bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Phase III Trial Treosulfan-based Conditioning Versus Reduced-intensity Conditioning (RIC)
Condition: Acute Myeloid Leukemia; Myelodysplastic Syndrome
MeSH terms: Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized allogeneic transplantation protocol compares i.v. Treosulfan-based
      conditioning therapy with reduced intensity i.v. Busulfan-based conditioning in adult AML and
      MDS patients at increased risk for standard conditioning therapies. The protocol is based on
      results of previous phase I/II trials evaluating Treosulfan/Fludarabine conditioning prior to
      allogeneic haematopoietic stem cell transplantation. The reference arm (reduced intensity
      i.v. Busulfan/Fludarabine) is considered to be accepted medical practice for the study
      patient population.
    

Detailed description: 
      To compare efficacy and safety of Treosulfan-based conditioning (test) with i.v.
      Busulfan-based reduced intensity conditioning (reference).

      The statistical aim of the study is to show non-inferiority with respect to:

      Event-free survival (EFS) within 2 years after transplantation. Events are defined as relapse
      of disease, graft failure or death (whatever occurs first).

        1. Comparative evaluation of incidence of CTC grade III/IV mucositis/stomatitis between day
           -6 and day +28

        2. Comparative evaluation of overall survival (OS) and cumulative incidence of relapse (RI)
           as well as non-relapse mortality (NRM) and transplantation-related mortality (TRM)within
           2 years after transplantation

        3. Comparative evaluation of day +28 conditional cumulative incidence of engraftment

        4. Comparative evaluation of day +28 and day +100 incidence of complete donor-type
           chimerism

        5. Comparative evaluation of cumulative incidence of acute and chronic GvHD within 2 years
           after transplantation

        6. Comparative evaluation of incidence of other CTC grade III/IV adverse events between day
           -6 and day +28

      Individual patients will be followed-up for at most 2 years after transplantation. Three
      confirmatory interim evaluations and one final analysis are planned, which allow to stop the
      trial as soon as the question of non-inferiority is answered (as outlined below). In
      addition, post-surveillance with respect to OS and EFS will be conducted one year after
      transplantation of the last randomised patient.
    

Intervention name(s): Busulfan; Treosulfan
Intervention type(s): Drug; Drug
Intervention description(s): 4 x 0.8 mg/kg/d Intravenous Day -4 and -3; 10 g/m2/d Intravenous Day -4, -3, -2
Intervention MeSH terms: Busulfan; Treosulfan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treosulfan; Busulfan; Conditioning; Allogeneic; Transplantation
Fursultiamine in Esophageal Squamous Cell Carcinoma Patients Who Receive Concurrent Chemoradiotherapy
Condition: Cancer Stem Cell
MeSH terms: Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Esophageal cancer is a common and fatal malignancy. It is the eighth most common incident
      cancer and the sixth leading cause of cancer death in the world. In Taiwan, esophageal cancer
      was newly diagnosed in 2199 patients and was the cause of 1507 deaths in 2011. Squamous cell
      carcinoma is the predominant histological tumor type, accounting for about 90% of the cases.
      Esophageal squamous cell carcinoma (ESCC) is an aggressive disease, characterized with
      extensive local growth and frequent metastases. Concurrent chemoradiotherapy (CCRT) with or
      without surgery is the treatment option for locally advanced ESCC. Further, target therapy is
      used in conjunction with CCRT and surgery in ESCC since several years ago. However, the
      therapeutic outcomes are not satisfactory due to the emergence of chemo-radioresistance. It
      is imperative to investigate new biomarkers and to find novel treatment targets in ESCC.

      A small population of tumor-initiating cells or cancer stem cells (CSCs) possess some
      biological functions like normal stem cells, including self-renewal, asymmetric cell
      division, slowly proliferation rate and drug-resistance. CSCs from many primary tumors and
      cell lines express specific stem cell markers, including Oct4, Sox2, Nanog, CD133
      (promimin-1), Nestin, CD44 ,CD24, ALDH (Aldehyde dehydrogenase) and c-Kit. There are many
      evidences that CSCs are responsible for tumor initiation, progression and metastasis. CSCs
      are also believed to have important roles in cancer recurrence due to their resistance to
      anti-cancer drugs and radiation. CSCs express high levels of ATP-binding cassette (ABC)
      transporters. ABC transporter can pump cytotoxic drugs out of cells and is one important
      mechanism of multidrug resistance in CSCs. In addition, CSCs have high reactive oxygen
      species (ROS) scavenger expression to remove ROS produced from irradiation therapy.

      Fursultiamine (also known as thiamine tetrahydrofurfuryl disulfide, TTFD) is a derivative of
      vitamin B and currently used for nutrition supplement. The investigators have identified that
      Fursultiamine suppressed OCT-4, SOX-2, NANOG expression and decreased ABCB1 and ABCG2 in
      tumor sphere of ESCC cell lines. In this project, the investigators will conduct a
      prospective phase II study to investigate the effect of Fursultiamine combined with CCRT in
      ESCC patients. Stem cell markers in clinical specimens collected before and after CCRT will
      be evaluated.
    


Intervention name(s): Fursultiamine
Intervention type(s): Dietary Supplement
Intervention description(s): Use of Fursultiamine in addition to CCRT
Intervention MeSH terms: Fursultiamin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Randomized Controlled Trial for Pain Relief After Office Ureteral Stent Removal
Condition: Pain; Urinary Stone; Urinary Calculi
MeSH terms: Urinary Calculi; Urolithiasis; Calculi
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective randomized double-blind controlled trial assessing the benefits of
      intramuscular ketorolac before or immediately after office ureteral stent removal.
    

Detailed description: 
      Patients who are undergoing cystoscopy with ureteral stent removal at the University of Texas
      Southwestern Medical Center and have no contraindications to receiving ketorolac will be
      eligible. Patients will be randomized to receive either a 1 mL injection of ketorolac
      tromethamine or 1 mL injection of normal saline (0.9%) as the control arm. Ketorolac is a
      member of the pyrrolo-pyrrole group of non steroid anti inflammatory drugs. The mechanism of
      action of ketorolac, like that of other NSAIDs, is not completely understood but may be
      related to prostaglandin synthetase inhibition. The peak analgesic effect occurs within 2-3
      hours. If no contraindications exist, ketorolac can be safely given to patients of any age in
      the 30 mg intramuscular formulation if given as a one time dose according to the package
      insert.

      Normal saline contains 0.9% of Sodium chloride in each mL. Like ketorolac, it is a clear
      solution and given that there are no major side effects of normal saline it is a good control
      for our study. It is packaged in a single dose vial that contains 100 mL. It is preservative
      free and stored at room temperature (20-25°C). Local pain at the injection site may occur,
      temporarily.

      The investigators will specifically look at pain scores before and after stent removal as
      well as narcotic medication use, telephone calls and/or emergency room visits for pain. Based
      on the rate of renal colic from our quality improvement project and prior work, the
      investigators calculated the maximum number of local subjects to be consented for this study
      to be n=116 (see biostatistics section). The study is expected to last 6 months.
    

Intervention name(s): Ketorolac; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): IM injection of either normal saline or Ketorolac; normal saline
Other intervention name(s): Toradol; Placebo
Intervention MeSH terms: Ketorolac
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: stent removal, pain, kidney stones
Acute Metabolic and Endocrine Responses of Glucose and Fructose in Healthy Young Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the metabolic and endocrine responses during 3
      hour after taking 75g fructose or glucose in young Chinese.
    

Detailed description: 
      The study was a double-blinded, randomized, crossover trial. Twenty healthy volunteers were
      randomized to two groups: group A (300ml of 22.5% glucose) and group B (300ml of 22.5%
      fructose).Volunteer was randomized into either group A or B, after an 8-h overnight fasting,
      took 300ml of solution at 0830 within 5 minutes. After one-week washout period, volunteer was
      crossed over for either group B or A. each intervention, venous blood was collected at 0h,
      0.5h, 1h, 2h, and 3h and blood pressure was tested at 0h, 1h, 2h, and 3h.
    

Intervention name(s): fructose; glucose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 75g fructose is dissolved in 300 ml water.After overnight fasting, 300ml of solution at 0830 within 5 minutes is taken by volunteers; 75g glucose is dissolved in 300 ml water.After overnight fasting, 300ml of solution at 0830 within 5 minutes is taken by volunteers
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: fructose; metabolism; acute
Brief Psychotherapies for Emotional Disorders in Primary and Secondary Care
Condition: Emotional Disorder
MeSH terms: Mood Disorders
Study type: Interventional

Summary: 
      The present work aims to develop a randomized clinical trial with a sample of 150 patients
      diagnosed with at least one of the following emotional disorder: somatoform disorder, panic
      disorder, generalized anxiety disorder and depression disorder. Participants are tested by
      several self-reports related to the emocional disorders mentioned in a repeated measures
      design, pre and post treatment. The investigators think this study will demonstrate that
      brief psychological treatments should be prioritized over pharmacological treatment for such
      pathologies in the Primary or Secondary Care context to improve the patient´s quality of
      life.
    

Detailed description: 
      Nowadays, the heavy demands placed on health systems exceed the resources in many developed
      countries. So-called "emotional disorders" and their mostly pharmacological treatment are, in
      no small part, responsible for this situation. However, research indicates that psychological
      treatment should be the first step when caring for these types of problems. The investigators
      expect that the results show that brief psychological therapies are more effective than
      pharmacological interventions. Moreover, it is expected that brief individual psychotherpay
      approach delivered in secondary care is more effective than brief group psychotherapy
      delivered in primary care.
    

Intervention name(s): Brief transdiagnostic cognitive-behavioral therapy; Pharmacological treatment
Intervention type(s): Behavioral; Drug
Intervention description(s): Time-limited transdiagnostic evidence-based psychological treatment; Treatment as usual in PC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity
    


Intervention name(s): Dapagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 5 mg, once daily, 12 weeks; Tablets, Oral, 0 mg, Once daily, 12 weeks
Other intervention name(s): BMS-512148
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy
Condition: Esophageal Cancer
MeSH terms: Lung Injury
Study type: Interventional

Summary: 
      A neutrophil elastase inhibitor may have effect on suppression of the lung injury after
      thoransthoracic esophagectomy. The investigators hypothesized that postoperative
      complication, particularly respiratory complication may be reduced by neutrophil elastase
      inhibitor after esophagectomy.
    

Detailed description: 
      The aim of this study was to clarify the usefulness of perioperative administration of
      sivelestat sodium hydrate, a selective inhibitor of neutrophil elastase in the pulmonary
      function, systemic inflammatory response, and the postoperative clinical course following
      video-assisted thoracoscopic esohpagectomy for esophageal cancer.
    

Intervention name(s): sivelestat sodium hydrate
Intervention type(s): Drug
Intervention description(s): saline or sivelestat sodium hydrate intravenously for 7 days starting the beginning of surgery
Other intervention name(s): Elaspol
Intervention MeSH terms: Sivelestat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Esophagectomy; Postoperative respiratory complications; neutrophil elastase inhibitor
Rituximab for Schizophrenia Spectrum Disorder (RITS-PS-2019)
Condition: Schizophrenia Spectrum and Other Psychotic Disorders; Treatment-resistant Schizophrenia
MeSH terms: Schizophrenia; Psychotic Disorders; Schizophrenia, Treatment-Resistant; Schizophrenia Spectrum and Other Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the addition of rituximab to 12 patients diagnosed with treatment
      resistant schizophrenia spectrum disorder in an open trial.
    

Detailed description: 
      Immunological factors may be determinants for some psychiatric disorders, thus
      immunomodulation may be helpful. Rituximab (antibodies against CD20, cluster of
      differentiation), a standard treatment for multiple sclerosis, is an anti-inflammatory drug,
      hitherto not tested for psychiatric disorders.

      The aim of this study is to investigate whether the psychiatric symptoms of
      treatment-resistant adult psychiatric patients, diagnosed with schizophrenia spectrum
      disorder (SSD), are significantly improved after treatment with rituximab. Our purpose is to
      implement recent insights from "Immunopsychiatry" to find efficacious, but still tolerable
      treatment for these patients.

      This is a single-site, 20-week, open pilot, add-on treatment as usual, trial, where the
      patients will be followed for 1 year.

      Rituximab will be administered with one single dose of 1000 mg. Investigators will analyse
      inflammatory and metabolic biomarkers in relation to the primary outcome, treatment response
      (defined as clinically relevant reduction in the validated measure PANSS). Other outcomes are
      "much" or "very much improved" on Clinical Global Impression - Improvement scale (CGI-I) and
      change in Personal and Social Performance Scale measuring overall disability.
    

Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): Infusion
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Immunopsychiatry; Schizophrenia spectrum disorder; treatment-resistant
A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients
Condition: Pharmacokinetics of Avycaz in ICU Patients
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to analyze the PK/PD of AvyCaz in critically ill patients in the
      Intensive Care Unit (12). This study will include medical and post-surgical patients who
      develop an infection where Avycaz can be utilized. Since these patients will have variable PK
      parameters, the investigators will also analyze (time-kill) these serum concentrations (ex
      vivo) against relevant clinical isolates (e.g. GNR with ESBL or KPC) from the ICU to
      determine microbiologic activity of Avycaz in critically ill patients with variable
      characteristics. Monte-Carlo simulations will also be conducted against clinical ICU isolates
      (JMI labs) to help determine appropriate dosing schedules based upon these PK parameters.
    


Intervention name(s): Ceftazidime/avibactam
Intervention type(s): Drug
Intervention description(s): Ceftazadime/avibactam dosing in ICU patients
Other intervention name(s): Avycaz
Intervention MeSH terms: Ceftazidime; Avibactam; Avibactam, ceftazidime drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Frequency of Circulating Tumor Cells (CTCs) and Amount of Cell-free DNA (cfDNA) in Cirrhotic Patients With Hepatocellular Carcinoma (HCC)
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Neoplastic Cells, Circulating
Study type: Observational

Summary: 
      All consecutive patients with liver cirrhosis, with clinical and imaging features suggestive
      of Hepatocellular Carcinoma (HCC) attending the Department of Hepatology, Institute of Liver
      and Biliary Sciences (ILBS) from February 2017 to December 2018 will be evaluated for
      inclusion.Based on the previous years data of HCC patients admitted to ILBS.

      Cirrhotic patients aged 18-70 years, with HCC proven by typical radiological features of
      arterial enhancement and delayed wash-out, on one or both of dynamic Computerized Tomographic
      or dynamic Magnetic Resonance Imaging (MRI), as per updated American Association for the
      Study of Liver Disease (AASLD) guidelines (details in appendix1).

      Age and gender matched patients with cirrhosis, but without HCC, seen during the same study
      period will serve as controls.

      Patient characteristics, etiology of cirrhosis, and liver function parameters will be noted.
      Investigator will stage the included patients as per the Barcelona Cancer of Liver Cancer
      (BCLC) criteria (details in appendix1). Investigator will then estimate Circulating Tumor
      Cells (CTC) and cfDNA in peripheral blood samples of the patients and controls.
    


Intervention name(s): Cirrhosis with HCC; Cirrhosis without HCC
Intervention type(s): Other; Other
Intervention description(s): Cirrhosis with Hepatocellular Carcinoma; Cirrhosis without Hepatocellular Carcinoma
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        -  Proven cirrhosis with HCC proven by standard radiological criteria within last 1
             month.

          -  Proven cirrhosis with no HCC on dynamic CT and/or dynamic MRI done within last 1
             month.
Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Endometriosis
Condition: Endometriosis; Chronic Pelvic Pain
MeSH terms: Endometriosis; Pelvic Pain
Study type: Interventional

Summary: 
      One of the main symptoms of endometriosis is pain, but his pathogenesis is not fully
      understood. The detection of mast cells in the endometriosis lesions supports the hypothesis
      that mast cell degranulation may contribute to development of pain and hyperalgesia.

      N-acylethanolamines (NAEs) are a class of endogenous compounds that regulate inflammation and
      pain, controlling mast-cell activation. The aim of the study is to investigate the efficacy
      of palmitoylethanolamide-polydatin combination on pain relief in symptomatic patients with
      endometriosis.
    


Intervention name(s): Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin
Intervention type(s): Drug
Intervention description(s): Palmitoylethanolamide 600 mg twice daily for 10 days sublingually and oral palmitoylethanolamide 400 mg and polydatin 40 mg, twice daily for 90 days
Intervention MeSH terms: Palmidrol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Is Tunneling Effective in Preventing Failure of Epidural Analgesia? A Randomized Trial
Condition: Epidural Catheter; Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This is a prospective randomized single blinded study in patients planned to undergo general
      anesthesia and epidural catheter insertion for pain control after abdominal, thoracic and
      orthopedic surgery.

      Patients meeting participation criteria will be selected and enrolled sequentially.

      The study recruitment will be carried out over one year with follow-up for each patient until
      either the catheter is dislodged or once decided that the patient is to be discontinued from
      the epidural pain control.
    

Detailed description: 
      Study Population and Sample Size The study aims to enroll 200 adult patients planned to
      undergo general anesthesia and epidural catheter insertion. The study sample will be selected
      to fulfill the selection criteria.

      Patients will be selected if they meet the following participation criteria:

      Planned Procedures and Assessments Follow -up on dislodgments, adverse events, pain and pain
      relief assessment, standard practice Study Site All study conduction from start to end
      including procedures and assessments, data acquisition and analysis and final study
      conclusion report and any publications will be at King Hussein Cancer Center (KHCC).

      Ethical Considerations The study will be submitted to the KHCC IRB for review. The study will
      not start before IRB approval is obtained.

      All patients who provide consent to participation in the study will be randomized and
      enrolled.

      Statistical Plan Descriptive statistics will be used to present the two groups baseline
      characteristics. Comparison between groups will be carried out using Chi-square test or
      t-test or Wilcox on rank test as appropriate. Comparison between groups while adjusting for
      other variables will be carried out using logistic regression. Odds ratios along with their
      95% confidence intervals will be calculated.
    

Intervention name(s): tunneling epidural catheter
Intervention type(s): Procedure
Intervention description(s): The epidural needle was used to horizontally tunnel the catheter for a length of five centimeters on either side of the insertion point.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cancer patients, Epidural analgesia, Postoperative pain, tunneling