cyrilzakka/clinical-trials huggingface dataset:
Addition of microRNA Blood Test to Lung Cancer Screening Low Dose CT

To demonstrate that the specificity of the Hummingbird microRNA profile for the diagnosis of lung cancer in a cohort of patients who meet current eligibility criteria for lung cancer screening in the U.S. is superior to the specificity of LDCT.

This is a prospective, longitudinal, blinded, observational diagnostic study on 400 individuals undergoing lung cancer screening with low-dose computed tomography (LDCT).

There will be two patient cohorts: Cohort 1: individuals undergoing their first or subsequent annual LDCT screening study; and Cohort 2: individuals referred for a follow-up diagnostic chest CT scan due to a lung-RADS category 3 or 4 result on a previous LDCT scan.

At study enrollment a blood sample will be drawn prior to the LDCT scan. On this blood sample a novel lung cancer test relying on microRNA signatures will be evaluated. The results will be compared with the CT scan results and follow-up tests including pathology. Histologic results and follow-up data will be collected on all patients for a minimum of 12 months post-enrollment. During the follow-up period, the results of all diagnostic chest CT scans, lung biopsies or lung resections will be captured from the Partners electronic medical record and entered into the case report form (CRF).

Eligibility Criteria:
Inclusion Criteria:

1. Subject is undergoing LDCT screening for lung cancer.
2. Subject is 55 to 80 years of age.
3. Subject has a minimum 30 pack-year smoking history.
4. Subject has not quit smoking more than 15 years ago.
5. Subject is without symptoms attributable to lung cancer.
6. Subject is able and willing to provide informed consent.

Exclusion Criteria:

1. Subject has a history of lung, gastrointestinal, hematological, breast, thyroid, or genitourinary cancers within the past ten years.
2. Subject is known to be infected with HIV, HBV, HCV, or tuberculosis or any other Biosafety Level 3 (BSL III) pathogen infections.
A Dose-response Study of Tranexamic Acid in Total Hip Arthroplasty

A single preoperative dose of tranexamic acid (TXA) reduces blood loss and red blood cell transfusion in primary hip arthroplasty. Numerous regimens have been tested, ranging from 10mg/kg up to 3g. However the optimal dose to administer is unknown.

This dose-response study is a randomized double blind study with five groups of 30 patients each. Patients will be randomized to placebo, tranexamic acid (TXA) 300 mg, tranexamic acid (TXA) 500 mg, tranexamic acid (TXA) 1000 mg or tranexamic acid (TXA) 3000 mg. In addition a pharmacokinetic/pharmacodynamic study will be performed to identify the contribution of tranexamic acid (TXA) plasma concentration as a predictor of intra and postoperative D-Dimer values.

Eligibility Criteria:
Inclusion Criteria:

* Patient requiring primary hip arthroplasty (less than 3 months)
* Informed Consent from the patient or their legally authorized representative
* Affiliation to French Social Security Healthcare system

Exclusion Criteria:

* Hip fracture of less than 3 months
* Bilateral hip arthroplasty or anterior approach to hip arthroplasty
* Haemorrhagic surgery in the previous 2 weeks
* Contraindication to tranexamic acid
* Contraindication to apixaban
* Chronic use of anticoagulant
* Pregnancy
* Previous participation to this study
Chlamydia and Mycoplasma in Coronary Artery Disease

To test the association between anti-Chlamydia serum titers and anti-Mycoplasma antibodies with Acute Coronary Syndromes.

One hundred and twenty-six patients were divided into 4 groups: Acute Coronary Syndrome with ST-elevation, Non-ST-elevation, stable coronary artery disease, and individuals without coronary disease. Anti-Chlamydia and anti-Mycoplasma IgG antibodies were measured at baseline and after 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 yrs
* Males and females
* Agreed to sign the informed consent

Exclusion Criteria:

* Refusal to sign the informed consent
* Follow-up not possible
* For the "acute" groups, time between the pain beginning and randomization \>24 hours
* Active infections
* Use of antimicrobial agents within the last 30 days
* End-stage diseases with life expectancy \<6 months
Type 2 Diabetes Mellitus Prevention Ukraine

Development, implementation and evaluation of the effectiveness of lifestyle recommendations for the prevention of type 2 diabetes in rural population of Ukraine

An oral glucose tolerance test and anthropometric measurements were performed for 300 randomly selected rural residents of the Kyiv region of Ukraine. Persons from impaired glucose regulation category (impaired fasting glucose - IFG) was enrolled to diabetes prevention intervention study (T2DPUA).

Individuals in the IFG category received advice on limiting sugar intake (not more than 25 g per day), increasing physical activity (30 minutes daily). 30 persons from this category were additionally advised to consume insoluble dietary fiber 15 g per day (Vitacel wheat fiber) for 3 months, after which a repeat anthropometric and biochemical study. Objective control of physical activity and body composition is also provided.

Eligibility Criteria:
Inclusion Criteria:

Persons with fasting blood glucose level \>=6.1 mmol/l; persons aged 18-79 who signed an informed consent for the study.

Exclusion Criteria:

Known diabetes; acute infectious diseases; other serious diseases
Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy

To evaluate the efficacy and safety of Huaier Granule for prevention of disease progression of hepatocarcinoma after non-radical hepatectomy.

A Prospective, Multicenter, Open-labeled, Parallel -controlled Clinical Study, to evaluate the efficacy and safety of Huaier Granule for prevention of disease progression of hepatocarcinoma after non-radical hepatectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Age: ≥ 18 and ≤ 75 years, both male and female;
2. Non-radical hepatectomy has been performed for hepatocellular carcinoma;
3. The hepatocellular carcinoma has been confirmed by pathological examination;
4. The liver and kidney function satisfies the following conditions within 15 days after surgery (excluding day 15): aspartate aminotransferase(AST), glutamic-oxalacetic transaminase(ALT)\<3 upper limit of normal(ULN), total bilirubin ≤2 ULN, serum creatinine \<1.5 ULN;
5. Other laboratory tests meet the following requirements within 15 days after surgery (excluding day 15): Hb≥9g/dl, platelet count≥60×109/L, neutrophil count\> 1.5×109/L;
6. The expected survival time ≥12 weeks;
7. The subjects volunteer to sign the informed consent.

Exclusion Criteria:

1. Non-hepatocellular carcinoma patients;
2. Those who received radical hepatectomy;
3. Those with hepatic decompensation;
4. Pregnant or lactating women;
5. Those with HIV infection or AIDS-associated diseases;
6. Those with severe acute and chronic diseases, such as infection, diabetes cardiac insufficiency, pulmonary insufficiency, renal insufficiency;
7. Those who can not take drugs by oral route; or those develop serious adverse drug reaction;
8. Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
9. Conditions that are considered not suitable for this study investigators.
Usefulness of Supportive SMS in Addition to an Internet Based Quit Smoking Program (Www.Slutta.no)

The purpose of the study is to investigate the effectiveness of a smoking cessation intervention delivered through a technological web based platform (www.slutta.no) with or without a supportive SMS function.

The study has two arms and are conducted in Norwegian. Users who registered with a new username on www.slutta.no, after study start May 12th 2010 and before November 1st 2012, are eligible. All phases of the trial, from randomization and informed consent procedures to data collection, are automated and conducted online. The following inclusion criteria are used: age 16 years or older, access to a mobile phone with a Norwegian phone number and they must submit an informed consent form.

Eligibility Criteria:
Inclusion Criteria (all arms):

* Aged 16 and older
* Current smoker: Willing to quit smoking within the next 12 weeks
* Former smokers; Having quit smoking within the previous six months
* Having a regular access to Internet
* Having a personal e-mail address
* Having a personal mobile cell phone with a Norwegian number
* Given informed consent
* Can read and understand Norwegian
* Reporting no association with the University Hospital of North Norway (arm1\&2)
* Reporting an association with the University Hospital of North Norway (arm3\&4)

Exclusion Criteria:

* Less than 16 years of age
* No personal e-mail address
* No personal mobile cell phone
* Not able to give the informed consent
Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers

Chronic foot ulcers occurring among diabetic patients are difficult to heal. The frequent elderly age with co-morbidities, vascular insufficiencies, peripheral neuropathies and super imposed infections, all contribute towards the chronicity and failure of treatment. Preserving the ulcerated limb is the patients' wish. On the other hand, an infected ulcer that never heals just unnecessarily prolongs suffering. Nevertheless, patients earnestly like to try all methods of healing before accepting amputation.

Objective:To determine whether a course of herbal preparation used as an adjuvant therapy for diabetic patients suffering from chronic foot ulcers may promote healing so that major leg amputation can be avoided.


Eligibility Criteria:
Inclusion Criteria:

* Well Controlled diabetic state
* Presence of gangrene or non-healing ulcer in diabetic patients over the foot or feet. Infection should be well controlled.
* Good glycaemic control

Exclusion Criteria:

* Pregnant women and women at risk of conception
* Patients taking digitalis glycosides
* Patients with abnormal liver function tests
* Patients with plasma creatinine great then 150 umol/l or unstable renal function
* Poorly controlled Diabetes Mellitus
* Uncontrolled infection
* History of adverse reaction to herbal medicine
* Unstable medical conditions
* Non-compliance with regime
Effects of a Multicomponent Training in Pre-frail Elderly

This study aim to evaluate the effects of 16 weeks of multicomponent training on postural control, cardiovascular and musculoskeletal systems in pre-frail elderly through nonlinear and linear measurements.

Frailty syndrome is described as a clinical state of vulnerability to stress resulting from the decline of resilience and physiological reserves associated with aging. It is also characterized by a reduction of the interaction between systems and that would be reflected by a loss of physiological complexity. Physical exercise, especially the multi-component, is pointed out as a key element in the intervention of frail elderly individuals. However, it is still unclear whether the improvement in functional capacity observed with this type of training would be related to changes in the physiological complexity of these elderly individuals. The aim of this study is to evaluate the effect of multi-component training on the dynamics of the cardiovascular, motor, neuromuscular and physical activity levels of pre-frail elderly. Thirty-six pre-frail elderly individuals will be divided into intervention (IG, n = 18) and control (CG, n = 18) groups at three different moments (pre-intervention, post-intervention, 16 weeks, and follow-up of detraining of 6 Weeks). The complexity will be evaluated by calculating the entropy of the biological signals: a) heart rate, blood pressure (in supine and orthostatic conditions), b) oscillations of the pressure center (in open, closed eyes, after standing in a chair And under dual-task cognitive condition), c) torque oscillations of the knee extensor muscle group.

Eligibility Criteria:
Inclusion Criteria:

* \>= 65 years old;
* conventional ECG without alterations in rest;
* medical release for physical exercise;
* understand the instructions and agree to participate.

Exclusion Criteria:

* historical stroke which produces loss of strength and aphasia;
* several impairment of motor skills;
* Parkinson disease;
* Diabetes Mellitus;
* Peripheral Neuropathy;
* Vestibular and visual disorders self-reported in anamnesis;
* Severe cognitive impairment;
* Cardiovascular disorders (atrial fibrillation, malignant ventricular arrhythmia; ventricular beats complexes ectopic, sinus tachycardia or supraventricular, second and third degree of atrioventricular block, use of pacemaker in the resting ECG);
* Unstable angina;
* Myocardial infarction;
* Elderly end stage.
Conflict Between Maternal Autonomy and Child Health in Substance-use

Qualitative project, comprising open-ended semi-structured interviews with healthcare workers, who provide antenatal care to substance-using women.

Maternal substance use during pregnancy (including legal and illicit substances) is a fairly common global phenomenon, including in the UK. This can have significant effects on pregnancy, infant outcome and enduring consequences into adolescence. Babies born with neonatal abstinence syndrome may spend months in neonatal care units, requiring complex, 24hour care. Here, healthcare workers may experience conflict between preserving maternal autonomy, and the challenge of caring for a withdrawing newborn.

However, there is discrepancy between the objectives of policy-makers "Reducing the harm to children from parental problem drug use should become a main objective of policy and practice" and those recommended in healthcare "These women need supportive and coordinated care during pregnancy." Therefore, conflict arises between mother-centred and child-centred models of caring for pregnant women who use substances.

The objective of the proposed project is to investigate how healthcare workers providing treatment for pregnant women who use illicit substances perceive their duty of care and whether they experience tension between the conflicting objectives of mother-centred and child-centred approaches through semi-structured qualitative interviews. The investigators will explore the ways in which healthcare workers frame problematic substance misuse in pregnant women, what they perceive to be the major challenges in providing care and their views on the responsibility of a mother to have a healthy baby. The main hypothesis is that healthcare workers providing care for pregnant women engaging in problematic substance misuse experience conflict between mother-centred and child- centred approaches to care.

Eligibility Criteria:
Inclusion Criteria:

* Healthcare workers will be recruited based on their employment status; they must currently provide some form of antenatal are for women who engage in problematic use of substances (limited to illicit drugs, excluding tobacco and alcohol).
* Healthcare workers will not be restricted by age, and all genders will be included. As the research is qualitative, a representative same is unnecessary.

Exclusion Criteria:

* Healthcare workers will be excluded if they do not have experience of providing ante-natal care for women who engage in problematic substance misuse (limited to illicit drugs, excluding tobacco and alcohol) during their pregnancy.
Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia

This is a randomized controlled study to assess the effect of choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.

In patients with type 2 diabetes with atherosclerotic combined dyslipidemia, the effect of choline fenofibrate on the progression of carotid intima media thickness and carotid artery plaque will be evaluated by 3D carotid ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes under treatment with HbA1c 6.0-10.0% at screening visit
* Male or female of 20 years or over
* Mixed dyslipidemia: triglyceride 200\~499 mg/dL, HDL-cholesterol male ≤45 mg/dL or female ≤50 mg/dL
* Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm
* Creatinine ≤1.8 mg/dL

Exclusion Criteria:

* Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL
* Uncontrolled hypertension
* Severe renal dysfunction
* GOT/GPT \>120/120 or chronic liver disease
* Pregnant or childbearing woman who does not have enough contraception
* Changes of medication related to chronic diseases (diabetes, hypertension, dyslipidemia, etc.) within 3 months
* Other antiplatlet medication such as cilostazol, clopidogrel (except aspirin)
Clinical Usefulness of Optical Skin Biopsy

Traditional biopsy requires the removal, fixation, and staining of tissues from the human body. Its procedure is invasive and painful. Non-invasive in vivo optical biopsy is thus required, which should provide non-invasive, highly penetrative, three-dimensional (3D) imaging with sub-micron spatial resolution. Optical biopsy based on scanning two-photon fluorescence microscopy (TPFM) is a good method for biopsy of skin due to its high lateral resolution, low out-of-focus damage, and intrinsic three-dimensional (3D) section capability. However current technology still presents several limitations including low penetration depth, in-focus cell damages, and multi-photon phototoxicity due to high optical intensity in the 800 nm wavelength region, and toxicity if exogenous fluorescence markers were required. We study the harmonics optical biopsy of a human skin sample using a femtosecond Cr:forsterite laser centered at 1230 nm. Higher harmonics generation is known to leave no energy deposition to the interacted matters due to their energy-conservation characteristic. This energy-conservation characteristic provides the "noninvasive" nature desirable for clinical imaging. In our study, we will evaluate the clinical applications of optical skin biopsy using harmonic generation microscopy.

Traditional biopsy requires the removal, fixation, and staining of tissues from the human body. Its procedure is invasive and painful. Non-invasive in vivo optical biopsy is thus required, which should provide non-invasive, highly penetrative, three-dimensional (3D) imaging with sub-micron spatial resolution. Optical biopsy based on scanning two-photon fluorescence microscopy (TPFM) is a good method for biopsy of skin due to its high lateral resolution, low out-of-focus damage, and intrinsic three-dimensional (3D) section capability. However current technology still presents several limitations including low penetration depth, in-focus cell damages, and multi-photon phototoxicity due to high optical intensity in the 800 nm wavelength region, and toxicity if exogenous fluorescence markers were required. We study the harmonics optical biopsy of a human skin sample using a femtosecond Cr:forsterite laser centered at 1230 nm. Higher harmonics generation is known to leave no energy deposition to the interacted matters due to their energy-conservation characteristic. This energy-conservation characteristic provides the "noninvasive" nature desirable for clinical imaging. In our study, we will evaluate the clinical applications of optical skin biopsy using harmonic generation microscopy.

Eligibility Criteria:
Inclusion Criteria:

* Skin lesions admitted for surgical resection.

Exclusion Criteria:

* none
Reproducibility of Virtual Exercise Assessments Versus Face-to-face Exercise Testing in Adults With Cystic Fibrosis

RExA-CF is investing if results from exercise tests (the Chester Step Test and the One-Minute Sit-to-Stand test) completed face to face are comparable to results of the same tests completed via a virtual teleconferencing platform. The study involves two exercise testing sessions (one face-to-face and one via a video link), with participants being randomised to complete the two exercise tests (the 1-minute sit-to-stand test and the Chester Step test). The two testing sessions will be completed within three weeks of each other, the order of which will be randomly allocated. One session will be completed face-to-face during a pre-arranged visit to the hospital, the other test session will be completed through a video call at a time convenient to the participants. After the second testing session participants will be asked some questions about the face-to-face and video tests to get their views about the two formats.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis (as confirmed by standard criteria)
* Sixteen years of age or over
* Home internet access
* Stable CF disease as judged by the medical team
* Registered with the Royal Brompton Hospital adult CF team

Exclusion Criteria:

* Inability to give consent for treatment or measurement
* Current participation in another interventional study
* Current moderate haemoptysis (greater than streaking in the sputum)
* Pregnancy
* Forced expiratory volume in 1 second (FEV1) below 30% predicted
* Dependency upon oxygen therapy (with home oxygen concentrators or portable oxygen cylinders) or non-invasive ventilation (NIV)
* Current neurological or musculoskeletal injury which would prevent completion of exercise tests
* Inability to complete the second set of exercise tests within three weeks
Detection of Covid-19 by Volatile Organic Compounds in Exhaled Breath

Our primary aim is to collect breath samples from COVID-19 positive patients at the time of diagnosis, during and after recovery using the same patient as his/her own control to identify VOCs specific to SARS-COV-2 viral infection. A secondary aim is to determine the patient's likely disease trajectory in terms of recovery versus progression to respiratory and or multi-organ failure.

Breath samples will be collected as soon as the patient is admitted to the Vancouver General Hospital COVID Ward with a diagnosis of COVID-19 by RT-PCR in nasopharyngeal/throat swab. A second breath sample will be obtained one week later, or before hospital discharge or if they become sicker prior to transfer to the intensive care. A third sample will be taken to 8-12 weeks after recovery from the illness with a negative COVID-19 RT-PCR test. VOCs in exhaled breath will be measured by gas chromatography-mass spectrometry (GC-TOF-MS or GCxGC-TOFMS). VOC profiles from the symptomatic phase and recovery phase will be compared to determine if there are unique VOCs associated with COVID-19 infection. Comparison of VOC profiles between those who recover and those who progressed will provide information on potential prognostic features. The results of this pilot study will form the basis to determine if a larger study is warranted.

Patients will be recruited from the COVID wards at VGH, all patients admitted will be given a letter of invite on admission if eligible and if interested and eligible will be enrolled. Sample for the study will be collected at the VGH COVID patient wards. Consenting patients and breath collection will be performed in the patients' hospital room with proper personnel protective equipment. A verbal consent will be collected as to not contaminate consent forms. A paper copy will be given or emailed to the participants to have for their own records. .We aim to recruit up to 20 patients. The final number will be dependent on the number of new cases in Vancouver available for the study after REB approval.

Additional participants will be recruited from community testing sites. Participants will be approached to be invited to participate while waiting in their vehicles at the drive-by testing sites.

Breath samples will be analyzed on a SepSolve GC-TOF MS system at the BC Cancer Research Institute.

Eligibility Criteria:
Inclusion Criteria:

* Are between the ages of 18 and 85 years
* Are test positive for COVID-19 (SARS-CoV-2)
* Are capable of providing informed consent to participate in the study

Exclusion Criteria:

* Too sick to provide a breath sample
* Unwilling to sign a consent
* Unwilling to be followed up after you have recovered from the illness.