bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Latent Autoimmune Diabetes of the Adult
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of the study is to clarify whether patients classified as Latent autoimmune
      diabetes of the adult (LADA) benefit from early treatment with insulin added to per oral
      treatment and lifestyle measures.
    

Detailed description: 
      Latent autoimmune diabetes of the adult (LADA) is usually defined as a form of diabetes where
      the onset of diabetes takes place approximately after 30 years of age, where there is
      presence of beta-cell directed antibodies (mostly anti-GAD) and where there is no clinical
      need for insulin treatment during the first 6 months after the diagnosis of diabetes.

      The aetiology and treatment of LADA patients is much less elucidated than is the case for
      type 1 diabetes (DM1) and type 2 diabetes (DM2). LADA constitutes about 10 % of the total
      diabetic population in many countries. LADA is therefore more common than insulin-requiring
      DM1.

      LADA patients lose beta-cell function faster than patients with DM2. Residual beta-cell
      function in DM1 is coupled to better metabolic control with lesser degree of hyperglycemia,
      lesser frequency of hypoglycaemic events and lesser diabetic complications.

      To retain beta-cell function in LADA patients is thus highly desirable.

      There are several strategies to retain beta cell function. One therapeutic strategy is to
      induce some degree of "beta cell rest" by treatment with exogenous insulin. Several
      observations indicate that such a strategy can have beneficial effects.

      This is a Scandinavian multicenter non-blinded clinical trial with 78 participants with newly
      diagnosed LADA. Participants will be randomized to either insulin- or per oral antidiabetic
      treatment. Participants will be followed up for 2 years after inclusion. Beta cell function
      and glycemic control will be monitored.
    

Intervention name(s): metformin+ NPH insulin; metformin + sitagliptin +/- repaglinide
Intervention type(s): Drug; Drug
Intervention description(s): Metformin 500 mg + 500 mg + 1000 mg NPH insulin , initially 0.20 U/kg body weight.; Metformin 500 mg + 500 mg + 1000 mg Sitagliptin 100 mg x 1 Repaglinide 1 mg x 3
Other intervention name(s): Insulatard; Januvia; Novonorm
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Repaglinide; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Latent autoimmune diabetes; adults; Beta cell rest; Insulin secretion
Hyperinsulinemic Euglycemic Clamp Protocol
Condition: Metabolic Cardiovascular Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to determine the safety and efficacy of TRC150094 in male
      patients with cardiometabolic risk. Cardiometabolic risk which is the overall risk of
      cardiovascular disease (CVD) and diabetes resulting from the presence of hypertension, HDL
      cholesterol, insulin resistance, dysglycemia and visceral obesity.
    

Detailed description: 
      20 Subjects will be enrolled in Veeda Clinical research,India and another 20 subjects at
      Amsterdam, the Netherlands. The maximum duration of participation in the study for each
      subject will be 9.5 weeks including a less than or equal to 4 weeks screening period, 4 weeks
      of treatment and a 10 days post treatment follow-up evaluation period.

      At each study site, 20 subjects will be enrolled. Each subject will attend the study centre
      in a fasting state, for a screening visit, 2 study visits (one baseline and one end of
      treatment), 1 intermediate safety visit and 1 post-study follow-up visit (Total 5 visits).
      The subjects at each site will be randomized to receive TRC150094 or placebo in a ratio of
      1:1. 50 mg dose will be administered once daily (morning) under fasting conditions. Dosing
      will take place daily on Days 1-28. Subjects will arrive at the study centre for screening
      visit. Physical examination, vital signs, safety biochemistry and laboratory investigations
      for verification of inclusion/ exclusion criteria will be performed during screening visit.
      Subjects meeting all the inclusion criteria and none of the exclusion criteria and who have
      given their informed consent for the study will be asked to come for the study on Day 0 (or
      day -1 if required). Baseline investigations (including baseline clamp procedure and hepatic
      MRS) will be done on Day 0 (or day -1). Subjects will receive properly labelled bottle
      containing either Active treatment or Placebo as per the randomization number of the subject.
    

Intervention name(s): TRC150094; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 50 mg Tablets once a day; Tablets once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: insulin sensitivity; cardiometabolic risk; hyperinsulinemic euglycemic clamp
Individual Workload Perception Scale - Revised (IWPS-R)
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to validate the psychometrics of the Individual Workload
      Perception Scale (IWPS).
    

Detailed description: 
      The purpose of this study is to validate the psychometrics of the Individual Workload
      Perception Scale (IWPS) designed to measure the perception of individual workloads of
      inpatient registered nurses.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        LPNS and Registered Nurses
      
Keywords: Registered Nurses; Workload; Clinical staff nurses that are currently working
A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and
      fetal adverse effects. The investigators developed a double-vasopressor automated system
      incorporating continuous non-invasive haemodynamic monitoring using NexfinTM with a two-step
      algorithm.
    

Detailed description: 
      Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and
      fetal adverse effects. We developed a double-vasopressor automated system incorporating
      continuous non-invasive haemodynamic monitoring using Nexfin cardiac output monitor with a
      two-step algorithm. The system delivered phenylephrine 25 mcg or ephedrine 2 mg (if heart
      rate<60 beats.min-1) every 30 seconds when systolic blood pressure was between 90-100% of
      baseline. The system delivered phenylephrine 50 mcg or ephedrine 4 mg (if heart rate<60
      beats.min-1) every 30 seconds when systolic blood pressure was <90% of baseline.

      A randomised controlled trial will be done to compare with manual bolus technique. With the
      manual bolus technique, phenylephrine 50mcg or ephedrine 4mg (if heart rate<60 beats.min-1)
      every 60 seconds when systolic blood pressure was between 90-100% of baseline. The system
      delivered phenylephrine 100mcg or ephedrine 8mg (if heart rate<60 beats.min-1) every 60
      seconds when systolic blood pressure was <90% of baseline.
    

Intervention name(s): vasopressor delivery automated system; phenylephrine; ephedrine; manual vasopressor delivery
Intervention type(s): Device; Drug; Drug; Device
Intervention description(s): vasopressor delivery using phenylephrine and ephedrine
Other intervention name(s): vasopressor delivery technique; vasopressor; vasopressor
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Ephedrine; Vasoconstrictor Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypotension
Effects of Therapeutic Play on Anxiety and Fear
Condition: Pediatric Cancer
Study type: Interventional

Summary: 
      This study was carried out as a randomized controlled experimental study in order to evaluate
      the effect of therapeutic game use on anxiety and fear levels before indwelling catheter
      intervention in children aged 6-12 years followed in the hematology oncology service. A
      simple randomization method was used to assign children to groups. Ethics committee and
      institutional permission was obtained for the research. Research data were obtained from a
      total of 80 children, 40 interventions and 40 controls, hospitalized in Istanbul Medical
      Faculty Pediatric Hematology Service between October 2022 and August 2023.

      Data; It was evaluated with the information form, child follow-up form, Child Anxiety Scale-
      State (ÇAS-D) and Child Fear Scale (CCS). For those assigned to the intervention group among
      the mother and child who signed the informed consent form; Before the indwelling catheter
      intervention, the children were shown the procedure on the amigrumi knitted baby developed by
      the researcher, the catheter application area was explained through the cardiovascular image
      and the catheter to be inserted was shown as an example. For those assigned to the control
      group; No intervention was applied other than the hospital&#39;s normal procedure. Data were
      evaluated using the SPPS 26 (IBM Corp. IBM 1989, 2019. SPSS Statistics for Windows, Version
      26.0. Armonk, NY: IBM Corp.) package program. It was determined that the MCQ and ÇAS-D scores
      of the children in the intervention group were significantly lower than those in the control
      group (p˂0.01). It was determined that the mean CTA and respiratory rate of the children in
      the intervention group just before and 2 hours after the application were lower than the
      control group (p&lt;0.001).

      According to the results of the research, it was determined that the therapeutic game applied
      before indwelling catheter intervention in children between the ages of 6-12 was effective in
      reducing children's anxiety and fear.
    

Detailed description: 
      According to the results of the research, it was determined that the therapeutic game applied
      before indwelling catheter intervention in children between the ages of 6-12 was effective in
      reducing children's anxiety and fear.
    

Intervention name(s): THERAPEUTICGAMES
Intervention type(s): Behavioral
Intervention description(s): THERAPEUTICGAMES
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study of the Tumor Microenvironment Affecting the Efficacy of Immunotherapy for Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Observational

Summary: 
      This study is a retrospective study of clinical specimens. The study subjects were patients
      with esophageal cancer who received immunotherapy. Tumor tissue specimens surgically removed
      from patients before treatment will be collected primarily. In situ immunohistochemistry and
      multicolor immunofluorescence will be performed. We hypothesize that there are differences in
      lipid metabolism-related proteins in tumor tissues and immune cells in the preexisting tumor
      microenvironment in patients with esophageal cancer prior to immunotherapy, and that there is
      a link between such differences and the efficacy of immunotherapy.
    


Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with esophageal cancer receiving immunotherapy
      
Biospecimen description: 
      FFPE
SEntine Lymph Node in earLY Ovarian Cancer (SELLY)
Condition: Sentinel Lymph Node; Ovarian Cancer Stage I
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional

Summary: 
      The present study aims at investigating the feasibility, the detection rate and the negative
      predictive value of sentinel node in predicting the presence or absence of lymph node
      metastasis in ovarian cancer patients
    

Detailed description: 
      Patients with early stage ovarian cancer have a good prognosis. However, nearly 15% of the
      initially diagnosed as early stage ovarian cancers, will be upstaged after an appropriate
      surgical staging due to lymphatic metastasis, despite of preoperative radiological data.
      Therefore, complete pelvic and para-aortic lymphadenectomy in these patients represents a
      crucial procedure. On the other hand, nodal dissection may be associated with threatening
      intra- and post-operative complications.

      If feasible and accurate, the sentinel lymph node procedure could be a modality to avoid
      unnecessary radical lymphadenectomy without missing important information on nodal status.

      With the present study we aim at exploring the role of sentinel node dissection in early
      ovarian cancer patients.

      Patients with ovarian cancer macroscopically limited to the ovary (early ovarian cancer) will
      receive injection of a tracer (patent blue or indocyanine green) which have already been
      proven safe and extremely effective in several other gynecologic and non-gynecologic
      malignancies. Then the retroperitoneal spaces will be opened as for a standard
      lymphadenectomy procedure and the lymph node marked with the tracer will be identified. After
      dissection of the sentinel node, lymphadenectomy will be completed according to current
      guidelines.

      Operative data, pathological findings and accuracy of sentinel node in predicting nodal
      status will be registered.
    

Intervention name(s): Sentinel node detection
Intervention type(s): Procedure
Intervention description(s): Patients will receive injection of tracer in the ovarian ligaments to identify the lymphatic drainage of the affected ovary and ultimately the sentinel node. Afterwards, systematic lymphadenectomy will be accomplished according to current guidelines.
Intervention model: Single Group Assignment
Intervention model description: All patients with early ovarian cancer will receive sentinel node procedure before full lymphadenectomy, in order to assess the accuracy of sentinel node in diagnosing the presence of nodal metastases.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ovarian cancer; laparoscopy; sentinel node; lymphadenectomy
A Clinical Study of Intravenous Immunoglobulin
Condition: Immunologic Deficiency Syndromes
MeSH terms: Immunologic Deficiency Syndromes; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to measure the pharmacokinetics, efficacy and safety of Immune
      Globulin Intravenous (Human) [IGIV], 5% Solution Omr-IgG-am™ in patients with primary
      immunodeficiency diseases.
    

Detailed description: 
      This is an open label, single-arm, prospective, multi-center, uncontrolled Phase III clinical
      study to evaluate the efficacy, pharmacokinetics and safety of Omr-IgG-am™ in patients with
      primary immunodeficiency diseases.

      Approximately 50 subjects will be enrolled for 16 Months:

      screening- 1 month treatment-12 months follow-up-3 months

      Subjects will be infused every 21 to 28 days according to their previous IVIG treatment
      schedule. Subjects treated every 28 days will receive 13 study IGIV infusions. Subjects
      treated every 21 days will receive 17 study IGIV infusions.

      We will record the incidence of acute infections, especially acute serious bacterial
      infections, during the year each subjet is on study.

      We will record the incidence of adverse events that occur during each infusion and up to 48
      hours after each infusion.

      At the time the study is explained to the subjects, each investigator will ask all subjects
      whose body weight is above 37 kg (or greater as defined by local standards) about their
      willingness to participate in the pharmacokinetic (PK) portion of the study. This will
      involve 4 additional visits after the 5th or 6th study IGIV infusion in order to draw blood
      samples for analysis.
    

Intervention name(s): Immune Globulin Intravenous (Human) Omr-IgG-am IGIV
Intervention type(s): Drug
Intervention description(s): IGIV infusions of 300-900 mg/kg every 3 or 4 weeks
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Deficiency Syndromes, Antibody; Antibody Deficiency Syndrome; Bruton's agammaglobulinemia; Common Variable Immune Deficiency; Hyper IgM syndromes
Patient-reported Outcome Measures Comparing Static Computer-aided Implant Surgery and Conventional Implant Surgery
Condition: Dental Implantation; Postoperative Pain; Computer-assisted Surgery; Patient Outcome Assessment; Dental Anxiety; Quality of Life; Oral Health
Study type: Interventional

Summary: 
      The aim of this randomized controlled trial was to compare PROMs in patients receiving single
      tooth replacement in posterior sites by s-CAIS and CIS.
    

Detailed description: 
      Since current patient-reported outcome measures (PROMs) evidence related to static
      computer-aided implant surgery (s-CAIS) compared with conventional implant surgery (CIS),
      particularly in partial edentulous patients, were still limited. The aim of this randomized
      controlled trial was to compare PROMs in patients receiving single tooth replacement in
      posterior sites by s-CAIS and CIS.
    

Intervention name(s): Modified Dental Anxiety Score (MDAS) questionnaire; Pain questionnaire; Oral Health-Related Quality of Life (OHRQoL) questionnaire
Intervention type(s): Other; Other; Other
Intervention description(s): MDAS was used to measure the patients' anxiety toward dental treatment before implant surgery (Humphris, Dyer, &Robinson, 2009). Originally, the MDAS questionnaire included five questions answered with a 5-category Likert scale. The original MDAS questionnaire does not cover anxiety toward implant surgery. Therefore, a question enquiring about patients' feelings towards implant surgery was added.; Patients were asked to describe the worst pain feeling using a standard 10 cm Visual Analog Scale (VAS) and the proportion of time spent in severe pain using a 5 category Likert scale. The number of analgesics taken per day was also asked.; The OHRQoL comprises 14 questions covering problems the patient may in three main categories: oral function, daily activity, and post-operative symptoms (Chaushu, Becker, Zeltser, Vasker, & Chaushu, 2004). Patients answered using a 5-category Likert scale.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Other
Keywords: Clinical Research; Dental Implant; Static Computer-Aided Implant Surgery (s-CAIS); Patient-Reported Outcome Measures (PROMs); Dental Anxiety; Pain; Oral Health-Related Quality of Life (OHRQoL)
North American Study for the Treatment of Refractory Ascites (NASTRA)
Condition: Ascites; Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Ascites
Study type: Interventional
Phase: Phase 3

Summary: 
      The NASTRA Clinical Trial is a multi-center, randomized, controlled clinical trial designed
      to determine if treatment with transjugular intrahepatic portasystemic shunts (TIPS) is
      superior to high volume paracentesis (total paracentesis, TP) for the treatment of refractory
      ascites due to cirrhosis. Only patients with clinically tense symptomatic ascites (shortness
      of breath, umbilical hernia, abdominal pain and/or distension, and/or limitation of activity)
      who have either diuretic-resistant ascites or diuretic-intractable ascites are being studied.
    


Intervention name(s): Transjugular intrahepatic portasystemic shunts (TIPS); Total paracentecis (TP)
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: refractory ascites; paracenteses
Interferon-Alpha for Diabetes Mellitus Type 1
Condition: Insulin-Dependent Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will see if interferon-alpha given early in the disease can stop or slow the
      immune attack on insulin-producing cells. In addition, the study will examine the safety and
      efficacy of interferon-alpha (given by mouth) to protect beta cell function. Patients between
      3 and 25 years of age with Type 1 Diabetes Mellitus less then six weeks may be eligible for
      this study. All study-related tests and medications at the NIH Clinical Center are provided
      at no cost.
    

Detailed description: 
      Type 1 diabetes mellitus (T1DM) results from autoimmune destruction of the insulin-producing
      pancreatic beta-cells. The onset of clinical symptoms represents the endpoint of a chronic
      progressive decline in beta-cell function when the number of functional beta-cells descends
      below the critical mass required for maintenance of euglycemia ([1], [2]). However, the
      pancreas still retains the ability to produce a substantial amount of insulin. The goal of
      secondary prevention in T1DM is to avert further destruction of the remaining beta-cells and
      therefore delay or stop entry into the final stages of the disease associated with end organ
      damage.

      The rationale for this study is to interfere with the autoimmune beta-cell destruction early
      on in order to preserve as much residual endogenous insulin production as possible. We plan
      to administer oral interferon-alpha (IFN-a) on a daily basis, which has been shown to modify
      the clinical course of diabetes, to alter cytokine release, and reduce expression of T cell
      activation markers in an animal model ([3]) and a pilot project in humans (S. Brod,
      University of Texas, unpublished data). The one-year study is designed as a double blind
      randomized protocol using either 5,000 or 30,000 units of IFN-a versus placebo. Five centers
      will participate in this protocol (University of Texas Health Science Center in Houston;
      Dallas; Children's Hospital, St. Paul, MN; Kansas City and NIH, Bethesda, Maryland).
    

Intervention name(s): 30,000 units hrINF-alpha; 5,000 hrINF-alpha; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): placebo was prepared as saline alone with 6mg human serum albumin (HSA).
Other intervention name(s): Human Recombinant Interferon-alpha; Human Recombinant Interferon-alpha
Intervention MeSH terms: Interferons; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes; Immunotherapy; Study Drug; Insulin Dependent Diabetes; Diabetes Mellitus; TIBM