bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Evaluation on Using Personal Face Masks With Spectacles Versus Contact Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The aim of this study was to explore satisfaction with vision correction and ease of use of
      PFM (Personal Face Masks) in a group of spectacle wearers who were randomised to continue
      wearing spectacles or be fitted with daily disposable contact lenses.
    

Detailed description: 
      This was a two arm parallel-group, randomised study. Subjects wearing single vision
      spectacles were recruited to participate in the study. Subjects were randomised to either
      continue to use their spectacles or to be fitted with the study daily disposable (DD) contact
      lens.
    

Intervention name(s): somofilcon A Daily Disposable Contact Lens; Single Vision Spectacle for Vision Correction; Personal Facemask
Intervention type(s): Device; Device; Other
Intervention description(s): Daily Disposable Contact Lens; Single Vision Spectacle; Personal Facemask
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Olanzapine Versus Active Comparator in the Treatment of Depression in Patients With Schizophrenia
Condition: Depression; Schizophrenia; Schizoaffective Disorder
MeSH terms: Depression; Depressive Disorder; Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a research study comparing the safety and efficacy of two active study medications
    


Intervention name(s): olanzapine; ziprasidone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olanzapine; Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Depression; Comorbid Depression; Schizophrenia; Schizoaffective Disorder
Effects of a Hydroxyapatite-based Mouth Gel on Calcium Content of Plaque
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this pilot study is to analyze if a hydroxyapatite-containing mouth gel has an
      influence on the calcium content of plaque.
    

Detailed description: 
      >= 20 subjects (7-11 years) use the hydroxyapatite-containing mouth gel for 3 days (3x per
      day); without using any other oral care product at this time. A dentist applies the gel on
      all teeth. At baseline and after 3 days plaque will be collected from buccal and labial
      surfaces (except surfaces with tartar). A "split-mouth" concept will be used:

      Subjects in group A:

      Baseline plaque collection: quadrant 1 and 4 Plaque collection after 3 days: quadrant 2 and 3

      Subjects in group B:

      Baseline plaque collection: quadrant 2 and 3 Plaque collection after 3 days: quadrant 1 and 4
      (The time between last application of the gel and plaque collection will be 1 h) The plaque
      will be dried and afterwards the calcium content of the plaque will be quantitively analyzed
      by atomic absorption spectroscopy (AAS).

      For all subjects: Calcium contents of plaque at baseline and after 3 days application will be
      compared by statistical methods.
    

Intervention name(s): Mouth gel
Intervention type(s): Other
Intervention description(s): Stop using the mouth gel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease
Condition: Dry Eye
MeSH terms: Neuralgia; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Study type: Interventional

Summary: 
      This project is designed as a prospective, randomized, open, controlled clinical trial. For
      the first time, acupuncture was applied to the treatment of dry ocular neuropathic pain. Its
      mechanism was discussed by comparing the efficacy between acupuncture and artificial tears.
    


Intervention name(s): Sodium hyaluronate eye drops; acupuncture
Intervention type(s): Drug; Other
Intervention description(s): eye drops, three times a day; three times a week
Other intervention name(s): artificial tears
Intervention MeSH terms: Ophthalmic Solutions; Lubricant Eye Drops; Hyaluronic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dry eye; pain; acupuncture
To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relationship between plasma drug levels and
      receptor binding in brain using PET; and to evaluate safety and tolerability after a single
      administration of PF-04995274 in healthy volunteers.
    


Intervention name(s): PF-04995274
Intervention type(s): Drug
Intervention description(s): Single dose of up to 5 mg PF-04995274, delivered in solution on study day 1
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy Volunteers
Testing BRCA 1/2 Mutation Using Next Generation Sequencing
Condition: Breast Neoplasms; Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Testing BRCA 1/2 mutation is important for patients with breast cancer, and Sanger sequencing
      is a standard method to identify BRCA 1/2 mutation. Next generation sequencing (NGS) is a
      high-throughput parallel sequencing that can provide genetic information with high accuracy.
      NGS is a faster and cost-effective method to detect gene mutations compared to Sanger
      sequencing. In this study, we evaluated the clinical role of NGS testing for BRCA 1/2
      compared to Sanger sequencing.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with breast cancer
      
Keywords: breast neoplasms, BRCA1, Sanger, NGS, Next generation sequencing
Integrated Interdisciplinary Program for Fall Prevention in Hospitalized Patients
Condition: the Fall Rates; the Severity of Injuries
Study type: Interventional

Summary: 
      Falls are very common accidents in Hospital. It not only results in injuries, less mobility
      among patients but increases their length of stay, cost and family burdens. Reducing the
      rates and injuries of falls is an urgent issue around hospitals.

      An integrated multidisciplinary fall prevention program (IMFPP) was implemented from 2006 in
      CCH. Members include physicians, nurses, case manager therapists, engineers and staffs of
      maintenance. The aim of this study is to determine whether IMFPP efforts support
      interventions with multiple components do reduce the fall rates and severity of injuries.
    


Intervention name(s): integrated multidisciplinary fall prevention program
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Unnecessary Gastric Decompression in Distal Elective Bowel Anastomoses in Children. A Randomized Study
Condition: Unnecessary Nasogastric Tube; Bowel Anastomosis
Study type: Interventional

Summary: 
      Objective. To study the role of nasogastric drainage to prevent postoperative complications
      in children with <b>distal</b> elective bowel anastomosis. Summary Background Data.
      Nasogastric drainage has been used as a routine measure after gastrointestinal surgery in
      children and adults, to hasten bowel function, prevent post operative complications and
      shorten hospital stay. However, there is no former study that states in a scientific manner
      its benefit in children. Methods. The investigators performed a clinical controlled,
      randomized trial, comprising 60 children that underwent distal elective bowel anastomoses
      comparing post operative complications between a group with nasogastric tube in place (n=29)
      and one without it (n=31). <b>As an equivalence study the investigators expected that the two
      techniques were equivalent.</b> Statistics: Descriptive statistics for global description.
      Student's t test for quantitative variables and chi square test for qualitative variables.
      Considering statistically significant a p-value less than 0.05. <b>Being an equivalence
      study, the default delta generated by the Stata command "equim" was used to demonstrate the
      equivalence between both groups.</b> Results: Demographic data and diagnosis were comparable
      in both groups (p=NS). No anastomotic leakage or entero-cutaneous fistulae was found in any
      patient. The investigators demonstrated equivalency since each confidence interval is
      entirely contained within delta, except for one variable (beginning deambulation), in which
      equivalency is suggested. There were no significant differences between groups in abdominal
      distention, infection, or hospital stay variables. Only one patient in the experimental group
      required placement of the nasogastric tube due to persistent abdominal distension (3.2%).
      Conclusions. The routine use of nasogastric drainage can be eliminated after distal elective
      intestinal surgery in children. It's use should be individualized.
    


Intervention name(s): Non application of nasogastric tube in the experimental group
Intervention type(s): Other
Intervention description(s): Avoid the 5 post operative application of nasogastric tube in the experimental group vs the control group with the usual nasogastric tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Bowel anastomosis; nasogastric tube; children
Safety, Pharmacokinetic, and Tolerability Study of Zecuity® in Adolescent Subjects With a History of Acute Migraine
Condition: Acute Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a Phase 1, multiple center, open label, single-dose study in otherwise healthy
      adolescent subjects with a history of acute migraine. Subjects will each receive one Zecuity
      patch application. Subjects will be admitted 2 hours prior to dosing on Day 1, and will
      remain in the clinical unit under supervision until the last pharmacokinetic (PK) sample is
      obtained. Blood will be obtained at prescribed times for PK analysis and safety assessments
      will be performed, including adverse event monitoring, 12-lead ECG test, patch adhesion
      evaluations, skin irritation evaluations, and vital signs.
    


Intervention name(s): PROT-CL-NP101-015.01
Intervention type(s): Drug
Other intervention name(s): Zecuity®; Sumatriptan
Intervention MeSH terms: Sumatriptan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Investigate the Effect of Food on Pharmacokinetics of Total EPA and Total DHA of AZD0585 in Healthy Male Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of food timing on pharmacokinetics (PK) of
      AZD0585 and the effect of food timing on tolerability and safety of AZD0585 in healthy male
      Japanese subjects.
    

Detailed description: 
      This study is an open-label, randomized, cross-over design with three single-dose treatment
      periods and a washout of at least 10 days in between each treatment visit. The study period
      consists of 5 visits to the study centre: Visit 1 (enrolment), Visit 2 (first single-dose
      treatment), Visit 3 (second single-dose treatment), Visit 4 (third single-dose treatment) and
      Visit 5 (follow-up).

      Target subject population is healthy male Japanese subjects aged 20-45 years. Following an
      overnight fast of at least 10 hours, a single dose of 4 g AZD0585 will be administered on 3
      separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion
      with different food restrictions.
    

Intervention name(s): AZD0585
Intervention type(s): Drug
Intervention description(s): Following an overnight fast of at least 10 hours, a single dose of 4 g AZD0585 will be administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: the effect of food timing on PK; the effect of food timing on Safety and Tolerability; AZD0585; Japanese
Concentration Controlled Everolimus With Reduced Dose Cyclosporine Versus Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      The 12 Month Core Study (CRAD001A1202) was designed to evaluate the efficacy and safety
      comparing concentration-controlled everolimus (1.5 mg/day starting dose) with reduced dose
      cyclosporine and corticosteroids versus 2 g/day mycophenolate mofetil (MMF) with standard
      dose cyclosporine and corticosteroids in de novo renal transplant recipients.

      Extension Study (CRAD001A1202E1): Until 24 months after renal transplantation, the study was
      designed to evaluate the long-term safety and efficacy comparing concentration-controlled
      everolimus with reduced dose cyclosporine (Neoral®) and corticosteroids versus mycophenolate
      mofetil with standard dose Neoral® and corticosteroids in de novo renal transplant
      recipients. Beyond 24 months after renal transplantation, the study was designed to provide
      everolimus treatment for patients in everolimus group until everolimus is approved and
      marketed in Japan.
    


Intervention name(s): Everolimus; Mycophenolate mofetil (MMF); Basiliximab; Cyclosporine A; Corticosteroid
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.75 mg twice daily, trough level adjusting between 3 and 8 ng/ml.; The initial dose of 2 gm/day Mycophenolate mofetil was started within 24-36 hours from reperfusion after transplantation. MMF was administered daily for 12 months in the core study and 12 months in the extension study.; Patients received first dose of basiliximab (20 mg) 2 hours prior to transplantation and 20 mg at Day 4 or according to local practice; The cyclosporine was initiated either pre-transplant or within 24 hours after transplantation following local regime. Standard dose of cyclosporine was administered with MMF. The Reduced dose of cyclosporine was administered with everolimus.; Corticosteroid was administered according to local practice during the trial but at a dose not less than 5mg per day for 12 months of the study
Other intervention name(s): Certican; MMF; Neoral®
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Cyclosporins; Basiliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Renal transplantation; everolimus; mycophenolate mofetil; cyclosporine; corticosteroid; basiliximab; Banff diagnosis; Acute rejection; Therapeutic drug monitoring (TDM); de novo renal transplant recipient
Docetaxel and Capecitabine in Advanced Gastric Cancer
Condition: Stomach Neoplasm; Neoplasm Metastasis
MeSH terms: Neoplasms; Neoplasm Metastasis; Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Up to date there is no worldwide accepted standard chemotherapy for the 1st-line treatment of
      advanced or metastatic gastric cancer.A combination of epirubicin, cisplatin and 5-FU (ECF)
      is the best examined combination and widely used. Recent studies (Thuss-Patience et al, J.
      Clin. Oncol. 2005) could show that a combination of docetaxel and 5-FU might be similarly
      effective as ECF. 5-FU and docetaxel +/- cisplatin combinations are investigated by many
      groups and may be a future reference treatment. Many data suggest that 5-FU infusion can be
      replaced by oral capecitabine with equal efficacy.

      As docetaxel/5-FU is probably similarly effective as epirubicin/cisplatin/5-FU and a
      replacement of 5-FU infusion by capecitabine makes the chemotherapy more comfortable for the
      patient we investigate in this study a chemotherapy of docetaxel and capecitabine as 1st-line
      therapy for metastatic or advanced gastric cancer.
    

Detailed description: 
      Patients with locally advanced or metastatic gastric adenocarcinoma who did not receive any
      prior chemotherapy for advanced disease can be enrolled in the study.

      Patients are treated with oral capecitabine 1000mg/sqm twice per day on the days 1-14 and
      docetaxel 75 mg/sqm on day 1 as a 1 hour i.v. infusion. chemotherapy is repeated every 21
      days. Staging by imaging is performed every 2 cycles.

      After 40 included patients an amendment was done and the starting of chemotherapy has been
      reduced to further improve tolerability. Starting dose of docetaxel was amended to 60 mg/sqm,
      d1, and starting dose of capecitabine reduced to 800 mg/sqm twice per day, d1-14. The patient
      number to be included was increased to 70 pts.

      Therapy is continued up to tumor progression to a maximum of 10 cycles. Therapy is stopped in
      case of severe side effects, tumor progression or withdrawal of consent.

      This investigator initiated study is supported by Hoffmann-La Roche and by Sanofi-Aventis.
    

Intervention name(s): Docetaxel; Capecitabine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Docetaxel; Capecitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastric cancer; metastatic; locally advanced; docetaxel; capecitabine
Gemcitabine/Taxotere/Xeloda (GTX) With Cisplatin in Subjects With Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objectives

      To assess the efficacy of the combination of gemcitabine, taxotere, and xeloda (GTX) with
      cisplatin in subjects with metastatic pancreatic cancer based on the progression-free
      survival (PFS) rate at 6 month.

      Secondary Objectives

        -  To assess safety and characterize toxicities of the combination of GTX with cisplatin in
           subjects with metastatic pancreatic cancer.

        -  To estimate disease control rate (DCR), PFS, and overall survival (OS).

        -  To estimate a PFS rate of an expansion cohort testing an alternative schedule.

      Study Design

      This study is a single arm phase II study to assess the efficacy of GTX with cisplatin in
      subjects with metastatic pancreatic cancer. Approximately 38 evaluable subjects will be
      enrolled, 28 in the initial cohort and 10 in the expansion cohort

      The study will have a safety run-in phase consisting of 6 subjects. To ensure that the
      combination is safe, the first six subjects will be treated at DL1 and observed for limiting
      toxicity for the first 2 cycles before continuation with further accrual. After the safety
      run-in, the study will be continuously monitored for adverse events.

      The primary endpoint will be the PFS rate at 6 month, which is defined as the proportion of
      subjects alive, free of disease progression at 6 months. The treatment regimen would be
      considered of insufficient activity for further study in this population if PFS rate at 6
      months is 50% or less, and the minimum required level of efficacy that would warrant further
      study with the proposed regimen is a 75% PFS rate at 6 months. The study design includes
      interim monitoring for futility using a predictive probability approach. We will stop the
      study early if given the information at the interim analysis, it is unlikely that the PFS
      rate at 6 months will be greater than 50% if the study continues to the end.
    


Intervention name(s): Gemcitabine; Taxotere; Xeloda; Cisplatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): IV on Days 4 and 11; IV on Days 4 and 11; orally, twice a day Days 1-14; IV Days 4 and 11
Other intervention name(s): Docetaxel; Capecitabine; Platinol; CDDP
Intervention MeSH terms: Gemcitabine; Docetaxel; Capecitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LY3832479 (LY-CoV016) in Healthy Participants 1
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the safety and tolerability of LY3832479 when it is
      given by injection just under the skin to healthy participants. Blood tests will be done to
      check how much LY3832479 is in the bloodstream and how long the body takes to eliminate it.
      Participation could last up to 16 weeks and may include up to six visits to the study center,
      with a one-week overnight stay.
    


Intervention name(s): LY3832479; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously; Administered subcutaneously
Other intervention name(s): LY-CoV016; Etesevimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science