bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Buckwheat and Couscous on Satiety and Food Intake in Young Adults
Condition: Food; Eating; Appetite
Study type: Interventional

Summary: 
      A diet rich in whole grains has been linked to multiple beneficial health outcomes, including
      cardiovascular health, weight loss and a decreased risk of acquiring type 2 diabetes.
      However, grain products vary due to their botanical origin, composition, and post-harvest
      processing. While wheat is considered a dominant grain crop in Canada, the minor crops,
      including gluten-free buckwheat, become popular alternatives to wheat products such as
      couscous. Both buckwheat groats and couscous are traditionally consumed in the form of the
      porridge or side dish, however, their acute effects on satiety and food intake remain
      unknown. The objective of this study is to investigate the short-term effects of couscous and
      buckwheat on satiety and short-term food intake in young adult males.
    


Intervention name(s): Food-1; Food-2; Food-3
Intervention type(s): Other; Other; Other
Intervention description(s): Cooked buckwheat; Cooked couscous; Water
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized crossover
Masking: None (Open Label)
Primary purpose: Basic Science
Comparison of Video Laryngoscopy and Direct Laryngoscopy for Nasotracheal Intubation During Pediatric Dental Surgery
Condition: Airway Complication of Anesthesia; Peroperative Complication; Intraoperative Hypertension; Tachycardia, Sinus; Desaturation of Blood
MeSH terms: Tachycardia; Tachycardia, Sinus; Intraoperative Complications
Study type: Observational [Patient Registry]

Summary: 
      Background and Objective: Airway control is a condition that should be evaluated primarily in
      anesthesia practice in the pediatric age group. Failed intubation or prolonged intubation
      duration can cause atelectasis and hypoxia in children. The aim of this study was to examine
      the effects of Macintosh laryngoscopy and McGrath videolaryngoscopy on hemodynamic parameters
      in pediatric patients who were scheduled to undergo elective dental surgery and required
      intubation for the application of general anesthesia.

      Methods: Sixty-six patients were divided into two groups according to the procedure used
      during intubation, namely, direct laryngoscopy or video laryngoscopy. The Cormack-Lehane and
      Mallampati scores, intubation duration, heart rate at minutes 0, 1, 3 and 5 during
      intubation, mean arterial pressure, EtCO2and SpO2 values were recorded for all the patients.
    

Detailed description: 
      Many techniques in the management of a difficult airway have been used in adult patients. In
      pediatric patients, awake fiberoptic intubation is difficult or even impossible . The video
      laryngoscope is a new tool produced by combining video technology and laryngoscope. Published
      studies on the video laryngoscope were mostly performed in adults . In this study, we used a
      Macintosh laryngoscope, which is a routinely used tool in anesthesiology, and a McGrath video
      laryngoscope, which is a type of a newly developed video laryngoscope that has not widely
      been used in the pediatric age group. The aim of this study was to examine the effects of
      Macintosh laryngoscopy and McGrath videolaryngoscopy on hemodynamic parameters in pediatric
      patients who were scheduled to undergo elective dental surgery and required intubation for
      the application of general anesthesia. We also evaluated whether Macintosh laryngoscopy and
      McGrath videolaryngoscopy improved the stress response and whether these approaches
      facilitated the intubation procedure.
    

Intervention name(s): Laryngoscopy
Intervention type(s): Device
Intervention description(s): During the intubation, the head of the patient was kept in a neutral position, patients were nasotracheally intubated
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study included 66 ASA I-II patients with an age range of 4-13 years and who were
        scheduled for elective dental surgery under general anesthesia with intubation.
      
Keywords: pediatric oral surgery; direct laryngoscopy; video laryngoscopy; nasotracheal intubation
Melatonin Decreases Eye Pressure in Normotensive Patients
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Observational

Summary: 
      Agomelatine is a melatonin drug used to treat depressive disorder. Agomelatine may also some
      effects on ocular pressures. In this study, we aimed to demonstrate that melatonin decreases
      intraocular pressures when given depressive patients.
    

Detailed description: 
      Melatonin has been shown to be effective to decrease intraocular pressure in experimental
      animal researches. Agomelatine is a melatonin derivative drug approved for the treatment of
      depression, which is also available in our country. Depending on animal experiments, it can
      be assumed that agomelatine can decrease intraocular pressure. Demonstrating that agomelatine
      is effective to reduce eye pressure may give a concurrent treatment of depressive patients
      with glaucoma. With this it may be possible to treat both diseases at the same time with
      single drug. In this study, the researchers intended to investigate the changes in ocular
      tension in normotensive depressive patients treated with agomelatine.
    

Intervention name(s): Agomelatine 25 MG Oral Tablet
Intervention type(s): Drug
Intervention description(s): We will treat our patients with Agomelatine tablet of 25 mg.
Intervention MeSH terms: Agomelatine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Investigators seek to analyze the intraocular pressure changes depending on Agomelatin
        treatment. Depressive patients who are deemed suitable for agomelatine treatment on a
        routine basis by psychiatry clinic will be monitored with regard to intraocular pressure
        changes. Treatment decision will be given by the psychiatrist independently from patient's
        enrollment to the study. Then, investigators will measure intraocular pressure before the
        treatment and one month after the treatment.
      
Keywords: Agomelatine; Depression; Intraocular pressure
Reliability and Validity of Urdu Version of Global Physical Activity Questionnaire (GPAQ-U)
Condition: Physical Activity
Study type: Observational

Summary: 
      The GPAQ questionnaire is used to measure the physical activity. In this study, Investigators
      will observe the reliability and validity of global physical activity questionnaire in Urdu
      language in Pakistan among students to assess physical activity.
    

Detailed description: 
      The aim of study is to translate and culturally adapt Global physical Activity Questionnaire
      (GPAQ) into Urdu language and secondly to investigate the reliability and validity of GPAQ in
      Pakistan among university students. This study will be cross sectional survey study in which
      convenience sampling technique will be used.

      The results of study will help to know the validity and reliability of GPAQ in Urdu version
      among students in Pakistan. The reliability of the questionnaire will be checked through
      internal consistency and test-retest methods. Internal consistency will be analyzed with
      Cronbach's alpha value. Test-retest reliability will be assessed using an intra-class
      correlation coefficient with 100 patients
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Students, because they are usually engaged in their studies and have no enough time to do
        any physical activity resulting in decline in their overall health status.
      
Keywords: GPAQ; reliability,; Validity; Urdu
Effect of the InsuPatch on Automated Closed-loop Glucose Control in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This research study designed to look at how well adolescents' and young adults' blood sugars
      can be controlled with a "closed loop artificial pancreas" using a continuous glucose sensor,
      an insulin pump, and a computer program that automatically determines how much insulin to
      give based on the glucose level. The investigators will also study the effect of wearing a
      small heating patch, the InsuPatch, at the site of insulin infusion, on the ability of the
      closed loop system to control the blood sugar levels and to reduce the rise in glucose levels
      after meals.
    

Detailed description: 
      This is an open-label, single-center, randomized crossover study evaluating the performance
      of a closed-loop (CL) insulin delivery system using a subcutaneous glucose sensor and an
      external insulin pump comparing the peak post-prandial glucose levels and the post-prandial
      glucose AUC during either CL control alone or CL control with the InsuPatch in an inpatient
      hospital research unit (HRU) setting. The closed loop visit consists of approximately 67
      hours over 4 days and 3 nights.
    

Intervention name(s): ePID closed loop system; InsuPatch
Intervention type(s): Device; Device
Intervention description(s): Insulin pump controlled by closed loop unit and algorithm; device which applies local heating at 40 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Virtual Reality-Based Relaxation Program on Pain Intensity, Anxiety Level in Patients to be Applied With Endoscopy
Condition: Anxiety; Pain
MeSH terms: Pain; Anxiety Disorders
Study type: Interventional

Summary: 
      This study was conducted to evaluate the effect of relaxation exercise with VR (Virtual
      Reality) glasses on pain severity, anxiety level, physiological symptoms of anxiety and
      satisfaction in patients undergoing endoscopy.
    

Detailed description: 
      Beginning 1-2 minute before the start of the procedure, the patients will be watched (30
      minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars
      Glasses.
    

Intervention name(s): Virtual reality glasses
Intervention type(s): Other
Intervention description(s): Beginning 1-2 minute before the start of the procedure, the patients will be watched (30 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses, with a music background, licensed product "Secret Garden", during the procedure (30 minutes).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is an experimental study with pre-test and post-test control groups
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: virtual reality glasses; Pain; Anxiety; Endoscopy
Use of Proteomics for the Diagnosis of a Platelet-related Bleeding Disorder
Condition: Inherited Platelet Disorders
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Blood Platelet Disorders
Study type: Interventional

Summary: 
      The goal of this study is to identify the platelet defect responsible for the bleeding in
      families from our inherited platelet disorders Israeli-Palestinian registry. The
      investigators plan to characterize platelet proteome expression after removing high abundance
      proteins. The investigators will compare the proteome of sick and healthy members of families
      with inherited platelet disorders, and identify and validate structural proteins, signaling
      cascades and biomarkers for detection and diagnosis of unknown platelet disorders. The
      investigators expect to discover new key findings that allow better understanding of human
      platelet function and allow better diagnosis and treatment of patients with inherited
      platelet function disorders.
    


Intervention name(s): Blood collection for platelet protein samples
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: inherited platelet disorders; proteome
Parents Matter!: Interventions to Promote Effective Parent-Child Communication
Condition: HIV Infections; Sexually Transmitted Diseases; Pregnancy
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Parents Matter is a community-based project whose goal it is to develop and test an
      intervention designed to promote effective parent-child communication about sexuality in
      order to promote sexual health among adolescents.
    

Detailed description: 
      Participants in the intervention are African American parents or guardians who have children
      in the 4th or 5th grade that are 12 or younger. Recruitment was done through schools, housing
      authorities, community based organizations, and churches. Participants were randomly assigned
      to participate in one of three interventions delivered by community based interventionists.
      The enhanced sexuality communication intervention consists of five 2.5 hour sessions
      conducted over 5 weeks with booster sessions at 12 and 24 months post-intervention. The full
      sexual communication intervention focuses on general parenting skills and sexual
      communication skills using a variety of presentation modalities: group discussion, video, and
      role-plays. The brief sexual communication intervention consists of a single 2.5 hour session
      in which parents are provided with information on general parenting skills and sexual
      communication skills. Thus, this intervention seeks to provide the same information as the
      full sexual communication intervention but in a condensed format with little group
      participation. The control intervention is a single 2.5 hour session focusing on general
      child health issues such as diet and exercise rather than parenting and sexual communication.
    

Intervention name(s): Full Parent communication intervention; Brief Parent Communication Intervention; Control Parent Intervention
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Parent-child communication; Primary prevention; sexual risk prevention; HIV
Chinese Multiple Dose Escalation (MDE) High Dose Study
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety,
      Tolerability, Pharmacokinetics, and Efficacy of Cotadutide in Overweight/Obese Subjects with
      Chinese ancestry with Type 2 Diabetes Mellitus
    

Detailed description: 
      This is a randomized, double-blinded, placebo-controlled study designed to evaluate the
      safety, tolerability, PK and efficacy of ascending doses of cotadutide in overweight or obese
      subjects with T2DM. This study will enroll subjects aged 18 to 74 years with a body mass
      index (BMI) ≥ 25 and ≤ 35 kg/m2. Subjects will have a diagnosis of T2DM and inadequate blood
      glucose control as defined by a HbA1c of 7% to 8.5%, and will be on metformin monotherapy in
      the three months prior to screening. Total 16 Chinese subjects will be randomized to
      cotadutide or placebo in a 3:1 ratio (cotadutide [n=12] and placebo [n=4]) at multicentre in
      China mainland. Those subjects who receive cotadutide once daily SC will be titrated to a
      maximum of 600 μg once daily SC, beginning at 50 μg once daily SC. The study has about 2
      weeks screening period, a run-in period of 10 days and an up to 7-week up-titration treatment
      period followed by a 3-week treatment extension period at the dose of 600 μg and followed by
      a 28-day follow-up period.
    

Intervention name(s): Experimental: Cotadutide; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Cotadutide: subcutaneous (SC) injection; Placebo subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Total 16 Chinese subjects will be randomized to cotadutide or placebo in a 3:1 ratio (cotadutide [n=12] and placebo [n=4]) at multicenter in China mainland.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Cotadutide; MEDI0382; D5671C00005; Type 2 Diabetes mellitus; Obesity; Overweight
Kinesiotaping Effect Glenohumeral Shoulder Subluxation
Condition: Stroke; Subluxation, Glenohumeral
MeSH terms: Joint Dislocations; Shoulder Dislocation
Study type: Interventional

Summary: 
      To evaluate the effectiveness of the kinesiotaping on pain, recovery of movement and daily
      life activities in Turkish hemiplegic patients.
    


Intervention name(s): kinesiotape
Intervention type(s): Device
Intervention description(s): During the rehabilitation program, all patients with GHS had kinesiotaping three times a week.
Intervention model: Single Group Assignment
Intervention model description: This study is a quasi-experimental, single-subject AB design.
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Fixed Dose Combination of Glimepiride and Metformin in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

        -  To evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL
           M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control as
           reflected by HbA1c during a 20-week treatment period in patients with type 2 diabetes
           mellitus (T2DM) inadequately controlled with metformin.

      Secondary Objectives:

        -  To evaluate the percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5% of fixed dose
           combination of 1 mg glimepiride and 250 mg metformin (AMARYL M 1/250mg) in comparison
           with glimepiride (AMARYL) alone at week 20.

        -  To evaluate the effect on Fasting Plasma Glucose of fixed dose combination of
           glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL)
           alone at week 20.

        -  To assess the safety and tolerability of fixed dose combination of glimepiride and
           metformin (AMARYL M 1/250mg).
    

Detailed description: 
      The study consists of an up to 2-week screening period, a 20-week treatment period, and a
      3-day safety follow-up period. Total study duration is up to 23 weeks.
    

Intervention name(s): Glimepiride and Metformin hydrochloride combination (HOE490); Glimepiride (HOE490)
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:tablet Route of administration: oral; Pharmaceutical form:tablet Route of administration: oral
Intervention MeSH terms: Metformin; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy Vagal Nerve Stimulation in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      This is a 12 week open label pilot study to determine the efficacy and safety of a surgically
      implanted, electrically active vagal nerve stimulation device in patients with active
      rheumatoid arthritis.
    


Intervention name(s): Cyberonics VNS System
Intervention type(s): Device
Intervention description(s): Active Implantable Electrical Vagal Nerve Stimulator
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vagus Nerve; Vagal Nerve Stimulation; Rheumatoid Arthritis; Implantable Medical Device
A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System
Condition: Urinary Tract Infections
MeSH terms: Urinary Tract Infections
Study type: Interventional

Summary: 
      The Velieve U.S. UTI Urine Analysis Test System (henceforth Velieve U.S.) is composed of a
      kit and a smartphone application. The device will be provided to the subject in a simulated
      home-use environment. All subjects will be asked to complete the urine test by following the
      application guidance,including providing a urine sample and scanning the urine strip after
      placing it on the Color-Board. The user will also complete a questionnaire to collect
      information regarding the use of the Velieve U.S. device. Following the usability test
      performed by the lay user, the subject's urine sample will be tested by the professional user
      using the comparator device.

      The use of the Velieve U.S. device will be evaluated for identified risks. Additionally,
      measurable usability criteria for specific, critical steps will be evaluated.
    


Intervention name(s): Velieve U.S.
Intervention type(s): Device
Intervention description(s): The Velieve U.S. is a home use, in-vitro diagnostic (IVD) device. The device is used for the semi-quantitative detection of blood and leukocytes, and the qualitative detection of nitrites in urine.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Anesthetics and Auditory, Visceral, and Heat Evoked Potentials
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the present study is to investigate and quantify the influence of commonly used
      anesthetics on auditory and pain evoked potentials.
    

Detailed description: 
      During surgery patients are exposed to different auditory and sensory stimuli. In this study
      we investigate the influence of different anesthetics to alertness and nociception. In
      addition to auditory stimuli (AEP as a measure of sedation), Contact Heat Evoked Potential
      Stimuli (CHEPS), and esophageal evoked potentials from the lower 1/3 of the esophagus are
      measured to quantify the effects of anesthetics. 60 Volunteers are enrolled into this study.
      For each drug, three different levels are measured:

        -  level 1 no medication

        -  level 2 low dose of medication

        -  level 3 light sedation dose (volunteer responds to command)

      Four drugs are measured in the study:

      propofol, sevoflurane, S-ketamine and remifentanil.
    

Intervention name(s): Propofol; Remifentanil; S-Ketamine; Sevoflurane
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): TCI 0.5 mcg/ml 1.0 mcg/ml; continuous infusion 0.05 mcg/kg/min 0.15 mcg/kg/min; continuous infusion 0.25 mg/kg/h 0.50 mg/kg/h; via face mask 0.40 Vol% 0.80 Vol%
Intervention MeSH terms: Ketamine; Remifentanil; Propofol; Sevoflurane; Esketamine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pain; SSEP; CHEPS; Propofol; Sevoflurane; S-Ketamine; Remifentanil; Healthy volunteers