bioihbjkbjnl/mcl2 huggingface dataset:
Tissue Retractors for Radiation Therapy of Head and Neck Tumors
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

Summary: 
      The rate of therapy-associated side effects during and after radiotherapy of head and neck
      tumors is essential. The most effective approach to reducing acute toxicity is to cut out
      healthy tissue from the radiation field. The distance between the tumor and normal tissue can
      be individually increased using personalized, 3D printer-based tissue retractors (GWR). Even
      the smallest geometric changes lead to a significant dose reduction in normal tissue and
      significant advantages for the patient.

      The current randomized phase II study evaluates the use of GWR with regard to acute toxicity.
      In addition, quality of life, long-term toxicity as well as local control and overall
      survival 12 months after radiotherapy are evaluated.
    

Detailed description: 
      The most effective approach to reducing acute toxicity after radiotherapy is to cut out
      healthy tissue from the radiation field. GWR can increase the distance between the tumor and
      normal tissue. Even the smallest geometric changes lead to a significant dose reduction in
      normal tissue and significant advantages for the patient. Adequate immobilization also
      reduces unwanted movements, especially of the tongue.

      The GWR are manufactured as combinable modules according to the "modular principle". This
      improves reproducibility and flexibility and reduces development and manufacturing costs. The
      study is being conducted as a monocentric, prospective, randomized phase II study. A total of
      34 patients who meet the inclusion criteria are examined for acute toxicity after
      radiotherapy of a malignant head and neck tumor. The primary goal of the study is to reduce
      acute toxicity through individual immobilization of the jaw and tongue. Secondary study goals
      are the evaluation of quality of life and long-term toxicity as well as local control and
      overall survival twelve months after radiotherapy. In both groups, radiation therapy is
      carried out in accordance with guidelines using image-guided radiotherapy.
    

Intervention name(s): tissue retractors
Intervention type(s): Device
Intervention description(s): Patients receive a tissue retractor to spare healthy tissue during the course of radiation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventiongroup: Personalized GWR Controlgroupt: standardized radiation protection tooth splints
Masking: None (Open Label)
Primary purpose: Treatment
One-hour Diagnostic Algorithm for NSTEMI
Condition: Non ST Segment Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Predictable values of the 1-hour algorithm for estimating the concentration of troponin using
      highly sensitive reagents are 98-100% for excluding myocardial infarction (MI) and 75-80% for
      identifying this pathology. Such algorithms are developed for the rapid confirmation or
      exclusion of myocardial infarction without ST-segment elevation and, when combined with
      clinical data and electrocardiogram, are used to assess the risk of adverse course of disease
      and to contribute to decision making about expediency of stay in the intensive therapy unit
      and early discharge.

      In mid-1980s, a new marker of myocardial damage was proposed, namely: fatty-acid-binding
      protein (FABP). However, the diagnostic value of FABP cannot be interpreted unambiguously
      because of insufficient number of studies determining the sensitivity and specificity of the
      test in various manifestations of acute coronary syndrome (ACS).

      Available literature presents a wide range of reference values of FABP for MI diagnosis.
      Reference value ranges are proposed by manufacturers of diagnostic kits based on previous
      studies. In addition, there is no information about the FABP changes during the first three
      hours of the disease, as well as there are no data on diagnostic value of changes in this
      indicator ("∆") in patients with ACS without ST-segment elevation. These considerations
      provide rationale and support novelty of the planned pilot study.
    

Detailed description: 
      After enrollment in the study, patients will undergo the following procedures:

        1. Physical examination (at baseline) and monitoring of vital signs (blood pressure, heart
           rate, breathing rate) at hours 1, 2, and 3 after admission to hospital.

        2. Registration of 12-lead electrocardiogram (ECG) (at baseline, after 24 hours, and at the
           day of discharge).

        3. At baseline (at the time of admission to hospital), venous blood will be obtained to
           perform blood tests for determination of troponin I, FABP, and CPK-MB levels. At the
           same time, venous blood will be sampled for routine clinical laboratory blood tests. At
           hours 1, 2, and 3 after admission to hospital, venous blood will be sampled for
           assessment of the troponin I and FABP levels.

        4. Echocardiography will be performed 24 hours after admission (LVEDV, LVESV, and EF). At
           day 3, standard echocardiography will be performed.
    

Intervention name(s): FABP
Intervention type(s): Diagnostic Test
Intervention description(s): Assessment of changes in FABP concentrations
Intervention model: Single Group Assignment
Intervention model description: Single-center study
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: FABP; non ST Segment Elevation Myocardial Infarction
The Influence of Aerobic Exercise on Serum Brain Natriuretic Peptide and C- Reactive Protein in Cardiovascular Disease
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effects of 8 weeks of aerobic exercise on
      serum concentrations of Brain Natriuretic Peptide and C - reactive protein in patients with
      cardiovascular disease. Patients were divided randomly into two groups: control and
      experimental aerobic group. This study was done with two - stage blood sampling: at the
      beginning and at the end of the treatment phase. All subjects were requested to avoid any
      exercise at least 48 hours before blood sampling. To study Brain Natriuretic Peptide and C -
      reactive protein changes, 5 milliliters of blood were taken from patient's brachial vein.
      Blood samples for subsequent measurements were frozen immediately and transported to the
      Hormone Laboratory for serum separation. The experimental group did the aerobic exercise
      programs for 8 weeks for 3 sessions per week and the control group did not receive any
      training. After completion of training, the final blood samplings were performed. Exercise
      intensity according to the heart rate remained stable until the last week. Brain Natriuretic
      Peptide and C - reactive protein levels were measured by ELISA tests. All statistical
      analysis were done using SPSS software (version 16) and at the significance level of p≤ 0.05
    


Intervention name(s): Aerobic exercise
Intervention type(s): Other
Intervention description(s): Aerobic exercise for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Brain Natriuretic Peptide; aerobic execise; C- Reactive Protein
Long-term Efficacy and Safety Study With Oralgen Grass Pollen
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is designed to give additional information on the efficacy, safety and local
      effects (tolerability) of a dose of sublingual immunotherapy administered once a day, during
      a second grass pollen season.
    

Detailed description: 
      Allergy is one of the most common chronic diseases. Allergies to grass, weed, and tree
      pollens characteristically result in seasonal rhinitis symptoms commonly termed hay fever.
      The risk of developing asthma has been noted to be higher in patients with rhinitis than
      among the general population (10% versus 3.6%), confirming the fact that rhinitis is often
      the first step of the natural history of asthma.

      Although several drugs effectively manage the symptoms of allergic rhinitis, conjunctivitis
      or asthma, they do not represent an etiopathogenic treatment of the considered diseases, and
      do not prevent the reappearance of the symptoms at the end of the treatment.

      Immunotherapy is generally considered to be appropriate for patients in whom rhinitis
      symptoms cannot be controlled by an optimal medication regimen and avoidance of the
      allergens. At present, specific immunotherapy is the only therapy available that acts on the
      main cause of the allergic reaction by modifying or down-regulating the immune response.

      Allergen immunotherapy is the administration of gradually increasing quantities of an
      allergen vaccine (extract) to an allergic subject, to reach a maintenance dose, which is
      effective in reducing the symptoms associated with exposure to the causative allergen.
    

Intervention name(s): Oralgen; placebo
Intervention type(s): Drug; Other
Intervention description(s): allergen solution sublingually; placebo control
Other intervention name(s): grasspollen extract; Placebo control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: randomised; double-blind; placebo-controlled; long-term efficacy and safety; Oralgen® Grass Pollen; allergic rhinoconjunctivitis; Allergy; Rhinoconjunctivitis; Immunotherapy; Grass pollen extract
Cardiovascular Screening for Family Members of People With Acute Coronary Disease
Condition: Cardiovascular Risk Factor
MeSH terms: Coronary Disease; Coronary Artery Disease
Study type: Interventional

Summary: 
      Over a 12-month period, patients admitted with acute coronary disease to the cardiovascular
      care unit at the Jewish General Hospital (JGH), an academic tertiary care referral center in
      Montreal, Quebec, will be approached to refer first-degree relatives and/or household members
      age 18 years or older to an outpatient cardiovascular (CV) risk factor screening and
      treatment program. Relatives and household members will undergo a focused history, physical,
      and CV risk factor assessment and will receive evidence-based guideline-recommended treatment
      as indicated. Participants will be referred to nutritionists, smoking cessation programs, and
      to other allied healthcare professionals as needed. A follow-up visit at 6-months will assess
      treatment adherence and improvement in CV risk factors. All family and/or household members
      including the index patient will be encouraged to attend all healthcare visits together.

      The effectiveness of the screening strategy will be measured by the total number of
      participants identified as intermediate or high modified Framingham 10-year risk of
      cardiovascular disease. The effectiveness of the primary prevention intervention will be
      measured by the change in percentage of the mean modified Framingham 10-year risk score for
      participants between the initial visit and 6-month follow-up. The value of the referral,
      screening, and treatment program, as well as participant engagement and satisfaction will
      also be systematically evaluated.
    


Intervention name(s): Family-oriented primary cardiovascular prevention
Intervention type(s): Other
Intervention description(s): An initial screening visit including a targeted history, physical exam, and investigations as per the Canadian Cardiovascular Society's recommendations for cardiovascular primary prevention. Counselling and informational handouts on improved cardiovascular risk factor and lifestyle habits. All family and household members, as well as the cardiovascular disease proband, are encouraged to attend and participate in all healthcare visits.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Postoperative Pain Management in Patients Undergoing Intramedullary Nail Fixation After Tibia and Femoral Fractures
Condition: Femur Fracture; Tibial Fractures
MeSH terms: Pain, Postoperative; Fractures, Bone; Femoral Fractures; Tibial Fractures
Study type: Interventional

Summary: 
      The purpose of this trial is to determine whether oral acetaminophen and intravenous
      ketorolac are viable alternatives to opioid medication regimens for the pain management of
      patients with tibial and femoral shaft fractures treated with intramedullary nailing. This
      study will explore an alternative for opioid medications for patients undergoing
      intramedullary nailing of tibial and femoral shaft fractures.
    


Intervention name(s): Use of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture
Intervention type(s): Other
Intervention description(s): This is a randomized controlled, single blind, parallel groups, opioid control trial of all patients (total of 150 patients) who suffered tibial and femoral shaft fractures and were treated with intramedullary nailing. Patients will be aleatory assigned to two study groups: Group-1 will receive non-opioid medications, and Group-2 will receive opioid medications. During the inpatient postoperative period, patients will undergo subjective evaluation of pain utilizing a previously validated questionnaire, the Visual Analogue Score (VAS). The first questionnaire will be completed twelve hours after surgery and during subsequent twelve-hour intervals until discharge. Secondary outcomes will include efficiency such as time to gastrointestinal motility, time to weight bearing of affected limb, resumption of ambulation, and length of hospital stay. The evaluation will take approximately 15 minutes to complete each time, we the entire participation time to be 60 minutes.
Intervention MeSH terms: Anti-Inflammatory Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Opioid use; Post-operative pain; Analgesic use; Femur fracture; Tibia fracture; Intramedullary Nailing
ADME Study of [14C]-Jaktinib in Healthy Male Subjects
Condition: Healthy Adult Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to evaluate the mass balance and biotransformation after single-dose
      of [14C]-Jaktinib orally in Chinese healthy male subjects.
    


Intervention name(s): [14C]-Jaktinib
Intervention type(s): Drug
Intervention description(s): Subjects will receive single dose of orally [14C]-Jaktinib on Day 1.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Test of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain
Condition: Procedural Pain
MeSH terms: Pain, Procedural
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The hypothesis of this study is that distraction cards used by the caretaker along with a
      vibrating cold pack placed proximal to the site of immunization will decrease the pain of
      routine pediatric immunizations when compared to a placebo device or standard care.
    

Detailed description: 
      Needle pain is the most common and the most feared source of childhood pain, resulting in
      needle phobia for 10$ of adults. Current standard of care for immunizations in the US is no
      pain relief. An inexpensive, immediately effective form of needle pain control could reduce
      needle phobia or vaccine refusal in the long term if demonstrated to be effective for
      immunization pain.

      Distraction can decrease procedural distress in children by 50%. The effect of using a
      multi-modal pain and distraction relieving approach has not been rigorously studied.
    

Intervention name(s): Device: Buzzy; Buzzy: sham device
Intervention type(s): Device; Device
Intervention description(s): "Buzzy", the vibrating cold pack, is held in place with a velcro strap or pressed by caretaker or nurse immediately prior and during immunizations. The vibration is activated and the device remains in place during the shot, moving locations if multiple shots are given. Distraction cards with pictures on one side and questions on the other are shown to the child while the caretaker asks the finding and seeking questions on the back.; The identical device without batteries or a cold pack is held in place proximal to the site with a velcro strap or pressed by parent or nurse immediately prior to immunizations. The device remains in place throughout the procedure, moving locations to complete multiple shots.
Other intervention name(s): Buzzy(R); Flippits(TM); Buzzy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pain
Pharmacist-led Therapeutic Nutritional Intervention in Type 2 Diabetes
Condition: Diet Modification
Study type: Interventional

Summary: 
      Type 2 diabetes represents a significant burden to both the individual and our healthcare
      system. Individuals with type 2 diabetes are typically prescribed one or more
      glucose-lowering medications, many of which have undesirable side effects (e.g., nausea, risk
      of cardiovascular complications, weight gain) and cost our healthcare system a lot of money.
      An alternative strategy to lower blood glucose is to consume a low-carbohydrate diet.
      However, adjusting medications after choosing to follow a low-carbohydrate diet can be
      difficult. Delivering a low-carbohydrate diet through pharmacists could circumvent this
      difficulty in medications adjustment because pharmacists are trained to adjust medications.
      In this study the investigators will determine whether type 2 diabetes patients can reduce
      medications and improve blood glucose by following a low-carbohydrate, low-calorie diet under
      the direction of a pharmacist.
    


Intervention name(s): Low-carbohydrate Therapeutic Nutrition
Intervention type(s): Behavioral
Intervention description(s): The pharmacist or pharmacy lifestyle coach will work with the participant to develop a diet plan that is low in carbohydrate and energy-restricted based on personal preferences and characteristics. A combination of pre-packaged low-carbohydrate foods and whole foods from pre-specified lists will be used.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pragmatic effectiveness trial of diet intervention led by community pharmacists versus treatment-as-usual waitlist control.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low-carbohydrate; Low calorie; Energy restricted
The Effects of Oxytocin on Startle Hyperreactivity in Patients With AUD and PTSD
Condition: Stress Disorders, Post-Traumatic; Alcoholism
MeSH terms: Alcoholism; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will investigate the effects of oxytocin on alcohol-related behaviors, social
      abilities, and physiological startle responses in healthy individuals and patients with
      posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) using a randomized,
      placebo-controlled, dose-tiered, between-subject study design. Specifically, the
      investigators will determine if intranasal administration of a single dose of the pro-social
      neuropeptide oxytocin decreases alcohol-related approach bias and cravings, enhances social
      abilities, and decreases physiological hyperactivity. The investigators will also determine
      the optimal dose to achieve these effects and will explore psychosocial predictors of
      responses to oxytocin. The proposed work has the potential to yield a novel pharmacological
      treatment for AUD and PTSD, both leading causes of disability in the US Military for which
      currently available treatments are inadequate.
    


Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: oxytocin; PTSD; Alcohol Use Disorder; social cognition; craving; fear-potentiated startle
A 10-Week Study for Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of an investigational
      anti-anxiety medication relative to placebo in patients with generalized anxiety disorder
      (GAD).
    


Intervention name(s): Gabitril
Intervention type(s): Drug
Intervention MeSH terms: Tiagabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment