bioihbjkbjnl/mcl2 huggingface dataset:
A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome
Condition: Fibromyalgia Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Investigation of efficacy and safety of treatment with milnacipran in the treatment of
      fibromyalgia syndrome.
    


Intervention name(s): milnacipran; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Screening for Colorectal Neoplasm in First Degree Relatives of the Affected
Condition: Colorectal Cancer Screening
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      To determine the prevalence of colorectal neoplasms in first degree relatives of those
      affected with sporadic colorectal cancer using colonoscopy as a screening tool. The
      prevalence will be compared to that of a defined matched cohort.
    

Detailed description: 
      Colorectal cancer is a second commonest tumor in Hong Kong and the second commonest cause of
      cancer related death. About 1 in 23 males will develop colorectal cancer in his life time.
      The disease tends to cluster in families. This may be a combination of factors including
      shared genes, shared environment or chance. Known familial syndromes occur in only about 5%
      of cases. The majority is not well understood and labelled sporadic colorectal cancer. The
      screening strategy in families of subjects with colorectal cancer has not been defined.
      Colonoscopy is among the most sensitive and specific screening tool for colorectal neoplasm.
      The current study determines the prevalence of adenomas among first degree relatives of
      patients diagnosed with colorectal cancer. To quantify risk in this cohort, a case control
      analysis is used. The prevalence of the cohort is compared to that of a control population.
      The control group consists of relatives of patients with normal colonoscopic findings during
      the same study period.
    

Intervention name(s): Colonoscopy; Colonoscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): To determine the adenomas during colonoscopy; To determine the adenomas during colonoscopy
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        First degree relatives of patients having CRC or patient having normal colonoscopy
      
Keywords: Colonoscopy; First degree relatives
Neuronal Responses to Social Feedback in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      The overall goal of the proposed project is to investigate the neuronal pathways regulating
      the effects of social acceptance and rejection in healthy controls and patients with Major
      Depressive Disorder (MDD). Social acceptance and rejection are defined as the explicit
      declaration that an individual is liked or not liked. Social acceptance can boost one's
      self-esteem and mood, whereas rejection can lower them. The neurological relationship between
      social acceptance/rejection and depressive symptoms is not known. Using functional magnetic
      resonance imaging (fMRI), it is hypothesized that social feedback will activate a specific
      interconnected neuronal pathway involved in social separation and reward. Executive
      functioning and response to monetary reward will also be assessed during fMRI using two
      additional tasks (monetary incentive delay, parametric go no-go) to determine how these
      cognitive brain functions regulate responses to social feedback.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Individuals diagnosed with major depressive disorder (MDD), and healthy controls
      
Biospecimen description: 
      saliva
    
Keywords: depression; social; rejection; acceptance; fMRI; reward; exclusion
Three Times Daily Dosing of UT-15C
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics of three-times daily dosing of UT-15C in healthy volunteers
    


Intervention name(s): UT-15C
Intervention type(s): Drug
Other intervention name(s): treprostinil diethanolamine; treprostinil diolamine; UT-15C SR
Intervention MeSH terms: Treprostinil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Volunteers
Use of Standing Frame and "Innowalk Pro" in Patients With TBI
Condition: Brain Injuries
MeSH terms: Brain Injuries
Study type: Interventional

Summary: 
      This study will explore physical and physiological responses to mobilization of patients with
      acquired brain injuries in subacute phase using a classic standing frame and a standing
      device with simultaneous passive movement of legs, "Innowalk Pro".
    

Detailed description: 
      Several studies underline the importance of early mobilization of patients with brain
      injuries, leading to shorter hospital stays, less contractures, and improved general
      function.

      The routine mobilization treatment in the rehabilitation of patients with severe brain
      injuries in Sunnaas Rehabilitation Hospital is initial use of a tilt table where tilt angle
      is gradually increased, and when tolerated, standing in a classic standing frame where the
      patient's lower body is fixed to the device in an upright standing position.

      "Innowalk Pro" is a robotic standing device where legs are fixed, but passively moved by
      electric motors in an upright standing position. An assumption is that standing in "Innowalk
      Pro" might be better tolerated at an earlier stage of rehabilitation than standing in a
      classic standing frame.
    

Intervention name(s): Use of standard standing frame; Use of a new device; Innowalk Pro
Intervention type(s): Device; Device
Intervention description(s): Two training sessions in a standard standing frame, max 30 min. pr. session; Two training sessions in Innowalk Pro, max 30 min pr. session
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: All together each included patient will attend five sessions. First session includes an orthostatic test and other baseline measurements. In order to describe test-to-test variation (reliability) when using the devices, two sessions are held in standard standing frame (A) and two sessions in "Innowalk Pro" (B), preferably within the same week. If, for practical reasons, this is not feasible, training is allowed in the following week. The order of the workouts is block randomized to ABAB or BABA at inclusion. The orthostic test and the training session are estimated to last approx. 1 hour including all measurements.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: standing; blood pressure; heart rate; surface electromyography of muscles in legs; perceived exertion
Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted COPD Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Open clinical trial with 1 year follow up comparing the impact of an Early Respiratory
      Rehabilitation program with the conventional Respiratory Rehabilitation in COPD re-admitted
      patients. Outcomes will be exacerbations, symptoms, functional capacity and quality of life
      related to health (HRQOL).
    

Detailed description: 
      Open clinical trial with 1 year follow up comparing the impact of an Early Respiratory
      Rehabilitation (ERR) program with the conventional Respiratory Rehabilitation (CRR) in COPD
      re-admitted patients. Outcomes will be exacerbations, symptoms, functional capacity and
      quality of life related to health (HRQOL). Sixty patients will be randomized into the two
      groups: ERR starts the program during admission and continues at home immediately after
      discharge for a period of 3 months; CRR was started at home one month after discharge from
      hospital and continues for 3 months. Recruitment of patients and starting the RR program will
      occur in the first year. In the second year we will continue the intervention to those who
      have not completed the year. Follow-up will last until the completion of the year of all
      patients.
    

Intervention name(s): Early Respiratory Rehabilitation Program; Conventional Respiratory Rehabilitation Program
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Early Respiratory Rehabilitation; Chronic Obstructive Pulmonary Disease; Re-admitted patients; Open clinical trial; Exacerbations
The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index
Condition: Elective Surgery; Healthy
Study type: Interventional

Summary: 
      The aim of the present study was to investigate whether injection rate of propofol has an
      influence on its maximum effect.
    

Detailed description: 
      The clinical daily routine indicates that slowing the rate of administration of propofol can
      lead to a reduction of up to 50% in the dose of propofol required to achieve the onset of a
      clinical endpoint of anesthesia (i.e. loss of consciousness) when titrating to effect.
      Therefore, it has been concluded that a slow injection requires a smaller dose of propofol as
      the graded effect is weakened by fast injection. This conclusion contradicts pharmacologic
      considerations, that a fast injection would lead to a higher peak concentration and in
      consequence, to a higher peak effect at the effect side, the brain.

      The present study was designed to measure the Electroencephalogram (EEG) peak effect of a
      propofol bolus (2 mg/kg) injected with different infusion rates.

      Although it is known that propofol has cardiovascular effects, the influence of injection
      rate on these cardiovascular changes is less clear. Others found that faster injection rates
      of propofol caused greater reductions in blood pressure. Other similar studies have shown no
      difference in blood pressure for different injection rates. An additional aim of this study
      was therefore to investigate the influence of different injection rates on hemodynamic
      parameters.
    

Intervention name(s): Propofol
Intervention type(s): Drug
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: BIS; Propofol; hemodynamic; pharmacokinetic
Isoflavones and the Coronary Circulation in Men and Women With Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to investigate the effect of genistein administration on coronary
      arteries in humans. We will measure the size of a coronary artery and the speed and amount of
      blood flow in response after subjects have ingested Supro® drinks (a soy protein drink
      containing genistein).
    


Intervention name(s): Genistein; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drink taken once daily; Drink taken once daily
Other intervention name(s): Supro
Intervention MeSH terms: Genistein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: arteries; blood flow; coronary artery disease; diet
Dexmedetomidine in Post Spinal Anesthesia Shivering
Condition: Shivering Caused by Spinal Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluated the effect of dexmedetomidine iv in three different doses in the
      treatment of shivering in patients undergoing minor elective abdominal surgery under spinal
      anesthesia, in comparison with intravenous pethidine.
    

Detailed description: 
      Among the pharmacological agents used in treatment of shivering, pethidine (meperidine) has
      been shown to be one of the most effective treatments.The α-2 receptor agonists are another
      important class of anti-shivering drugs that, unlike meperidine, produce little respiratory
      depression.

      Dexmedetomidine is a highly selective α-2 adrenoceptor agonist with potent effects on the
      central nervous system . Intravenous dexmedetomidine reduces both the vasoconstriction and
      shivering thresholds . Clinical studies had demonstrated the efficacy of dexmedetomidine in
      prevention of shivering . Few clinical trials investigated its efficacy in treatment of
      established shivering. The optimum dose for shivering control with the least hemodynamic
      derangements is still under research.
    

Intervention name(s): Pethidine 0.4mg/kg; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): 2ml intravenous bolus slowly injected in 2minutes.; 2ml intravenous bolus slowly injected in 2minutes
Other intervention name(s): Meperidine; Precedex
Intervention MeSH terms: Meperidine; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anesthesia; dexmedetomidine; pethidine; shivering; spinal
Evaluation of State and Shade of White Spot Lesions After Using Different Remineralizing Agents (An in Vivo Study)
Condition: White Spot Lesion
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the effect of Biomimetic remineralizing agent and resin
      modified glass ionomer varnish on color shade and state of white spot lesions immediately,
      after 3 months, and after 6 months. (An in vivo study).
    


Intervention name(s): Biomimetic remineralizing agent; Resin Modified Glass Ionomer Varnish
Intervention type(s): Other; Other
Intervention description(s): Self-assempling peptide; Resin Modified Glass Ionomer Varnish
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1
Condition: Advanced Malignancies
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The main purpose of this study is to examine the safety and tolerability of CDX-1401 when
      given in combination with an immune stimulant (resiquimod) to patients with advanced cancers
      that are known to express the NY-ESO-1 protein.
    

Detailed description: 
      NY-ESO-1 is a protein that is often made by some types of tumor cells, but only made by a few
      types of normal cells. Because it is primarily made by cancer cells, the NY-ESO-1 protein is
      a promising target against which to stimulate an immune response that may destroy cancer
      cells. CDX-1401 is a cancer vaccine that is specially designed to create this type of immune
      response. To enhance the immune response, CDX-1401 will be given with 1 or 2 immune
      stimulants called Resiquimod and poly-ICLC (Hiltonol).

      This clinical trial includes Phase 1 and Phase 2 segments. During the Phase 1 segment, six
      groups of 6 to 24 patients will be treated with different dose levels of CDX-1401 in
      combination with either one or both of the immune stimulants (Resiquimod and/or poly-ICLC).
      This phase of the study will test the safety profile of the vaccine treatment, and will
      assess which dose to test in future studies. During the Phase 2 segment, 14 patients whose
      cancer tested positive for the NY-ESO-1 protein in laboratory testing, will receive the study
      treatment to determine if it has an effect on their cancer. All patients enrolled in either
      part of the study may continue to receive study treatment until their disease has progressed
      or until it is necessary to stop the treatment for safety or other reasons. In addition, all
      patients will be "followed" for 24 months after enrollment in order to collect survival
      information.
    

Intervention name(s): CDX-1401 in combination with Resiquimod and/or Poly-ICLC; CDX-1401; Resiquimod; poly-ICLC
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): CDX-1401 is administered as an injection into the skin every 2 weeks for 4 doses. It is given in combination with Resiquimod and/or poly-ICLC. Resiquimod is administered as a topical gel applied to the skin or given as an injection under the skin, and poly-ICLC is given as an injection under the skin. Depending on the treatment group assignment, either one or both of the immune stimulants will be given on the day of and the day after CDX-1401 administrations. This treatment may be repeated every 12 weeks.
Intervention MeSH terms: Poly I-C; Carboxymethylcellulose Sodium; Poly ICLC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NYESO1; cancer vaccine; immunotherapy; breast cancer; ovarian cancer; non-small cell lung cancer; myeloma; sarcoma; melanoma; Resiquimod; Poly-ICLC; Hiltonol; esophageal cancer; bladder cancer; chondrosarcoma; adenocarcinoma
Nutritional Supplementation and Muscle Health: A Pilot Study on Immune Function
Condition: Immunosenescence; Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      The ability of older adults to improve their muscle strength through exercise training
      appears related to how well their immune system functions. Thus, a nutritional supplement
      which improves immune function could theoretically boost strength gained for older adults
      from exercise. The purpose of this pilot study is to determine if a nutritional supplement
      has any effect on immune function.

      Veterans (age 60-80 yrs, N=12) be randomized in a double-blind placebo-controlled fashion to
      consume supplement or placebo for four weeks. After two weeks of consumption, subjects will
      be treated with a vaccine for tetanus, diphtheria, and pertussis. Blood will be drawn from
      each subject before and after vaccination to determine the effects of the supplement on
      immune response to vaccination. Additionally, subjects will undergo blood draw and muscle
      biopsy before and after two weeks of supplementation to determine the effects of
      supplementation on other measures of immune function (e.g. cytokine and growth factor
      levels). This is an important issue due to the serious health consequences associated with
      muscle loss in older adults and the need for improved strategies for rehabilitation.
    


Intervention name(s): Muscle Armor Supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: immunosenescence; sarcopenia
Safety and Efficacy of POL6326 for Mobilization of Hematopoietic Stem Cells in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I study to determine and compare the safety/tolerability of single ascending doses of
      POL6326 by intravenous infusion.
    

Detailed description: 
      Phase I Study

        -  to determine and compare the safety of single ascending doses of POL6326 by intravenous
           infusion

        -  to determine the relationship between 2-hour single intravenous infusion doses of
           POL6326 and the concentration of HSC and mature WBC in peripheral blood using
           immunophenotypic assays.
    

Intervention name(s): POL6326
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peripheral blood; HSC; Mobilization; CXCR4; volunteers
Ultrasound Biomicroscopic Analysis of Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses
Condition: Lens Subluxation
MeSH terms: Lens Subluxation
Study type: Observational

Summary: 
      To report the Ultrasound Biomicroscopic findings following Cionni Ring bag fixation and
      in-the-bag IOL Implantation. To assess the relationship of the Bag and Cionni ring
      positioning in relation to surrounding ocular structures, in pediatric eyes
    

Detailed description: 
      Cionni ring fixation of the capsular bag in conjunction with placement of an IOL has been
      found to be safe and effective compared with other current alternatives, even given the
      exceptionally high difficulty levels and complexity of these cases, in both adult and
      pediatric eyes. One limitation of techniques requiring trans-scleral suturing is that the
      suture cannot always be passed under adequate visualization, and, once the knot is secured,
      the exact position of the Cionni ring cannot always be accurately localized. Analysis of
      Cionni ring position with respect to the IOL and iris is important, as faulty placement of
      the ring or IOL can lead to complications which can threaten vision, especially in children
      with a high predisposition towards postoperative adverse events. Unfortunately, pupillary
      dilatation and slit-lamp examination may not always be adequate to assess the Cionni ring or
      the eyelet position, as it occupies the peripheral section of the capsular bag. UBM has been
      shown to be accurate and reproducible in examining the haptic position in relation to the
      sulcus and ciliary body, anterior chamber depth (ACD), vitreous incarceration, focal iris
      abnormalities, angle anatomy, and relationship of the iris to the lens (straight or tilted).
      This study aims to provide information on UBM findings following Cionni ring implantation in
      pediatric eyes for non-traumatic subluxation of the crystalline lens.
    

Intervention name(s): Lens Subluxation Surgery
Intervention type(s): Procedure
Intervention description(s): Surgical Intervention to include Cionni Ring implantation and in-the-bag IOL implantation
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children undergoing Cionni Ring Implantation with in-the-bag implantation for subluxated
        lenses
      
Keywords: Cionni Ring; Ultrasound Biomicroscopy