bioihbjkbjnl/mcl2 huggingface dataset:
Virtual Visits (Utilization of Virtual Care in Postoperative Patients to Improve the Patient Experience)
Condition: Appendectomy, Laparoscopic; Cholecystectomy, Laparoscopic; Cholecystectomy, Robotic
Study type: Interventional

Summary: 
      The purpose of this study is to implement and evaluate postoperative virtual care visits for
      patients who undergo a laparoscopic appendectomy, laparoscopic cholecystectomy, or robotic
      cholecystectomy. The investigators aim to better understand whether postoperative virtual
      care visits will not result in a greater composite measure of the occurrence of hospital
      encounters within Atrium Health (AH) for the 30 days following surgery than standard
      in-person clinic care. The investigators also aim to better understand whether postoperative
      virtual care visits provide time and cost savings, and provide equal or improved patient
      satisfaction and convenience.
    

Detailed description: 
      Participants will be randomized to complete either a postoperative follow-up visit using
      virtual care technology or by attending a standard in-person visit at the clinic. The virtual
      visit uses a camera-enabled device and internet access to provide live access to the medical
      professional. Surveys to assess patient satisfaction and convenience will be administered by
      email on the day of the postoperative follow-up visit. Additional information including
      demographics, hospital encounters within 30 days of surgery, length of time of the follow-up
      visit, travel cost and time, whether additional follow-up care is required, and complications
      after surgery will be collected to evaluate postoperative virtual care visits. Subject
      participation in the study will end after follow-up care is complete or at 30 days, whichever
      occurs last.
    

Intervention name(s): Virtual Visit
Intervention type(s): Other
Intervention description(s): Participants will be given information about how to enroll in virtual care. Participants will use their own camera-enabled device with internet connection to see and speak to the medical professional in real-time and complete the virtual follow-up visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Virtual Visits; Telehealth
SEGATROM: Sensory and Gastrointestinal Impact of Taste Receptor Variants on Human Metabolism and Nutrition
Condition: Disorder of Glucose Regulation
Study type: Interventional

Summary: 
      We investigate the impact of taste receptors (sweet, bitter and umami) on human metabolism.
      There ist growing evidence, that components of the taste signalling system, including the
      taste receptor proteins , have important functions in the regulation of metabolic parameters
      in non-gustatory tissues.
    

Detailed description: 
      We apply different sweet, bitter and umami taste compounds in a single dose in the human
      intervention. We use substances as for instance glucose, sucrose,saccharin and lactisol in
      the sweet part, and substances from cabbage, beer or red endive in the bitter part. For umami
      we take glutamate.

      Blood samples are collected at baseline and 6 times thereafter up to 3hours, to analyse the
      incretins GLP-1(glucagon-like peptide 1) and GIP(gastrointestinal polypeptide) and other
      peptide hormones as insulin and PYY(peptide tyrosin trosin) in human beings.

      Gastrointestinal mucosa is taken by gastroscopy from the lower duodenum from study subjects
      for analysis for the presence or absence of functional taste receptors in gastrointestinal
      tissues.
    

Intervention name(s): sweet block; bitter block; umami-block; gastroscopy
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): oral application of the above mentioned substances in 300 ml tap water in 5 min. , collection of blood at 0,15,30, 60 ,120,180 minutes for measurement of incretins GIP(gastrointestinal polypeptide) and GLP-1 (glucagon like peptide 1), Protein hormones PYY(Peptide YY),CCK (cholecystokinin), Leptin and Insulin; oral application of the above mentioned substances in 300 ml tap water, collection of blood samples at -15,0,15,30,60,120,180 min for Insulin, GIP,GLP-1, PYY and glucose; oral application of umami substances as glutamate with and without IMP, collection of blood samples as above; gastroscopy with and without oral application of saccharin, tissue samples from th upper duodenum by endoscopy for the detection of taste receptor cells in the upper bowel
Other intervention name(s): Sugars as sucrose, glucose, palatinose, galactose; artificial sweeteners as saccharin; sweet taste antagonist as lactisol; application of; sinigrin; lactucopicrin; iso-alpha-acid; application of glutamate and glutamate+IMP,; tissue samples; sweet taste receptor stimualtion; artificial sweetener saccharin; SGLT-1
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: SGLT1 (sodium dependent glucose transporter); Glut-transporters; taste receptors genes; sweet taste receptor T1R2T1R3; bitter taste receptors of the hTAS2gene family
Evaluation of Pandemic Vaccination Campaign
Condition: Influenza Caused by the Novel A(H1N1)v Influenza Virus
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      A cohort of 4000 community-dwelling adults is followed to evaluate the effectiveness of the
      Finnish national A(H1N1)v influenza vaccination campaign in preventing the first episode of
      laboratory-confirmed A(H1N1)v influenza. The safety of vaccination and the severity of the
      disease are followed primarily from health care registers. In a subgroup of 200 participants,
      the humoral and cellular immunogenicity of the vaccine will be studied.
    


Intervention name(s): Follow-up
Intervention type(s): Other
Intervention description(s): Nasopharyngeal/oropharyngeal and blood samples, interviews, questionnaires, register data
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The subjects will be invited from the population assigned to use the services of Tampere
        health centre, according to the target groups for pandemic vaccination. Invitations will be
        distributed at the maternity clinics for pregnant women, at work places for health
        professionals, and letters will be sent home to random sample of subjects at age groups of
        18-24 years, 25-64 years and potetially later at 65-75 years of age.
      
Biospecimen description: 
      nasal/oral swabs, serum samples and peripheral blood mononuclear cells
    
Keywords: A(H1N1)v influenza; vaccination; pandemic
COVID-19 and Lung Ultrasound Utility
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Ultrasounds are usually done by a specially trained health professional in the hospital or
      emergency department (ED) setting. Using a novel single-probe device, the ultrasound can be
      plugged into an iOS / Android device. The purpose of this research is to assess the
      usefulness of lung ultrasound imaging, performed by the patient in the home setting for the
      management of the COVID-19 disease using this novel highly-portable ultrasound.
    

Detailed description: 
      This will be a prospective self-controlled design. The study subjects will receive a
      telehealth visit from a healthcare provider (HCP) to assess for any change in their COVID-19
      symptoms. The HCP will recommend the patient remain at home, or to go to an emergency
      department based on standard of care and clinical decision making. Subsequently, the study
      subjects will receive a teleguidance session with a Radiologist who is trained in lung
      ultrasound (LUS) in order to obtain images of their chest. The physician performing LUS
      remotely will report LUS findings in a standard quality assurance (QA) document, including
      image quality, interpretation, and recommendations. This QA report will be study data and not
      shared with the patient. The two providers will be blinded, except when there is a
      disagreement between the Telemed LUS and clinical interview.

      The study staff will determine when this disagreement occurs. They will notify the study
      investigators and radiologist, who will then discuss and come to an agreement within 24
      hours. If deemed concerning, they will then contact the HCP and unblind them as to the
      radiographic findings. There will be no delay in medical care advised by the subject's HCP.

      Specifically, the nurse will inform the HCP by a phone call that the physician performing LUS
      remotely found a significant change in LUS findings. The HCP will then be given access to the
      LUS report (as well as images if desired), and will review the decision to seek medical care
      with the telemed doctor.
    

Intervention name(s): Device: Butterfly iQ
Intervention type(s): Device
Intervention description(s): The Butterfly iQ is an ultrasound system that enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients. It is a non-invasive device and does not impose any health hazards.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism
Condition: Calcium Metabolism Disorders
MeSH terms: Metabolic Diseases; Calcium Metabolism Disorders
Study type: Interventional

Summary: 
      This prospective, single-blind, matched controlled study aims to evaluate the effect of
      proton pump inhibitors on biochemical markers of calcium and bone metabolism in an effort to
      establish additional biological plausibility for the apparent association between proton pump
      inhibitors (PPIs) and osteoporosis-related fractures.

      Young males (age 18-45 years), who are either healthy volunteers, or who complain of daily or
      frequent heartburn but are otherwise healthy, will be recruited and enrolled in the study.
      Patients with heartburn will be assigned to the intervention group and will be assigned to
      take a PPI for three months. Healthy volunteers will be matched by age to patients in the
      intervention group and will act as the control group. 70 patients will be enrolled in total.
      Blood studies for all subjects will be taken at 0, 1 and 3 months to test for various
      biochemical markers of calcium and bone metabolism, which act as surrogate markers of calcium
      absorption and bone remodeling.

      Levels of biochemical markers in the two groups will be compared using two-way analysis of
      variance (ANOVA). Changes in biochemical parameters within a group will be assessed using
      repeated measures ANOVA.
    


Intervention name(s): Rabeprazole or Esomeprazole or Lanzoprazole
Intervention type(s): Drug
Intervention description(s): 1/3 of the patients are taking Pariet (Rabeprazole) 20 mg once daily 1/3 of the patients are taking Nexium (Esomeprazole) 40 mg once daily 1/3 of the patients are taking Lanzor (Lanzoprazole) 30 mg once daily
Intervention MeSH terms: Esomeprazole; Rabeprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Calcium; bone; metabolism; Proton Pump Inhibitors; Rabeprazole; Esomeprazole; Lanzoprazole; Vitamin D; bone and bones
Inhaled Fluticasone Furoate/Vilanterol Safety and Tolerability, PK and PD Study
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the safety and tolerability, pharmacokinetics, and
      pharmacodynamics of fluticasone furoate/vilanterol (FF/VI) 100/25mcg administered using the
      novel dry powder inhaler in children aged 5 to 11 years with persistent asthma.
    

Detailed description: 
      This study will investigate the safety and tolerability, pharmacokinetics, and
      pharmacodynamics of fluticasone furoate/vilanterol (FF/VI) 100/25mcg administered using the
      novel dry powder inhaler in children aged 5 to 11 years with persistent asthma. Fluticasone
      furoate (FF, GW685698) is a novel once daily inhaled corticosteroid (ICS) and vilanterol (VI,
      GW642444) is an inhaled once daily long-acting beta2 agonist (LABA). FF/VI is a novel
      ICS/LABA combination with once-daily dosing being developed for the treatment of asthma in
      adults, adolescents, and children of 5 years and above.

      This study will be a randomized, double-blind, repeat dose, two period crossover study, with
      FF as the control. During each of two treatment periods subjects will receive either FF/VI
      100/25 micrograms (mcg) or FF 100 mcg daily on 14 consecutive mornings via the novel dry
      powder inhaler. Approximately 26 subjects will be recruited into this study, with a target of
      20 completed subjects. Safety, tolerability, pharmacokinetics and glucose , potassium and
      cortisol levels will be investigated.
    

Intervention name(s): Fluticasone Furoate; Fluticasone Furoate/Vilanterol
Intervention type(s): Drug; Drug
Intervention description(s): 100mcg delivered via a novel dry powder inhaler on days 1-14 of one study treatment period.; 100/25 mcg delivered via a novel dry powder inhaler on days 1-14 of one study treatment period.
Other intervention name(s): FF; FF/VI
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: pediatric ages 5 to 11 years
Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI)
Condition: Major Depressive Disorder, Recurrent, Unspecified; Major Depressive Disorder, Single Episode, Unspecified
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of the study is to explore the Tolerability and Safety of the H-Coil deep
      Transcranial Magnetic Stimulation (TMS) in combination with Serotonin Selective Reuptake
      Inhibitor (SSRI) for Subjects with Major Depression Disorder (MDD) who Complete/ Discontinued
      the Deep TMS Multicenter study for Subjects with Major Depression Disorder (MDD) (Protocol#
      CTP-0001-00).
    


Intervention name(s): H-Coil Deep TMS in combination with SSRIs
Intervention type(s): Device
Intervention description(s): The study group will receive DTMS treatment three times a week for four weeks in combination with SSRI medications.
Other intervention name(s): H-Coil Deep TMS Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; MDD; SSRIs; TMS
A Study to Assess the Effect of Multiple Doses of AZD5718 on Pharmacokinetics of Oral Midazolam in Healthy Subjects
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      In clinical practice, AZD5718 will be co-administered with CYP3A substrates. Therefore, it is
      important to determine the impact of AZD5718 on the pharmacokinetics (PK) of CYP3A4
      substrates. The primary objective of this study is to evaluate the effect of AZD5718 on the
      PK of midazolam, a known sensitive CYP3A4 substrate.
    

Detailed description: 
      This is a Phase 1, fixed sequence, open-label study in healthy subjects, performed at a
      single study center. This study will consist of 3 treatment periods to assess the PK of
      midazolam when administered alone and in combination with multiple doses of AZD5718.

      The study will comprise:

        -  A screening period of maximum 28 days;

        -  Three treatment periods during which subjects will be resident from the day before first
           dosing (Day -1) until at least 24 hours after last dosing (Day 7); discharged on the
           morning of Day 8, and;

        -  A final Follow-up Visit within 5 to 7 days after the last administration of
           investigational medicinal product (IMP).
    

Intervention name(s): Midazolam; AZD5718
Intervention type(s): Drug; Drug
Intervention description(s): The subjects will receive single doses of midazolam solution 2 mg/mL orally on Day 1 alone in Treatment Period 1 and on Day 7 co-administered with oral AZD5718 tablet in Treatment Period 3.; The subjects will receive oral AZD5718 tablet once daily starting on Day 2 to Day 6 in Treatment Period 2 and on Day 7 co-administered with midazolam in Treatment Period 3.
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Intervention model description: Fixed sequence
Masking: None (Open Label)
Primary purpose: Other
Keywords: AZD5718, CYP3A4 substrate, Drug-drug Interaction, Fixed sequence, Midazolam, Open-label, Pharmacokinetics
Clinical Evaluation of Two Toric Contact Lenses in Current Non-toric Lens Users
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the clinical performance, defined as successful fit,
      of two toric contact lenses (one daily disposable and the other daily wear reusable contact
      lens to correct astigmatism) in current spherical soft contact lens wearers, contact lens
      drop-outs, and non-users of toric contact lenses (neophytes).
    


Intervention name(s): Senofilcon A Toric (AOfA); Etafilcon A Toric (1DAMfA)
Intervention type(s): Device; Device
Intervention description(s): Soft toric contact lenses for astigmatism; Soft toric contact lenses for astigmatism
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Re-directed T Cells for the Treatment (FAP)-Positive Malignant Pleural Mesothelioma
Condition: Malignant Pleural Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Study type: Interventional
Phase: Early Phase 1

Summary: 
      MPM patients are not eligible for surgical procedures like decortication or
      pleuro-pneumectomy and have a median survival of 12 months with palliative chemotherapy.
      Therefore, new therapeutic approaches are of crucial need in this clinical situation. This is
      a phase I trial for patients with malignant pleural mesothelioma with pleural effusion
      testing the safety of a fixed single dose of 1x10e6 adoptively transferred FAP-specific
      re-directed T cells given directly in the pleural effusion. Lymphocytes will be taken 21 days
      before transfer from peripheral blood. CD8 positive T cells will be isolated and
      re-programmed by retroviral transfer of a chimeric antigen receptor (CAR) recognizing FAP
      which serves as target structure in MPM.

        -  Trial with immunomodulatory product / biological
    

Detailed description: 
      This is a phase I trial for patients with malignant pleural mesothelioma. A fixed single dose
      of adoptively transferred FAP-specific CD8 positive re-directed T cells will be given in the
      pleural effusion.

      Three patients who are at the time point of screening not operable will be treated with
      re-directed T cells administered into the pleural effusion after completion of 3 cycles of
      palliative chemotherapy. In the case of one AE grade III/IV or one SAE - and the occurrence
      of DLT both judged to be treatment related by an independent safety monitoring board - the
      patient number will be expanded to 6 patients. The study will be stopped if one additional
      DLT occurs also judged to be treatment related.

      Patients will be treated with 1x10e6 re-directed FAP-specific T cells injected in the pleural
      effusion. The study ends 35 days after adoptive T cell transfer. Re-directed FAP-specific T
      cells will be administered at day 0 (day 14 of the third cycle of palliative chemotherapy).
      The study is designed to demonstrate safety of 1x10e6 re-directed FAP-specific T cells. The
      next patient will be enrolled earliest, when the previous patient completed day +14 and the
      safety monitoring board has not declared any DLTs. The palliative chemotherapy is not part of
      the study protocol.
    

Intervention name(s): Adoptive Transfer of re-directed T cells
Intervention type(s): Genetic
Intervention description(s): Adoptive Transfer of 10e6 re-directed T cells in the pleural effusion
Intervention model: Sequential Assignment
Intervention model description: Adoptive Transfer of re-directed FAP-specific T cells
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malignant pleural mesothelioma; re-directed T cells; FAP; fibroblast activation protein; CD8 positive T cells; pleural effusion
Oral Care and Gram-negative Pathogen in Children
Condition: Tracheal and Oropharyngeal Colonization by Gram-negative Pathogens
Study type: Interventional

Summary: 
      Critical care nursing interventions related to oral care can reduce the microorganisms in the
      oropharynx available for translocation to other sites. THis is a randomized, controlled and
      double blinded study performed in a pediatric intensive care unit (PICU) from a Brazilian
      university hospital which objectives were to analyze 0.12% chlorhexidine digluconate
      influence on Gram-negative pathogens colonization of oropharyngeal and tracheal secretions of
      mechanically ventilated children.
    


Intervention name(s): 0,12% digluconate chlorhexidine; toothbrushing
Intervention type(s): Other; Other
Intervention description(s): Oral care with 0.12% Chlorhexidine Digluconate and toothbrushing is realized twice a day and took about 10 minutes to complete, depending on the child's acceptance and clinical conditions.; Gel is applied on a toothbrush, and the teeth are cleaned in quadrants; all teeth surfaces are cleaned (vestibular, lingual, occlusal, and incisal). After each quadrant is cleaned, 10 mL of water (dispensed via a syringe) is used to rinse the quadrant and continual aspiration is used to remove all the gel and debris. After all the teeth are cleaned, the ventral surface of the tongue is brushed with posterior to anterior movements.
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: oral hygiene; ventilator-associated pneumonia; infection control; intensive care; pediatric nursing; pediatrics
A Social Network AOD Intervention for Homeless Youth Transitioning to Housing
Condition: Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This project will pilot test a computer-assisted social network intervention, using
      motivational interviewing techniques, that can help case managers work with formerly homeless
      young adults who recently transitioned to supportive housing to reduce substance use and
      increase permanent supportive connections during this critical transitional period.
    


Intervention name(s): Motivational Network Intervention; Usual Care
Intervention type(s): Behavioral; Other
Intervention description(s): See earlier description; See earlier description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention