bioihbjkbjnl/mcl2 huggingface dataset:
FX-322 in Adults With Severe Sensorineural Hearing Loss
Condition: Hearing Loss, Sensorineural; Noise Induced Hearing Loss; Sudden Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Loss, Noise-Induced; Hearing Loss, Sudden
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b, prospective, randomized, double-blind, placebo-controlled, single-dose,
      multicenter, safety study of FX-322, administered by intratympanic injection, in adults with
      severe sensorineural hearing loss.
    

Detailed description: 
      This is a Phase 1b placebo-controlled, double-blind, single-dose safety study of
      intratympanic FX-322 dosed in subjects with severe sensorineural hearing loss.

      Approximately 30 subjects are planned to be enrolled in this study. The subjects will be
      randomized to receive one dose FX-322 (24) or placebo (6) and will return for safety,
      otologic, and audiologic assessments at Days 30 and 90 after the study injection.
    

Intervention name(s): FX-322; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Active Comparator; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Approximately 30 subjects are planned to be enrolled in this study. The subjects will be randomized to receive FX-322 or placebo randomized 4:1.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intratympanic administration; Restoration of hearing loss
Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blind, placebo-controlled study to be conducted in
      the United States in subjects with atopic dermatitis.
    


Intervention name(s): Tradipitant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Capsule; Oral Capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Pruritus; Eczema
Incremental Clomiphene Citrate Doses in Successive Cycles and FSH, LH and Steroid Hormone Levels
Condition: Unexplained Infertility; Ovulation Disorder
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was planned to assess the initial and endogenous FSH, LH and steroid responses to
      incremental CC doses in successive ovulation induction cycles to treat anovulation in
      patients with unexplained infertility.
    

Detailed description: 
      In the Bagcilar Research and Training Hospital Obstetrics and Gynecology department
      outpatient clinic for infertility, the basal gonadotropin and androgen levels are routinely
      measured. In unexplained infertility couples with normal ovarian reserves the first line drug
      used for ovulation induction is CC. The starting dose is 50mg/day and the treatment is
      started within the 2nd to the 5th days of the menstrual cycle and continued for 5 days.
      Starting on the 2nd-3rd day following the last dose of the drug, the follicular growth was
      monitored with the transvaginal ultrasound and blood levels of hormones including FSH, LH,
      estradiol, progesterone, androstenedione, testosterone, and dehydroepiandrosterone sulphate
      were measured every 2-3 days. In this follow-up, if no follicular growth was observed day21
      of the cycle, the CC dose was increased to CC 100mg/day (2X1, 50mg). If follicular growth and
      ovulation is achieved with no concluding conception, the same dose of CC is used in the
      following 2-3 cycles. When a maximum number of 2 dominant follicles are obtained ovulation is
      triggered with recombinant human chorionic gonadotropin (rhCG) and timed coit or intrauterine
      insemination is conducted.
    

Intervention name(s): Clomiphene Citrate
Intervention type(s): Drug
Intervention description(s): Clomiphene citrate used in incremental doses in nonresponsive cases.
Other intervention name(s): CC
Intervention MeSH terms: Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: infertility; unexplained infertility; ovulation induction; clomiphene citrate
Voiding Class Study for Symptom Reduction and Quality of Life in Children With LUTS
Condition: Lower Urinary Tract Symptoms
MeSH terms: Lower Urinary Tract Symptoms
Study type: Observational

Summary: 
      Lower urinary tract dysfunction (LUTD) is a common pathology within children and shows a wide
      spectrum of lower urinary tract symptoms (LUTS). These symptoms have a significant impact on
      a child's well-being. For the treatment of LUTS in children urotherapy, a non-medicamentous
      form of therapy, is implemented as standard therapy. It can be described as a bladder
      re-education and rehabilitation programme where the participants are informed on the anatomy
      and physiology of the normal and pathological urinary system. Urotherapy has been offered as
      individual therapy for a long time but is now also offered as group therapy (the voiding
      school). This is, as compared to the individual therapy, more cost-effective and gives the
      participants the feeling not to be alone in the situation. The effectiveness of the
      individual therapy for children with LUTD has already been determined, however little
      research has been done on the effectiveness of urotherapy in group (the voiding class). The
      present study wants to investigate the effect of the group therapy on the symptoms and
      quality of life of children with LUTD.
    

Detailed description: 
      The current study is a prospective cohort-study in which information of the impact of the
      voiding class on the symptoms and well-being of the children is obtained through two
      questionnaires, respectively the Vancouver Symptom Score for Dysfunctional Elimination
      Syndrome (VSSDES) and the Paediatric Incontinence Questionnaire (PinQ). Participants of this
      study are as well asked to complete drinking and voiding charts and nocturnal diaries. These
      questionnaires and documents are filled in before and after the voiding class. The collected
      data will be further analysed statistically trough Statistical Package for the Social
      Sciences (SPPS), to determine significant improvements in symptoms and quality of life.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with Lower Urinary Tract Dysfunctions attending the group urotherapy, the voiding
        school
      
Keywords: Voiding class; Quality of Life; Children
Aztreonam Lysine for Pseudomonas Infection Eradication Study
Condition: Cystic Fibrosis
MeSH terms: Pseudomonas Infections; Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, multi-center study in pediatric patients age 3 months to less than 18
      years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary
      colonization/infection. All eligible participants will be treated with a 28-day course of
      Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily. After completion of study drug,
      subjects will be followed up through Day 196 for safety and recurrence of PA.

      The primary objective is to evaluate the proportion of participants with PA-negative cultures
      at all time points during a 6-month monitoring period (through Day 196) after cessation of
      AZLI treatment. Microbiological cultures will be obtained at Baseline, Day 28 (end of AZLI
      treatment), Day 56 (1 month after completing AZLI treatment), Day 112 (3 months after
      completing AZLI treatment), and Day 196 (6 months after completing AZLI treatment).
    


Intervention name(s): Aztreonam for Inhalation Solution (AZLI)
Intervention type(s): Drug
Intervention description(s): AZLI 75 mg administered 3 times daily via the investigational eFlow® nebulizer
Other intervention name(s): Cayston®
Intervention MeSH terms: Aztreonam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic fibrosis; CF; PA; Pseudomonas aeruginosa; AZLI; aztreonam
A Study to Assess the Safety of MEDI7836 in Healthy Adults.
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety of a single ascending dose of MEDI7836 in healthy adult male subjects
      and healthy adult female subjects of non-childbearing potential.
    

Detailed description: 
      This is a Phase 1a, randomised, blinded (the investigator and subject will be blinded to
      treatment assignment and sponsor will be unblinded to treatment assignment),
      placebo-controlled study to evaluate the safety of single-ascending SC doses of MEDI7836 in
      healthy adult males subjects and healthy adult female subjects of non-childbearing potential.
      The study will be conducted at a single site in the United Kingdom (UK). Four dosing cohorts
      of MEDI7836 or placebo are planned for this study for a total of 32 subjects (24 subjects
      receiving MEDI7836, 8 subjects receiving placebo).
    

Intervention name(s): Placebo SC; MEDI7836 Dose 1; MEDI7836 Dose 2; MEDI7836 Dose 3; MEDI7836 Dose 4
Intervention type(s): Drug; Biological; Biological; Biological; Biological
Intervention description(s): Participants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1.; Participants will receive a single-dose of MEDI7836 Dose 1 SC injection on Day 1.; Participants will receive a single-dose of MEDI7836 Dose 2 SC injection on Day 1.; Participants will receive a single-dose of MEDI7836 Dose 3 SC injection on Day 1.; Participants will receive a single-dose of MEDI7836 Dose 4 SC injection on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effectiveness of Therapy Via Telemedicine Following Cochlear Implants
Condition: Congenital Sensorineural Deafness
MeSH terms: Deafness; Hearing Loss, Sensorineural
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the effectiveness of post-cochlear implant or hearing aid fitting
      Aural Rehabilitative Therapy (ART) delivered by means of telemedicine technology.
    

Detailed description: 
      Children with congenital sensorineural deafness can acquire relatively normal language if
      they undergo cochlear implantation surgery or hearing aid fitting followed by aural
      rehabilitation therapy in the first three to four years of life. High quality therapy,
      however, may not be available in many areas. This study will assess the effectiveness of
      post-cochlear implant or hearing aid fitting ART delivered by means of telemedicine
      technology. This will be accomplished primarily by evaluating subjects' language abilities
      using the 5th Edition of the Preschool Language Scales.
    

Intervention name(s): Telemedicine; In-person ART
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Half of subjects will undergo six months of ART administered via telehealth. Therapy will be provided in the usual manner, except a computer will be used to facilitate the interaction.; Half of subjects will undergo six months of ART administered in person. Therapy will be provided in the usual manner.
Other intervention name(s): Telehealth; Standard of Care
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Cochlear Implant; Hearing Aid; Telemedicine
Assessment of Visual Field-related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy
Condition: Non-arteritic Ischemic Optic Neuropathy
MeSH terms: Optic Nerve Diseases; Optic Neuropathy, Ischemic; Ischemia
Study type: Observational

Summary: 
      This present research project intends to collect five quantitative test series:

        -  perimetric examination using static stimuli, assessing the entire (80 degree) visual
           field with a fast thresholding algorithm (GATE) [Schiefer 2008] to know the extent/
           magnitude of the visual field defect and its variability within the cohort and over time

        -  D-BCVA, using FrACT [Bach 2007] and EDTRS chart [Ferris 1982]

        -  RAPD (using swinging flashlight test).

        -  IOP (using applanation tonometer)

        -  RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm, and volume scan) Optic
           disk morphology will be documented by fundus photography. This assessment of the
           above-mentioned data is needed in order to allow for estimation of the spontaneous
           course / fluctuation of the (quantified) functional and morphometric parameters of the
           N-AION patients during the follow-up period. This is essential for the estimation of the
           sample size of the subsequently intended SINN study, that is intended to compare
           different therapeutic strategies in N-AION patients.
    


Intervention name(s): perimetry; D-BCVA; RAPD; IOP; Spectralis OCT; Fundus photography
Intervention type(s): Device; Other; Other; Device; Device; Other
Intervention description(s): perimetric examination using static stimuli, assessing the entire (80 degree) visual field with a fast thresholding algorithm (GATE) [Schiefer 2008] to know the extent/ magnitude of the visual field defect and its variability within the cohort and over time; D-BCVA using EDTRS chart; RAPD using swinging flashlight test; IOP using applanation tonometer; RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm and volume scan); Optic disk morphology will be documented by fundus photography
Other intervention name(s): Static Perimetry, Octopus 101, thresholding algorithm; Best Corrected Visual Acuity, EDTRS Chart; SWIFT-Test; intraocular pressure; RNFT, RNFV, volume scan, star scan, Spectralis OCT
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with acute N-AION (less then 7 days); male and female > 18 years
      
Keywords: N-AION; perimetry; visual field loss; Mean Defect; Total Loss Volume; D-BCVA; RAPD; retinal nerve fibre thickness/volume; optic nerve head
GSK1349572 First Time in Human Study
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine safety, tolerability and pharmacokinetics of GSK1349572
    


Intervention name(s): GSK1349572
Intervention type(s): Drug
Intervention MeSH terms: Dolutegravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: GSK1349572,; healthy volunteers
Breath Analysis in Children by New Point-of-care Instruments
Condition: Asthma; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Asthma; Fibrosis
Study type: Observational

Summary: 
      In this study new hand-held devices for measuring exhaled breath will be tested in children
      with asthma, CF, and healthy controls. Main objectives will be feasibility and discriminative
      value of these techniques.
    

Detailed description: 
      Rationale: Assessment of volatile organic compounds (VOCs) is a new recently developed
      non-invasive technique to assess airway inflammation. The non-invasive character makes it
      highly suitable for use in (preschool) children. However, the analysis of VOCs by gas
      chromatography mass spectrometry technique (GC-MS), the gold standard, is expensive and time
      consuming. Therefore, new hand-held devices (such as electronic Noses (eNoses) and Ion
      Mobility Spectrometer techniques) have been developed. However, these new point-of-care
      instruments have not been studied in children.

      Objectives: 1) To test whether new point-of-care instruments for the measurement of VOCs in
      exhaled breath are feasible for use in children aged 6 to 16 years; 2) To explore whether
      these techniques can differentiate between healthy children, asthmatic children and children
      with Cystic Fibrosis (CF).

      Study design: Cross-sectional study design. Several VOCs tests will be performed in all
      participants.Besides, fraction of exhaled nitric oxide (FeNO) and inflammatory markers in
      exhaled breath condensate (EBC) will be measured.

      Study population: Three groups of children aged 6 to 16 years: 20 healthy children, 20
      children with doctor's diagnosed asthma, 20 children with CF.

      Main study parameters/endpoints: Each technique will be evaluated for its use and feasibility
      in children. For each technique, VOC profiles between study groups will be evaluated for its
      discriminative power.
    

Intervention name(s): inflammation markers in exhaled breath
Intervention type(s): Diagnostic Test
Intervention description(s): non-invasive, cross-sectional, assessment of inflammation markers in exhaled breath with various techniques (observational)
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Three groups of children aged 6 to 16 years: 20 healthy children, 20 children with doctor's
        diagnosed asthma, 20 children with CF.
      
Biospecimen description: 
      inflammation markers in exhaled breath
    
Keywords: paediatrics; breath analysis; volatile organic compounds; respiratory diseases
Anterior Lingual Frenectomy is Inadequate in Improving Breastfeeding Outcomes: a Prospective Cohort Study
Condition: Ankyloglossia; Breastfeeding
MeSH terms: Ankyloglossia
Study type: Interventional

Summary: 
      A previously published study (https://www.ncbi.nlm.nih.gov/pubmed/27641715) identified
      breastfeeding improvements following lingual frenotomy and/or maxillary labial frenectomy. In
      the previous cohort, babies were excluded from the study if they had previously undergone an
      attempted frenotomy prior to seeing the P.I. in the office. The proposed study will only look
      at those babies who did undergo a previous frenotomy to determine:

        1. the presence of continued problematic breastfeeding symptoms

        2. if further tongue tie or lip tie release improves those outcomes
    


Intervention name(s): Lingual frenotomy and/or maxillary labial frenectomy
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ankyloglossia; breastfeeding; lip tie
Early Evaluation of Chemosensitivity for Low/Intermediated-risk Mid-low Stage II/III Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Chemosensitivity of rectal cancer is not discussed clearly. With previous study, the
      investigators design this phase II trial to explore the effect of 2 cycles Xelox
      chemotherapy,so as to explore the early detection of sensitivity of tumor. With inclusion of
      early,intermediate,and bad stage II/III rectal cancer patients, four cycle of Xelox
      chemotherapy was given. After the second cycle, MRI,TRUS,DE,endoscopy,and blood DNA test was
      down to compare with these characteristics of four cycles.so that to detect the data about
      the chemosensitivity of tumor in the early stage.
    

Detailed description: 
      Chemosensitivity of rectal cancer is not discussed clearly. With previous study, the
      investigators design this phase II trial to explore the effect of 2 cycles Xelox
      chemotherapy,so as to explore the early detection of sensitivity of tumor. With inclusion of
      early,intermediate,and bad stage II/III rectal cancer patients, four cycle of Xelox
      chemotherapy was given. After the second cycle, MRI,TRUS,DE,endoscopy,and blood DNA test was
      down to compare with these characteristics of four cycles.so that to detect the data about
      the chemosensitivity of tumor in the early stage.In future, a phase III trial that explore
      the effect of radiation or surgery in these chemoresistant patients.
    

Intervention name(s): XELOX
Intervention type(s): Drug
Intervention description(s): Xelox chemotherapy,that oxaliplatin 130mg/m2 d1,capecitabine 1000mg/m2 twice daily d1-14,every 3 weeks
Intervention model: Single Group Assignment
Intervention model description: a group of patients receive 4 cycle of Xelox chemotherapy, MRI,TRUS, DE,endoscopy, blood DNA test,before, between and after chemotherapy was compared to detect the effect of chemotherapy in 2 cycles.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rectal cancer；; neoadjuvant Chemotherapy
Conventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Bariatric surgery has been established as the best treatment for morbid obesity, compared
      with diet or medical treatment. Laparoscopic approach have improved the results of this
      surgery in terms of postoperative pain, reduction in the number of complications and hospital
      stay, as well as better cosmetic results. Conventional laparoscopic technique requires five
      to seven abdominal incisions to facilitate placement of the multiple trocars. New Single
      Incision Laparoscopic Surgery (SILS)has been developed as a new technique where only one
      incision is needed for the introduction of all trocars. Altough this technique can be
      performed with conventional laparoscopic instruments, new devides have been developed for
      facilitate this operations by SILS. The investigators think that reducing the number of
      incision would decrease the postoperative pain and improve cosmetic results in our patients,
      being a safe and technically feasible intervention supported by these special devices.
    


Intervention name(s): Convetional laparoscopic Sleeve Gastrectomy; SILS Sleeve gastrectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Convetional laparoscopic sleeve gastrectomy using 5 ports (incisions) in the abdominal wall; Single incision Sleeve gastrectomy using only one port (incision) on the abdominal wall assisted by an special Traction Device for single port surgery (Endograb)
Other intervention name(s): Endograb™ (Virtual Ports, Misgav, Israel)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment