cyrilzakka/clinical-trials huggingface dataset:
A Training Program of Drug Allergy for Healthcare Professionals

Drug allergy is often under-recognized, yet over- (mistakenly) diagnosed, especially in Hong Kong. There is also a dire shortage of allergy specialists and facilities to tackle the overwhelming drug allergy pandemic. Fortunately, when trained, non-specialist physicians and nurses have demonstrated comparable capabilities in drug allergy evaluation compared to specialists. To potentially promote and propagate the role of non-specialist physicians and nurses toward drug allergy care, the investigators propose a study to investigate the impact of an intensive and focused drug allergy educational course conducted at the University of Hong Kong.

Two identical didactic courses on drug allergy were designed. Each course will last 12 hours and conducted over 2 consecutive days (6 hours each day). All candidates will attend physically and on-site. Various aspects of drug allergy with pre-set learning objectives will be taught in-person by instructors (physicians or nurses specializing in drug allergy nominated by the University of Hong Kong). Course materials and instructors will be identical for each course.

Aims of the study Primary objective

* Investigate the change in knowledge among participants of a 2-day drug allergy educational course
* Investigate the change in clinical practice among participants of a 2-day drug allergy educational course

Secondary objectives

* Investigate the sustained change(s) in knowledge (if any) of participants of a 2-day drug allergy educational course
* Investigate the sustained change(s) in clinical practice (if any) of participants of a 2-day drug allergy educational course

Hypothesis The investigators hypothesize that candidates (practicing physicians and nurses) of the drug allergy course will gain knowledge on drug allergy, which in turn will influence and change their clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Registered nurses or doctors actively practicing in Hong Kong
* English speaking;
* Able to complete quizzes and questionnaires;
* Aged 18 or above

Exclusion Criteria:

* People who are unable to communicate in Cantonese or Mandarin
* People who are participating in other drug allergy training course
Cell Saver Use in Bilateral Total Hip Arthroplasty (THA)

This study will investigate the efficacy of using cell saver during bilater total hip arthroplasty


Eligibility Criteria:
Inclusion Criteria:

* Subject is over 21 years of age
* Subject with bilateral degenerative disease of hips who are candidate for one-stage bilateral THA
* Subject willing and able to provide written informed consent

Exclusion Criteria:

* Subject with significant comorbidities identified by Charleston index of ≥ 3
* Subject with malignancy
* Subject with history of heart disease, myocardial infarction, pulmonary insufficiency, pulmonary embolus, documented fat emboli syndrome, adult respiratory distress syndrome, documented patent ductus arteriosus or septal defect, chronic renal failure and/or acute hepatic failure or chirhosis
* Subjects with hematologic disorders such as anemia (Hb \< 10 g/dL) and sickle cell disease, acquired or congenital coagulopathies, acquired or congenital bleeding disorders,
* Subject who received anticoagulant such as aspirin or Warfarin (Coumadin) or antiplatelet agents such as clopidogrel (Plavix) within 7 days of surgery
* Subject who received hemostatic agents such as tranexamic acid and aprotinin
* Subjects utilizing acute normovolumic haemodilution
* Subject is not permitted to remain without his/her anti-coagulant regimen (eg Plavix) for 48 hours postoperatively
* Subject is known to be pregnant.
* Subject has erythropoietin agonist/stimulating agent within 90 days prior to surgery.
* Presence of contaminants such as urine, fat, bowel contents, and most importantly infection in the operative field
* Presence of vasoactive drugs such as papaverine in the operative field
PET Scan in Treating Patients With Metastatic Prostate Cancer

RATIONALE: New imaging procedures, such as PET scan, may improve the ability to detect new or recurrent prostate cancer.

OBJECTIVES:

* Measure the pharmacokinetics, whole body retention of isotope, and biodistribution of C11-methionine and FDG by PET imaging and serial sampling of blood in men with progressive prostate cancer.
* Explore metabolism of each PET scan by comparing the sensitivity of C11-methionine or FDG by PET scanning in androgen independent prostate cancer metastases with the sensitivity of C11-methionine or FDG in androgen dependent metastases on a site by site basis.
* Compare C11-methionine and FDG PET scanning to standard of care diagnostic studies which include the Tc 99m bone scan, computed tomography, and magnetic resonance imaging.

Patients fast for 6 hours prior to PET imaging with the exception of liberal water intake which is encouraged. A two way catheter is placed in the urinary bladder, and continuous isotonic saline irrigation is performed throughout scan acquisition to reduce the interference in imaging lesions in the pelvic lymph nodes and adjacent pelvic bones caused by radiation excreted in urine held in the bladder.

Each patient receives C11-methionine intravenously. PET imaging begins immediately after injection for approximately 60 minutes total using standard imaging procedures. Immediately following the completion of imaging after C11-methionine administration, each patient receives FDG intravenously. PET imaging begins approximately 45 minutes thereafter for approximately 60 minutes using standard imaging procedures.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed prostate adenocarcinoma
* Must have an at least 50% increase in PSA which is sustained for a minimum of 3 observations obtained at least 1 week apart
* Must have development of new lesions on bone scintigraphy or greater than 50% increase in measurable disease on CT or MRI scan
* Metastatic disease

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* Karnofsky greater than 60%

Hematopoietic:

* ANC greater than 1,000/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* Not specified

Renal:

* Not specified

Cardiovascular:

* No clinically significant cardiac disease

Pulmonary:

* No clinically significant pulmonary disease

Other:

* No active infection not controlled by antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Pilot Study of Sedation With Propofol in Refractory Pains Due to Care in Palliative Care Unit

In the palliative care unit, certain patients suffer from pain associated with medical procedures/care which is poorly controlled by antalgics. These situations may necessitate temporary sedation to improve comfort and facilitate treatment. No proven consensus exists, either in the literature or in clinical studies conducted, on the choice of sedative agent however Midazolam is the general recommendation.

The investigators believe that Propofol could be used in this instance

In the palliative care unit, certain patients suffer from pain associated with medical procedures/care which is poorly controlled by antalgics. These situations may necessitate temporary sedation to improve comfort and facilitate treatment. No proven consensus exists, either in the literature or in clinical studies conducted, on the choice of sedative agent however Midazolam is the general recommendation.

The investigators believe that Propofol could be used in this instance. The arguments in favour of Propofol include its pharmaco-kinetic characteristics and the fact that it is currently used in other circumstances. Propofol has an action delay which is more rapid that Midazolam therefore its effect is seen 1 minute after a bolus and 5 minutes after for Midazolam. The effect after a short administration lasts only a few minutes however the effect of Midazolam is more prolonged (sometimes several hours). As with Midazolam, a titrated use in weaker doses, should allow sufficient sedation, in the context which interests us, without marked secondary effects.

It is not unreasonable to think that the short action duration of Propofol could minimise respiratory risks in the hours after the treatment compared to Midazolam. With Propofol, the patient wakes as soon as the painful medical procedure has finished, with Midazolam sedation may be prolonged to several hours leading to a risk respiratory depression or secretion retention.

For these reasons; the investigators would like to verify that the use of Propofol is feasible in the context of refractory pain associated with medical procedures (dressing changes, movement during personal care tasks e.g. washing) in the palliative care unit. This is a preliminary study prior to completion of a more extensive multi-centre research project on the role Propofol could play in this situation.

Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized in palliative care unit
* dying terminally patients
* pains resisting to fentanyl and MEOPA (Melange equimolaire Oxygène protocyde d'Azote) (EMONO = equimolar mixture of oxygene and nitrous oxide)

Exclusion Criteria:

* contra-indication to soya
* contra-indication to egg lecithin
* Respiratory insufficiency
Efficacy and Safety of Moxonidine in Indian Patients

The purpose of this study is to demonstrate efficacy and safety of Moxonidine in Indian subjects.


Eligibility Criteria:
Inclusion Criteria:

Hypertension

Exclusion Criteria:

Severe concomitant diseases, CHF, secondary hypertension, severe hypertension, significant hepatic disease, unstable angina
Ketorolac in Postoperative Infants: Pharmacokinetics and Safety

Infants handle ketorolac differently than adults. Study of handling of this pain medication given to infants following surgery. Detailed analysis of how the drug is eliminated from age 2 months to 18 months. Compared morphine use in infants who received the drug to the group getting placebo. Safety testing for kidney and liver function, breathing measured by continuous oximetry, and any bleeding issues.

Population kinetic analysis of ketorolac stereo-isomer concentrations after single dose given postoperatively in infants aged 2-18 months. Safety assessments of renal and hepatic function tests by blood tests before and after drug administration, urinalysis pre- and post-drug, continuous oximetry before and for 12 hours after drug. Morphine use between active drug groups and placebo group in the first 24 hours after surgery was assessed as a surrogate analgesic measure in these non-verbal infants. A modified infant pain scale was used to assure consistent pain management.

Eligibility Criteria:
Inclusion Criteria:

* Non-prematurely-born infants admitted to hospital following surgery ages 2-18 months, studied by age group 12-18 months, 6-12 months, \< 6 months

Exclusion Criteria:

* Bleeding history in infant or family
* Coagulopathy
* Gastrointestinal bleeding history
* Renal or hepatic disease assessed by history and by pre-drug blood tests
* Premature birth (\<36 weeks gestation)
Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability

Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability

This study is designed to investigate the safety, tolerability and pharmacokinetics of a new drug, AZD5363, in patients with advanced cancer . This study will investigate how the body handles AZD5363 (ie, how quickly the body absorbs and removes the drug), the comparison of a capsule and a tablet formulation and the effect of food on AZD5363 tablet formulation.

Eligibility Criteria:
Inclusion Criteria: -

* Aged at least 18 years
* The presence of a solid, malignant tumour, excluding lymphoma, that is resistance to standard therapies or for which no standard therapies exist
* The presence of at least one lesion that can be accurately assessed at baseline by Computerised Tomography (CT), Magnetic Resonance Imaging (MRI) or plain X-ray and is suitable for repeated assessment
* Estimated life expectancy of more than 12 weeks

Exclusion Criteria: -

* Clinically significant abnormalities of glucose metabolism
* Spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids)
* Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and Human Immunodeficiency Virus (HIV)
* Evidence of clinically significant cardiac abnormalities, uncontrolled hypotension, left ventricular ejection fraction below the lower limit of normal for the site or experience of significant cardiac interventional procedures
* A bad reaction to AZD5363 or any drugs similar to it in structure or class
Effectiveness of a Procedure for Previously Failed Glaucoma Surgery

Transconjunctival mitomycin-C in needle bleb revision may be an effective procedure to treat cases with a previously failed trabeculectomy. We will investigate approximately 100 consecutive cases with follow up of up to 9 years. We anticipate that this procedure is an effective, safe, and appropriate option for successful glaucoma treatment.

The healing process after filtering surgery for glaucoma may cause an unsuccessful outcome for the trabeculectomy procedure. In order to control the rising intraocular pressure due to the failed trabeculectomy, medications may be restarted and/or filtering surgery may need to be repeated. Our primary research showed that transconjunctival mitomycin-C in needle bleb revision may be an effective procedure to control this situation.

This retrospective study will follow over 100 patients from May 1997 to May 2006. This long-term follow up will help assess the future role of this technique in glaucoma practices.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of glaucoma
* Failed filtering procedures- defined as intraocular pressure exceeded target pressure thus inducing possible further optic nerve damage

Exclusion Criteria:

- Needling combined with other ocular surgical or laser treatments
A Clinical Trial to Evaluate the Clinical Efficacy of Cyclosporine 0.1% (Ikervis®) for Moderate to Severe Dry Eye Patients. (IKE-03-SWITCHING)

A clinical trial to evaluate the efficacy and safety of Cyclosporine 0.1% (Ikervis®) for moderate to severe dry eye patients who changed to Cyclosporine 0.1% eye drop(Ikervis®) due to lack of treatment effects of the previous Cyclosporine 0.05% eye drop.

Eligible patients who agree to participate in the clinical trial in writing will be administered Cyclosporine 0.1% eye drop(Ikervis®) one drop once daily for 12 weeks. Efficacy and safety will be evaluated at baseline, 4 weeks, 8 weeks, and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 19 and less than 80 years old
2. A patient with moderate or severe dry eye who has used Cyclosporine 0.05% eye drop for more than 3 months and has no or insufficient treatment effect

   - No or insufficient treatment effect should meet the following criteria through tests used to diagnose dry eyes
   * A SANDE (Symptom Assessment in Dry Eye) score of 40 or more on the severity and frequency of dry eye symptoms.
   * Cornea staining score (NEI scale) 3 or more points
   * Tear Break Up Time(TBUT) 10 seconds or less
   * Tear volume tested by Tear Meniscometry less than 5mm
   * Has One or more of the dry eye symptoms; stinging, irritating, itching or blurred vision.
   * Use of diquafosol tetrasodium 3% eye drop and/or artificial tears are allowed with no change of products and dosage throughout the trial period
3. A person who voluntarily agrees in writing to participate in this clinical trial

Exclusion Criteria:

1. Use of eye drops within four weeks of the consent date such as steroids, glaucoma, allergies and anti-inflammatory drugs, etc.
2. Systematic steroid within four weeks of the consent date
3. Patients with pterygium
4. Start new immunosuppressive drugs or change in dosage that can affect immune function within four weeks of the consent date due to an unregulated systemic disease.
5. Severe MGD patient
6. Ophthalmic surgery (including Lasik/Lasek) and trauma in eyes within the last three months
7. Wearing contact lenses during a clinical trial period
8. Planning an eye surgery (including Lasik/Lasek) during the clinical trial period
9. Hypersensitivity to the clinical trial drug
10. Active or suspected eye infections
11. Pregnant or breastfeeding, or women planning to become pregnant
12. Participation in other clinical trials within three months
13. Any person who is deemed unfit for clinical trial by a investigator
Retrospective Review of Saphenous Vein Incompetence: Venaseal Versus Endovenous Thermal Ablation

This study is a retrospective, chart review of treatment of patients with symptomatic varicose veins. Treated limbs must have the Great Saphenous Vein and/or Small Saphenous Vein treated with either cyanoacrylate closure (VenaSeal) or Endothermal Ablation (either Radiofrequency Ablation or Endovenous Laser Ablation).

This single site, retrospective, comparison study aims to review up to 400 treated limbs with symptomatic varicose veins to compare the need for/utilization of adjunctive phlebectomy performed as a concomitant or staged procedure in conjunction with either cyanoacrylate closure versus endothermal ablation of incompetent saphenous veins through 6 months of the index procedure. The overall cost of treatment for both groups will be compared.

Some of the secondary aims of this study include:

1. To assess changes in Clinical, Etiology, Anatomy, and Pathology (CEAP) clinical class after completion of treatment.
2. To assess changes in revised Venous Clinical Severity Score (rVCSS) and compare the two groups.
3. To assess the need for adjunctive therapies.
4. To record and compare retrospectively the adverse events between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Limb with saphenous vein incompetence, treated with one of the following:

   VenaSeal ™ Endovenous Laser Ablation Radiofrequency Ablation
2. CEAP Clinical Class between 2-5
3. Limb treated from October 1st, 2015-present
4. At least 2 months of follow-up post index procedure
5. Treatment of either the great saphenous vein (GSV), the small saphenous vein (SSV), or both. Treatment of accessory saphenous veins (ASV) is allowed as long as either the GSV, SSV, or both the GSV and SSV were treated as well in that limb at the index procedure.

Exclusion Criteria:

1. Limb treatment of the accessory saphenous vein (ASV) without concomitant great saphenous vein (GSV) and/or small saphenous vein (SSV) treatment
2. Limb treatment for reasons other than symptomatic varicose veins
3. Limbs without follow-up information at least 2 months following the index procedure
4. Subjects who participated in another clinical trial as part of their saphenous vein treatment
5. Investigator decision (concurrent condition that would make inclusion inappropriate, protected subject population) -
Intraoperative Radiation Therapy in Early Stage Breast Cancer

Single arm study to assess the effectiveness of single dose intraoperative radiation therapy in patient with in situ and early stage breast cancer.

The purpose of this clinical study is to assess the effectiveness of IORT, using an electronic brachytherapy system, in patients with limited-volume in situ and early stage breast cancer, with endpoints of:

* Local recurrence in early stage breast cancer patients treated with IORT.
* Toxicity associated with IORT.
* Long-term disease-specific and overall survival
* Cosmetic results using the Harvard Scale at start and follow-up periods in patients treated with IORT.
* Quality of life in patients treated with IORT.
* Health care costs associated with IORT.

Eligibility Criteria:
Inclusion Criteria:

General Inclusion Criteria

1. Age ≥ 45 years.
2. Clinical stage Tis, T1, T2 (≤ 3cm), N0, M0 (AJCC Classification).
3. Invasive ductal or lobular carcinoma, DCIS and/ or pleomorphic lobular carcinoma in situ.

Exclusion Criteria:

1. Scleroderma, systemic sclerosis and active lupus.
2. Participation in an investigational drug or device study.
3. Previous ipsilateral radiation to the thorax or breast.
4. Multifocal breast cancer.
5. Pregnant patients.
6. Patient not competent to provide informed consent.
7. Neoadjuvant systemic therapy.
8. Lymphovascular invasion on biopsy pathology
Active Knee Prosthesis Study

The purpose of the study is to investigate the clinical and functional outcomes of a powered knee prosthesis for people with a transfemoral amputation in the domain of gait, free space control, and embodiment


Eligibility Criteria:
Inclusion Criteria:

* Male or Female age 22-65.
* The patient must have a unilateral transfemoral amputation .
* The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above).
* The patient must have adequate socket to support the device.

Exclusion Criteria:

* Women who are pregnant.
* Severe co morbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy, vulnerable patient population, BMI \>40, etc.).
The Cervix as a Natural Tamponade in Postpartum Hemorrhage Caused by Placenta Previa and Placenta Previa Accreta

Placenta previa and placenta accrete carry significant maternal and fetal morbidity and mortality. Several techniques have been described in the literature for controlling massive bleeding associated with placenta previa cesarean sections. The aim of this study is to evaluate the efficacy and safety of the use of the cervix as a natural tamponade in controlling postpartum hemorrhage caused by placenta previa and placenta previa accreta.

Background: Placenta previa and placenta accrete carry significant maternal and fetal morbidity and mortality. The maternal mortality in women with placenta accreta may reach as high as 7-10%. Several techniques have been described in the literature for controlling massive bleeding associated with placenta previa cesarean sections, including uterine packing with gauze, balloon tamponades, the B-Lynch suture, insertion of parallel vertical compression sutures, a square suturing technique and embolization or ligation of the uterine and internal iliac arteries, but there is a wide variation in the success rate of these maneuvers. In a case report, Dawlatly et al. (2007) described a simple technique of suturing an inverted lip of the cervix over the bleeding placental bed that was successful in controlling the bleeding, saving the patient's life, and preserving her uterus.

The objective of this trial is to evaluate the safety and efficacy of the use of this Dawlatly stitch as a natural tamponade for controlling postpartum haemorrhage in cases of placenta previa and/ or placenta previa accreta.

Eligibility Criteria:
Inclusion Criteria:

1. All participating women had one or more previous cesarean deliveries.
2. were diagnosed with placenta previa and/ or placenta previa accreta by ultrasound. When the ultrasound result was not conclusive for placenta accreta, MRI was performed.
3. All participating women desired to preserve their fertility
4. Patients with focal (partial) placenta previa accreta/ placenta previa.

Exclusion Criteria:

1. placenta percreta.
2. diffuse placenta accreta or increta.
3. uncontrollable postpartum hemorrhage.