bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial With Vinflunine as Maintenance Therapy in Metastatic Urothelial Cancer
Condition: Carcinoma, Transitional Cell
MeSH terms: Carcinoma, Transitional Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a clinical trial to evaluate the efficacy and safety of the drug vinflunine
      administered after the standard treatment of the combination gemcitabine+cisplatin, when it
      has reached stabilization or response of the disease, as the first treatment inmeditely after
      the diagnosis of advanced or metastatic urothelial cancer.
    

Detailed description: 
      Vinflunine is a drug recently approved in Europe for the treatment of advanced or metastatic
      urothelial cancer after platinum-failure. It has proved to improve the survival results
      compared with the best suportive care. In adition, the tolerability was favourable, specially
      for not leading appearance of neuropathy nor other cumulative toxic effects.

      In this study, it is proposed to test the feasibility, in terms of tolerability and efficacy
      of monotherapy with vinflunine in patients who, after completing the first-line
      cisplatin-based treatment for Transitional Cell Carcinoma of the Urothelial Tract (CCTU),
      have reached a stabilization or objective response. In order to have an adequate control
      group in the proposed design will be a phase II trial in which one group will receive
      standard management (follow-up until progression disease).
    

Intervention name(s): Vinflunine; Undefined (standard care)
Intervention type(s): Drug; Other
Intervention description(s): Vinflunine 320 mg/m2 IV infusion in 20 minutes every 21 days (280mg/m2 if PS=1, age ≥ 75 years, previous pelvic radiotherapy or creatinine clearance < 60ml/min).; All the current interventions used by each institution for the study disease.
Other intervention name(s): Javlor; undefined
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: urothelium; transitional; carcinoma; cancer; metastatic; tract
Effectiveness of Two Types of Fixed Lingual Retainers in Preventing Mandibular Incisor Relapse
Condition: Relapse
MeSH terms: Recurrence
Study type: Interventional

Summary: 
      The study evaluates effectiveness of two types of fixed retainers in post orthodontic
      patients. Half of the subjects are randomly allocated Group 1 retainer (FRC) and other half
      is given Group 2 retainer (MSW) and followed for a period of one year.
    

Detailed description: 
      54 subjects were recruited and divided into two groups by random allocation. Consents were
      obtained . Group 1 received fiber reinforced composite retainer and group 2 received
      multistranded stainless steel wire retainer. The patients were recalled at every three months
      interval for a period of 12 months. They were evaluated for number of fractures, failure
      pattern based on adhesive remnant index and relapse tendency by measuring little's
      irregularity index.
    

Intervention name(s): Orthodontic retainers
Intervention type(s): Device
Intervention description(s): Orthodontic retainers were bonded on the lower teeth of the subjects after fixed orthodontic treatment and were evaluated for their effectiveness for the followup of one year.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: fixed retainers; alignment
Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      Oocyte donation is a well established procedure in assisted reproduction treatments (ART). It
      is demonstrated that the use of hormonal substitution therapy, for the synchronization of the
      cycles between the recipients and the donors, provides good results, similar to the ones
      obtained with the natural cycle. In the patients - recipients with preserved ovarian
      function, the recipient's natural cycle is annulled, thus preventing the spontaneous
      Luteinizing Hormone surge. Simultaneously and while waiting for the suitable donor, her
      endometrium is prepared. When the donation occurs and fertilization with the husband sperm
      takes place, her cycle is stimulated again in order to synchronize her window of implantation
      with the donor's ovulation.

      Two different medications are commonly used to inhibit spontaneous ovulation: either GnRHa
      agonist or GnRH antagonists. The present study consists of the comparison between the single
      dose GnRH agonist (Decapeptyl 3,75 IM) and the 7 day dosage of GnRH antagonist (Cetrotide
      0,25 mg). The administration of GnRHa is used fundamentally as a long liberation formulation,
      administered in a single intramuscular injection (IM), which is more practical in terms of
      use. Nevertheless, the unnecessary persistence and the potentially unfavorable action of
      GnRHa during the luteal phase and early gestation have questioned its use. The recovery of
      the Hypophysarian function begins only 8 weeks after the single injection of long liberation
      of triptorelina 3.75 mg. The GnRH antagonist (Cetrotide 0,25 mg) makes the hypofisary
      inhibition shorter than with the analogues and can prepare similar endometrium
      characteristics as a natural cycle. The recipients will be assigned randomly to a group of
      treatment or another.
    


Intervention name(s): Antagonist GnRH Cetrotide; Agonist GnRH Acetate Triptoreline
Intervention type(s): Drug; Drug
Intervention description(s): Cetrotide 0.25 mg. daily/ 7 days; Acetate Triptorelina (Agonist GnRH), 3.75 mg. single dose
Intervention MeSH terms: Triptorelin Pamoate; Cetrorelix; Prolactin Release-Inhibiting Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oocyte donation; endometrial preparation
Evaluation of Benztropine for Cocaine Craving - 2
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the efficacy of benztropine (or DA reuptake
      inhibitor) with atropine and placebo in affecting stimulated craving to cocaine cues.
    


Intervention name(s): Benztropine
Intervention type(s): Drug
Intervention MeSH terms: Benztropine
Primary purpose: Treatment
The Effect of Lesion Characteristics in MRgFUS on Tremor in Essential Tremor and Parkinson's Disease
Condition: Tremor
MeSH terms: Parkinson Disease; Tremor; Essential Tremor
Study type: Observational

Summary: 
      The study will investigate Essential Tremor and Parkinson's Disease patients who underwent
      Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS). We will evaluate the effect of
      lesion characteristics on tremor and on quality of life after the procedure as compared with
      the baseline prior to the procedure.
    

Detailed description: 
      The purpose of the study is to investigate the effect of lesion characteristics in ExAblate
      Transcranial Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) of the Vim
      thalamic nucleus. Clinical measures will be used to study patients suffering from
      medication-refractory tremor, Essential Tremor or idiopathic Parkinson's Disease.

      This study is designed as a prospective, observational, and clinical study. Assessments will
      be made before and after MRgFUS for; clinical tremor relief, quality of life (QoL)
      improvements, assessment of adverse events, and correlations of these measures with the size
      and shape of the lesion and the surrounding edema .
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients which were diagnosed with ET or Idiopathic PD with medication refractory tremor
        that underwent MRgFUS procedure.
      
Keywords: Magnetic Resonance guided Focused Ultrasound; Tremor; Essential Tremor; Parkinson's Disease
GEMOX: Oxaliplatin in Pancreatic Cancer
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objective:

        -  To evaluate overall response rate (based on RECIST criterion)

      Secondary objective:

        -  To evaluate time to progression, clinical benefit, quality of life and safety
    


Intervention name(s): Oxaliplatin
Intervention type(s): Drug
Intervention MeSH terms: Oxaliplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Administration of Kisspeptin in Patients With Hyperprolactinemia
Condition: Hyperprolactinemia; Hypogonadism
MeSH terms: Hyperprolactinemia; Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to learn more about how kisspeptin, a naturally occurring hormone,
      affects women with high levels of prolactin (also called hyperprolactinemia). All
      participants will receive kisspeptin in a pulsatile fashion. Subjects in one group will
      attend two 12-hour visits with frequent blood draws. Subjects in the second group will wear a
      pump that administers kisspeptin subcutaneously (SC) over eight days and attend seven short
      blood sampling visits.
    


Intervention name(s): Kisspeptin 112-121; GnRH
Intervention type(s): Drug; Drug
Intervention description(s): 0.313 ug/kg IV or 0.313 ug/kg - 13.19 ug/kg SC; 0.075 ug/kg IV
Other intervention name(s): Metastin 45-54; gonadotropin-releasing hormone
Intervention MeSH terms: Hormones
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kisspeptin; Hyperprolactinemia; GnRH; Hypogonadism
Inhibition of the Endogenous GIP Response With a GIP Receptor Antagonist
Condition: Glucose Metabolism Disorders
MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      Delinieation of GIP's effects during an oral glucose tolerance test (OGTT) in humans using
      GIP receptor antagonisation.
    

Detailed description: 
      Aim: To evaluate the role of GIPR signalling in postprandial physiology, including bone and
      glucose homeostasis, using a naturally occurring GIP fragment (GIP-A), which antagonises the
      GIPR.

      Eighteen healthy men (age 18-70 years, BMI 19-35 kg/m2) with normal kidney and liver
      parameters and haemoglobin levels and no first-degree relatives with type 2 diabetes will be
      included in a randomised, double-blinded, placebo-controlled cross-over study. Study consists
      of four study days with concomitant infusions of A) GIP-A, B) GLP-1 receptor antagonist
      Exendin[9-39], C) GIP-A + Exendin[9-39], or D) saline (placebo).
    

Intervention name(s): GIP-A; GLP-1 receptor antagonist Exendin[9-39]; Placebo; GIP-A + Exendin[9-39]
Intervention type(s): Other; Other; Other; Other
Intervention description(s): GIP-A (GIP receptor antagonist); Exendin[9-39]; Saline (9mg/mL); GIP receptor antagonist + GLP-1 receptor antagonist
Other intervention name(s): EX(9-39); Saline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: GIP; GIP receptor antagonist
The Effect of Poverty on Psychological Well-being of Children
Condition: Child
Study type: Observational

Summary: 
      The aim of this study is to explore the impacts of poverty and income disparity on the
      psychological well-being of Hong Kong Chinese children.
    

Detailed description: 
      It is well documented that poverty has a negative impact on the physiological well-being of
      children in the West. There is an imperative need for health care professionals to develop
      and evaluate interventions to promote the psychological wellbeing of children living in
      poverty. First, however, it is crucial to assess and understand how the impact of poverty, in
      particular the impact of income disparity, affects the psychological wellbeing of Hong Kong
      children before any intervention to promote it can be planned, developed, or evaluated.
      Unfortunately, while much public concern about poverty has concentrated on children's
      physical development, the impact of poverty and income disparity on their psychological
      well-being remains relatively underexplored. Because the cultural context in which they live
      is drastically different from that of Western children, the way that Chinese children view
      the nature and meaning of poverty, as well as their responses to it and to any psychosocial
      interventions, will in all likelihood differ considerably from those of Western children.
      Hence, the aim of this study is to explore the impacts of poverty and income disparity on the
      psychological well-being of Hong Kong Chinese children.
    

Intervention name(s): Questionnaires
Intervention type(s): Other
Intervention description(s): Participants were asked to respond to the Chinese version of the Center for Epidemiologic Studies Depression Scale for Children, the Rosenberg self-esteem scale, and the Pediatric Quality of Life Inventory.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Hong Kong Chinese pupils from Grades 5 and 6 of the elementary schools in Hong Kong
Epstein-Barr Virus Status in Diffuse Large B Cell Lymphoma
Condition: Diffuse Large B-cell Lymphoma
MeSH terms: Epstein-Barr Virus Infections; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Observational

Summary: 
      The investigators analyzed clinical outcome in DLBCL patients according to age group to
      define the impact of EBV status on the clinical outcome.
    

Detailed description: 
      Epstein-Barr virus (EBV) positive diffuse large B-cell lymphoma (DLBCL) has been recognized
      as a new provisional entity in the 2008 World Health Organization (WHO) classification of
      tumors of hematopoietic and lymphoid tissue. This lymphoma is defined as EBV+ clonal B-cell
      proliferation in immunocompetent adults older than 50 years. To denote patient age in
      definition of this disease, age cutoff was defined as older than 50 years. However, this
      cutoff is clearly arbitrary without any scientific background. the knowledge on EBV+DLBCL in
      young adult is very scanty. This EBV+DLBCL in young adult can be the same disease entity or
      it can be a distinct disease form EBV+DLBCL of elderly.
    

Intervention name(s): EBER
Intervention type(s): Other
Intervention description(s): EBV RNA was detected by an in situ hybridization (ISH) technique using the EBV ISH kit (Leica Microsystems, Bannockburn, IL, USA).
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        (1) pathologically confirmed de novo DLBCL, according to the World Health Organization
        (WHO) classification: (ii) registered in Samsung Medical Center (SMC) Lymphoma Cohort Study
        I/II (ClinicalTrials.gov Identifier: NCT00822731, NCT01877109) or identified from Asan
        Medical Center (AMC) medical database: (iii) adequate amount and quality of
        paraffin-embedded biopsy specimen or unstained slides for EBV-encoded RNA (EBER) in situ
        hybridization.
      
Biospecimen description: 
      EBV RNA was detected by an in situ hybridization (ISH) technique using the EBV ISH kit (Leica
      Microsystems, Bannockburn, IL, USA).
    
Keywords: diffuse large B-cell lymphoma; Ebstein-Barr Virus
A Phase 1 Study to Evaluate The Effect of Ketoconazole on the Pharmacokinetics of Tivozanib in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the effect ketoconazole on the Pharmacokinetic profile of
      tivozanib.
    

Detailed description: 
      This Phase 1, open-label, two-period, single-sequence study is designed to evaluate the
      effect of steady-state ketoconazole on the PK profile, safety, and tolerability of a single
      1.5-mg tivozanib dose. On Day 1 of the first period, subjects will receive a single 1.5-mg
      dose of tivozanib and remain at the unit for at least 48 hours postdose followed by
      outpatient visits for PK sampling and safety assessments up to 3 weeks postdose. For Period
      2, subjects will be administered 400 mg of ketoconazole once daily (QD) for 3 days. On the
      4th day of Period 2, 1.5mg of tivozanib will be administered with 400mg of ketoconazole. PK
      sampling will continue for 3-weeks postdose while the subjects continue to receive 400mg of
      ketoconazole daily. An end of study visit will be completed 1-week after the last dose of
      ketoconazole.
    

Intervention name(s): tivozanib
Intervention type(s): Drug
Intervention description(s): Tivozanib is a novel and potent pan-vascular endothelial growth factor (VEGF) receptor (VEGFR) tyrosine kinase inhibitor with potent activity against all 3 VEGFRs (VEGFR-1, -2, and -3). In nonclinical models and studies performed in humans, tivozanib has shown strong antiangiogenesis and antitumor activity.
Intervention MeSH terms: Tivozanib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AV-951; Tivozanib; Healthy Subjects; ketoconazole; Pharmacokinetics
Smartphone Application Based Reminder Therapy in Orthodontic Patients
Condition: Orthodontic Appliance Complication
Study type: Interventional

Summary: 
      This randomized control trial was performed to asses the efficiency of smartphone application
      based reminder therapy on plaque control and oral hygiene at two points in time.
    

Detailed description: 
      This randomized controlled trial was performed to assess the effect of the smartphone
      application based reminders for oral hygiene reinforcement on orthodontic patients. Methods:
      60 orthodontic patients were randomly allocated to either control or experimental group (30
      each). Experimental groups received reminders twice a day by a smartphone application. Plaque
      scoring was done by using Turesky modified Quigley-Hein plaque index (TMQHPI) at
      baseline(T0), after 2 weeks(T1) and after 6 weeks(T3). Results: Significant difference in
      plaque scores was found at T2(6 weeks), but no significant difference was found at T1(2
      weeks). Conclusions: Active smartphone-based reminder therapy for oral hygiene maintenance
      during fixed appliance orthodontic treatment decreases the plaque scores in patients in
      medium to long term
    

Intervention name(s): Smartphone application based reminder
Intervention type(s): Other
Intervention description(s): Brushing reminders were given to the patients in experimental group through a smartphone application twice daily
Other intervention name(s): Routine oral hygiene instructions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Control Trial
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: oral hygiene; smartphone application; plaque index
Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum
Condition: Colon Polyp
MeSH terms: Polyps
Study type: Interventional

Summary: 
      Adenomas are premalignant polyps of the colon that should be resected endoscopically.
      Complete resection of adenomatous polyps is the major task of colonoscopy. In some cases
      polyp may be poorly accessible making endoscopic resection difficult. Polypectomy may be
      conducted using the so-called piece meal technique in these cases. However, leaving polyp
      residual polyps in the colon bears the risk of malignant degeneration as colorectal cancer
      may arise form adenomatous remnants. In case of difficult polyp locations endoscopic
      resection may also be time consuming. On the other hand endoscopists are facing an increased
      time pressure due to rising numbers of procedures during the last decades.

      The Endocuff Vision device (EVD) is a cap that can be mounted to the tip of a standard
      endoscope. The EVD has small flexible branches on its outside. The branches turn out during
      withdrawal. By that the branches are getting in contact with colonic wall. This mechanism
      leads to a more stabilized position of the colonoscope in the bowel. It is hypothesized that
      resection circumstances may be improved by using an EVD. In addition, stabilizing the scope
      during resection may result in a reduced time effort. Until now no controlled trials exist
      investigating the effect of EVD on the time effect during polyp resection. Therefore a
      randomized controlled trial needed comparing standard polypectomy versus polypectomy using
      the EVD during routine colonoscopy procedures.
    


Intervention name(s): Endocuff Vision assisted polypectomy; Standard polypectomy
Intervention type(s): Device; Other
Intervention description(s): EVD mounted to the tip of the endoscope, therefore EVD assisted polypectomy; Absence of an EVD, standard polypectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: colonoscopy; polyp; resection
Parent Training in Child Safety Practices
Condition: Injury
Study type: Interventional
Phase: Phase 2

Summary: 
      This project completed an intervention designed to teach parents of children aged 0-2 years
      of age how to prevent injuries to their child. The intervention consisted of a two DVD
      package with information on creating a safe home environment and correctly choosing and
      installing an appropriate car safety seat. The study hypothesis was that parents who used the
      intervention would score significantly higher on measures of knowledge, motivation, intention
      and self-efficacy in implementing injury prevention strategies.
    


Intervention name(s): Keeping Baby Safe 2-DVD package; The Injury Prevention Program (TIPP) sheets
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Keeping Baby Safe is a 2-DVD package that teaches childhood injury prevention skills to parents of children from birth to 24 months of age. One DVD addresses automobile passenger safety and focuses on the correct choice and proper installation of child safety seat for the age of the parent's child. The second DVD covers a core set of home safety skills: (a) preventing falls, (b) preventing fires and burns, (c) preventing poisoning, (d) firearm safety, (e) preventing drowning, (f) preventing suffocation and choking, (e) play equipment safety, and (f) animal safety. Content in the home safety DVD is based on information the American Academy of Pediatrics (AAP) recommends that physicians provide to parents during well-baby visits.; American Academy of Pediatrics The Injury Prevention Program (TIPP) sheets. Paper-based information sheets parents would typically receive from their pediatrician or general practitioner at well-baby visits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: injury; child; cars; pedestrians; child safety; interactive; computer; prevention; internet; CD-ROM