bioihbjkbjnl/mcl2 huggingface dataset:
Effects Of Rehabilitation Incorporating Gait Training On Clinical Measures Associated With Chronic Ankle Instability
Condition: Chronic Ankle Instability
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a randomized controlled trial (RCT) regarding the conservative treatment of chronic
      ankle instability (CAI) with an impairment based rehabilitation program. Individuals with CAI
      have deficits in neuromuscular control and altered gait patterns. Ankle destabilization shoes
      are used clinically and may improve neuromuscular control by increasing lower extremity
      muscle activation, which may improve gait patterns. The investigators' purpose is to
      determine whether a 4-week rehabilitation program that includes ankle destabilization shoes
      (experimental) has beneficial effects on self-reported function and ankle gait kinematics
      compared to traditional rehabilitation without destabilization shoes (control) in CAI
      patients. In addition, the investigators will compare ankle strength and balance between CAI
      patients and healthy individuals with no history of ankle injury prior to the 4-week
      rehabilitation. The investigators hypothesize the experimental group will have greater
      improvement in self-reported function and frontal and sagittal plane kinematics during
      walking compared to the control group. In addition, the investigators hypothesize that
      patients with CAI will have a decrease in ankle strength and balance when compared to healthy
      individuals. The design is a single-blinded randomized controlled trial. Forty CAI patients
      will complete baseline self-reported function questionnaires and walking gait trials and then
      be randomized into control and experimental groups. Both groups will complete 4-weeks of
      supervised rehabilitation with or without destabilization shoes and then repeat the
      questionnaires and walking trials.
    


Intervention name(s): Traditional Instability Tools; Ankle Destabilization Shoes
Intervention type(s): Other; Other
Intervention description(s): Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools.; Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use ankle destabilization shoes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways
      to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors,
      such as pegfilgrastim, cause the body to make blood cells. It is not yet known whether
      doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating
      soft tissue sarcoma.

      PURPOSE: This randomized phase III trial is studying giving doxorubicin alone to see how well
      it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in
      treating patients with locally advanced or metastatic soft tissue sarcoma.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the progression-free and overall survival of patients with locally advanced or
           metastatic soft tissue sarcoma treated with doxorubicin with vs without ifosfamide and
           pegfilgrastim as first-line therapy.

        -  Compare the response in patients treated with these regimens.

        -  Compare the treatment-related mortality of patients treated with these regimens.

        -  Compare the toxicity of these regimens in these patients.

      OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
      according to WHO performance status (0 vs 1), age group (less than 50 years of age vs 50
      years of age and over), presence of liver metastases (yes vs no), histological grade (2 vs
      3), and participating center. Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive doxorubicin IV on day 1 (or IV continuously on days 1-3).

        -  Arm II: Patients receive doxorubicin IV on days 1-3 and ifosfamide IV over 4 hours on
           days 1-4. Patients also receive pegfilgrastim subcutaneously on day 5.

      In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease
      progression or unacceptable toxicity.

      Patients are followed every 8 weeks until disease progression and then every 12 weeks
      thereafter.

      PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.
    

Intervention name(s): pegfilgrastim; doxorubicin hydrochloride; ifosfamide; multimodality therapy
Intervention type(s): Biological; Drug; Drug; Procedure
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Ifosfamide
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult angiosarcoma; adult epithelioid sarcoma; adult fibrosarcoma; adult leiomyosarcoma; adult liposarcoma; adult rhabdomyosarcoma; adult synovial sarcoma; stage III adult soft tissue sarcoma; adult malignant fibrous histiocytoma; adult neurofibrosarcoma; stage II adult soft tissue sarcoma; stage IV adult soft tissue sarcoma
Blood and Tissue Sample Collection for Future Colon Cancer Biomarker Studies in Patients Undergoing Colonoscopy
Condition: Colorectal Cancer; Health Status Unknown
MeSH terms: Colonic Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Collecting and storing samples of blood and tissue from patients undergoing
      colonoscopy to study in the laboratory may help doctors learn more about colon cancer and
      identify biomarkers related to colon cancer in the future.

      PURPOSE: This laboratory study is collecting blood and tissue samples for future colon cancer
      biomarker studies in patients undergoing colonoscopy.
    

Detailed description: 
      OBJECTIVES:

        -  Collect blood and tissue samples (including polyps, abnormal growths, cancer, and normal
           tissue) from patients undergoing colonoscopy.

      OUTLINE: Patients undergo blood and tissue sample collection during colonoscopy. Samples are
      stored for future biomarker proteomic profiling.
    

Intervention name(s): biologic sample preservation procedure; diagnostic colonoscopy
Intervention type(s): Other; Procedure
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients scheduled for colonoscopy either as routine screening or for a specific problem.
      
Keywords: colon cancer; health status unknown
Suggamadex and Fast-track Cardiac Anesthesia in a Developing Country
Condition: Suggamadex; Surgery for Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      The purpose of this study is to retrospectively review our preliminary experience during a
      surgical trip to Tuxtla, Mexico, using suggamadex to reverse neuromuscular blockade following
      CPB and cardiac surgery for repair of CHD in infants and children.
    


Intervention name(s): Surgery
Intervention type(s): Procedure
Intervention description(s): Sugammadex to reverse neuromuscular blockade
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Last September 2015, patients in Tuxtla, Mexico who underwent cardiac surgery and
        cardiopulmonary bypass surgery for congenital heart defect where suggamadex was used for
        reversal of neuromuscular blockade.
The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection
Condition: Influenza; Healthy
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is provide a better understanding of the adaptive immune response
      to the licensed influenza vaccines in children.
    

Detailed description: 
      This is a Phase I study of up to 100 healthy children, ages 6 months to 10 years of age, who
      will receive either Flumist® live, attenuated influenza virus vaccine, quadrivalent (LAIV4)
      or the current Fluzone® inactivated influenza vaccine, quadrivalent (IIV4). The volunteers
      will be enrolled into one of 3 Groups. Volunteers will return each year until 2018-2019 for
      annual flu immunizations and study visits. Questionnaires will be administered annually to
      record demographic characteristics, vaccination history, exposure to animals, day care and
      medically attended illness. There are no exclusions for gender, ethnicity or race.

      Volunteers in the Non-twin Flu/MMRV naive group will also receive the measles, mumps, rubella
      and varicella (MMRV) vaccine at approximately 12-15 months of age (to be administered by the
      volunteers' personal pediatrician, not as a study vaccine). They will then come for a study
      visit to collect blood 60 days later.

      Each twin is counted as a single participant. All reporting numbers reflect the number of
      participants, not the number of twin pairs.
    

Intervention name(s): Fluzone®; FluMist®
Intervention type(s): Biological; Biological
Intervention description(s): Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine): The pediatric dose (6-35 months) will be supplied in a prefilled, single dose syringe, 0.25 mL (no preservative). Each 0.5 mL dose of Fluzone® Quadrivalent (36 months-adult) will be supplied in a prefilled, single dose syringe, 0.5 mL (no preservative). Both formulations given IM.; FluMist® Quadrivalent: live, attenuated influenza virus vaccine quadrivalent, given by intranasal spray
Other intervention name(s): IIV4; LAIV4
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Inactivated, influenza vaccine quadrivalent; Live, attenuated influenza vaccine quadrivalent; Young children; Identical twins
Exercise in the Fasted State, Glucose Metabolism and Energy Balance
Condition: Energy Balance; Blood Glucose
Study type: Interventional

Summary: 
      The ability to control our blood glucose (sugar) concentrations after a meal is a strong
      predictor of the risk of disease. Our bodies respond to glucose ingestion by reducing the
      amount of glucose from the liver entering the bloodstream. At the same time muscle increases
      the amount of glucose it take up from the bloodstream. This ensures that our blood glucose
      levels do not get too high. The investigators want to understand what happens to these
      processes following exercise after breakfast and after an overnight fast. In addition, the
      investigators also want to understand whether exercising with or without breakfast influences
      our appetite, food intake and activity levels later in the day.
    


Intervention name(s): Exercise; Breakfast
Intervention type(s): Behavioral; Dietary Supplement
Intervention description(s): Moderate intensity exercise; Breakfast consumption
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Opioid Free Anesthesia and Major Spine Surgery
Condition: Opioid Use; Postoperative Pain; Spine Disease
MeSH terms: Spinal Diseases
Study type: Interventional

Summary: 
      This study compares the intraoperative opioid free anesthesia approach in multilevel spine
      posterior instrumentation surgery to a conventional opioid-based anesthesia. Half of
      participants will receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine
      while the other half will receive opioid based anesthesia with fentanyl, remi-fentanyl and
      ketamine
    

Detailed description: 
      Opioid analgesics are commonly used in clinical practice for per and postoperative pain
      treatment. However their use is associated with a lot of undesirable effects. From this comes
      the idea of using opioid free anesthesia intra-operatively in an attempt to decrease opioids
      postoperative use and accordingly, their associated side effects.

      Intravenous (IV) lidocaine has been found to have analgesic, antihyperalgesic, and
      anti-inflammatory properties. It was found to significantly improve postoperative pain, when
      its intraoperative use was compared with placebo .

      Dexmedetomidine is a selective alpha-two adrenergic receptor agonist that has
      antinociceptive, analgesic, opioid sparing and sedative properties. Similar to lidocaine,
      dexmedetomidine was shown to lower postoperative pain, opioid consumption and accordingly,
      opioid related side effects.
    

Intervention name(s): opioid free Anesthesia vs Opioid based Anesthesia
Intervention type(s): Drug
Intervention description(s): Compare the opioid based anesthesia with Fentanyl and Remifentanyl to opioid free anesthesia with dexmedetomidine and lidocaine and their effect on postoperative pain.
Intervention MeSH terms: Analgesics, Opioid; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lidocaine; Dexmedetomidine; Opioid-free
Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation
Condition: Ventricular Dysfunction, Left
MeSH terms: Ventricular Dysfunction; Ventricular Dysfunction, Left
Study type: Observational

Summary: 
      The purpose of this study is to characterize changes in the plasma proteome over time
      following left ventricular assist device (LVAD) implantation.
    


Intervention name(s): LVAD
Intervention type(s): Device
Other intervention name(s): HeartMate II
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study participants will be recruited from the University of Colorado Hospital Advanced
        Heart Failure Program.
      
Biospecimen description: 
      Change in plasma proteins. [Time Frame, Days 7, 14, 30, 60, 90, and 180 post-LVAD
      implantation][Designated as safety issue: No]
Evaluation of Dentin Hypersensitivity Using Glass Ionomer Cements
Condition: Dentin Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this randomized, double-blind, split-mouth clinical trial is to evaluate and
      compare the desensitizing efficacies of the resin-modified glass ionomer cement ClinproTM XT
      (3M ESPE, Minnesota, USA) and the conventional glass ionomer cement Vidrion R (SS White,
      Gloucester, UK) at 2-year follow-up.
    

Detailed description: 
      Subjects will require to have at least two teeth in different hemiarchs with dentin
      hypersensitivity. Teeth will be randomized into 2 groups, receiving either Clinpro XT or the
      conventional glass ionomer cement Vidrion R. Prior to the desensitizing treatment (baseline),
      painful symptoms will be assessed by tactile and air blast tests using the Visual Analogue
      Scale (VAS). Treatment evaluations will be conducted up to 2-year post-treatment.
    

Intervention name(s): Resin-modified glass ionomer cement Clinpro XT; Glass Ionomer cement Vidrion R
Intervention type(s): Drug; Drug
Intervention description(s): Clinpro XT (3M ESPE, Minnesota, USA); Vidrion R (SS White, Gloucester, UK)
Other intervention name(s): Clinpro XT (3M Espe, USA); Vidrion R (SS White, Gloucester, UK)
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dentin Sensitivity; Dentin Desensitizing Agents; Glass Ionomer Cements; Randomized Controlled Trial
Limb Salvage Post Venous Injury:Case Series
Condition: Limb Salvage
Study type: Observational

Summary: 
      The venous injury diagnosis depends on history of trauma with symptoms and signs suggestive
      of venous injuries and color flow duplex study is of increasing value as a screen for
      detection of an occult venous injuries. It is associated with arterial, peripheral nerve
      injuries and bone fractures. Within this study of one-year duration, a seventy-five patients
      with acute venous injuries were included. The injured vein was either repaired or ligated
      according to hemodynamic state of patient and site and type of injury.
    

Detailed description: 
      This is a retrospective cross section study of one-year duration from January 2017 and
      January 2019 at Najaf Teaching medical city/Iraq . The study included a Seventy-five patients
      with acute venous injuries. The Venous surgical interference for late complicated vascular
      injuries and iatrogenic venous injuries were excluded and the information was obtained from
      the hospital records and direct evaluation of patients.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All limb injured patient
      
Keywords: limb salvage; venous injury; edema; amputation; fasciotomy.
Bioequivalency Study of Perindopril Erbumine 8 mg Tablet Under Fasted Conditions
Condition: Essential Hypertension
MeSH terms: Essential Hypertension
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Perindopril Erbumine 8 mg
      tablets under fasting conditions.
    


Intervention name(s): perindopril erbumine
Intervention type(s): Drug
Intervention description(s): 8 mg tablet
Other intervention name(s): Aceon
Intervention MeSH terms: Perindopril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioavailability of Infacort When Administered Onto Food Compared to Direct Oral Administration
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, open-label, randomised, single dose, three-period, crossover study
      to evaluate the bioavailability of Infacort® administered as 'sprinkles' with soft food and
      yoghurt compared with direct administration to the back of the tongue in
      dexamethasone-suppressed healthy adult male subjects.

      The study will comprise of a pre-study screen, followed by 3 treatment periods and a
      post-study follow-up.
    


Intervention name(s): Infacort
Intervention type(s): Drug
Intervention description(s): Immediate-release multiparticulate formulation of hydrocortisone.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PET Scan Imaging of Beta Cell Mass
Condition: Type 1 Diabetes; Obesity
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The investigators hypothesize that PET scans will be able to differentiate between normal,
      reduced or increased BCM in human subjects. Subjects with normal BCM will be recruited from
      among normal weight nondiabetic people with plasma insulin levels within the normal range.
      Subjects with predicted reduced BCM will be recruited from among patients with T1DM who have
      with low or not measurable insulin levels. If results from the nondiabetic subjects and the
      subjects with T1DM are found to differ significantly, subjects with increased BCM will be
      recruited from among patients with hyperinsulinemia including those with obesity and the
      metabolic syndrome. PET scan measurements of the pancreas will be obtained and compared in
      people predicted, on the basis of biochemical testing, to have normal or reduced, or
      increased BCM.
    

Detailed description: 
      An important determinant of progression to diabetes is beta cell mass (BCM). Measurement of
      plasma insulin has been used as a surrogate marker but insulin levels often do not correlate
      well with beta cell mass and development of means to assess BCM would provide an important
      endpoint. For example, high-risk individuals could be monitored prior to onset of diabetes or
      patients could be monitored prospectively to determine the progression of their disease and
      response to therapy.

      Both Type 1 diabetes mellitus (T1DM) and Type 2 diabetes mellitus (T2DM) develop when there
      is impaired insulin production. The amount of insulin that can be produced, the amount of
      insulin producing beta cells in the pancreas and level of insulin and glucose in the blood
      are, however, imperfectly correlated. The development of a reliable method to noninvasively
      quantitate the beta cell mass (BCM) would be of great benefit by providing an important
      endpoint for the development of new treatments of T1DM and T2DM. The investigators have
      previously identified a specific marker on islet cells called vesicular monoamine transporter
      2 (VMAT2) that they now propose to use in positron emission tomography (PET) scanning to
      determine islet cell mass. This radioligand, [11C] Dihydrotetrabenazine (DTBZ), has been used
      previously in human subjects in clinical trials evaluating PET scanning of the brain in
      patients with bipolar illness and schizophrenia compared to healthy control subjects.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Potential subjects with diabetes will be recruited from among the patients cared for at the
        Naomi Berrie Diabetes Center. Nondiabetic subjects will either be referred by their
        physicians or by word of mouth. Primary care physicians will be made aware of the study by
        fliers.
      
Biospecimen description: 
      Blood
    
Keywords: Diabetes Mellitus; T1DM
Lipid and Adipokine Profiles Following Subcutaneous Injection of ATX-101 Into Abdominal Fat Tissue
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Open Label Study to Evaluate the Serum Lipid and Adipokine Profiles Following Subcutaneous
      Injection of ATX-101 into Abdominal Fat Tissue
    

Detailed description: 
      Phase 1, Open Label Study to Evaluate the Serum Lipid and Adipokine Profiles Following
      Subcutaneous Injection of ATX-101 (Sodium Deoxycholate Injection) into Abdominal Fat Tissue
    

Intervention name(s): ATX-101
Intervention type(s): Drug
Intervention description(s): ATX-101 2mg/cm2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment