cyrilzakka/clinical-trials huggingface dataset:
Comparison of AOCT and AOPT for the Treatment of Medial Large Cystic OLT

Autologous osteoperiosteal transplantation using tissue harvested from the iliac crest is used to treat large cystic osteochondral lesions of the talus. This study is to compare clinical and radiological outcomes between patients undergoing AOPT and those undergoing AOCT for large cystic OLTs.

From March 2015 to March 2018, 23 patients who underwent AOPT and 23 patients who underwent AOCT to treat large cystic OLTs (\>10mm) were retrospectively evaluated. For comparability, the two groups were matched based on their demographics, including sex, age, body mass index, side of injury, follow-up period, and the preoperative cyst volume. Clinical outcomes were assessed using the visual analog scale (VAS), the American Orthopaedic Foot \& Ankle Society (AOFAS) score, and the Tegner score. Donor-site morbidity was recorded according to the symptoms, including pain, stiffness, swelling and discomfort. Radiological outcomes were evaluated using the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, and the International Cartilage Repair Society (ICRS) score was obtained during second-look surgery.

Eligibility Criteria:
Inclusion Criteria:

* presence of medial large cystic OLTs (\>10 mm in diameter) confirmed by preoperative magnetic resonance imaging (MRI)
* patients who underwent either primary AOPT or AOCT

Exclusion Criteria:

* small cystic OLTs
* ankle osteoarthritis
* ankle pigmented villonodular synovitis
* prior surgery on the ipsilateral ankle
* injuries or relevant trauma to the affected ankle after surgery
Diagnostic Accuracy of Ultrasonography in Detecting Benign Radiolucent Lesions

This is an in vivo study which aims to evaluate the diagnostic accuracy of ultrasonography in detecting benign radiolucent lesion in the both jaws. The ultrasonography-based diagnosis of contents will be compared to those findings obtained from the histological examination (i.e. the gold standard). The second part of this study will examine the measuring accuracy by comparing ultrasonography-based 3D measurements with those obtained from CBCT images of the lesion assuming that CBCT 3D measurements are the gold standard.

Jaw is a common anatomical site for development of odontogenic and nonodontogenic lesions, and because of the wide variation of these lesions, the diagnosis is complex. Many techniques have been used to arrive at the final diagnosis such as conventional radiographs, computed tomography (CT), low dose cone beam CT, MRI.The use of ultrasonography has been shown to be important in evaluating the solid and cystic components of jaw lesions. Although ultrasound imaging technology is a safe and a minimally invasive procedure, and has been in use in medicine for many years, its use in dental medicine has been limited and mainly restricted to soft tissue applications. Studies evaluating the role of ultrasonography in the diagnosis of bone lesions of the jaw are limited.

Eligibility Criteria:
Inclusion Criteria:

* the presence of a radiolucent or mixed-appearance intraosseous lesion in the upper or lower jaw requiring surgical removal
* no previous trauma to the maxillofacial region.
* no previous surgical intervention in the same area of the lesion.

Exclusion Criteria:

* the presence of a completely radiopaque lesion indicating solid content.
* patients with systemic conditions associated with bony pathology such as hyperparathyroidism, Paget disease, ﬁbrous dysplasia, multiple myeloma, etc...
Radiotherapy for Prostate Cancer: Conventional Dose Versus High Dose

3-D conformal radiotherapy offers the opportunity to reach higher tumor doses with acceptable complication rates compared to conventional radiotherapy. There are retrospective and preliminary prospective reports of a better local control / disease free survival (including PSA control) using higher tumor doses. A prospective randomised phase III study is required to validate these reports. The purpose of this randomized phase III study is to investigate and compare the tumor control and toxicity in prostate cancer patients treated to 68 Gy and 78 Gy;

Patients were stratified by hospital, treatment group, age and (neo)adjuvant hormonal therapy. Four treatment groups with specific radiation volumes were defined depending on the estimated risk of tumour involvement of the seminal vesicles (based on T-stage, initial PSA and Gleason Score or Differentiation Grade).The dose was delivered with daily fractions of 2 Gy, five times a week. The total duration of the treatment was 7 weeks for patients treated to 68 Gy and 8 week for 78 Gy.

Objectives:

* To test in a phase III randomised study the hypothesis that higher radiation doses lead to a higher freedom from failure rate for localized prostate cancer.
* To test the hypothesis that a higher freedom from failure rate leads to a longer disease-free survival and overall survival.
* To limit acute and late toxicity with respect to gastro-intestinal and urological toxicity.
* To evaluate different PSA related endpoints for local failure and distant metastasis.
* To establish a database of patients treated to escalated doses with Dose Volume Histograms of the normal tissues at risk for each individual patient and common toxicity endpoints.
* To validate a model to estimate normal tissue complication probabilities (NTCPs) of rectum and bladder, based on the above-mentioned database, and to obtain reliable parameter values for NTCP estimations.

Eligibility Criteria:
Inclusion Criteria:

* locally confined adenocarcinoma of the prostate
* all T-stages with a PSA \< 60ng/ml, except any T1a tumor and well-differentiated (or Gleason score \< 5) T1b-c tumors with PSA-levels ≤ 4 ng/ml
* Karnofsky Performance Status of 80 or more

Exclusion Criteria:

* distant metastases
* positive regional lymph nodes proven by surgical or cytological sampling
* on anticoagulants
* previous prostatectomy
* previous pelvic irradiation
Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging

The purpose of the study "Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging" is to enable self-operation of a monitoring device in home-simulated environment

One of the main challenges in developing a retinal imager is to design it to be self-operated by elderly patients in their home setting The study's objective is to explore ergonomic solutions that will allow the user to perform imaging on their own. The study will be done in a home-simulated environment using a dedicated ergonomic system (termed "PAF" - Positioning And Fixation system) that stimulates the retinal imager and enables to record the tested subject using standard cameras. The prototype doesn't include the retinal imager and does not include any imaging capabilities aside from standard means of photography Subjects will be evaluating for positioning accuracy and comfort by comparing different methods. Pupil position will be recorded using commercial off the shelf cameras when the subject is performing simple ergonomic tasks while looking at a screen presenting images.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65
* Able to understand and sign the informed consent form
* Ability to communicate verbally
* AMD (interim and advanced) or diabetic retinopathy (with and without DME)

Exclusion Criteria:

* Visual acuity \>=20/200 in the better eye
A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD

To assess the effect of treatment with Glycopyronnium (GP) MDI administered twice daily (BID) and Formoterol Fumarate (FF) MDI administered BID on specific image-based airway volumes and resistance in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) following chronic dosing after approximately two weeks treatment.


Eligibility Criteria:
Inclusion Criteria:

* Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative urine pregnancy test at Visit 1, and agrees to use acceptable contraceptive methods used consistently and correctly
* Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
* Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
* At Visit 1, FEV1/FVC ratio must be \<0.70
* At Visit 1, post-bronchodilator FEV1must be \>30% and \<80% predicted normal value, calculated using The Third National Health and Nutrition Examination Survey (NHANES III) reference equations.

Exclusion criteria:

* Significant diseases other than COPD, i.e., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
* Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
* Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
* Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the run-in period (Visit 1 to Visit 2).
* Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the run-in period (Visit 1 to Visit 2).
* Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated.
* Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.
Dose-finding Study to Assess the Safety and Effect of SYL1001 in Patients With Ocular Pain

The aim of this pilot study is to compare the analgesic effect of two strengths of SYL1001 eye drops versus placebo in patients with ocular pain associated with Dry Eye Syndrome. General and local tolerability are also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Give written informed consent to participate in the study, after having received all information relating to the design, aims and possible risks resulting therefrom.
* Common symptoms of persistent, daily, mild to moderate dry eye lasting more than three months: OSDI scale between 13-70 and VAS scale between 2 -7.
* Eye tests in both eyes: Corneal fluorescein staining (Oxford scale \> 0), Tear break-up time \< 10 seconds and Schirmer's test with anaesthesia \< 10 mm/5min.

Exclusion criteria:

* Women who are pregnant or breastfeeding or who have a positive urine pregnancy test. Women who do not commit to use a medically acceptable method of contraception from the time of selection and throughout the study.
* Any current, relevant disease, including respiratory disease, cardiovascular disease, endocrine disease, neurological disease, haematological disease, kidney disease, oncological disease, liver disease, gastrointestinal dysfunction, hypertension or active acute infectious processes.
* Previous chronic or recurrent processes which, according to the investigator, could affect the development of the study.
* Concomitant use of other medications with analgesic activity by any route of administration at the time of entry into the study.
* Change in any concomitant eye and/or systemic medication of the patient one month before the study and during the study.
* Changes in the pre-established administration schedule of artificial tears during the 15 days before the study and during the 10 days of the study.
* Initiation of treatment with cyclosporine or changes in the dosage or administration schedule of cyclosporine within the 6 months before inclusion in the study.
* History of hypersensitivity to drugs.
* Use of contact lenses during the treatment and previous 15 days.
* History of drug abuse or drug or alcohol dependence.
* Laboratory abnormalities which, in the investigator's opinion, are clinically significant.
* Previous refractive surgery.
* Having participated in another clinical trial within the 2 months prior to inclusion.
* Another eye disease that is significant in the investigator's opinion.
Lidocaine in the Prevention of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation

Direct laryngoscopy and endotracheal intubation procedure stimulate the sympathetic nervous system, causing catecholamine release into the circulation and consequently hemodynamic changes.There are many studies showing that lidocaine is used intravenously to suppress the sympathetic response to laryngoscopy and endotracheal intubation. Nebulized lidocaine is often used to provide upper airway local anesthesia in fiberoptic guided awake intubation.

In this study, the researchers aimed to compare the results of using intravenous lidocaine and nebulized lidocaine to suppress the hemodynamic response caused by laryngoscopy and endotracheal intubation retrospectively.

Researchers' hypothesis; Nebulized lidocaine administration is more effective than intravenous lidocaine administration in suppressing the hemodynamic response due to laryngoscopy and endotracheal intubation in patients under general anesthesia.

2% lidocaine drug to suppress the hemodynamic response due to laryngoscopy and endotracheal intubation; patients administered intravenously will be evaluated in one group, and patients administered inhaled through a nebulizer will be evaluated in another group.

Nebulized lidocaine in the researchers' clinic; it is administered by adding 2% lidocaine + physiological saline to a nebulizer and inhaling for 3-5 minutes in the presence of 4-6 liters/minute of oxygen.

Preoperative examination forms and intraoperative follow-up forms of the patients included in the study will be examined by the researchers. The dose of lidocaine applied and the method of administration will be recorded. In addition, the agents used in anesthesia induction (fentanyl, propofol, rocuronium bromide, etc.) and the hemodynamic changes of the patients (heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure,oxygen saturation) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 and under the age of 80 who underwent surgery under general anesthesia

Exclusion Criteria:

* Patients under the age of 18 and over the age of 80
* Patients who are not operated under general anesthesia
Ethical Challenges of Consent in Data Sharing

In recent years, Mahidol Oxford Tropical Medicine Research Unit (MORU) has coordinated some of the largest international studies involving many sites in low-income and hard-to-reach settings. It has been our policy for many years to support sharing of data across collaborative research networks in order to maximize their utility. However there is increasing support from research funders, regulatory agencies and journals for sharing individual-level data from genomic, medical and public health research beyond research collaborations. A number of potential advantages of sharing individual level data from clinical and public health research have been identified in the literature. These include maximizing the utility of data, allowing verification of research results, and minimizing the burdens and costs of unnecessary duplication of research. In low- and middle-income settings it may be particularly important to effectively share data to maximize its utility and enable timely responses to important public health issues such as resistance to antimalarial treatments. Many authors have called for data sharing to be carefully curated, to minimize potential harms including breaches of privacy, the publication of poor quality or biased secondary research, and insufficient acknowledgment of the contribution of researchers generating datasets. In low- and middle-income settings, the need for data sharing policies and processes to promote equitable use of data, including the development of sustainable capacity to both share and analyse datasets, has been recognized.

It is foreseeable that the impact of this policy will be significant both practically and ethically. In the practical sense, there have already been changes in our data management processes and resources, clinical trial agreements and negotiations with collaborators. Ethically, this policy has impact on the consent process which includes the increasing use of broad consent, the changes in the language of information sheets, study protocols and ethics application documents and the actual consent taking by research staff.

Now that that these new data-sharing mechanisms have been put in place there is a need to evaluate their impact on practice. The aim of this study is to identify and analyse ethical challenges related to consent following implementation of a new data sharing policy with the aim of refining the data sharing policy and its related consent processes


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or female, aged 18 years or above.
* Able to speak and understand Thai, English, Burmese or Karen

Exclusion Criteria:

* Lack of relevant experience or expertise
Study Comparing Ultrasound-guided FICNB Block to Systemic Analgesia in Treatment of Pediatric Femur Fracture

The goal of this prospective observational study is to compare pain control strategies in children with femur fractures. Researchers will compare ultrasound-guided fascia iliaca compartment nerve block to IV pain control alone. The main questions it aims to answer are:

* Are ultrasound-guided fascia iliaca compartment nerve blocks as effective as IV pain control in controlling pain?
* Do patients who receive an ultrasound-guided fascia iliaca compartment nerve block require less opioid pain medication than those that don't?

Participants will be asked to provide pain scores during their Emergency Department stay. Participants parents will be asked to complete a brief survey at the time their child is leaving the Emergency Department.


Eligibility Criteria:
Inclusion Criteria:

* Acute femur fracture (less than 24 hours from initial injury)
* Glasgow Coma Scale of 14 or greater at time of enrollment

Exclusion Criteria:

* Allergy or hypersensitivity to local anesthetic agents
* Pregnant
* Prisoner
* Neurovascular injury to the affected limb
* Bilateral femur fractures
* Confirmed, or significant clinical suspicion for, injury to their head, neck, chest, abdomen, back or pelvis
* Imaging suggestive of a head, neck, chest, abdomen, back or pelvic injury
* Laboratory results suggestive of a head, neck, chest, abdomen, back or pelvic injury
* A fracture not limited to the extremities (i.e. vertebral compression fracture)
* A significantly displaced extremity fractures (aside from the primary femur fracture)
* An open fracture (aside from the primary femur fracture)
* An additional fracture to the limb of the primary femur fracture (i.e. tibia fracture in the same leg as the primary femur fracture).
A Prospective, Single Arm, Open Label, Proof of Concept Clinical Study of Sulfasalazine in the Treatment of Active Systemic Lupus Erythematosus

The goal of this clinical trial is to learn if sulfasalazine is safe and feasible in the treatment of active lupus erythematosus (SLE). The main questions it aims to answer are:

Does drug sulfasalazine with stable background treatment help lower the disease activity (SLEDAI) at week 16? How many patients can reach SRI-4 at week 16? Can this regimen help lower the prednisone dosage the patients need at week 16? What about the change of the type I interferon related genes expression at week 16?

Participants will:

Take sulfasalazine 750mg/dose, twice a day for 16 weeks. The dosage will be increased to 1000mg/dose within one month, twice a day if the patient could tolerate.

Visit the clinic once every 4 weeks for checkups and tests.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of SLE according to the 2012 SLICC SLE classification criteria.
* 18 to 65 years old, regardless of gender.
* Active SLE, i.e. SLEDAI-2K score ≥ 4 points at enrollment.
* Receiving standard of care:

  1. Prednisone dosage≤20mg/day, with or without hydroxychloroquine (HCQ,≤400mg/day), classic immunosuppressive agents (IS),ie, mycophenolate mofetil(≤2.0g/day), azathioprine (≤2mg/kg/day), cyclosporine(≤5.0mg/kg/day), tacrolimus(≤3.0mg/day), methotrexate(≤20mg/week), leflunomide(≤40mg/day), or biological agents such as belimumab(≤ 10mg/kg/month) and telitacicept (≤160mg/week);
  2. No more than three types of combined classic IS or biological agents, not including HCQ.
  3. Prednisone dosage should NOT be increased within one month of the screening period, and the immunosuppressants regimen should be stable for at least one month.
* Agree to sign the informed consent form.
* Agree to receive contraception through intrauterine devices or oral contraceptives (progesterone or compound progesterone) or condoms.

Exclusion Criteria:

* Severely active SLE: SLEDAI-2K \>12 at screening.
* 24-hour urine protein≥ 3g/24 hours.
* eGFR \< 60mL/min/1.73m2 (EPI formula).
* Baseline prednisone dosage\>40mg/d at screening.
* Other autoimmune diseases, such as rheumatoid arthritis, Sjogren's syndrome, myositis, scleroderma, autoimmune liver disease, etc.
* Leukopenia or thrombocytopenia (WBC≤3×109/L or PLT≤50×109/L) not caused by SLE.
* Liver dysfunction (ALT or AST more than twice the normal upper limit).
* Allergic to sulfonamide drugs.
* Pregnant or breast-feeding.