cyrilzakka/clinical-trials huggingface dataset:
Vitamin D3 Supplementation for AlloHSCT-RCT

This study is to assess whether a single oral loading dose of 100,000 IU vitamin D3 prior to allogeneic hematopoietic stem cell transplant (aHSCT) can achieve optimal 25 hydroxy-vitamin D3(25-OH-D3) levels (\>75nmol/L) at one month post aHSCT, and maintain adequate levels for at least three months, compared to our standard practice of 2000 IU vitamin D3 daily. 25-OH-D3 levels will be measured prior to vitamin D3 supplementation, and 30 as well as 100 days post vitamin D supplementation. We hypothesize that the intervention will prevent vitamin D insufficiency or deficiency in aHSCT recipients, therefore benefit aHSCT-associated morbidity, including osteoporosis.

This is a randomized non-blinded single centre prospective clinical trial designed to validate whether a single oral loading dose of 100,000 IU vitamin D3 prior to allogeneic hematopoietic stem cell transplant (aHSCT) can achieve optimal 25 hydroxy-vitamin D3(25-OH-D3) levels (\>75nmol/L) at one month post aHSCT, and maintain adequate levels for at least three months, compared to our standard practice of 2000 IU vitamin D3 daily.

84 patients will be enrolled. Following completion of all baseline data collection, participants will be randomized 1:1 to the intervention group or the control group on the admission day for aHSCT

Patients in the intervention group will receive a single oral loading dose of 100,000 IU vitamin D3, with subsequent vitamin D3 2000 IU daily. Patients assigned to the control group will receive our current standard of care, 2000 IU vitamin D3 daily.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing allogeneic stem cell transplantation at the Leukemia/BMT Program of British Columbia.
2. Age greater than or equal to 18 years.
3. Able to provide written informed consent.

Exclusion Criteria:

1. Hypercalcemia, hypervitaminosis D, or allergic/ sensitive to vitamin D.
2. Not meeting eligibility criteria to proceed with allogeneic stem cell transplantation as per the Leukemia/BMT Program of BC.
Belatacept Conversion in Proteinuric Kidney Transplant Recipients

Background: Proteinuria develops in about 30% of kidney transplant recipients and is a strong predictor of graft loss. The amount of proteinuria has a direct correlation with the risk of graft failure. Novel therapies are urgently needed to reduce proteinuria and prevent graft loss in transplant recipients, since ACE inhibitors carry a number of limitations in the transplant setting, including significant reduction in renal function, anemia and hyperkalemia.

Preliminary data: B7-1 is expressed at significant levels in about 10% of kidney allograft biopsies with predominance in patients with proteinuria.

Hypothesis: We hypothesize that B7-1 targeting therapy may reduce proteinuria and improve graft survival in proteinuric transplant recipients that have B7-1 staining on allografts. In addition, the absence of CNI nephrotoxicity and the potential protective effect of Belatacept on DSA production may be of benefit in this subset of transplant patients.

Objectives:

Primary: Determine the effect of Belatacept conversion in reducing proteinuria by 25% at 12 months in renal transplant recipients (≥1gram/d) that are either B7-1-positive or negative on kidney biopsy.

Secondary: Assess the effect of Belatacept conversion in the percent change of renal function from baseline to 12 months; donor-specific anti-HLA antibodies presence and intensity (MFI); correlation of B7-1 positivity on immunofluorescence on biopsy with B7-1-expression in urine extracellular vesicles; adverse events; acute rejection episodes; blood pressure control; new onset diabetes; hyperlipidemia; graft survival; and patient survival.

A total of 36 patients will be recruited.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female adult kidney transplant recipients older than 18 years old
2. eGFR ≥30 ml/min
3. ≥6 months after transplantation
4. Proteinuria ≥1 gram/day in spot urine protein/creatinine ratio
5. Ability to provide written informed consent for the study.
6. Maintenance immunosuppression of CNI (cyclosporine or tacrolimus), antiproliferative agent (azathioprine, MMF or MPA) with either steroids or not.

Exclusion Criteria:

1. Age \<18 years
2. eGFR\<30 ml/min
3. active acute cellular rejection (ACR; higher than borderline) or ACR in the previous 6 months; active acute antibody-mediated rejection
4. recurrent FSGS
5. EBV IgG negative
6. patient on mTOR inhibitor (e.g. Everolimus, Sirolimus)
7. patient only on CNI (cyclosporine or tacrolimus) and steroids
Cardiac Rehab for Advanced Heart Failure-LVAD Candidates

This study is a pilot study evaluating the feasibility and early efficacy of cardiac rehabilitation to improve frailty and symptoms in patients with advanced heart failure (NYHA class III-IV), who are being considered for LVAD therapy.

Frailty in patients with advanced heart failure is not thoroughly described, but in those studies that assessed frailty, it was a common phenomenon. Furthermore, some data suggest an association between pre-LVAD implant frailty and post-implant complications and survival. Interventions for frailty have been utilized in various populations, including the elderly frail and the frail from cardiovascular causes. These interventions target physical strengthening and endurance and have been shown on occasion to improve functional outcomes. The current study, a pilot study, seeks to assess frailty in a prospective cohort of patients being evaluated in Heart Failure Clinic for consideration of LVAD implantation due to NYHA class III-IV dyspnea and enroll these patients in a six-week focused cardiac rehabilitation protocol aimed at improving frailty and functional independence. The primary endpoint of the study is improvement in frailty markers at the end (gait speed, handgrip strength), and secondary endpoints include improvement in the indices of quality of life and symptomatology via validated questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Candidate for a Left Ventricular Assist Device (LVAD)
* Advanced Heart Failure as determined by New York Heart Association classification III or IV

Exclusion Criteria:

* Unable to perform physical activities required by protocol due to anatomic or musculoskeletal comorbidities
* Physical activity is contraindicated
HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL

The objective of this clinical study is to compare the safety and effectiveness of Valchlor versus HyBryte following 12 weeks of treatment.

Participants will be randomized to receive HyBryte or Valchlor in a 1:1 randomization. Participants will be treated for 12 weeks and follow-up visits will be conducted 1, 2, and 4 weeks after completion of the treatment phase of the trial.

Prior to randomization, each participant will have at least 3 and up to 5 lesions identified (index lesions) that will be evaluated during the treatment phase and during the follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Minimum of 3 active treatment-accessible CTCL lesions
* Subjects must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage IA, IB, or Stage IIA
* Subjects willing to follow the clinical protocol and voluntarily give their written informed consent
* Female subjects not pregnant nor nursing and willing to undergo a pregnancy test within 30 days prior to treatment initiation

Exclusion Criteria:

* History of severe allergic reaction to any of the components of HyBryte or mechlorethamine (Valchlor)
* Pregnancy or mothers who are breast-feeding
* All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to use effective contraception
* Subjects with history of sun hypersensitivity or photosensitive dermatoses (eg, porphyria, systemic lupus erythematosus (SLE), Sjogren's syndrome, etc.)
* Subjects whose condition is spontaneously improving
* Subjects receiving Valchlor (or any topical compound containing Mechlorethamine) in the preceding 2 months
* Subjects receiving topical steroids or other topical treatments (eg, targretin gel) on treatment accessible lesions for CTCL within 2 weeks of enrollment
* Subjects receiving systemic steroids, psoralen ultraviolet A (UVA) radiation therapy (PUVA), narrow band ultraviolet B (UVB) light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment
* Subjects who have received electron beam irradiation within 3 months of enrollment
* Subjects with a history of significant systemic immunosuppression
* Subjects taking other investigational drugs or drugs of abuse within 30 days of enrollment
* Subject has any condition that, in the judgment of the Investigator, is likely to interfere with participation in the study
* Subjects receiving drugs known to cause photosensitization within 2 weeks of starting HyBryte therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks
Retromolar Route Access With and Without A Retromolar Gap

Retromolar Intubation is a successful option for intubation in patients with an existing retromolar gap in the case that the conventional method fails.

Therefore the investigators want to test if the retromolar gap is essential for performing the retromolar intubation technique.

For successful endotracheal intubation an optimal visualisation of the vocal cords is essential. A study comparing retromolar and conventional laryngoscopy showed in patients with an existing retromolar gap, that the retromolar technique is superior for endotracheal intubation especially in patients with a failed 'conventional' intubation attempt. The aim of the following study is to test if a retromolar gap at the right mandible is necessary for the successful performance of the retromolar laryngoscopy technique.

Therefore, 20 patients with and 20 patients without a retromolar gap will be investigated.

The anesthesiologist will visually determine the view of the vocal cords and score it according to Cormack \& Lehane. For an improved view a backward, upward, right-ward pressure (BURP) will be performed, if needed, and scored again.

Finally, endotracheal intubation will be performed by the 'conventional' intubation method. If, however, intubation is not possible, then the retromolar technique will be used. In the case that both methods fail, then any (other) intubation method will (can) be used.

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 35kg/m2
* Elective surgery
* Absence of at least one molar of the right mandible in arm I (20 patients)

Exclusion Criteria:

* Emergency patients
* Prevalence of reflux disease
* Toothless patients
* Diaphragmatic hernia
* Patient is not sober
* Ventilation problems during induction of anaesthesia
* Patient with a tracheostomy
Adolescent Idiopathic Scoliosis and Proprioceptive Defect

This is the first clinical study to examine the spinal and peripheral proprioceptive deficits in longitudinal terms among subjects with adolescent idiopathic scoliosis.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of adolescent idiopathic scoliosis
* did not receive or failed conservative treatment

Exclusion Criteria:

* spinal injury, fracture, or spinal tumour
* neurological deficit
* brain or spinal cord abnormality
* developmental delay
* psychological disorder
Evaluation of a Diagnostic Device for Detection of Nasal Staphylococcus Aureus

To establish the clinical test performance characteristics of sensitivity, specificity and predictive values for direct detection of nasal Staphylococcus aureus colonization against clinical microbiology laboratory culture methods.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects 18 years of age or older, male or female and from any race or culture.
2. Subjects who are ambulatory (able to walk unaided or with a cane, walker, wheelchair) on the day of their pre-operative visit for non-emergent surgery.

Exclusion Criteria:

1. Subjects who are on the nasal topical antibiotic Mupirocin (Bactroban® Nasal Ointment) within the last 4 weeks.
2. Subjects who are present at the preoperative visit with prescribed nasal medical devices (e.g. CPAP = Continuous Positive Airway Pressure or Nasal Cannula), nasal prosthetics, the wearing of nasal jewelry or trauma to the nose or anything that may inhibit sampling of the anterior nares.
Effect of Bariatric Surgery Versus Medical Therapy on Metabolic Syndrome

Bariatric surgery (BS) is known to improve the components of metabolic syndrome (MS) in obese patients. However, few studies have evaluated the impact of bariatric surgery versus medical therapy (MT) in patients with MS, especially in patients with low body mass index (BMI). This study aimed to assess the effect of bariatric surgery on MS in patients with low BMI by comparing BS (BMI\<35 kg/m2 and BMI≥35 kg/m2) with MT (BMI\<35 kg/m2). A retrospective study including patients with MS undergoing bariatric surgery and medical therapy at a single institution. We follow up the 5 years effect of bariatric surgery versus medical therapy on the remission of MS, its individual components, atherosclerotic cardiovascular disease (ASCVD) risk, and medication used.

1. Study design and patients

   This study aimed to compare bariatric surgery(BS) with medical therapy (MT) for the management of low BMI patients with MS, approved by the ethics committee and institutional review at our hospital. 100 patients underwent bariatric surgery and 100 patients receiving medical therapy for obesity and type 2 diabetes between 2010 and 2020 at our institution. All patients met the Chinese guidelines developed by the Chinese Society for Metabolic \& Bariatric surgery (CSMBS). All patients achieve diagnostic criteria for MS, defined by the presence of at least 3 of the 5 following criteria derived from the joint interim statement (JIS) definition.
2. outcome and Data collection

   All patients follow up the change of improvement in MS and its components following bariatric surgery and medical therapy, including waist circumference, hyperglycemia, hypertension, hyperlipidemia, long-term CVD risk, and medication use
3. Treatments

3.1 BS group The bariatric surgical procedures performed included Roux-en-Y gastric bypass and sleeve gastrectomy.

3.2 MT group According to the guidelines in China, patients in the medical therapy group received glucose-lowering, lipid-lowering, and antihypertensive medications, with the following targets: glycosylated hemoglobin\<7%; systolic blood pressure\<140 mmHg, diastolic blood pressure\<80 mmHg; low-density lipoprotein cholesterol\<2.6 mmol/L; and high-density lipoprotein cholesterol\>1.3 mmol/L for female or 1.0 mmol/L for male.

Eligibility Criteria:
1. Inclusion Criteria:

   * BMI\<35 kg/m\^2
   * Underwent bariatric surgery or medical therapy
   * Patients met the diagnostic criteria for MS, defined criteria derived from the joint interim statement (JIS)
2. Exclusion Criteria:

   * Patients who failed to follow up
   * Insulin dependent diabetes
   * congenital dementia
   * brain trauma
   * epileps
   * severe hypoglycemic coma
   * cerebrovascular disease
   * ischemic
   * heart disease
   * renal dysfunction
   * alcohol abuse
   * mental illness
   * psychoactive substance abuse
   * unwillingness to provide informed consent
Statewide Implementation of Electronic Health Records

To determine the effects of Electronic Health Record use on medication error rates in primary care office practices.

Hypothesis: Adoption of Electronic Health Records through this program will reduce medication errors

From the practices committed to implementing EHR in early 2005, we randomly selected 15 adult community-based primary care physicians. We selected 15 similar physicians in practices that were not planning to adopt in that time period.

At each of these physicians' practices we documented rates of medication errors for one week prior to the implementation of an EHR using duplicate prescription pads. Two months after the implementation in the adopting group, allowing some time for familiarization with the tool, we collected two weeks of data using computer-based information (in the adopting arm) and duplicate prescriptions (in the non-adopting arm).

Eligibility Criteria:
Inclusion Criteria:

* All patients of physicians participating in the study

Exclusion Criteria:

* Any patients who are not part of a panel of a participating physician
* Any patients who are younger than 18 years of age
* Any patients who came in for a second visit within each data collection period
Effectiveness of Gum Chewing on Ileus in Chinese Colorectal Patients Underwent Laparoscopic Colorectal Surgery

Gum chewing group will have less ileus and early resume of bowel motion than control group.

The standardize surgical techniques, less used of epidural analgesia, early ambulation and used of naso-gastric tube for decompression are aimed to reduce the paralytic ileus after abdominal surgery . Most Western studies have examined and found that gum chewing are able to prevent postoperative ileus or promotes early bowel function after abdominal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed colorectal cancer undergoing laparoscopic resection in in Queen Mary Hospital
* At least 18 years
* Speak Cantonese
* Able to follow study protocol and chewing gum study

Exclusion Criteria:

* Cognitive disability
* Requirement of epidural analgesia
* Requirement of intensive care unit/ High dependency unit care postoperatively
* Inability to chew
* Presence of procedure other than colorectal resection
* Non Chinese
The Measurement of Vital Signs in Children by Lifelight® Software in Comparison to the Standard of Care

A prospective basic science study for collection of training and testing data for development of Lifelight® Junior

This study will be hospital-based, including paediatric emergency department (PED), inpatient wards and outpatient departments).

The participants will have their vital signs (such as heart rate, respiratory rate, oxygen saturation, blood pressure and temperature) measured using standard-of-care methods. Concurrent with this, videos of the participants' face/torso, and audio of the sounds made by the participants (cry, wheeze, cough) will be recorded. These data will later be used to train the Lifelight® Junior algorithms so that the technology can help in detection of illness and deterioration in children.

Primary Objective Collect the data needed to develop Lifelight® Junior so that it can measure the heart rate, respiratory rate and oxygen saturation of children.

Secondary Objective

1. Assess the feasibility of developing other (direct or indirect) measurement functions in Lifelight® Junior, including temperature, blood pressure, heart rate variability and audio analysis (cry, wheeze, cough).
2. Evaluate the impact of subject-specific variables on the vital sign measurements e.g., medication, cosmetics, facial/body hair and skin tone.
3. Obtain data to understand patient and parent/guardian/carer vital sign measurement habits and preferences
4. Assess the usability of Lifelight® Junior for measuring vital signs in children

To ensure the study collects data that can train Lifelight® Junior in an efficient way, the recruitment should be divided as follows:

* At least 12% of study participants should fall into each of the following age bands:

  * Age 0-1
  * Age 1-2
  * Age 2-5
  * Age 5-11
  * Age 11-14
  * Age 14-18
* At least 40% of the study participants shall be male and at least 40% shall be female.
* At least 40% of the study participants shall be each of the following:

  * Febrile (≥ 38°C) measured how?
  * Afebrile
  * Ill (as judged by the clinical staff), of whom at most 50% shall have an acute respiratory illness e.g., bronchiolitis, asthma, viral induced wheeze, pneumonia, croup, etc.
  * Well, including children with a minor injury

Ideally, 15% of participants should have a Fitzpatrick skin tone of 4, 5 or 6 First reference to this - need to bring it in earlier and to reference it. However, this is not a hard target as achieving this figure is dependent on the demographic diversity of the study region.

Eligibility Criteria:
Inclusion Criteria:

* Children (0-18 years old) attending the paediatric ED or who are inpatients on the paediatric wards at STSFT

Exclusion Criteria:

* Critically ill children (judged so by treating physicians), including unconscious children
* Children who are non-compliant in terms of excessive movement during the measurement
* Children of parents/guardians/carers who are non-English speakers
A Study to Evaluate the Efficacy and of Stillen Tab. and to Demonstrate the Non-inferiority of Stillen Tab.

This is a multicenter, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy of 4-week treatment with Stillen tab. in patients with acute or chronic gastritis. Subject will receive Stillen tab or Mucosta tab., three times a day for four weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age is over 20 years old, under 75 years old, men or women
* Patients diagnosed with acute or chronic gastritis by gastroscopy
* Patients with one or more erosions found by gastroscopy
* Signed the informed consent forms

Exclusion Criteria:

* Patients with peptic ulcer and gastroesophageal reflux disease
* Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 2 weeks
* Patients with surgery related to gastroesophageal
* Patients with Zollinger-Ellison syndrome
* Patients with any kind of malignant tumor
* Patients administered with anti-thrombotic drugs
* Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease
* Women either pregnant or breast feeding
Acute Effects of Exercise in Women With Fibromyalgia (FM)

The investigators previous studies of aerobic exercise in women with fibromyalgia (FM) have shown that exercise improves body functions and/or symptom severity in most patients, but not in all. About a third of patients with FM have been shown to have low levels of IGF-1. The purpose of this project is to study individual and biological factors that interact with outcomes of short-term (acute) exercise in FM.

Method. A controlled prospective exercise study. Thirty women with FM and 30 healthy age-matched women, aged 20-50 years, will be recruited to the study. Two 15-minute ergometer bicycle exercise tests will be conducted in feasting patients, separated by one month. The first exercise test is at a low and the second at a high intensity. Measurements comprise blood test, pain rating and pain threshold, conducted before and after the test. The levels of IGF-1, IL-6 and IL-8 will be measured, and the changes in them will be related to health status and pain.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of fibromyalgia
* age 20-50 years

Exclusion Criteria:

* heart disease
* neurological disease
* severe osteoarthritis