bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Two Method to Reducing Pain and Fear During Draw Blood From Children
Condition: Pain, Procedural; Pain Management; Child, Only
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      This study was conducted to evaluate the effects of two different distraction methods on
      reducing pain and fear during blood collection from children.

      The study was conducted between January 2020 and May 2021.
    

Detailed description: 
      The study was a pretest-posttest, parallel group randomized controlled experimental design.

      H0: The pain and fear mean scores of the intervention group, in which the distraction method
      (ball squeezing and blowing bubbles) was applied during the blood collection process, was not
      different from the control group.

      The study was carried out with the participation of 111 children aged 6-12 years and their
      parents, who underwent blood collection in the emergency department of a state hospital.

      Children were randomly assigned to blowing bubbles (n:37), ball squeezing (n:37) and control
      (n:37) groups. Bubble blowing and ball squeezing methods were used to distract attention
      during the blood collection process. Data were collected with Child and Family Information
      Form, Wong Baker Faces Pain Scale, Child Fear Scale. Pretest and posttest measurements were
      recorded separately by the child, parent and researcher. Descriptive statistics, Chi-square
      test, one-way analysis of variance, Tamhane's T2 test, t test for dependent groups were used
      in the analysis of the data. The statistical significance of the results was taken as p<0,05
    

Intervention name(s): Bubble blowing method
Intervention type(s): Procedure
Intervention description(s): The investigators were used "Bubble blowing method" and "ball squeezing method".
To child were used a ball squeezing method during the blood collection process.
Other intervention name(s): Ball squeezing method
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment First sub purpose was designed as parallel group, two intervention groups in pre-test and post-test order, and a randomized controlled control group.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: pain; procedural; fear; child; distraction methods
Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury
Condition: Craniocerebral Trauma; Pediatrics
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Craniocerebral Trauma
Study type: Interventional

Summary: 
      Mild traumatic brain injury (mTBI) is a very common reason for presentation to pediatric
      emergency departments. So as not to overlook the risk of complications, which occur at a rate
      of 0-7%, measures such as cranial computed tomography (CCT-scan) and/or short inpatient
      observation are prescribed. Ultimately, the majority of these measures could be avoided and a
      large Australian cohort shows that the risk of brain tumors is 2.44 times higher for children
      who had a CCT-scan (3.24 for age 1-4 years). Assay of a sensitive biomarker in blood, such as
      the S100B protein, has the potential to reduce the number of these unnecessary measures.
    

Detailed description: 
      Based on initial results from a previous prospective study, a multicenter interventional
      study will be necessary to validate the routine use of this biomarker .The ultimate goal is
      to include serum S100B assay in the current recommendations for m traumatic brain injury
      (mTBI) management based on the study of Kupperman et al. (2009), as mTBI accounts for 5-8% of
      pediatric emergency admissions in France (60-100 per 100,000 children). The study of
      Kuppermann et al. strongly dictated the recommendations for mTBI management by the French
      Society of Emergency Medicine (SFMU) . Then, from these 2 publications, the French Society of
      Pediatrics (SFP) redacted their recommendations after adjustment method recommendations for
      clinical practice, used by the French High Authority of Health (HAS) .

      The use of serum S100B assay as part of the management of pediatric mTBI should make it
      possible to reduce the number of additional examinations, in particular a 30% reduction in
      the number of CCT-scans, with a resultant reduction in radiation exposure, known to be a risk
      factor for cancer. The study protocol corresponds to a diagnostic prospective, controlled,
      multicenter study using a randomized stepped wedge cluster design, in which pediatric
      patients (aged ≤ 16 years) presenting to the pediatric emergency room for mTBI with a GCS
      score of 15 will benefit from usual care ("conventional management" arm) in the control
      group, and from S100B management in the interventional group.
    

Intervention name(s): usual care; S100B
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Diagnosis; Craniocerebral Trauma; Pediatrics; S100B; mild traumatic brain injury
Study to Evaluate the Influence of Tegoprazan on the Pharmacokinetics of Proguanil in Healthy Volunteers
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to evaluate the influence of tegoprazan on the pharmacokinetics of
      proguanil in healthy volunteers.
    

Detailed description: 
      Evaluation criteria

        -  Pharmacokinetic assessment with plasma concentrations of proguanil and cycloguanil

        -  Safety assessments with adverse event monitoring including subjective/objective
           symptoms, physical examination, vital signs, electrocardiogram, and laboratory tests
    

Intervention name(s): Atovaquone / Proguanil 250/100 mg; Tegoprazan 50 mg; Esomeprazole 40 mg; Vonoprazan 20 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Atovaquone / Proguanil 250/100 mg tablet; Tegoprazan 50 mg tablet; Esomeprazole 40 mg tablet; Vonoprazan 20 mg tablet
Other intervention name(s): Malarone; K-cab; Nexium; Takecab
Intervention MeSH terms: Atovaquone; Proguanil; Atovaquone, proguanil drug combination; Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?
Condition: Type 2 Diabetes Mellitus; Hyperglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether intake of protein supplement just before
      meals lowers the blood sugar levels after the meals. It is believe that pre-meal
      administration of a high-protein supplement can effectively improve glycemic control in type
      2 diabetes (DM).
    

Detailed description: 
      11.3% of the population aged 20 years or older (25.6 million individuals) has diabetes. In
      the population aged 65 years or older, the prevalence of diabetes reaches to 26.9%.

      Type 2 DM is caused by insulin resistance accompanied by insufficient compensatory insulin
      response. Therefore insulin secretagogues are a significant component of the therapeutic
      armamentarium. Insulin secretagogues, such as sulphonylureas and meglitinides, are routinely
      prescribed to lower post prandial glucose levels in type 2 DM. However, these medications are
      cleared by the liver and the kidneys and cannot be used in the presence of relevant
      co-morbidities. These medicines can also cause side effects, including hypoglycemia.
      Limitations of these medicines are likely to lead diabetic patients and their health care
      providers to seek alternate methods to treat postprandial hyperglycemia. Thus, our research
      which aims to identify an alternate insulin secretagogue is important and timely.

      Whey protein (WP), a rich source of essential and branch chain (BC) amino acids (AA), is a
      potent insulin secretagogue. Although it is well known that protein and/or AA intakes
      stimulate insulin secretion, protein supplements are not being used clinically in order to
      lower post-prandial glycemia. WP can be a satisfactory alternative to the pharmaceutical
      insulin secretagogues.
    

Intervention name(s): Whey protein; Placebo group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Whey protein group participants will take supplement drinks that contain whey protein, daily before breakfast and before dinner for 3 months.; Placebo group participants will take supplement drinks that do not contain whey protein, daily before breakfast and before dinner for 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Whey protein; protein supplement; Diabetes; Type 2 DM; Hyperglycemia; Insulin secretagogue
A Study Comparing the Pharmacokinetic and Pharmacodynamic Profiles for Sitagliptin, Saxagliptin and Vildagliptin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-142)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A five-period crossover study to assess and compare the trough dipeptidyl peptidase IV
      (DPP-4) inhibition at 24-hours following the final morning dose for sitagliptin, saxagliptin
      and vildagliptin after 5 days of once daily dosing and vildagliptin after 5 days of twice
      daily dosing in participants with T2DM. The primary hypothesis is that following multiple
      daily dose administration to achieve steady-state drug concentrations, 100-mg sitagliptin
      will demonstrate greater DPP-4 inhibition at 24-hours after the final dose compared to 5-mg
      saxagliptin and 50-mg vildagliptin (once daily administration) in participants with T2DM.
      Each participant will receive all 5 treatments in randomized order. There will be a washout
      interval of at least 10 days between the last dose of study drug in one period and the first
      dose of study drug in the following period.
    


Intervention name(s): Sitagliptin 100 mg; Saxagliptin 5 mg; Vildagliptin 50 mg; Vildagliptin 50 mg BID; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Sitagliptin 100 mg: one sitagliptin 100 mg tablet once daily in the morning following a fast of at least approximately 8 hours on Days 1 through 5 in one out of five treatment periods.; Saxagliptin 5 mg: one saxagliptin 5 mg tablet once daily in the morning following a fast of at least approximately 8 hours on Days 1 through 5 in one out of five treatment periods.; Vildagliptin 50 mg: one vildagliptin 50 mg tablet once daily in the morning following a fast of at least approximately 8 hours on Days 1 through 5 in one out of five treatment periods.; Vildagliptin 50 mg BID: one vildagliptin 50 mg tablet BID (twice daily), once in the morning following a fast of at least approximately 8 hours and once in the evening on Days 1 through 5 in one out of five treatment periods.; Placebo: one placebo for sitagliptin tablet once daily in the morning following a fast of at least approximately 8 hours on Days 1 through 5 in one out of five treatment periods.
Other intervention name(s): Januvia™; Onglyza™; Galvus™; Galvus™
Intervention MeSH terms: Sitagliptin Phosphate; Vildagliptin; Saxagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PAP Therapy in Patients With Obesity Hypoventilation Syndrome
Condition: Obesity Hypoventilation Syndrome
MeSH terms: Hypoventilation; Obesity Hypoventilation Syndrome; Obesity; Syndrome
Study type: Interventional

Summary: 
      The role of different levels of compliance and long-term effects of positive airway pressure
      (PAP) therapy on gas exchange, sleepiness, quality of life, depression and death rate in
      patients with obesity hypoventilation syndrome (OHS).
    

Detailed description: 
      Various forms of positive airway pressure (PAP) therapy are effective in providing short and
      long-term benefits in these patients with or without obstructive sleep apnea (OSA). However,
      there are limited data concerning the impact of long-term effects of PAP therapy on survival
      and functional status in individuals with obesity hypoventilation syndrome (OHS) and OSA.
      Therefore we aimed to assess the role of different levels of compliance and long-term effects
      of PAP on gas exchange, sleepiness, quality of life, depression and death rate in patients
      with OHS, two year after PAP initiation.
    

Intervention name(s): Positive airway pressure (PAP)
Intervention type(s): Device
Intervention description(s): Positive airway pressure (PAP) is a mode of respiratory ventilation used in the treatment of sleep apnea.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue
Condition: HIV/AIDS; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to look at how the body handles the drugs darunavir and
      etravirine. It will measure the amount of darunavir and etravirine in blood, semen, and in
      the rectum of men. The aim is to understand how much of the drug (taken by mouth) reaches the
      reproductive and intestinal tracts. It is believed that the presence of this drug in these
      areas may be beneficial in preventing the AIDS virus (HIV) from being passed from one person
      to another. The study will take samples of blood, semen and rectal mucosal tissue to measure
      drug levels. This study will also collect information on side effects.
    


Intervention name(s): darunavir; Ritonavir; Etravirine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Healthy male volunteers will take darunavir 600 mg orally twice daily for 15 doses (8 days); Healthy male volunteers will take ritonavir 100 mg orally twice daily for 15 doses (8 days); Healthy male volunteers will take etravirine 200 mg orally twice daily for 15 doses (8 days)
Other intervention name(s): Prezista; Norvir; Intelence
Intervention MeSH terms: Ritonavir; Darunavir; Etravirine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: HIV seronegativity
SHR-1210 in Recurrent/Metastatic Nasopharyngeal Carcinoma Who Have Received Previous At Least Two Lines of Chemotherapy.
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open label, single-arm, multi-center, phase 2 Study of SHR-1210 in
      recurrent/metastatic nasopharyngeal carcinoma(R/M NPC) patients who have received previous at
      least two lines of chemotherapy.
    

Detailed description: 
      The primary objective of this phase 2 study is to assess objective response rate of SHR-1210
      in patients with R/M NPC. The secondary objective is to observe the duration of response,
      progression free survival, time to response, overall survival and safety of SHR-1210 in R/M
      NPC. ADA is also investigated.
    

Intervention name(s): SHR-1210
Intervention type(s): Drug
Intervention description(s): A humanized monoclonal immunoglobulin PD-1 antibody
Other intervention name(s): Camrelizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurrent/Metastatic Nasopharyngeal Carcinoma; PD-1
Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single
      incision (Embryonic NOTES) colon surgery has been attempted.

      However, there are not sufficient evidences for single incision colon surgery in colon
      cancer.

      The investigators are researching the efficacy and safety of single incision laparoscopic
      sigmoidectomy in sigmoid colon cancer.
    

Detailed description: 
      After several randomized clinical trials, laparoscopic colon surgery has been performed
      widely. As a minimal invasive approach, single Incision (Embryonic NOTES) colon surgery has
      been attempted. Several studies reported the feasibility of single incision colon
      surgery.However, there are not sufficient evidences for single incision colon surgery,
      especially in colon cancer.

      The investigators are researching the efficacy and safety of single incision laparoscopic
      sigmoidectomy in sigmoid colon cancer. Harvested numbers of lymph node will be assessed for
      the efficacy and postoperative morbidity and mortality will be assess for the safety.
    

Intervention name(s): Single Incision Laparoscopic Surgery
Intervention type(s): Procedure
Intervention description(s): Single Incision Laparoscopic Sigmoidectomy
Other intervention name(s): Embryonic NOTES Sigmoidectomy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colorectal Cancer, laparoscopic surgery
Feasibility and Safety of Fasting in Fertility Treatment
Condition: Sub Fertility, Female; Fertility Disorders; Cycle Disorders Menstrual; Ovulation Disorder; Ovulation Absent; Ovulation Delayed; Ovulation; Failure or Lack of; Sub-fertility
MeSH terms: Infertility; Infertility, Female; Anovulation; Menstruation Disturbances
Study type: Interventional

Summary: 
      This exploratory study investigates fasting as a potential supportive therapy in infertility
      treatment for women suffering from infertility
    

Detailed description: 
      This 2-arm, randomized, controlled exploratory clinical trial aims to explore fasting as a
      novel supportive treatment in infertility. The participants will be randomized in two groups:
      fasting and waiting list. All groups will be trained and accompanied by medical experts and
      dieticians. In addition, qualitative interviews will be conducted including individual and
      focus group interviews with a subgroup of participants.
    

Intervention name(s): Fasting
Intervention type(s): Behavioral
Intervention description(s): Prolonged fasting for 7-10 days (caloric intake <500 kcal in liquid form)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are 2 parallel groups following different nutritional regimes. Additionally Qualitative Interviews with Patients and Doctors/Medical Staff.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: fasting; natural therapies; caloric restriction; lifestyle modification; dietary restriction; dietary intervention; prolonged fasting; weight loss; complementary medicine; integrative medicine
Right Lateral Positioning and Its Effect on Induction of General Anesthesia for Children
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      The quality of induction with sevoflurane, along with its ability to generate optimal
      conditions for Laryngeal Mask Airway (LMA) insertion without supplemental opioids or muscle
      relaxants, has also been well documented. An ideal inhalation induction technique besides
      being rapid and comfortable for the patient should be economical. To achieve rapidity, use of
      vital capacity breaths with 8% sevoflurane is a more popular method of induction compared
      with the conventional incremental induction.
    

Detailed description: 
      100 pediatric patients (age range, 1 to 8 years) scheduled for lower abdominal surgery under
      anesthesia will be included. All children in both groups will be premedicated with midazolam,
      0.5 mg/kg orally, about 30 minutes before the induction of anesthesia. A parent or guardian
      accompanied the child into the operating room to allow the child to remain calm and
      cooperative for inhalation induction. Before induction, pulse oximetry and electrocardiogram
      monitoring will be attached. For each group, inhalation induction was initiated using a face
      mask using "tidal volume" and "vital capacity" breathing in high sevoflurane concentration
      (8%).
    

Intervention name(s): supine position; Right lateral position
Intervention type(s): Procedure; Procedure
Intervention description(s): Anesthesia induction with sevoflurane for the patient while he is in supine position.; Anesthesia induction with sevoflurane for the patient while he is in right lateral position.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Right lateral; Induction; Children; Anesthesia
Effect of AN-PEP Enzyme on Gluten Digestion
Condition: Gluten Digestion
Study type: Interventional

Summary: 
      The aim is to demonstrate how fast and to what extent AN-PEP can degrade gluten in vivo in
      the stomach and how much gluten enters the small intestine. A second question is whether the
      caloric density of a meal can influence the efficacy of AN-PEP breakdown.
    

Detailed description: 
      In this trial, the effect of AN-PEP enzyme on gastrointestinal breakdown of gluten will be
      investigated in healthy subjects. In addition, it will be assessed if meal calories can
      affect the efficacy of AN-PEP. Subjects receive intragastrically, either AN-PEP or placebo,
      with either a high or a low caloric meal in a double-blind, randomized, placebo-controlled,
      cross-over fashion. Gastrointestinal fluid will be sampled to measure breakdown of gluten.
    

Intervention name(s): AN-PEP
Intervention type(s): Dietary Supplement
Intervention description(s): Endoprotease enzyme (AN-PEP)
Other intervention name(s): Aspergillus Niger Prolyl EndoProtease enzyme (AN-PEP)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: gluten