bioihbjkbjnl/mcl2 huggingface dataset:
Cardiac SPECT With Rotating Slant Hole Collimator
Condition: Coronary Artery Diseases; Chest Pain
MeSH terms: Coronary Artery Disease; Chest Pain
Study type: Observational

Summary: 
      The goal is to conduct a clinical pilot study to evaluate the use of a rotating multi-segment
      slant-hole collimator in the detection of myocardial defects.
    

Detailed description: 
      Myocardial perfusion SPECT is recognized as an effective clinical diagnostic imaging
      technique in the assessment of myocardial perfusion and coronary artery diseases. It is the
      most important clinical application of SPECT imaging techniques.

      The goal is to conduct a clinical pilot study to evaluate the use of rotating multi-segment
      slant-hole (RMSSH) SPECT in the detection of myocardial defects especially in very sick
      patients in the nuclear medicine clinics, emergence room, and intensive care units.
      Comparison of the clinical utilities of the cardiac RMSSH SPECT technique with conventional
      cardiac planar and SPECT with parallel-hole collimation will also allow us to evaluate the
      potential application of the technique to a wider patient population.

      The objective of this study is to test the hypothesis that quantitative 99mTc myocardial
      perfusion RMSSH SPECT provides similar diagnostic accuracy in patients with cardiac diseases
      as conventional SPECT imaging techniques.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Males and Females 18-80 who are scheduled for a clinical Cardiac Stress Test
      
Keywords: Myocardial Perfusion SPECT
Video Gaming Improves Robotic Surgery Simulator Success
Condition: Robotic Surgery; Simulator
Study type: Observational

Summary: 
      Investigators aimed to investigate the effects of video game habits, duration of experience,
      and training in different surgical clinics on the success of robotic surgery simulators.

      In this prospective, observational, comparative, and multi-clinic study, all participants
      played the Temple Run and Piano Tiles 2™ mobile games for one month after responding to a
      questionnaire including their sociodemographic characteristics, surgical experience, and past
      and current video game experience. At the end of the study period, participants experienced
      four different robotic surgery simulator tasks (Camera Targeting 1, Energy Switching 1, Ring
      & Rail 2, Vertical Defect Suturing) in the da Vinci® Skills Simulator™. Additionally,
      sociodemographic data were statistically analyzed with mobile game scores, and 13 different
      performance scores were obtained from the simulator.
    


Intervention name(s): Video game & Robotic surgery simulator success
Intervention type(s): Other
Intervention description(s): A questionnaire was administered to all participants, asking about their demographic information, surgical experience, hobbies, and previous video game playing experiences.
After the questionnaire, the participants were asked to play the Temple Run (Imangi Studios, NC, USA) and Piano Tiles 2™ mobile games for one month. At the end of the period, with the da Vinci® Skills Simulator™ for one hour, all participants performed four different robotic surgery simulator tasks (Camera Targeting 1, Energy Switching 1, Ring & Rail 2, Vertical Defect Suturing) that require the ability to apply basic robotic surgery rules and measure surgical skills.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Residents from general surgery, urology, and pediatric surgery clinics were included in the
        study. Sixty of the 64 total participants completed all the processes. Four participants
        were excluded from the study.
      
Keywords: robotic surgery; simulation-based learning; video game experience; surgical education
Clinical Trial to Assess Efficacy, Safety and Tolerability of Botulinum Toxin A (Xeomin®) in Treatment of Expression Wrinkles in the Upper Third of the Face
Condition: Skin Aging
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determinate whether Xeomin® (Botulinum toxin Type A) is safe,
      effective and tolerable in woman aged 30 to 50 years old for treatment of mild, moderate or
      severe expression lines (wrinkles) in the upper third of the face. The main outcome was the
      change in appearance of the wrinkles two weeks (visit 3) after product application as
      compared with baseline assessment.
    

Detailed description: 
      Ageing is a dynamic and unchangeable process involving all individuals and affecting the
      several organic systems. This process is expressed through multiple symptoms and signs, the
      wrinkles and flaccidity being the most common and visible ones.

      In both developed and emerging countries, the interest in skin ageing is, to a greater
      extent, the result of the progressive increase in the absolute number and the proportion of
      people experiencing the ageing process in the last century. The psychosocial, as well as the
      physiological effects of the skin ageing raised a huge demand for a better understanding of
      this process and, in particular, of the effective interventions.

      The use of the botulinum toxin type-A (BTX/A) for aesthetic indication emerged as a result of
      the clinical observation of those patients treated for facial different dystonia and who
      presented additional improvement of their expression lines.

      The expression lines are most easily noted on the upper third of the face, where surgical
      treatments are fully invasive and show lesser noticeable results. The upper third of the face
      was targeted for BTX/A treatment and reported in several scientific literature articles as
      well succeeded.
    

Intervention name(s): Botulinum Toxin A
Intervention type(s): Biological
Intervention description(s): 100 U DL50 lyophilized powder for reconstitution in 1 ml Saline Solution 0.9%.
Other intervention name(s): Xeomin®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Botulinum Toxin A; Wrinkles
Eltrombopag Taste Testing in Healthy Adult Volunteers
Condition: Healthy Subjects; Purpura, Thrombocytopenic, Idiopathic
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 1

Summary: 
      Based on a need for a pediatric formulation of eltrombopag for the treatment of pediatric
      thrombocytopenia, this study will help determine the best tasting pediatric formulation of
      eltrombopag. Healthy adult volunteers who are able to taste bitterness and who do not have a
      high sensitivity to bitterness will be enrolled. The subjects will evaluate different
      formulations and rate them based on the bitterness and effectiveness of sweetners. The
      outcome of this study will help support a decision for a new pediatric formulation of
      eltrombopag.
    


Intervention name(s): eltrombopag
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: healthy adult volunteers; eltrombopag
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A
      compared with vedolizumab and with placebo in the treatment of participants with moderate to
      severe UC. This study will consist of two parts, Part A and Part B. Part A will test the
      induction of clinical remission and Part B will test the durability of clinical remission.
    


Intervention name(s): UTTR1147A; UTTR1147A Placebo; Vedolizumab; Vedolizumab Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.; The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.; Vedolizumab will be administered IV, as specified in the prescribing information.; The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.
Other intervention name(s): Efmarodocokin alfa; RO7021610; RG7880; IL-22Fc; Entyvio
Intervention MeSH terms: Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study in Healthy People to Test Whether BI 730357 Influences the Amount of Caffeine, Warfarin, Omeprazole, and Midazolam in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial will be performed to assess the influence of BI 730357 on the pharmacokinetics of
      caffeine, warfarin, omeprazole and midazolam.
    


Intervention name(s): Percoffedrinol®; Coumadin®; Antra MUPS®; Midazolam-ratiopharm®; BI 730357
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet; Tablet; Gastro-resistant tablet; Oral solution; Film-coated tablet
Other intervention name(s): Caffeine; Warfarin sodium; Omeprazole; Midazolam
Intervention MeSH terms: Midazolam; Caffeine; Omeprazole; Warfarin
Intervention model: Single Group Assignment
Intervention model description: Two Periods (Period 1 and Period 2) for each participant.
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC "BIOCAD") With Methotrexate in First Line Biological Therapy of Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The mail goal of this study is to establish superiority in efficacy of Acellbia® applied in a
      dose of 600 mg (Day 1 and Day 15) in combination with methotrexate in patients with active RA
      seropositive previously untreated with biological therapy, compared to standard therapy with
      methotrexate.
    


Intervention name(s): Acellbia; Placebo; Methotrexate
Intervention type(s): Biological; Drug; Drug
Intervention description(s): Acellbia is rituximab biosimilar, monoclonal antibody which binds CD20.; Placebo solution will look identical to the Acellbia solution.
Other intervention name(s): rituximab
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: rheumatoid arthritis; rheumatism; Acellbia; methotrexate; biologic therapy; monoclonal antibody; rituximab
Pharmacological Intervention in Diabetic Retinopathy
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional

Summary: 
      The purpose of this study is to determine if diabetic retinopathy can be treated with
      prostaglandin analogues, prostaglandin synthesis inhibitors or carbonic anhydrases
      inhibitors.
    

Detailed description: 
      Disturbances in retinal perfusion is believed to be involved in the pathophysiology of
      diabetic retinopathy. These disturbances may be due to changes in the basal diameter of
      retinal arterioles and to disturbances in the autoregulation of the diameter of these vessels
      when the blood pressure and the retinal metabolism changes. In vitro studies have shown that
      prostaglandins and carbonic anhydrases inhibitors are involved in the tone regulation of
      retinal arterioles, but it is unknown whether this finding is relevant in clinical practice.
      This can be tested in vivo by an retinal vessel analyzer measuring the dynamics of the
      retinal vessel diameter changes.
    

Intervention name(s): Latanoprost, diclofenac and dorzolamide (eyedrops); Diclofenac; Dorzolamide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 eyedrop twice daily in one week; dicolfenac eyedrops twice daily i one eye; dorzolamide eyedrops twice daily, in one eye for one week
Other intervention name(s): Xalatan; Voltaren ophtha; Trusopt; Voltaren ophtha; Trusopt eyedrops
Intervention MeSH terms: Diclofenac; Dorzolamide; Latanoprost; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
The Effect of Cognitive Group Exercise Combined With Physical Exercise in MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The aim of this study is to investigate the effect of cognitive rehabilitation in group with
      physical exercise in patients with Multiple Sclerosis. We assume that cognitive therapy is an
      effective treatment for multiple sclerosis.
    

Detailed description: 
      The aim of this study is to investigate the effect of cognitive rehabilitation in group with
      physical exercise in patients with Multiple Sclerosis.
    

Intervention name(s): Cognitive exercise; Home exercise
Intervention type(s): Other; Other
Intervention description(s): Cognitive exercise will be applied; Home exercise will be applied
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with definitive Multiple Sclerosis between 20-65 years, with an Mini
        Mental State Test score less than 24, with an Extended Disability Status Scale score less
        than 4, trained for at least 5 years, have not received steroid therapy in the last 1 month
Investigation of the Relationship Between Internet Gaming Disorder and Sensorimotor Functions in Adolescents
Condition: Internet Gaming Disorder
MeSH terms: Internet Addiction Disorder
Study type: Observational

Summary: 
      Using computer for long have been shown to cause vision problems, musculoskeletal pain
      particularly in neck, postural deviations, obesity and physical inactivity in several
      studies. The relation between obesity and physical activity, neck pain and postural
      deviations with altered sensorimotor function has been also shown with many studies. However,
      there were not enough study that assess sensorimotor congruence such as proprioception and
      reaction time in adolescents diagnosed with Internet Gaming Disorder (IGD). This study aimed
      to evaluate the proprioception and reaction time and investigate its relation with the
      relationship with neck pain, proprioception and reaction time in adolescents with IGD.
    

Detailed description: 
      The aim of this study is to evaluate reaction time, motor dexterity, cervical posture and
      proprioception and its relationship with Internet Gaming Disorder (IGD) in adolescents. It's
      anticipated that 60 adolescents aged between 10-18 years will be included to this study (30
      healthy adolescent; 30 adolescent with IGD. After recording sociodemografic data of
      participants, age of starting to use the internet, the age of starting to play games on the
      internet, the time spent on the internet, the name and type of the game played will be
      questioned. The presence of musculoskeletal pain and its localization, if any, will be
      recorded. The severity of internet addiction will be assessed with Internet Addiction Scale,
      motor dexterity will be assessed with The 9 Hole Peg Test, reaction time of upper extremity
      will be assessed with Ruler Drop Method, the severity of forward head posture will be
      assessed with Cervical Range of Motion (CROM) device, and lastly, proprioception of cervical
      region will be assessed with Joint Position Error which will be evaluated CROM device. All
      parameters will be compared between healthy adolescents and adolescents with IGD.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This study will include 60 male adolescents diagnosed with Internet Gaming Disorder by the
        psychiatrist in Basaksehir Cam and Sakura City Hospital Child and Adolescent Psychiatry,
        Istanbul. The individuals who volunteers and meets the inclusion criteria will be included
        in the study.
      
Keywords: internet gaming disorder; fine motor skills; adolescent; sensorimotor function
Investigating the Influence of Semaglutide on the Pharmacokinetics of Single Doses of Atorvastatin and Digoxin in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is conducted in Europe. The aim of the trial is to investigate the influence of
      semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of single
      doses of atorvastatin and digoxin in healthy subjects.
    


Intervention name(s): semaglutide; digoxin; atorvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered as a subcutaneous injection (s.c., under the skin). Initiated with weekly semaglutide dosing of 0.25 mg in the first 4 weeks, 0.5 mg the next 4 weeks, and 1.0 mg in the third 4 week period.; Oral administration. Digoxin will be given as 2 single doses of 0.5 mg.; Oral administration. Atorvastatin will be given as 2 single doses of 40 mg.
Intervention MeSH terms: Digoxin; Atorvastatin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis
Condition: Pouchitis; Ulcerative Colitis
MeSH terms: Pouchitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of our study is to investigate the efficacy and safety of fecal microbiota
      transplantation (FMT) in the treatment of antibiotic dependent chronic pouchitis. This is a
      double-blinded randomized placebo controlled study. 13 patients receive a fecal
      transplantation from the healthy tested donor and 13 patients in the control group receive
      their own feces.
    

Detailed description: 
      Pouchitis is the most common long term complication among patients with ulcerative colitis
      who have undergone restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA). The
      etiology of pouchitis remains unclear. There is significant clinical evidence implicating
      bacteria in the pathogenesis. It has been shown that fecal microbiota transplantation (FMT)
      is an effective treatment for recurrent Clostridium difficile -infection. Case reports have
      also shown promising results of FMT in patients with inflammatory bowel disease. Currently
      there is no established effective treatment for chronic antibiotic dependent or refractory
      pouchitis. The aim of our study is to investigate the efficacy and safety of fecal
      transplantation in the treatment of chronic pouchitis instead of antibiotic therapy. Another
      aim is to evaluate phylogenetic analysis of the fecal microbiota trying to find
      microorganisms contributing to good results in fecal transplantation in IPAA patients.

      Patients receive FMTs on weeks 0 and 4. Antibiotic treatment has been stopped 36 hours before
      the first FMT.
    

Intervention name(s): Fecal microbiota transplantation; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.; Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: FMT
Comparison of Three Corneal Horizontal Marking Techniques Using iTrace™
Condition: Corneal Horizontal Marking.
Study type: Observational

Summary: 
      Before astigmatism reducing surgery, accurate corneal horizontal marking before surgery is
      important. Due to new corneal topographic method, iTrace™ surgical workstation, precise
      evaluation of corneal horizontal marking is available. In this study the investigators
      compared three known corneal horizontal making techniques and evaluate accuracy of each
      methods using iTrace™.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Who visited professor Tae Im Kim's clinic, department of ophthalmology, Severance hospital.
      
Keywords: Toric marking, Corneal horizontal marking
Clinical and Economic Outcomes of Ceftaroline Fosamil for ABSSSI Documented or at Risk of MRSA
Condition: Skin Diseases, Infectious; Staphylococcal Skin Infections
MeSH terms: Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Staphylococcal Skin Infections; Skin Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The proposed study is a prospective, open-label, randomized, multi-center trial of
      ceftaroline versus vancomycin for the treatment of ABSSSI in patients documented or at risk
      for MRSA. Patients admitted to the Detroit Medical Center, Henry Ford Hospital, or St. John
      Medical Center in Detroit Michigan with a documented ABSSSI between April 2012 and November
      2015 will be evaluated for inclusion. Patients must present with at least 3 of the following
      local signs/symptoms: pain, tenderness, swelling erythema, warmth, drainage/discharge,
      induration, and lymph node swelling/tenderness. Patients will be randomized 1:1 ceftaroline
      or vancomycin with optional anaerobic and/or Gram-negative coverage. The assignment of study
      drug will follow a randomized list that was previously generated via a computerized random
      mix block generator (nQuery Advisor® 7.0) and available at each of the study sites. Patients
      will be randomized to ceftaroline intravenously at 600 mg infused over 1 hour every 12 hours
      for patients with normal renal function. Patients randomized to vancomycin will receive the
      standard 15 mg/kg dose based on total body weight infused over 1 hour q 12 hour, dose and
      interval adjusted based on creatinine clearance and via institution-specific pharmacy
      protocol to target serum trough concentrations of 10-20 mg/L within the first 72 hours.
      Outcomes measured in the Clinically Evaluable patient population include day two or three
      size reduction (percentage) and clinical response at end of therapy or discharge.
    


Intervention name(s): Ceftaroline; Vancomycin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vancomycin; Ceftaroline fosamil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ceftaroline fosamil; Vancomycin; Acute bacterial skin and skin structure infections; Methicillin-resistant S. aureus