bioihbjkbjnl/mcl2 huggingface dataset:
Distraction Method on Pain and Anxiety During Circumcision
Condition: Pain; Anxiety; Urological Nursing
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Circumcision is a common procedure in infants, children and young people around the world for
      cultural, religious or medical reasons. Since this is a painful procedure, it is performed
      under local anesthesia or general anesthesia. It is recommended to perform this procedure
      under local anesthesia if there is no risk. Although local anesthesia is used during the
      procedure, pain and anxiety levels of children may increase. Distraction methods are commonly
      used and effective methods to reduce pain and anxiety during painful procedures. The aim of
      this study was to evaluate the effect of tablet playing during circumcision on pain and
      anxiety in school age children.
    

Detailed description: 
      Circumcision is a common procedure in the worldwide. To our knowledge, although there have
      been several randomized controlled trials using video and game techniques, which are
      distractions to reduce pain and anxiety during painful procedures, no randomized controlled
      trials using playing the game with Tablet to reduce pain and anxiety during circumcision have
      been found. Non-pharmacological studies, such as play therapy, are needed to reduce pain and
      anxiety in school-age children undergoing circumcision under local anesthesia. The aim of
      this study is to provide evidence about the effectiveness of playing the game with Tablet
      used to reduce pain and anxiety during circumcision, and to contribute to nursing care in
      pain management.
    

Intervention name(s): Tablet group
Intervention type(s): Other
Intervention description(s): Children in the Tablet group started to play the game with Tablet about 5-10 minutes before circumcision, and continued to play the game during the whole procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: anxiety; children; circumcision; nursing; pain
Aprepitant Versus Gabapentin Prophylaxis for Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgeries
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To evaluate the efficacy of pre-empetive administration of Aprepitant, Versus Gabapentin
      prophylaxis for reducing the incidence of postoperative nausea and vomiting in Laproscopic
      gynacological surgeries.
    

Detailed description: 
      Postoperative nausea and vomiting (PONV) is frequently encountered in the surgical recovery
      room. Laparoscopic surgery is one important risk factor for increased incidence of PONV.
      Gabapentin, an anticonvulsant with known postoperative analgesic properties, has shown some
      activity against PONV. Results from clinical trials evaluating the anti-emetic efficacy of
      gabapentin are conflicting.

      Aprepitant, a neurokinin-1 (NK1) receptor antagonist, blockades the central effects of
      substance P. Substance P is a neurotransmitter found in central areas associated with emesis
      such as the dorsal vagal complex and area postrema.
    

Intervention name(s): dexamethasone; Gabapentin; Aprepitant
Intervention type(s): Drug; Drug; Drug
Intervention description(s): dexamethasone 8 mg iv 2 minutes before induction of anesthesia; oral gabapentin 600 mg 1 hour before induction of anesthesia; oral aprepitan 80mg 1 hour before induction of anesthesia.
Other intervention name(s): Decadron; Neurontin; Emend
Intervention MeSH terms: Dexamethasone; Gabapentin; Aprepitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Information About a Doctor or a Possibility of Choosing Doctor's Gender and Attendance to Screening Colonoscopy
Condition: Colorectal Cancer; Screening
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of the study is to investigate whether the information about a doctor or
      possibility to choose doctor's gender included in invitation letter is associated with
      attendance rate to screening colonoscopy.
    

Detailed description: 
      Study is performed as a part of NordICC (Clinical trials NCT 00883792) trial, which is
      intended to investigate the effect of screening colonoscopy on colorectal cancer incidence
      and mortality. NordICC trial is a multicenter, randomized study conducted in Norway, Sweden,
      Netherlands and Poland.

      This study is designed to assess two factors potentially influencing patients attendance.
      These two factors are: identification of particular doctor performing examination and the
      possibility of choosing doctor's gender.
    

Intervention name(s): Invitation letter
Intervention type(s): Behavioral
Intervention description(s): Invitation letter sent 6 weeks prior to prespecified screening colonoscopy appointment date and followed by reminder letter within 3 weeks if no response is received.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Attendance; Colorectal cancer; Screening; Invitation letter
Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)
Condition: Shingles
MeSH terms: Herpes Zoster
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will look at how well Zostavax™ works in preventing shingles in participants ages
      50-59 years old.
    


Intervention name(s): Zoster Vaccine, Live (Zostavax™); Comparator: Placebo
Intervention type(s): Biological; Biological
Intervention description(s): A single dose 0.65 ml Zostavax™ (Live, attenuated Zoster Vaccine) was administered by subcutaneous injection on Day 1.; A single dose of 0.65 ml Placebo (A vaccine stabilizer of Zostavax™ with no live virus) was administered by subcutaneous injection on Day 1.
Other intervention name(s): V211; Zostavax™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Utility of Lung Ultrasonography as a Predictor of Fast Track Extubation
Condition: Exta Vascular Lung Water
Study type: Observational

Summary: 
      Fast-tracking in cardiac surgery refers to early extubation to reduce costs and perioperative
      morbidity. The use of lung ultrasound is recently accepted as a tool in the assessment of
      several lung conditions. The aim of this study was to assess the use of lung ultrasound score
      as a quantitative method to assist in the decision of early extubation.
    

Detailed description: 
      background: Fast-tracking in cardiac surgery refers to early extubation to reduce costs and
      perioperative morbidity. The use of lung ultrasound is recently accepted as a tool in the
      assessment of several lung conditions. The aim of this study was to assess the use of lung
      ultrasound score as a quantitative method to assist in the decision of early extubation.

      Methedology: in this prospective, observational study, 45 pediatric patients who will go
      elective repair of congenital acyanotic heart diseases were included and were examined with
      Lung ultrasound together with arterial blood gases preoperative and postoperative and given a
      score range from 0-3 according to number of B lines in each region and sensitivity of
      post-operative lung ultrasound score to extubation within 6 hours was examined Demographic
      data: Patients' name, age, sex, diagnosis, relevant medical and surgical history. And
      Assessment data: Baseline arterial blood gases and lung ultrasound score assessment after
      induction of anesthesia and at the end of surgery.

      Primary outcome will be the sensitivity of lung ultrasound scores immediately at the end of
      pediatric cardiac operation in prediction of extubation. and Secondary outcome will be
      correlation between lung ultrasound score and Po2/Fio2 ratio at the end of operation
    

Intervention name(s): Lung ultrasound examination
Intervention type(s): Diagnostic Test
Intervention description(s): 45 pediatric patients who will go elective repair of congenital acyanotic heart diseases will be included and will be examined with Lung ultrasound together with arterial blood gases preoperative and postoperative and given a score range from 0-3 according to number of B lines in each region and sensitivity of post-operative lung ultrasound score to extubation within 6 hours was examined.
Other intervention name(s): The lung ultrasound score
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients suffering from Acyanotic congenital heart diseases.
TMS Treatment for Depression in the National Health Service
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This research programme purports to test the effectiveness of two Transcranial Magnetic
      Stimulation (TMS) protocols (Repetitive high frequency protocol and Theta Burst protocol) in
      reducing the symptoms of depression. The study also uses Magnetic Resonance Imaging (MRI)
      scans to improve the localization of TMS targets.
    


Intervention name(s): Theta-Burst Stimulation; High frequency stimulation
Intervention type(s): Device; Device
Intervention description(s): At 80% motor threshold determined using single pulse stimuli. Depending on the hemisphere determined by connectivity analysis and neuronavigation in each individual, either continuous (left prefrontal) or intermittent (right prefrontal) train of pulses will be delivered.; Left prefrontal stimulation. 120% motor threshold with a pulse sequence of 10 Hz for 4 seconds, followed by a 26 second quiet period. Treatment will last for a total of 37.5 minutes this is a total of 3,000 pulses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial Magnetic Stimulation; Neuronavigation; Magnetic Resonance Imaging
FDG-PET Imaging in Young Cystic Fibrosis Patients
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this research is to determine how a person's lungs will uptake
      [18F]fluorodeoxyglucose (FDG), as measured with positron emission tomography (PET) scanning
      in young cystic fibrosis (CF) patients.
    

Detailed description: 
      Our recent study in CF adults, supplemented by recent pre-clinical and clinical studies by
      our group suggests that labeled fluorodeoxyglocose-based positron emission tomography
      (FDG-PET) imaging may be a valuable quantitative biomarker of lung inflammation. The proposed
      study would validate our earlier findings, but in a younger patient population. The
      implications of such a test could be highly significant for both the testing of promising new
      anti-inflammatory agents and for patient management decisions. To capitalize on this exciting
      opportunity, the critical next step is to show that we can identify a cohort of young CF
      patients with both stable lung function and normal (or near normal) FDG-PET imaging studies.
      Similar patients, then, would become the subjects for a future prospective cohort study to
      determine if FDG-PET imaging can in fact serve as a predictor of future changes in lung
      function.
    

Intervention name(s): FDG-PET
Intervention type(s): Diagnostic Test
Intervention description(s): All subjects underwent FDG-PET and low-dose volumetric CT imaging. After completing a transmission scan, [18F]FDG was injected intravenously at the start of dynamic scan acquisition. Regions of interest were drawn over multiple tomographic slices to determine average whole-lung and regional lung tissue [18F] FDG uptake. Patlak graphical analysis was used to determine the rate of [18F]FDG uptake from the blood input function and lung tissue activity curves, measured as the influx constant Ki (slope of the linear regression from the Patlak plot). Corrected Ki (i.e., Ki divided by the initial volume of distribution). Lung density was calculated from the attenuation image by standard methods.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: In this pilot study, we examined the value of FDG-PET scans as a noninvasive measure of neutrophilic inflammation in adolescents and young adults with cystic fibrosis. All subjects underwent scans.
Masking: None (Open Label)
Primary purpose: Diagnostic
Study to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety/tolerability and
      pharmacokinetics/pharmacodynamics of CKD-519
    

Detailed description: 
      A Dose-block Randomized, Double-blind, Placebo-controlled, Multiple Dosing, Dose-escalation
      Phase I Clinical Trial to Investigate the Safety/Tolerability and
      Pharmacokinetics/Pharmacodynamics of CKD-519 After Oral Administration in Healthy Adult
      Volunteers
    

Intervention name(s): CKD-519; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dyslipidemia
Quantification of Side Effects During Hepatitis C Therapy
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      This study aims to assess the frequency and severity of adverse events during Hepatitis C
      therapy with or without first generation protease inhibitors.
    

Detailed description: 
      Hepatitis C Virus infection is one of the main causes of chronic liver disease worldwide with
      current estimates of approximately 130 - 210 million individuals (according to 3% of the
      world population) chronically infected with the hepatitis C virus. However, hepatitis C virus
      infections are among the most common causes leading to chronic hepatitis, liver cirrhosis and
      liver related death worldwide.

      The current standard of care is a combination of pegylated Interferon and Ribavirin
      (dual-therapy). Since 2011, direct-acting antiviral drugs inhibiting viral protease are
      approved as an addition to the standard therapy (triple-therapy).

      The occurrence of adverse events as well as their severity generally depends on the therapy
      regimen and is influenced by type and dosage of medications.

      Most common adverse events (affects up to 95% of patients) are fever, fatigue, headache,
      nausea, arthralgia, depression, skin reactions, neutropenia, and anemia.

      A more frequent occurrence of adverse events with triple-therapy compared to dual- therapy
      has become clear since it's introduction, particularly with regard to anemia, neutropenia,
      gastrointestinal discomfort, fatigue, dysgeusia, and skin reactions. How- ever, there is
      accumulating evidence for a more often appearance of infections and/or infestations in
      patients receiving triple-therapy.

      The medical consequence from adverse events is a reduction of quality of life and
      consecutively the loss of antiviral therapy adherence. Thus, early recognition and immediate
      treatment of adverse events are crucial aspects in the success of antiviral treatment.

      Aim of this study is to quantify reported adverse events with respect to therapy reg- imen
      (dual-therapy vs. triple-therapy) in patients who are treated at the Department of Internal
      Medicine, Division of Gastroenterology and Hepatology at the Medical University Graz.
      Furthermore, a detailed review of international treatment recommendations, as well as an
      analysis of possible predictor parameters for the appearance of adverse events and treatment
      success is done.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with chronic hepatitis C undergoing therapy with pegylated interferon and
        ribavirin +/- a firstgeneration protease inhibitor
Nonablative Fractional Diode Laser for Treatment of Skin Resurfacing and Pigmented Lesions
Condition: Skin Texture; Pigmented Lesions
Study type: Interventional

Summary: 
      This study is intended to evaluate the efficacy and safety of a new diode fractional laser
      for skin resurfacing and treatment of pigmented lesions.
    

Detailed description: 
      This study is a prospective, open-label, clinical trial to study the effects of the
      nonablative, fractional diode laser for skin resurfacing.

      Up to 60 eligible participants will be enrolled at up to three (3) sites. Participants will
      receive up to 4 treatments to the face, and other off-face locations may be treated.
      Participants will complete follow-up visits for clinical evaluation and photography at 1 and
      3 months after the final treatment.
    

Intervention name(s): Nonablative Fractional Diode Laser
Intervention type(s): Device
Intervention description(s): The FRAX 1940 is a fractional 1940 nm solid-state diode laser that delivers linear arrays of microbeams to create nonablative microscopic treatment zones (MTZs) in the skin.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      Prospective, randomized, controlled, open label, trial of LVAD patients with 1:1
      randomization to either apixaban or warfarin.
    

Detailed description: 
      This pilot study will be a prospective, randomized, controlled, open label, trial of
      HeartMate 3 (HM3) LVAD patients with 1:1 randomization to either apixaban or warfarin. All
      patients will be treated with aspirin 81 mg daily as per the LVAD manufacturer instructions
      for use (IFU).
    

Intervention name(s): Apixaban; Warfarin; LVAD implant
Intervention type(s): Drug; Drug; Device
Intervention description(s): Patients randomized to apixaban will be started on a dose of 5 mg BID.; Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5.; Subjects will undergo HeartMate 3 LVAD implant prior to randomization
Intervention MeSH terms: Warfarin; Apixaban
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open-label, prospective, randomized, 1:1 intervention arm versus control
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: ventricular assist device; LVAD; anticoagulation; apixaban; warfarin
The Efficiency of the Hair2Go Device: A Prospective, Open, Label Study With Before-After Design
Condition: Hair Removal
Study type: Interventional

Summary: 
      The purpose of this study is to determine efficiency of Hair2Go device for short-term and
      long-term removal of unwanted hair adjunctive to shaving using a before-after study design.
    

Detailed description: 
      This study is a multicenter study, designed to determine the efficacy of the Hair2Go hair
      removal device and to compare the extent of hair removal with and without maintenance
      treatments. Preferably, two anatomical regions to be treated will be selected including the
      axilla and either the legs (calves) or forearms. The size of the area treated will be
      approximately 5x5 cm2. Additional areas including the face can be treated according to the
      subject's request with the PI's discretion but are not mandatory. Subjects will be provided
      with the device and will be instructed as to the method of usage. The subjects will be
      expected to self-administer the treatment at the clinic in a "simulated home environment".
      The duration of the treatment session is approximately 30-60 minutes. Each of the selected
      anatomical regions (both left and right sides) will be treated with either low, medium, or
      high Elōs energy level according to the PI's discretion. However all anatomical regions
      except for the axilla will be treated with either low or medium elōs energy levels only. Only
      the axilla will be treated up to an energy of 4J//cm2 A defined area of 5x5 cm2cm2 in the leg
      will not be treated and will serve as a reference for the temporal changes in hair growth
      that might be subject to factors, including fluctuations in hormone levels. Both sides (left
      and right) of the same anatomical region will receive the basic treatments. One side will
      receive 3 additional maintenance treatments in 4 week intervals ("Maintenance" vs "No
      maintenance" side) until the end of the experiment. More specifically, the study includes up
      to 11 visits at the clinic: initial consultation, 7 basic treatments in 1 week intervals
      followed in one side by 3 maintenance treatments, each 4 weeks apart. Follow ups will be
      conducted at 4 and 12 weeks after the last basic treatment.
    

Intervention name(s): Hair2Go (Mē)
Intervention type(s): Device
Intervention description(s): Treatment with Hair2Go Device 7 times every week with maintenance treatments once a month for 3 months
Other intervention name(s): Mē my elōs
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hair reduction; hair removal; hair clearance
Effects of Various Bariatric Surgical Procedures on Intestinal Triglyceride-rich-lipoprotein (TRL) Metabolism in Obese Patients
Condition: Obese Patients; Production Rates of These TRL Before and After the Bariatric Surgery; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Morbidly obesity (body mass index 40 kg/m²), the most serious, is more and more frequent.
      Cardiovascular diseases are the first cause of morbidity and mortality. An excess of TRL
      particles is one of the characteristics, represents a major cardiovascular risk factor. The
      overproduction of the intestinal TRL (which apoprotein B48 is the specific tracer) is
      recently recognized of insulin-resistance and the atherogenous role of these intestinal TRL
      has been shown. In front of this important overmortality, the bariatric surgery quickly
      developed. Three main procedures are performed: 2 based exclusively on the gastric
      restriction (the adjustable gastric banding and the sleeve gastrectomy) and one associating a
      malabsorption (the gastric bypass).
    

Detailed description: 
      It is a monocentric, prospective, comparative study. After identification of the eligible
      subjects, the kinetics (production and clearance rates) of the intestinal TRL will be
      performed in the hospital, using a stable isotope method (5,5,5-D3-L-Leucine), in 3 groups of
      obese patients (12 patients per surgery procedure), before and 6 months after the surgery
    

Intervention name(s): Surgical and medical procedures
Intervention type(s): Procedure
Intervention description(s): this study want to compare the differential effect of the 3 bariatric surgery procedures on the production rates of the intestinal TRL: the adjustable gastric banding the sleeve gastrectomy the gastric bypass
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: obese patients; TRL; the bariatric surgery