bioihbjkbjnl/mcl2 huggingface dataset:
Opioid Induced Gait Variability
Condition: Opioid Induced Motor Disturbances
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      While the analgesic effects of opioids are well known, evidence suggest that there are
      differences in the adverse dizziness of the different opioid types, which may influence the
      gait function differently. However, this has not been investigated scientifically under
      controlled conditions. Normal gait function is characterized by cyclic movements with a high
      degree of predictability. As such, the amount of kinematic variability can provide important
      information about a condition or an intervention that may affect the gait function .
      Three-dimensional gait analysis is a recognized method to assess changes in stride-to-stride
      variability associated with a medical condition or caused by an intervention. Thus, opioid
      induced changes in gait variability, and possible differences between opioid types, can be
      assessed objectively from differences in the variability of movements obtained from a
      three-dimensional gait analysis.

      The purpose of this study is to investigate differences in gait variability induced by two
      different single-dose opioid formulations and an inert placebo in healthy volunteers and knee
      osteoarthritis patients.
    

Detailed description: 
      The study is designed as an experimental single center, double-blind treatment, cross-over
      study with inert placebo, Tapentadol (Palexia Depot), and Tramadolhydrochlorid (Mandolgin
      Retard), with a minimum of 7days wash-out periods.

      At day 1 (Visit 1), baseline measurements are carried out before tablet administration.
      Immediately after baseline measurements one tablet is administered, and hourly measurements
      are performed for 6 hours. Subsequently all participants enter a minimum 7 day washout
      period, after which they return to the facility to repeat the procedures at Visit 2 (day 8+)
      and Visit 3 (day 15+). The order of treatments will be randomized (1:1:1).
    

Intervention name(s): Tapentadol 50 mg Oral Tablet; Tramadol Hydrochloride 100 mg Extended Release Oral Tablet; Placebo Oral Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet administered; 1 tablet administered; calcium tablet
Other intervention name(s): Palexia Depot (50 mg); Mandolgin Retard (100 mg); Calcium tablet
Intervention MeSH terms: Tramadol; Tapentadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Reactogenicity, Safety, and Immunogenicity of a Live Monovalent H5N2 Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety profile of two intranasal doses of LAIV A/17/turkey/Turkey/05/133
      (H5N2) in healthy adults.
    


Intervention name(s): LAIV H5N2; Placebo
Intervention type(s): Biological; Other
Intervention description(s): 2 doses provided intranasally; 2 doses of placebo provided intranasally
Other intervention name(s): A/17/turkey/Turkey/05/133(H5N2)live influenza vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza; vaccine; pandemic
Effects of Teriparatide on Distal Radius Fracture Healing
Condition: Colles' Fracture
MeSH terms: Colles' Fracture; Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional
Phase: Phase 2

Summary: 
      Effects of Teriparatide on Distal Radius Fracture Healing
    


Intervention name(s): Teriparatide; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Teriparatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) Inhalation to Improve Host Defense and Pulmonary Barrier Restoration
Condition: ARDS
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial evaluates efficacy and safety of inhaled molgramostim (rhGM-CSF) in 45 patients
      with pneumonia associated acute respiratory distress syndrome (ARDS). A third of the patients
      will receive 150 mcg inhaled molgramostim, another third 450 mcg and the remaining third will
      receive inhaled placebo for 3 days. The patients will be followed for 28 days.
    


Intervention name(s): inhaled molgramostim (rhGM-CSF); inhaled placebo
Intervention type(s): Drug; Drug
Intervention description(s): formulated as the active substance without molgramostim
Intervention MeSH terms: Molgramostim; Sargramostim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute lung injury, molgramostim, GM-CSF, pneumonia, barrier restoration
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
Condition: Hyperparathyroidism, Secondary
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, single-arm, extension study to characterize the long-term safety and
      tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in
      adults with Chronic Kidney Disease (CKD) on hemodialysis.
    

Detailed description: 
      This is a multicenter, single-arm, extension study in which adults with secondary
      hyperparathyroidism currently receiving hemodialysis and previously treated in Amgen studies
      20120231 (NCT01785875), 20120334 (NCT01576146), or 20120360 (NCT01896232) will continue to be
      treated with etelcalcetide until approximately 2.5 years after the first participant was
      enrolled.
    

Intervention name(s): Etelcalcetide
Intervention type(s): Drug
Intervention description(s): Etelcalcetide was supplied as a sterile, preservative-free, ready-to-administer aqueous solution.
Other intervention name(s): KAI-4169; AMG 416; Parasabiv
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Secondary Hyperparathyroidism (SHPT), chrominc kidney disease (CKD), hemodialysis
Long Term Study of Canakinumab (ACZ885) in Patients With Gout
Condition: Gouty Arthritis
MeSH terms: Arthritis; Arthritis, Gouty
Study type: Interventional
Phase: Phase 2

Summary: 
      This 24-week open-label extension study is designed to provide additional long-term safety
      data up to a total of 1-year for patients rolling over from the core study, and to collect
      further efficacy and tolerability data for all the patients, irrespective whether they have
      an acute flare of gout or not. Patients will be treated on demand with canakinumab (ACZ885)
      in this extension study.
    


Intervention name(s): Canakinumab
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gouty; Gouty arthritis; Gout flares; Anti-interleukin-1β monoclonal antibody
Autologous Tolerogenic Dendritic Cells for Treatment of Patients With Rheumatoid Arthritis
Condition: Musculoskeletal Diseases; Joint Disease; Arthritis; Arthritis, Rheumatoid; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases
MeSH terms: Arthritis; Arthritis, Rheumatoid; Rheumatic Diseases; Joint Diseases; Musculoskeletal Diseases; Collagen Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Tolerogenic dendritic cell (tDC)-based clinical trials for the treatment of autoimmune
      diseases are now a reality. Clinical trials are currently exploring the effectiveness of tDC
      to treat of type 1 diabetes mellitus, rheumatoid arthritis, multiple sclerosis and Crohn's
      disease. The general objective of this study is to evaluate the safety and tolerability of a
      single intra-articular injection (into the knee joint) of autologous monocyte-derived
      dendritic cells generated in the presence of interferon-alpha (IFN-α)/granulocyte-macrophage
      colony-stimulating factor (GM-CSF) and tolerized with Dexamethasone in rheumatoid arthritis
      (RA) patients.
    

Detailed description: 
      A phase I dose-escalating clinical trial will be conducted to determine the safety and
      tolerability of a single intra-articular injection (into the knee joint) of autologous
      tolerogenic dendritic cells, and to enable selection of a suitable dose regimen for phase II
      trial. The primary objective of the phase I study will be to determine whether tDC-based
      therapy is safe and well tolerated and to establish the dose-response with disease activity
      measured over 6 months. Patients will serve as their own controls (pre- and post-treatment).
      Five doses of tDCs will be tested. The Study will start with intra-articular injection (into
      the knee joint) of 1x106 cells. Depending on safety/tolerability outcomes, the dose will
      gradually increase to 3x106, 5x106, 8x106 and 10x106 cells. The safety will be determined by
      the evaluation of the number of participants with adverse events (AEs) and severe adverse
      events (SAEs) following the intra-articular administration of tDC (within 6 months of
      injection). Systemic RA disease activity will be measured using DAS28 (Disease Activity Score
      using 28 joints) and the Health Assessment Questionnaire (HAQ), a standard instruments used
      in RA. Patients will be monitored at baseline and at 3, 7 days and 1, 3, 6 months post
      treatment.
    

Intervention name(s): tolerogenic dendritic cells
Intervention type(s): Biological
Intervention description(s): dose-escalation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis; Auto-immune disorders; Tolerogenic Dendritic Cells
Accuracy of TCOM vs NIRS in Predicting Wound Outcomes in Patients Treated With or Without Revascularization
Condition: Wound Heal
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      The primary purpose of this project is to compare the accuracy of transcutaneous oxygen
      monitoring and near infrared spectroscopy in assessing cutaneous oxygen levels in chronic
      wounds of patients following revascularization procedures as well as those with
      conservatively managed chronic wounds. This study will also compare the efficiency and
      practicality of both methods in guiding treatment decisions and management of these wounds.
    


Intervention name(s): Near Infrared Spectroscopy
Intervention type(s): Diagnostic Test
Intervention description(s): The Kent Camera is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of the following in superficial tissue:
oxygen saturation (StO2),
relative oxyhemoglobin level (HbO2), and
relative deoxyhemoglobin (Hb) level
The Kent Camera displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports multispectral tissue oxygenation measurements for selected tissue regions. The Kent Camera is indicated for use to determine oxygenation levels in superficial tissues.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This prospective study will include up to 200 adult patients who present with non-healing
        lower extremity wounds to the University of Kansas Medical Center. Patients will be grouped
        into two study arms depending on the degree of tissue ischemia (above or below 40 mmHg) and
        required treatment (conservative wound care alone or revascularization). Relevant clinical
        information will be obtained from patients' medical records including demographics,
        clinical history, intervention details, surgical records, and imaging data. Wound healing
        will be assessed at presentation, at the time of revascularization (pre and
        post-operative), and every 6 weeks thereafter by clinical assessment, Wagner
        classification, TCOM PO2 measurements and NIRS PO2 measurements. TCOM will guide treatment
        decisions and management, which is the current standard of care.
Traditional Thai Massage and Scapulocostal Syndrome
Condition: Scapulocostal Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of traditional Thai massage on pain
      intensity, pressure pain threshold, muscle tension, anxiety, cervical range of motion,
      patient satisfaction and side effects in the treatment of scapulocostal syndrome.
    


Intervention name(s): Traditional Thai massage; Ultrasound therapy and hot pack
Intervention type(s): Other; Other
Intervention description(s): The participants will receive thirty minutes session of traditional Thai massage onto the scapular region for 9 sessions over a period of 3 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Traditional Thai Massage; Scapulocostal Syndrome
Psychological Interventions in Children After Road Traffic Accidents or Burns
Condition: Acute Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Traumatic, Acute
Study type: Interventional

Summary: 
      Within a randomized controlled design the effects of a brief early psychological intervention
      (child, parents) after road traffic accidents or burns shall be examined in a sample of 120
      children and adolescents (aged 2 to 16 years). During the first seven days after the accident
      a screening for the risk of developing a posttraumatic stress disorder is conducted to divide
      the participants into a "high risk" and a "low risk" group. Participants with a low risk are
      excluded from the intervention study but reassessed six months after their accident to
      validate the screening instrument. After a baseline assessment within 14 days after the
      accident participants of the high risk group are randomly assigned to an intervention group
      (n = 60) or a control group (n = 60). The latter receive standard medical care. Children of
      the intervention group are provided with a brief age appropriate two-session intervention
      that includes a detailed reconstruction of the accident, psychoeducation and discussion of
      helpful coping strategies. Both the control and the intervention group are reassessed by
      blind raters at 3 and 6 months after the accident. Assessment of outcome includes measures of
      posttraumatic stress symptoms, depression, anxiety, behavior, and health-related quality of
      life.
    


Intervention name(s): Early psychological intervention
Intervention type(s): Other
Intervention description(s): 3 modules: psychoeducation, reconstruction of the trauma, coping skills
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: posttraumatic stress; prevention; children; acute stress disorder due to burn injury or injuries associated with road traffic accidents
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Schizophrenia is a major psychotic disorder that presents an enormous burden to the patients
      and their relatives. Despite treatment with second generation antipsychotics, negative
      symptoms and cognitive impairment often persist and determine an unfavourable course
      including reduction in life quality. Prefrontal repetitive transcranial magnetic stimulation
      (rTMS), a promising noninvasive biological technique, applied adjuvant to ongoing
      antipsychotic treatment was demonstrated to be safe and was associated with improvement in
      negative symptoms in the majority of the small placebo-controlled trials.

      The primary objective of the trial is to investigate the efficacy of high-frequency rTMS
      (add-on to antipsychotic therapy) in the treatment of negative symptoms in schizophrenia
      compared to sham stimulation (placebo).
    


Intervention name(s): Repetitive transcranial magnetic stimulation; Sham repetitive transcranial magnetic stimulation
Intervention type(s): Other; Other
Intervention description(s): 10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC) (15 sessions/3 weeks, 1000 stimuli per session, stimulation intensity 110 % related to the individual resting motor threshold); in total 15.000 stimuli.; placebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session; in total 15.000 stimuli
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia, negative symptoms, TMS, magnetic stimulation
MYSTAR-5-YEAR: Long-term Follow-up of Patients With Ischemic Heart Disease Treated With Cell Therapy
Condition: Acute Myocardial Infarction
MeSH terms: Heart Diseases; Myocardial Infarction; Myocardial Ischemia; Coronary Artery Disease; Infarction
Study type: Observational

Summary: 
      The MYSTAR-5-YEAR study controls the patients 5 years after treatment with combined
      (intramyocardial and intracoronary) delivery of autologous BM-MNCs.

      The clinical endpoint of this prospective non-randomized observational study is the MACCE,
      defined as major adverse cardiac and cerebrovascular events. Patients will be investigated by
      echocardiography, SPECT and MRI. 2D (NOGA-guided SPECT) and 3D (NOGA-guided MRI) imaging will
      refine the evaluation with more exact analysis of the intramyocardial injected areas (ROI).
    

Detailed description: 
      Background: Based on the available long-term results of cardiac stem cell therapies, it
      seems, that it offers short-term moderate benefits, but the long-term outcome is still matter
      of debate. In 2008, the Austrian arm of the MYSTAR study (a prospective multi-center
      single-blind trial) including patients with recent AMI and treated with combined
      (intramyocardial and intracoronary) delivery of autologous BM-MNCs has been completed with
      1-year FUP. The MYSTAR results showed moderate but significant improvement in infarct size
      and LV function similar to other trials, and confirmed safety, feasibility and efficacy of
      BMC treatment in AMI patients. The patients enrolled in the study reach the 5 to 8 years FUP
      at 2011, raising the question whether the combined delivery of autologous BM-MNCs results in
      a long-term benefit for these patients.

      Aim of the study: To investigate the long-term, 5 years clinical outcome of patients enrolled
      into the MYSTAR study.

      Study design: Prospective non-randomized single-center Austrian long-term FUP registry.

      Study patients: A total of 60 patients with previous cardiac stem cell therapy (participated
      in the MYSTAR study) will be included in the present study

      Primary endpoint: occurrence of MACCE (major adverse cardiac and cerebrovascular events,
      including all-cause death, re-AMI, revascularization and stroke) during the mean 5 years
      follow-up.

      Secondary endpoints: improvements of clinical symptoms, expressed as CCS and NYHA scores,
      change in global LV EF, measured by echocardiography, size of infarction determined by
      stress-rest SPECT, LV and RV volumes, function and cardiac output measured by cardiac MRI.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients included into the MYSTAR randomized study
      
Keywords: Cell-based cardiac regenerative therapy; Intramyocardial injections; NOGA procedure; Acute myocardial infarction
Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery
Condition: Intraoperative Bleeding
MeSH terms: Blood Loss, Surgical
Study type: Interventional
Phase: Phase 4

Summary: 
      In endoscopic sinus surgery a clear surgical field of view is a very important aspect for
      good surgical outcome. This study is to evaluate the preoperative preparation to acquire best
      surgical field of view by comparing between the use of topical adrenaline and the use of
      combination of topical adrenaline with infiltration of 1% lidocaine with adrenaline in
      patients scheduled for endoscopic sinus surgery for rhinosinusitis.
    


Intervention name(s): Epinephrin; 1% lidocaine with epinephrin 1:100,000; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Topical application of 2 pieces of Epinephrin (1:1,000)-soaked cottonoid in nasal cavity; 4 ml intranasal infiltration of 1% lidocaine with epinephrine (1:100,000) at 2 sites (2 ml infiltration at each site); 4 ml intranasal infiltration of saline at 2 sites (2 ml infiltration at each site)
Other intervention name(s): Adrenaline
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Efficacy Nad Safety of DWP16001 Compared to Active Drug in the Treatment of Type 2 Diabetes Mellitus
Condition: T2DM (Type 2 Diabetes Mellitus)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy and safety of DWP16001 compared to
      active drug in the treatment of type 2 diabetes mellitus.
    


Intervention name(s): DWP16001 Amg
Intervention type(s): Drug
Intervention description(s): Tablets, Orally, Once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment