bioihbjkbjnl/mcl2 huggingface dataset:
Role of Rapid On-site Evaluation for Mutational Analysis of EBUS-TBNA Specimens
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional

Summary: 
      The purpose of the study is to determine if rapid on-site evaluation of EBUS-TBNA samples can
      increase the percentage of patients with advanced non-squamous non-small cell lung cancer in
      whom both pathologic subtyping and mutational analysis are obtained.
    


Intervention name(s): Rapid on-site evaluation; EBUS-TBNA
Intervention type(s): Other; Device
Intervention description(s): Rapid on-site evaluation consists on the cytological evaluation of samples obtained during a diagnostic procedure by a pathologist present in the diagnostic suite. In the present study, cytological samples obtained with EBUS-TBNA during bronchoscopy will be evaluated.; EBUS-TBNA is a needle aspiration procedure guided by endobronchial ultrasounds performed during bronchoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Comparing One Intraarticular Injection of a Novel HYAJOINT Plus With Synvisc-One for the Treatment of Knee OA
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Viscosupplementation has been widely used for the treatment of knee osteoarthritis (OA).
      There is no well controlled trial comparing one injection regimen of HA for the treatment of
      knee OA. The purpose of this study was to compare the efficacy and safety of one
      intraarticular injection of a novel crosslinked HA (HYAJOINT Plus) with Synvisc-One for the
      treatment of knee OA.
    

Detailed description: 
      In a prospective, randomized controlled, double-blind trial with 6-month follow up, patients
      with knee OA (Kellgren-Lawrence grade 2 or 3) were randomized to receive one intraarticular
      injection of 3 ml HYAJOINT Plus (microbial fermented HA, 20 mg/ml) (N=66) or 6 ml Synvisc-One
      (avian derived HA, 8 mg/ml) (N=66). The primary outcome was change in the visual analog scale
      (VAS) pain (0-100mm) over 6 months. Secondary outcomes included The Western Ontario and
      McMaster Universities Osteoarthritis Index (WOMAC), Lequesne index, Timed Up-and-Go test
      (TUG), single leg stance test (SLS), use of rescue analgesics and patient satisfaction.
    

Intervention name(s): HYAJOINT Plus; Synvisc-One
Intervention type(s): Device; Device
Intervention description(s): The patients in the HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus (2% microbial fermented HA, 20 mg/ml).; The Synvisc-One group received one injection of 6 ml Synvisc-One (0.8% avian derived HA, 8 mg/ml).
Other intervention name(s): Hyaluronic acid
Intervention MeSH terms: Hyaluronic Acid; Hylan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee osteoarthritis; Hyaluronic acid; Viscosupplementation
Casein Phosphopeptide--amorphous Calcium Phosphate on Human Enamel Subjected to in Vivo Acid Attacks
Condition: Dental Erosion
MeSH terms: Tooth Erosion
Study type: Interventional
Phase: Phase 4

Summary: 
      40 specimens were prepared from fresh-extracted human molars and further embedded using the
      acrylic resin. Specimens were randomly divided into 2 groups according to the treatment
      before in vivo erosion (n=20): CPP-ACP for 3 min (CPP-ACP group) and deionized water for 3
      min (control group). 10 healthy volunteers were recruited and customized maxillary appliance
      containing 4 specimens (2 from CPP-ACP group and 2 from control group) was fabricated for
      each volunteer. Participants were instructed to drink 150 ml cola in 5 min using the gargling
      method after placing appliances intraorally for 2 h. The in vivo attacks were performed 4 X 5
      min with 1-h interval daily over 7 d. The surface microhardness and surface microstructure of
      the specimens were evaluated at the baseline and after the treatment. The data were
      statistically analyzed using three-way ANOVA and post hoc tests. Data were considered
      statistically significant at a level of P <0.05.
    


Intervention name(s): CPP-ACP; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): The surfaces of specimens were pretreated with CPP-ACP for 3 min; The surfaces of specimens were pretreated with deionized water for 3 min
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Study of C-CAR066 in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy
Condition: Diffuse Large B Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, non-randomized and dose-escalation study to evaluate the safety and
      efficacy of C-CAR066 in treatment of r/r DLBCL who received CD19 CAR-T therapy.
    

Detailed description: 
      This study plans to enroll 10 patients to assess the safety and efficacy of C-CAR066.
      Subjects who meet the eligibility criteria will receive a single dose of C-CAR066 injection.

      The study will include the following sequential phases: Screening, Pre-Treatment (Cell
      Product Preparation, Lymphodepleting Chemotherapy), C-CAR066 infusion and Follow-up Visit.
    

Intervention name(s): C-CAR066
Intervention type(s): Drug
Intervention description(s): Autologous 2nd generation CD20-directed CAR-T cells, single infusion intravenously
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reproductive Health Survivorship Care Plan Pilot
Condition: Breast Cancer; Hot Flashes; Vaginal Dryness; Estrogen Deprivation Symptoms
MeSH terms: Breast Neoplasms; Hot Flashes
Study type: Interventional

Summary: 
      Most young breast cancer patients undergo chemotherapy and/or endocrine therapy, treatments
      that impair ovarian function and result in significant reproductive health late effects.
      These late effects include symptoms of estrogen deprivation (e.g., hot flashes and vaginal
      dryness), which are distressing in young breast cancer survivors (YBCS). The goal of this
      pilot study is to test the feasibility of a 4-week text message based intervention on hot
      flashes and vaginal dryness in YBCS. YBCS will be randomized in a 1:1 ratio to the
      intervention (text messages on hot flash and vaginal dryness management) and control arms.
      All participants will be prompted to provide daily hot flash frequency and severity via text
      messaging. The primary hypothesis is YBCS will have high rates of daily hot flash reporting
      via text messaging. Secondarily, we will compare changes in hot flash frequency, hot flash
      severity and vagina dryness between the intervention and control arms.
    


Intervention name(s): Text message management prompts
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Wearable With Photoplethysmography and 6-lead Electrocardiography for Atrial Fibrillation Detection
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      A single center prospective case-control study to evaluate ability of a wearable to
      differentiate between atrial fibrillation (AF) and sinus rhythm (SR).
    


Intervention name(s): Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)
Intervention type(s): Device
Intervention description(s): Participants will use the wearable (the tested device) to record at least 2 minutes of photoplethysmography and 6-lead ECG. In addition, each subject will be monitored with synchronous ECG Holter monitoring (with eMotion Faros 90).
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants of defined groups will be enrolled in Vilnius University Hospital Santaros
        Clinics.
      
Keywords: wearable; electrocardiography; photoplethysmography
Could Meditation Modulate the Neurobiology of Learning Not to Fear?
Condition: Healthy Individuals; Highly Stressed
Study type: Interventional

Summary: 
      It is well-established that the practice of mindfulness meditation leads to improvements in
      mental health and well-being and the cultivation of positive emotions. However, the neural
      mechanisms of these improvements are largely unknown. A few recent studies suggest that
      mindfulness meditation impacts the structure and function of the ventromedial prefrontal
      cortex, the hippocampus, and the amygdala. Interestingly, recent studies have shown that
      these regions are part of a brain circuit that is critical for the extinction of conditioned
      fear responses, and for the retention of fear extinction memory. Building on the overlap of
      these regions and on conceptual considerations, the project investigates whether mindfulness
      meditation could influence one's capacity to retain the memory of fear extinction.
      Meditation-naïve participants will be randomized to either a mindfulness-meditation based
      training or an active control training that controls for all mindfulness-unspecific
      components. Participants will undergo a fear conditioning, extinction and extinction recall
      protocol in an MRI scanner before and after the trainings. We hypothesize that participants
      who have practiced mindfulness meditation will show greater improvements in fear extinction
      memory after the course, and that these improvements will be correlated with anatomical and
      functional changes in the brain regions of interest. Improvements in fear extinction memory
      will also be related to improvements in self-reported psychological well-being. Merging the
      fields of an ancient spiritual tradition and a fundamental learning mechanism, the project
      investigates the underlying neural mechanisms of a practice for the enhancement of mental
      health and well-being.
    


Intervention name(s): Mindfulness-Based Stress Reduction course
Intervention type(s): Behavioral
Intervention description(s): an eight-week mindfulness-based stress reduction course
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: mindfulness, fear conditioning
Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics and safety of co-administration
      of VX-770 and VX-809 in healthy adults.
    

Detailed description: 
      Cystic fibrosis (CF) is an inherited disease resulting from defects to a gene known as the
      cystic fibrosis transmembrane conductance regulator (CFTR). CF affects approximately 70,000
      children and adults worldwide (30,000 in the United States) and is the most common fatal
      genetic disease in persons of European descent. Despite progress in the treatment of CF with
      antibiotics and mucolytics, the predicted median age of survival for a person with CF is in
      the mid-30s. Though the disease affects multiple organs, most morbidity and mortality is
      caused by progressive loss of lung function.

      This is a Phase 1, randomized, double-blind, placebo-controlled, multiple-dose study of
      orally administered VX-809 and VX-770 in healthy subjects. The study will evaluate safety and
      tolerability of co-administration of VX-809 and VX-770 in healthy volunteers.

      Enrollment is planned for 24 subjects at 1 clinical site. Subjects will be randomized to
      receive study drug or placebo during three 14-day treatment periods separated by 14-day
      washout periods. In Treatment Period 1, subjects randomized to study drug will receive VX-809
      every 24 hours. In Treatment Period 2, subjects randomized to study drug will receive VX-770
      every 12 hours. In Treatment Period 3, subjects randomized to study drug will receive VX-809
      every 24 hours and VX-770 every 12 hours. Subjects randomized to placebo will receive placebo
      during all treatment periods.
    

Intervention name(s): VX-809; VX-770; VX-809 & VX-770; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): VX-809 capsule, once daily for 14 days; VX-770 tablet, once every 12 hours for 14 days; VX-809 capsule, once daily, and VX-770 tablets, once every 12 hours, for 14 days; Matching Placebo
Intervention MeSH terms: Ivacaftor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Fecal Bacteria in Early Diagnosis of Colorectal Cancer
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      The aim of the study is to identify and verify one or more gut bacteria of which the
      abundance in feces may help to early diagnosis colorectal cancer.
    

Detailed description: 
      Gut microbiota is closely related to human gut neoplasm. According to recent statistics, the
      abundance of FN (Fusobacterium Nucleatum) is connected with the development and progression
      of CRCs (colorectal cancers). Subsequent research shows identifying multiple
      microbial-specific genes in human feces using qPCR (quantitative Polymerase Chain Reaction)
      may help diagnosis of early stage colorectal cancer. Currently little is known about the
      relationship between single abundance of specific gut microbiota and colorectal cancer in
      different stage. Moreover, finding early-stage CRCs is still of great challenge partially due
      to precancerous diseases like colorectal adenoma which remain difficult to differentiate from
      early-stage CRC under endoscope. Conventional clinic methods predicting CRCs largely depend
      on serum CEA (serum Carcino Embryonic Antigen) and OB(fecal occult blood test), which lack of
      adequate sensitivity and specificity especially in early stage CRCs. The investigators' work
      focuses on the abundance of gut microbiota in feces from people with colon neoplasm and its
      comparison with classical indicators such as CEA and OB, aiming to reveal and testify its
      potential role on assisting diagnosis of CRCs in different stage as a none-invasive
      cost-effective method.
    

Intervention name(s): gut microbiota
Intervention type(s): Biological
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Chinese people
      
Biospecimen description: 
      feces of participants
    
Keywords: gut microbiota
Bowel Function After Minimally Invasive Urogynecologic Surgery
Condition: Functional Disorder of Intestine
MeSH terms: Intestinal Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effect of a standardized postoperative bowel
      regimen of over-the-counter medications in subjects undergoing minimally invasive
      urogynecologic surgery.
    

Detailed description: 
      See above
    

Intervention name(s): Docusate; Bowel medications
Intervention type(s): Drug; Drug
Intervention description(s): Docusate 100mg BID; Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID
Other intervention name(s): Colace; Colace; Psyllium; Polyethylene glycol; Dulcolax
Intervention MeSH terms: Psyllium; Bismuth subsalicylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Urogynecology
Systematic Initiative to Increase Activity in Schools
Condition: Obesity; Cardiovascular Fitness
Study type: Observational

Summary: 
      This initiative is a prospective study evaluating the effects of implementing physical
      activity strategies in Wisconsin schools with low socioeconomic status on childhood fitness.
    

Detailed description: 
      This initiative is a prospective study evaluating the effects of implementing physical
      activity strategies in Wisconsin schools with low socioeconomic status on childhood fitness.
      Forty-nine schools participated in the study providing de-identified fitness data for
      students for 3 consecutive years. Twenty-five schools initiated physical activity
      interventions in year one and 24 schools initiating physical activity interventions in year
      two.
    

