bioihbjkbjnl/mcl2 huggingface dataset:
Preload Optimization Guided by Inferior Vena Cava Collapsibility Index
Condition: Adverse Effect
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the optimal preload guided by inferior vena cava
      collapsibility index in parturients with prophylactic norepinephrine infusion undergoing
      cesarean section.
    

Detailed description: 
      Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for
      cesarean section. The incidence of post-spinal anesthesia hypotension is as high as
      62.1-89.7% if prophylactic measures are not taken. Vasopressors has been highly recommended
      for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential
      substitute drug for phenylephrine, norepinephrine has gradually been used in parturients
      undergoing cesarean section. There's some evidence that prophylactic infusion of
      norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension
      in parturients undergoing cesarean section. However, the investigator's study (NCT03997500)
      had been shown that inferior vena cava collapsibility index (IVC-CI) markedly decreased in
      prophylactic norepinephrine infusion versus normal saline after spinal anesthesia and fetal
      delivery, suggesting that more prudent fluid management is required. The ideal dose of
      preload and coload is still unknown. Thus, the purpose of this study is to investigate the
      optimal preload guided by IVC-CI in parturients with prophylactic norepinephrine infusion
      undergoing cesarean section.
    

Intervention name(s): Control group; 4 ml/kg group.; 8 ml/kg group.; 12 ml/kg group.
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): No preload was given before spinal anesthesia.; 4 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.; 8 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.; 12 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.
Other intervention name(s): Crystalloid; Crystalloid; Crystalloid; Crystalloid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Preload; Inferior vena cava collapsibility index; Norepinephrine; Cesarean section; Dose-finding
Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of HKI-357 Administered Orally to Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of
      single doses of HKI-357 administered to healthy subjects.
    


Intervention name(s): HKI-357
Intervention type(s): Drug
Intervention description(s): Single-dose capsule
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: healthy subjects
The Efficacy and Safety of Intraarticular Sodium Hyaluronate (Hyalgan) After Proximal Tibial Osteotomy in Treatment of Knee Osteoarthritis Patients
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of Hyalgan after proximal
      tibial osteotomy in treatment of knee osteoarthritis patients. Normally, OA patients who were
      treated with osteotomy will not be treated with any SYSADOA after operation, even though
      their cartilage's not completely loss, so osteotomy plus HA injection should provide more
      benefit to patients than osteotomy alone.
    


Intervention name(s): Sodium Hyaluronate (Hyalgan); Osteotomy alone
Intervention type(s): Drug; Procedure
Intervention description(s): 1% Sodium Hyaluronate in prefilled syringe; no injection
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Implementation of 23 Hour Surgery Model in a Tertiary Hospital
Condition: Ambulatory Surgery; Laparoscopy; Shoulder Impingement Syndrome; Ovarian Cysts; Cholecystolithiasis; Appendicitis; Gynecologic Surgical Procedures; Ambulatory Surgical Procedures; Neurosurgery
MeSH terms: Appendicitis; Ovarian Cysts; Shoulder Impingement Syndrome; Cholecystolithiasis; Cholelithiasis; Gallstones
Study type: Observational

Summary: 
      Extended day surgery or 23 h surgery (23-hour surgery) is a surgical model where patients
      arrive to the hospital from home at the day of surgery, are operated and recover in a 23 h
      surgery unit. 23H surgery units are usually situated near postoperative recovery unit. THe 23
      H surgical model was implemented in Kuopio University Hospital 2015 and between May 2017-May
      2018 patients were recruited in the present prospective follow up cohort study. Patients were
      informed and they gave their informed consent. The patients were contacted two weeks after
      the study and details of their recovery were asked.
    

Detailed description: 
      Extended day surgery or 23 h surgery is a surgical model where patients arrive to the
      hospital from home at the day of surgery, are operated and recover in a 23 h surgery unit.
      23H surgery units are usually situated near postoperative recovery unit. THe 23 H surgical
      model was implemented in Kuopio University Hospital 2015 and between May 2017-May 2018
      patients were recruited in the present prospective follow up cohort study. Patients were
      informed and they gave their informed consent. The patients were contacted two weeks after
      the study and details of their recovery were asked. Satisfaction to the care in 23 h unit and
      surgical process, were asked. Amount of readmissions, reoperations, contacts to health care
      professionals and adverse events are recorded.

      Detailed information about intensity of pain, analgesic need and use in the hospital was
      recorded and pain interference in daily life for short term recovery period was asked.
    

Intervention name(s): 23 h surgery
Intervention type(s): Other
Intervention description(s): Patients were treated in 23 surgical unit
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults undergoing 23 h surgery
      
Keywords: 23 h surgery; postoperative recovery; outcome; patient satisfaction; postoperative pain; analgesic; oxycodone; multimodal pain management; extended day surgery
Functional Outcome Measures With Vibrotactile Feedback to Prostheses
Condition: Unilateral Transradial Amputation
Study type: Interventional

Summary: 
      Investigators wish to evaluate the effects of adding VTF to upper limb prostheses on
      functional outcome measures of upper limb prosthetic users.
    

Detailed description: 
      Investigators will perform three experiments:

        1. Investigators will add vibrotactile feedback to prosthetic users during the execution of
           a standardized functional test and performance of simple grasping tasks, with a
           disruption to the normal visual feedback, and examine whether their performance and arm
           kinematics are improved with tactile feedback;

        2. Investigators will examine the effects of adding the feedback to a prosthesis on the
           performance and visual attention during a dual task assignment in prosthetic users, and

        3. Investigators will provide prosthetic users with the feedback, to use it at their
           natural surroundings for a week, and study the reported activity and satisfaction
           levels.
    

Intervention name(s): Vibrotactile feedback system
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Asphyxia Neonatorum; Asphyxia
Study type: Interventional

Summary: 
      Neonatal anoxic-ischaemic enkephalopathy is a dramatic perinatal complication due to brain
      asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal
      damage and loss.

      For the moment, only total or partial body hypothermia can partially prevent cell loss.
      However, no treatment exists to restore neuronal functions.

      Cord blood stem cells are a promising treatment for the near future. However, before
      conducting a clinical trial to evaluate the safety and feasibility of autologous cell therapy
      in neonatal asphyxia, in vitro characterization of the cord blood stem cell in situation of
      neonatal asphyxia, compared to normal situation, is needed.

      The primary objective of this study is to characterize cord blood stem cells of neonates with
      neonatal asphyxia and to compare them with those from healthy newborn. The quantitative and
      qualitative, functional characterization will insist on cell populations which could
      potentially participate to neuronal regeneration. Secondary objectives are to assess such
      characteristics in conditions of cryo-preservation, compared to fresh cell preparation
    

Detailed description: 
      Methods :

      Descriptive, bi-centre study on 10 cord blood samples from newborn infants with neonatal
      asphyxia (5) according to pre-defined criteria, compared healthy neonates (5). The total
      duration of the study will be 2 years. Parents will be informed and a signed parental consent
      will be asked in the hours following birth before the in vitro study.

      Biological analysis will include elementary analyses for cell quality control, endothelial
      progenitor exploration, and investigation of mesenchymal stem cells function and of their
      neuronal differentiation potential (on fresh and frozen samples).

      Statistical analysis: comparison between the 2 groups (neonatal asphyxia versus control)
      would use non parametric test (Mann-Whitney)

      This study will allow to evaluate the therapeutic potential of cord blood stem cells
      autologous transplantation in neonatal asphyxia. It will contribute to the determination of
      the feasibility of a clinical trail of autologous, cord blood stem cells therapy in such
      disease.
    

Intervention name(s): in vitro characterization of the cord blood stem cell
Intervention type(s): Other
Intervention description(s): The quantitative and qualitative, functional characterization will insist on cell populations which could potentially participate to neuronal regeneration. and assessment such characteristics in conditions of cryo-preservation, compared to fresh cell preparation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cord blood stem; neonatal asphyxia
Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to
      and kill tumor cells. Colony-stimulating factors such as GM-CSF may increase the number of
      immune cells found in the bone marrow or peripheral blood. Interleukin-2 may stimulate a
      person's white blood cells to kill melanoma cells. Combining vaccine therapy with GM-CSF and
      interleukin-2 may be kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of vaccines made from melanoma cells with
      or without GM-CSF followed by interleukin-2 in treating patients with stage III or stage IV
      melanoma.
    

Detailed description: 
      OBJECTIVES: I. Compare the effectiveness of vaccination with synthetic melanoma peptides
      pulsed on autologous dendritic cells versus vaccination with synthetic melanoma peptides plus
      sargramostim (GM-CSF) in decreasing tumor burden in patients with high risk melanoma (pulsed
      autologous dendritic cell arm closed 1/8/2001). II. Determine whether these regimens result
      in increased tumor specific immune responses as measured in vitro and in vivo. III. Determine
      whether these regimens stimulate T-cell responses in these patients.

      OUTLINE: This is an open label study. Patients are included in treatment arm II only (arm I
      closed 1/8/2001): Arm I: Patients undergo leukapheresis to collect dendritic cells. Patients
      receive a mixture of synthetic melanoma peptides (gp100 antigen, tyrosinase, and tetanus
      peptides) pulsed on autologous dendritic cells IV and subcutaneously (SC). Arm II: Patients
      receive a mixture of synthetic melanoma peptides (gp100 antigen, tyrosinase, and tetanus
      peptides) and sargramostim (GM-CSF) emulsified in Montanide ISA-51 SC and intradermally.
      Patients receive vaccination during weeks 0, 1, 2, 4, 5, and 6 for a total of 6 doses and
      interleukin-2 SC daily on days 7-49. Patients receive 3 additional vaccinations at different
      sites not involved with the tumor concurrently with the first 3 vaccinations. Patients are
      evaluated at 8 weeks, 12 weeks, 6 months, 12 months, and 24 months.

      PROJECTED ACCRUAL: A total of 27-54 patients will be accrued for this study within 2 years.
    

Intervention name(s): aldesleukin; gp100 antigen; incomplete Freund's adjuvant; sargramostim; tetanus peptide melanoma vaccine; tyrosinase peptide
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Systemic subcutaneous delivery of low-dose IL-2.
Other intervention name(s): Interleukin-2
Intervention MeSH terms: Aldesleukin; Interleukin-2; Sargramostim; Freund's Adjuvant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III melanoma; stage IV melanoma; recurrent melanoma
Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve
Condition: Aortic Valve Stenosis
MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic
Study type: Observational

Summary: 
      Investigators sought to demonstrate that the increase in the stroke volume during a
      dobutamine stress echocardiography might impact the prognosis of a patient addressed for a
      low flow low gradient suspected severe aortic valve stenosis.
    


Intervention name(s): Electrocardiogram; 2D and 3D echocardiography; Dobutamine stress echocardiography; Blood tests; Cardiac MRI; Cardiac scanner; 6-minutes walking test; Duke Activity Score
Intervention type(s): Device; Device; Device; Biological; Device; Device; Other; Other
Intervention description(s): ECG at inclusion and M12; 2D and 3D echocardiography at inclusion and M12; dobutamine stress echocardiography at inclusion; Blood test electrolytes, creatinine, hemoglobin, NT-proBNP, CRP, ST-2 at inclusion and M12; Cardiac MRI at inclusion; Cardiac scanner at inclusion; 6-minutes walking test at inclusion and M12; Duke Activity Score at inclusion and M12
Intervention MeSH terms: Dobutamine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with low flow low gradient aortic stenosis
      
Keywords: Aortic valve stenosis; low flow; dobutamine stress echocardiography
Pilot Study to Assess Number of Patients for Main Trial
Condition: Wound Healing
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the study was to investigate the efficacy of Bepanthen® wound healing
      ointment compared to placebo in a superficial abrasive wound model. The primary objective was
      the re-epithelization at Day 5.

      The secondary objectives were re-epithelization at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15,
      assessment of cosmetic outcome/acceptance at Day 15 (investigator only) and at Day 36
      (investigator and subject), and documentation and analysis of safety parameters.
    


Intervention name(s): Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30 g of 5% of the active ingredient dexpanthenol plus other ingredients as ointment; Placebo to Bepanthen® ointment without active ingredient dexpanthenol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-301 Clinical Trial
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Observational

Summary: 
      This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment
      in phase 3 clinical trial (ALLO-ASC-DFU-301) for 24 months
    

Detailed description: 
      This is an open-label follow up study to evaluate the safety for the subjects with
      ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-301) for 24 months.
      ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells.
      Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as
      vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can
      enhance wound healing and regeneration of new tissue, finally may provide a new option in
      treating a Diabetic Foot Ulcer.
    

Intervention name(s): ALLO-ASC-DFU; Vehicle sheet
Intervention type(s): Biological; Procedure
Intervention description(s): Application of ALLO-ASC-DFU sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.; Application of Vehicle sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial
        of ALLO-ASC-DFU-301.
Obinutuzumab in Combination With GDP Chemotherapy in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
Condition: Lymphoma, Non-Hodgkin's
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a pilot study to determine the overall survival rate and toxicities of obinutuzumab
      given with GDP chemotherapy for relapsed or refractory CD20+ aggressive non-Hodgkin lymphoma.
      Patients who have CD20+ and progressed R-CHOP therapy will be enrolled into the study. About
      30 patients are planned to be enrolled from Princess Margaret Cancer Centre.

      If the enrollment is very slow then additional site may be included. Patients will receive
      Obinutuzumab +GDP for 3 cycles intravenously. CT scan will be used to evaluate the response
      rate after cycle 2 and PET-CT will be used after cycle 3. Responders (complete metabolic
      response, partial metabolic response) should proceed to autologous stem cell transplant
      (ASCT). Patients who have progressed after three cycles or less are to have their protocol
      treatment discontinued, with subsequent treatment at investigator discretion. Patients will
      be followed up to 24 months from transplant done or last chemo. Mandatory tissue submission
      and optional tissue and blood submission are required for the correlative component of this
      study.
    


Intervention name(s): Obinutuzumab; Gemcitabine; Dexamethasone; Cisplatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Type II anti-CD20 monoclonal antibody; Antineoplastic agent; Corticosteroid; Antineoplastic Agent
Other intervention name(s): GAZYVA; Decadron
Intervention MeSH terms: Dexamethasone; Gemcitabine; Obinutuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lymphoma; Non-Hodgkin's; CD20+; Obinutuzumab; GDP Chemotherapy; Refractory and aggressive non-Hodgkin lymphoma
The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation
Condition: Metabolic Syndrome
MeSH terms: Endotoxemia; Metabolic Syndrome; Inflammation
Study type: Interventional

Summary: 
      In spite of the growing evidence for the beneficial effects of probiotics, their anti-obesity
      effects are not well examined. No previous studies were conducted in this research area in
      the UAE. Hence, the aims of this study are to 1) Investigate the link between metabolic
      derangements associated with obesity and levels of LPS and LBP; 2) Study the relatedness of
      low grade inflammation with the ME; 3) Investigate the food intake assessment; and 4)
      Investigate the effectiveness of probiotics supplement on the obesity, ME and inflammation.

      This project will have two phases: 1) a cross-sectional, in which 250 adults will be
      recruited for the collection of anthropometric measures, food intake, and fasting blood
      samples to measure serum LPS, LBP, Lipid profile, IR, insulin-like growth factor, hs-CRP,
      IL-6, and glucose. 2) Intervention phase, in which 50 overweight subjects will be randomly
      assigned to either receive a daily probiotic (25 subjects) or a placebo capsule (25 subjects)
      during the intervention period.
    

Detailed description: 
      General Objective:

      To study the relatedness of obesity, with the associated metabolic endotoxemia and low-grade
      inflammation, and the effectiveness of probiotics intervention in adults, in UAE.

      Specific Aims:

        -  Investigate the link between metabolic derangements associated with obesity and levels
           of LPS and LBP among the population in Sharjah, UAE.

        -  To examine the associated factors of obesity among the same population, including
           socio-demographic data, anthropometric measures, body composition analysis, and food
           frequency assessment.

        -  To investigate the correlation of the inflammatory marker Il-6 and hs-CRP to the levels
           of endotoxemia in lean, overweight and obese subjects.

        -  To evaluate the change in endotoxemia, body mass index (BMI) and inflammatory markers,
           after consumption of probiotics capsules of blended strains of Lactobacillus for 8
           consecutive weeks among overweight and obese individuals.
    

Intervention name(s): Probiotane; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): probiotics capsules of blended strains including Lactobacillus acidophilus, L. casei and L. rhamnosus; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention