whether
      genetic and dietary factors independently affect biochemical markers (phenotypes) of the
      proposed genes. They will also test whether these phenotypes are more clearly identified when
      genetic and dietary factors are examined together. Because polyunsaturated FAs are important
      as activators of PPARs and their capacity to regulate gene expression at the level of
      transcription, this metabolic system is a suitable candidate for the study.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Hispanic American of mestizo background living in Costa Rica
      
Biospecimen description: 
      Whole blood
Differential Adaptation of Renal Function in Intense Physical Exercise
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Study type: Interventional

Summary: 
      In recent years there has been a significant increase in the number of participants in high
      intensity and duration sports events. This type of physical exercise has been reported to
      lead to an apparently transitory deterioration in kidney function. The injury mechanisms
      involved in this process have not been fully studied, but several have been proposed as
      potential causes, such as tissue ischemia, disruption of the permeability of the glomerular
      basement membrane, damage to the ultra-structure of skeletal muscle, structural involvement
      of the renal parenchyma, exercise-associated hyperthermia or insufficient hydration during
      exercise.

      Urinary biomarkers, which are a more precise tool than serum creatinine when it comes to
      detecting subclinical kidney damage, may be key to elucidate the characteristics of
      exercise-related kidney injury.

      The aim of this study is to carry out an integrative analysis of the development of
      exercise-associated subclinical acute kidney injury.
    


Intervention name(s): 10 km continuous running; 1.5 km continuous swimming
Intervention type(s): Other; Other
Intervention description(s): Trial participants will perform a 10 km continuous running exercise; Trial participants will perform a 1.5 km continuous swimming exercise.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Trial participants will participate sequentially in two tests that involve high intensity physical exercise (10 km continuous running and 1.5 km continuous swimming). Both tests will be separated from each other a minimum of 30 days.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Acute kidney injury
A Safety Study of ARRY-403 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study, involving a 10-day dosing period, designed to test the safety of
      investigational study drug ARRY-403 (as monotherapy or in addition to stable metformin
      therapy) in patients with Type 2 diabetes. Approximately 128 patients from the US will be
      enrolled in this study.
    


Intervention name(s): ARRY-403, glucokinase activator; oral; Placebo; oral
Intervention type(s): Drug; Drug
Intervention description(s): multiple dose, escalating; matching placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Intravitreal Bevacizumab for Inflammatory Neovascular Membranes
Condition: Vogt Koyanagi Harada Disease; Serpiginous Choroiditis; Multifocal Choroiditis
MeSH terms: Uveomeningoencephalitic Syndrome; Choroiditis; Multifocal Choroiditis; White Dot Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      Intravitreal injection of Bevacizumab in patients with Neovascular Membranes secondary to
      intraocular inflammation. We injected a single injection of Bevacizumab (2.5 mg/0.1 ml) and
      evaluate visual acuity , Fluorescein angiogram and retinal thickness by Optical Coherence
      Tomography (OCT) in 4 patients with Vogt Koyanagi Harada disease, 1 patient with Serpiginous
      Choroidopathy and 1 patient with Multifocal Choroiditis.
    


Intervention name(s): Bevacizumab; Intravitreal Injection of Bevacizumab
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Bevacizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neovascular Membrane; Uveitis; Bevacizumab
EMS for Abdominal and Gluteal Muscle Toning
Condition: Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      Evaluate the use of Electromagnetic Muscle Stimulation for body contouring.
    


Intervention name(s): The ZELTIQ System
Intervention type(s): Device
Intervention description(s): The EMS device will be used to perform the treatments.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Trial of Extended Treatment With Liatermin (r-metHuGDNF) Administered by Continuous Intraputaminal (IPu)Infusion to Subjects With Idiopathic Parkinson's Disease Who Have Completed a Previous Trial of Liatermin
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine long-term efficacy of continuous IPu liatermin
      infusion administered with concomitant standard anti-Parkinsonian therapy.
    


Intervention name(s): Liatermin
Intervention type(s): Biological
Intervention description(s): Liatermin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bilateral, idiopathic Parkinson's Disease
Simvastatin Effect on Portal Hypertension
Condition: Portal Hypertension; Esophageal Varices; Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Esophageal and Gastric Varices; Hypertension; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      It´s a clinical research of the effects in portal hypertension caused by simvastatin. We are
      going to use the hepatic venous pressure gradient(HVPG) measurement and the azygos flow at
      echoendoscopy to evaluate the benefits of the drug. Preliminary studies demonstrated that
      simvastatin can lower portal pressure.
    

Detailed description: 
      The simvastatin can target the liver enhancing nitric oxide intra-hepatic and lowering
      resistance that may be responsible for most of cirrhosis complications. Indeed, the potential
      use of this drug may ameliorate the HVPG and azygos flow. Portal hypertension is responsible
      for most of the cases of death in cirrhosis. The esophageal varices, ascites and hepatorenal
      syndrome are the most harmful consequences of cirrhosis that should be prevented. In that
      way, simvastatin appears as a promising therapy.The study will include two groups of patients
      using aleatory randomization and one group will receive simvastatin while the other will
      receive placebo blindly. At the start and at the end of the study the patients will be
      submitted to HVPG measurement and azygous vein flow measure.

      The endpoints will be the normalization of HVPG or lower significantly(20% or more.

      The patients will be followed for 6 months after the end of the study.
    

Intervention name(s): Simvastatin; Placebo pill
Intervention type(s): Drug; Drug
Intervention description(s): 40mg / pill, one pill orally once a day for three months
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Portal Hypertension; Hepatic Venous Pressure Gradient; Esophageal Varices; Liver Cirrhosis; Simvastatin; Nitric oxide; HVPG
Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, multicenter, placebo-controlled, double-blind study will evaluate the
      efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing
      motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the
      clinic.

      Patients who successfully complete this study will be eligible to enroll into a 12 month
      treatment extension (CVT-301-004E) study.
    


Intervention name(s): CVT-301 Low Dose; CVT-301 High Dose; Placebo
Intervention type(s): Drug; Drug; Other
Other intervention name(s): Inhaled levodopa; Inhaled levodopa; Inhalation-grade lactose
Intervention MeSH terms: Levodopa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Motor fluctuations; levodopa; inhaled drugs; OFF episodes
Effect of Adductor-Canal-Blockade on High Pain Responders After Total Knee Arthroplasty
Condition: Pain After Total Knee Arthroplasty
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether Adductor-Canal-Blockade (ACB) is superior
      to placebo when it comes to analgetic efficacy in high pain responders after Total Knee
      Arthroplasty (TKA). High pain responders are defined as patients reporting VAS > 60 during
      knee flexion the 1. or 2. day after surgery.
    

Detailed description: 
      The patients will be included the 1. or 2. day after surgery. All TKA patients will be
      screened. Those reporting VAS > 60 during active 45 degrees knee flexion will be asked to
      participate.

      Included patients will receive 2xACB (singleshot) first placebo (30ml saline) and then
      ropivacaine (30ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be
      45 minutes between the two blockades. The blockades will be ultrasound guided.
    

Intervention name(s): Ropivacaine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Arm RP is receiving 30 ml of ropivacaine 7,5 mg/ml at first blockade (ACB) and after 45 minutes another blockade (ACB) with placebo (saline 30 ml).
Arm PR is receiving 30 ml of placebo (saline) at first blockade (ACB) and after 45 minutes another blockade (ACB)with ropivacaine.; please see intervention description for ropivacaine
Other intervention name(s): Naropin; NaCl, placebo
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total knee arthroplasty; Adductor canal blockade (ACB); High pain responders; US-guided nerve block
Influence of Alcohol and Peer Passengers on Risky Driving Behavior in Young Adults
Condition: Accidents, Traffic
Study type: Interventional

Summary: 
      Among the many risk factors that contribute to young drivers' crash involvement, two are
      critical: peer passenger presence, which is unique to young drivers, and the influence of
      alcohol, a universal risk for drivers but one against which young drivers are most
      susceptible. Clarification of how passenger presence interacts with alcohol consumption to
      increase risk is needed. The impact of experimentally manipulated passenger characteristics
      and alcohol quantity on risky driving is observed using driving simulation and a random
      assignment experimental design with a sample of 18-21 year old male and female drivers.
    


Intervention name(s): Passenger
Intervention type(s): Behavioral
Intervention description(s): Driving with risk accepting or risk averse passenger
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Risk; Young drivers; Alcohol; Passengers; Gender
The Involvement of Breast Cancer Patients During Oncological Consultations
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The main aim of the study is to assess if a pre consultation intervention facilitates greater
      participation of patients (and accompanying key persons when present) in the consultation
      process by determining an increase in questioning and/or in the number of different illness
      related issues (e.g. diagnosis, treatment, prognosis) being discussed with the oncologist.

      Other aims are to assess the effect of the intervention on the oncologist's level of patient
      involvement, on patient satisfaction and coping and to explore the role of key persons
      accompanying the patient.

      The investigators expect that patients who have the opportunity to rehearse their informative
      needs before the consultation will ask a greater number of questions which in turn will
      determine their greater involvement by the physician and a greater number of satisfied needs.
      The investigators expect also that the straightforward use of a list of printed questions of
      potential relevance for cancer patients and their companions at an early stage of illness, by
      modifying the process of information exchange, increases their participation and satisfaction
      with the consultation, with potential benefits for treatment adherence and consequently
      treatment efficacy.
    


Intervention name(s): prompt-sheet; control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Prompt sheet is a form on which to write the reply to the following request: "Please indicate the arguments which you want to discuss today with your oncologist" and a written list of possible questions the patient (companion) would like to ask to the oncology.; Patients and companions of the control group receive a form on which to write their reply to the following request: "Please indicate the arguments which you want to discuss today with your oncologist"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Breast cancer; Patient involvement; Question prompt-sheet; Doctor-patient communication; RCT
A Single Dose Study Of Antimineralocorticoid Activity Of PF-03882845 In Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      24-hr urinary sodium/potassium ratio will be a sensitive biomarker of antimineralocorticoid
      activity. The dose-response relationship of the antimineralocorticoid activity of PF-03882845
      can be established following single oral doses.
    


Intervention name(s): 3 mg PF-03882845; 10 mg PF-03882845; 30 mg PF-03882845; 100 mg PF-03882845; Spironolactone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 3 mg PF-03882845, single oral dose; 10 mg PF-03882845, single oral dose; 30 mg PF-03882845, single oral dose; 100 mg PF-03882845, single oral dose; 100 mg spironolactone, single oral dose
Intervention MeSH terms: Spironolactone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Single dose; cross-over; active-control; placebo control; antimineralocorticoid activity
Deep Learning for the Discrimination Among Different Types of Keratits: a Nationwide Study
Condition: Keratitis; Automatic Judgement; Image
MeSH terms: Keratitis
Study type: Observational

Summary: 
      Detecting the cause of keratitis fast is the premise of providing targeted therapy for
      reducing vision loss and preventing severe complications. Due to overlapping inflammatory
      features, even expert cornea specialists have relatively poor performance in the
      identification of causative pathogen of infectious keraitis. In this project, the
      investigators aim to develop an automated and accurate deep learning system to discriminate
      among bacterial, fungal, viral, amebic and noninfectious keratitis based on slit-lamp images
      and evaluated this system using the datasets obtained from mutiple independent clinical
      centers across China.
    


Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Child, Adult, Older Adult
      
Keywords: Keratitis; Slit-lamp Image; Deep Learning
Effectiveness of Kegal Exercises on Urinary Incontinence Impact in Geriatric Incontinence
Condition: Urinary Incontinence in Geriatric Population
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      This research study was used to determine effectiveness of kegal exercise on urinary
      incontinence impact in geriatric incontinence. There were two groups, One group was
      experimental which was subjected to Kegel exercises while other was control group without any
      treatment.
    


Intervention name(s): Kegel Exercises
Intervention type(s): Behavioral
Intervention description(s): Kegel exercise group will get exercise within duration of 3 to 6 weeks based on age factor. Kegel exercise can be performed at any time and at any place without any restrictions.
following steps will be followed by kegel exercises group members:
Tighten and hold pelvic floor muscles for five seconds (count 1 one thousand, 2 one thousand, 3 one thousand, 4 one thousand, 5 one thousand).
Relax pelvic muscles and perform 10 to 20 Kegel exercises three to four times each day.
Squeeze the muscles in anus like holding a bowel movement focus penile area
Relax the pelvic floor muscles after each attempt.
Repeat this exercise 10 to 20 times.
While performing Kegel exercises:
Do not hold the breath. Do not push down. Squeeze the muscles together tightly and imagine, trying to lift this muscle up. Do not tighten the muscles in the stomach, buttocks, or thighs.
While the control group did not participate in any kegel exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention