cyrilzakka/clinical-trials huggingface dataset:
Early Screening of Autism Spectrum Disorder in General and Pediatric Practices

Early screening for Autism Spectrum Disorder has been validated using different screening tools, in particular M-CHAT-R and ITC in different countries. Unfortunaltely, in France, they are not often used. Thus, medium age for diagnosis in France is late. Yet, early interventions has shown efficiency (grade B of HAS 2010 recommendations, HAS 2018) . The American have described an efficient method using partnership between pediatricians and autism specialists (Miller et al). Autism Spectrum Disorders concern 1% of population. The third Autism Plan in France then HAS 2018 Recommandations and The 2018 National Strategy for Autism have propose to implement three levels for early diagnostic : the frontline is constituted by professionals who can detect the firsts signs ( in nurseries, general practice, pediatric practice, early childhood centers), the second line is constituted by the proximity network of professionals who can diagnose " simple " autism ( CMP, CAMSP, neurologic pediatricians), the third line is constituted by expert teem in specialized hospital centers for neurodevelopmental disorders diagnostic.

This organization is, for now, not efficient. First lines professionals are not always formed to autism detection. When the screening is efficient, professionals have difficulties to address children to proximity teem trained to autism diagnostic because of delays or lack of professionals. The second line professionals are note always trained to use diagnostic tools and tend to address all the children to the third line, even when the diagnostic is not complex. The third lign is saturated by all these requests.

The investigator propose to improve autism screening in our region of Rhône-Alpes basing on the detection in nursery, and by first line doctors in order to diagnose autism before 3 year of age. After screening, a specialized teem will realize a follow-up by phone to guide practitioners to a diagnostic teem in proximity. Early screening realized near family house is compulsory to facilitate accessibility and collaboration between professionals. Diagnostic should be realized in a three month delay, conform to the recommendations. Our project proposes to screen the general population of children who hasn't been screened yet for autism.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 16 and 24 months

Exclusion Criteria:

* Patient with previous Autism spectrum disorder (ASD) diagnostic
Performance of White Light, NBI and Iodine Staining Endoscopy in the Diagnosis of Esophageal Lesions

The investigators aim to evaluate the performance of Narrow Band Imaging (NBI) endoscopy in Esophageal Squamous Cell Carcinoma (ESCC) screening, as compared to the currently used White Light Endoscopy (WLE) and Lugol's Iodine Staining Endoscopy (ISE). NBI is a simple, safe and non-invasive technique, which can provide real-time optical staining for suspicious lesions. This trial is designated to enroll 10000 participants from five centers located in different regions (North, West and South) in China, which would provide real-world evidence for the recommendation of endoscopic diagnostic technique used in ESCC screening projects.


Eligibility Criteria:
Inclusion Criteria:

* Patients seek for endoscopic examinations at the endoscopy center in any of the five hospitals included in this study
* Aged 45-69 years
* Have entire esophagus
* Provide written informed consent and leave personal identification and contact information

Exclusion Criteria:

* Have contraindications to endoscopic examination (Including but not limited to severe arrhythmia, myocardial infarction, heart failure, hemiplegia, asthma, severe hypertension (≥ 180 / 110mmHg), psychosis, etc )
* Have a history of drug allergy
* Have a history of upper gastrointestinal surgery
* Have a history of radiotherapy or chemotherapy
Effect of Core Stability and Sensorimotor Training Exercises on Postural Stability Post Lower Limb Burn

The purpose of the study is to determine the effect of core stability and sensorimotor training exercises on postural stability post lower limb burn.

The need for this study develops from the lack of information in the published studies about the effectiveness of core stability exercises and sensorimotor training on the rehabilitation of burned patients.

Severe burn injuries, particularly those encompassing over 20% of the total body surface area (TBSA), trigger elevated catabolism and hypermetabolic responses in adult and pediatric burn patients. This wide spectrum of pronounced effects stemming from the hypermetabolic response and catabolism includes substantial muscle mass depletion, reduced muscle strength and endurance, hindered wound healing, impaired sensory perception, constrained ambulatory capacity, postural instability, and diminished functional mobility.

Core stability exercises improve neuromuscular system performance that causes the optimal lumbar-pelvic -hip chain mobility and good acceleration and deceleration, appropriate muscular balance, proximal stability and good function.

Sensorimotor training exercise emphasizes postural control and progressive challenges to the sensorimotor system to restore normal motor programs in patients. The proprio sensory system helps the motor system to maintain equilibrium on a reflex, automatic basis. In response to a sudden load, "the muscles will respond rapidly to stabilize the body, i.e., they will try to maintain balance and posture.

The present study is designed to investigate the effect of core stability and sensorimotor training exercises on postural stability in burned patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients are both males and females.
* Their age will range from (20-50) years.
* Patients will suffer from lower limb second degree burn (Partial thickness of thermal injury).
* Total body surface area (TBSA) for the burns will be ranged from 20% to 35% .
* Patients will begin the training program after complete wound healing.
* Patients will be given their informed consent.

Exclusion Criteria:

* Patients who had an open wound at or near treatment site.
* Patients who had chemical or electrical burn.
* Musculoskeletal disorders that will impair performance during training and tests.
* Uncontrolled cardiovascular or pulmonary diseases .
* Neurological and renal disorders.
* Metabolic or vascular disease with a neurological component such as diabetes.
* Malignant conditions.
* Psychiatric illness, severe behavior or cognitive disorders.
* Uncooperative patients.
* Pregnancy.
Effects of Continuous Infusion of Intravenous Nefopam on Postoperative Pain and Opioid Consumption After VATS

This prospective, randomized, double-blinded study is designed to evaluate the postoperative analgesic effect of the continuous infusion of intravenous nefopam in patients undergoing video-assisted thoracic surgery (VATS). We hypothesize that the continuous infusion of intravenous nefopam can significantly reduce postoperative opioid consumption and pain severity in patients with VATS.

Adult patients undergoing elective unilateral VATS segmentectomy or lobectomy are randomly allocated to receive continuous nefopam infusion (n=45) or not (n=45), in addition to a standard postoperative analgesic regimen comprising of IV fentanyl-based patient-controlled analgesia (PCA). At the end of induction, the nefopam group will receive intravenous nefopam 20mg mixed with 50ml of normal saline, and at the end of surgery this group will receive intravenous nefopam 60mg mixed with 50ml of normal saline at a rate of 2ml/hr. The control group will receive intravenous normal saline 50ml at the end of induction and receive intravenous normal saline 50ml at a rate of 2ml/hr.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo elective unilateral VATS segmentectomy or lobectomy under general anesthesia
* American Society of Anesthesiologists (ASA) physical classification I-II
* Consent to IV-patient controlled analgesia use
* Willingness and ability to sign an informed consent document

Exclusion Criteria:

* Do not understand our study
* Allergies to anesthetic or analgesic medications
* Continuous local anesthetics infiltration for postoperative pain control
* Patients who receive mechanical ventilation more than 2 hours after surgery
* Pregnancy/Breast feeder
* Medical or psychological disease that can affect the treatment response
Translation and Validation of Stroke Impact Scale 3.0 in Urdu for Pakistan

BACKGROUND Knowledge about the perceived impact of stroke on survivors' lives is still scarce in Pakistan due to the lack of translated and culturally adapted self-rating scales. The stroke impact scale is a comprehensive self-reported outcome measure designed to assess the quality of life following the stroke. Although the psychometric properties of SIS found to be superior to the conventional generic quality of life scales, it has not been translated and tested in Pakistan.

OBJECTIVE To translate and cross-culturally validate the Urdu version of stroke impact scale 3.0 for Pakistan MATERIAL AND METHODS Established guidelines were followed for translation and adaption of the Stroke impact scale 3.0. A prospective cohort of 116 patients with mild to moderate stroke self-reported their recovery on the Urdu version of SIS 3.0. The patients were concurrently evaluated on the established scales to assess the validity using the Spearman correlation coefficient. ANOVA was used to determine the discriminant validity. Ninety patients were consecutively re-evaluated to determine the test-retest reliability, precision, minimal detectable change (MCD) and clinically minimally important difference. The coefficients of ICC, Cronbach's alpha, and weighted kappa were calculated to establish the stability and consistency of the scale. The receiver operating curve was used to estimate the MCID of SIS-16 using global rating scale as an anchor.

KEYWORDS: Stroke, Stroke Impact Scale, Outcome Measures, Quality of Life


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute, subacute or chronic stroke
* Patients with hemorrhagic or ischemic or recurrent stroke attack
* Age of patients between 50-80
* Ability to read and write Urdu with minimum education to 5th grade

Exclusion Criteria:

* Patients with severe neurological comorbidities
* Patients having communication difficulties, such as patients with global aphasia or reduced consciousness.
Early Detection of Breast Cancer Using Tomosynthesis Imaging

The purpose is to develop digital tomosynthesis to improve the detection of breast cancers. The aims are optimizing digital mammography and tomosynthesis acquisition, creating visualization tools, prospective pilot studies to evaluate radiologist performance, and computer-aided detection.

Finding breast cancer early has been shown to improve the chance of survival. Mammography (x-ray imaging of the breast) helps find breast cancer early. Some breast cancers, however, are not seen on mammography, which creates two-dimensional images for the radiologist to see. The goal of this study is to make a breast tomosynthesis or tomosynthesis 3D (three-dimensional) x-ray system by taking x-ray images from many angles. This is similar to a CAT (computerized axial tomography) scan for the breast and can give radiologists 3D information so that they can find breast cancers which might otherwise be hidden from view.

Eligibility Criteria:
Inclusion Criteria:

All Subjects accepted for this clinical study must:

* Be already scheduled to undergo screening mammography, diagnostic mammography, or breast biopsy for standard clinical indications
* Provide written informed consent
* Be able to communicate effectively with clinical study personnel.

Exclusion Criteria:

Subjects with any of the following conditions will be excluded from this clinical study:

* Childbearing potential and subject refuses serum pregnancy test or test result is positive.
The Effect of Yoga in Chronic Low Back Pain

The purpose of this study is to determine if yoga is an effective intervention in treating individuals with chronic low back pain (LBP).

Chronic LBP is a major public health problem associated with functional and psychological disability. Conservative interventions are often prescribed to people suffering from chronic LBP, but alternative interventions like yoga are not well researched. The regulator practice of yoga may improve pain, disability or quality of life in people with chronic LBP.

Study participation will last approximately 24 weeks. Yoga sessions will last 12 weeks for 2 one hour sessions per week

Eligibility Criteria:
Inclusion Criteria:

* a history of chronic LBP with degenerative joint or disc disease \> than 3 months (47-48)
* present with at least minimal pain (3 out on a 0 - 10 pain scale where 0 = no pain, 10 = maximum pain imaginable)
* disability (30% or more per Oswestry Disability Scale),
* score more than 24 on the Folstein Mini-Mental State Exam
* English comprehending individuals naïve to structured yoga practice

Exclusion Criteria:

* known current pregnancy
* claustrophobia
* glaucoma
* significant or chronic decline in immune function such as reported immune related diagnosis like pneumonia or systemic infection
* LBP resulting from something other than disc or joint disease
* spinal stenosis, spinal fusion or other orthopedic surgery in the past six months
* mental disease/psychosis such as dementia
* prior history of chronic neurological disorders (e.g. stroke, Parkinson's disease, multiple sclerosis)
* fibromyalgia
* radiculopathy
* standard MRI exclusion criteria
* inability to make regular time commitments
* no transportation means to the scheduled yoga sessions
* experience with regular practice of yoga within the past year.
DP-R212 Pharmacokinetic Study

An open-label, multiple-dose study to evaluate the pharmacokinetic drug-drug interaction of amlodipine and rosuvastatin in healthy adult male subjects.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18-29
* signed the informed consent form prior to the study participation

Exclusion Criteria:

* Clinically significant disease
* Previously donate whole blood within 60 days or component blood within 14 days
* Clinically significant allergic disease
* Taken IP in other trial within 90 days
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Sex Differences in Neuropeptide Y Serum, But Not in Fat Intake and Body Mass Index

One's appetite has a role in controlling food intake and maintaining energy balance, but its effect on body metabolism related to obesity is still questionable. The purpose of this study was to determine the levels of neuropeptide Y in healthy people and to see differences in gender and anthropometric parameters. The hypothesis of this study was that there would be differences in neuropeptide Y levels in groups with gender and anthropometric parameter differences.

One's appetite has a role in controlling food intake and maintaining energy balance, but its effect on body metabolism related to obesity is still questionable. The purpose of this study was to determine the levels of neuropeptide Y in healthy people and to see differences in gender and anthropometric parameters. The hypothesis of this study was that there would be differences in neuropeptide Y levels in groups with gender and anthropometric parameter differences. This study was a cross-sectional study involving 62 study subjects, male and female, who did not have chronic diseases or metabolic disorders. This research was conducted from April to September 2020. The parameters examined in this study were neuropeptide Y levels and anthropometric parameters. The statistical analysis performed was the Mann-Whitney test to see the differences between groups. The mean age of the research subjects was 40.48 ± 10.85 years, with the same ethnic distribution. The distribution of men and women was more women than men. Based on anthropometric examination, it was found that obesity nutritional status was more common in the female group than in the male group; however, serum neuropeptide Y levels were found to be significantly different between male and female groups (male group was higher).

Eligibility Criteria:
Inclusion Criteria:

* healthy groups for Neuropeptide Y Serum diagnosis

Exclusion Criteria:

* Non-healthy groups for Neuropeptide Y Serum diagnosis
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes

The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index procedure).

The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index procedure). Following successful creation of the AV fistula, the cohort randomized to the treatment group will receive the SeCI; the control group will not receive an implant. The primary hypothesis is that the proportion of subjects that meet requirements for fistula suitability for dialysis six months following the index procedure will be higher in the treatment group in comparison to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Currently on hemodialysis for ≤12 months or expected to initiate hemodialysis within approximately 6 months of the creation of the AV fistula.
* Vascular anatomy suitable for creation of the AV fistula, determined by pre procedure duplex ultrasound
* Successful creation of a single stage radiocephalic or brachiocephalic end to side fistula

Exclusion Criteria:

* Prior AV access created on the limb where the fistula surgery is planned
* ST-elevation MI or cerebrovascular accident within 30 days of the index procedure
* Known hypersensitivity to the following: sirolimus, beef or bovine collagen
* Hypotension with systolic blood pressures \<100 mm Hg at the time of screening
* Known or suspected active infection at the time of the AV fistula surgery
* Known to be HIV positive
* Prisoner, mentally incompetent, and/or alcohol or drug abuser
Motivational Interviewing Tailored Programme for Promoting Advance Care Planning Behaviours

This proposed study is designed to test the effects of motivational interviewing (MI) in increasing the uptake of ACP behaviours among patients with palliative care needs. A randomised controlled trial with repeated blinded outcome assessment will be conducted to assess the effects of a MI-tailored ACP (MI-ACP) programme on palliative care patients recruited from the outpatient palliative care clinics and home palliative care services of two hospitals. A total of 204 patients will be recruited and randomly assigned to experimental and control groups. The patients in the experimental group will receive a MI-ACP programme facilitated by a trained nurse, whereas the patients in the control group will receive usual care. Primary outcome is the behavioural changes in ACP. Secondary outcomes are perceived stress, decisional conflict and quality of life. Study outcomes will be measured at baseline, 1 month and 3 months after enrolment.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or over
* newly referred to palliative care services
* with a palliative performance scale (PPS) score of 60 or above; and
* with full level of consciousness

Exclusion Criteria:

* uncommunicable because of sensory impairment or language barrier
* cognitively impaired
* are receiving active psychiatric treatment
* already had signed an advance directive
Evaluation of Quality of Care - Haemodialysis Public-Private-Partnership, Hospital Authority

Patients with end-stage renal failure (ESRF) have lost the function to excrete urea and maintain electrolyte balance, which is lethal unless they are given renal replacement therapy (Gibney, Hoste et al. 2008). As one of the initiatives of service improvement, the HA has introduced the haemodialysis public-private partnership (HD PPP) programme to shorten the waiting time for patients with ESRF needing HD treatment. HD PPP programme is a new service provision model that purchases healthcare services from non-Government healthcare organizations. The evaluation on the quality of care (QOC) is an essential part of the programme in order to inform future policy. The Department of Family Medicine and Primary Care of the University of Hong Kong has been appointed by the HA to carry out the evaluation of the QOC of the programme.

The Action Learning and Audit Spiral methodologies to measure whether the target standard of care intended by the HD PPP programme is achieved. Each HD PPP participating hospitals and centers will be invited to complete a structure evaluation questionnaire. Sixty patients who have agreed to join HD PPP and 60 control patients who have refused to take part in HD PPP will be included. The participants will be followed up by telephone to evaluate the effect of the programme on quality of life (QOL), patient enablement, and global rating of change in health condition. Data on the process of care and clinical outcomes of care will be retrieved from the HA medical records.

Main Outcome Measures: The primary outcomes are the proportion of participants who have received the planned process of care and adequate haemodialysis (HD) measured by the Kt/V

Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be calculated. The outcomes of HD PPP subjects will be compared at 6, 12, 24, 36 and 48 months by paired sample t-test. The outcomes between HD PPP subjects and control group will be compared by independent sample t-test or Chi-square test.

Results: The QOC of the HD PPP programme will be determined. Areas of deficiency and possible areas for quality enhancement will be identified.

Conclusion: The results of this study will provide empirical evidence on whether the HD PPP can achieve equivalent QOC as the usual HA care in order to guide service planning and policy decision making for patients with ESRF.


Eligibility Criteria:
Inclusion Criteria:

* Patients currently being followed up at the HA on haemodialysis, peritoneal dialysis, or are new ESRF cases will be recruited.

Exclusion Criteria:

* Patients who do not have a good vascular access, are not hemodynamically stable for HD, are not mentally sound, ambulatory and independent, are unable to understand and communicate in Chinese language, or refuse to give consent will be excluded from the HD PPP programme.
A Study to Assess Efficay and Safety of LC350189 Different Doses in Gout Patients With Hyperuricemia

The aim of this 12-week randomized multicenter double-blind parallel group placebo-controlled dose finding study is to assess the efficacy and safety of three different doses of LC350189 in subjects with hyperuricemia and a diagnosis of gout.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects or the subject's legally acceptable representatives who sign a written informed consent form prior to the initiation of any study procedures.
2. Subjects with hyperuricemia and a history or presence of gout per American College of Rheumatology (ACR) criteria.

Exclusion Criteria:

1. Subjects with secondary hyperuricemia (e.g., due to myeloproliferative disorder, or organ transplant).
2. Subjects experiencing an active acute gout attack within 3 weeks prior to screening (Visit 1).