cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating Epidemiology of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in Australia

The study is a cross sectional, epidemiology study of disease severity for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in four geographic regions in Australia (Illawarra, Sutherland, Hunter Urban and Hunter Rural).


Eligibility Criteria:
Inclusion criteria include:

Adult patients with a diagnosis of rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who have visited a primary care centre within one of the specified catchment areas for their condition within the last 24 months.
Developing a Simple Test to Diagnose Overactive Bladder

In order to develop a test to diagnose overactive bladder from urine, it is essential that this test is at least as accurate as the tools that clinicians currently use. As such, this study will compare the performance of the device in development to the performance of existing methods.


Eligibility Criteria:
Inclusion Criteria:

* The participant is willing and able to give informed consent for participation in the study
* The participant has been diagnosed with over-active bladder
* Aged 18 years or above
* Male or Female

Exclusion Criteria:

* The participant is unwilling to give informed consent for participation in the study
* The participant is unable to represent their own interests or is particularly susceptible to coercion (i.e. is deemed as vulnerable)
* The participant has been diagnosed with neurologic disease (stroke, MS, Parkinson's disease, spinal cord injury); history of uterine, cervical, vaginal or urethral cancer; history of cyclophosphamide use or any type of chemical cystitis; history of benign or malignant bladder tumours; has had Botulinum injections, neuromodulation or augmentation cystoplasty
* Aged 17 years or younger.
Regional Ventilation During High Flow Nasal Cannula and Conventional Nasal Cannula in Patients With Hypoxia

High-flow nasal cannula (HFNC) that uses heated and humidified oxygen was recently introduced for bedside care. It has been shown to be associated with reduced risks of tracheal intubation rates and mortality in adult hypoxic patients.

The mechanisms of the effects of HFNC are thought to be related to the favorable effects of the heated and humidified gas, the high-flow rate used to minimize the entrainment of room air, and an increase in the ventilation efficiency, including the elimination of nasopharyngeal dead space, positive end-expiratory pressure (PEEP) effects, and improvements in paradoxical abdominal movement. Regarding the effects on lung volume, global ventilation in the lungs increases during HFNC, which is thought to attribute to PEEP effects. However, how regional ventilation is affected during HFNC in comparison with conventional NC remains unknown.

Because PEEP in mechanically ventilated patients improves the regional homogeneity of ventilation, investigators postulated that HFNC via PEEP effects would result in more homogeneous regional distributions in the ventilation changes. Investigators therefore assessed global and regional ventilation in patients with hypoxia receiving care via HFNC using electric impedance tomography and compared these results with conventional nasal cannula.


Eligibility Criteria:
Inclusion Criteria:

* Age \>20 years
* Subjective dyspnea in room air
* SaO2\< 90% in room air
* Oxygen requirement for nasal cannula \< 6 L/m

Exclusion Criteria:

* Unstable vital signs

  * SBP \<90 mmHg
  * DBP \< 60 mmHg
  * Heart rate \> 120 bpm
  * Respiratory rate \> 30 bpm
  * Persistent dyspnea under oxygen therapy using NC
* Severe hypoxia

  * PaO2/FiO2\< 200 mmHg
* Unable to cooperate

  * Delirium
  * Reduced cognitive function
Neurological Outcomes Following Carpal Tunnel Wound-closure Techniques

single-centre randomised prospective trial will conducted at the University Hospital of Split in Croatia. The investigators plan to enrol 100 patients, randomly assigned to suture-based wound closure (n=50) or tissue adhesive-based wound closure (n=50) with two-component skin adhesive Glubran Tiss 2®. The neurological outcomes will assessed postoperatively during the follow-up period at intervals of 2, 6, and 12 weeks respectively.

All surgical procedures will be performed with a tourniquet and local anaesthesia using 2% lidocaine in the palmar soft tissues and carpal tunnel. For all subjects, the standard carpal canal decompression procedure will began withskin incision in the radial half of the palm, followed by carpal ligament transection and cutting. Following primary closure, two different techniques were used depending on the subject's randomization group:

1. The skin will be stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0.
2. After subcutaneous stitches with 4-0 Coated VicrylTM Plus PS-2, 3/8 ; a two-component skin adhesive, Glubran Tiss 2® will be applied. Each subject will received 0.35 mL of Glubran Tiss® in the open wound, and before bandaging, subjects rested for 20 seconds for a polymerization process.

The neurological outcomes will assessed postoperatively during the follow-up period at intervals of 2, 6, and 12 weeks respectively.

Eligibility Criteria:
Inclusion Criteria: (all of the above)

* age \>18 years
* carpal tunnel syndrome
* weakness of thumb abduction
* with atrophy of the thenar
* median nerve conduction impairment estimated by electromyography

Exclusion Criteria: (one or more)

* threatening haemorrhagic complications (patients with peroral anticoagulation and/or antithrombotic therapy)
* previous wrist trauma or surgery on the wrist region
* another aetiology of neuropathy
* previous allergic reactions (with lidocaine, cyanoacrylate, formaldehyde, tapes, or adhesives)
* personal or family history of keloids or hypertrophic scars
* severe general illness with cachexia
Safety and Effectiveness of the Akura Thrombectomy System for Use in the Removal of Emboli From the Pulmonary Arteries in Treating Acute Pulmonary Embolism (PE)

This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).


Eligibility Criteria:
Inclusion Criteria:

* The patient is 18 years of age or older and deemed medically eligible for interventional procedure, per institutional guidelines and clinical judgement
* Clinical signs, symptoms and presentation consistent with acute PE
* PE symptom duration ≤ 14 days
* CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
* CTA evidence of RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment is based on the Investigator's interpretation of RV/LV ratio at baseline)
* Systolic BP ≥ 90 mmHg (initial SBP may be \< 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation)
* Stable HR \< 130 BPM prior to the procedure

Exclusion Criteria:

* Prior PE \<180 days from index procedure
* Thrombolytic use within 30 days prior to baseline CTA
* Pulmonary hypertension with peak pulmonary arterial pressure (PAP) \> 70 mmHg by right heart catheterization
* Vasopressor requirement after fluids to keep pressure at ≥ 90 mmHg
* FiO2 requirement \> 40% or \> 6 LPM (to keep oxygen saturation \> 90%)
* Hematocrit \< 28% (Note: hematocrit required within 6 hrs. of index procedure)
* Platelets \< 100,000/μL
* eGFR \<30 ml/min per 1.73 m2
* International normalized ratio (INR) \> 3
* Major trauma injury severity score (ISS) \> 15
* Presence of intracardiac lead in right ventricle or atrium placed ≤ 6 months of enrollment
* Cardiovascular or pulmonary surgery within the last 7 days
* Actively progressing cancer treated by chemotherapeutics
* Known bleeding diathesis or coagulation disorder
* Left bundle branch block
* History of severe or chronic pulmonary arterial hypertension
* History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
* History of uncompensated heart failure.
* History of underlying lung disease that is oxygen dependent
* History of chest irradiation
* History of heparin-induced thrombocytopenia (HIT)
* Contraindication to systemic or therapeutic doses of anticoagulants
* Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
* Known residual iliac deep vein thrombosis (DVT), inferior vena cava (IVC) clot or clot in transit (right atrium and/or right ventricle)
* CTA imaging or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for mechanical thrombectomy intervention (e.g. inability to navigate to target location, predominantly chronic clot or non-clot embolus)
* Life expectancy \< 90 days, as determined by investigator (e.g., stage 4 cancer, frailty or severe COVID infections)
* Female who is pregnant or nursing
* Current participation in another investigational drug or device treatment study
Efficacy and Safety of BAI Combined With DEB-BACE of EqualSpheres in the Treatment of Advanced NSCLC

This is a prospective, single-arm, open-label study designed to evaluate the efficacy and safety of bronchial infusion chemotherapy（BAI） combined with drug-loaded microsphere embolization of EqualSpheres in advanced Non-small cell lung cancer (NSCLC). Progression-free survival (PFS) will be evaluated as the primary endpoint.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old, male and female;
2. According to the Guidelines for the Diagnosis and Treatment of Primary Lung Cancer (2022 edition), the patient was diagnosed with NSCLC by imaging and histopathology;
3. TNM stages were III-IV;
4. Newly diagnosed, first-line treatment failure, refusal or inability to perform conventional treatment (surgery, chemoradiotherapy);
5. ECOG PS ≤2;
6. Expected survival \> 3 months;
7. Sign the informed consent voluntarily, and the compliance is good.

Exclusion Criteria:

1. Previously received interventional therapy (iodine particle implantation, ablation, TACE treatment);
2. Combined with extensive and uncontrolled extrapulmonary metastases, such as liver metastasis, bone metastasis, and brain metastasis;
3. Have had or currently having other primary malignant tumors;
4. White blood cell \< 3×109/L, platelet count \< 50×109/L, HGB \< 90 g/L;
5. Hepatic and renal insufficiency (creatinine \> 2 mg/L; AST and/or ALT \> 2 times the normal upper limit);
6. Coagulation dysfunction (INR \> 1.5) or known bleeding disease (except lung cancer combined with hemoptysis), or anticoagulation therapy;
7. Patients with active infection requiring antibiotic treatment;
8. Uncontrolled hypertension, diabetes, and cardiovascular disease with obvious symptoms;
9. contrast agent allergy;
10. Women with pregnancy or lactation.
A Pharmacodynamic Study of SLM0807, HKB0701 and CJ30001 in Healthy Subject

This trial is conducted to

1. assess whether SLM0807 alters pharmacodynamics of HKB0701
2. estimate the pharmacodynamics of HKB0701 after multiple administration of CJ30001 and multiple co-administration of HKB0701/SLM0807 in healthy subject


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers who are in age range of 20-50years and the weight range is not exceed ±20% of ideal weight. Ideal weight = \[height -100\]\*0.9
* Subjects with no history of any significant chronic disease
* Subjects with FPG\<100mg/dL and 2hr glucose after 75g OGTT\<140mg/dL
* Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
* Available for the entire study period
* Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

* Subjects who have taken any drugs to induce or inhibit hepatic enzyme activity within 30days prior to drug administration
* Subjects who have symptom of an acute illness within 4 weeks prior to drug administration
* Subjects with a history of clinically significant allergies including drug allergies
* Subjects whose clinical laboratory test values are outside the accepted normal range(Especially,AST or ALT \>1.25 times to normal range or total bilirubin \> 1.5times to normal range)
* Subjects with a history of drug, caffeine abuse(caffeine drink \>5cups/day)
* Subjects with a history of alcohol abuse(alcohol\>30g/day) or who have ever drank alcohol within 7 days prior to drug administration
* Heavy smoker ( \>10cigarettes/day)
* Subjects who have had a diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice)
* Subjects who have donated plasma within 60days prior to drug administration
* Subjects who have participated in a clinical study within 90days prior to drug administration
* Subjects who have received any drugs that might confound the results of the trial in the opinion of principal investigator within 10days prior to drug administration (cimetidine within 7days prior to drug administration)
* Female subjects who are pregnant, breastfeeding or not using medically acceptable birth control
Comparison Between The Results of Open and Microsurgical Decompression in Degenerative Spinal Canal Stenosis in Lumbar Spine

To compare the outcomes of open and microsururgical decompression in degenerative spinal stenosis in lumbar spine

Lumbar spinal stenosis is defined as a circumscribed, osteoligamentous narrowing of the spinal canal. The clinical burden includes backaches and symptoms in the legs that deteriorate upon standing and walking (neurogenic claudication). Lumbar spinal stenosis is the most common cause of lumbar spine diseases in patients \> 65 years old requiring surgical treatment; it is estimated that ∼0.1% of the population will need some procedure to treat degenerative lumbar spine conditions. Surgical treatment for lumbar spinal stenosis is indicated in cases of conservative treatment failure. It is also indicated in cases with very acute symptoms and radicular involvement associated with dermatome sensorial and motor changes and progressive worsening of severe neurogenic claudication. Vertebral canal decompression can be performed with several techniques. The gold standard is the open technique with laminectomy or laminotomy, in which laminae are resected or opened; next, the ligamentum flavum, usually thickened, is resected, exposing the nervous structures under compression. Laminotomy can be unilateral, bilateral or divide the spinous process. Damaging the paraspinal muscles and liberal removal of posterior bone may cause iatrogenic spinal instability. The Microsurgical spinal canal decompression decreases paravertebral musculature injury, reducing postoperative complications related to hematomas, seromas and infections and trunk extensor musculature atrophy. The dural sac is decompressed after its exposure and removed to allow the resection of the lateral recess and foramen opening to decompress an adjacent and/or emerging nerve root. It is believed that MIS may limit surgery-related morbidity and mortality by reducing the degree of surgical trauma while maintaining similar surgical outcomes.

Eligibility Criteria:
Inclusion Criteria:

patients present with degenerative lumber spinal canal stenosis in one or two level

Exclusion Criteria:

1. degenrative listhesis.
2. degenerative scoliosis.
3. other secondary causes of lumber canal stenosis as tumor , abscesses and infection.
4. Patients with previous lumbar operation
Galantamine Treatment for Nonfluent Aphasia in Stroke Patients

Cognitive impairment after stroke is common and has a major effect on morbidity and quality of life. Acetylcholinesterase inhibitors have demonstrated benefit in vascular dementia, but efficacy in treating more circumscribed cognitive deficits following stroke, such as aphasia, has not been systematically investigated.

This study evaluated the efficacy of Galantamine (Reminyl) in subjects with chronic, stable non-fluent aphasia secondary to stroke. Subjects enrolled in a double-blind placebo- controlled cross-over study that employed a comprehensive battery of language tests and measures of general cognitive and behavioral status that will be used to control for factors that may influence language functioning. The primary study outcome was a within-subject comparison of changes in language function and behavioral scores between placebo and active-treatment phases (12 weeks each). Our hypothesis was that by increasing acetylcholine levels, and facilitating activity of other neurotransmitters affecting attentional systems, Galantamine would produce gains in both language and behavioral scores in patients suffering chronic effects in cognitive systems due to injury following stroke.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of aphasia with relatively spared comprehension.
* Onset 6 months or greater prior to enrollment.
* Native English speaker
* Right-handed.
* Adults (18 years of age or older).

Exclusion Criteria:

* Patients receiving ongoing individual speech therapy. (Most patients are no longer eligible for individualized speech therapy after 6 months from stroke onset, thus this should not eliminate many patients).
* Extremely mild or extremely severe aphasia. (Boston Naming Test Score \<3 or \>45 items named from 60 items).
* Global dementia (and any other patient with reduced decisional capacity requiring a legally authorized representative for consent).
* Presence of major cognitive deficit other than aphasia caused by stroke related disease.
* Contraindications to cholinomimetic agents: History of active peptic ulcer disease within 1 year, Severe asthma, unstable angina, bradyarrhythmia with resting pulse less than 50, sick sinus syndrome, or seizures.
* Major psychiatric disorders that affect cognition including: psychosis, major depression, bipolar disorder, alcohol or substance abuse.
* Major medical conditions that alter cognition (e.g., heart failure, dialysis dependent renal failure, hepatic failure, active cancer).
* Impairments that affect metabolism of the medication including: Severe renal impairment (Creatinine clearance equal to or greater than 9), and moderate or severe hepatic impairment (Child-Pugh score \>7)
* Patients using medications that have major effects on brain neurotransmitter systems or cognition within 2 months of enrollment. Exclusionary medications are: medications with significant anti-cholinergic activity (tricyclic antidepressants, diphenhydramine), anti-Parkinsonian medications (including Sinemet, amantadine, bromocriptine, pergolide, selegiline), and narcotic analgesics (\> 2 doses per week).
A Clinical Observation of 1064-nm Q-Switched Fractional Laser Combined With Oral Tranexamic Acid on Treating of Melasma.

1.Melasma is a common acquired condition of symmetric hyperpigmentation, typically occurring on the face, with higher prevalence in females and darker skin types. Treatments for melasma include topical, oral, procedural, and combination treatments.

2.1064-nm Q-Switched laser is one of the most widely used lasers for pigmented diseases in recent years. This wavelength laser can be effectively absorbed by pigment, which leads to damage of pigment and melanocyte. Previous 1064-nm Q-Switched laser treatment of melasma requires the use of large flare and low energy scanning repeatedly in the lesion area, and the terminal reaction is reddish and skin lesion temperature increased by 2℃. So the course of treatment is even longer and is closely related to the treatment of the doctor's subjective judgment. Current 1064-nm Q-Switched fractional laser is designed with focusing lens and can be scanned only once for skin lesions during treatment. Further more, the treatment energy of a single point is higher and it has stronger ability to destroy melanin. Finally, 1064-nm Q-Switched fractional laser promotes the expulsion of melanin particles from the superficial dermis and basal epidermis.

3.Tranexamic acid (TA) works by inhibiting the plasmin-plasminogen pathway. Increase in plasmin in keratinocytes leads to increase in production of arachidonic acid and alpha-melanocyte-stimulating hormone (alpha-MSH) production. Thus, by inhibiting the plasmin pathway, TA results in decreased melanogenesis. Studies support the use of oral TA as an adjuvant therapy for in refractory cases of melasma or as a second-line or third-line agent, and there is some early evidence supporting the utility of oral TA as monotherapy. Overall, randomized controlled trials have found that combination treatment regimens using oral TA as adjunct therapy results in greater reduction of melasma.


Eligibility Criteria:
Inclusion Criteria:

.Subjects must be clinically diagnosed by the investigator to melasma and MASI score ≥24.

* no other treatment was performed for the skin lesions for half a year before the treatment
* (patients with a "no" in any of the above criteria are not eligible for inclusion) .Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.

Exclusion Criteria:

* subjects with a recent history of exposure to sunlight;
* subjects allergic to topical anesthesia;
* subjects with scar constitution;
* subjects with skin malignant tumors or precancerous lesions; .subjects with diabetes, heart disease, epilepsy, connective tissue disease, etc.
* subjects who Pregnant or breast feeding;
* subjects with recent skin infections (such as viruses, bacteria, etc.);
* the methods are being used to treat subjects with similar diseases;
* subject who have taken isotretinoin A in the past year; .subject with facial dermatitis.
The Effect of Coffee on People with High Intensity Exercise and the Characteristics of Caffeine Metabolism

The purpose of this project is to explore the relationship between the effect of coffee on exercise performance and caffeine metabolism.

The investigators will study the relationship between the impact of coffee on exercise and caffeine metabolism. The investigators will recruit healthy elite athletes. Participants will be forbidden to consume stimulant drinks such as coffee for 24 hours before the experiment. When the participants arrive at the lab on the day of the experiment, they will sign an informed consent form, a health history questionnaire and a daily coffee consumption questionnaire. Each participant does six rides, with one day of caffeine washout before each ride. In all trials, each participant will ride at the same time of day. Before riding, drink 200 ml water, decaffeinated coffee or coffee in random order, and the caffeine content of coffee is 200 mg. After 60 minutes of drinking, they start riding, after the completion of the riding, the subjects perceived and judged the perception between the baseline load and the comparison load. After the completion of the judgment, the next level of stimulus parameters will randomly generated to conduct the experiment. Each person conducted 6 groups of intervention experiments. Changes in average exercise performance, heart rate, electrocardiogram and body temperature will be observed after drinking decaffeinated coffee or coffee compared with drinking water. The concentration of caffeine and its metabolites in urine before and after drinking within 3 hours will be measured by liquid chromatography-mass spectrometry (LC-MS) or gas chromatography-mass spectrometry (GC-MS).

Eligibility Criteria:
Inclusion Criteria:

Healthy adults 18-40 years old

Exclusion Criteria:

Diabetes Hypoglycemia Gout Osteoporosis Gastric ulcer Pancreatitis Intestinal obstruction Blood phobia Pathological hypo or hyper tension Impaired glucose tolerance Claustrophobia HIV,etc.