bioihbjkbjnl/mcl2 huggingface dataset:
, "Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"
Condition: Epistaxis
MeSH terms: Epistaxis
Study type: Interventional

Summary: 
      Comparison is made between standard nasotracheal tubes and a specially designed nasotracheal
      tube during nasotracheal intubation in children undergoing general anesthesia for dental
      surgery.
    

Detailed description: 
      The Parker flex-tip, midline-beveled nasotracheal tube theoretically slides past obstruction
      in the nasopharynx causing less mucosal damage than standard nasotracheal tubes.

      The investigators aim to test whether mucosal injury during nasotracheal intubation in
      children undergoing general anesthesia for dental procedures can thus be minimized taking
      into consideration adenoid size, and differences in nasopharyngeal diameter.
    

Intervention name(s): Parker flex-tip nasotracheal tube; Standard nasotracheal tube
Intervention type(s): Device; Device
Intervention description(s): specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size; standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Nasotracheal intubation; adenoid size; epistaxis; nasopharyngeal mucosal injury
Bioequivalence Study of Ivermectin From Revemact 6 mg Tablets (Man. by EVA Pharma for Horus for Pharmaceutical Industries, Egypt) and Stromectol 2*3 mg Tablets (Merck Sharp & Dohme B.V., Haarlem, The Netherlands)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, three-way, three-sequence, two treatment, partial
      replicate, crossover, open-label study to determine the bioequivalence of Ivermectin from
      Revemact 6 mg tablets (Man. by EVA Pharma for Horus for Pharmaceutical Industries, Egypt) and
      Stromectol 2*3 mg tablets (Merck Sharp & Dohme B.V., Haarlem, The Netherlands) after a single
      oral dose administration of each to healthy adults under fasting conditions.
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for
      untransformed data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax,
      AUC0→t and AUC0→∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Revemact; Stromectol (first dose); Stromectol (second dose)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet contains 6 mg Ivermecin; 2 tablet contain 6 mg Ivermecin; 2 tablet contain 6 mg Ivermecin
Other intervention name(s): Stromectol; Stromectol; Stromectol
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Phase 2a Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the
      Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in
      Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity
    

Detailed description: 
      TOP1288, the first in a new class of agents called narrow spectrum protein kinase inhibitors
      (NSKIs), is being developed as a novel, non-absorbed treatment for ulcerative colitis (UC).
      UC is a disease of unknown cause characterised by inflammation of the lining of the large
      intestine and manifesting with abdominal pain and bloody diarrhoea. TOP1288 given rectally
      has a local anti-inflammatory action in experimental models of UC.

      A Phase I placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD)
      study of TOP1288 conducted in 61 healthy volunteers demonstrated that rectal administration
      of TOP1288 at doses up to 200 mg BID for 4 days was safe and well tolerated, with minimal
      systemic absorption. TOP1288 200 mg, administered once daily, therefore offers the potential
      for a safe and effective novel approach to treating patients with this serious condition.

      This Phase 2a proof-of-concept study will evaluate the 200 mg daily dose of TOP1288, based on
      its favourable tolerability in the Phase 1 study. It will be administered as TOP1288 200 mg
      Rectal Solution compared against Placebo Rectal Solution, which contains all non-active
      excipients present in the active solution. This is a randomised, double-blind,
      placebo-controlled multicentre study designed to evaluate the safety/tolerability and
      efficacy of TOP1288 200 mg Rectal Solution following once-daily bedtime treatment for 4
      consecutive weeks. The study will include approximately 40 sites in Europe. Randomization to
      study treatment will be 2:1, with approximately 40 subjects randomised to TOP1288 and
      approximately 20 subjects randomised to placebo.

      The Screening period will be up to 28 days prior to the first day of dosing with double-blind
      study treatment (Visit 1). A central reading facility will be used to determine eligibility
      based upon the Screening flexible sigmoidoscopy.

      Visit 2 is scheduled for Day 7 of dosing, and Visit 3 for Day 29 of dosing. There will be a
      1-week safety follow-up period after Visit 3. The total duration of study participation for a
      given subject will be up to ~65 days or 9 weeks
    

Intervention name(s): TOP1288; Placebo (for TOP1288)
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Satiety Response After Mixed Fiber Doses
Condition: Satiety
Study type: Interventional

Summary: 
      People who eat more dietary fiber have a lower body weight than people who eat less fiber.
      Potential mechanisms include greater feelings of satiety, reductions in food intake, changes
      in blood glucose, insulin, or gut hormones.

      The investigators hypothesize that increasing doses of mixed fiber will influence satiety
      response, food intake, glucose, insulin, ghrelin, GLP-1, and PYY 3-36, in a dose-dependent
      manner, when given to subjects in muffins for breakfast.
    


