bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Feasibility of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To investigate the feasibility, safety, efficacy and optimal dose of umbilical cord blood
      mononuclear cell transplant in the treatment of chronic spinal cord injuries.
    

Detailed description: 
      This is an open-label, dose-escalating clinical trial. Three groups of four patients will
      receive transplants of increasing doses of HLA-matched umbilical cord blood mononuclear cell
      into the spinal cord. In the fourth group, we will transplant the highest volume of cells
      that did not increase neurological deficits along with a single bolus of 30mg/kg
      methylprednisolone sodium succinate. In the fifth group of four subjects, we will inject that
      volume of cells plus a bolus intravenous dose of 30mg/kg methylprednisolone sodium succinate
      and a 6-week course of oral lithium carbonate titrated to 0.6-1.0 mM serum levels. All the
      subjects are encouraged to stand or walk for one hour a day after the cell transplantation.

      The neurological and walking outcomes will be assessed 1, 2, 6, 24 and 48 weeks after
      transplantation. The outcomes of the five treatment groups will be compared by analysis of
      variance and, if possible, correlation with cell dose. Efficacy and safety will be analyzed
      comparing neurological change scores amongst the five different treatment groups. Loss of
      motor (>5 points) or sensor scores (>2 points) from baseline pre-treatment levels would be
      considered deleterious. Increases in scores above baseline would be considered beneficial.
    

Intervention name(s): Umbilical Cord Blood Mononuclear Cell; Methylprednisolone; Lithium
Intervention type(s): Biological; Drug; Drug
Intervention description(s): The cord blood mononuclear cells are obtained from thawed units of HLA-matched human umbilical cord blood. The cells will be slowly injected into the posterior gray matter after laminectomy and opening of the dura.; 30 mg/kg methylprednisolone; oral lithium, titrated to maintain 0.6-1.0 mM serum level
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinal cord injury; cord blood mononuclear cell; Methylprednisolone; Lithium Carbonate
A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Condition: Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b, open-label, multicenter study evaluating the safety and tolerability of
      ABT-199 in combination with rituximab in up to 50 subjects with Relapsed Chronic Lymphocytic
      Leukemia and Small Lymphocytic Lymphoma. The primary objectives of this study are to assess
      the safety profile, to determine the maximum tolerated dose and establish the Recommended
      Phase Two Dose of ABT-199 when administered in combination with rituximab. The dose
      escalation portion of the study will include approximately 30 subjects. Once the recommended
      phase two dose and schedule have been determined, up to 20 additional subjects will be
      enrolled in an expanded safety portion of the study. Subjects who meet criteria for CR, CRi,
      or MRD-negative PR during the study may discontinue ABT 199. If disease progression occurs,
      as defined by iwCLL NCI/WG criteria for tumor response, or MRD progression, subjects may
      re-initiate ABT-199.
    


Intervention name(s): ABT-199; Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): ABT-199 is taken continuously once daily. This is a dose escalation study, therefore the dose of ABT-199 will change throughout the study.; Rituximab will be given by intravenous infusion on day 1 of Months 1, 2, 3, 4, 5, and 6. May be reinitiated for an additional 6 months.
Other intervention name(s): venetoclax
Intervention MeSH terms: Rituximab; Venetoclax
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety; Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia; Rituximab; Tolerability; Pharmacokinetics; ABT-199; Cancer; Preliminary; Efficacy; Maximum Tolerated Dose; Venetoclax
Thromboelastography Normal Reference Values in China Hunan Province
Condition: Coagulopathy; Blood Transfusion Complication
MeSH terms: Transfusion Reaction
Study type: Observational

Summary: 
      The purpose of this study was to establish the normal reference range of Thrombelastogram
      parameters in Hunan by a multicenter study, and to analyze the specificity of
      Thrombelastogram detection and the influence of gender, age and blood type on
      Thrombelastogram. The study will provide basic data and statistical basis for the
      establishment of normal reference range of Thrombelastogram in Hunan.
    

Detailed description: 
      Thrombelastograghy (TEG) is an important test to assess the blood coagulation function to
      monitor the whole process of perioperative coagulation. TEG can evaluate the coagulation
      cascade, from platelet aggregation, clot strengthening and fibrin cross-linking to eventually
      clot lysis in small volume of whole blood. The reference range is one important element to
      influence the TEG results. At present, a number of studies have shown that reference range of
      TEG exists significant differences between different racial and geographic. At the same time,
      reagent manufacturers also suggested that each TEG laboratory should establish its own
      reference range. So it is important to establish our own reference range of TEG to guide the
      clinical blood transfusion and treatment.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Permanent resident in Hunan, 18< Age <65.
      
Keywords: Thrombelastograghy; reference ranges; racial; geographic; Blood Transfusion
Different Dosing Time of Bowklean for the Bowel Preparation
Condition: Bowel Preparation
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to compare the efficacy of administration routine
      bowel cleansing medication (Bowklean) for the Bowel Preparation at Different Times Prior
      Colonoscopy in the morning or in the afternoon.
    

Detailed description: 
      Sodium picosulfate/magnesium citrate (SPMC) is a small-volume bowel cleansing agent with
      similar efficacy and better tolerability than polyethylene glycol. However, there was limited
      data about the bowel cleansing efficacy of SPMC in comparing the same-day and split-dose
      preparation for afternoon colonoscopy.

      This randomized, single-center, endoscopist-blinded, non-inferior study compared same-day
      (101 subjects) and split-dose (96 subjects) preparation with SPMC for afternoon colonoscopy.
      One additional prospective observation group of 100 subjects receiving colonoscopy in the
      morning was included as an observation group to compare bowel preparation in morning and
      afternoon colonoscopy. Efficacy of bowel cleansing was evaluated by the Aronchick Scale,
      Ottawa Bowel Preparation Scale (OBPS), Boston Bowel Preparation Scale (BBPS), and the Bubble
      Scale (TBS).
    

Intervention name(s): Bowklean
Intervention type(s): Drug
Intervention description(s): assigned intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The 1st group: split dose, day before, colonoscopy in the morning. The 2nd group: split dose, day before, colonoscopy in the afternoon. The 3rd group: same day, colonoscopy in the afternoon.
Masking: None (Open Label)
Primary purpose: Other
Efficacy of Electric 3D Versus Manual Toothbrushes in Patients With Fixed Orthodontic Appliances
Condition: Gingivitis; Dental Plaque
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional

Summary: 
      This study evaluates if electric toothbrushes with a 3D action (rotation / oscillation and
      pulsation) are more effective than manual toothbrushes in removing plaque and reducing
      gingival inflammation in patients under orthodontic treatment with fixed appliances.
    

Detailed description: 
      This trial is designed as a randomized, controlled, investigator blinded superiority trial,
      with two parallel groups and a 1:1 allocation ratio. Equal number of males and females will
      be allocated to each group.

      One group of orthodontic patients will receive an electric toothbrush with orthodontic head
      and the other group will receive a manual orthodontic brush. Tooth brushing instructions will
      be provided. Measurements of two plaque indices and two gingival indices will be taken at
      baseline and at 3 monthly intervals.
    

Intervention name(s): Electric3D; Manual
Intervention type(s): Device; Device
Intervention description(s): Oral-B 3D with orthodontic head; Oral-B orthodontic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy
Condition: Fatigue; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      RATIONALE: Physical activity may help lessen fatigue caused by cancer in patients receiving
      chemotherapy. It is not yet known whether a home-based walking and resistance-band exercise
      program is effective in lessening fatigue.

      PURPOSE: This randomized phase III trial is studying how well exercise works in lessening
      fatigue caused by cancer in patients undergoing chemotherapy.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the efficacy of a home-based walking and progressive-resistance exercise
           program in reducing cancer-related fatigue (CRF) in patients undergoing chemotherapy.

      OUTLINE: This is a multicenter study. Patients are stratified according to participating
      site, chemotherapy course length (2 weeks vs 3 weeks), gender, and degree of fatigue reported
      on the study assessment questionnaire (≤ 5 vs > 5). Patients are randomized to 1 of 2
      intervention arms.

        -  Arm I: Patients receive standard chemotherapy.

        -  Arm II: Patients receive a home-based walking kit comprising an Exercise for Cancer
           Patients Manual, a pedometer, and therapeutic resistance bands. Patients undergo
           moderately intense aerobic exercise (walking) monitored by a pedometer, and low to
           moderately intense progressive-resistance exercise using therapeutic resistance bands
           for 6 weeks. Patients also receive standard chemotherapy.

      Patients in both arms undergo assessment of their aerobic capacity and strength by the
      6-minute walk test and handgrip dynamometry at baseline and at day 41. They also have a
      fasting blood draw and wear an actigraph for one week at baseline and week 6. Patients
      complete Functional Assessment of Chronic Illness Therapy-Fatigue and -Cognitive Subscales,
      Brief Fatigue Inventory, Multidimensional Fatigue Symptom Inventory, Center for
      Epidemiological Studies-Depression Scale State Trait Anxiety Inventory, Pittsburgh Sleep
      Quality Inventory, Profile of Mood States, Aerobic Center Longitudinal Study Physical
      Activity, and Symptom Inventory questionnaires at baseline and at day 41 and keep a daily
      exercise diary during study intervention.
    

Intervention name(s): exercise
Intervention type(s): Behavioral
Intervention description(s): home based walking and progressive resistance training exercise
Other intervention name(s): EXCAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: fatigue; unspecified adult solid tumor, protocol specific
Pharmacodynamic Effects of Ribavirin in Patients With Tonsil and/or Base of Tongue Squamous Cell Carcinoma
Condition: HEAD & NECK Cancer
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Study type: Interventional

Summary: 
      Human papillomavirus (HPV-16) is an important factor in the development of many tonsil and/or
      base of tongue squamous cell cancers. Although HPV-16 is not thought to cause cancer by
      itself, it appears to contribute to the development of tonsil and/or base of tongue cancer in
      many patients. It is likely that treatment for many patients with tonsil and/or base of
      tongue cancer could be improved if effective therapy to control HPV-16 is developed. The
      investigators in this study want to learn if ribavirin shows evidence of activity against
      HPV-16.

      Ribavirin is a pill therapy that is approved by the Food and Drug Administration (FDA) as
      part of the standard treatment for Hepatitis C. Laboratory experiments suggest that ribavirin
      might also be useful in the treatment of head and neck cancers. However, ribavirin has not
      yet been tested against head and neck cancer in patients. The purpose of this study is to
      find out the effects of ribavirin on tonsil and base tongue squamous cell cancer in patients.

      The main purpose of this study is to see if ribavirin changes the expression of certain
      proteins related to HPV infection in the tumor. The study will also find out if ribavirin
      changes how the tumor appears in a PET/CT scan (positron emission tomography/computed
      tomography scan).
    


Intervention name(s): ribavirin
Intervention type(s): Drug
Intervention description(s): The clinical intervention in this study is ribavirin therapy for approximately 14 days. Ribavirin 800 mg/day is administered in divided doses, 400 mg PO qAM and 400 mg PO qPM.
Intervention MeSH terms: Ribavirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ribavirin; VIRAZOLE; tonsil; base of tongue; squamous cell carcinoma; 10-218
Effects of Chest Wall Elastance on Pulmonary Mechanics of Acute Respiratory Failure (ARF)
Condition: Airway Pressure Stress Index; Transpulmonary Pressure Stress Index; Acute Respiratory Failure; Chest Wall Elastance
MeSH terms: Respiratory Insufficiency; Respiratory Distress Syndrome
Study type: Observational [Patient Registry]

Summary: 
      Patients with chest wall elastance increasing could worsen lung function. Increasing of chest
      wall elastance plays a great role in lung mechanics, and could influence mechanical
      ventilation settings. Therefore, It could help the physicians to find appropriate indicators
      and optimize the treatments of ARF patients to explore the mechanisms of lung mechanics
      changse in the patients with high chest wall elastance.
    

Detailed description: 
      Mechanical ventilation(MV) is an important treatment for acute respiratory failure(ARF)
      patients, could improve hypoxemia, maintain lung volume and promote alveolar opening.
      However, because of barotrauma, volutrauma and biotrauma, MV could cause or aggravate acute
      lung injury not only in acute respiratory distress syndrome(ARDS) patients, but in patients
      with normal lung function1,2.

      Patients with chest wall elastance increasing could worsen lung function. Increasing of chest
      wall elastance plays a great role in lung mechanics, and could influence mechanical
      ventilation settings. Therefore, It could help the physicians to find appropriate indicators
      and optimize the treatments of ARF patients to explore the mechanisms of lung mechanics
      changse in the patients with high chest wall elastance.

      The present study is set out to examine the effects of high chest wall elastance on changes
      of lung mechanics and the correlation of airway pressure(Paw) stress index and transpulmonary
      pressure(PL) stress index.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        acute respiratory failure patients
      
Keywords: Airway pressure stress index; Transpulmonary pressure stress index; Acute Respiratory Failure; Chest wall elastance; Lung stress
The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Multiple-dose, open-label, single-period study consisting of three consecutive phases
    

Detailed description: 
      Multiple-dose, open-label, single-period study consisting of three consecutive phases: Phase
      A - run-in warfarin dose-finding phase Phase B - warfarin pharmacokinetics (PK) and
      international normalised ratio (INR) profiling Phase C - warfarin alone at their
      individualised doses
    

Intervention name(s): BIA 2-093; Warfarin
Intervention type(s): Drug; Drug
Other intervention name(s): ESL, Eslicarbazepine acetate; Uniwarfin
Intervention MeSH terms: Eslicarbazepine acetate; Warfarin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Analysis of the Quality of Life, the Clinical Effectiveness and Cost-effectiveness of a Novel Educational Programme in Patients With Psoriasis and Atopic Dermatitis
Condition: Psoriasis; Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Psoriasis; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      'OnderHUIDs' is an educational program (Department of Dermatology, University Hospital, Gent)
      for patients with psoriasis and atopic dermatitis. We want to stimulate the patient to
      actively participate in their therapeutic approach by enhanced self care. We call the
      hypothesis that this program will help the patients learn to cope with their disease and to
      be loyal to their treatment, which will result in a better quality of life, better clinical
      outcome and cost effectiveness.
    


Intervention name(s): education on skin disease conditions; Stress-reduction techniques; Lifestyle factors and psycho-education; no educational program
Intervention type(s): Behavioral; Behavioral; Behavioral; Other
Intervention description(s): information about several skin diseases skin function recommendation on care of skin; Physical Training yoga mindfulness-based stress reduction; by dietician and psychiatrist; standard care without educational program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Moderate and severe psoriasis and atopic dermatitis
Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder
Condition: Body Weight Change; Schizophrenia; Schizoaffective Disorder; Psychotic Disorder
MeSH terms: Overweight; Body Weight; Body Weight Changes; Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to compare the affects of aripiprazole and olanzapine on
      weight change.
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Patient weight change; changes in metabolic status
Monitored Anesthesia Care: Dexmedetomidine-Ketamine Versus Dexmedetomidine- Propofol For Chronic Subdural Hematoma
Condition: Conscious Sedation
MeSH terms: Hematoma, Subdural; Hematoma, Subdural, Chronic; Hematoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Inadequate sedation and analgesia indicated by intraoperative movements are markers of
      inadequate MAC during burr-hole surgery for chronic subdural hematoma evacuation especially
      when general anesthesia poses high risk for the patients.

      Dexmedetomidine, ketamine, propofol intravenous infusion and other agents was used to provide
      monitored anesthesia care with variable success if used as solitary agents as each drug has
      its limited use.
    

Detailed description: 
      -  Null hypothesis (H0): There are no differences between the effects of dexmedetomidine-
           ketamine and dexmedetomidine- propofol combination for monitored anesthesia care during
           burr-hole surgery for chronic subdural hematoma evacuation.

        -  Alternative hypothesis (H1): There are differences between the effects of
           dexmedetomidine- ketamine and dexmedetomidine- propofol combination for monitored
           anesthesia care during burr-hole surgery for chronic subdural hematoma evacuation.
    

Intervention name(s): dexmedetomidine- ketamine; dexmedetomidine- propofol
Intervention type(s): Drug; Drug
Intervention description(s): patients will receive combination of ketamine 1mg/kg and dexmedetomidine 1ug/kg diluted in 10 ml 0.9% saline infused over 10 min together as an intravenous bolus dose then a maintenance of 0.5ug/kg/h dexmedetomidine and ketamine 0.5 mg/kg/h continuous infusion in two separate syringes pump to achieve modified Observer's Assessment of Alertness and sedation score (OAA/S) 3 and the infusion will stopped by finishing the skin suture.; patients will receive combination from 0.5 mg/kg propofol and dexmedetomidine 1ug/kg diluted in 10 ml 0.9% saline infused over 10 min together as an intravenous bolus dose then a maintenance of 0.5ug/kg/h dexmedetomidine and propofol 0.5 mg/kg/h continuous infusion in two separate syringes pump to achieve modified Observer's Assessment of Alertness and sedation score (OAA/S) 3 and the infusion will stopped by finishing the skin suture.
Other intervention name(s): precedex- katalar; precedex- diprivan
Intervention MeSH terms: Dexmedetomidine; Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment