cyrilzakka/clinical-trials huggingface dataset:
The Relationship of Body Function, Participation and Quality of Life in Patients With Burn: A Longitudinal Study

The relationship of body function, participation and quality of life in patients with burn: A longitudinal study

Early rehabilitation to partial-thickness and full-thickness dermal injury are of vital importance for burn patient. Literature reviews have shown that burn patients experiences ADL and quality of life (QOL) difficulties. Due to varied severity, the outcome and expression of each patient also differs. The limitation of body function may consequently affect social participation and QOL thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of burn injuries admitted to Burn Center or followed in burn clinic
* Age \>14
* No mental diseases
* Understand written Chinese or could complete the questionnaires with staff's assistance

Exclusion Criteria:

* Died during or after hospitalization
* Refused to participate in the investigation
* Concurrent medical illness that affecting the subjectivity of post burn sequelae (ex. progressive muscular or mental diseases, trauma or seizure)
* Age \>74
RS-3000 Lite Agreement Study

The primary objectives of the study are to assess the agreement between the two different scan mode of the RS-3000 Lite.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who do not have pathology in both eyes

Exclusion Criteria:

Subjects who have any of the following conditions:

* Diabetes mellitus (DM) and/or diabetic retinopathy
* Uncontrolled Hypertension (HT)
* Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision
* Cardiac, hepatic, renal and hematologic diseases
* A current condition requiring systemic administration of steroid
* A history of, or currently receiving, anticancer therapy
* Epileptic seizures which are optically induced
* Dementia

Note: Additional criteria may apply
The Effects of Aerobic Exercise in Patients With Ankylosing Spondylitis

The aim of our study is to investigate the effects of aerobic exercise and stretching exercises applied in high-intensity interval training protocol on disease activity, quality of life, spinal mobility and calprotectin, visfatin, leptin, IL-33 serum levels in patients with Ankylosing Spondylitis.

Ankylosing spondylitis (AS) is a painful and progressive chronic inflammation of the axial skeleton, mainly affecting the vertebral and sacroiliac joints. The management of AS aims to improve and maintain spinal mobility and normal posture, alleviate symptoms, reduce functional limitations and minimise complications. Due to the characteristic features of the disease, recommended spinal mobility exercises and aerobic exercises focus on reducing symptoms, improving functional capacity and quality of life, and improving and maintaining spinal mobility. Calprotectin, visfatin, leptin can be evaluated as biomarkers in inflammatory rheumatic diseases as an alternative to acute phase proteins and may reflect disease activity.

This study was designed as a prospective randomised controlled trial. Participants will be randomized into 2 groups and the intervention group will be given aerobic exercise and stretching exercise, and the other group only stretching exercise. BASDAI, BASMI, BASFI, ASQOL, ASDAS-CRP, Chest Expansion, 6 Minute Walk Test and Borg Scale will be used as assessment parameters.

Calprotectin, Visfatin, Leptin, IL-33 serum levels will be analysed by ELISA kit with blood samples taken in the early morning at the beginning of treatment, at the end of treatment (4th week) and at the 12th week after the beginning of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ankylosing spondylitis according to 2009 ASAS diagnostic criteria,
* 20-60 years old, male and female gender,
* No change in anti-rheumatic drugs and dosage in the last 3 months
* Those who have not done regular physical activity in the last 3 months,
* Patients who do not have any orthopedic, neurological or mental illness that may affect exercise will be included in the study.

Exclusion Criteria:

* Active malignancy and/or history of malignancy in the last 5 years,
* Uncontrolled cardiopulmonary disease,
* Unstable angina pectoris, cardiac arrhythmias and myocardial infarction within the last 3 months
* Presence of pregnancy or those planning a pregnancy in the near future,
* History of major surgery (including joint surgery) within the last six months
* Use of assistive devices for ambulation or orthopaedic joint prosthesis
* Patients with total spinal ankyloses
* Patients with a history of syncope, exercise-induced arrhythmia
* Regular exercise in the last 3 months
* Patients with contracture of the knee joint that prevents cycling exercise
Bingo Drug-Coated Balloon in Real World

The purpose is to observe and evaluate the safety and efficacy of Bingo drug-coated balloon in the real world.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older, regardless of gender;
2. Patients suitable for PCI with paclitaxel drug-coated balloon;
3. Patients able to understand the purpose of this study, provide an informed consent and cooperate with clinical follow-up.

Exclusion Criteria:

General exclusion criteria

1. Contraindications to PCI;
2. In-stent restenosis;
3. Life expectation less than 1 year;
4. Patients not suitable for enrollment considered by investigator.

Angiographic exclusion criteria:

1. Target lesion with the following conditions after pre-dilatation:

1. Residual stenosis larger than 30% ;
2. TIMI flow grade less than 3;
3. Type C-F dissection (NHLBI grade).
Brimonidine for Intraoperative Hemostasis

The purpose of this study is to observe and report the effects of topical ophthalmic brimonidine in oculofacial plastic surgery.

Brimonidine ophthalmic solution (Alphagan) is mainstay in glaucoma therapy to reduce intraocular pressure. The medication is an alpha2 adrenergic agonist, which increases uveoscleral outflow of aqueous humor. Alpha2 agonists also have vasoconstrictive properties, which has been utilized in over-the-counter medications like Lumify for redness relief. An unexploited utility of its vasoconstrictive property is reduction in intraoperative bleeding during ophthalmic surgery. The purpose of this study is to observe and report the effects of brimonidine in oculofacial plastic surgery.

There are reports in ophthalmic literature that observe the hemostatic effect of topical brimonidine across different subspecialties. It has been shown to reduce intraoperative bleeding and post-operative subconjunctival hemorrhages in pterygium removal, strabismus surgery, LASIK, and cataract surgery. One study claimed that it had a comparable hemostatic effect to phenylephrine.

Many of the procedures in oculoplastic surgery involve manipulation and incision of eyelid skin and conjunctival tissue. Some examples include blepharoplasty, ptosis repair, medial spindles, lateral tarsal strips, canthotomy and cantholysis with subsequent repair, retraction repair, and orbital fracture repair. Rapid and adequate control of intraoperative bleeding is crucial to the success of oculoplastic surgery. Although surgeons take proper precautions to prevent inadequate hemostasis (discontinuing blood thinners, use of electrocautery, and administration of intradermal epinephrine), excessive bleeding can still occur. This can impair surgeon performance by obscuring visualization, and negatively affect the patient due to prolonged operative times, and delayed healing due to hematoma formation. The most feared complication of oculoplastic surgery is intraorbital hemorrhage, which can cause orbital compartment syndrome causing vision loss.

Therefore, any intervention to minimize bleeding is very advantageous to the patient. Use of Brimonidine drops intraoperatively will improve hemostasis, resulting in improved visualization, reduced operative time under anesthesia, and reduced risk of significant intraorbital hemorrhage. Due to both brimonidine's vasoconstrictive properties and relatively favorable safety profile, it raises the question: can brimonidine be used to achieve better hemostasis in oculoplastic procedures?

Eligibility Criteria:
Inclusion Criteria:

* Above the age of 18
* Ophthalmic conditions requiring oculoplastic surgery

Exclusion Criteria:

* Known allergy or adverse effects to brimonidine
* Hypotony
* Acute ophthalmic infection
* History of hypotension
* Orthostatic hypotension
* Pregnancy
* History of Central Nervous System (CNS) depression from medication use
* Thrombotic disorders
* Asymmetrical oculoplastic conditions that may interfere with tear drainage (e.g. unilateral NLDO)
* Current use of brimonidine
Application of Augmented Reality (AR) in HIV Self-test in Men Who Have Sex With Men Community

Objective: To apply augmented reality (AR) technology in HIV self-test and to assess its impacts in enhancing testing performance among men who have sex with men (MSM).

Design: Parallel randomised controlled, open label, trial. Block randomisation with a block size of 4 would be used to allocate the study arms.

Participants: men who have sex with men in Hong Kong

Intervention: Self-test assisted by AR vs self-test with instruction sheets

Main outcome measures: Effectiveness, usability, learnability, efficiency and satisfaction scores; rate of completion and result upload; acceptability of AR approach in assisting self-test

Anticipated results: 200 MSM would be recruited with 50 and 150 in control and intervention group, respectively. The scores in the intervention group are 10% higher than the control group. Proportion of satisfied participants in the intervention group is 10% more than the control group. AR approach is feasible and acceptable to MSM for assisting in HIV self-test.

About 200 MSM would be recruited through community-based organisations and Internet channels where MSM socialise and seek partners. Fifty and 150 participants would be randomly assigned into the control and intervention group by block randomisation with a block size of 4, respectively. After giving informed consent, subjects would be invited to complete an online questionnaire and request for an HIV self-test kit in the online portal before randomisation. Participants in the control group would be given a standard commercially available self-test kit which included bilingual instruction sheets. Subjects in the intervention arm would be asked to use the AR element to assist the same standard commercially available self-test kit. All participants would be asked to upload the test result and complete a post-test questionnaire on the usability of the test and the AR approach. The result would be validated by an experienced research staff. Subjects with a positive result would be contacted for follow up. Main outcome measures in this study would include the confidence in performing the self-test and the usability of HIV self-testing between the two arms.

Eligibility Criteria:
Inclusion Criteria:

* Adult men who have sex with men
* Has access to a smartphone with internet access

Exclusion Criteria:

* Unable to communicate in written Chinese or English
* Unable to give informed consent
A Study of DER 45-EV Gel to Treat Rosacea

To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 years of age or older
* Facial rosacea, with 12 or more inflammatory lesions (with no more than 2 nodules)
* Mild, Moderate or Severe (2, 3 or 4) rating of rosacea on the IGA
* Females of child-bearing potential must have negative urine pregnancy test result at baseline and must be willing to use an effective form of contraception throughout the study

Exclusion Criteria:

* Subjects who are pregnant, breast feeding, or planning a pregnancy during the study
* Allergy or sensitivity to ingredients in test product
* Any dermatological conditions of the face that may interfere with study evaluations
* Subjects unable to avoid or minimize exposure to factors that may exacerbate or trigger rosacea
Multicentre Booster & Immune Memory Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine or a Single Dose of 23-valent Plain Polysaccharide Vaccine in Healthy Children Aged 11-18 Mths, Previously Vaccinated in Study 103488

Booster and immune memory study

Total: All 689 subjects enrolled in study 103488. 23PS group: Aventis Pasteurs' 23-valent polysaccharide pneumococcal vaccine (Pneumovax 23) + DTPa-HBV-IPV/Hib; 10V group: GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib

Eligibility Criteria:
Inclusion criteria: Male or female between, and including, 11-18 months of age at the time of vaccination and who previously participated in the study 11PN-PD-DIT-002 and received at least one dose of pneumococcal conjugate vaccine during the primary study, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject. Exclusion criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the first dose of vaccine(s) and during the entire study period. Administration of any additional pneumococcal vaccine or DTPa combined vaccine since study end of 11PN-PD-DIT-002 study
Best Needle Size for FNA of Palpable Breast Mass:Randomised Controlled Study

Needle size from22 to 25 were used for fine needle aspiration of palpable breast lumps. In this study we choose one, randomly, and fallow the result of cytologic evaluation regarding specimen adequacy.

Patient assigned randomly to FNA of palpable breast mass with different needle size:21-22-23-24

Eligibility Criteria:
Inclusion Criteria:

* Any Woman with palpable Breast Mass

Exclusion Criteria:

* Previous open Biopsy or Surgery
* Active infection
* Breast cysts
* Patient refusal to do FNA
Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2

The purpose of this study is to evaluate if treatment with vitamin D increase beta cell function and insulin sensitivity in subjects with pre-diabetes or newly diagnosed diabetes mellitus type 2.


Eligibility Criteria:
Inclusion Criteria:

* Meeting criteria for IFG, IGT, IFG+IGT or diabetes mellitus at OGTT.
* BMI ≤ 32 kg/m2.
* HbA1c ≤ 7.0 % (MonoS) or ≤ 63 mmol/mol (IFCC).
* Fasting plasma glucose \< 9 mmol/l
* S-25-OH-vitamin D3 \< 75 nmol/l.

Exclusion Criteria:

* Treatment with any vitamin D preparation.
* Regular sun-bathing in solarium.
* Hypercalcemia at screening, defined as free s-calcium \> 1.35 mmol/l.
* Hyperphosphatemia at screening, defined as s-phosphate \> 1.5 mmol/l.
* Sarcoidosis or other granulomatous disease.
* Treatment with phenytoin, barbiturates, rifampicin, isoniazid, cardiac glycosides, orlistat or colestyramin.
* Impaired hepatic function.
* Impaired renal function
* Cardiac disease defined as:

  * Unstable angina pectoris
  * Myocardial infarction within the last 6 months
  * Congestive heart failure NYHA class III and IV
* Cerebral stroke within the last 6 months.
* Anti-diabetic medication of any kind.
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty

Patients undergoing buccal urethroplasty will often have significant post-operative oral pain from the graft site. Various graft harvest techniques and methods for post-harvest hemostasis including graft site closure have been explored. Despite the frequency of this clinical scenario there is no established best practice for peri-operative pain management in this patient population. In addition to traditional post operative pain control, groups have sought various peri-operative anesthetic regimens to improve post operative pain. This has led recently to the description of various regional blocks including buccal and periorbital blocks for peri-operative local anesthetic. No study has looked at superiority of regional pain management in this patient population. This study will aim to assess three established anesthetic protocols for oral pain control in a blinded, randomized controlled trial.

Hypothesis: Patients who have buccal block will have lower post op pain without any increase adverse oral outcomes.

This is a blinded, randomized, controlled trial following patients undergoing buccal urethroplasty (see criteria). This study will aim to assess three established anesthetic protocols for oral pain control. Each study arm holds equal weight. Approximately 60 subjects will be randomized in a 1:1:1 ratio to receive the following graft harvest techniques, which are all considered standard of care.

Group 1: Current Buccal Harvest

* Infiltration of lidocaine 1% with 1:100,000 epinephrine (maximum 10cc)
* Graft site hemostasis with monopolar cautery
* No suture closure of graft site

Group 2: Basic buccal procedure + Long acting local

* Infiltration of lidocaine 1% with epinephrine (maximum 10cc)
* Graft site hemostasis with monopolar cautery
* No suture closure of graft site
* 0.5% Marcaine (maximum 5cc) at case conclusion

Group 3: Basic buccal procedure + Buccal block

* Infiltration of lidocaine 1% with epinephrine (maximum 10cc)
* Graft site hemostasis with monopolar cautery
* No suture closure of graft site
* Buccal block with 0.5% Marcaine (maximum 5cc) at case conclusion

Eligibility Criteria:
Inclusion Criteria:

* Men, age 18 or older
* Undergoing anterior urethroplasty with buccal grafting
* Able to consent

Exclusion Criteria:

* Taking chronic opiates for pain
* Diagnosis of chronic pain
* Prior buccal urethroplasty
* Vulnerable population (e.g. prisoner)
* Renal dysfunction or allergy preventing NSAID use
* Liver dysfunction or allergy preventing Tylenol use
* Medical allergy to local anesthetic
* Medical allergy to Peridex/Magic Mouthwash
* NYHA Class III/IV
* Hematologic condition that excludes patient from surgery
* Post-operative complication resulting in inpatient stay
* Anesthetic complication
* No buccal site surgical complication
Computer Guided Doing of Tacrolimus in Renal Transplantation

Dosing of tacrolimus is challenging due to the large inter-individual variation in its pharmacokinetics. The investigators have developed a pharmacokinetics population model that can be used to estimate individual doses of tacrolimus in renal transplant recipients. The model will be prospective tested in a randomized clinical trial.

The hypothesis is that the computer model is superior to experienced transplant physicians in reaching and keeping the patients in the target range of tacrolimus.

Patients will be randomized to either computer or standard dosing strategies at time of transplantation or as early after transplantation as possible in case of deceased donor transplants.

For patients in the computer arm the model will calculate the dose with the highest probability to reach the specified concentration target.

For all concentrations a predictive error will be calculated and this will be the primary endpoint that the statistics will be calculated on.

All patients will be followed for between 8 to 12 weeks post-transplant, according to center praxis.

Eligibility Criteria:
Inclusion Criteria:

* renal transplant recipients using tacrolimus as part of their immunosuppression
* above 18 years
* signed informed consent

Exclusion Criteria:

* no specific
ADA Linagliptin in Long Term Care

This is a study to determine whether glycemic control, as measured by change in HbA1c and frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with poorly controlled diabetes (HbA1c \>7.5%) will be randomized to a 6-month intervention with linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC residents with T2D. We will also determine differences in clinical outcome, resource utilization, and hospitalization costs between LTC residents with T2D treated with linagliptin and basal and correction insulin. We will compare differences in complications (infectious and non-infectious, neurological and cardiovascular events), emergency room visits and hospitalizations between groups during the 6 months of intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females with known history of type 2 diabetes, treated with diet, OADs as monotherapy or in combination therapy (excluding DPP4 inhibitors), or sliding scale insulin.
2. Subjects with HbA1c \> 7.5% and/or any blood glucose greater than or equal to 180 mg/dL

Exclusion Criteria:

1. Subjects with a history of type 1 diabetes or with a history of diabetic ketoacidosis
2. Treatment with insulin or GLP1 analogs during the past 3 months prior to admission.
3. Recurrent severe hypoglycemia or hypoglycemic unawareness.
4. Subjects with history of gastrointestinal obstruction or gastroparesis.
5. Patients with acute or chronic pancreatitis or pancreatic cancer.
6. Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated ALT and AST \> 3 times upper limit of normal, or significantly impaired renal function (GFR \< 45 ml/min).
7. Treatment with corticosteroids, parenteral nutrition and immunosuppressive treatment.
8. Mental condition rendering the subject unable to understand the nature and scope of the study.
Motor Imagery and Action Observation in Respiratory Training

The principal aim of this study was to asses the effects of motor imagery and action observation training on ventilatory and functional capacity through a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60
* Healthy and with no respiratory pathology subjects

Exclusion Criteria:

* Any cognitive impairment that hindered viewing of audiovisual material.
* Difficulty understanding or communicating.
* Presence of systemic pathology, Central Nervous System or rheumatic disease.
* Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
* Collaboration of pregnant women.
* Underage subject
The Mechanism of Melanocyte Self-Assembly on Biomaterials and the Functional Analysis

The aim of this study is to survey melanocytes in the ability of self-assembly on biomaterials and functional analysis in vitro. Also, this study may provide a better way for treatment of vitiligo after understanding the functional aspects of melanocytes.

Vitiligo is a chronic disease that causes loss of melanocyte and pigment of the skin. Traditional treatments for vitiligo including topical corticosteroids and phototherapy lead to limited clinical effects. Autologous melanocyte transplantation is another way to treat vitiligo. However, the effect is largely affected by whether cultivated melanocytes are successfully uptaken by vitiliginous skin. The aim of this study is to survey the self-assembly on biomaterials and functional analysis. In the long run, this study may provide a better way for treatment of vitiligo.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving cosmetic removal of moles

Exclusion Criteria:

* No special exclusion criteria