bioihbjkbjnl/mcl2 huggingface dataset:
Intravitreal Aflibercept or Ranibizumab for Rubeosis Iridis
Condition: Glaucoma; Rubeosis Iridis
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 3

Summary: 
      Aflibercept (Eylea®) and ranibizumab (Lucentis®) are an anti-VEGF, but there are differences
      between the two drugs. To determine and compare whether intraocular aflibercept and
      ranibizumab decreases rubeosis iridis (RI) in patients with neovascular glaucoma (NVG).
    

Detailed description: 
      Aflibercept (Eylea®) and ranibizumab (Lucentis®) are an anti-VEGF, but there are differences
      between the two drugs. Lucentis is administered in the form of smaller molecules, which is
      thought to give Lucentis an advantage over Eylea in its ability to penetrate the eye's retina
      and halt abnormal blood vessel growth contributing to advanced macular degeneration and
      scarring that causes blindness. They may have a role in treating ocular disorders involving
      fibrovascular proliferation. To determine and compare whether intraocular aflibercept and
      ranibizumab decreases rubeosis iridis (RI) in patients with neovascular glaucoma (NVG).
    

Intervention name(s): Aflibercept; Ranibizumab
Intervention type(s): Drug; Drug
Intervention description(s): 12 eyes received an intraocular injection of 2.00 mg of aflibercept (IA) and IOP were measured by tonometer. The neovascularization was evaluated by biomicroscope.; 12 eyes received an intraocular injection of 1.25mg ranibizumab and IOP were measured by tonometer. The neovascularization was evaluated by biomicroscope.
Other intervention name(s): Eylea; Lucentis
Intervention MeSH terms: Ranibizumab; Aflibercept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rubeosis iridis; glaucoma; ranibizumab; aflibercept
An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study of efficacy and safety of Plecanatide in pediatric subjects aged 12 to < 18
      years diagnosed with Chronic Idiopathic Constipation.
    

Detailed description: 
      The purpose of the study is to evaluate efficacy, safety, and pharmacokinetics (PK) of oral
      Plecanatide 0.5, 1.0 and 1.5 mg tablets dosed once a day as compared to matching placebo,
      when administered for 8 weeks in adolescents with chronic idiopathic constipation.

      This study will consist of a 4-week screening period, 8 weeks of treatment, and a 2-week
      follow-up. The study will assess the effects of Plecanatide on bowel movement frequency and
      other clinical features of CIC.
    

Intervention name(s): Plecanatide; Matching placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Trulance; No other names
Intervention MeSH terms: Plecanatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effects of Scapular Muscles Training Using a Suspension System in Patients With Non Spacific Chronic Neck Pain and Scapular Dyskinesia
Condition: Scapular Dyskinesis
MeSH terms: Dyskinesias; Neck Pain
Study type: Interventional

Summary: 
      The study aimed to investigate the effect of scapular muscle training using a suspension
      system in patients with non spacific chronic neck pain with scapular diskinesia
    


Intervention name(s): Suspension system; Scapular training exercises
Intervention type(s): Device; Other
Intervention description(s): suspended from the handles of the straps by either their hands or feet while the non-suspended pair of extremities are in contact with the ground leading to muscle activation due to unstable base of support; Scapular muscle strength by resistance
Other intervention name(s): Sling therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Scapular diskinesia; Non spacific chronic neck pain; Suspension system
Evaluation of the Effect of Different Doses Dexmedetomidine Infusion on Lung Mechanics and Oxygenation in Obese Patients
Condition: Obesity; Drug
Study type: Interventional
Phase: Phase 2

Summary: 
      • The objective of this study is to evaluate the effect of different doses of dexmedetomidine
      infusion intraoperative on lung mechanics and oxygenation regarding PaO2/Fraction of inspired
      oxygen), Intraoperative oxygenation, lung compliance (static and dynamic), dead space, and
      PaCO2,heart rate, mean arterial blood pressure in obese patients undergoing laparoscopic
      cancer surgeries
    

Detailed description: 
      Dexmedetomidine is a selective agonist of α2receptorswhose tendency to α2 receptors is eight
      times more than that of clonidine. It also has powerful sedative, analgesic,
      anti-inﬂammatory, and organ protective properties. dexmedetomidine has favorable respiratory
      effects in humans. The effects of dexmedetomidine on oxygenation and lung mechanics had been
      investigated in obstructive lung disease. Dexmedetomidine decreased dead space and improved
      both lung compliance and oxygenation in chronic obstructive pulmonary disease (COPD) patients
      undergoing lung cancer surgery. Morbidly obese patients are characterized by the high
      prevalence of restrictive lung disease.The study include 2 equal groups, each group is 35
      patients: Group A(N=35) dexmedetomidine is infused intraoperative after intubation at dose of
      (1μg/Kg LBW) bolus, followed by 0.5μg/Kg/hour continuous infusion till the end of surgery and
      Group B(N=35) dexmedetomidine is infused intraoperative after intubation at dose of (0.5μg/Kg
      LBW) bolus, followed by 0.3μg/Kg/hour continuous infusion till the end of surgery.
    

Intervention name(s): Dexmedetomidine Injection [Precedex]
Intervention type(s): Drug
Intervention description(s): two different doses dexmedetomidine bolus then maintenance infusion till end of surgeries and evaluation of lung mechanics and oxygenation
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study include 2 equal groups, each group is 35 patients: Group A(N=35) dexmedetomidine is infused intraoperative after intubation at dose of (1μg/Kg LBW) bolus, followed by 0.5μg/Kg/hour continuous infusion till the end of surgery and Group B(N=35) dexmedetomidine is infused intraoperative after intubation at dose of (0.5μg/Kg LBW) bolus, followed by 0.3μg/Kg/hour continuous infusion till the end of surgery.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Active and Passive Cervical Flexion-rotation Tests
Condition: Cervicogenic Headaches
MeSH terms: Post-Traumatic Headache; Headache
Study type: Observational

Summary: 
      Motion limitations have been previously reported in people with headaches originating from
      the neck/cervicogenic headaches. A test involving flexing and rotating the neck has been
      found useful to diagnose this type of headache. This observational study investigates this
      neck motion test when performed actively by the patient and passively by the examiner, then
      compares the results of motion attained.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        two groups of subjects were included; those with cervicogenic headaches and an asymptomatic
        group of healthy volunteers
      
Biospecimen description: 
      This study compares observation of neck range of motion measures during the flexion rotation
      test (combining neck flexion with neck rotation) in two groups of subjects, one group has
      headaches and one groups is a healthy, asymptomatic group.
    
Keywords: headache diagnosis; flexion rotation test; range of motion; upper cervical
Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient
Condition: Carcinoma, Small Cell
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Small Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      Belotecan (Camtobell, CKD-602, Chong Kun Dang Pharm., Korea) is a new camptothecin
      derivative, that exhibits anticancer effects by inhibiting topoisomerase I. The investigators
      will have a randomized prospective multicenter trial of Belotecan/Cisplatin versus
      Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung
      cancer.

      Primary endpoints

        -  to assess Response Rate

      Secondary endpoints

        -  to assess Overall response duration, Time to progression, Overall survival
    


Intervention name(s): Belotecan; Etoposide; Cisplatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Belotecan : 0.5mg/㎡/day for Day 1 to 4, repeated every 3 weeks; Etoposide 100mg/㎡/day for Day 1 to 3, repeated every 3 weeks; Cisplatin 60mg/㎡/day for Day 1, repeated every 3 weeks
Other intervention name(s): Camtobell
Intervention MeSH terms: Etoposide; Belotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Small cell lung cancer; Camptothecin; Response rate
Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa
Condition: Dystrophic Epidermolysis Bullosa
MeSH terms: Epidermolysis Bullosa; Epidermolysis Bullosa Dystrophica
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase I/II open-label study to evaluate the efficacy and safety of ALLO-ASC-DFU in
      patients with Dystrophic Epidermolysis Bullosa.
    

Detailed description: 
      ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells.
      Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as
      vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can
      enhance wound healing and regeneration of new tissue, finally may provide an new option in
      treating a Dystrophic Epidermolysis Bullosa.
    

Intervention name(s): Allogeneic mesenchymal stem cells; Polyurethene Film
Intervention type(s): Other; Device
Intervention description(s): Dressing for Dystrophic Epidermolysis Bullosa wound.; Dressing for Dystrophic Epidermolysis Bullosa wound.
Other intervention name(s): ALLO-ASC-DFU
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epidermolysis Bullosa; stem cell
Hemodialysis Health Management Model
Condition: Physical Inactivity; Nutritional Wasting
MeSH terms: Wasting Syndrome; Cachexia
Study type: Interventional

Summary: 
      Aim: By application of wearable devices and health management platform to strengthen physical
      activity and improved life quality in hemodialysis patients.
    

Detailed description: 
      Background: End stage renal disease (ESRD) is a global public health issue. The dialysis
      therapy brings huge economic burden to many countries. If patients are able to monitor their
      lifestyle, it not only promotes health, but also reduces the cost of health care.

      Aim: By application of wearable devices and health management platform to strengthen physical
      activity and improved life quality in hemodialysis patients.

      Material and Methods: The investigators plan to recruit 30 CKD patients as trial subjects for
      intervention. The intervention included wearable devices and health management platform for
      24 weeks. Patients record their own diet diary by a smartphone application, and their
      exercise-related data are collected by wearable devices. Then, all the collected information
      will be upload to health management platform. The investigators compare physical and
      laboratory examinations before and after the intervention.
    

Intervention name(s): Health platform; Social media; exercise including an 18-minutes calisthenics
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Each participant was provided with a wearable device (a Heart Rate Smart Wristband, GSH405-B6, Golden Smart Home Technology Corporation). Each participant downloaded an app (WowGoHealth app) to connect with the health management platform (GSH AI health platform). Participants' exercise-related data, including number of steps walked, distance, consumed calories, and heart rate, were collected by the wearable devices. All participants were taught to record a dietary diary (taking photos of meals) using a smartphone application. All collected information was uploaded to the health management platform. For the intervention group, we encouraged exercise including an 18-minutes calisthenics made by the Health Promotion Administration, Ministry of Health and Welfare (https://www.youtube.com/watch?v=r3xJW-b2tZY).; We built a LINE group to inspire the intervention group.; exercise including an 18-minutes calisthenics
Intervention model: Parallel Assignment
Intervention model description: intervention group and control group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemodialysis; Wearable device; Health management platform
EXPAREL Infiltrated Into the TAP for Postoperative Analgesia in Unilateral Abdominal Hernia Repair
Condition: Hernia
MeSH terms: Hernia; Hernia, Abdominal; Internal Hernia
Study type: Interventional
Phase: Phase 4

Summary: 
      Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the
      Transversus Abdominis Plane (TAP).
    

Detailed description: 
      This is a prospective, open-label, non-randomized study evaluating the effectiveness of
      abdominal analgesia when using 266 mg EXPAREL to infiltrate into the TAP unilaterally.
    

Intervention name(s): EXPAREL
Intervention type(s): Drug
Intervention description(s): single dose 266 mg of undiluted EXPAREL
Other intervention name(s): bupivacaine liposome injectable suspension
Intervention MeSH terms: Bupivacaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: analgesia; hernia repair
Identify Predictors That Distinguish Between Tofacitinib Responders and Non-responders Based on Genotype and Cellular and Molecular Profiles From Pinch Biopsies, Blood and Stool Samples
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative
Study type: Observational

Summary: 
      This is a prospective cohort study enrolling ulcerative colitis patients who initiate
      tofacitinib therapy. Investigators will collect clinical data, blood and stool samples prior
      to initiation of tofacitinib and, at minimum, monthly after the start of therapy. They will
      collect tissue from colonoscopies prior to initiation of therapy and within 6 months on
      therapy. Clinical characteristics and response to treatment will then be associated with
      genotype, blood immune profiles, stool microbiota, and cellular and molecular profiles of the
      biopsies to generate a treatment response model. Using predictors identified in our model, we
      will then attempt to validate the model and findings with the OCTAVE (Pfizer), SPARC (CCF),
      and RISK (CCF) data.
    


Intervention name(s): GWAS analysis by Illumina BeadChip
Intervention type(s): Diagnostic Test
Intervention description(s): will generate comprehensive genotype data for patients. Samples will be used for transcriptional profiling, microbiota profiling by 16S analysis and immunological profiling by flow cytometry
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients 18-70 with moderate to severe ulcerative colitis defined as a total mayo score
        between 6 and 12, and an endoscopic subscore of 2 or 3.
      
Biospecimen description: 
      Microbiota profiling by 16S sequencing RNA seq transcriptional profiling oof blood and biopsy
      Immunological profiling by multi parameter flow cytometry
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia
Study type: Interventional

Summary: 
      This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM®
      versus placebo, for the treatment of BPD in premature infants. Subjects who participated in
      and completed the initial stage of the Phase II trial (NCT01828957) will be followed-up until
      60 months of corrected age.
    

Detailed description: 
      Subjects who completed the initial stage of the Phase II clinical trial will be followed-up
      at 7 additional visits: corrected age of 6, 12,18, 24, 36, 48, and 60 months.
    

Intervention name(s): Pneumostem®; normal saline
Intervention type(s): Biological; Biological
Other intervention name(s): Human umbilical cord blood-derived mesenchymal stem cells
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Human Umbilical Cord Blood Derived Mesenchymal Stem Cells; Bronchopulmonary dysplasia; Premature infants
Inspiratory Muscle Training and Asthma
Condition: Asthma
MeSH terms: Asthma; Respiratory Aspiration
Study type: Interventional

Summary: 
      This is a pilot study which will assess the feasibility of a follow on main study. This study
      will examine the impact of inspiratory muscle training on quality of life, rescue drug
      medication usage, and other markers of asthma in adult asthmatics in the UK.
    


Intervention name(s): inspiratory muscle training
Intervention type(s): Other
Intervention description(s): Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H&B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma, inspiratory muscle training
Bioavailability of Dienogest 2.0 mg With Regards to Reference Product
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This Pivotal study will investigate the bioavailability in women of 1 tablet formulations
      containing Dienogest 2.0 mg. The Pivotal study will be performed at a single site with 30
      subjects. Participants will take 1 tablet of the test product and reference product in 2
      periods and 2 sequences (either test after reference or reference after test). There will be
      a washout of at least 14 days between each study period.
    

Detailed description: 
      The primary objective of the study is to investigate the relative bioavailability of
      Dienogest of 1 tablet formulation with Dienogest 2.0 mg and to demonstrate bioequivalence of
      both formulations in terms of rate and extent of absorption:

        -  Test Product: Product manufactured by Laboratorios Andrómaco S.A.

        -  Reference Product: Visannette [Trademark], product of Bayer AG, Germany. The 90%
           confidence intervals for the intra-subject coefficient of variation (Test versus
           Reference Product) for the main pharmacokinetic parameters area under the plasma
           concentration-time curve from time zero to time t (AUC0-t) and from time zero to 72
           hours (AUC0-72), and maximum plasma concentration (Cmax) for total Dienogest will be
           determined. Participants will be confined in the study site for approximately 36 hours
           during each study period (for 12 hours pre-dosing and for 24 hours post dosing) during
           which pharmacokinetic (PK) blood samples will be obtained. 16 blood samples will be
           taken up to 24 hours after the administration in each period. Participants will return
           to the site to provide additional blood samples at 48 h, and 72 h postdose.

      The washout period between the two study periods will be at least 14 days. The samples from
      each participant will be analyzed with 2 methods of highperformance liquid
      chromatography-tandem mass spectrometry bioanalytical assays to quantify total Dienogest in
      plasma.

      The safety objective is to evaluate the tolerability of both formulations in women by
      collecting adverse events.
    

Intervention name(s): Dienogest 2.0 mg Test Drug; Dienogest 2.0 mg Reference Product
Intervention type(s): Drug; Drug
Intervention description(s): Bioequivalence; Bioequivalence
Other intervention name(s): Investigational Medicinal Product; Visannette (Trademark)
Intervention MeSH terms: Dienogest; Nandrolone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
NAC Effect on Hox Genes Expressions in RIF
Condition: Female Infertility
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 3

Summary: 
      Comparison of the group treated with NAC-supplementation and placebo- administered groups
      showed elevations in HOXA cluster genes (all members) expression level in endometrium of
      women with RIF.
    

Detailed description: 
      Despite significant developments in assistant reproductive technology (ART) that have
      overcome many underlying causes of infertility, pregnancy success rates remain relatively
      low, mainly due to implantation failure. Embryo quality and endometrial receptivity are two
      significant factors that believed to be the key points in implantation. Since recent studies
      that showed high expression of some HOXA genes affects on successful implantation rate, thus
      we examined the expression of HOXA genes in NAC supplementation during window of implantation
      (WOI) in women with (RIF). Also the effect of NAC on the improvement of implantation in RIF
      patients was investigated. Forty unfertile women with a diagnosis of RIF, referred to Royan
      Institute were included in the study. The study was of the type a single center, double
      blinded, placebo controlled, randomized trial. Expression of HOXA genes were assessed on the
      day of WOI (using Real Time PCR) biopsies from endometrium. Subjects randomly assigned to
      receive either NAC (A) or placebo (B) with both effervescent tablets having similar color,
      size and appearance. The patients were randomly categorized in two groups (A/B) to receive
      NAC 1200 mg/day or placebo, for at-least 6 weeks before starting ovarian stimulation.
      Pipelled-based biopsy from endometrium was done on specific day (19-21) of their cycle. Then
      patients were undergone ovarian stimulation (using NAC) ended to IVF treatment. RNA
      extraction and cDNA synthesis were performed from endometrium samples and then we evaluated
      expressions levels by Real-time PCR. Then we analyzed our data by independent Sample T-test
      and Mann-whitney U Test.
    

Intervention name(s): N-acetyl cysteine; Placebos
Intervention type(s): Drug; Drug
Other intervention name(s): NAC; Placebo effervescent tablet
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Implantation; Recurrent implantation failure; N-acetyl cysteine; HOXA cluster genes; Window of implantation