cyrilzakka/clinical-trials huggingface dataset:
"Holding-cuddling" Plus Oral Sucrose Versus Oral Sucrose for Reducing Venipuncture Pain in Newborns and Infants

"Holding-cuddling" plus oral sucrose versus oral sucrose for reducing venipuncture pain in newborns and infants.

Neonates and infants routinely undergo venipuncture in pediatric and neonatal intensive care units.

Such procedure is painful and several units administer 24% oral sucrose with pacifier during venipuncture, as this non-pharmacological intervention is considered safe and effective for procedural pain relief in infants from birth to 3 months of age. However, several studies point out that further research is needed to assess its efficacy in combination with other behavioral interventions for analgesia during painful procedures. Current knowledge suggests that multisensorial stimulation associated with oral sucrose could allow even more effective analgesia. To date, the studied stimulation strategies are based on massage, voice, eye contact and fragrance during heel prick. The "holding-cuddling" - that is the fact of holding the child in a safe, reassuring and warm position during the examination or medical intervention is promoted by various hospitals in order to favor the comfort of all the caregivers during such a procedures. This intervention should be primarily parents-driven but, in case of unavailability, it can be performed by the nursing staff. The hypothesis of this study is that the combination of "holding-cuddling" plus oral sucrose in more effective than oral sucrose in diminishing behavioral pain response during a venipuncture in newborns or infants less than three-month-old.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalization at CHU de la Réunion - site sud in Neonatal Intensive Care Unit or Neonatology Unit. (Neonate reanimation, pediatric reanimation or Neonatology services)
* Informed consent from holder(s) of the parental authority

Exclusion Criteria:

* Intubated ou sedated patients
* Treated with a combined analgesic during venipuncture
* Having indications against sucrose
* For which behavorial items from DAN scale are difficult to evaluate regarding their pathology (ex: severe neuromotor handicap)
Compression Is Life In Cardiac Arrest - Quality Study (CILICA-QS)

Context: Chest compressions quality is known to be essential in cardiopulmonary resuscitation. Despite a known harmful effect of chest compressions interruptions, current guidelines still recommend provider switch every 2 minutes. Feedback impact on chest compressions quality preservation during cardiopulmonary resuscitation remains to be assessed.

Study design: simulated prospective monocentric randomized crossover trial.

Participants and methods: Sixty five professionals rescuers of the pre-hospital care unit of University Hospital of Caen (doctors, nurses and ambulance drivers) are enrolled to performed continuous chest compression on manikin (ResusciAnne®, Laerdal), twice, with and without a feedback device (CPRmeter®). Correct compression score (the main criterion) is defined by reached target of rate, depth and leaning at the same time (recorded continuously).

Hypothesis: Feedback device preserve chest compression quality above the 2 minutes recommended switch over during cardiopulmonary resuscitation.


Eligibility Criteria:
Inclusion Criteria:

* Operational staff of University hospital of Caen pre-hospital unit
* Ability in CardioPulmonary Resuscitation

Exclusion Criteria:

* medical contraindication
* refusal
China Liver Cancer Clinical Registry Cohort Database

This study was led by the Department of Hepatobiliary Surgery of the First Affiliated Hospital of the University of Science and Technology of China (USTC), in close cooperation with many participating units across the country, to establish a standardized clinical information database of hepatocellular carcinoma cohorts, which will provide a guarantee for conducting high-quality real-world clinical studies and clinical research.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years, no gender limit
* Patients without surgery are initially diagnosed with hepatocellular carcinoma, intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma-cholangiocarcinoma, or metastatic hepatocellular carcinoma based on the results of imaging and laboratory tests, or patients with surgery are diagnosed with hepatocellular carcinoma, intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma-cholangiocarcinoma, or metastatic hepatocellular carcinoma based on the results of pathologic tests
* Signed informed consent, good compliance, willingness to accept follow-up and provide blood and postoperative pathology residual samples

Exclusion Criteria:

* Combination of severe central nervous system disease, respiratory disease, autoimmune disease, chronic renal insufficiency, long-term use of immunosuppressive drugs, combination of severe uncontrolled infections
* Concurrent active cardiovascular disease, cerebrovascular accident within 6 months, myocardial infarction, unstable angina pectoris, or congestive heart failure of class II or greater according to the New York Heart Association criteria, severe arrhythmia requiring medication
* Pregnant or breastfeeding women
* Participation in other therapeutic clinical trials during the course of the patient's illness in which the treatment cannot be specified or information about the treatment cannot be collected
The Effect of Preoperative Counseling on Patient Fear From Visual Experience During Vitrectomy Surgery Under Regional Anesthesia

This RCT aims to study the effect of preoperative counselling in reducing patients fear and visual perception during vitrectomy under local anaesthesia.

This was a single-blinded, randomised clinical trial conducted at University of Malaya Medical Centre, Kuala Lumpur, Malaysia, and approved by the Institutional Review Board of the hospital. Patients aged 18-75 years scheduled for vitrectomy under regional anaesthesia were included. Patients who could not understand English, who had psychiatric illness or mental retardation, or who refused to give consent were excluded.

After obtaining informed consent, patients were randomised to two groups: Group A received additional preoperative counseling while Group B did not receive any additional counseling. Both groups received routine preoperative counseling regarding potential risks and benefits of vitrectomy by an ophthalmologist one day prior to the operation.

The information covered during counselling and the method of delivery were standardised for all patients. An ophthalmologist reviewed the patient one day prior to the operation and patients who were randomised to additional counselling were counselled regarding the possible visual perceptions that they might encounter during surgery. These included lights, colours, movements, flashes, instruments and surgeon's hands or face. Twenty four hours after the surgery, another ophthalmologist blinded to the patient randomisation interviewed the patients on their visual perceptions during surgery using a standard questionnaire. Patients were interviewed regarding the types of visual sensations they perceived and if they caused fear to them. Patients were asked to grade their fear based on a visual analogue scale. The fear was graded from 0 to 10, with a score of 0 meaning no fear and a score of 10 being the maximum or extreme fear. At the end of the questionnaire the interviewer was allowed to ask the patient if he or she has received preoperative counselling and if they prefer to be or not to be counselled. Patients were asked to describe in details the images and objects that they saw during the operation. The data were analyzed using SPSS version 17.0.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-75 years scheduled for vitrectomy under regional anaesthesia were included

Exclusion Criteria:

* Patients who could not understand English, who had psychiatric illness or mental retardation, or who refused to give consent were excluded.
Electronic KIDCLOT Interactive Thrombosis/Thrombophilia Education; A Quality Assurance Initiative

Effective patient education improves health literacy and engagement thus improving long-term health outcomes. Health literacy is imperative to make informed health decisions and relies on the ability to obtain, process and understand health information; and is the cornerstone of safe health management. It is necessary to evaluate educational initiatives to determine their effectiveness in knowledge translation.

A more effective way to provide patient education is to utilize media technology. Current education styles do not teach patients in the best way as they are not consistent with how people of all ages currently learn (through technology). In addition, patient teaching most commonly occurs during highly stressful times like hospital visits with new diagnoses. Current patient educational methods are costly given the amount of health provider time required.

Electronic KITE teaching modules are infographic visual representations that present information quickly and clearly, integrating words and graphics to tell a story to reveal information. Infographic presentations are tools which facilitate self-directed learning with understandable, accessible information presented in an engaging way with an aim to enhance learning for children and their families. Patients are able to learn at a pace consistent with their learning style to facilitate knowledge development and health literacy.

A more effective way to provide patient education is to utilize media technology. Current education styles do not teach patients in the best way as they are not consistent with how people of all ages currently learn (through technology). In addition, patienteaching most commonly occurs during highly stressful times like hospital visits with new diagnoses. Current patient educational methods are costly given the amount of health provider time required.

Electronic KITE teaching modules are infographic visual representations that have been developed to provide patient teaching related to warfarin and its management.

How much patients have learned will be assessed using the KIDCLOT validated knowledge quizzes. Children 8 years and older to have cognitive capacity will complete the quizzes if able. Caregivers will complete all quizzes linked with the modules they have completed.

Patients may be enrolled into the appropriate cohort based on the health provider decision for management.

1. Warfarin international normalized ratio (INR) testing
2. Warfarin with home INR testing
3. Warfarin transition from home INR testing to warfarin self management.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients and their caregivers who are receiving treatment with anticoagulant therapy.

Exclusion Criteria:

* Non-english speaking patients.
Safety Study of Nexvax2 in Subjects With Coeliac Disease

The main purpose of this study is to determine the safety of weekly injections of Nexvax2 given for three weeks to patients with coeliac disease who have been on a gluten-free diet.

The second purpose of this study is to compare the immune response over the three week study period in coeliac disease patients given Nexvax2 compared to those given saline.


Eligibility Criteria:
Key Inclusion Criteria:

1. Age 18 to 60 years (inclusive)
2. Have coeliac disease meeting the following criteria:

   * the Principal Investigator is satisfied coeliac disease has been correctly diagnosed,
   * HLA DQ2 genotype (both HLA DQA1\*05 and DQB1\*02, homo- or hetero-zygous),
   * no known or suspected gluten exposure for 2 months prior to enrolment
   * were prescribed and have intended to follow a gluten-free diet for at least one year
   * antibodies to tissue transglutaminase (tTG) IgA and/or deamidated gliadin peptide (DGP) IgA and IgG within normal reference range at time of screening.
3. Either male or non-lactating, non-pregnant females who are postmenopausal, sterile or using at least two acceptable and highly effective birth control methods.

Key Exclusion Criteria:

1. Subjects possess the genes encoding HLA DQ8 (either DQA1\*03 or DQB1\*0302).
2. Uncontrolled complications of coeliac disease which, in the opinion of the Investigator, would impact immune response or pose an increased risk to the subject.
3. Systemic biological agents less than 6 months prior to Day 1.
4. Receipt of systemic immunomodulatory agents or experimental drugs less than 30 days prior to Day 1.
5. Any of the following laboratory abnormalities at Screening:

   * ALT, AST or alkaline phosphatase (ALP) \> 1.5 times the upper limit of normal (ULN)
   * Calculated creatinine clearance \< 80 mL/min
   * Haemoglobin (Hb) outside of the normal range
   * Platelet count \<125 x 109/L
   * Serum potassium outside of the normal range
   * White blood cell (WBC) count outside of the normal range
   * Thyroid stimulating hormone (TSH) outside of the normal range
   * Any other clinically significant abnormal lab values, as determined by the Clinical Investigator.
6. Subjects who smoke or who have smoked at all in the past 3 months.
7. Positive pregnancy test at Screening or Baseline.
8. History of any medically significant condition considered by the Investigator to adversely affect participation in the trial.
9. Non-compliance with a gluten free diet or flare in coeliac disease symptoms from Screening to Baseline.
10. Clinically relevant abnormality on ECGs.
Concomitant Tricuspid Repair in Patients With Left Heart Surgery

Tricuspid regurgitation is common in patients with severe left heart diseases, such as degenerative mitral regurgitation. However, the evidence base is insufficient to inform a decision about whether to perform concomitant tricuspid-valve repair during left heart surgery in patients who have mild tricuspid regurgitation. To inform decision making, we will conduct a multicenter, randomized trial to assess the benefits and risks of tricuspid-valve repair at the time of left heart diseases in patients with mild tricuspid regurgitation who were undergoing surgery for left heart surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing left heart valve surgery with mild tricuspid regurgitation;
2. Patients aged 18-80 years;
3. Agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

1. Infective endocarditis within 3 months;
2. Primary tricuspid regurgitation;
3. Isolated tricuspid regurgitation
4. Lactating women and suspected pregnant or pregnant women;
5. Patients with mental disorders, drug and alcohol dependence;
6. Those who participated in other clinical trials one month before the trial;
7. Refusal to participate in this study without informed consent.
Upper GI Handling of Branded vs. Generic Alendronate

To compare upper GI handling of fosamax and generic, because the main AE profile of alendronate is before systemic absorption in the esophagus; differences could be relevant to the side effect profile.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal females aged greater 55 years
* Prescribed alendronate 70 mg tablets for a therapeutic indication throughout the previous 3 months and expected to continue on this treatment for the duration of the study
* Willing to abstain from alcohol for 24 hours before each dose and until the end of each study day
* Willing to abstain from smoking for 24 hours before each dose and until the end of each study day

Exclusion Criteria:

* History of drug hypersensitivity
* Suffers from dysphagia, achalasia, or other conditions or medications affecting upper gastrointestinal motility
The Effects of Preoperative Aspirin on Graft Patency and Cardiac Events in Off-pump Coronary Artery Bypass

Antiplatelet therapy is critical in the management of coronary artery disease.For patients undergoing off-pump coronary artery bypass graft,controversy remains regarding the safety of preoperative antiplatelet therapy.And there is little study about the effect of continuing aspirin until the surgery day on graft patency.So we would like to perform this study to evaluate the effects of preoperative aspirin on graft patency and cardiac events in off-pump coronary bypass.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective, off-pump coronary artery bypass with at least two grafts
* patient able to give informed consent

Exclusion Criteria:

* on-pump CABG
* combined with the valve surgery
* Preoperative use of clopidogrel and warfarin
* allergy to aspirin
* History of severe liver disease
* History of bleeding diathesis,significant GI bleed
* Patient has known renal failure or contraindication for Cardiac CT Angio
* Redo CABG
Study of Laser Treatment of Melasma

The purpose of this study is to evaluate the RevLite laser in the treatment of refractory mixed type melasma.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type III-VI
* mixed (epidermal and dermal) melasma diagnosed by Wood's Lamp exam
* age 18 or older
* melasma persisting for greater than 6 months that has failed to respond to conventional treatment with hydroquinone or other topical lightening agents
* written and verbal informed consent
* willing and able to comply with study instructions and return to the clinic for required visits

Exclusion Criteria:

* Pregnancy, breastfeeding, taking birth control pills or plans to become pregnant during the study
* history of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis
* any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy
* uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy)
* any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study
* currently enrolled in an investigational drug or device trial, or has received an investigational drug or has been treated with an investigational device within 30 days prior to entering this study
* inability to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
* unreliability for the study (this includes subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits)
* use of photosensitizing drugs within a timeframe where photosensitization from these drugs may still be present
* need to be exposed to artificial tanning devices or excessive sunlight during the trial
* Diabetes Type I or II
* sensitivity to hydroquinone or Retin-A
* evidence of a compromised immune system or hepatitis
* use of bleaching creams or retinoids within the last 30 days
Monitoring of Biomarkers by Portable Breath Gas Sensors: an Exploratory Study

Breath analysis is a non-invasive procedure to detect and monitor diseases and it is particularly attractive for patients who have to routinely check biomarkers, such as diabetics (blood glucose) or end-stage renal disease patients (creatinine). Preliminary data in a small study with healthy subjects showed a high correlation between blood glucose levels and acetone. Therefore, the objective of this study is to correlate biomarkers (glucose level and creatinine, respectively) with the corresponding target breath components (acetone and NH3, respectively) detected by portable gas sensors in the general population and to assess possible predictive models for biomarker estimations from the corresponding target breath component and predictive models to estimate abnormal biomarker concentrations.

Breath analysis is a non-invasive procedure to detect and monitor diseases and it is particularly attractive for patients who have to routinely check biomarkers, such as diabetics (blood glucose) or end-stage renal disease patients (creatinine). The proposed breath sensors analyse breath in real-time with on-line display of breath parameters, are portable, simple to operate, inexpensive and offer a sufficiently low limit of detection for the target breath markers, thus making them of high interest for daily clinical practice. Preliminary data in a small study with healthy subjects showed a high correlation between blood glucose levels and acetone.

The primary objective of this study is to correlate biomarkers (glucose level and creatinine, respectively) with the corresponding target breath components (acetone and NH3, respectively) detected by portable gas sensors in the general population. The secondary objectives of the study are to assess possible predictive models for biomarker estimations from the corresponding target breath component and predictive models to estimate abnormal biomarker concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age ≥ 18 years

Exclusion Criteria:

* Moribund or severe disease prohibiting protocol adherence
* Physical or intellectual impairment precluding informed consent or protocol adherence
* Pregnant patients
Effects of Post-Isometric Relaxation Versus Static Stretching in Patients With Levator Scapulae Syndrome.

Group A will be treated with Postisometric relaxation technique and Group B will be treated with Static stretching technique. Postisometric relaxation will be performed with the frequency of 5 times, such that it includes (30 isometric contraction of the muscle to be stretched for 10 seconds, followed by rest period of 5 seconds and then a stretch of 10 seconds hold. Stretching exercise will be performed with 30 second hold and with 5 repetitions. All Exercises will be performed 3 times per week for total of 4 weeks. Outcome measures will be conducted through pain, range of motion, disability and muscle length after 4 weeks.

A Randomized Clinical Trial will be conducted at Tehsil Head Quarter Hospital Daska through consecutive sampling technique on 42 patients which will be allocated using computer generated sampling (random number table) into Group A and Group B. Group A will be treated with Postisometric relaxation technique and Group B will be treated with Static stretching technique. Postisometric relaxation will be performed with the frequency of 5 times, such that it includes (30 isometric contraction of the muscle to be stretched for 10 seconds, followed by rest period of 5 seconds and then a stretch of 10 seconds hold. Stretching exercise will be performed with 30 second hold and with 5 repetitions. All Exercises will be performed 3 times per week for total of 4 weeks. Outcome measures will be conducted through pain, range of motion, disability and muscle length after 4 weeks. Data will be analyzed during SPSS software version 25. The normality of data will be assessed by Shapiro-wilk test after which it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Both males and females.
* Age range of 24-59 years.
* Neck and medial border scapular pain for at least 3 months.
* NPRS score greater than 3.
* Reduced side flexion and rotation of neck.
* Symptoms persisted for at least 3 months.
* Positive levator scapulae length test.
* Have suffered from myofascial pain

Exclusion Criteria:

* Neuropathies.
* Vertebral fractures.
* Pregnancy.
* Fibromyalgia.
* Cancer.
* Traumatic neck injury.
* Previous cognitive and functional disorders.
* Coagulopathy(