bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel
Condition: Ultrasound
Study type: Interventional

Summary: 
      The purpose of this single-blind, randomized control trial will be to investigate whether
      simply having warmed gel, as compared to room-temperature gel, during a bedside ultrasound
      significantly improves patient satisfaction scores.
    

Detailed description: 
      ED physicians who identify that a patient will require an ultrasound will page the ultrasound
      team as part of standard of care. At that time, an investigator will obtain verbal consent
      from the patient and provide an information sheet to help explain study details/answer any
      questions. The patient will then be randomized to either warmed gel or room temperature gel.
      Investigators will handle the gel using a heat-resistant glove (ULine Terry Cloth Glove) to
      maintain blinding to the gel temperature. A bedside ultrasound study will then be performed
      by emergency physicians not otherwise involved in the study using the study gel. Immediately
      upon ultrasound completion, the patients will complete a satisfaction survey. The images from
      the study will be saved and subsequently reviewed by an emergency physician with fellowship
      training in ultrasound to score image quality from 1 (low) to 5 (high).
    

Intervention name(s): Heated ultrasound gel; Room temperature gel
Intervention type(s): Device; Device
Intervention description(s): Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to "medium" setting (102 degree fahrenheit).; Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Acceptability Dermacyd Wipes - Lactoserum - Hygiene
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the safety of the gynecological formulation in
      normal and usual usage condition of Dermacyd Wipes
    


Intervention name(s): lactoserum
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Efficacy and Safety of ZL-3101 in Subjects With Subacute Eczema
Condition: Eczema
MeSH terms: Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, randomized, placebo-controlled multi-center phase IIA study to
      evaluate the clinical efficacy and safety of Fugan ointment versus placebo applied to
      involved skin of subjects with mild to moderate subacute eczema.
    

Detailed description: 
      In this study, patients will be recruited and randomized in a ratio of 2:2:1 into Fugan bid
      group (Fugan AM + Fugan PM), Fugan qd group (Fugan AM + Placebo PM), and placebo group
      (Placebo AM + Placebo PM). Randomization will be stratified by disease severity (mild IGA=2
      vs. moderate IGA=3).

      The patients will be given 3-week treatment and followed up for two weeks after the
      treatment.

      Screening period is set as 1 week. Subjects will be given 3-week treatment and followed up
      for two weeks after the treatment.

      Approximately 310 subjects will be randomized to achieve 250 evaluable subjects completing
      the study.
    

Intervention name(s): ZL-3101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A brown ointment, 10g/tube, 0.4g herb/g ointment, Topical; A brown ointment, 10g/tube, 0.02 g herb/g ointment (5% of Fugan active ointment), Topical
Other intervention name(s): Fugan ointment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: subacute
Study to Evaluate the Effect of Omalizumab on Improving the Tolerability of Specific Immunotherapy in Patients With Persistent Allergic Asthma
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to investigate the use of omalizumab as a pretreatment for patients
      with persistent allergic asthma who are candidates for allergen immunotherapy (ie, allergy
      shots) and will test the hypothesis that omalizumab may reduce the rate of systemic reactions
      to immunotherapy in patients with persistent allergic asthma.
    


Intervention name(s): Placebo; Omalizumab; Immunotherapy; Immunotherapy
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Doses of placebo were administered subcutaneously every 2 to 4 weeks according to the US product label, depending on the patient's body weight and baseline serum IgE.; Doses of omalizumab were administered subcutaneously every 2 to 4 weeks according to the US product label, depending on the patient's body weight and baseline serum IgE.; Customized allergen extracts were prepared centrally for each patient based on his/her specific skin test results. Four vials containing dilutions of the patient's extract were provided. Investigators initiated dosing according to the protocol for the cluster dosing titration regimen, beginning with vial #4 (the most dilute) and progressing to vial #1, which was the most concentrated or "maintenance" solution. Each dose was administered subcutaneously into the deltoid region as a single injection. During study visits that required multiple IT injections, each injection was to be given at least 30 minutes apart. During weeks that required multiple visits for IT injections, each visit was to be separated by at least 48 hours.; Customized allergen extracts were prepared centrally for each patient based on his/her specific skin test results. Four vials containing dilutions of the patient's extract were provided. Investigators initiated dosing according to the protocol for the cluster dosing titration regimen, beginning with vial #4 (the most dilute) and progressing to vial #1, which was the most concentrated or "maintenance" solution. Each dose was administered subcutaneously into the deltoid region as a single injection. During study visits that required multiple IT injections, each injection was to be given at least 30 minutes apart. During weeks that required multiple visits for IT injections, each visit was to be separated by at least 48 hours.
Intervention MeSH terms: Omalizumab; Immunomodulating Agents; Immunologic Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergic Asthma, IgE, immunotherapy, omalizumab
The Effect of IMB Model-Based Diabetes Education and Motivational Interviewing on Care Outcomes in Adults With T2DM
Condition: Type2 Diabetes; Self Efficacy; Self Management; HbA1c; BMI
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study was conducted to examine the effects of IMB model-based diabetes education and
      Motivational Interviewing for adults with Type 2 diabetes on care outcomes This study was
      conducted to examine the effects of IMB model-based diabetes education and Motivational
      Interviewing interventions on care outcomes for adults with Type 2 diabetes (diabetes
      knowledge, health belief, self-efficacy, self-management, HbA1c and BKİ).
    

Detailed description: 
      This study was conducted to examine the effects of Information, Motivation and Behavioral
      Skills (IMB) model-based diabetes education and motivational interviewing on care outcomes in
      adults with Type 2 diabetes. The study is a single-blind, randomized controlled trial with
      pre-test, post-test and follow-up test measurements from experimental research designs. The
      study was carried out in the Endocrinology and Metabolic Diseases Polyclinic, and the data
      were collected between June 2021 and February 2022. The sample of the study (intervention
      group=30, control group=30) consisted of 60 individuals with type 2 diabetes. Study data were
      collected with Adult Diabetes Information Scale, Health Belief Model Scale, Diabetes
      Self-Efficacy Scale, Diabetes Self-Management Scale and metabolic control parameters
      follow-up form. IMB model-based diabetes education and motivational interview program were
      applied to the individuals in the experimental group for three months. Initially, diabetes
      education was given in small groups in four sessions, then Motivational Interviews were held
      individually every two weeks for a total of five sessions via WhatsApp.
    

Intervention name(s): IMB model based Diabetes Education and Motivational Interviewing
Intervention type(s): Behavioral
Intervention description(s): IMB model-based interventions were applied to the intervention group for 3 month. For the information component of the IMB model, diabetes education consisting of four sessions was given in groups of five in the first two weeks. Each patient was given a "Diabetes Management Education Booklet" prepared by the researchers. For the motivation component of the IMB model, total 5 sessions 30-minute motivational interview was made with individual Whatsapp calls once every two weeks starting from the third week.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a parallel group randomized controlled study
Masking: Single (Participant)
Primary purpose: Supportive Care
Transperineal Ultrasound to Assess the Progress of Labour
Condition: Placenta Praevia; Vaginismus
MeSH terms: Vaginismus; Placenta Previa
Study type: Observational

Summary: 
      This is a prospective observational study of transperineal ultrasound between 24-42 weeks
      gestation and a prospective longitudinal observational study in all term (37-42 weeks)
      labouring women.
    

Detailed description: 
      This is a prospective observational study of transperineal ultrasound between 24-42 weeks
      gestation and a prospective longitudinal observational study in all term (37-42 weeks)
      labouring women.

      AIMS:

      This study aims to firstly assess the effectiveness and acceptability of transperineal
      ultrasound in women presenting between 24 and 42 weeks gestation in comparison with digital
      vaginal examination (VE). Secondly, in all term (37-42 weeks) labouring women, investigators
      aim to create an ultrasound based labour record, "a sonopartogram" and from this develop a
      predictive model for the outcome of labour.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Group 1: acceptability and feasibility group

        Group 2: predictive model group
      
Keywords: transperineal ultrasound; labour; sonopartogram; prediction model
Validity of the Turkish Version of the Profile Fitness Mapping Neck Questionnaire for Patients With Neck Pain
Condition: Pain; Neck Pain; Evaluations, Diagnostic Self; Assessment, Self
MeSH terms: Neck Pain
Study type: Observational [Patient Registry]

Summary: 
      As patients improve on one parametric result, the results on the other parametric may worsen,
      but the total score may not be affected. For this reason, it would be useful to make
      measurements that evaluate all the parameters of the patients. Thus, it would be more
      advantageous to score both pain and symptoms separately, as well as activity limitations.
      Therefore, neck specific surveys are needed to meet this need.

      For this reason, this study was planned to determine the validity of the questionnaire named
      "Profile Fitness Mapping Neck Questionnaire" in patients with neck pain.
    

Detailed description: 
      The translation of the original version of "Profile Fitness Mapping Neck Questionnaire" to
      Turkish will be translated by two independent professional translators. Afterwards, a person
      without a medical history and a native English speaker will be translated into English again.
      Once the translation stages are complete, the translators will be brought together to discuss
      the two versions of the questionnaire. Then the final state will be translated into the main
      language of the questionnaire and the compliance will be checked.

      First of all, people who have been suffering from low back pain for at least six months will
      complete the "Profile Fitness Mapping NeckQuestionnaire", "Neck Disability Index", "SF-36
      health related quality of life questionnaire" and "Visual Analog Scale".

      Seven days after the questionnaire, the "Profile Fitness Mapping Neck Questionnaire" will be
      completed again.
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): Profile Fitness Mapping Neck Questionnaire
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with neck pain
One Week of Magnesium Supplementation Lowers IL-6, Perceived Pain and Increases Post Exercise Blood Glucose in Response to Downhill Running
Condition: Magnesium Deficiency
MeSH terms: Magnesium Deficiency
Study type: Interventional

Summary: 
      This study investigated the effect of magnesium supplementation on exercise performance and
      functional recovery in recreational endurance athletes in conjunction with measures of blood
      glucose, lactate, IL-6 and sIL-6R.
    

Detailed description: 
      Magnesium status can directly affect circulating glucose concentrations both during and post
      exercise. In addition, magnesium supplementation has been shown to reduce circulating IL-6
      concentrations post exercise in humans. It is conceivable that such observations are linked
      through the role of IL-6 in glucose regulation, possibly in combination with sIL-6R.
      Together, magnesium intake may have the potential to effect exercise performance and recovery
      through glucose availability. This in turn may be connected to the production of IL-6 and
      sIL-6R which have been established to influence exercise fatigue and perception of pain
      (muscle soreness).
    

Intervention name(s): Magnesium oxide; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Magnesium capsule; Cornflour capsule manufactured to mimic the 166.6 mg magnesium capsule.
Intervention MeSH terms: Magnesium Oxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Magnesium; Supplementation; Interleukin-6; Soluble interleukin-6 receptor; Glucose; Pain; Exercise performance; Exercise recovery; Downhill running
Effect of Behavioral Therapy Versus Interferential Current on Bladder Dysfunction in Patients With Multiple Sclerosis
Condition: Bladder Dysfunction on Patients With Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      study the effect of behavioral therapy and interferential current on management of bladder
      dysfunction in patients with multiple sclerosis
    

Detailed description: 
      Fifty patients with multiple sclerosis (MS) (secondary progressive type SPMS) suffering from
      bladder dysfunction were divided equally into two groups randomly; Group A received
      biofeedback training (behavioral therapy) while group B received interferential training.
      Both groups were assessed by urodynamics for detrusor pressure and maximum flow rate before
      and after eight weeks of behavioral therapy and interferential training.

      Data analysis was managed using SPSS for windows, version 22 (SPSS, Inc., Chicago, IL). The
      current test involved two independent variables. The first one was the (tested group);
      between subject factors which had two levels (group A received behavioral therapy and group B
      who received IF ) .The second one was the (measuring periods); within subject factor which
      had two levels (pre, post). In addition, this test involved two tested dependent variables
      (detrusor pressure and maximum flow rate ) .T independent and dependent tests were used to
      compare between and within groups respectively. Data was considered statistically significant
      when P < .05
    

Intervention name(s): biofeedback training and interferential therapy
Intervention type(s): Device
Intervention description(s): compare the effect of applying both types of devices on the pelvic floor muscles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department
Condition: Migraine
MeSH terms: Migraine Disorders; Emergencies
Study type: Interventional

Summary: 
      This is a pilot feasibility acceptability study to examine the impact of smartphone-based
      progressive muscle relaxation (PMR) on migraine quality of life, frequency, intensity, and
      disability. Feasibility is measured by: a) Proportion of patients who enrolled in the
      study/were recruited for the study, b) Number of days PMR practiced/week as determined with
      the backend analytics in the RELAXaHEAD app, c) Minutes/day spent doing PMR, d) Reasons for
      non-adherence. Acceptability is measured by: a) Satisfaction using Likert scale questions on
      RELAXaHEAD usability, content, and functionality b) Willingness to repeat a similar treatment
      intervention in the future (Definitely No/Probably No/Unsure/Probably Yes/ Definitely Yes) c)
      Attrition. In addition, whether use of electronically based PMR introduced in the emergency
      department (ED) improves migraine quality of life (MSQv2) and migraine related disability
      (MIDAS) at 3 months post ED-discharge (or post enrollment date if recruited post ED
      discharge) compared to those who are not introduced to PMR will be assessed. All participants
      will be asked to track their headache frequency and intensity using our smartphone
      application (app) and will be asked to complete migraine quality of life assessments and
      migraine related disability at follow-up.
    

Detailed description: 
      While explaining the study, potential participants will be assured that they will receive all
      of the medication for their acute headache that they would otherwise receive. Once consented,
      participants will be randomized to PMR therapy or monitored usual care (MUC). Participants
      will be told that either group is being tested as an enhancement to the care they typically
      get in the ED for headache. (At the end, they will be informed which group they were in.) The
      study team will collect participants' health histories (biologic variables) and baseline data
      in REDCap, download the app onto subjects' smartphones, and conduct the sessions.
    

Intervention name(s): PMR (Progressive muscle relaxation therapy); Monitored Usual Care (MUC)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Technique for learning to monitor and control the state of muscular tension. The relaxation therapy should take about 20 minutes a day.; Subjects will be given basic migraine information such as evidence-based ways to treat migraine: treat early, limit acute medications < 2-3 days/week, and call the primary care physician (PCP) if abortive medications are used more frequently.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Prevalence and Predictors of Esophageal Thermal Lesions in High-power-Short-duration Ablation of Atrial Fibrillation
Condition: Esophagus Injury; Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      Patients with documented atrial fibrillation who were referred to our clinic for catheter
      ablation will undergo standard HPSD ablation and subsequent esophagoscopy.

      After esophagoscopy patients will be followed up for one month in the form of a telephone
      follow-up.

      The primary endpoint of the study assessed by esophagoscopy performed on the day after the
      index catheter ablaton is the incidence of esophageal thermal lesions.

      Secondary endpoints include:

        1. The size of the esophageal thermal lesions.

        2. The severity of esophageal thermal lesions.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients with documented atrial fibrillation who were referred to our clinic for
        pulomary vein isolation
      
Keywords: Atrial Fibrillation; Esophagus Injury; Pulmonary vein isolation; Esophagoscopy
CS02 vs Placebo With Metformin in Type 2 Diabetes Mellitus (T2DM)
Condition: T2DM With Inadequate Glycemic Control
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to compare the efficacy and safety of 3 doses CS02 Tablet in
      combination with a stable dose of metformin monotherapy against CS02 PTM (placebo) Tablet in
      combination with a stable dose of metformin monotherapy over a 12 weeks treatment period in
      subjects with type 2 diabetes mellitus with inadequate glycemic control on metformin alone.
    


Intervention name(s): CS02 tablet and placebo tablet
Intervention type(s): Drug
Intervention description(s): Subjects receive CS02 tablet or placebo tablet BID daily with a stable dose of metformin monotherapy of ≥ 1500 mg/day for 12 weeks treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Beetroot Juice Ingestion and Vertical Jump Performance
Condition: Dietary Supplements
Study type: Interventional

Summary: 
      Beetroot juice is a dietary supplement with good evidence for improving sports performance in
      different sport contexts, however, the evidence about the effects of beetroot juice in jump
      capacity is unclear. Thus, the aim of this study was to conduct a comprehensive examination
      of beetroot juice effects on vertical jump performance
    

Detailed description: 
      Beetroot juice is a dietary supplement with good evidence for improving sports performance in
      different sport contexts, however, the evidence about the effects of beetroot juice in jump
      capacity is unclear. Therefore a deeper knowledge about the effects of beetroot juice on
      several components of vertical jump performance remain largely unexplored between we can
      mention phase duration peak power, average power, peak velocity, initial force, and peak
      force. Thus, the aim of this study was to conduct a comprehensive examination of beetroot
      juice effects on several countermovement jump components.
    

Intervention name(s): Beetroot juice
Intervention type(s): Dietary Supplement
Intervention description(s): 140 mL of beetroot juice or beetroot juice placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment