bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Clinical Trial of Intranasal Dexamethasone as an Adjuvant in Patients With COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This Clinical Trial evaluates nasal administration of Dexamethasone as an adjuvant treatment
      strategy for non-critically ill hospitalized participants with SARS CoV-2 infection.
    

Detailed description: 
      Approximately 30% of the admitted patients with Covid-19 require admission to the intensive
      care unit for respiratory assistance, ranging from a high flow nasal cannula to invasive
      ventilation. These patients are affected by respiratory dysfunctions and even dysfunction of
      the brain respiratory control centers. Additionally, exacerbated inflammation leads to
      endothelial and coagulation disorders that aggravate the course of the illness. No effective
      therapy has yet been found to treat forms SARS-CoV-2 bass. One of the adjunctive therapeutic
      alternatives addressed is the use of intravenously administered glucocorticoids (GC), aimed
      at reducing exacerbated peripheral inflammation. They have been used at early stages of
      infection in high doses and with controversial results. In our laboratory at the Biomedical
      Research Institute from the National Autonomous University of Mexico (UNAM), we have shown
      that dexamethasone, a GC (DXM) administered intranasally, reaches the central nervous system
      through the olfactory nerve (alike various pathogens, including coronaviruses) and reduces
      neuroinflammation more effectively than when applied intravenously. Additionally,
      biodistribution studies indicate that the DXM is detectable from the first minute after its
      application, both in the central nervous system and in the respiratory system. The objective
      of this study is to evaluate the safety, efficacy and tolerability of dexamethasone in
      patients hospitalized with SARS-CoV-2 with moderate-severe forms, with an without the
      requirement of mechanic ventilation, including syndrome of acute respiratory distress or
      pneumonia (as diagnosed by CAT) with alveolar / interstitial lung involvement.
    

Intervention name(s): IV Dexamethasone; Nasal Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): 6 mg from Day 1 to 10 after randomization; 0.12 mg/kg/daily for 3 days from day 1, followed by 0.06 mg/kg/daily from day 4 to 10 after randomization.
Other intervention name(s): ST; Nasal DXM
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, randomized, controlled trial adult patients with confirmed COVID-19 infection
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Dexamethasone; SARS CoV-2 infection; COVID-19; Severe Acute Respiratory Syndrome; Nasal administration
Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male Volunteers
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of escalating doses of
      GS-9411 in healthy male volunteers. GS-9411 is a sodium channel inhibitor, that may restore
      airway hydration and mucociliary clearance in the lung.
    

Detailed description: 
      GS-9411 is being evaluated as a potential therapy to improve airway hydration and mucociliary
      clearance in patients with cystic fibrosis. This study is evaluating the safety and
      tolerability of 3 dose levels of GS-9411 as an inhaled product, compared to a matched
      placebo.
    

Intervention name(s): GS-9411; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled GS-9411 dissolved in sterile saline; Inhaled volume-matched placebo in sterile saline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cystic fibrosis; CF; mucociliary clearance; amiloride; ENaC; ENaC Inhibitor; airway hydration; epithelial sodium channel inhibitor
Training and Calibration of Dental Examiners
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 3

Summary: 
      Training and calibration of dental examiners
    


Intervention name(s): Fluoride; Triclosan; Chlorhexidine gluconate; Fluoride
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Brush half mouth twice daily for four days; Brush half mouth daily for four days; Mouth rinsing with 15 ml for 30 seconds twice a day for four days; Brush half mouth daily for four days
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Triclosan; Fluorides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Image Guided Adaptive Radiotherapy in the Head-and-neck Region
Condition: Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

Summary: 
      Aim of this study is the clinical evaluation of an image-guided adaptive radiotherapy
      concept. This involves the adaption of the radiotherapy treatment plan according to changes
      in tissues and variations in patients position and posture during a radiotherapy treatment
      course, based on repeat CT scans.

      It is investigated, if dosimetric improvements can be achieved using this approach and if the
      method using the software-package "ReDeform" can be implemented in clinical Routine.
    

Detailed description: 
      Aim of this study is the clinical evaluation of an image-guided adaptive radiotherapy (ART)
      concept. This involves the adaption of the radiotherapy treatment plan according to changes
      in tissues and variations in patients position and posture during a radiotherapy treatment
      course, based on repeat CT scans.

      It is prospectively investigated, if dosimetric improvements can be achieved using this
      approach and if the method using the software-package "ReDeform" can be implemented in
      clinical Routine. For that purpose 2 repeat CT scans are acquired during the radiotherapy
      course (week 3 and week 5 of radiotherapy). The Initial CT scan is "matched" to the follow-up
      CT-scan by means of deformable image registration.
    

Intervention name(s): Follow-up CT scans during week 3 and week 5 of treatment
Intervention type(s): Radiation
Intervention description(s): Scheduled follow-up planning CT scan and re-optimisation of the intensity modulation radiation therapy (IMRT)-based radiotherapy Treatment plan. Dosimetric Evaluation and assessment of morphologic changes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ultrasound Staging in the Placenta Accreta
Condition: Obstetric Labor Complications; Staging of Placental Invasion
MeSH terms: Obstetric Labor Complications
Study type: Interventional

Summary: 
      The investigators evaluated the efficacy of a staging system introduced by the American
      Institute of ultrasound in medicine 2015 including sonographic parameters associated with
      morbidly adherent placenta for antenatal prediction of placental invasion.
    

Detailed description: 
      Morbidly adherent placenta (MAP) defines a spectrum of conditions, including placenta
      accreta, increta, and percreta, which are associated with significant maternal and fetal
      morbidity and mortality. Ultrasound evaluation, with grayscale, is the recommended first-line
      modality for diagnosing MAP. Grayscale ultrasound features suggestive of placenta accreta
      include the loss of myometrial interface or retroplacental clear space, reduced myometrial
      thickness and the presence of intraplacental lacunae. Using a staging system by antenatal
      ultrasound can predict placental invasion antenatally.
    

Intervention name(s): Ultrasound
Intervention type(s): Device
Intervention description(s): Pregnant women in 3rd trimester with anterior placenta previa and lower cesarean section scar. Ultrasound was done and according to parameters of the morbidly adherent placenta, a staging system was conducted.
Intervention model: Single Group Assignment
Intervention model description: Pregnant women in 3rd trimester
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of SBP in Patients With LC
Condition: SBP; Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver
      cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several
      antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear
      which drug is most effective. Our aim of study is to compare the efficacy of the three
      current antibiotics for the treatment of SBP in patients with liver cirrhosis.

      The primary hypothesis is that the efficacy of all the antibiotics will not significantly
      different. This is non-inferiority trial.
    

Detailed description: 
      Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver
      cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several
      antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear
      which drug is most effective. Our aim of study is to compare the efficacy of the three
      current antibiotics for the treatment of SBP in patients with liver cirrhosis.

      The primary hypothesis is that the efficacy of all the antibiotics will not significantly
      different. The expected success rates (infection resolution rates) are 83%, 87%, and 78% for
      cefotaxime, ceftriaxone, and ciprofloxacin. This is non-inferiority trial. The level of
      significance is 5%. The power of this stuy is 80%. Non-inferiority margin is 15%. Therefore
      87 patients for each group are needed.
    

Intervention name(s): Cefotaxime; Ceftriaxone; Ciprofloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3 g; 2 g; 400 mg
Intervention MeSH terms: Ciprofloxacin; Ceftriaxone; Cefotaxime; Cefoxitin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SBP; liver cirrhosis; antibiotics
Chlamidia Antibodies Test for Tubal Factor Screening
Condition: Sterility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the usefulness of a Chlamydia Antibody Test for
      screening of tubal factor in patients who undergo artificial insemination.
    


Intervention name(s): CAT test; Histerosalpingography
Intervention type(s): Other; Other
Intervention description(s): A CAT test is performed in order to diagnose tubal factor causes; A Histerosalpingography is performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Chlamidia Antibody test, Hysterosalpyngography, Tubal disease
Pulsed Radiofrequency Treatment in Lumbar Facet-Related Pain
Condition: Facet Joint Pain; Pain Syndrome; Pain, Chronic
MeSH terms: Arthralgia; Chronic Pain
Study type: Interventional

Summary: 
      Facet joint-related pain is one of the leading causes of low back pain. Facet joint-related
      disorders can have a negative impact on quality of life and daily living activities, in
      addition to the pain.Conservative treatment methods such as analgesic medications, physical
      therapy, and manual therapy are used for facet joint-related low back pain, and
      interventional pain management practices are used in patients who do not respond adequately
      to these treatments.

      Pulse radiofrequency application, which is a recent popular treatment in interventional pain
      management, is also frequently applied in the treatment of facet-joint related pain. Pulsed
      radiofrequency intervention can be applied directly intra-articularly or can be applied to
      the median branch, which is important structure in pain transmission. Although both methods
      are frequently used in pain management, there is a lack of information in the literature
      about which is more effective. This study aimed to compare the treatment results of
      intraarticular pulse radiofrequency application and median branch pulse radiofrequency
      application in facet joint-related low back pain.
    


Intervention name(s): Intra-articular pulsed radiofrequency; Median branch pulsed radiofrequency
Intervention type(s): Procedure; Procedure
Intervention description(s): Intra-articular pulsed radiofrequency procedures for the treatment of facet joint-related low back pain are performed under sterile conditions in the operating room. The application is performed under fluoroscopy guidance using a 20 gauge 10 mm active tip radiofrequency needle. When the intra-articular joint, which is the target tissue, is reached with the help of fluoroscopy images, pulse radiofrequency treatment will be applied with the parameters being maximum temperature 42 degrees, 45 volts, duration 6 minutes, pulse rate 2 hertz and pulse width 20 milliseconds.; Median branch pulsed radiofrequency procedures for the treatment of facet joint-related low back pain are performed under sterile conditions in the operating room. The application is performed under fluoroscopy guidance using a 20 gauge 10 mm active tip radiofrequency needle. When the median branch region, which is the target area, is reached with the help of fluoroscopy images, location confirmation will be provided by giving sensory and motor stimulation. Pulse radiofrequency treatment will be applied with the parameters being maximum temperature 42 degrees, 45 volts, duration 6 minutes, pulse rate 2 hertz and pulse width 20 milliseconds.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Biliary Cancers: EGFR INhibitor, Gemcitabine and Oxaliplatin
Condition: Advanced Biliary Cancer
MeSH terms: Biliary Tract Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine - Oxaliplatin
      Chemotherapy Alone or in Combination with Cetuximab in Patients with Advanced Biliary Cancer.
    

Detailed description: 
      The BINGO trial is an open-label randomized phase II study evaluating the efficacy and
      tolerance of gemcitabine-oxaliplatin combination chemotherapy (GEMOX regimen) alone or in
      combination with cetuximab in patients (pts) with ABC. The BINGO study also comprises
      ancillary translational research and functional imaging studies which aim to identify markers
      predictive for treatment efficacy in ABC.

      All eligible pts will be randomized 1:1 to receive:

        -  Arm A: GEMOX alone every two weeks.

        -  Arm B: GEMOX + cetuximab every two weeks.

      Randomization will be stratified according to:

        1. tumor stage (locally advanced vs metastatic),

        2. primary tumor location (gallbladder vs non-gallbladder),

        3. prior treatments (surgery or radiotherapy or brachytherapy or photodynamic therapy [PDT]
           or adjuvant chemotherapy vs none),

        4. center. EGFR tumor status has to be assessed for every pt by immunohistochemistry (IHC)
           using biopsy or surgical material, at any time prior to inclusion into the study, but it
           is neither an inclusion/exclusion criterion nor a stratification factor.
    

Intervention name(s): Gemox, Cetuximab
Intervention type(s): Drug
Intervention description(s): GEMOX (Arms 1 and 2), every two weeks:
Day 1: gemcitabine 1000 mg/m² intravenous (IV) infusion over 100 minutes (10 mg/m²/min) Day 2: oxaliplatin 100 mg/m² IV infusion over 2 h
Cetuximab (ErbituxÒ) (Arm B only) every two weeks:
(chemotherapy will be started one hour after the end of the cetuximab infusion).
Day 1 or Day 2: 500 mg/m² IV infusion over 150 minutes
Intervention MeSH terms: Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of Age on the Absorption and Metabolism of Cocoa Flavanols
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Accumulating evidence suggests that regular consumption of foods and beverages rich in
      flavanols, such as cocoa, tea, apples and wine, may have cardiovascular benefits. Several
      well-controlled randomised human intervention studies have shown that cocoa flavanols have
      beneficial effects on blood pressure, endothelial function and other biomarkers of
      cardiovascular health. These vascular improvements have been correlated in time with changes
      in plasma flavanol metabolites. The health benefits of flavanol consumption are therefore
      likely dependent on changes in their absorption, distribution, metabolism and excretion
      (ADME). Recent studies have provided detailed information regarding the absorption and
      metabolism of cocoa flavanols. However, there is a lack of information on whether there are
      changes in flavanol absorption and metabolism with increasing age.
    


Intervention name(s): Flavanol rich drink; Acetaminophen
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): 2x500 mg Acetaminophen
Other intervention name(s): Comparison of two different doses of a flavanol rich drink; Paracetamol
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ADME; Flavanols; Age; Pharmacokinetics
Nutrition Intervention in Treating Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Dietary fat may be involved in the growth of cancer cells. Restricting dietary fat
      may help fight cancer.

      PURPOSE: Randomized clinical trial to study the effectiveness of a low fat diet in treating
      postmenopausal women who have stage I, stage II, or stage IIIA breast cancer that has been
      completely removed by surgery.
    

Detailed description: 
      OBJECTIVES: I. Determine whether dietary fat reduction will effectively prolong disease-free
      and overall survival in women surgically treated for early stage breast cancer who are
      receiving adjuvant therapy with or without either tamoxifen, cyclophosphamide, methotrexate,
      fluorouracil (CMF), doxorubicin, cyclophosphamide (AC), fluorouracil, doxorubicin,
      cyclophosphamide (FAC, CAF), or AC followed by paclitaxel. II. Evaluate whether differences
      in the lipid profile are associated with dietary group assignment and dietary fat.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, nodal
      status, ER status, and type of adjuvant chemotherapy. The first group receives intensive
      dietary intervention for reduction of total fat intake to 15% of calories, with repeated
      individual and group counseling sessions. The second group receives USDA/DHHS dietary
      guidelines and minimal intervention. All patients who are estrogen receptor positive receive
      concurrent therapy with tamoxifen; cyclophosphamide, methotrexate, fluorouracil (CMF)
      followed by tamoxifen; doxorubicin, cyclophosphamide (AC) followed by tamoxifen;
      fluorouracil, doxorubicin, cyclophosphamide (FAC, CAF) followed by tamoxifen; or AC,
      paclitaxel followed by tamoxifen. Patients are followed annually throughout the study.

      PROJECTED ACCRUAL: Approximately 2,500 women will be accrued for this study.
    

Intervention name(s): educational intervention; therapeutic dietary intervention
Intervention type(s): Other; Procedure
Allocation: Randomized
Primary purpose: Treatment
Keywords: recurrent breast cancer
A Study on Pharmacokinetics (PK), Efficacy and Safety of Subcutaneous (SC) Versus Intravenous (IV) Rituximab, in Combination With CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) in Previously Untreated Participants With CD20 Positive Diffuse Large B-Cell Lymphoma (DLBCL)
Condition: Lymphoma, Large B-Cell, Diffuse
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter China-only study to investigate the PK, efficacy and safety of SC
      rituximab versus IV rituximab, both in combination with CHOP (cyclophosphamide, doxorubicin,
      vincristine, prednisone) in previously untreated participants with CD20 positive DLBCL.
      Participants will be randomized to receive eight cycles of rituximab SC or rituximab IV
      combined with six or eight cycles of standard CHOP chemotherapy. After the end of study
      treatment, participants will be followed-up every 3 months for 6 months.
    


Intervention name(s): Rituximab IV; Rituximab SC; Rituximab IV; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Paracetamol; Diphenhydramine hydrochloride or alternative antihistamine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Rituximab will be administered intravenously through Cycle 1-8 at a standard dose of 375 mg/m^2 (milligram per square meter).; Rituximab will be administered subcutaneously through Cycle 2-8 at a dose of 1400 milligram (mg).; Rituximab will be administered intravenously in Cycle 1 at a standard dose of 375 mg/m^2.; Cyclophosphamide will be administered IV at a dose of 750 mg/m^2; Doxorubicin will be administered IV at a dose of 50 mg/m^2; Vincristine will be administered IV at a dose of 1.4 mg/m^2; Prednisone will be administered orally at a dose of 100 mg/day; All participants are required to receive 1000 mg oral paracetamol as premedication prior to starting each infusion of rituximab; All participants are required to receive 50-100 mg oral diphenhydramine hydrochloride or alternative antihistamine as premedication prior to starting each infusion of rituximab
Other intervention name(s): MabThera; MabThera; MabThera
Intervention MeSH terms: Diphenhydramine; Promethazine; Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine; Histamine H1 Antagonists; Histamine Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mabthera, Rituximab, SC, Subcutaneous, DLBCL