bioihbjkbjnl/mcl2 huggingface dataset:
Comparison Between 2 Protocols for the Treatment of Class II Division 2 Malocclusion
Condition: Class II Div 2 Incisal Relationship
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      The aim of this prospective study was to compare between two different treatment modalities
      of class II division 2; to start treatment in upper arch first until adequate overjet is
      obtained or to start in the lower arch first with removable anterior bite plane in upper
      arch.
    

Detailed description: 
      Fifty four subjects with class II division 2 participated in this study. The subjects were
      randomly divided into two groups; Group one (28 patients): orthodontic treatment with upper
      arch bond up first and lower arch was bonded when 4 mm overjet was reached. The treatment
      continued until 0.019 x 0.025 " stainless steel wires were reached in both arches. Group 2
      (26 patients): orthodontic treatment with lower arch bond up first with removable anterior
      bite plane in upper arch. When 0.019 x 0.025" stainless steel wire was reached, the upper
      arch was bonded. The treatment continued until 0.019 x 0.025" stainless steel wires were
      reached. Three cephalograms were taken for each patient in both groups; pretreatment (T0) ,
      after bonding the other arch (T1) and at the end of leveling and alignment in both arches
      (T2). Cephalometric measurements and superimpositions were made. Skeletal and dentoalveolar
      treatment changes were compared within and between the 2 groups.
    

Intervention name(s): Fixed appliance
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial
Primary purpose: Treatment
Keywords: Class II division 2; Alignment; Leveling
Does Intra-operative MarginProbe Use Reduce Re-excision Rates?
Condition: Breast Cancer
Study type: Interventional

Summary: 
      The new device we are looking at is called the MarginProbe. It is a disposable probe which
      measures the margins of tissue removed to check they are clear of cancer cells, during breast
      conservation surgery. After specimen radiology, allows the Surgeon to remove further tissue
      if necessary, during the same operation if any involved margins are identified. This
      minimises the need for further repeat operations.

      Previous studies carried out elsewhere in the world (USA and Israel) have identified that the
      probe reduces re-excision rate but there has never been a study in the UK.

      The trial involves randomly allocating patients once they are in theatre, to either the
      MarginProbe procedure after breast conserving surgery and radiology has been completed, or
      not.
    

Detailed description: 
      Almost 60% of all patients diagnosed with breast cancer (48000 annually in the UK) undergo
      breast conserving surgery (BCS. Surgical removal of the cancer aims to reduce the risk of
      local recurrence and patient mortality. In order to minimise the amount of tissue removed,
      excision up to the cancer-free area (margins) is undertaken. Further surgery, following
      initial breast cancer surgery, is required in 25% - 30% of patients because of disease found
      at the edges of the tissue removed.

      Reducing the need for further operations benefits patients (by reducing the number of
      operations required, improving cosmetic outcome and minimising anxiety) and the NHS (by
      realising economic benefits).

      MarginProbe, a disposable probe which measures the margins of tissue removed during breast
      cancer surgery, allows the surgeon to remove further tissue during the same surgical
      procedure to clear any involved margins, minimising subsequent re-operations. Four hundred
      and sixty patients in 6 specialist Breast Units will be randomly allocated after BCS (and
      specimen radiology), by telephone randomisation, to either:

        -  MarginProbe assessment of the surgical specimen with re-excision of margins if required;

        -  Standard BCS (clinical and radiological clear margins) whereby the wound will be closed
           and the surgery completed (standard UK practice).
    

Intervention name(s): MarginProbe
Intervention type(s): Device
Intervention description(s): Surgery to take place as per standard care. When the surgery is nearly concluded, patient to be randomised. If randomised to device arm, the MarginProbe device will be used on the outer edge of the tumour and shavings. If the MarginProbe device indicates that cancer is detected, a further shaving is to be taken. Surgery then to be concluded as per standard care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®
Condition: Vaginal Disease
MeSH terms: Vaginal Diseases
Study type: Interventional

Summary: 
      This study evaluates treatment with the medical device Ainara® compared to a HA-based gel
      (Hyalogin) on the improvement of vaginal dryness
    

Detailed description: 
      This is an open, comparative, multicenter study that evaluates the performance and safety of
      the medical device Ainara®.

      In this study we use polycarbophilic vaginal moisturizing gel (Ainara®) compared with a
      HA-based gel (Hyalogin) for symptomatic treatment of vaginal dryness and we will monitor its
      impact on vaginal dryness symptoms evaluated by Vaginal Health Index and Vaginal Analogue
      Scale.
    

Intervention name(s): Ainara; HyaloGin
Intervention type(s): Device; Device
Intervention description(s): Each administration kit (subject kit) for patients of Ainara® will contain a box with 1 tube with 30 g gel, 1 cannula and 1 plunger. The gel quantity is enough for one subject over the course of the study (1 g at each administration).; Active Comparator: HyaloGin Each administration kit (subject kit) for patients allocated to HyaloGyn® group will contain a box with: 1 tube with 30g gel and 10 single-use applicators consisting of a piston and one opaque plastic plunger.
The gel quantity is enough for one subject (3g application every three days over the course of the study).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is an open-label, comparative, multicenter study with two parallel group of subjects. The clinical investigation will be performed in three clinical sites.
The calculated sample size of subjects is 50 (25 subject for each arm). To obtain this number of evaluable subjects it will be needed to screen about 60 subjects (including 6 potential screening failure) and to enroll 54 subjects (estimating 4 subjects drop out). From the equal distribution per groups of treatment point of view, the minimum and maximum number of patients recommended for each of the three centers will be 8 and 25, respectively.
The research question is: in a population of menopausal transition women affected by vaginal dryness, will a 1-month treatment with polycarbophilic vaginal gel (Ainara®) significantly decrease the symptomatology evaluated by VHI and VAS in comparison with that occurred in a group of patients treated with a HA-based gel (HyaloGyn®)?
Masking: None (Open Label)
Primary purpose: Treatment
Combination of RAD001 and Erlotinib in Patients With Advanced Non Small Cell Lung Cancer Previously Treated Only With Chemotherapy
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to assess the value of combined treatment with RAD001 and erlotinib in
      patients with advanced Non Small Cell Lung Cancer treated only with chemotherapy as systemic
      therapy.
    


Intervention name(s): RAD001; erlotinib
Intervention type(s): Drug; Drug
Intervention MeSH terms: Erlotinib Hydrochloride; Everolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non Small Cell Lung Cancer; NSCLC; Advanced lung cancer; RAD; RAD001; erlotinib
Outcome of Autosomal Dominant Polycystic Kidney Disease Patients on Peritoneal Dialysis: a National Retrospective Study Based on Two French Registries (the French Language Peritoneal Dialysis Registry and the French Renal Epidemiology and Information Network).
Condition: Polycystic Kidney Diseases
MeSH terms: Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Observational

Summary: 
      Pathological features of Autosomal Dominant Polycystic Kidney disease (ADPKD) include
      enlarged kidney volume, a higher frequency of digestive diverticulitis and abdominal wall
      hernias. Therefore, many nephrologists have concerns about the use of peritoneal dialysis
      (PD) in ADPKD patients. We aimed to analyze survival and technique failure in ADPKD patients
      treated with PD.
    

Detailed description: 
      Pathological features of Autosomal Dominant Polycystic Kidney disease (ADPKD) include
      enlarged kidney volume, a higher frequency of digestive diverticulitis and abdominal wall
      hernias. Therefore, many nephrologists have concerns about the use of peritoneal dialysis
      (PD) in ADPKD patients. We aimed to analyze survival and technique failure in ADPKD patients
      treated with PD. We conducted two retrospective studies on patients starting dialysis between
      2000 and 2010, and based on two French registries: The French Renal Epidemiology and
      Information Network (REIN) and The French Language Peritoneal Dialysis Registry (RDPLF).
    

Intervention name(s): Dialysis
Intervention type(s): Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients starting dialysis and included from the French Renal Epidemiology and Information
        Network (REIN) and The French Language Peritoneal Dialysis Registry (RDPLF)
Using Neuroimaging to Investigate Major Depressive Disorder
Condition: Major Depressive Disorder; Depression; Anxiety
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders; Depressive Disorder, Major
Study type: Observational

Summary: 
      The purpose of this neuroimaging study is to investigate the brain correlates of Major
      Depressive Disorder with anxiety symptoms as well as potentially identify predictors of
      treatment outcome.
    

Detailed description: 
      The purpose of this study is to test whether the structural and functional connectivity
      between the dorso-lateral prefrontal cortex (DLPFC) and amygdala will decline as symptoms of
      co-morbid anxiety (Anxiety Factor Score) increase in patients with MDD. This decrease in
      connectivity will also account for decrease in treatment response. The structural
      connectivity will be assessed using Diffusion Tensor Imaging (DTI) and the functional
      connectivity will be assessed using resting state BOLD fMRI.We propose to use the fMRI and
      DTI to identify biological markers that are associated with treatment response in a cohort of
      patients with a spectrum of Anxiety Factor Scores.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community sample
      
Keywords: Major Depressive Disorder; Depression; Anxiety
Immunogenicity of Rotavirus Vaccine
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all
      diarrhea related deaths in children worldwide. Two vaccines against Rotavirus, Rotarix® and
      Rotateq® were licensed in many high and middle income countries in 2006, but lack of efficacy
      data in low income countries had prevented WHO from making a universal recommendation of
      their use until recently. This study will be conducted in Pakistan and will look at two
      objectives:

        1. To compare the immunogenicity of Rotarix® vaccine when administered at 6 and 10 weeks of
           life and at 6, 10 and 14 weeks of life.

        2. To compare the immunogenicity of Rotarix® vaccine in infants breast fed at the time of
           vaccine administration with infants whose breast feeding is withheld for one hour before
           and after vaccine administration.
    


Intervention name(s): Rotavirus vaccine
Intervention type(s): Biological
Intervention description(s): live attenuated oral rotavirus vaccine; lyophilized; 1 ml
Other intervention name(s): Rotarix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Rotavirus; Rotavirus vaccine; Dosing schedule; Immunogenicity; Breast feeding; Pakistan
A Study Measuring Effects on Intima Media Thickness: An Evaluation of Rosuvastatin 40 mg (METEOR)
Condition: Hypercholesteremia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to see if rosuvastatin will be effective in decreasing the
      thickness of the walls of the arteries in the neck for people who already have some evidence
      of thickening of these walls.
    


Intervention name(s): Rosuvastatin calcium
Intervention type(s): Drug
Other intervention name(s): Crestor
Intervention MeSH terms: Rosuvastatin Calcium; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Keywords: Hypercholesteremia
Icotinib Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors
Condition: Vestibular Schwannoma; Neurofibromatosis Type 2
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma; Neurilemmoma; Neuroma, Acoustic; Neurofibromatosis 2
Study type: Interventional
Phase: Phase 2

Summary: 
      1)Preliminarily evaluate the treatment effect of Icotinib Hydrochloride Tablets on NF2;
      2)Preliminarily evaluate the safety and the patient's tolerance of the treatment of Icotinib;
      3)Provide an objective basis for an enlarged randomized double-blind trial.
    

Detailed description: 
      Neurofibromatosis type 2 (NF2) is a hereditary tumor predisposition syndrome caused by
      mutations in the NF2 tumor suppressor gene. Individuals with NF2 have a higher likelihood to
      develop multiple nervous system tumors, including schwannomas, meningiomas, and ependymomas.
      The hallmark of NF2 is bilateral vestibular schwannomas. Historically, most NF2 patients
      experience complete hearing loss either from tumor progression or after treatment of the
      tumors with surgery or radiation. Effective treatments are urgently needed for NF2 patients
      with progressive hearing loss because hearing loss is associated with impairment in social,
      emotional,and communication function and with increased depression.

      Previous studies of NF2 patients treated with Erlotinib suggested that inhibition of
      epidermal growth factor receptor (EGFR) could result in hearing improvement and reduction in
      tumor size.

      Much evidence implicates human epidermal growth factor (HER) receptors in vestibular
      schwannoma growth.Some studies have demonstrated that Merlin, the NF2 gene protein product,
      controls surface availability of the EGFR, ErbB2, and ErbB3 receptors in human and Drosophila
      models. Besides, cell culture models of mouse embryo fibroblasts (MEFs) support the role of
      EGFR in NF2-associated tumorigenesis. Nf2-deficient cells in culture lack contact-dependent
      inhibition of growth and continue to grow in confluent cultures. This effect appears to be
      mediated by EGFR signaling. Treatment of Nf2-deficient cells with EGFR inhibitors such as
      gefitinib can restore contact-dependent inhibition, suggesting that this class of drugs might
      be useful for NF2 patients with progressive vestibular schwannomas. In this way, Icotinib can
      inhibit the nutrition of the tumor and decrease the tumor's growth and metastasis. Based on
      these studies, we perform this clinical trial to known the treatment effect and tolerability
      of Icotinib on NF2.
    

Intervention name(s): Icotinib
Intervention type(s): Drug
Intervention description(s): Method of drug administration:oral; Dosage: 125mg/m3/d; Course of treatment: 3 months;Total four treatment courses.
Other intervention name(s): Icotinib Hydrochloride Tablets
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neurofibromatosis Type 2; Vestibular Schwannoma; Other NF2-related tumors
Beer, Marathon, Genetics, Inflammation and the Cardiovascular System: Be-MaGIC-Trial
Condition: Inflammation; Heart Failure; Sudden Cardiac Death
MeSH terms: Death, Sudden, Cardiac; Inflammation; Death
Study type: Interventional

Summary: 
      The purpose of the study is to determine the myocardial function and vascular adaptation
      after strenuous exercise in association with consumption of polyphenols. The investigators
      aim to investigate the effects of extreme endurance exercise on the inflammatory system.
      Furthermore, the role of the cardiovascular response and adaptive mechanisms of the
      vasculature are examined. Subclinical injuries to the myocardium and vascular wall are being
      investigated.
    

Detailed description: 
      Regular exercise leads to an improvement of cardiovascular risk factors in patients with
      coronary heart disease, atherosclerosis and metabolic disorders.

      Aerobic exercise has anti-inflammatory effects. In contrast, the exertional exercise of
      marathon running causes an acute pro-inflammatory impulse. This may lead to myocardial injury
      and, in case of preexisting plaques, may result in plaque rupture and acute myocardial
      infarction.

      We aim to define the critical role of inflammatory markers and cardiovascular risc factors as
      a predictor of an increased risk for myocardial and endothelial dysfunction in marathon
      runners.

      Diagnostic tools include measurements of microvasculature, the large vessels and
      echocardiography. Inflammatory markers include high sensitive c-reactive protein (CRP) and
      interleukins.

      All variations are analysed on the basis of consumption of polyphenols as they are found in
      in hops (Humulus lupus L.) and beer.
    

Intervention name(s): polyphenols (non-alcoholic beer); beverage without polyphenols
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1.0 - 1.5 l non-alcoholic beer per day; 3 weeks before and during a marathon run; 1.0 - 1.5 l of beverage without polyphenols (otherwise the same composition as non-alcoholic beer) per day; 3 weeks before and during a marathon run
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioavailability Study of Metronidazole Capsules Under Fed Conditions
Condition: To Determine the Bioequivalence Study Under Fed
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the single-dose Bioavailability of Kali and G.D.
      Searle, Inc.
    

Detailed description: 
      To compare the relative Bioavailability of Metronidazole 375 mg Capsules with that of Flagyl
      375 mg Capsules in healthy, adult subjects under fed conditions
    

Intervention name(s): Metronidazole; Flagyl
Intervention type(s): Drug; Drug
Intervention description(s): Capsules, single-dose, fed; Capsules, single-dose, fed
Other intervention name(s): Flagyl; Metronidazole Capsules
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence, single-dose, fed
Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia
Condition: Barrett Oesophagus; Low Grade Dysplasia
MeSH terms: Barrett Esophagus; Hyperplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      Radiofrequency ablation versus endoscopic surveillance in the management of low grade
      dysplasia in Barrett oesophagus: a multicentric randomised controlled trial.
    

Detailed description: 
      Background: The occurrence of low grade dysplasia (LGD) in Barrett oesophagus (BE) is known
      as a pre-cancerous state. Current recommendation in case of LGD is a close endoscopic
      surveillance every 6 to 12 month and continuous Proton pomp inhibitor (PPI) treatment.
      Endoscopic radiofrequency ablation (RFA) has been demonstrated as an efficient treatment to
      eradicate high grade dysplasia (HGD) and most of LGD and BE.

      Main aim of this study: To demonstrate that the prevalence of patients with LGD 3 years after
      a RFA treatment is lower than in a surveillance group.

      Patients & Methods: French multicentric randomized controlled trial for patients with BE with
      confirmed LGD: RFA vs endoscopic surveillance.

      120 patients are planned to be included for at least 40 patients randomized in each group.

      Primary endpoint: Prevalence of LGD in each group 3 years after randomization

      Secondary endpoints:

        -  Prevalence of LGD in each group 1 and 5 years after randomization

        -  Rate of complete eradication of BE at 1, 3 and 5 years after randomization

        -  Incidence of HGD and adenocarcinoma at 3, 5 years after randomization

        -  Rate of complications in RFA group after randomization

        -  Cost - efficacy comparison of the 2 strategies
    

Intervention name(s): Endoscopic radiofrequency ablation; Endoscopic surveillance
Intervention type(s): Procedure; Other
Intervention description(s): HALO device Use of HALO 360° device for the fist procedure and possible use of HALo 90° device for further treatment sessions Treatment zone of 12cm high maximum. Energy delivered 10 J/cm², power 300W; Upper gastro-intestinal endoscopy every 6 to 12 month under propofol sedation with acetic acid magnification of mucosa and multiple biopsy samples.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Barrett oesophagus; Low grade dysplasia; Radiofrequency ablation
Oral Peptones Load in Normocalcemic and Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects
Condition: Hyperparathyroidism; Hypercalcemia
MeSH terms: Hypercalcemia; Hyperparathyroidism; Hyperparathyroidism, Primary
Study type: Interventional

Summary: 
      The purpose of this study is to assess if subjects with hyperparathyroidism with normal serum
      calcium levels have different responses in the calcium regulating hormonal handling compared
      to a) patients with primary hyperparathyroidism and high serum calcium levels; b) healthy
      subjects.

      The differences will be evaluated with oral peptones load and subsequent blood samples
      collected every 15 minutes for two hours. Ionized calcium, phosphate, gastrin and PTH levels
      will be evaluated.
    


Intervention name(s): Oral peptones load
Intervention type(s): Other
Intervention description(s): Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Receptors, Calcium sensing; Parathyroid Hormone