cyrilzakka/clinical-trials huggingface dataset:
Subcutaneous Versus Intravenous Morphine When Switching From Oral to Parenteral Route in Palliative Cancer Patients

The investigators aim to establish whether the intravenous or the subcutaneous route of administration has clinically significant advantages when parenteral administration of morphine is started with a combination of continuous infusion and bolus doses in palliative cancer patients.

Patients admitted to a Hospital palliative medicine unit with an indication for parenteral administration of morphine will be recruited.

The patients will have two similar infusion pumps with continuous infusion and bolus function. One infusion pump will be connected to an intravenous line, the other to a subcutaneous line. One pump contains morphine, one placebo. The primary endpoint is the time from initiation of infusion with titration to the final infusion rate that provides pain control is reached.

Intravenous administration has theoretical advantages in more predictable pharmacokinetics and shorter time to maximum effect. Subcutaneous administration is less invasive, requires less specialized personnel and equipment, and probably poses a lower risk of complications than an intravenous line. Traditionally the subcutaneous route has been the recommended first choice for parenteral administration of opioids for palliative cancer patients.

The investigators aim to establish whether the intravenous or the subcutaneous route of administration has clinically significant advantages when parenteral administration of morphine is started with a combination of continuous infusion and bolus doses in palliative cancer patients.

Patients admitted to a Hospital palliative medicine unit with an indication for parenteral administration of morphine will be recruited.

The patients will have two similar infusion pumps with continuous infusion and bolus function. One infusion pump will be connected to an intravenous line, the other to a subcutaneous line. One pump contains morphine, one placebo. The primary endpoint is the time from initiation of infusion with titration to the final infusion rate that provides pain control is reached. Secondary endpoints are time from bolus administration to pain relief, comparison of Tmax, Cmax, and size of AUC0-60 after bolus doses, the number of bolus doses first 24 and 48 hours, and the number of patients reaching acceptable pain relief within 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* Unsatisfactory pain control despite titration of oral or transdermal opioids
* Planned discharge to home or nursing home

Exclusion Criteria:

* Estimated survival time \<2 weeks
* A clear indication for either intravenous or subcutaneous administration
* Patient unable to report patient reported outcomes needed in the study due to language barriers or cognitive impairment
* Impossible to establish venous access
Time Outdoors as an Intervention for Myopia in Children

The purpose of this study is to determine whether improved outdoor time has an effect on the onset and progression of myopia in children.

1. To evaluate the effect of increased time outdoors on the incidence of myopia in non-myopic children;
2. To evaluate the effect of increased time outdoors on the progression of myopia in myopic children;
3. To explore if there is dose-response effect of time outdoors on the incidence and progression of myopia.

Eligibility Criteria:
Inclusion Criteria:

1. at baseline be enrolled in grade 1 and 2 of primary schools;
2. have a parent or guardian who is able to read and comprehend Mandarin and give informed consent as demonstrated by signing a record of informed consent;
3. Children verbally consent when registration for examination

Exclusion Criteria:

1. Any systemic or ocular pathology that may affect the refractive error status of the eye;
2. Strabismus and amblyopia;
3. Intellectual disability;
4. Using any anti-myopia treatments (orthokeratology, atropine, accommodation function training, acupuncture, auricular point sticking, progressive addition spectacle lenses or other anti-myopia contact lenses).
5. Not suitable for inclusion in the study as deemed by the investigator.
Utilizing GI: Exploring an Optimum Glycaemic Profile for Cognitive Function Across the Day

This study provides participants with two diets that vary in their glycaemic index values (low vs. high), whilst also measuring cognitive performance and mood.

Therefore, the current study introduces cognitive testing into study procedures. Participants will consume the favourable and unfavourable conditions (each containing three meals) on separate days following a crossover, randomised, couterbalanced design. The primary dependent variable is cognitive function, whilst secondary measures include glucose and mood. It is hypothesised that the favourable meal profile will be associated with cognitive and physiological benefits relative to the unfavourable meal profile.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 25 years of age
* Willing to participate in the entire study (signed informed consent required)
* Male or female (not pregnant)

Exclusion Criteria:

* Suffer from diabetes
* Are anaemic
* Smoker
* Have any food intolerances or allergies
* History of alcohol or drug misuse
* Diagnosed with any of the following;

  * High blood cholesterol
  * High blood pressure
  * Thyroid disorder
  * Heart problems, stroke or any vascular disease in the past 12 months
  * Inflammatory diseases such as rheumatoid arthritis
  * Bone related conditions, such as osteoporosis
  * Renal, gastrointestinal, respiratory, liver disease or cancer
* You are presently taking part in another clinical trial or research study
* You are an elite athlete (very high intensity training more than 3 times a week)
* You are currently on a specific diet, and are unwilling to cease during the testing period
* You are intending to regularly use medication which affects gastrointestinal motility
Posterior Cornea in Primary Open Angle Glaucoma

Characterization of posterior corneal changes in primary open angle glaucoma patients, using Scheimpflug examination.

A cohort of primary open angle glaucoma (POAG) patients is submitted to Scheimpflug Pentacam examination. The results are compared with a control group of age and central corneal thickness matched healthy subjects

Eligibility Criteria:
Inclusion Criteria:

* Primary open angle glaucoma, with the diagnosis supported on structural and functional complementary exams according to the current European Glaucoma Society guidelines
* Healthy subjects from the General Ophthalmology Outpatient Clinic

Exclusion Criteria:

* age inferior to 18 years old
* primary closed angle glaucoma
* secondary open angle glaucoma
* previous intra-ocular surgery
* known or suspected corneal disease
* previous intra-ocular inflammation
* previous ocular trauma
Progress of Mild Alzheimer's Disease in Participants on Acupuncture Versus Sham Acupuncture

To determine if adjunctive acupuncture acts as an AD treatment rather than a placebo, and identify if benefits are linked to shifts of the gut microbiota.

Acupuncture is used as an adjuvant therapy for Alzheimer's disease (AD), but available evidence for efficacy is weak. Growing studies suggest that resident gut microbiota contributes to the development and progression of AD. Acupuncture is reported to treat gastrointestinal and neurodegenerative disorders via the gut-brain axis. The aim is to determine if adjunctive acupuncture acts as an AD treatment rather than a placebo, and identify if benefits are linked to shifts of the gut microbiota.

This is a randomized, participant-masked, sham-controlled trial. One hundred and sixty participants with mild AD will be randomly assigned (1:1) to either active acupuncture or non-penetrating sham acupuncture (3 times weekly for 14 weeks) added to donepezil treatment (5 mg per day for 28 weeks). The primary efficacy outcome is the change from baseline to week 28 in the Alzheimer's disease Assessment Scale (ADAS-cog12). Secondary efficacy outcomes include other assessments of the Mini-Mental State Examination (MMSE), the Alzheimer's disease Cooperative Study-Activities of Daily Living (ADCS-ADL), Neuropsychiatric Inventory (NPI) and gut microbiota.

Eligibility Criteria:
Inclusion Criteria:

* Meets the diagnostic criteria for probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA)
* Scored 1.0 by the Clinical Dementia Rating Scale (CDR) Global Score

Exclusion Criteria:

* Dementia due to other causes
* Evidence of a clinically relevant or unstable psychiatric disorder
* Has irritable bowel syndrome or inflammatory bowel disease
* Has unstable or severe cardiovascular, hepatic, renal, respiratory, endocrinologic, neurologic diseases and other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study
* Has visual or hearing disorder, defeating completion of evaluation
* Use of AD therapy (except for donepezil hydrochloride) which cannot be stopped
* Use of antibiotics within 1 month prior to enrollment
* Has a history of gastrointestinal surgery (except for appendicitis and hernia surgery)
* Without a reliable caregiver who will accompany the participant during treatment and assessment, and monitor administration of the prescribed medications
* With cardiac pacemaker or metal allergy
* Once experienced electroacupuncture treatment before at any time (manual acupuncture is allowed)
* Premenopausal woman
Prevalence & Progression of Subclinical Atherosclerosis

To evaluate subclinical atherosclerotic disease in menopausal women.

BACKGROUND:

Decreased ovarian function and premenopausal obesity are likely the primary determinants of early coronary atherosclerosis as measured by calcification on EBCT. Aortic calcification occurs earlier than coronary calcification, may predict coronary calcification, and is expected to be the best marker of risk associated with traditional factors in these younger women. Preliminary data indicate that changes in coronary and aortic calcification can be observed over short periods of time in these women. A period of diminishing estrogen levels is the optimum time to observe changes in endothelial function which likely precede measurable atherosclerosis and thus may be the earliest markers for disease potential. Vascular stiffness, a marker for the biologic aging of the vascular system, is highly correlated with measures of insulin sensitivity which is altered in women at mid-life in conjunction with increases in central adiposity. Racial differences in disease prevalence and the relative importance of certain risk factors are likely.

DESIGN NARRATIVE:

Subclinical atherosclerosis will be evaluated in 728 women (305 African American, 423 Caucasian) enrolled in the Pittsburgh and Chicago sites of the Study of Women's Health Across the Nation (SWAN), a multicenter study characterizing the biological and psychosocial antecedents and sequellae of menopause. The extent to which diminishing ovarian function affects vascular function and accelerates the development of atherosclerosis in the coronary arteries, aorta and carotid arteries will be evaluated. Serial measures of coronary and aortic calcification (by electron beam computed tomography \[EBCT\] ), carotid atherosclerosis, endothelial function and aortic stiffening will be performed two years apart. The prevalence and progression of subclinical atherosclerosis will be evaluated in relation to serial measures of ovarian function, psychosocial and behavioral factors, markers of clotting and inflammation as well as traditional cardiovascular risk factors, all collected in SWAN. The study is conducted jointly by Dr. Lynda Powell (R01HL65581) at Rush-Presbyterian-St. Luke's Medical Center in Chicago and Dr. Kim Tyrrell (R01HL65591) at the University of Pittsburgh.

Eligibility Criteria:
No eligibility criteria
Treatment of Social Phobia and Panic Disorder in Adults

The purpose of this study is to compare a stepped care model for the treatment of social phobia and panic disorder with standard psychological treatment. The stepped care model comprises three steps: short psycho-education, a 10 weeks Internet-based self-help program, 12 weeks individual cognitive-behavioural therapy. Patients are assessed at each step and taken out of the study if they show significant clinical improvement and follow for 12 months. Patients are randomized to either the stepped care model or standard psychological treatment, i.e. individual cognitive-behavioural therapy. All treatment components are manualized.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnoses of panic disorder or social phobia
* Informed consent

Exclusion Criteria:

* Alcohol/drug dependency
* Major depressive disorder
* Psychosis
* Unstable medication
Impact of an ICU Diary on the Well-being of Patients and Families. A Prospective Multicenter Mixed Study

The purpose of this study is to assess the influence of an ICU diary implemented during the ICU stay on the psychological well-being of patients and families after ICU discharge.

Implementation of an ICU diary in a randomized design in 36 ICUs in France The ICU diary contains entries from staff and families or relatives

Quantitative description of psychological well-being of the patients and families or relatives are evaluated 3 months after ICU discharge

Qualitative evaluation of how the patient uses the diary is scheduled by a phone interview 6 months after ICU discharge.

An amendment of the ethic committee permitted to increase in 2016/02 both the number of eligible patients to 700 and the number of centers.

Eligibility Criteria:
Inclusion Criteria:

* Patients with his family admitted in an ICU and mechanically ventilated more than 48 hours

Exclusion Criteria:

* Patients without families admitted in an ICU and mechanically ventilated more than 48 hours
* Patients or families not fluent in French
* Patients moribund
* Patients with a neurologic or psychiatric disease responsible for admission or pre-existing before the ICU admission
* Patients admitted after a cardiac arrest
* Deaf and mute patients
High Sensitive CRP in Prediabetics and Diabetes

The aim of this study was to study the level of high-sensitivity CRP in sera of pre-diabetic and newly diagnosed patients with type 2 diabetes mellitus and its correlation with HOMA IR and HbA1c

This study will include (180) subjects, 60 pre-diabetic patients, 60 patients with newly diagnosed type 2 diabetes ( within one month of diagnosis) and 60 normal healthy non diabetic individuals as a control group. The study individuals will be recruited from the Diabetes and Internal Medicine Clinics of Fayoum University Hospital

Eligibility Criteria:
Inclusion Criteria:

* Pre-diabetic patients:

  * A fasting blood glucose level (100 to 125 mg/dL). or
  * A 2-hour blood glucose level (140 to 199 mg/dL) .or
  * Hb A1C 5.7% to 6.4%.
* Newly diagnosed type 2 diabetes: (maximum within one month from diagnosis)

  * A fasting blood glucose level \>126 mg/dl
  * A 2-hour blood glucose level \> 200 mg/dl
  * Hb A1C \> 6.5%

Exclusion Criteria:

* Pregnant or lactating females.
* Patients who have recent infection.
* Patients with acute inflammatory diseases as autoimmune diseases.
* Patients with malignancy or on chemotherapy.
* Patients with acute or chronic liver or renal diseases
Expanded Access for Repotrectinib

This is an expanded access designed to provide access to Repotrectinib for eligible participants.


Eligibility Criteria:
Inclusion Criteria:

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Exclusion Criteria:

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Trans & Non-binary Reference Intervals While on Hormone Therapy Study

This study will find out what the reference intervals are for common blood tests in transgender people taking hormone therapy.

Reference intervals help doctors interpret blood test results. They are expressed as two numbers, and most normal results fall between them. If a results fall outside of them, it may be because of a disease. Some blood tests are also affected by normal difference between people, such as age, sex or ethnicity. For these tests, different reference intervals are given for each group of people. Having accurate reference intervals benefits patients because it allows doctors to identify disease faster.

Transgender people have a gender identity which does not match their sex characteristics at birth. Gender identity is the feeling of being a gender, and sex is the biological aspects of growing up male or female. Transgender people may use hormone therapy to help change their appearance to fit their gender identity. This involves taking either oestrogen or testosterone.

For blood tests which are affected by sex, it is not clear what reference intervals should be used for transgender people who are on hormone therapy. This is because they have a mixture of male and female sex characteristics. Answering this question will allow doctors to identify disease in them faster.

The study will take place at cliniQ, at King's College Hospital, which provides health services to transgender people. It will recruit healthy transgender people who attend the clinic for blood tests to monitor their hormone therapy. Participants will fill out a questionnaire, give a urine sample, then have their appointment as normal. Extra tests will also be performed on their blood sample. The aim is to recruit 240 participants. Participant's tests results will then be used to calculate reference intervals.

The study is funded by Viapath Group LLP.


Eligibility Criteria:
Inclusion Criteria:

* Transgender or nonbinary people.
* Aged 18 or older.
* Taking testosterone or oestrogen therapy.
* For 12 months or more.
* Having routine hormone therapy monitoring at the clinic.

Exclusion Criteria:

* Unable to give informed consent (including participants who cannot communicate in English).
* History of chronic liver disease, chronic kidney disease, diabetes, or severe cardiovascular disease (including myocardial infection, deep vein thrombosis, stroke and pulmonary embolism).
* Blood test results that indicate severe disease.
* Pregnant or within one year after childbirth.
* Other conditions which could put participants at risk by participating, or which could influence the results of the study.
Is Xylitol Toothpaste Effective in Preventing Tooth Decay?

The study will identify children at high caries risk and then advise/instruct their parents/caregivers in practicing evidence-based risk-based at home preventive measures for their infants with daily use of xylitol or fluoride toothpaste. This study plan to invite the children aged 12-15 months old with high caries risk to do the clinical trial. Every infants will be randomly allocated into two groups. Participants in the test group will be asked to use xylitol (20%) toothpaste to brush their teeth twice every day with the help of caregivers. Participants in the test control group will be asked to use fluoride (1000ppm) toothpaste to brush their teeth twice every day with the help of caregivers. The same oral health instruction and children' diet instruction will be done for every participant's caregivers.

For every dental examination, clinical chatting form for the children will be collected after filling in by examiner. Questionnaire will be collected after filling in by the caregivers. And infants' plaque and saliva will be collected to detect the S. mutans level. We plan to do the dental examination three times for one infant including the first time recruiting, one year follow-up, and two year follow-up.

The establishments of the good oral health-related habits will safeguard and have sustained benefits for the children. The study can provide evidence on the effectiveness of xylitol toothpaste and risk of high fluoride toothpaste among young children. In the long term, the findings of the study might serve as a foundation for establishing an effective oral health care promotion programme throughout Hong Kong and beyond. The framework, if shown to be effective, could help development of the oral health policies and promotion programmes to achieve better oral health among young children eventually.


Eligibility Criteria:
Inclusion Criteria:

Infants aged 12-15 months old with high caries risk

Exclusion Criteria:

Infants who has systematical disease
Early Progressive Feeding in Human-Milk Fed Extremely Preterm Infants: A Randomized Trial

To test the hypothesis that progressive feeding without minimal enteral feeding (MEF) compared to progressive feeding preceded by a 4-day course of MEF will result in an increased number of days alive on full enteral feeding in the first 28 days after birth in extremely preterm infants receiving human milk.

Qualifying participants will be randomly assigned to one of two study groups: 1) Early progressive feeding without MEF or 2) Progressive feedings preceded by 4 days of MEF. Regardless of study group assignment, donor human milk will be offered if not enough of the mother's expressed breastmilk during the intervention phase of the trial.

Intervention group: Progressive feeding of 20-24 ml/kg/d on day 1 of feeding, followed by daily increments of 24-25 ml/kg/d as tolerated until full enteral feeding achieved.

Control group: MEF with feeding volumes of 20-24 ml/kg/d for 4 days followed by progressive feeding (daily increments of 24-25 ml/kg/d) as tolerated until full enteral feeding achieved.

Both groups will receive fast progressive feeding (\>/= 24 ml/kg/day)

If parent agrees, stool "dirty" diapers will be collected 5 times (at birth, 1, 2, 3 and 4 weeks of life).

Eligibility Criteria:
Inclusion Criteria:

* admission to the NICU within 48 hours with gestational age between 22.0 and 28.6 weeks

Exclusion Criteria:

* small for gestational age (\<10th percentile birthweight), major congenital or chromosomal anomalies, and infants with terminal illness in which decision to withhold or limit support have been made
Pedicle Screw Placement With XVS

Open label, prospective, single arm, multi-center study. Pedicle screws placement in sacral/lumbar vertebrae will be performed via open procedural technique, by at least two (2) different surgeons, using the XVISION SPINE system.

Pedicle screw placement accuracy will be assessed by two independent, experienced radiologists, using the Gertzbein score.

Subjects will undergo intraoperative 3D scan prior to screws placement to enable 3D model rendering and XVISION SPINE system registration.

Subjects will undergo intraoperative 3D scan post procedure to enable offline scoring of pedicle screw placement using the Gertzbein score.

Surgeons performing the procedures will be requested to fill in usability questionnaires at the end of the procedure


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 18 - 80 yrs.
2. Subjects with Spondylosis scheduled to undergo an elective short (6 or less consecutive vertebrae) S1-L1 open spinal fixation surgery using pedicle screws.
3. Subjects requiring a posterior approach surgical procedure.
4. Subjects with normal global spinal alignment (coronal, sagittal view) and/ or patients with degenerative spine disorders.

Exclusion Criteria:

1. Subjects with severe Osteoporosis (T score \<-3.5)
2. Subjects with kyphosis at the operated area (≥ stage 3)
3. Subjects with Spondylolisthesis Grade III and above.
4. Subjects scheduled for revision fusion surgery (prior laminectomy or discectomy is not excluded).
5. Subjects with significant abnormalities of bones (e.g. osteogenesis imperfecta, tumors, infection or malignancy, etc.)
6. Subjects with neurologic diseases or damage (e.g. due to trauma, tumor, Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida or neurofibroma)
7. Subjects with spinal cord abnormalities with any neurologic symptoms or signs
8. Paraplegia.
9. Pedicle fracture documented before or during surgery.
10. Women pregnant or lactating
11. Subjects requiring anterior release or instrumentation.
12. Subjects who are unwilling to sign written informed consent and assent to participate in the study.

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