bioihbjkbjnl/mcl2 huggingface dataset:
3D Printed Models in Mohs Micrographic Surgery
Condition: Mohs Micrographic Surgery
Study type: Interventional

Summary: 
      Patients undergoing Mohs micrographic surgery (MMS) frequently experience anxiety. It has
      been suggested that enhanced patient education prior to the procedure may decrease patient
      anxiety. The purpose of the study is to investigate if optimized participant education
      enhances participant understanding, decreases participant anxiety and increases participant
      satisfaction.
    

Detailed description: 
      1. To investigate if participant education with a 3 dimensional printed (3DP) MMS model and
           standardized script protocol increases participant understanding of MMS more than
           current standard of care (control group) at the University Hospitals Cleveland Medical
           Center MMS Clinics.

        2. To investigate if participant education with a 3DP MMS model and standardized script
           protocol decreases perioperative participant anxiety during MMS more than current
           standard of care (control group) at the University Hospitals Cleveland Medical Center
           MMS Clinics.

        3. To evaluate if participant satisfaction with a 3DP MMS model and standardized script
           protocol increases participant satisfaction during MMS more than current standard of
           care (control group) at the University Hospitals Cleveland Medical Center MMS Clinics.
    

Intervention name(s): 3D printed model; Verbal Counselling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A printed 3D model of MMS will be created showing a model of skin, and a tumor to visually depict the surgery; Participants will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and MMS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be recruited from University Hospitals Department of Dermatology MMS Clinics at the Cleveland Medical Center, Chagrin Highlands and Westlake Locations. These patients will be randomly assigned to a control (50%) or experimental group (50%) prior to the onset of the study protocol.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: 3D printing; Patient education
Absorption, Metabolism, and Excretion of a Single Dose of Ferriprox® in Patients With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the pharmacokinetics of deferiprone and its
      3-O-glucuronide metabolite following administration of a single 1500 mg dose of Ferriprox in
      patients with sickle cell disease.
    

Detailed description: 
      This is a single-arm, single-dose study of Ferriprox in patients with sickle cell disease.
      Patients found to be eligible will visit the clinic the day before receiving the drug, in
      order to reconfirm eligibility and to undergo baseline assessments, and will receive a single
      dose of 1500 mg Ferriprox under fasting conditions. Blood and urine samples for
      pharmacokinetic assessment will be collected over a 10-hour period. Standard safety
      assessments will be performed throughout the study, and patients will return for a safety
      follow-up.
    

Intervention name(s): single 1500 mg dose of Ferriprox
Intervention type(s): Drug
Intervention description(s): A single dose of 1500mg of Ferriprox (three 500mg tablets) administered under fasting conditions
Other intervention name(s): deferiprone
Intervention MeSH terms: Deferiprone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: sickle cell disease; iron overload; pharmacokinetics; Ferriprox; deferiprone
Non-invasive Brain Stimulation to Enhance Treatment of Dysarthria Post-stroke
Condition: Dysarthria; Stroke
MeSH terms: Stroke; Dysarthria
Study type: Interventional

Summary: 
      The proposed study aims to determine if transcranial direct current stimulation can enhance
      the effect of speech therapy in post-stroke patients with dysarthria.
    

Detailed description: 
      A total of 60 Cantonese-speaking post-stroke patients who are suffering from dysarthria will
      be recruited and randomly divided into real tDCS and sham groups. All the participants will
      receive individualized speech therapy based on the results of their speech assessment.

      For the real tDCS group, an anodal high-definition tDCS of 2 milliamperes (mA) lasting for 20
      minutes will be delivered to the orofacial area of the primary motor cortex (SM1) during
      speech therapy. For the sham tDCS group, stimulation given during speech therapy will only
      last for 30 seconds in order to cause a similar sensation on the scalp as the real
      stimulation group. There will be a total of 10 daily sessions during a 2-week period.
    

Intervention name(s): tDCS active; tDCS sham
Intervention type(s): Device; Device
Intervention description(s): An anodal high-definition tDCS of 2 mA lasting for 20 minutes will be delivered to the orofacial area of the primary motor cortex (SM1) during speech therapy.; An anodal high-definition tDCS of 2 mA lasting for 30 seconds will be delivered to the orofacial area of the primary motor cortex (SM1) during speech therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
DPBRN Persistent Pain and Root Canal Therapy
Condition: Root Canal Therapy; Persistent Tooth Pain
MeSH terms: Toothache
Study type: Observational

Summary: 
      The purpose of this study is to document by survey the occurence of tooth pain present 3
      months and 6 months after root canal therapy in the patients recruited for the DPBRN
      "Peri-operative tooth pain" study. This study will access the feasibility of obtaining 3
      month and 6 month follow-up data on the patient enrolled in the DPBRN "Peri-operative tooth
      pain" study.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The participants directly involved in this study are the patients who have sought dental
        treament in the practitioner-investigators' practices. The practitioner-investigators will
        be endodontists and general dentists.
      
Keywords: post-operative pain; root canal therapy; feasibility; post-surgical persistent pain
Prognostic Factors Affecting Survival of Gastric GIST
Condition: Gastric GIST
Study type: Observational

Summary: 
      Gastrointestinal stromal tumor (GIST) is the most common non-epithelial mesenchymal tumor of
      the gastrointestinal tract. Surgical treatment is the only curative therapy for primary
      localized GIST. This study aimed to identify the clinicopathological characteristics of
      gastric GISTs and to study the predictive factors for recurrence in Tunisian patients.
    

Detailed description: 
      The prognosis of gastric GIST depends on various tumor factors with the most important being
      the mitotic index and tumor necrosis. Imatinib therapy has revolutionized the treatment of
      advanced GIST.

      They have been the subject of much controversy in terms of their histogenesis,
      classification, treatment and prognosis. GISTs are histologically similar to smooth muscle
      and nerve tumors such as leiomyomas, leiomyosarcomas or schwannomas. Currently they are well
      characterized with the recent discovery of the C-KIT gene mutation and the expression by
      tumor cells of the C-KIT protein.

      Moreover, the discovery of this receptor is at the origin of the introduction of a "targeted
      therapy": an anti-tyrosine kinase molecule having revolutionized the therapeutic management
      of these tumors. However, the standard curative treatment of GIST remains complete surgical
      resection with negative margin from the tumor.
    

Intervention name(s): total or subtotal gastrectomy
Intervention type(s): Other
Intervention description(s): resection of the gastric tumor
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        There were 34 patients with the mean age of 58.2 years and male predominance. The disease
        was localized, locally advanced and metastatic in 26, 6 and 2 cases, respectively. Complete
        surgical resection was performed in 32 cases.
Clinical Performance and Safety of the VITA AV Clinical System
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      The primary objective of this clinical investigation is to demonstrate that treatment with
      the VITA AV clinical system is feasible and to evaluate clinical performance and safety when
      used to improve the symptoms and signs of vaginal atrophy (VA) due to menopause.
    

Detailed description: 
      After recruitment of the subject, the initial assessment of the enrolled patient will be
      performed, which includes screening, baseline evaluations & pre-procedural assessments,
      suitability of device size for each patient (vaginal dilator kit- for sizing and recording)
      and endoscopic images will be done by the clinician.

      Subjects will be introduced to the therapy over a 2-4week familiarisation period to determine
      their dosage. Subsequently, subjects will receive 3x treatment sessions over a 12-week window
      with a final follow-up 4 weeks after the final treatment session.
    

Intervention name(s): VITA AV Clinical System
Intervention type(s): Device
Intervention description(s): The VITA AV Clinical System that works on the principle of negative pressure suction to the vaginal wall to treat VA, based on the idea of the clinical application in wound healing which is intended to elicit improvements in the rate of angiogenesis, moisture and HA production post-treatment. It is believed that the VITA AV Clinical System will provide a more effective treatment by improving the underlying cellular deficiencies associated with VA.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Residual Neuromuscular Blockade in Pediatric Anesthesia
Condition: Residual Neuromuscular Blockade
MeSH terms: Delayed Emergence from Anesthesia
Study type: Observational

Summary: 
      Residual neuromuscular blockade (RNB) is frequent and it is associated with postoperative
      morbidity and mortality. The incidence of the RNB in pediatric anesthesia is currently not
      known. The aim of this prospective observational cohort study is to evaluate the early RNB
      just before extubation and late RNB at the time of arrival to postanesthetic care unit
      (PACU).
    

Detailed description: 
      Residual neuromuscular blockade (RNB) is frequent and it is associated with negative impact
      on postoperative morbidity and mortality. The incidence of the RNB in adult is well
      described, however in pediatric subpopulation it is currently not known. The aim of this
      prospective observational cohort study is to evaluate the early RNB just before extubation
      and late RNB at the time of arrival to postanesthetic care unit (PACU). In the trial will be
      enrolled all pediatric patients (28 weeks of age and older - 19 years old) whom will be
      administered neuromuscular blocking agent during anesthesia. The demographic data will be
      collected including: age, weight, type of surgery, ASA status. The anesthesia management will
      be described including: airway management, type and cumulative dose of neuromuscular blocking
      agent (NMBA) and time and dose of the last administered bolus of NMBA. The residual
      neuromuscular blockade will be measured according to the standards: TOF Watch accelerometry
      at the moment prior to extubation (two measurements) in TOF mode and at the arrival to
      postanesthetic care unit (PACU) (two measurements) in TOF mode.
    

Intervention name(s): Residual neuromuscular blockade measurement
Intervention type(s): Device
Intervention description(s): Just prior extubation in OR and at the arrival to PACU the residual neuromuscular blockade will be measured by accelerometry
Other intervention name(s): accelerometry
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Paediatric patients undergoing surgery with neuromuscular blocking agents were administered
      
Keywords: Residual neuromuscular blockade
Comparison of Intralase and Visumax Femtosecond Laser for Laser In Situ Keratomileusis
Condition: Myopia
MeSH terms: Myopia
Study type: Observational

Summary: 
      Emtosecond lasers are used in cutting the flap in LASIK procedures (laser corrective surgery
      for refractive error). Their use has decreased the incidence of serious complications when
      compared to the use of microkeratomes(mechanical blades). The commonest femtosecond laser
      currently used is 'Intralase'. A newer femtosecond laser 'Visumax' (Zeiss) is now available
      and differs from the Intralase in that it does not interfere with the curvature of the cornea
      when creating the flap. The Intralase applanates the cornea flat during flap creation which
      causes the intraocular pressure to be higher. Both Intralase and Visumax lasers are available
      to patients and surgeons to use at SNEC. The aim of the investigators study is to compare the
      two lasers in a randomization of left and right eyes in the same patient. The investigators
      want to measure any difference that the lower intraocular pressure may have during the
      creation of the flap. This will be measured with a questionaire on patient experience during
      the procedure and the outcomes of vision, refraction, contrast sensitivity, wave-front
      analysis, tear function,corneal sensation and flap thickness measured with anterior segment
      OCT during the post-operative follow up period. To date no-one has compared the use of these
      two femtosecond lasers. Both lasers are currently used clinically for flap creation at SNEC.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Myopic patients presenting to refractive service eligible for LASIK
      
Keywords: Lasik; Femtosecond Laser; Visumax; IntraLase; Myopia; Myopic Patients undergoing LASIK
A Mass Balance Study With a Microtracer Dose of 14C-esketamine in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the metabolic disposition of radiolabeled
      esketamine administered by the oral and intravenous routes in healthy male participants.
    

Detailed description: 
      This is a single-center, open-label (identity of study drug will be known to participant and
      study staff), single-dose, parallel-group study. The study consist of Screening Phase (Days
      -21 to -2), Open-label treatment Phase (Day -1 up to Day 8) and End of Study (9 to 13 days
      after last study assessment). The total duration of study from the Screening Phase through
      Follow-up, is 37-41 days. Participants will be assigned to 1 of the two groups (Cohort 1 and
      Cohort 2) during the treatment phase. The participants will be primarily evaluated to
      determine the metabolic disposition of radiolabeled esketamine administered by the oral and
      intravenous routes. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Esketamine 50 mg; Esketamine 20 mg
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg of oral esketamine, fortified with a microtracer dose of 14C-esketamine, as an aqueous solution mixed with apple juice for administration (80 mL total volume); 20 mg of intravenous esketamine in 30 mL, fortified with a microtracer dose of 14C-esketamine, as a 30-minute intravenous infusion.
Intervention MeSH terms: Esketamine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Healthy; JNJ-54135419; Esketamine
Decapeptyl SR With Livial Add Back Therapy in the Management of Chronic Cyclical Pelvic Pain in Pre Menopausal Women
Condition: Endometriosis
MeSH terms: Endometriosis; Pelvic Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single-centre, open-label, within patient comparison study to assess the efficacy
      and safety of Decapeptyl SR when administered in combination with Livial for the treatment of
      women with chronic cyclical pelvic pain. This will be for a 2 year period with a 6 month post
      treatment follow up. The study aims to recruit 40 patients.
    

Detailed description: 
      A screening visit,will be performed and written informed consent will be obtained from the
      patient. In addition the patient's medical history will be checked, vital signs recorded,
      pain and general health questionnaires completed, blood samples collected and any prior or
      concomitant medications will be noted. Bone density will be determined using a DEXA scan
      performed in the interval between the screening and baseline visits. One month after the
      screening visit, patients will return to the clinic for the baseline visit. At this visit a
      physical examination and urine pregnancy test will be performed, vital signs measured,
      specific validated questionnaires on pain and endometriosis related health will be completed
      and symptoms of oestrogen deficiency will be documented. Patients who are still considered to
      be eligible for the trial will receive an injection of Decapeptyl SR 11.25 mg, and will be
      dispensed sufficient Livial 2.5 mg tablets to last until the next study visit. Patients will
      return for repeat Decapeptyl SR injections every 3 months until Month 21 at which time the
      last Decapeptyl SR injection will be administered. At these visits patients will also be
      dispensed further supplies of Livial.

      Follow-up assessments will be performed during the treatment period 3, 6, 12, 18 and 24
      months after the baseline visit. A final follow-up assessment will be conducted 6 months
      after stopping treatment. At each follow-up visit specific validated questionnaires on pain
      and endometriosis related health will be collected and symptoms of oestrogen deficiency will
      be noted. Physical examination, vital signs, bone density assessment and haematology and
      biochemistry analysis will be repeated at selected timepoints.

      Health economic data will be collected at all study visits.
    

Intervention name(s): Decapeptyl SR 11.25mg
Intervention type(s): Drug
Intervention description(s): 11.25 mgs, Intra muscular (IM) every 3 months for 2 years
Other intervention name(s): Triptorelin acetate
Intervention MeSH terms: Triptorelin Pamoate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endometriosis; chronic cyclical pelvic pain
A Study to Assess the Disturbances in Calcitonin Gene in Patients With Gum Disease and Osteoporosis
Condition: Generalized Chronic Periodontitis; Osteoporosis
MeSH terms: Osteoporosis; Periodontitis; Chronic Periodontitis
Study type: Observational

Summary: 
      Osteoporosis and Periodontitis are multifactorial diseases which share common risk
      factors.The aim of the present study is to ellucidate polymorphisms in Calcitonin receptor
      gene? in patients with Osteoporosis and Periodontitis.
    

Detailed description: 
      Periodontitis is a polymicrobial inflammatory disease which includes various modifiable and
      nonmodifiable risk factors. The non modifiable risk factors include genetic polymorphisms
      like metabolism associated genetic polymorphisms ( Vitamin D and Calcitonin).

      Osteoporosis is a systemic skeletal disease characterized by low bone mass and
      micro-architectural deterioration of bone tissue with consequent increase in bone fragility
      and susceptibility to fractures.

      Bone loss is a common feature shared between periodontal disease and osteoporosis.

      Out of all genetic factors Calcitonin gene polymorphism contributes to the development of
      both osteoporosis and chronic periodontitis.
    

Intervention name(s): CTR Gene
Intervention type(s): Genetic
Intervention description(s): 2ml blood sample collected from patients to extract DNA for Assessment of CTR Gene polymorphism
Other intervention name(s): Calcitonin Gene, Hypocalcaemic agent
Intervention MeSH terms: Calcitonin
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients both male and female aged between 35-60 Years with Osteoporosis and Chronic
        Periodontitis.
      
Biospecimen description: 
      2ml of blood sample from each subject was collected in EDTA containing vials and kept at -20
      degrees until DNA extraction. The genomic DNA was isolated and C/T polymorphism in CTR gene
      was identified by PCR followed by restriction digestion pattern by Alu 1 restriction enzyme.
    
Keywords: Osteoporosis; Chronic Periodontitis; Calcitonin gene Polymorphism
PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients
      with breast cancer receiving chemotherapy
    


Intervention name(s): PEG-rhG-CSF; rhG-CSF
Intervention type(s): Drug; Drug
Other intervention name(s): pegfilgrastim; filgrastim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PEG-rhG-CSF
Study of Naproxen Capsules to Treat Dental Pain
Condition: Dental Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe
      and effective for the treatment of dental pain.
    


Intervention name(s): Naproxen Test; Naproxen Test; Naprosyn; Naprosyn; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 200-mg single dose; 400-mg (2 x 200-mg); single dose; single dose; single dose
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment