bioihbjkbjnl/mcl2 huggingface dataset:
Changes of Cerebral Oxygenation During Anesthesia Induction
Condition: Cerebral Oxygen Saturation
Study type: Observational

Summary: 
      The aim of this study was to investigate the changes of cerebral oxygen saturation (rSO2)
      during anesthesia induction.
    

Detailed description: 
      The aim of this study was to investigate the relationship between the cerebral oxygen
      saturation (rSO2) and pressure of carbon dioxide (PaCO2) and oxygen (PaO2) in arterial blood
      and to identify the covariates between rSO2 and PaCO2 and PaO2 during the period of
      anesthesia induction.
    

Intervention name(s): 100% Oxygen
Intervention type(s): Drug
Intervention description(s): We will investigate the changes of cerebral oxygenation during anesthesia induction of standard general anesthesia with 100% oxygen
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Female patients scheduled for elective radical operations for mastocarcinomaat in the First
        Hospital of China Medical University will be recruited for the study
Sublingual Immunotherapy of Birch Pollen Associated Apple Allergy
Condition: Birch Pollen Related Apple Allergy; Birch Pollen Allergy
MeSH terms: Rhinitis, Allergic, Seasonal; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      More than 70% of birch pollen allergic patients suffer from allergic reactions to certain
      foods, e.g. stone fruits, hazelnut and some vegetables. However, specific immunotherapy (SIT)
      with birch pollen extract is not effective for the treatment of associated food allergy in a
      substantial number of patients. Based on our previous clinical and immunological
      investigations of birch pollen related food allergy (BPRFA) the investigators hypothesize
      that for effective SIT of this abundant food allergy the disease-eliciting food allergens
      should be employed. To prove this concept, the investigators aim to sublingually administer
      the major apple allergen, Mal d 1, to birch pollen-allergic patients with concomitant apple
      allergy and evaluate clinical and immunological effects of this treatment. The investigators
      choose Mal d 1 as model food allergen because (i) its cross-reactivity with Bet v 1 has been
      well characterized,(ii) apple is the most frequent trigger for BPRFA and (iii)
      recombinant(r)Mal d 1 was well tolerated after sublingual administration to 20 birch
      pollen-allergic patients in a previous study. Sublingual administration of a defined
      concentration of GMP-rMal d 1 will be compared with equal doses of GMP-rBet v 1 as a positive
      control and placebo-treatment. Clinical parameters will include skin prick tests (SPT) and
      objective and subjective assessment of apple and birch pollen-induced allergic symptoms.
      Immunological parameters will comprise the analysis of antibody and T cell responses to Mal d
      1 and Bet v 1 as well as the evaluation of basophil activation.

      The proposed pilot study will be a first investigation of the concept to specifically treat
      BPRFA with the involved food allergens and thus, represents an important step in the
      development of an efficient and safe therapy in the future.
    


Intervention name(s): rMal d 1; rBet v 1; placebo drops
Intervention type(s): Drug; Drug; Other
Intervention description(s): 25 µg daily as sublingually administered drops, 16 weeks; 25 µg daily administered sublingually as drops over 16 weeks; 25 µg of placebo Drops daily administered sublingually over 16 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mal d 1, Bet v 1, sublingual immunotherapy,
Intervention Mapping to Adapt a Mindfulness-based Intervention for Adults With Diabetes and Emotional Distress
Condition: Type 2 Diabetes; Stress
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      We will conduct a single-arm pilot study of an integrated mindfulness-based stress reduction
      (MBSR)/diabetes self-management education (DSME) intervention in a small group of
      participants, low-income adults with type 2 diabetes and diabetes distress. We will evaluate
      the preliminary efficacy, acceptability, and feasibility of the intervention.
    

Detailed description: 
      The intervention will comprise components of MBSR and DSME and will be delivered in a group
      setting with 8 weekly sessions. We anticipate enrollment of 30 participants, who will be
      adults with poorly controlled type 2 diabetes and elevated diabetes distress recruited from
      Cooper Green Mercy Health Systems, a safety-net health system serving residents of Jefferson
      County, Alabama. A trained masters-level interventionist will deliver the integrated
      intervention. The aim of the intervention is to reduce diabetes distress and improve glycemic
      control.

      Participants will be assessed at baseline and 2 months. We will assess the preliminary
      efficacy of the intervention through pre/post evaluation of diabetes distress, diabetes
      self-management behaviors, and glycemic control as measured by hemoglobin A1c. Additionally,
      we will assess acceptability of the intervention through follow-up qualitative, focus groups
      with intervention participants; the feasibility of intervention delivery will be assessed
      using process measures.
    

Intervention name(s): Integrated MBSR/DSME intervention
Intervention type(s): Behavioral
Intervention description(s): Integrated mindfulness-based stress reduction/diabetes self-management education intervention. The intervention will comprise components of MBSR and DSME and will be delivered in a group setting with 8 weekly sessions. A trained masters-level interventionist will deliver the integrated intervention.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes distress; Mindfulness-based intervention; Diabetes self-management education
Multicenter Study of Denture Adhesive
Condition: Edentulous
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      To establish evidence based guidelines for denture adhesives (powder and cream), multicenter
      cross over randomized clinical trial will be carried out.

      The null hypotheses are that there are no difference on improvement from baseline to post
      application of two adhesives powder and cream, in terms of general satisfaction, oral related
      quality of life, masticatory function and oral conditions.
    

Detailed description: 
      This is multicenter study of 10 academic affiliated institutions. The clinical trial will be
      carried out in randomized allocation at each site, and data will be gathered. The
      intervention will be 3-arms and center institution (Nihon University) will generate each site
      random numbers for allocation and each site will follow this randomization. Research protocol
      had been published at Nihon University and distributed to each site.To survey its protocol
      compliance, the study meeting will be held periodically (twice an year).
    

Intervention name(s): Denture Adhesives: Cream; Denture Adhesives: Powder; Saline
Intervention type(s): Other; Other; Other
Intervention description(s): Using Polident as denture adhesive to compare its effect on PRO and subjective outcomes.; Using Poligrip powder as denture adhesive to compare its effect on PRO and subjective outcomes.; work as control for Denture Adhesives: Cream and Powder
Other intervention name(s): Polident; Poligrip powder; Otsuka normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Food on the Bioavailability of a Single Dose of SSP-004184SS in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effect of food on the pharmacokinetic profile of SSP-004184 compared to
      administration under fasted conditions.
    


Intervention name(s): SSP-004184SS
Intervention type(s): Drug
Intervention description(s): Disodium salt
Other intervention name(s): SPD602
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Recombinant Human Endostatin Continued Pumping Into Vein Combining With CCRT in Unresectable Stage III NSCLC
Condition: Stage III Non-small-Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Resistance of hypoxic tumor cells to radiation is a significant reason of failure in the
      local control of tumors, especially the squamous cell carcinomas. Preclinical models have
      shown that Endostar may transiently "normalize" the tumor vasculature to make it more
      efficient for oxygen delivery, thereby providing a window of opportunity for enhanced
      sensitivity to radiation treatment. This study is to evaluate the safety, toxicity, and
      efficacy of the addition of Endostar Continued Pumping into Vein to the standard CCRT regimen
      in patients with unresectable stage III NSCLC.
    

Detailed description: 
      Primary

      Evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy
      (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).

      Secondary

      Measure changes in VEGF and other angiogenic cytokines and antiangiogenic factors in plasma
      samples from these patients.

      Evaluate the application of CT perfusion imaging to determine changes in tumor vascular
      mophology and function during treatment.
    

Intervention name(s): Recombinant human endostatin; Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles; cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles; laboratory biomarker analysis; CT perfusion imaging
Intervention type(s): Drug; Drug; Drug; Other; Other
Intervention description(s): Recombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7,combined with concurrent chemo-radiotherapy.
Intervention MeSH terms: Etoposide; Cisplatin; Endostatins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recombinant human endostatin; Non-small-Cell Lung Cancer; chemoradiotherapy
A Single and Multiple Doses Safety, Tolerability, Pharmacokinetics and Food Effect Study of KVD824 in Healthy Volunteers
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 3 part phase 1, randomized, double-blind, placebo-controlled, study of the safety,
      tolerability, and pharmacokinetics of KVD824 following administration of single and multiple
      ascending oral doses; followed by a crossover food effect sub-study in healthy male
      volunteers.
    

Detailed description: 
      Part A was a single-centre randomized, double blinded, placebo control to investigate the
      safety and tolerability of single ascending doses of KVD824 administered to healthy male
      volunteers.

      Part B was a single centre, randomized, double blinded, placebo control to investigate the
      safety and tolerability of multiple ascending doses of KVD824 administered to healthy male
      volunteers.

      Part C was a single-centre, open labelled to investigate the food effect.
    

Intervention name(s): KVD824; Placebo to KVD824
Intervention type(s): Drug; Drug
Intervention description(s): Active; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Functional Implications of Arthroscopic Iliopsoas Release
Condition: Arthroscopic Iliopsoas Release
Study type: Observational

Summary: 
      The purpose of this study is to investigate the functional effects of arthroscopic iliopsoas
      release. To complete this aim, we will recruit patients who have undergone arthroscopic
      iliopsoas release by Dr. Aoki. Each subjects contralateral nonoperative hip will serve as
      their own control. To delineate the effects of arthroscopic surgery alone from those
      resulting from iliopsoas release in addition to arthroscopic surgery, we will recruit a
      second control group consisting of patients who have undergone arthroscopic surgery by Dr.
      Aoki without iliopsoas release.

      For both hips of each subject, we will:

        -  Quantify the muscle volume of the iliopsoas muscle with MRI.

        -  Quantify hip flexion strength with isokinetic dynamometry.

        -  Quantify patient function and satisfaction with functional outcome surveys.

      This data will allow us to test the following hypotheses:

        -  Compared to the non-operative hip, hips undergoing arthroscopic iliopsoas release have
           decreased iliopsoas muscle volume and hip flexion strength.

        -  Compared to hips undergoing arthroscopic surgery without iliopsoas release, hips
           undergoing arthroscopic iliopsoas release have decreased iliopsoas muscle volume and hip
           flexion strength.

        -  Patient function and satisfaction positively correlates to muscle bulk and strength.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing arthroscopic surgery by Dr. Aoki, divided into two groups:

        Those undergoing arthroscopic psoas release, and those undergoing arthroscopic surgery
        without psoas release,
      
Keywords: Arthroscopic; Iliopsoas; MRI
Effects of Mobile Application Dexteria Fine Motor Skills on Hand Dexterity and Grip Strength in Chronic Stroke Patients
Condition: Stroke, Ischemic; Skill, Social; Occlusion
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional

Summary: 
      To determine the effects of mobile application dexteria fine motor skills on hand dexterity
      and grip strength in chronic stroke patients
    

Detailed description: 
      This study will be conducted to investigate the effects of mobile applications of dexterity
      fine motor skills on hand dexterity and grip strength in chronic stroke patients. Data will
      be collected from Jinnah hospital Lahore and Riphah Rehabilitation center Lahore. All 22
      patients will be taken using random sampling. Both study groups will be given common
      treatment of conventional hand function. The subjects will randomly assign to the experiment
      group with mobile apps training and the control group without mobile app training. Mobile
      applications like Dexteria, ScribbleKid, PegLight and Bowling game will be used for the
      purpose of training and success rate will be considered as outcome measure. Test and tools
      include the Nine Hole Peg Test (NHPT), the Fugl-Meyer Motor assessment (FMA), The Box &amp;
      Block Test (BBT), and Grip strength will be assessed using a hand dynamometer. SPSS 25
      version will be used for data entry and analysis.
    

Intervention name(s): app based training with conventional therapy; conventional therapy
Intervention type(s): Other; Other
Intervention description(s): The experimental group will receive an additional mobile application therapy including , dexterity fine motor skills, bowling game, scribble game and peglight game in addition to the conventional therapy for hand function.; conventional hand function rehabilitation therapy including, strengthening exercises which consist of palm down wrist flexion exercise, dexterity( shifting exercise) and fine motor skills(nine peg hole exercise)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: total 22 participants will be enrolled. In experimental group app based training will be performed along with conventional hand fine motor skills and dexterity therapy. Conventional hand therapy will be given to the second group.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke, Ischemic; Skill, Social; Occlusion
Effects of an Integrative Treatment Model to Reduce Anxiety and Depression in Minor Mental Health Problems and Medically Unexplained Symptoms
Condition: Depression; Anxiety; Irritable Bowel Syndrome; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Irritable Bowel Syndrome; Medically Unexplained Symptoms; Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      Minor mental health problems, MMHP, like mild depression and anxiety, and medically
      unexplained symptoms, MUS, symptoms with no known underlying organic disease, are strongly
      associated to each other. MMHP and MUS have an impact on well-being and quality of life, lead
      to impaired social and cognitive function and could result in reduced work capacity. The
      investigators have designed the present study as a pragmatic trial to investigate the
      effectiveness of an integrative treatment model, therapeutic acupuncture, versus conventional
      treatment in patients with MMHP or MUS in primary care. The investigators examined whether
      the effects of the integrative treatment model differed from those achieved with therapeutic
      acupuncture or conventional treatment. Primary endpoints were anxiety and depression
      (assessed with the Hospital Anxiety and Depression scale), health-related quality of life
      (SF-36) and coping with stress, sense of coherence (SOC) during the eight weeks of treatment
      interventions.

      Statistical power was calculated based on an expected 50% reduction in HAD anxiety and
      depression scores after eight weeks of integrative treatment; a 30% reduction in acupuncture;
      and 20% in conventional care. A total of 120 (40/arm) were needed to achieve a power of 83%
      at p <0.05. Treatment effects were calculated as the difference between values at baseline,
      after four weeks and after the complete intervention period, i.e. after eight weeks.
      Nonparametric analyses were carried out to test differences between independent samples
      (Kruskal-Wallis and Mann-Whitney U) and related samples (Wilcoxon).
    


Intervention name(s): Conventional treatment; Integrative treatment; Therapeutic acupuncture
Intervention type(s): Behavioral; Other; Other
Intervention description(s): Conventional treatment; Person-centred dialogue combined with therapeutic acupuncture (mild manual acupuncture with deqi). Eight individual sessions, once a week, duration approximately 60 minutes; Eight individual sessions, once a week, with therapeutic acupuncture. The participants received acupuncture needles in the appropriate acupuncture points, in the same way as the integrative treatment model, but without person-centred dialogue.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Integrative medicine; Acupuncture; Minor mental health problems; Medically unexplained symptoms; Minor mental health problems (e.g. minor depression and anxiety) and Medically unexplained symptoms (e.g. IBS, fibromyalgia, etc)
Influence of Pain on Exercise-induced Hypoalgesia
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to investigate how acute pain induced by hypertonic saline prior
      to exercise influence the magnitude of exercise-induced hypoalgesia after a 3 min isometric
      wallsquat exercise in healthy subjects. The study is a single blinded (investigator)
      randomized cross-over trial The results from the study may be of great importance to the
      understanding of exercise-induced hypoalgesia, and whether the presence of pain affects the
      effects of exercise.
    

Detailed description: 
      Exercise is recommended to promote and maintain health and as treatment for more than 25
      chronic diseases and pain conditions.

      The mechanisms underlying pain relief of exercise are largely unknown but may be related to
      the modulation of central descending pain inhibitory pathways after acute exercise bouts.
      Exercise-induced hypoalgesia (EIH) is typically assessed as the temporary change in PPTs
      after a short acute exercise bout and EIH is seen as a proxy of descending pain inhibitory
      control. In general, EIH seems hypoalgesic (functional) in asymptomatic subjects. A
      hyperalgesic (impaired) EIH response has been reported in different chronic pain populations,
      although a functional EIH response also has been reported in subgroups of knee osteoarthritis
      patients. This implies differences in the acute response to exercise between healthy
      (pain-free) subjects and chronic pain patients, but it is still unknown whether the presence
      of pain itself affects the pain alleviating response (i.e. the EIH response) to acute
      exercise.

      It is hypothesized that acute pain will decrease the EIH response magnitude following
      hypertonic saline injection compared with the control injection. This study will increase the
      insight into the EIH mechanisms in healthy subjects in general, and how the presence of pain
      affects the body's own ability to modulate pain during exercise.
    

Intervention name(s): Pain (hypertonic saline); No pain (Hypotonic saline)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A bolus injection (1 ml) of hypertonic saline (5.8%) is injected into the right quadriceps femoris of the quadriceps femoris muscle 1 minute before performance of the 3 min wall squat exercise; A bolus injection (1 ml) of isotonic saline (0.9%) is injected into the right quadriceps femoris of the quadriceps femoris muscle 1 minute before performance of the 3 min wall squat exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is a 2-arm randomized controlled cross-over trial with 1 week between arms
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Exercise-induced hypoalgesia; Pressure pain threshold; hypertonic saline
Pediatric Myocardial Protection With Potassium Cardioplegia
Condition: Cardioplegia
Study type: Interventional
Phase: Phase 2

Summary: 
      The advances in cardiac surgery and anesthesia for pediatric patients planned for repair of
      congenital heart disease encourage us to discuss problems that occur during this surgery
      especially during Cardiopulmonary Bypass (CPB). Cardiopulmonary Bypass induces a damaging
      systemic inflammatory response, in addition to a myocardial ischemia-reperfusion injury (IRI)
      as a result of cessation and re-initiation of coronary artery circulation
    

Detailed description: 
      After approval of the local ethics committee of Assiut University and obtaining written
      informed consent from parents or guardians of all patients, 60 patients with congenital heart
      disease will be included. Patients will be randomly allocated into three groups
    

Intervention name(s): Cold blood cardioplegia (large volume); Cold blood cardioplegia (small volume)
Intervention type(s): Drug; Drug
Intervention description(s): Hearts will be arrested with cold blood cardioplegia, first dose (arrest dose) will be 30 ml/kg and the frequent doses every 20 min will be 15 ml/kg; Hearts will be arrested with cold blood cardioplegia first dose (arrest dose) will be 10 ml/kg and the frequent doses every 20 min will be 5 ml/kg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: myocardial protection; potassium cardioplegia; tropinin; Custodiol