Intervention name(s): Mixed Fiber Supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Breakfast Muffin containing 0g, 4g, 8g, and 12g of mixed fiber (total fiber amount as listed).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Food intake; Gut hormones; Fiber; Visual analog scales
How Common Are Sleep Disorders and Problems With Emergence From Anesthesia in Surgical Patients
Condition: Emergence Delirium; Parasomnias
MeSH terms: Delirium; Emergence Delirium; Parasomnias
Study type: Observational

Summary: 
      Emergence delirium (ED), also called emergence agitation or post-anesthetic excitement, is
      defined as a dissociated state of consciousness, occurring on awakening from general
      anesthesia, in which children exhibit psychomotor agitation, crying and thrashing and are not
      consolable for a period of time, usually 5-15 minutes. Emergence delirium is a common problem
      in pre-school children, with estimates of the incidence ranging from 10-70% of children in
      this age group. These children are agitated, seemingly unaware of their surroundings, and
      typically do not respond to parents or caregivers. They are therefore at risk for
      self-inflicted traumatic injury and complications secondary to disruptions of intravenous
      lines, surgical incisions, or drains. Children with ED typically require more resources in
      the postoperative period than children who do not exhibit ED. Predicting the likelihood of ED
      would allow for better allocation of resources in the post-anesthetic care unit (PACU).

      The peak incidence of ED in children occurs in the same age range at which the peak incidence
      of parasomnias (PS) occurs. The description of parasomnias is strikingly similar to the
      description of ED; the American Academy of Sleep Medicine defines parasomnias as "undesirable
      physical events or experiences that occur during entry into sleep, within sleep or during
      arousals from sleep." Parasomnias can be diagnosed using a sleep questionnaire.

      The purpose of this pilot study is to determine the incidence of ED and PS in our population,
      in order to determine the number of patients necessary to enroll in a larger study to either
      confirm or reject the hypothesis that ED and PS are correlated.
    


Intervention name(s): children's sleep habits questionnaire
Intervention type(s): Other
Intervention description(s): survey of children's sleep habits completed by parent
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        One hundred children age 1-6, ASA PS I or II, undergoing surgery by either elective
        otolaryngology (ENT) (including but not limited to: tonsillectomy, adenoidectomy, and lymph
        node biopsy) or elective urologic surgery (including but not limited to: circumcision,
        cystoscopy and related procedures, orchidopexy or hernia), requiring intravenous line
        placement, at American Family children's Hospital at the University of Wisconsin will be
        enrolled in the study. The child's caregiver will complete a sleep questionnaire prior to
        anesthesia and surgery. From the time the anesthetic is discontinued, after surgery, a
        study coordinator will observe the child's emergence from anesthesia and rate emergence
        using the PAED scale every 5 minutes until the child is awake.
A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Japan. The aim of the trial is to evaluate the pharmacokinetic
      (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the trial
      drug on the body) properties of FIAsp (faster-acting insulin aspart) and the currently
      marketed insulin aspart (NovoRapid®) in Japanese subjects with type 1 diabetes.
    


Intervention name(s): Faster-acting insulin aspart; insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): Single dose injected subcutaneously (s.c, under the skin); Single dose injected subcutaneously (s.c, under the skin)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of Raltegravir in a Large Urban HIV Clinical Population in Milan
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      This will be a retrospective analysis of efficacy, safety and tolerability of raltegravir as
      part of an optimized therapy in a clinical setting.

      Follow-up is calculated from the treatment initiation (with or without raltegravir) up to the
      date of discontinuation of the considered regimen or the date of last visit or the date of
      lost to follow-up, whichever came first.

      The Aim of the study is to evaluate the efficacy and safety of raltegravir-containing
      regimens in a urban clinic setting.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This study will include subjects who received raltegravir and were previously exposed to
        NRTIs, NNRTIs, PIs, regardless of the stage of HIV disease at the start of the treatment.

        A control group will be used for the evaluation of the primary and secondary objectives in
        comparison to patients treated with raltegravir (study patients). The control group will be
        constituted by subjects who never received raltegravir, matched (in a ratio 1:3) with the
        study subjects by gender, age (± 3 years), CD4+ cells counts (± 50 cells) and HCV
        co-infection status yes/no). For control patients, the last antiretroviral regimen
        prescribed will be considered.
      
Keywords: Raltegravir; efficacy; safety; raltegravir-containing regimens; HIV urban clinic setting
Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)
Condition: Hypercholesterolemia; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Hypercholesterolemia; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high
      risk for coronary heart disease to study the effects of ezetimibe/simvastatin and
      atorvastatin on lipids.
    


Intervention name(s): ezetimibe (+) simvastatin; Comparator: atorvastatin calcium; Comparator: Placebo (unspecified)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.; Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets.
Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.; Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets.
ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets.
Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
Other intervention name(s): MK0653A; Vytorin®; Lipitor ®
Intervention MeSH terms: Atorvastatin; Simvastatin; Ezetimibe; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Home Program and Telerehabilitation for the Treatment Process in Patients With Breast Cancer-Related Lymphedema
Condition: Breast Cancer Related Lymphedema; Telerehabilitation
MeSH terms: Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
Study type: Interventional

Summary: 
      During the Covid-19 pandemic, rehabilitation services for all patients were affected, and a
      term that was previously in use but gained popularity during the pandemic entered our
      vocabulary: 'Telerehabilitation'. The purpose of our study is to evaluate the treatment
      process and adherence of patients undergoing telerehabilitation.
    

Detailed description: 
      Our study is a randomized single-blind prospective study. Patients aged 18 to 75 years with
      stage 1-2 lymphedema associated with breast cancer and upper extremity lymphedema, who had
      undergone breast surgery at least 3 months prior, were included in the study. Group 1:
      Patients were given a brochure explaining the massage and exercises they should perform. They
      were periodically contacted by a physiotherapist and clinician to remind them of their tasks.
      Group 2: Patients underwent telerehabilitation exercises and massages three times a week
      guided by a physiotherapist and clinician, and on the remaining days, they continued their
      self-administered tasks. Patients were evaluated three times: before treatment, at weeks 5
      and 8 after treatment. During each visit, patients' inter-limb volume difference, Quick DASH
      and Life Impact Scale scores, pain, tension, stiffness, and heaviness sensations were
      assessed.
    

Intervention name(s): Manuel Lymphatic Drainage(MLD), Exercises
Intervention type(s): Other
Intervention description(s): MLD:It is a unique massage technique that uses specific hand movements to provide a gentle pumping effect on the skin.
Massage movements follow the direction of lymph flow and produce rapid results. The aim of this method is to achieve maximum skin tightening effect with minimum pressure.
Exercise, on the other hand, increases physical performance, improves body composition, and provides an increase in quality of life by providing acute and chronic reductions in fatigue. Both aerobic exercises and strengthening exercises have been found effective on physical performance. It shows that a mixed program consisting of components such as aerobics, strengthening, coordination and stretching can positively affect flexibility, pain and energy expenditure in breast cancer patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
The Platelet-Rich Plasma in the Therapy of Temporomandibular Disorders
Condition: PRP; Temporomandibular Disorder; Myalgia; Bruxism
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Myalgia; Bruxism
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The Platelet-Rich Plasma intramuscular injections into the masseter and temporalis muscle
      were performed to reduce painful temporomandibular disorder symptoms,such as myalgia,
      myofascial pain and myofascial pain with referrals. Patients(n=120) were randomly divided
      into two groups: experimental(n=60) and control group(n=60). In controls injections with 0,9%
      NaCl were performed. Pain intensity was measured with NPRS (numeriic pain rating scale, 0= no
      pain, 11= the worst pain that one can imagine) before(0 day), during(10 day) and after(20
      day) the therapy with PRP injections.
    

Detailed description: 
      Patients(n=120) attending The Department of Temporomandibular Disorders and Orthodontics at
      the Silesian Medical University Poland, Zabrze were enrolled to the study and randomly
      divided into one of two groups: experimental and control group. Platelet-Rich Plasma(PRP) was
      prepared for each patient and an intramuscular injections of 0,5 ml PRP into 6 points at each
      side were performed in experimental group. A follow-up appointment was made after 10 and 20
      days and in each visit an injection of PRP or 0,9% NaCl was performed. Pain intensity was
      measured in NPRS(numeric pain rating scale) and collected data data were analyzed.
    

Intervention name(s): Platelet-Rich Plasma intramuscular injections; Placebo Comparator: 0,9% NaCl intramuscular injections
Intervention type(s): Biological; Biological
Intervention description(s): A platelet-rich plasma intramuscular injections into the trigger points of painful muscles were performed.; A 0,9% NaCl intramuscular injections into the trigger points of painful muscles were performed.
Other intervention name(s): PRP intramuscular injections; Saline intramuscular injections
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An intervention performed in experimental group and control group
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Evaluation of PK and Safety of D-0120 and Allopurinol
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Evaluation of safety and PK interaction between D-0120 and Alopurinol in healthy adult
      subjects
    


Intervention name(s): D-0120 in combination with Allopurinol
Intervention type(s): Drug
Intervention description(s): noted above
Intervention MeSH terms: Allopurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: D0120 Allopurinol
Masking: None (Open Label)
Primary purpose: Other
Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors
Condition: Hypertension; Hypercholesterolemia
MeSH terms: Hypertension; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate whether a Caduet based treatment strategy might result in greater reduction in
      total cardiovascular risk as compared to usual care in subjects with hypertension and
      additional risk factors.
    


Intervention name(s): Amlodipine besylate/atorvastatin calcium single pill combination
Intervention type(s): Drug
Intervention description(s): Open label amlodipine besylate/atorvastatin calcium single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion
Intervention MeSH terms: Amlodipine; Atorvastatin; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment