bioihbjkbjnl/mcl2 huggingface dataset:
Neuropathic Pain and Quality of Life in ICU Survivors
Condition: Critical Illness
MeSH terms: Neuralgia; Critical Illness
Study type: Observational

Summary: 
      Previous research on intensive care unit (ICU) survivors shows that rehabilitation is
      challenging, because of patients experiences of disease related problems both under and after
      treatment. Approximately 20 % of patients die within hospital, up to 80% suffer from
      hallucinations and nightmares, deal with paranoiac experiences, chronic pain and other
      symptoms and disability (Angus et al 2004; De Letter et al 2001; Ely et al 2001; Nelson et al
      2006; Van den Berghe et al 2001; Van den Berghe et al 2003) . A recent study shows that 28%
      of intensive care survivors have chronic pain that reduce their health related quality of
      life (Boyle et al 2004).

      The aim of this study is to perform a survey about prevalence of pain type, and which
      consequences this causes when it comes to function and quality of life up to 12 months after
      the ICU stay.

        1. What type of pain has ICU survivors and how do pain change over time, related to
           treatment/rehabilitation and the illness' development?

        2. What is the relationship between different pain characteristic, quality of life,
           anxiety, depression, fatigue, sleep and PTSD in these patients?

        3. What is these patients largest obstacle for good QoL after discharge from hospital?
    

Detailed description: 
      A prospective and longitudinal survey 3 time points for data collection:

        1. ICU - background data about the patients ICU stay (days on ventilator, medication,
           treatment, SAPS II, SOFA etc).

        2. 3 months after ICU discharge - survey about pain, QoL, sleep, fatigue, Post traumatic
           stress disorder (PTSD), anxiety and depression.

        3. One year after ICU discharge - the same as 3 months.

      Survey instruments:

      Pain - Brief Pain Inventory, Neuropathic Pain Syndrome Inventory, Pain diary QoL - SF 12,
      Sleep - General Sleep Disorder Scale Fatigue - Lee Fatigue Scale Anxiety and depression -
      Hospital Anxiety and Depression Scale PTSD - PTSS 10 Social Provision - Revised Social
      Provision Scale
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients in a Norwegian ICU. Medical and surgical patients, no thorasic surgery or
        trauma.
      
Keywords: Critical illness; pain; quality of life
Inflammatory and Metabolic Outcomes After Obese Woman Performed High Intensity Interval Training
Condition: Obesity and Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The main purpose of this study is to compare the effects of high intensity interval training
      and moderate intensity continuous training on inflammatory profile and metabolic markers,
      after 8 weeks of intervention trial in obese women.
    


Intervention name(s): CTR; MICT; HIIT
Intervention type(s): Other; Other; Other
Intervention description(s): no counseling or nutritional therapy and no exercise; no counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based moderate continuous intensity training (MICT).; no counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based high intensity interval training (HIIT)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three-arm parallel, Randomized-controlled study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: High intensity interval training; Inflammation; Obesity; adipokines
A Clinical Trial to Assess the Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor
Condition: Halitosis
MeSH terms: Halitosis
Study type: Interventional
Phase: Phase 1

Summary: 
      A mouthwash containing chlorine dioxide would be effective to reduce oral malodor.
    

Detailed description: 
      A randomized, double blind, crossover, placebo-controlled clinical trial was conducted among
      15 healthy male volunteers, who were divided into 2 groups: experimental or control group. In
      the first test phase, the subjects in the experimental group were instructed to rinse with
      the mouthwash containing ClO2 and those in the control group with the placebo mouthwash
      without ClO2. In the second test phase after one week washout period, same procedure was
      conducted with the opposite mouthwashes. Oral malodor was evaluated at before rinsing, right
      after rinsing and follows up every 30 minutes till 4 hours with OM, and the concentrations of
      hydrogen sulfide (H2S), methyl mercaptan (CH3SH) and dimethyl sulfide ((CH3)2S) which are the
      main volatile sulfur compounds (VSCs) of human oral malodor were evaluated with GC.
    

Intervention name(s): Chlorine Dioxide
Intervention type(s): Other
Intervention description(s): Experimental mouthwash (ClO2 Fresh®): 0.16% sodium chlorite (NaClO2) with an efficacy of 0.1% chlorine dioxide (ClO2),Placebo mouthwash: glycerin, mint oil and distilled water, contents are almost the same as those in the experimental mouthwash except ClO2.
Other intervention name(s): ClO2 Fresh®
Intervention MeSH terms: Chlorine dioxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: chlorine; dioxide; mouthwash; organoleptic; measurements; volatile; sulfur; compounds
Real-time Interactive Digital Healthcare System in Post Operation Patients With Breast Cancer; Pilot Study
Condition: Breast Cancer; Rehabilitation
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study aims to examine the effect of hospital-home linkage short-term rehabilitation
      therapy using real-time interactive digital healthcare system (Uincare Homeplus) in
      post-operative patients with breast cancer. This is prospective pilot study. 20 breast cancer
      patients who underwent wide local excision-axillary lymph node diessection or modified
      radical mastectomy will be examined, and those with limited range of motion (ROM) of affected
      shoulder will be enrolled in the study. Shoulder ROM, Quick-DASH, pain evaluation with NRS,
      quality of life evaluation with FACT-B and EQ-5D will be evaluated on enrollment, 4-week,
      8-week, and 12-weeks after enrollment.
    

Detailed description: 
      The limited range of motion (ROM) of the shoulder occur often after receiving breast cancer
      surgery, which may be due to post-operative pain, stiffness of shoulder girdle muscle, and
      etc. Due to this limited ROM, the patients may suffer difficulty in activities of daily life
      and quality of life may be reduced.

      Uincare Homeplus is software manufactured in Korea, which uses infrared, kinect camera and
      motion capture technology to track 3D motion of the patients' articulation. Using this
      technology, the patients can receive feedback of their motion immediately.

      The objective of the study is to examine the effect of hospital-home linkage short-term
      rehabilitation therapy using real-time interactive digital healthcare system (Uincare
      Homeplus) in post-operative patients with breast cancer.
    

Intervention name(s): Uincare
Intervention type(s): Device
Intervention description(s): Interactive digital healthcare system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Multi-Site Near Infrared Spectroscopy (NIRS) Monitoring of Children During Tilt Table Testing
Condition: Syncope
MeSH terms: Syncope
Study type: Observational

Summary: 
      PURPOSE OF THE STUDY

      This study will explore the use of multi-site NIRS monitoring during tilt table testing,
      combining somatic and cerebral saturations data with hemodynamic data to establish the
      non-invasive assessment of global cardiac output distribution trends.

      HYPOTHESIS / SPECIFIC AIMS

      Study Aims: To evaluate the utility of multi-site NIRS monitoring in the cardiovascular
      hemodynamic assessment of children and adolescents during tilt table testing by establishing
      a non-invasive method to predict cardiac output maldistribution with the use of two-site NIRS
      monitoring in children and adolescents with syncope.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children ages 7 through 21 years who present to exercise stress lab for investigation of
        syncope.
      
Keywords: Infrared Spectroscopy; Syncope; Tilt Table Testing
CGM Use in Children With Type 2 Diabetes
Condition: Type 2 Diabetes; Hyperglycemia Due to Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Study type: Interventional

Summary: 
      The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system
      for a 10 day wear period in pediatric Type 2 diabetes patients improves short term time in
      range glucose control and 3-6 month glycemic control.
    

Detailed description: 
      The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system
      for 10 days has an impact on short and long term glycemic control and behavior in youth onset
      Type 2 diabetes.
    

Intervention name(s): Continuous glucose monitor
Intervention type(s): Device
Intervention description(s): Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
Other intervention name(s): Dexcom G6 CGM
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: continuous glucose monitoring (CGM); Hemoglobin A1c
Cortisol Measurement During Intravenous Access With a Medical Clown
Condition: Stress, Physiological
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the presence of a medical clown in a
      pediatric emergency department procedure room would reduce children's anxiety. The
      investigators hypothesize that this positive influence will be expressed as lower levels of
      the stress hormone (Cortisol) in the blood.
    


Intervention name(s): Clown
Intervention type(s): Behavioral
Intervention description(s): Comparison of routine venipuncture with a distraction technique by a medical clown
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Medical clown; Pediatric emergency medicine
Non-contrast Cardiac CT as a Risk Stratification Tool in Patients With Non-cardiac Chest Pain
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      Background:

      Only around 20% of all patients seen in hospital with suspected Acute Coronary Syndrome will
      have Acute Myocardial Infarction. However, several studies indicate that patients where ACS
      had been excluded by conventional methods sustain a higher cardiac morbidity and mortality
      than the background population. Not all of these patients can be identified by traditional
      risk factors such as cholesterol, hypertension, and diabetes or with conventional methods
      such as ECG, troponin and clinical symptoms. Non-Contrast Cardiac-CT measures the amount of
      calcification in the coronary arteries and might be a useful addition in predicting future
      cardiac events in this patient group. The aim of this study is through a double-blinded study
      to determine whether non-contrast CT scan with calcium score can be used to identify patients
      at increased risk of death and cardiac event within the following 12 months after an acute
      admission where troponin measurements were normal.

      Methods:

      The study will investigate patients with suspected Acute Coronary syndrome who have been
      examined and subsequently sent home from an emergency- or cardiology department without ACS
      or another obvious explanation. 750 patients, age 30-70 years who are included in the study:
      "Identification of risk factors in non-cardiac chest pain patients" will be offered a
      non-contrast CT scan with calcium score within 14 days after the hospital contact. The
      participants will be included in a 12 months follow up, where the result of the calcium score
      is not revealed neither for the patient nor the investigator. After 12 months the results of
      the scan is compared with the rate of cardiac events. This project is a multicenter study and
      recruits patients from 6 emergency - and cardiology departments in the region of Southern
      Denmark.

      The study commences at September 2014 and results of this project are expected to contribute
      to the risk stratification of Non-cardiac chest pain patients.
    


Intervention name(s): Non-contrast Cardiac CT scan
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will investigate patients with suspected Acute Coronary syndrome who have been
        examined and subsequently sent home from an emergency- or cardiology department without ACS
        or another obvious explanation. 750 patients, age 30-70 years
Clinical and Radiographic Evaluation of Oral Findings in Children of Multiple and Single Births
Condition: Oral Findings in Children of Multiple and Single Births; Radiographic Evaluation of Oral Findings in Children of Multiple and Single Births
Study type: Interventional

Summary: 
      Clinical and radiographic evaluation of oral findings in children of multiple and single
      births
    

Detailed description: 
      In this study, the study groups comprised MZ and DZ twin pairs, triplets and singletons
      between the ages of 2 and 17 who attended the Department of Pediatric Dentistry at Suleyman
      Demirel University between January 2018 and September 2020. Twins and triplets who had
      developmental anomalies such as cleft lip and palate, premature tooth loss, systemic diseases
      or syndromes that could influence oral health or had already undergone or were undergoing
      orthodontic therapy, as well as those whose family did not give consent, were excluded from
      the study.

      All children were assessed by the same experienced pedodontist (E.O.) to avoid interexaminer
      variability. The oral examination was performed using sterile mouth mirror and probe. The
      prevalence of dental caries was recorded using dmft index (decayed, missing and filled teeth)
      in primary dentition and DMFT index (Decayed, Missing and Filled teeth) in permanent
      dentition. When evaluating patients over 6 years old, the missing tooth component was not
      included in the primary dft scores.

      Oral hygiene practices, such as tooth brushing frequency and the children's past or present
      oral habits (digit sucking, nail biting, tongue thrust, bruxism, lip biting, pencil biting,
      cheek biting and mouth breathing), were also recorded.

      The primary molar relationships were evaluated as flush terminal plane and mesial and distal
      step. The permanent molar relationships were recorded as Class I, Class II (Division 1 and 2)
      and Class III. Occlusal traits such as increased overjet, deep bite, open bite and anterior
      and posterior crossbite were recorded as present (1) or absent (0) with the help of a dental
      probe
    

Intervention name(s): The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple births
Intervention type(s): Other
Intervention description(s): The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple births
Intervention MeSH terms: Salicylic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: dental caries; multiple births; oral habits; singletons; twins
Effect of Added Fruit Pomace Fiber, Juice, and Whole Fruit on Postprandial Glycemia
Condition: Glycemic Index
Study type: Interventional

Summary: 
      Compare the effects of whole orange, orange juice alone, and orange juice with added orange
      pomace fiber, and whole apple, apple juice alone, and apple juice with added apple pomace
      fiber, on 2h glycemic response.
    


Intervention name(s): Fruit; Fruit juice; Fruit juice plus fiber
Intervention type(s): Other; Other; Other
Intervention description(s): Phase 1 is 227g of orange fruit, Phase 2 is 230g of apple fruit; Phase 1 is 250g of orange juice, Phase 2 is 235g of apple juice; Phase 1 is 157g of orange juice + 100g of orange pomace fiber (39% pomace by weight), Phase 2 is 129g of apple juice + 106g of apple pomace fiber (45% pomace by weight)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Cross-over
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Juice; Fiber
The Effect of Hypotensive Anesthesia on Hemoglobin Levels During Total Knee Arthroplasty
Condition: Anesthesia
Study type: Observational

Summary: 
      The current study investigates the effect of hypotensive anesthesia on patient hemoglobin
      levels during primary total knee arthroplasty. Considering that because of the tourniquet
      there is no blood loss during the first 60 minutes of the procedure changes in hemoglobin
      during the first 60 minutes should be primarily related to decrease in blood pressure and
      secondary to fluid loading during hypotensive anesthesia.
    

Detailed description: 
      The specific aim of this prospective study is to collect serial hemoglobin levels
      intraoperatively during hypotensive anesthesia to evaluate if intraoperative intravenous
      fluid substitution will change hemoglobin levels during the time the tourniquet is inflated
      (no blood loss).

      The combination of vasodilation during hypotensive anesthesia and fluid substitution will
      result in decrease of hemoglobin levels during the tourniquet time.

      Tubes of 5cc to measure hemoglobin and hematocrit levels preoperatively, prior to inflation
      of the tourniquet, 15 minutes, 30 minutes, 45 minutes and 60 minutes after tourniquet
      inflation and in PACU as well as POD 1.
    

Intervention name(s): Blood drawn
Intervention type(s): Diagnostic Test
Intervention description(s): Hemoglobin and Hematocrit Levels
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients scheduled for primary total knee arthroplasty who meet the qualifications will
        be consented prior to the surgery.
      
Keywords: Blood management; Blood transfusion; Hemoglobin; Hypotensive Anesthesia; Total Knee Arthroplasty
Pediatric Epilepsy Study in Subjects 1-24 Months
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with
      partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age
      who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will
      be added to the subject's current epilepsy medications.
    


Intervention name(s): lamotrigine
Intervention type(s): Drug
Intervention MeSH terms: Lamotrigine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: epilepsy; pediatric; partial seizures
Randomized, Double-blind, Placebo-controlled Study in Patients With Fistulizing Crohn's Disease
Condition: Fistulizing Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to investigate the safety and tolerability of locally
      administered DLX105 in treating enterocutaneous fistulas in Crohn's Disease patients.

      The study will consist of a screening period of approx. 2 weeks, a 4-week treatment period
      and a 2-week follow-up period. An end-of study visit is scheduled on Day 43, 2 weeks after
      the last study visit.
    

Detailed description: 
      Beside investigation of the safety and tolerability of locally administered DLX105, the
      purpose of the study is also to evaluate the response rate and time to response of
      enterocutaneous fistulas following local injection of DLX105 (secondary objective).
    

Intervention name(s): DLX105; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10mg DLX105/injection injected into the fistula over a treatment period of 4 weeks.; Placebo injections are administered over the treatment period of 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: non-invasive management; Fistula; Crohn's Disease; local administration; non-invasive
Efficacy of Ginsana in Improving Half-time Hemoglobin Re-oxygenation in Healthy People
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to assess the efficacy of ginsana in improving half-time hemoglobin re-oxygenation in
      healthy, recreational sportspeople and to assess the safety of the product
    


Intervention name(s): GINSANA; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment