bioihbjkbjnl/mcl2 huggingface dataset:
A Cardiac Surgery Virtual Nutrition Intervention Program Feasibility Study-VIP Study Protocol
Condition: Nutritional Deficiency
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      This feasibility study will look to identify the impact that a remote/virtual nutritional
      intervention can have on nutrition literacy and knowledge retention of the cardiac surgery
      patient.
    

Detailed description: 
      The proposed VIP study will utilize an interventional feasibility design to implement and
      evaluate the impact of a virtual nutrition intervention prehab program on cardiac surgery
      patients. The VIP study looks to measure patient adherence and acceptability, and
      practicality of the remote platform in hopes it will illicit change to the current standard
      of nutrition care being provided to cardiac surgery patients.

      The current standards of care do not call for dietitian involvement for cardiac surgery
      patients' pre-surgery and little to no involvement for patients not receiving CABG surgery.
      This feasibility study looks to address this gap in current patient nutrition care.

      The study intervention will provide eligible patients (n=20) with access to four 25-30 minute
      virtual sessions with a registered dietitian during the two-week period prior to surgery. The
      dietitian will provide the patient with nutrition counseling prior to the patient's elective
      cardiac surgery. Zoom (or equivalent) software will be utilized as a remote platform to
      connect the dietitian virtually with participants during all sessions. The four sessions will
      follow the same presentation format and will provide all participants with identical
      nutrition education with curriculum content progressing in each subsequent session. Each
      session will be comprised of protein education and goal setting, with education content
      building on previous sessions with a goal of improving patient protein intake
      perioperatively.

      Data will be collected on: (1) participant demographics, (2) physical function, (3)
      nutritional status and (4) nutrition literacy.
    

Intervention name(s): Virtual Nutrition Education
Intervention type(s): Other
Intervention description(s): 4 interventional sessions will be provided using a virtual communication platform and delivered remotely to each participant by a registered dietitian. The virtual counseling sessions will be led by a registered dietitian and delivered to each participant remotely
Intervention model: Single Group Assignment
Intervention model description: Study sessions will be provided using a virtual communication platform and delivered remotely to each participant by a registered dietitian. The virtual counseling sessions will be led by a registered dietitian and delivered to each participant remotely while in the comfort of their own residence or where it is deemed to be comfortable and safe.
Masking: None (Open Label)
Primary purpose: Treatment
Physiological Changes in Adults With Metabolic Syndrome Exposed to Ultrafine Air Particles
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to examine the acute health effects of concentrated ambient
      ultrafine (UF) particulate matter (PM) exposure in patients with metabolic syndrome. Without
      lifestyle changes or medical intervention these patients are at considerable risk for
      developing diabetes and cardiovascular disease. Subjects (25-70) were exposed to both UF PM
      and filtered air for 2hr (at least 2 week interval), physiologic endpoints were measure pre-,
      post-, and 20hr post-exposure. Our hypothesis is that PM exposure in this population will
      result in changes in vascular and endothelial response as assessed by flow-mediated
      dilatation of the brachial artery and various heart rate variability and blood endpoints.
      This study and similar studies of susceptible populations are needed to provide the EPA with
      information regarding the health risks associated with ambient levels of UF PM.
    


Intervention name(s): Ultrafine Air Pollution Particulate Matter; Filtered Air
Intervention type(s): Other; Other
Intervention description(s): Ultrafine (particle diameter less than 2.5 microns) Air Pollution Particulate Matter, concentrated from the ambient air outside of the Chapel Hill EPA Human Studies Facility; Filtered Air
Other intervention name(s): ultrafine particulate matter; concentrated ambient particulates (CAPS); clean air
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effect of Indacaterol Maleate in Chronic Obstructive Pulmonary Disease (COPD) on Lung Volume and Related Dyspnea
Condition: COPD; Lung Diseases; Dyspnea; Hypoxemia; Tachycardia
MeSH terms: Lung Diseases; Dyspnea; Tachycardia; Hypoxia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether indacaterol maleate 300 micrograms (mcg) is
      effective in the acute treatment of COPD and in particular on reducing lung hyperinflation
      and dynamic volumes.
    

Detailed description: 
      Enrolled patients: COPD of any disease severity in stable conditions. 48 hours of inhalatory
      drugs wash out.

      Evaluation: Plethysmographic test, blood gas analysis, blood pressure, cardiac frequency and
      Borg scale evaluation in basal condition and after 60 minutes of indacaterol maleate 300 mcg
      inhalation.
    

Intervention name(s): Indacaterol maleate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dry powered, 300 mcg, only one inhalation with 24 hours duration; Dry powered, same to study drug, only one inhalation
Other intervention name(s): Onbrez, Hirobriz, Onbrize, Oslif Breezehaler, Arcapta
Intervention MeSH terms: Maleic acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD; Inspiratory capacity; Residual volume; Total lung resistance; Arterial Oxygen
Biological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)
Condition: Allergy to Tree Pollen
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Biological Standardization of Cupressus arizonica Allergen Extract.
    

Detailed description: 
      This is an open, unblinded and non-randomized biological assay. The study design is a slight
      modification of the recommendations proposed by the Nordic Guidelines.
    

Intervention name(s): Cupressus arizonica
Intervention type(s): Biological
Intervention description(s): Four different concentrations of Cupressus arizonica allergen extract, positive control and negative control
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Allergy to Cupressus pollen
Mozobil for Autologous Stem Cell Mobilization
Condition: Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma; Stem Cell Mobilization; Autologous Stem Cell Transplantation
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate Plerixafor (MOZOBIL) plus recombinant human G-CSF
      (G-CSF) efficiency in mobilizing sufficient number of stem cells from Lymphoma (NHL and HL)
      patients for autologous transplantation.
    


Intervention name(s): Plerixafor
Intervention type(s): Drug
Intervention description(s): Plerixafor (mozobil) 240 mcg/kg SC will be administered in the evening, 10 hours prior to initiation of apheresis.G-CSF will be administered in the morning at 10 mcg/kg SC for 4 days prior to apheresis.
Other intervention name(s): Mozobil and Neupogen
Intervention MeSH terms: Plerixafor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-Hodgkin's lymphoma; Hodgkin's lymphoma; stem cell mobilization; autologous stem cell transplantation
Investigating Transcranial Direct Current Stimulation (tDCS) in Accelerating Learning in a Healthy Older Population
Condition: Associative Memory in Healthy Subjects
Study type: Interventional

Summary: 
      The overall objective of this study is to explore whether transcranial Direct Current
      Stimulation (tDCS) can accelerate associative learning and boost associative memory in
      healthy subjects.
    

Detailed description: 
      The overall objective of this study is to explore whether transcranial Direct Current
      Stimulation (tDCS) can accelerate associative learning and boost associative memory in
      healthy subjects.

      The aim of this study is to investigate the effects of transcranial Direct Current
      Stimulation (tDCS) stimulation during a verbal paired-associate learning task to determine if
      tDCS may be used as a way to enhance brain plasticity during an associative memory task, and
      to accelerate learning and to optimize associative memory performance. We hypothesize that
      participants who receive tDCS stimulation will improve their associative memory performance.
    

Intervention name(s): Active tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): Real stimulation; Sham stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to one of two groups: (1) active tDCS (2) Sham tDCS.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Aging; Memory; Associative learning; transcranial direct current stimulation
Effect of the Pneumoperitoneum on Dynamic Variables Delta PP and PVI During Trendelenburg Position.
Condition: Surgery
MeSH terms: Pneumoperitoneum
Study type: Interventional
Phase: Phase 2

Summary: 
      Arterial pulse pressure variation induced by mechanical ventilation (ΔPP) is considered one
      of the best parameter to predict fluid responsiveness in patients under general anaesthesia.
      Pleth Variability Index (PVI) has been proposed as a less invasive alternative. However, the
      pneumoperitoneum has been recently seen suggested as a limitation to their interpretation.
      The aim of this observational study is to compare changes in ΔPP and PVI related to
      autotransfusion associated with a Trendelenburg manoeuver before and during laparoscopy in
      patients undergoing elective surgery.
    


Intervention name(s): PVI and deltaPP after trendelenburg position change
Intervention type(s): Device
Intervention description(s): Comparison of hemodynamic parameters during surgery after position change
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Lung Recruitment Assessment With Lung Ultrasound In Pediatric Patient Scheduled For Laparoscopic Surgery
Condition: Atelectasis
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      Anesthesia-induced atelectasis is a well-known entity observed in approximately 68-100% of
      pediatric patients undergoing general anesthesia. The collapse of dependent lung zones starts
      with anesthesia induction but can persist for hours or even days after surgery. Such
      anesthesia-related atelectasis has a number of negative clinical consequences such as the
      impairment of arterial blood oxygenation and lung mechanics as well as the predisposition for
      ventilator-associated lung injury. The adjustment of ventilator settings for preventing the
      occurrence of atelectasis and for reducing pulmonary complications remains controversial.

      Lung sonography (LUS) plays an important role in diagnosing pulmonary diseases in children,
      including atelectasis of different origins. LUS has demonstrated its high sensitivity and
      specificity for diagnosing anesthesia-induced atelectasis in children.
    

Detailed description: 
      Compare lung aeration between two different mechanical ventilation strategies (protective
      mechanical ventilation and recruitment maneuvers) in pediatric patients scheduled for
      abdominal laparoscopic surgery using ultrasound imaging and a four-point-aeration score to
      assess the lung aeration.
    

Intervention name(s): Lung recruitment maneuver
Intervention type(s): Other
Intervention description(s): The lung recruitment maneuver consists in a brief and controlled increment in airways pressure (15 cmH2O of PEEP + 15 cmH2O of driving pressure) for 10 breaths.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: atelectasis; children; lung ultrasound; lung recruitment
Selenium Treatment in Autoimmune Thyroiditis (AIT)
Condition: Autoimmune Thyroiditis; Hashimotos Thyroiditis
MeSH terms: Thyroiditis; Hashimoto Disease; Thyroiditis, Autoimmune
Study type: Interventional

Summary: 
      Selenium suppresses autoimmune destruction of thyrocytes and decreases titers of serum TPOAb
      in AIT patients. Older 4 clinical trials approved the efficacy of the daily dose of 200micg.
      It's believed that Se saturates the deficient stores of GPX so GPX saves the thyrocytes
      against to oxidative stresses. Although less than 70 micg/d is sufficient to maximize GPX
      activity, none of the authors tested the doses less than 200 micg/d. Our hypothesis was that
      If 100 micg/d can not suppress the TPOAb titers,it means autoimmune destruction can not be
      blocked by saturation of deficient stores of GPX solely and the mechanism of action requires
      more than repletion of deficient stores. It's important not only to estimate the optimal dose
      but to understand the mechanism of action. High dose therapy may also suppress TPOAb levels
      in Se-non-deficient AIT patients, if it is so, Se therapy may becomes the solely treatment
      modality which can suppress the autoimmunity in more than 400 million AIT patients. Because
      there've been no way to suppress autoimmune war and replacement of LT4 had been the only
      treatment modality for palliation. An other independent part of the study is to test the
      effect of Se in adolescent AIT patients.
    


Intervention name(s): L-Selenomethionine
Intervention type(s): Drug
Intervention MeSH terms: Selenium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Thyroiditis; Autoimmune; Hashimoto's; TPOAb; Selenium
Low Versus High-Intensity Aerobic Training in Community-dwelling Older Men With Post-COVID 19 (SARS-CoV-2) Sarcopenia
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      Sarcopenia is the major health concern and common consequence of COVID-19 in the ageing
      population. The objective of this study is to find and compare low and high-intensity aerobic
      training protocols on clinical and psychological effects in community-dwelling older men with
      post-COVID 19 Sarcopenia.
    


Intervention name(s): low-intensity aerobic training
Intervention type(s): Other
Intervention description(s): A low-intensity aerobic training group started with 15 minutes of warm-up, which includes static stretching of the upper and lower limb muscles. then participants were instructed to do 30 minutes of low-intensity aerobic training exercises, which include 20 minutes on the treadmill and 10 minutes of cycle ergometer, followed by 10 minutes of cool down.
- In high-intensity training (HAT) the same protocol has been followed, but the intensity of exercises was fixed between 60% to 80 % of maximum heart rate. The strength training includes major group muscles such as shoulder flexors, extensors, and abductors, elbow flexors and extensors, hip flexors& extensors, knee flexors&extensors, abdominal and back muscles also were trained. Each group of muscles was trained for 10 repetitions for 3 sets with a rest period of 5 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Retrospective Review of Malignant Liver Tumors
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Observational

Summary: 
      This study will review the treatment and outcomes of patients having primary and metastatic
      hepatic malignancies. Patients treated with surgical resection, percutaneous radiofrequency
      ablation (RFA), and transarterial chemoembolization (TACE) will be compared with patients not
      receiving these treatments. Tumor recurrence and survival data will be compared to the
      published literature to determine the efficacy of current treatment strategies in this
      patient population.
    

Detailed description: 
      Subjects will be identified by diagnosis and procedure codes from a university surgical
      practice and the St. John Medical Center Cancer Registry. Data will be obtained by review of
      both the clinic and hospital charts. In addition we plan to review and utilize liver tumor
      treatment and outcomes data from a national database. Treatment decisions, in cases managed
      by the primary investigator, were made on a clinical basis, often in collaboration with an
      interventional radiologist. Of the patients managed by the principal investigator, all
      procedures were undertaken after an informed consent process. Subjects were not exposed to
      risk beyond that posed by the recommended treatment. All treatments were within the scope of
      standard medical care. The primary investigator has no knowledge of the treatments chosen for
      the patients he did not manage. The subject's referring physician may be contacted to obtain
      follow-up data on the subject. The follow-up data will include: is the patient alive with
      disease; alive without disease, alive unknown; dead free of disease; dead with disease; dead
      unknown.
    

Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic and patients treated at St. John Medical Center in Tulsa, OK
      
Keywords: hepatocellular carcinoma; colorectal carcinoma metastatic to liver; primary liver cancer
Mass Balance Study of 14C-labelled GFT505 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Human mass-balance studies with radiolabelled study drug are needed to evaluate the amount of
      drug that is recovered over time via different elimination routes of the body, i.e., whole
      blood, blood cells, plasma, urine, feces, and expired air. The ideal case is to be able to
      demonstrate a (near) complete recovery (≥95 %) of the administered dose.

      A good understanding of the metabolic pathway of the study drug is equally important.
      Mass-balance data, together with metabolic profiles in excreta, are used to characterize the
      biotransformation pathways of a drug and to help evaluate its drug-drug interaction
      potential.

      To this purpose, in this study, blood, urine, and feces are collected to investigate the
      metabolic profile of GFT505, and plasma and urine are collected to investigate the
      non-radioactive pharmacokinetics of GFT505 and its principle metabolite GFT1007. Other
      metabolites will be investigated in plasma and urine according to the radioactivity results.
      Non-radioactive pharmacokinetics of GFT505 and metabolites in feces will be investigated
      according to the radioactivity results.
    

Detailed description: 
      This is a Phase I open-label, single oral dose and single center study of 14C-labelled GFT505
      and its metabolites in healthy subjects.

      After an overnight fast, subjects will be administered one dose of 14C-labelled GFT505
      containing an equivalent of 120 mg of the compound with 240 mL of non-carbonated water. The
      total amount of administered radiocarbon will be 1.63-1.81 megaBecquerel (MBq) (44.1-48.8
      μCi).

      Blood, urine, and feces will be collected at scheduled time intervals from before
      administration of the radiolabelled study drug throughout confinement at the clinical center
      and thereafter, if needed. Several samples of expired carbon dioxide will be obtained up to
      48 h after the administration of radiolabelled study drug.

      Radiocarbon will be assayed in all available samples (whole blood, plasma, urine, feces, and
      expired air) by liquid scintillation spectrometry. The metabolic profile of GFT505 will be
      assayed in plasma, urine, and feces. Non-radioactive pharmacokinetics of GFT505 and its
      principle metabolite GFT1007 will be assayed in plasma and urine. Other metabolites will be
      investigated in plasma and urine according to the radioactivity results. Non-radioactive
      pharmacokinetics of GFT505 and metabolites in feces will be investigated according to the
      radioactivity results.
    

Intervention name(s): 14C-labelled GFT505 120 mg
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GFT505; Mass balance; Pharmacokinetics; Metabolites; Healthy subjects; Healthy male volunteers
Clinical Performance Evaluation of a Glass-ionomer Restorative System Evaluation
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this clinical trial was to compare the clinical performances of a glass ionomer
      restorative system with a micro hybrid resin based composite in class I and class II
      cavities. A total of 140 (80 class I and 60 class II) lesions in 59 patients were restored
      with a glass ionomer restorative system (Equia) or a micro hybrid composite(Gradia Direct).
      Restorations were evaluated at baseline and yearly during 9 years according to the
      modified-USPHS criteria. Data were analyzed with Cohcran's Q and McNemar's tests (p<0.05).
    

Detailed description: 
      Since the introduction of glass ionomers many modifications of these materials have been
      performed over the years. Compared to other permanent filling materials like resin-based
      composites, glass ionomers show several advantages, such as the ability to adhere to moist
      enamel and dentin and anti- cariogenic properties such as the long-term fluoride release. So,
      it was doubtful that glass ionomers represent a capable counterpart of amalgam or resin-based
      composites in posterior teeth.
    

Intervention name(s): EQUIA; Gradia Direct Posterior
Intervention type(s): Device; Device
Intervention description(s): Placing glass ionomer restorations, the dentin and enamel of cavities were conditioned with 20% polyacrylic acid for 20 seconds, washed, and briefly dried. Equia Fil was injected into the cavity. Isolation was maintained using cotton rolls and a saliva ejector. After the setting time of 2.5 minutes, the restoration was polished wet using high-speed fine diamonds. When the restoration was briefly dried, Equia Coat was applied and photocured for 20 seconds using a photo-curing light.; The enamel and dentin were conditioned with G-Bond adhesive using a microtip applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, Gradia Direct Posterior resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments.
Other intervention name(s): Glass ionomer restorative system; Micro hybrid composite
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: glass ionomer; composite resin