bioihbjkbjnl/mcl2 huggingface dataset:
Infantile Hemangioma With Minimal or Arrested Growth : Epidemiology, Clinical Characteristics and Evolution
Condition: Hemangioma, Capillary
MeSH terms: Hemangioma; Hemangioma, Capillary; Port-Wine Stain
Study type: Observational

Summary: 
      Infantile hemangioma (IH) is the most common vascular tumor of infancy, characterized by its
      clinical history. Absent at birth or present under the form of a premonitory mark, they
      display a rapid proliferative phase starting in the first weeks of life. Then, after a
      plateau phase, they slowly involute. However, a subtype of IH named "abortive", "minimal or
      arrested growth", "reticular" or "telangiectatic" hemangioma differs from typical IH because
      it doesn't have a proliferative component, or only a minimal one. This subtype of hemangioma
      has been recently described and data are lacking regarding its proportion among infantile
      hemangioma and its differences with "classic" infantile hemangioma. The aim of this study is
      to estimate the proportion of abortive hemangioma among infantile hemangioma. Also, the
      investigators aim to compare the clinical characteristics of "classic" infantile hemangiomas
      and abortive hemangiomas. Lastly, investigators wished to study the evolution of abortive
      hemangioma.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        - Children between 0 and 18 years old followed in the dermatology department of CHRU de
        Nancy between January 2014 and December 2020 presenting with one or more infantile
        hemangioma
Drug Resistance Factors In Healthcare-associated Pneumonia
Condition: Pneumonia; Critical Illness
MeSH terms: Pneumonia; Healthcare-Associated Pneumonia; Critical Illness
Study type: Observational

Summary: 
      Recently clinical guidelines categorize pneumonia in to three types: community,
      healthcare-associated, and hospital-acquired. Much of the existing research to describe the
      epidemiology of pneumonia in critically ill patients comes from single-center studies or from
      retrospective database analyses, which limit generalizability and lead to over-prescription
      of broad-spectrum antibacterial agents. This will be a prospective, multicenter
      epidemiological study to characterize pneumonia epidemiology in critically ill adult
      patients.
    

Detailed description: 
      Pneumonia is one of the leading causes of death in the United States and is associated with
      significant costs to the healthcare system. Recent treatment guidelines describe a new
      subtype of pneumonia, healthcare-associated pneumonia (HCAP), to identify those patients who
      present to a hospital from the community and are thought to be at greater risk for developing
      pneumonia due to multidrug resistant organisms (MDRO).

      The HCAP categorization scheme is intended to improve the prescription of initial appropriate
      empiric antibacterial agents and minimize the morbidity and mortality associated with
      inappropriate empiric selection.However, one of the chief criticisms of the guideline
      recommendations is that the criteria used to define HCAP is overly broad, which may result in
      greater use of broad-spectrum antibiotics.

      The prevailing notion is that many patients in the community will be at the lowest risk for
      experiencing MDR pneumonia and can be treated with a less broad anti-infective regimen.
      Patients with increasing exposure to the healthcare system will receive initial
      anti-infective therapy that is more broad in an effort to target MDROs. The investigator
      group believes that it is not simply exposure to the healthcare system that predicts the
      incidence of MDR pneumonia (i.e., criteria for HCAP), but rather, the "intensity" of exposure
      to the healthcare system that is predictive of MDR pneumonia. The aim of this study is to
      identify risk factors for MDR HCAP pneumonia in critically ill patients. .
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients admitted to an intensive care unit requiring anti-infective therapy for the
        traetment of pneumonia.
Assessment of Carotid Artery Stenosis and Lower Limb Peripheral Ischemia Prior to CABG
Condition: Carotid Artery Diseases; Peripheral Artery Disease
MeSH terms: Carotid Stenosis; Carotid Artery Diseases; Peripheral Arterial Disease; Ischemia
Study type: Interventional

Summary: 
      From our experience among Egyptian population in our institution, there is an increased
      prevalence of hidden subclinical peripheral artery disease along with carotid artery
      affection. Thus, increasing the risk of post-operative morbid complications.We aim to
      evaluate routine/ non-selective carotid and peripheral arterial screening in asymptomatic
      patients undergoing coronary artery bypass grafting in the Egyptian populationIt is a
      prospective, non-randomized, comparative study including two groups of patients. The study
      will start from the day of approval of the ethical committee. It will include 260 patients,
      on basis of "all new comers". Patients will be examined and classified as "high-risk" group
      (ɳ = 130) or "low-risk" group (ɳ=130).

      All patients will have the "routine" preoperative investigations along with evaluation of
      extracranial carotid system by non-invasive carotid duplex and lower limb arterial system by
      non-invasive bilateral lower limb arterial duplex.
    


Intervention name(s): carotid duplex, both LL arterial duplex
Intervention type(s): Diagnostic Test
Intervention description(s): assessment of carotid stenosis and lower limb peripheral ischemia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: carotid; peripheral arterial disease; endarterectomy
Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines
Condition: Meningitis; Meningococcal Disease
MeSH terms: Meningococcal Infections; Meningitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This aim of the study is to assess post-marketing safety of a single dose of Menactra®
      vaccine with the intent to support conversion from monitored release to initial registration
      of Menactra® vaccine in the Philippines.

      Primary Objective:

      To describe the serious adverse events occurring within 30 days among participants who have
      received one dose of Menactra® vaccine.
    

Detailed description: 
      Each study participant will receive one dose of Menactra® vaccine and will be monitored for
      safety for 30 days post-vaccination.
    

Intervention name(s): Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Menactra®; Menactra®; Menactra®
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcal disease; Menactra®
Pharmacokinetics (PK) of 20 mg Teduglutide in Participants With Moderately Impaired Hepatic Function Compared to Healthy Participants
Condition: Hepatic Impairment
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to compare the pharmacokinetic profile of teduglutide in healthy participants
      with normal hepatic function with participants who have moderate hepatic impairment.
    

Detailed description: 
      24 participants (equally divided between participants with normal hepatic function and those
      with moderate hepatic impairment (defined by the protocol as a Child-Pugh classification of
      grade B score of 7-9)will be given a single injection of teduglutide (20mg) through
      subcutaneous injection into the abdomen. Blood samples would be taken within 30 minutes of
      dose through 24 hours post-dose. Participants in both groups are matched up by sex, age, BMI,
      and renal function.
    

Intervention name(s): Teduglutide
Intervention type(s): Drug
Intervention description(s): Participants will receive 20 mg dose of lypholized powder of teduglutide mixed with sterile water and injected subcutaneously into the abdomen.
Other intervention name(s): GATTEX
Intervention MeSH terms: Teduglutide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Extraction of Stromal Vascular Fraction and Stem Cells From Fat Tissue
Condition: Soft Tissue Mass Removal
Study type: Interventional

Summary: 
      Human Adipose Tissue is considered as a new source for Stromal Stem Cells and offers a large
      therapeutic potential for many rare and common diseases that impacts millions of patients
      worldwide. The Stromal Vascular Fraction (SVF) of Adipose Tissue is relatively easy to
      extract with minimally invasive procedures such as elective liposuction in large quantities
      and therefore may be a cost effective source for cellular therapies in a wide range of
      medical specialties. In this study we aim to demonstrate the efficacy of Antria Cell
      Preparation Process© in obtaining human adipose derived Stromal Vascular Fraction (SVF) by
      performing histology, various cell counts, multiple surface marker tests and measurement of
      the residual amount of digestive enzymes as a safety measure for human clinical trials.
    


Intervention name(s): Liposuction
Intervention type(s): Procedure
Intervention description(s): Elective Liposuction
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Stem; Cell; Antria; Adipose; Stromal; Vascular; Fraction; Shahram; Shah; Rahimian
The Optimal Timing of Carbon Dioxide Insufflation During Colonoscopy in Unsedated Patients
Condition: Outpatients
Study type: Interventional

Summary: 
      Insufflation of carbon dioxide (CO2) instead of air can reduce pain resulting from colon
      distension after colonoscopy because CO2 is rapidly absorbed from the colon and excreted
      through the lungs. This reduces the effects of colonic distension and minimizes intracolonic
      gas at the end of the examination. The aims of the study were to evaluate the timing of
      administering CO2 insufflation and to identify predictors of discomfort for colonoscopy.
    


Intervention name(s): Insufflation with CO2
Intervention type(s): Procedure
Intervention description(s): Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.
Other intervention name(s): the Olympus UCR Endoscopic CO2 Regulation Unit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057)
Condition: Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      Male volunteers receive a new hormonal contraceptive consisting of an implant releasing a
      hormone and hormone injections in order to investigate the suppressive effect on sperm
      production and reversibility of sperm production after end of treatment.
    


Intervention name(s): etonogestrel with testosterone undecanoate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 42 or 44 weeks with etonogestrel implant and testosterone undecanoate injections every 10 to 12 weeks; 42 or 44 weeks with placebo implant and placebo injections
Intervention MeSH terms: Methyltestosterone; Etonogestrel; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Chest CT for the Placement of the Uniblocker
Condition: Therapeutic Procedural Complication
Study type: Interventional

Summary: 
      Video laryngoscope and chest CT iminge for the placement of the Uniblocker
    

Detailed description: 
      Comparing the traditional method of Uniblocker intubation and video laryngoscope combined
      with chest CT iminge guide the precise localization of Uniblocker
    

Intervention name(s): video laryngoscope and chest CT iminge; Conventional intubation of uniblocker
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Clown Care for Botulinum Toxin (BTX)
Condition: Cerebral Palsy; Pain
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Children with cerebral palsy (CP) undergo multiple painful procedures such as Botulinum toxin
      (BTX) injections that are administered several times a year. While clown care reduces
      preoperative anxiety, its effect on painful procedures has not been assessed. We hypothesized
      that medical clowning reduces pain and anxiety during BTX injections.
    

Detailed description: 
      PATIENTS AND METHODS: Twenty five children with CP (mean age 7.4±4.8 years; 19 boys),
      enrolled in this randomized controlled study underwent BTX injections (3±1.7 muscles per
      procedure). Prior to treatment each child was assigned to receive either medical clown
      intervention (study) or standard care (control). Outcome measure was the Visual Analogue
      Scale (VAS) as reported by the child (n =14) or parent (n =11) prior and subsequent to each
      procedure.
    

Intervention name(s): standard; clown care
Intervention type(s): Other; Behavioral
Intervention description(s): Preparation and information regarding the BTX procedure: placing EMG electrodes, wiping the area with an alcohol swab, cooling with ethyl chloride, needle insertion into the muscle and the importance of EMG noise.
Injection performed under EMG guidance. Two sites of injection per muscle were used to enhance diffusion. The child could often see the procedure when the upper limb was treated but not during lower limb injections.
Memory change and positive reinforcement: Following the BTX injection, the medical staff present spoke to the child positively and offered prizes Volunteer attendance: In the daycare unit there are young volunteers routinely present, assisting with technical aspects of the procedure.; Cognitive coping Imagery Empowerment Reflecting emotions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Needle, Anxiety, Pain, Clowns
Pharmacokinetics of Two Fatty Acid Ketone Esters
Condition: Pharmacokinetics
Study type: Interventional

Summary: 
      Randomized, cross over pharmacokinetic study of a novel ketone di-ester and C6 ketone
      di-ester in ready to drink beverage matrices.
    

Detailed description: 
      Recruiting 12 healthy adults to participate in a pharmacokinetic (PK) study of a novel ketone
      di-ester and C6 ketone di-ester in ready to drink beverage matrices. Following randomization,
      subjects will participate in three full days of PK sample collection. Blood samples will be
      collected for 8 hours following test product consumption on all PK days.
    

Intervention name(s): C6 ketone di-ester; Novel ketone di-ester
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): C6 ketone di-ester; Novel ketone di-ester
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Three way crossover in a random order
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Physical Training Program in Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional

Summary: 
      Purpose: to assess the efficacy of a physical training program in patients with ankylosing
      spondylitis (AS) in a randomized controlled study
    

Detailed description: 
      AS is a chronic inflammatory rheumatic disorder affecting spine, peripheral joints and
      entheses. Patients undergo pain, stiffness and reduced mobility of spine and joints. Patients
      experience limitations in physical activities and reduced quality of life. Some uncontrolled
      studies reported benefits of physical activity in patients with AS.

      The aim of the present study is to assess the efficacy of a physical training program in
      patients with AS.

      Patients will be randomized in two parallel arms: program of personalized physical training
      (intervention group [PEPc]) or program of information about physical activity (control group
      [PIAP]).

      Patients will be evaluated at 12 and 24 weeks on activity, functional and metrological scores
      (ASAS 20, ASAS 5/6, ASDAS, BASDAI, BASFI, BASMI); biological inflammation (CRP); NSAID use
      and pain VAS.

      Primary outcome: percentage of patients reaching an ASAS 20 response at 12 weeks.

      Secondary outcomes: ASAS 20 at 24 weeks, ASAS5/6, ASDAS, BASDAI, BASFI, BASMI, CRP, NSAID use
      and pain VAS at 12 and 24 weeks.

      Statistical analysis: comparison of the percentage of patients reaching an ASAS 20 response
      at 12 weeks in each arm using a Fisher's exact test (main outcome).
    

Intervention name(s): Personalized physical training program
Intervention type(s): Other
Intervention description(s): 9-week personalized physical training program (ergometric bicycle)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ankylosing spondylitis; Physical training program
Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered to Healthy Human Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as
      multiple daily doses at various dose levels.
    


Intervention name(s): BIRB 796 BS, low dose; BIRB 796 BS, high dose; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated and Taken up by the Body With or Without Food
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of the single rising doses (SRD) trial part are to investigate safety,
      tolerability and pharmacokinetics (PK) of BI 1819479 in healthy male subjects following
      administration of single rising doses.

      The main objective of the food effect part is to investigate the influence of food on the
      relative bioavailability of BI 1819479.
    


Intervention name(s): BI 1819479; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 1819479; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single rising dose part is single-blind, randomized, placebo-controlled within parallel dose groups.
food effect part is randomized, open-label, two-way, two-period, crossover design.
Masking: Single (Participant)
Primary purpose: Treatment
A Trial of Ligation Plus Nadolol Versus Nadolol Alone in the Prophylaxis of First Variceal Bleeding in Cirrhosis
Condition: Variceal Bleeding; Cirrhosis
MeSH terms: Liver Cirrhosis; Hemorrhage; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The value of banding ligation plus beta blocker in the prophylaxis of first episodes of
      variceal bleeding has not yet been evaluated. This study was conducted to compare the
      efficacy and safety of banding ligation plus nadolol versus nadolol in the prophylaxis of
      first bleeding in cirrhotic patients with high-risk esophageal varices.
    

Detailed description: 
      Currently, endoscopic variceal ligation (EVL) has replaced EIS as the endoscopic treatment of
      choice for management of bleeding esophageal varices. The advantages of EVL include requiring
      fewer treatment sessions to achieve variceal obliteration, lower rebleeding rates and fewer
      complications (5-9). Controlled studies that compared EVL with beta-blocker in the prevention
      of first variceal bleeding suggested that EVL was at least equal to beta-blockers in the
      prophylaxis of first variceal bleeding. However, portal pressure may be elevated after
      repeated EVL. Hence the combination of nadolol and EVL is a reasonable approach to prevent
      the first episode of variceal bleeding.
    

Intervention name(s): Ligation of varices; Nadolol
Intervention type(s): Procedure; Drug
Intervention description(s): all varices are ligated until obliteration; Nadolol (beta-blocker)
Intervention MeSH terms: Nadolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prophylaxis; ligation; beta blockers; First bleeding rate