cyrilzakka/clinical-trials huggingface dataset:
Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis

In patients with asymptomatic aortic stenosis (AS), the prognostic value of reduced left ventricular (LV) ejection fraction is well known. Consequently, there is class I indication for surgery in these patients when LV ejection fraction \<50%. However, there is growing evidences suggesting that subclinical LV dysfunction, and more particularly longitudinal myocardial dysfunction, may be a powerful early predictor of outcome, even when LV ejection is still preserved. In asymptomatic AS patients with LV ejection fraction \>50%, a reduced LV global longitudinal strain, as assessed using speckle tracking imaging with transthoracic echocardiography, may be an accurate marker to identify early subclinical LV dysfunction and thus, to improve the risk stratification, the management and the timing of surgery. Several mono-centric observational small studies recently reported results emphasizing the role of LV global longitudinal strain in AS patients. Therefore, a meta-analysis may be conducted and may provide meaningful data. The investigators hypothesized that LV global longitudinal strain is a determinant of outcome in asymptomatic patients with AS and preserved LV ejection fraction.


Eligibility Criteria:
Inclusion Criteria:

* studies selected in PubMed, Embase, Ovid, and Google Scholar, published between 2005 and 2015 without language restriction according to the following criteria: "aortic stenosis" AND "longitudinal strain"

Exclusion Criteria:

* Studies reporting global longitudinal strain derived from VVI and not speckle tracking analysis.
* Studies with cohort of patients with aortic valve replacement indication
A Study of the Continuous Glucose Monitoring System for Home Use in Patients With Diabetes

Subjects in the upper arm group will have a sensor of the CGM System inserted on each arm (left and right upper arm). Subjects in the abdomen group will have 2 sensors inserted, one on each side of the abdomen (left and right abdomen) The sensors will be placed for 29 days. After sensor insertion, the CGM system should be calibrated with capillary blood glucose readings from a self-monitoring blood glucose meter。


Eligibility Criteria:
Inclusion Criteria:

1. Type 1 or 2 diabetes mellitus
2. Male or female age ≥ 18 years old and ≤ 70 years old
3. Willingness to adopt measures to prevent water coming into contact with the device sensor (e.g. abstain from swimming, sauna, avoid hitting the sensor with direct jets of water)
4. Ability to communicate with the investigators, able to operate medical device after training and comply with the testing procedures outlined in this protocol (including, but not limited to, willing to wear the continuous glucose monitor and testing capillary blood glucose)
5. Subjects who show understanding of the study procedures and willing to sign a written informed consent form.

Exclusion Criteria:

1. Hospitalization due to diabetic ketoacidosis or severe hypoglycemia, within 3 months prior to screening
2. HbA1c \>13% or urine ketone 3+
3. Use of pacemaker
4. Body Mass Index (BMI) ≤18.0kg/m2
5. Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites, i.e. upper arm or abdomen (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis)
6. Any psychiatric disease such as depression or anxiety
7. Any severe hepatic, renal, cardiac, cerebral, respiratory or neurological diseases (e.g. serum ALT, AST, Creatinine level ≥3 times the upper limit of normal)
8. Has a MRI scan, CT scan or other procedure requiring the subject be under strong magnetic or electromagnetic environment, scheduled during the proposed study participation
9. Blood loss \>400ml in the past 3 months (including blood donation)
10. Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study
11. Difficulty in sampling venous blood or cannot tolerate venipuncture
12. Participated in other investigational studies in the past 3 months
13. Currently pregnant or lactating women, or positive pregnancy test
14. Any condition that, in the opinion of the investigator, renders the subject not suitable for the study.
Impact of the Diagnosis of Celiac Disease

The main purpose of this study is to assess the impact of the diagnosis of celiac disease on general health, healthcare resource utilization, quality of life and lifestyle. We hypothesize that diagnosis and subsequent dietary treatment may have positive impact on these variables.

All new members with biopsy-proven celiac disease joining the Finnish Celiac Society will be categorized in three groups according to symptoms and signs leading to the diagnosis as classical symptoms, extraintestinal symptoms and screen-detected, the latest being further divided to those presenting with symptoms and those who are totally asymptomatic. Several parameters assessing general health and well-being, quality of life and healthcare resource utilization are evaluated at baseline and after one and five years on trial. Quality of life is compared to that of non-celiac controls.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis within one year
* biopsy-proven diagnosis

Exclusion Criteria:

* Celiac disease diagnosis previously than within one year
* No biopsy-proven diagnosis
Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease

The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.


Eligibility Criteria:
Inclusion criteria:

* Patients willing to participate with confirmed diagnosis of COPD
* 40 years of age or older
* having a 10 pack year smoking history
* able to perform serial pulmonary function tests
* able to use both a Dry powder inhaler (DPI) and Respimat device

Exclusion criteria:

* Significant other disease
* clinically relevant abnormal hematology, chemistry, or urinalysis
* history of asthma
* diagnosis of thyrotoxicosis
* paroxysmal tachycardia related to beta agonists
* history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year
* active tuberculosis, cystic fibrosis, clinically evident bronchiectasis
* significant alcohol or drug abuse
* pulmonary resection
* taking oral beta adrenergics
* taking unstable oral steroids
* daytime oxygen
* enrolled in rehabilitation program
* enrolled in another study or taking investigational products
* pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control
* those who are not willing to comply with pulmonary medication washouts
Investigation of the Automatic Technology on the Naída M Hearing Devices

In this clinical trial, an un-controlled, repeated measures open design with within-subject comparison will be used to evaluate the effect of the device under investigation on sound perception. This design was shown to be successful in previous studies for the evaluation of sound coding strategies.

Furthermore, a within-subject comparison decreases the variance in the results allowing for fewer subjects when the population using the investigational device is not large in general.

The primary endpoint of this clinical investigation is the difference in speech intelligibility measured in percent correct with AutoZoomControl compared to an omnidirectional microphone on Naída M hearing devices.The Naída CI M90 sound processor is a behind-the-ear (BTE) sound processor based on the Phonak Marvel hearing aid platform. It replaces the market approved Naída CI Q-Series processors. The Naída Link M90 hearing aid is a behind-the-ear (BTE) hearing aid based on the Phonak Marvel hearing aid platform. It is especially designed to be used for bimodal CI users equipped with a Naída CI M90 sound processor.

Eligibility Criteria:
Inclusion Criteria:

* · CI users with a CII, HiRes90K (Advantage) or HiRes Ultra (3D) implant system Bilateral users: two implant systems Bimodal users: hearing aid contralateral

  * Minimum of 18 years of age
  * Minimum of six months experience with their implant system
  * Minimum of six months experience with the Naída CI Q-Series sound processor
  * Ability to give feedback on sound quality
  * Speech reception thresholds of no more than 5 dB SNR \> 10 at the French Matrix test obtained during previous visits in the clinical routine
  * Fluent in French language

Exclusion Criteria:

* Difficulties additional to hearing impairment that would interfere with the study procedures

  * Concurrent participation in other study
  * Incapacity for consent
Mechanisms of Muscle Blood Flow Dysregulation and Exercise Intolerance in Chronic Kidney Disease

Patients with chronic kidney disease (CKD) experience fatigue and exercise intolerance. Increased oxidative stress in CKD may be a contributing factor. The role of impaired muscle blood flow regulation has not been fully explored. The investigators hypothesize that functional sympatholysis is exaggerated in CKD and this is associated with increased oxidative stress. The investigators also hypothesize that exercise training will improve functional sympatholysis and oxidative stress

Progressive muscle weakness and premature fatigue are characterize the condition of chronic kidney disease (CKD) which can be very debilitating. Mechanisms underlying exercise intolerance in CKD is not completely understood. Previous studies have demonstrated impaired skeletal muscle vasodilation during exercise in CKD patients, which may contribute to exercise intolerance. Normally, there is blunting of sympathetic mediated vasoconstriction in exercising muscle to allow for steady blood supply to exercising muscles. This phenomenon is called functional sympatholysis. Functional sympatholysis is impaired by increases in reactive oxygen specie and may be impaired in CKD.

Experiments will be performed on 2 groups of subjects 1) Normal kidney function (eGFR\>90) 2) Stage 2-3 CKD (eGFR 30-89). VAsoactive medications will be held for 72 hours before study. All participants will attend a baseline study visit, which will include a physical examination, a medical history review, vital sign measurements, and blood collection. Muscle nerve activity and muscle oxygenation will be measured while the subjects perform hand grip exercise at 30% maximum voluntary contraction with and without lower body negative pressure (- 20 mmHg). Muscle blood flow will be measured before and after hand grip exercises. CKD subjects will then be randomized to exercise training (to squeeze a tennis ball repeatedly for at least 30 min/day) or no exercise training for 28 days. Procedures in baseline visit will be repeated followed by cross over to alternate group for 28 days followed by repeat of baseline procedures. Blood flow, muscle oxygenation and muscle nerve activity will be compared between CKD and normal subjects as well as before and after exercise training for CKD subjects.

Eligibility Criteria:
Inclusion Criteria:

* Normotensive adults
* CKD 2-3

Exclusion Criteria:

* Blood Pressure ≥140/90
* eGFR \>60ml/min/1.73 m2 or eGFR \<30ml/min/1.73 m2
* Any evidence of cardiopulmonary disease, left ventricular hypertrophy or systolic dysfunction by echocardiography.
* Diabetes mellitus or other systemic illness
* Pregnancy
* Any history of substance abuse or current cigarette use
* Any history of psychiatric illness
* History of malignancy
The Effect of Consumption of Date Fruit and Nipple Stimulation in Late Pregnancy

The study was conducted to determine the effect of consumption of date fruit and nipple stimulation on labor.

The samples were applied to pregnant women satisfying the research criteria in a state hospital in Istanbul between October 2013 and June 2014.

The study was designed to be randomly controlled. Block randomization method was used to determine the experimental and control groups. Randomization was done by a biostatistician outside the researcher. 198 pregnant women were randomly assigned to the date fruit, nipple and control groups. From the 37th gestational age to the onset of labor, 6 date fruits were consumed per day by the date fruit group and the nipple stimulation was applied 6 minutes per day for the nipple group. No intervention was made for the control group. For the collection of research data, "Structured Information Form" and "Wijma Birth Expectancy / Experience Scale Version" were used.

Eligibility Criteria:
Inclusion Criteria:

* Women who nulliparous at the 37th gestational age, have singleton pregnancy, have the BMI is less than 25 kg/m2, planning to have a normal vaginal delivery, have vertex presentation, a volunteer to participate in the study, no smoking in pregnancy and have moderate birth fear according to W-DEQ were included in the study.

Exclusion Criteria:

* Women who have risk pregnancy (such as preterm labor risk, preeclampsia eclampsia, premature rupture of membranes, placenta previa, gestational diabetes, fetal anomaly and chronic diseases) were excluded in the study.
Lidocaine Compared to Magnesium Sulfate to Prolong Spinal Anesthesia: Non-inferiority Randomized Clinical Trial

This study evaluates the addition of continuous infusion of lidocaine or continuous infusion of magnesium sufate in the duration of spinal anesthesia.

Both lidocaine and magnesium sulfate have been shown to prolong spinal anesthesia.

The number of studies using magnesium sulfate to improve spinal anesthesia is greater than the number of studies using lidocaine, and methodology varies significantly between studies.

Adverse effects of lidocaine are different from magnesium sulfate's. Lidocaine has a wider therapeutic interval with fewer side effects, including: Drowsiness, Feeling Anxious, Feeling Cold, Nervous, Numbness And Tingling, Signs And Symptoms At Injection Site, Twitching.

Magnesium sulfate's side effects include: heart disturbances, breathing difficulties, poor reflexes, confusion, weakness, flushing (warmth, redness, or tingly feeling), sweating, lowered blood pressure, feeling like you might pass out, anxiety, cold feeling, extreme drowsiness, muscle tightness or contraction, or headache.

Eligibility Criteria:
Inclusion Criteria:

* Will receive spinal anesthesia for TURP por Histerectomy

Exclusion Criteria:

* Protocol violation;
* Severe adverse events;
* Change to general anesthesia or addition of epidural anesthesia;
* Complete or partial spinal block failure;
* Mental status alteration (agitation, confusion, loss of conciousness).
Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women

The purpose of this research is to evaluate the effectiveness of the ELITONE-UUI electrical muscle stimulation device on treating urge incontinence. The aim of the device is to stimulate the pelvic floor muscles and surrounding structures to improve urinary incontinence.

The purpose of this research is to evaluate the effectiveness of the ELITONE-UUI electrical muscle stimulation device on treating urge incontinence in women. The aim of the device is to stimulate the pelvic floor muscles and surrounding structures to improve urinary incontinence. This is a randomized prospective controlled study of two active groups with a stimulation frequency difference between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Predominant urge urinary incontinence as determined by responses to a series of three standard questions from the King's Health Questionnaire; specifically:

  * An affirmative response to "Is it very difficult to control when you have a strong urge to urinate?",
  * An affirmative or negative response to "Do you lose urine with physical activities such as coughing, sneezing, running?",
  * And, if an affirmative response to the second question, an affirmative response to "Are more of your incontinence episodes due to a strong urge to urinate than to abdominal pressure such as sneezing?"
* Mild-moderate incontinence symptoms as determined by self-reported typical number of accidents of 1 or more per 24 hours. Symptom severity is later verified with data from the Daily Log (See 5.4)

Exclusion Criteria:

* Less than 1 incontinence accident (leak) per day\*
* Severe incontinence as determined by self-reported \>5 accidents per day
* Currently pregnant, may be pregnant, attempting to become pregnant, or delivery within previous 6 weeks
* Vaginal or pelvic surgery within previous 6 months
* Severe Obesity as defined by BMI \>= 35
* Change in incontinence medication type or dosing within the last 3 months.
* History or symptoms of urinary retention, extra-urethral incontinence, overflow incontinence
* Pelvic pain/painful bladder syndrome
* Active urinary tract infection (UTI) or history of recurrent UTIs (more than three in a year), or recurrent vaginitis (bacterial/fungal)
* Tissues protruding outside the vagina at rest
* Presence of incontinence-associated dermatitis or other perineal skin disorders or lesions,
* Complete denervation of the pelvic floor
* Conductive inter-uterine devise (IUD/Coil) or metal implants in the abdominal or pelvic area, including the hip and lumbar spine,
* Chronic coughing
* Previous use of Interstim device or Botox for UI
* Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems.
* Cancer, epilepsy or cognitive dysfunction
* Underlying neurologic/neuromuscular disorder
* Impaired decision making, suicidal thoughts, or drug/alcohol dependence
* Lacks capacity to consent for themselves.
To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children

The purpose of this study is to evaluate the effectiveness(immunogenicity) and safety of 'GC1107' administered intramuscularly in healthy children

Randomized, double blind, multicenter, phase Ⅱ/Ⅲ study

Eligibility Criteria:
Inclusion Criteria:

* healthy Korean children(age: 10 \~ 17)

  * In the case of step1 (for step 1) 11\~12 years
* who got the basic vaccination(5 times vaccination of diphtheria and tetanus until 6 years old.)
* Subjects willing to provide written informed consent and able to comply with the requirements for the study or informed consent was obtained from the subject's legal guardian

Exclusion Criteria:

* Subjects with antitoxin of diphtheria and tetanus ≥1.0IU/mL (ELISA)

  * only applicable in step 1
* subjects who have not recovered from the acute disease within 2 weeks
* who has experienced the temporary platelet decrease or has the medical history of neurologic complication
* who has the medical history of allergic disease related to the components of investigational drug
* who has experienced the severe adverse events for the diphtheria and tetanus vaccination
* who got the vaccination of diphtheria and tetanus within 5 years
* who has not recovered from the acute disease within 2 weeks
* who got the treatment of blood product within 3 months
* who got the immunoglobulin should have the wash-out period
* who be infected from the diphtheria and tetanus
* Subjects who are scheduled to participate in other clinical trial studies during the study.
* Current participation in a clinical study involving any other drugs including vaccine within 4 weeks of enrollment of the study vaccine.
* Subjects who have participated in any other clinical trials within 4 weeks of the administration of the study
* Subject who have received adrenocortical hormones or immunosuppressive drug within 4weeks of enrollment
* Subjects with a history of chronic disease obstacles to the study.
* Subjects who have episode of acute febrile (at least 37.5) after injection of vaccine during the study
* Subject who have plan of operation during the study.
* Individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study.
Pain Management After Forefoot Surgery

The purpose of this study was to compare the efficacy of transdermal fentanyl to placebo both administered together with peroral nonsteroidal antiinflammatory drug (NSAID) and paracetamol in treatment of postoperative pain after hallux valgus or hallux rigidus surgery.


Eligibility Criteria:
Inclusion Criteria:

* unilateral hallux valgus or hallux rigidus surgery
* 18-75 yrs old
* ASA I-III

Exclusion Criteria:

* previous history of intolerance to the study drug
* history of alcoholism
* drug abuse
* psychological or other emotional problems that are likely to invalidate informed consent
* sleep apnoea
* BMI ≥ 35 kg/m2
Ultrasound Guided Percutaneous Tracheostomy Compared to Bronchoscopy Guided Percutaneous Tracheostomy

TRACHUS trial is a randomized non-inferiority trial designed to evaluate the safety and efficacy of ultrasound guided percutaneous tracheostomy compared to bronchoscopy guided percutaneous tracheostomy.

TRACHUS trial is a randomized non-inferiority trial designed to evaluate the safety and efficacy of ultrasound guided percutaneous tracheostomy compared to bronchoscopy guided percutaneous tracheostomy.

Patients will be randomly assigned to be submitted to ultrasound or bronchoscopy guided percutaneous tracheostomy and then the procedure related complications and clinical outcomes will be evaluated and compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* All intubated and mechanically ventilated patients indicated for a tracheostomy by the ICU assistant team

Exclusion Criteria:

* Patients with unfavorable anatomy judged by the patient assistant team (short neck, tracheal deviation, cervical anatomical anomaly, previous cervical surgery, cervical trauma or inability to perform neck extension), preference for surgical tracheostomy by the patient assistant team or patients unable to provide informed consent.
Misoprostol Prior to Office Hysteroscopy in Patients With no Risk Factors for Experiencing Unacceptable Pain

The aim of this study is to assess whether vaginal misoprostol reduces pain during office hysteroscopy in parous patients with no risk factors for experiencing severe or unacceptable pain.

Cervical ripening with misoprostol to minimize the pain experienced during office hysteroscopy has been proposed by several authors.

The use of misoprostol is usually associated with undesired side effects and therefore any beneficial effect of misoprostol on reducing pain should be weighed against its undesired side effects (nausea, vomiting, diarrhea, fever, shivering, pain) and coasts. Till now , no studies have yet determined whether misoprostol should be used routinely or for the subgroup of patients at higher risk for cervical stenosis.

The aim of this study is to assess whether vaginal misoprostol reduces pain during office hysteroscopy in parous patients with no risk factors for experiencing severe or unacceptable pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients with at least one vaginal delivery who have an indication for office hysteroscopy.

Exclusion Criteria:

* Nulliparous patients, menopausal patients and patients with cervical pathology, and previous history of caesarean section or cervical surgery