Intervention name(s): physical activity
Intervention type(s): Behavioral
Intervention description(s): 4 strategies are: (1) increased activity time during physical education class, (2) active recess, (3) opportunities for activity before and after school, and (4) active classroom breaks
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Wisconsin schools with low socio-economic status (grades 3-8)
Pain Comparison Whit Visual Analog Scale (EVA) Between Four Analgesic Methods During Trans Rectal Prostatic Biopsy
Condition: Cancer of Prostate
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      Define the best analgesic method between peri prostatic blockage, analgesic suppository, oral
      analgesic and topic anesthetic gel, during trans rectal prostate biopsy
    

Detailed description: 
      Comparison between four analgesic methods during trans rectal prostatic biopsy.

      OBJECTIVE: To define the best analgesic method between the peri-prostatic block, the
      analgesic suppository, the oral analgesic, the final anesthetic gel, during the trans rectal
      prostate biopsy determined at the end of the procedure with a visual analogue scale for pain
      (VAS pain) in a Interview 15 to 30 minutes at the end of the procedure.

      METHODS: experimental, retrospective, longitudinal, comparative, during May to July 2017, 350
      trans rectal prostate biopsies were performed, all cases were randomly assigned to one of the
      four study groups. The data analysis will be performed by calculating measures of central
      tendency and dispersion for quantitative variables and ANOVA test, for qualitative variables
      Chi square to determine statistical differences between the three moments of pain in the
      parameters of introduction of the ultrasound transducer, sampling of Prostate of the minimum
      12 biopsies and discomfort in general of the procedure
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patients from the consultation were taken from the first time they were derived from
        the peripheral clinics or from the ones derived from our same medicine, with suspicion of
        prostate cancer and that the criteria for carrying out the trans rectal prostate biopsy
        were met.
      
Keywords: Cancer of Prostate; Analgesic method
Anti-CD20 Antibody Therapy for Sjogren's Syndrome
Condition: Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in
      treating patients with Sjogren's syndrome (SS). Rituximab is a laboratory-made antibody
      currently used to treat some kinds of lymphoma. Rituximab may also help people with SS, a
      disease of the immune system. However, the safety of rituximab in SS patients must first be
      established.
    

Detailed description: 
      SS is the second most common autoimmune disease; it is caused by immune cells attacking and
      destroying the glands that produce tears and saliva, and occurs more often in women than in
      men. Currently, there are no established disease-modifying treatments for SS. Traditional
      treatment strategies for SS primarily address dryness symptoms. Rituximab targets the CD20
      antigen on the surface of B cells, and was approved in 1997 for the treatment of patients
      with low-grade or follicular B-cell non-Hodgkin's lymphoma. In a small study, rituximab was
      also shown to relieve the symptoms of rheumatoid arthritis. Because SS is associated with the
      development of B cell-related cancers and rituximab has the potential to treat autoimmune
      disease, rituximab may alleviate the symptoms of SS. This study will evaluate the safety of
      rituximab in people with SS.

      This study will last 1 year. At 4 and 2 weeks before the start of the study, patients will
      undergo medical and medication history assessment, a physical exam, blood and urine
      collection, rheumatologic evaluation, an eye exam, and salivary gland tests. The screening
      visit 4 weeks before study start will also include an electrocardiogram (ECG), a chest x-ray,
      and a tuberculosis exam. Patients will receive IV rituximab at study entry and at Week 2;
      blood collection will occur prior to infusion and post-infusion for pharmacokinetics studies.
      There will be 6 follow-up study visits that will occur at Weeks 4, 8, 14, 26, 30, and 52.
      Blood and urine collection; a physical exam; rheumatologic evaluation; and eye, skin, and
      salivary gland tests will occur at selected study visits.
    

Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): 1000 mg intravenous infusion
Other intervention name(s): Rituxan
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autoimmune Diseases
Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
Condition: Other Acute Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and
      effective for the treatment of postoperative bunionectomy pain.
    


Intervention name(s): Indomethacin; Indomethacin; Indomethacin; Celecoxib; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 40 mg TID capsules; 40 mg BID capsules; 20 mg TID capsules; 200 mg capsules; Capsules
Intervention MeSH terms: Celecoxib; Indomethacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment