bioihbjkbjnl/mcl2 huggingface dataset:
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and
      safe in the treatment of patients with MDD.
    


Intervention name(s): Quetiapine fumarate
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: MDD; Quetiapine fumarate, sustained release; Depression
Nerve Growth Factor in Chronic Pancreatitis
Condition: Chronic Pancreatitis
MeSH terms: Pancreatitis; Pancreatitis, Chronic
Study type: Observational

Summary: 
      This study is to understand the role of nerve growth factor(NGF) and other cytokines in the
      pancreatic fluid of patients with chronic pancreatitis.

      Hypothesis:

        1. Pain does not correlate with changes in the PD morphology suggesting that pain in CP is
           not only a mechanical problem

        2. Pain in CP correlates better with the levels of NGF in the pancreatic juice. NGF is
           variably expressed in different morphological stages of CP and regulates the sensitivity
           of the peptidergic nociceptors and is upregulated in pancreatic inflammation.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Test group: Subjects with CP in each morphological stage and matched for age, race, gender,
        narcotic dependence and etiology of CP will be enrolled Controls: Subjects undergoing upper
        gastrointestinal endoscopy (UGIE) for non-pancreatic causes.
      
Biospecimen description: 
      Pancreatic fluid obtained by duodenal aspiration
    
Keywords: Tio identify role of NGF in pain in CP; Identify biomarkers related to progression of CP
Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03826)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was conducted to compare the taste acceptability of Zyrtec syrup with
      desloratadine syrup in children. Children between 6 and 11 years of age received 5 mL of each
      syrup, separated by 15 to 20 minutes on a single day.
    

Detailed description: 
      This study is a cross-over study design.
    

Intervention name(s): Desloratadine (Clarinex); Cetirizine (Zyrtec)
Intervention type(s): Drug; Drug
Intervention description(s): Each subject received 5 mL of desloratadine syrup one time; Each subject received 5 mL of cetirizine syrup
Other intervention name(s): SCH 034117, Clarinex; Zyrtec
Intervention MeSH terms: Cetirizine; Desloratadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Animal-assisted Therapy for Children and Adolescents With Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Chronic pain is highly prevalent in children and adolescents, up to one in four children will
      develop pain that persists or recurs for three or more months. Chronic pain is not only
      linked to significant psychological, physical, and social concerns for affected children and
      their families, but also places an enormous burden on healthcare systems - in the United
      States, chronic pain costs around $19.5 billion dollars each year and ranks among the most
      expensive pediatric health problems. Chronic pain significantly decreases quality of life and
      is associated with numerous missing days at school or at work.

      Several interventions exist, however, for some, the risk-benefit profile is not favorable, or
      the effect sizes are small and the clinical effect can be questioned. In general, a
      multidisciplinary approach that includes medical, psychological, and physiological aspects
      has been shown to be most promising in the treatment of chronic pain in children and
      adolescents.

      Clinical impressions suggest that an Animal-assisted Therapy (AAT) intervention could be
      promising, but to the best of our knowledge, this is the first study to investigate the
      effectiveness of an AAT intervention for children and adolescents with chronic pain. With
      this pragmatic trials investigators aim to investigate the pre- and post-intervention
      differences in pain levels, levels of emotional distress, and quality of life within
      participants with chronic pain.
    


Intervention name(s): Animal-assisted therapy
Intervention type(s): Behavioral
Intervention description(s): Six sessions of animal-assisted intervention for children and adolescents, group format. The sessions will focus on psycho-education on pain, mindfulness, defocusing, getting active, and resources. Additionally, the intervention includes two family visits.
Intervention model: Single Group Assignment
Intervention model description: Pragmatic trial
Masking: None (Open Label)
Primary purpose: Treatment
App Reminder on ASA Adherence
Condition: Thromboembolic Event
MeSH terms: Thromboembolism
Study type: Interventional

Summary: 
      The purpose of this study is to explore the impact of using a smartphone app reminder on
      medication adherence twice daily in adults prescribed 81 milligrams of aspirin for 35 days as
      anti-thrombotic therapy after knee or hip arthroplasty.

      This study will randomly assign participants to get usual postoperative care which is
      teaching with verbal instructions and printed information about taking the aspirin at the
      time of discharge, or to have an app on your smartphone with preset reminders in addition to
      usual postoperative discharge teaching after surgery.
    

Detailed description: 
      The purpose of this study is to evaluate the impact of using a smartphone application (app)
      reminder on medication adherence twice daily in 200 adults prescribed 81 milligrams of
      aspirin (ASA) for 35 days as anti-thrombotic therapy after knee or hip arthroplasty. The aim
      is to determine if an app downloaded on a smartphone that reminds patients twice a day to
      take their ASA as prescribed will improve ASA adherence and clinical outcomes for patients
      after total knee and total hip joint arthroplasty compared to those in the usual care.

      This is a two group, randomized control study with random assignment into the control group
      for usual care or the intervention group to receive a medication reminder app for their smart
      phone (daily for 35 days) plus usual care. Participants will receive a baseline interview for
      demographic and other data and 36 day follow-up assessment, both conducted in person.
    

Intervention name(s): Standard Education; Medication Reminder App
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive the usual verbal education and printed information provided to patients about the importance of taking aspirin to prevent thromboembolic events after orthopedic surgery, medication dosage and scheduling.; Participants will use a medication reminder app that is set in collaboration with the participants for times that fit into their daily lifestyle. The app will alert participants when it is time (selected by the participant) to take their medication.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Orthopedics
Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis
Condition: Non-Cystic Fibrosis Bronchiectasis
MeSH terms: Bronchiectasis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate if INS1007 can reduce pulmonary exacerbations over a
      24-week treatment period in participants with non-cystic fibrosis bronchiectasis.
    

Detailed description: 
      Phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter,
      multi-national study to assess the efficacy, safety and tolerability, and pharmacokinetics
      (PK) of INS1007 administered once daily for 24 weeks in participants with non-cystic fibrosis
      bronchiectasis (NCFBE).
    

Intervention name(s): Brensocatib 10 mg; Brensocatib 25 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered once per day for 24 weeks; Administered once per day for 24 weeks; Administered once per day for 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: P aeruginosa; bronchiectasis; active neutrophil elastase
Feasibility Study Evaluating the ParaPatch System
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      A multi-center, open-label, prospective, feasibility study evaluating the ParaPatch System
      for the treatment of urinary incontinence and overactive bladder.
    

Detailed description: 
      -  Baseline Period

           o The baseline period will allow for washout of any medication affecting bladder
           function and to allow subject to begin her voiding diary.

        -  Prospective data collection will take place in the form voiding diary. Leak frequency,
           and other relevant parameters will be collected.

        -  Inclusion/exclusion criteria will be rechecked at end of baseline.

        -  Qol questionnaires will be completed in the office at the end of baseline period.

        -  Evaluation Period

           o During the evaluation period, the subjects will use the ParaPatch System.

        -  No medications affecting bladder function will be allowed during the evaluation period.

        -  Subjects will complete voiding diaries, during the evaluation period. Data capture to
           include: adverse events, medication use, leak frequency and other relevant parameters.

        -  Qol questionnaires will be completed in the office at the end of evaluation period.

        -  Follow-up Period

           o Subjects will be followed for after the evaluation period to check for residual
           Adverse Events.

        -  No medications affecting bladder function will be allowed during the follow-up period.

        -  Subjects will be called by the clinical coordinator at the end of the Follow-up period
           and asked about potential Adverse Events.
    

Intervention name(s): ParaPatch
Intervention type(s): Device
Intervention description(s): A device for the treatment of urinary incontinence
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Pharmacokinetic (PK) Comparability of 2 Fixed Subcutaneous (SC) Doses of Aducanumab (BIIB037) With a Single, Weight-Based Intravenous (IV) Dose in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the pharmacokinetic (PK) comparability of 2
      fixed subcutaneous (SC) doses of aducanumab with a single, weight-based intravenous (IV) dose
      of aducanumab in healthy volunteers. The secondary objectives of the study are to assess the
      safety and tolerability of aducanumab administered SC in healthy volunteers and to
      characterize additional PK parameters of 2 fixed SC doses of aducanumab and a single,
      weight-based IV dose of aducanumab.
    


Intervention name(s): Aducanumab
Intervention type(s): Biological
Intervention description(s): Administered as specified in the treatment arm.
Other intervention name(s): BIIB037; Aduhelm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to MTX Due to Treat Moderate and Severe Rheumatoid Arthritis.
Condition: Moderate and Severe RheumatoId Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to initially access the safety and effectivity of RC18 combined
      with methotrexate (MTX) in comparison with the use of methotrexate alone in participants with
      moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response to MTX therapy.
    


Intervention name(s): Placebo plus MTX; RC18 160 mg plus MTX
Intervention type(s): Biological; Biological
Intervention description(s): All patients had a foundation MTX therapy.The researchers evaluated the efficacy of the patient in 12 week.Study investigator evaluate the patients of curative effect.The researchers evaluated the efficacy of the patient in 12 week.Evaluation of efficacy in patients if not get the ACR20 response, adjust the treatment plan given the test drug.Test group continue to the test drug,placebo group switch to the test drug.; The trial was divided into two groups: (1) placebo + MTX; (2) telitacicept 160 mg + MTX. MTX was used as the basic treatment, the dose of MTX was stable during the trial, and could not be adjusted. Telitacicept or placebo was administered once a week for the first 24 weeks. Beginning at week 24, subjects in the placebo group will enter the RC-18 treatment group. All subjects received RC-18 treatment once a week from week 24 to week 48.
Other intervention name(s): MTX=Methotrexate; RC18; MTX=Methotrexate
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Clinical Study of the Effects of Modified BII+Braun on Quality of Life After for Distal Gastric Cancer
Condition: Quality of Life
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      The jejunum of the input segment is properly ligated with double line 7 at 3-5cm from the
      anastomotic site, and the jejunum of the output segment is extended to 30cm
    

Detailed description: 
      The T1-4a N0-3 M0 gastric adenocarcinoma patients were used to evaluate whether the quality
      of life after modified BII+Braun digestive tract reconstruction was superior to the
      traditional BII+Braun digestive tract reconstruction
    

Intervention name(s): modified BII+Braun
Intervention type(s): Procedure
Intervention description(s): modified BII+Braun digestive tract reconstruction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Gastric cancer; Quality of life
Study to Assess the Efficacy/Safety of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido
Condition: Hypoactive Sexual Desire Disorder (HSDD)
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate efficacy and safety of a testosterone patch as treatment
      for low libido in naturally menopausal women who are taking estrogen or estrogen/progestin
      therapy.
    

Detailed description: 
      Naturally menopausal women with hypoactive sexual desire disorder (HSDD) were randomized into
      a 24-week, multicenter, multinational, double-blind (DB), parallel-group, placebo-controlled
      study. Patients were randomized to receive a placebo or testosterone transdermal system
      throughout the study. Safety was assessed by adverse events, lipids, serum chemistry with
      hepatic, renal and carbohydrate metabolism evaluation, and hematology. Physical exam
      including clinical assessments of facial hair and acne were monitored.
    

Intervention name(s): Testosterone Transdermal System; Placebo patch
Intervention type(s): Drug; Drug
Intervention description(s): testosterone (300 mcg/day) patch replaced twice a week for two years; placebo patch replaced twice a week for two years
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Natural Menopause
Electrical Impedance Imaging of Patients With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      The goal of this feasibility study is to evaluate the ability of Electrical Impedance
      Tomography (EIT) for providing regional and quantitative information about the extent and
      nature of bronchial obstruction in patients with cystic fibrosis. It is not being conducted
      to diagnose, treat, prevent, or cure any kind of disease. In electrical impedance tomography
      low amplitude, low frequency current is applied on electrodes, and the resulting voltage is
      measured and used to computed the electrical properties of the interior of the chest as they
      change in time. The computed properties are used to form an image, which can then be used for
      monitoring and diagnosis.
    

Detailed description: 
      The goal of this study is to evaluate the ability of Electrical Impedance Tomography (EIT)
      hardware and software in patients with cystic fibrosis (CF) for providing regional and
      quantitative information for identifying regions of obstruction and consolidation, and
      determine whether these measures will correlate with improvements seen after hospitalized
      treatment for a pulmonary exacerbation (PE). In particular, EIT will be used to identify
      regions of obstruction (air trapping) and consolidation comprised of atelectasis and airway
      occlusion (consequences of mucus plugging) in CF patients, and to determine whether EIT can
      demonstrate the beneficial effects of antibiotic treatment for CF patients with an acute PE
      by correlating changes in quantitative EIT measures with clinical measures known to improve
      following therapy, with patients serving as their own controls. Regional changes in air
      trapping and consolidation from pre to post treatment as indicated by the EIT images will be
      calculated, with subjects serving as their own control.
    

Intervention name(s): CT scan
Intervention type(s): Device
Intervention description(s): Applied only when part of the patient's standard care
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        There are three groups in this study. Group 1 consists of healthy controls between the ages
        of 2 and 21. Group 2 consists of persons with cystic fibrosis between the ages of 2 and 21
        who are either clinically indicated for a pulmonary CT scan or will receive one as part of
        their routine care. Group 3 consists of persons with cystic fibrosis between the ages of 8
        and 21 who are being started on IV antibiotics for a clinically diagnosed pulmonary
        exacerbation.

        Sampling is by convenience or invitation to volunteer.
      
Keywords: Cystic fibrosis; Electrical Impedance Tomography
VETC is an Effective Marker for Postoperative Adjuvant Immunotherapy
Condition: HCC; Recurrence
MeSH terms: Recurrence
Study type: Observational

Summary: 
      Vessels that encapsulate tumor clusters (VETC) is an invasive metastatic factor in HCC
      independent of the epithelial mesenchyme transition (EMT), and VETC-positive patients have a
      higher rate of postoperative recurrence. However, it is not clear how the surgical prognosis
      of VETC-positive patients can be improved.
    

Detailed description: 
      Previous studies have identified VETC as a new metastatic pattern independent of EMT that may
      be associated with immunosuppression as well as poor prognosis. Multiple retrospective
      studies find higher rates of postoperative recurrence, distant metastasis in VETC-positive
      patients. How to improve surgical prognosis in VETC-positive patients needs to be explored.
      There is no consensus on postoperative adjuvant therapy for HCC. In recent years, adjuvant
      immunotherapy (sintilimab) and adjuvant immunotherapy combined with targeted therapy (T+A)
      have been shown to be effective in improving the surgical prognosis. Therefore, we
      retrospectively collected three surgical resection cohorts, the surgical resection alone
      group, the postoperative adjuvant PD-1 monotherapy group, and the postoperative adjuvant PD-1
      monotherapy combined with Lenvatinib group, to compare these postoperative adjuvant therapies
      in a subgroup of VETC patients.
    

Intervention name(s): PD-1 monoclonal antibody and lenvatinib
Intervention type(s): Drug
Intervention description(s): Adjuvant PD-1 group: Patient receives first adjuvant PD-1 monoclonal antibody 2-4 weeks postoperatively, 200mg IV over 21 days for 9 cycles.
Adjuvant PD-1 plus Lenvatinib group: Patient receives first adjuvant PD-1 monoclonal antibody 2-4 weeks postoperatively, 200 mg IV 21 days for 9 cycles; lenvatinib is initiated orally 2-4 weeks postoperatively for 6 months.
Intervention MeSH terms: Lenvatinib; Antibodies; Antibodies, Monoclonal
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who met the inclusion and exclusion criteria were retrospectively collected for
        this study.
Reliability of Functional Measures in Hemodialysis Patient.
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Observational

Summary: 
      The investigators pretend to calculate values absolute and relative reliability that have not
      been yet reported (Short Physical Performance Battery, one-leg balance and Timed Up and go).
    

Detailed description: 
      Patients suffering from End Stage Renal Disease are commonly involved in haemodialysis
      treatment, which is the most common treatment at this stage. Haemodialysis substitutes the
      renal function but is associated with several alterations that lead to decrease in functional
      capacity and health related quality of life (HRQoL). Many studies show that functional
      capacity, physical activity level and HRQoL is significantly worse than their healthy
      sedentary age - matched counterparts. It is unknown if low physical activity, uraemia or
      anaemia are responsible for the decreased functional capacity of this cohort. Physical
      performance tests are frequently used to assess haemodialysis patients since is a feasible
      and low-cost evaluation. The purpose of the present study is quantified how the functional
      capacity changes over a -6 months period in a group of haemodialysis patients. Additionally
      the investigators pretend to calculate values absolute and relative reliability that have not
      been yet reported (Short Physical Performance Battery, one-leg balance and Timed Up and go).
    

Intervention name(s): functional tests
Intervention type(s): Other
Intervention description(s): Test-retest reliability of physical function in hemodialysis patients
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People with Chronic Kidney Diseases undergoing hemodialysis treatment