cyrilzakka/clinical-trials huggingface dataset:
Arterial Calcification in the Diabetes

The blood concentration of the protein RANKL could be predictive of the calcification of the leg arteries, which is a major complication occurring during diabetes. The objective of the DIACART study is to show that blood RANKL concentration predict the progression of calcification of the leg arteries in diabetic patients, independently of other cardiovascular risk factors.

Introduction: Peripheral arterial disease (PAD) is the primary major amputation risk factor in diabetes. The PAD is particularly common among diabetic patients at high cardiovascular risk (20-30% of coronary patients have PAD). The calcification of atherosclerotic plaque and media leg arteries contributes to narrowing of the arterial lumen and exposes the diabetic patient to critical limb ischemia. The receptor RANK (Receptor Activator for Nuclear Factor κ B) and its ligand RANKL form a complex which initially was described as being involved in bone metabolism by activating osteoclasts but the RANK / RANKLigand system could also be involved in the process calcification and arterial obstruction, especially in the lower limbs. Currently there is anti-RANKL antibody used in humans that could possibly slow down this process. But it is necessary to prove the involvement of this system in PAD in diabetic patients at high cardiovascular risk before proposing a therapeutic trial.

Assumptions: the concentration of RANKL could be predictive of calcification of leg arteries in diabetes Main objective: To show that serum RANKL concentrations predict the progression of calcification of the leg arteries in diabetic patients, independently of other cardiovascular risk factors.

Secondary Objectives:

* To show the link between other proteins of bone remodeling, markers of inflammation and glycation, and calcification of leg arteries.
* Measuring the rate of calcification leg arteries.
* Phenotype diabetic patients who have the highest rate of calcification. Primary Outcome: Predictive power of serum RANKL concentration at T0 on the progression of calcification of leg arteries between T0 and T24 months.

Methodology: prospective observational study. The calcium score of leg arteries will be evaluated by a scanner at T0 and 24 months.

Inclusion criteria:

* type 2 diabetes
* women over 60
* men over 50 years
* men and women with known coronary artery disease Non-inclusion criteria:
* severe renal failure
* immunodeficiency
* acute infectious or inflammatory disease
* history of bypass surgery or sub-popliteal angioplasty Number of subjects required: 188 patients will be included. Total study duration: 24 months Inclusion period: 24 months

Eligibility Criteria:
Inclusion criteria:

* type 2 diabetes
* women over 60
* men over 50 years
* men and women with known coronary artery disease

Non-Exclusion criteria:

* severe renal failure
* immunodeficiency
* acute infectious or inflammatory disease
* history of bypass surgery or sub-popliteal angioplasty
In Vivo Molecular Imaging Predicts Therapeutic Response in Ulcerative Colitis

Molecular imaging with infliximab antibody with FITC has the potential to predict therapeutic responses to infliximab antibody and can be used for personalized medicine in ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with active ulcerative colitis will receive infliximab antibody therapy.

Exclusion Criteria:

* Patients with impaired blood clotting.
* Patients with short bowel syndrome.
* Patients during the pregnancy and lactation period.
* Patients received enema therapy within 1 month before inclusion in the study, or had anti-TNF therapy within the last 12 months.
* Patients participated in another clinical trial or administrated other investigational drugs within 4 months prior to the screening visit.
* Patients with moderate to severe heart failure, active tuberculosis or acute infections.
Prospective Longitudinal Effects of Intra-articular Corticosteroid Injection on Synovial Fluid Oxygen

Inflammatory arthritis such as rheumatoid arthritis (RA) and psoriatic arthritis (PsA) are characterized by synovial inflammation of joints, potentially leading to joint destruction and functional disability. Inflamed joints have lower oxygen levels. Studying how oxygen level within the joint affect inflammation may lead to new treatments for patients with arthritis. Anti-inflammatory corticosteroid injection into the joint is well tolerated and widely used in clinical practice but its effects on oxygen level within joints is unknown. Therefore, patients who require corticosteroid injection into the joint as routine clinical care will have biological samples collected before and after the injection. This will give new information to put into context the biological effects within the joint, and accelerate development of new treatment approaches in the future.


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.
* Fulfil American College of Rheumatology/European League Against Rheumatism criteria (ACR/EULAR) 2010 Rheumatoid Arthritis Classification Criteria or fulfil Classification Criteria for Psoriatic Arthritis 2006 (CASPAR).
* Participant has been selected for intra-articular corticosteroid injection as part of their routine clinical care.
* Selected joint for biopsy must be minimum Grade 2 synovial thickening for large joint (knee) and medium joint (wrist), or minimum Grade 3 synovial thickening for small joint (metacarpophalangeal).

Exclusion Criteria:

* Current enrolment in any other clinical study involving an investigational study treatment.
* Intramuscular, intravenous or intra-articular administration of corticosteroid within 4 weeks prior to baseline visit.
* Oral corticosteroid \> 10 mg/day prednisolone or equivalent within 4 weeks prior to baseline visit.
* Oral corticosteroid dose not stable for at least 4 weeks prior to baseline visit.
* Oral non-steroidal anti-inflammatory drugs (including aspirin \> 75 mg/ day and selective-cyclooxygenase inhibitors) dose not stable for at least 4 weeks prior to baseline visit.
* Disease modifying anti-rheumatic drugs (DMARDs) dose not stable for at least 4 weeks prior to baseline visit.
* History of septic arthritis.
* Participants on warfarin, heparin, low molecular weight heparin, direct oral anticoagulants. Oral anti-platelet agents are permitted.
* History of haemophilia.
Multi-center Research Project for Glioma Molecular Pathology Intraoperative Rapid Detection

We explores the accuracy and sensitivity of rapid intraoperative detection of IDH, TERT, BRAF indicators through a prospective clinical multi-center study. This part includes a total of 300 fresh tissue samples, paired blood samples, relevant clinical information and follow-up information from 300 patients with different grades of adult glioma. By comparing with the postoperative sequencing results, the specificity and sensitivity of intraoperative IDH and TERT rapid detection results are clear.


Eligibility Criteria:
Inclusion Criteria:

* 1. Glioma patients with Informed Consent Form 2. Glioma patients with intact clinical information

Exclusion Criteria:

* 1. Glioma patients without Informed Consent Form 2. Glioma patients without intact clinical information
Effect of the BioFire FilmArray (BCID2) for the Rapid Detection of Bloodstream Infection in Haematologic Patients With Febrile Neutropenia

The goal of this observational study is to assess if the molecular diagnostic tool BioFire FilmArray BCID2 is more useful for the microbiological diagnosis of bloodstream infections in hematological patients with febrile neutropenia, compared to the conventional microbiologic studies.

The study compares the sensibility and specificity of these two techniques.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patients hospitalised for the treatment of haematological malignancy or undergoing an autologous or allogeneic hematopoietic stem cell transplant or receiving CAR-T cell therapy
* Patients presenting with febrile neutropenia (defined as axillary temperature ≥ 38.0°C and \<500 neutrophils/mm3 or \<1000 with an expected rapid decrease in 24-48 hours),
* Patient to whom blood cultures are ordered as standard care for the microbiological diagnosis of the febrile neutropenia episode.

Exclusion Criteria:

* Axillary temperature \<37.5ºC.
* High clinical suspicion of a non-infectious cause of fever at the moment when blood cultures are drawn (high suspicion of drug related fever, infusion reaction).
* Previously enrolled patients in whom the time between inclusion and the current episode is less than four weeks.
* Patients with febrile neutropenia in whom no blood cultures are drawn.
Safety and Efficacy of FLACS With the FEMTO LDV Z8 Laser Compared to Conventional Cataract Surgery in Chinese Patients

This trial will be designed as a multi-center randomized non-inferiority clinical trial to demonstrate safety and efficacy of the FEMTO LDV Z8 laser for cataract surgery in a Chinese population in China compared to the conventional technique.

In this three center, prospective, interventional, randomized controlled study we aim to determine safety and efficacy of the FEMTO LDV Z8 laser as compared to conventional technique in Chinese patients diagnosed with cataract of any severity grade that are eligible to undergo cataract surgery with age 50 years and a maximum age of 80 years in China.

Eligibility Criteria:
Inclusion Criteria:

* Eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation
* Provision of signed and dated informed consent form
* Male or female, between 50 and 80 years of age (50 and 80 are included).
* IOL chosen for implantation a monofocal aspheric IOL of 6mm optic diameter
* Willing to comply with all study procedures and able to return for scheduled follow-up examinations
* Willing to adhere to the medication (to prevent inflammation and infection) regimen

Exclusion Criteria:

* Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light
* Poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally (e.g., intraoperative floppy iris syndrome)
* Glaucoma or ocular hypertension, pseudoexfoliation
* Corneal endothelial pathology where endothelial cell count is compromised (Fuchs endothelial dystrophy and others)
* Complicated cataract, such as traumatic, white, intumescent or posterior and anterior subcapsular cataracts
* Nystagmus or hemofacial spasm preventing placement of the patient interface
* Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye
* Allergy to medications required in surgery, pre- and post-operative treatment
* History of lens or zonular instability
* Keratoconus or keratectasia
* Immune compromised or diagnosis of ophthalmic disease: ocular herpes zoster or simplex, lupus, collagenosis and other acute or chronic illnesses that increases the risk to the subject or confounds the outcomes of this study in the opinion of the study PI (Principal Investigator)
* Anterior chamber depth (ACD) \< 1.5 mm or \> 4.8 mm as measured from the corneal endothelium.
* Developmental disability or cognitive impairment that would make informed consent and the assessment of visual acuity impossible
* Concurrent participation in another ophthalmological clinical study
The IBEP Study: an Intervention for Lifestyle Modification in Women With Gestational Diabetes

The IBEP study is a randomized control trial of a healthy lifestyle intervention program for women with gestational diabetes. The primary aim of the study is to evaluate whether women with gestational diabetes enrolled in an intensive behavioral educational program (IBEP) demonstrate lower mean fasting glucose levels measured by 2 hour 75 gram oral glucose tolerance test (OGTT) at 6 weeks postpartum compared to women with gestational diabetes who undergo routine gestational diabetes education and counseling.


Eligibility Criteria:
Inclusion Criteria:

* women diagnosed with gestational diabetes between 20 and 34 weeks gestation

Exclusion Criteria:

* women on chronic steroid therapy
* women with a diagnosis of GDM \<20 weeks or \>34 weeks
Adaptation of the Pediatric Asthma Control & Communication Instrument (PACCI) in a Pediatric Emergency Department

This study examined whether the Pediatric Asthma Control and Communication Instrument for the Emergency Department (PACCI-ED), a 12-item questionnaire, can help doctors in the emergency department accurately assess a child's asthma control.

This study involved an intervention with the doctors in the emergency department of an urban pediatric hospital. The intervention was done when one of the doctors involved in the study treated a child aged 1-17 years for an asthma exacerbation. Parents answered questions on the PACCI-ED about their children's asthma. Half of the doctors were allowed to see the PACCI-ED results and half were not. The two groups of doctors were compared on their ability to correctly identify asthma control categories, whether a child's asthma was worsening or improving, whether the family was administering controller medications as often as they should, and how much burden the child's asthma was for the family.


Eligibility Criteria:
Inclusion Criteria:

* Child presented to study institution emergency department during study period
* Child was 1 - 17 years-old
* Child has physician-diagnosed asthma by parent report
* Attending physician for child believed emergency department visit was due to asthma
* Attending physician for child completed informed consent and was randomized to PACCI-ED or control group at beginning of study

Exclusion Criteria:

* Child has major pulmonary or cardiac co-morbid illness
* Family of child was non-English speaking
* Child was triaged to the med-trauma bay for severe respiratory distress
Effect of Different Exercise Modalities Training in Patients With Obstructive Sleep Apnea.

The objective of this study was to compare different exercise modalities (moderate continuous intensity training, high intensity interval training, and inspiratory muscle training) on Apnea-Hypopnea index and oxidative stress in patients with Obstructive sleep apnea.

Forty patients with OSA aged 20 and 50 years old, dividing into 4 groups (MICT, HIIT, IMT, and CON) by stratified (with sex, age, and OSA severity) and single random sampling. The MICT group received 50 minutes of running at 65-70% of maximum heart rate 3 days/week for 12 weeks. The HIIT groups received 28 minutes of running (High intensity at 85-90% of maximum heart rate 2 minutes interval with low intensity 50-55% of maximum heart rate 2 minutes) 3 days/week for 12 weeks. The IMT group received Powerbreathe ® device, performing 240 breath (8 sets) per day at 50% of Maximal inspiratory pressure (MIP), 5 days/week for 12 week. The CON group did not have any intervention but usual care. Data collection was split 2 days (1st day for polysomnography evaluation, and 2nd day for questionnaire, blood collection, body composition, exhaled nitric oxide, pulmonary function, respiratory muscle strength and aerobic capacity). All variables were measured before and after exercise program.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with mild (AHI 5-15) or moderate (AHI 15-30) OSA, aged between 20 - 50 years.
2. BMI between 18.5 - 24.9 kg/ m2.
3. No history of exercise more than 150 min/week for 4 weeks.
4. No used CPAP or discontinue at least 2 weeks.
5. No history for surgery for OSA treatment. Screened by physician that patients have not had Uncontrolled diabetes (blood sugar 180 mg/dL) Uncontrolled hypertension (BP 139/89 mmHg) Any coronary artery disease Any neuromuscular disease Chronic Obstructive Pulmonary Disease; COPD Any cognitive disease Other sleep-related disorders Cancer

7. Not a person with current smoker, menopause or pregnancy. 8. Stable medication. 9. Willing to participate in this research.

Exclusion Criteria:

1. Cannot participate at least 80% of exercise program.
2. Inevitable event (injury, sickness, etc.)
3. Unwilling to continue this research.
Trigeminal Nerve Stimulation in Treatment-resistant Generalized Anxiety Disorder: a Feasibility Study

This is a feasibility study for trigeminal nerve stimulation (TNS) in patients with treatment-resistant generalized anxiety disorder (TR-GAD). Ten participants will receive TNS for 8 weeks as an augmentation strategy to pharmacological treatment for generalized anxiety disorder (GAD).

* The primary objective is to ascertain if TNS is a safe and well-tolerated treatment for patients with TR-GAD.
* The secondary objective will be to monitor changes in GAD symptom severity throughout the study.

Results from this study will inform a randomized controlled trial to be conducted in the future.


Eligibility Criteria:
Inclusion Criteria:

* Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5) criteria for generalized anxiety disorder.
* Subjects on a stable dose of an selective serotonin reuptake inhibitor (SSRI) or serotonin and noradrenaline reuptake inhibitor (SNRI) for at least 8 weeks.
* Treatment-resistant - treatment resistance will be defined as lack of response to at least two drugs, from two different classes of drugs considered first-line or second-line for GAD. Only trials lasting at least 8 weeks, and with at least the minimum effective dose of the given medication will be considered failed trials.

Exclusion Criteria:

* Moderate to severe major depressive disorder
* Moderate to high suicidality
* Diagnosis of obsessive compulsive disorder (OCD), PTSD, bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities and dementia or other neurological diseases including trigeminal neuralgia
* Pregnant or breastfeeding women
* Participants who are experiencing seizures
* Implanted vagal nerve stimulation (VNS) or other electrical devices
* Participants who are already undergoing transcutaneous electrical nerve stimulation
* Consumption of cannabis, any cannabis by-products, illicit drugs, or alcohol above 3 drinks per week
* Consumption of natural health products that may affect anxiety or depression symptoms
MRE Consumption and Gut Health

The objective of this study is to determine the impact of consuming MREs as the sole source of subsistence for 21 days on gut bacteria community composition and gut health. Up to 80 free-living adults will be randomized to consume their usual diet or only MREs for 21 consecutive days. MREs will be provided by the Military Nutrition Division, US Army Research Institute of Environmental Medicine (USARIEM). Fecal, urine and blood samples will be collected periodically before, during and after the intervention to measure gut barrier integrity, gut bacteria community composition, and markers of gut health, inflammation, and nutritional status.


Eligibility Criteria:
Inclusion Criteria:

* BMI \</= 30

Exclusion Criteria:

* Use of antiobiotcs within 3 months of study participation
* Use of pro- or prebiotic supplements within 2 weeks of study participation
* Vegetarian diets
* Use of laxatives, stool softeners, or anti-diarrheal medications at least once a week.
* Fewer than 4 bowel movements, on average, per week
* History of gastrointestinal disease
* Colonoscopy within 3 months of study participation
* Food allergies or aversions or other issues with foods that would preclude MRE consumption, including gluten, milk, nuts, or eggs.
* Use non-steroidal anti-inflammatory medications (NSAIDs) or antihistamine prescribed by a physician or clinician, or unwillingness to discontinue the use of these substances during the study.
* Actively trying to lose weight
* Pregnant or lactating
* Recent blood donation
Combined Ultrasound and Fluoroscopy Guided Cervical Transforaminal Injection

The combined use of Doppler ultrasound and fluoroscopy may increase efficacy and safety during cervical transforaminal epidural injection of steroid and local anaesthetic

The study will detect by which technique we have to start and confirm by the other to reach the favourable outcome.

In a previous Ultrasound study involving the C5C6 levels, a performance time of 248.8 ± 82.7 seconds was reported. On the basis of these findings, a 30% difference in performance time would represent an effect size of 0.82 and would require 20 patients per group to achieve an alpha error of 0.05 and beta error of 0.1. For dropped cases; 5% will be added. So a total sample size of 64 patients (32 per group) will be required.

Statistical Analysis: will be performed using SPSS version 22 statistical software. For quantitative data, normality will be first assessed with the Shapiro test and then analyzed with the Student t-test. Data that will not have a normal distribution, as well as ordinal data, will be analyzed with the Mann-Whitney U test. For binomial data, Fisher exact test will be used. All P values presented will be 2-sided and values of less than 0.05 will be considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from radicular discogenic pain
* Patients suffering from radicular foraminal pain Patients suffering from radicular pain secondary to spinal canal stenosis
* Patients suffering from radicular pain after failed cervical disc surgery
* Not responding to conservative management for at least 3 months
* Patients with recalcitrant symptoms after transforaminal steroid injection.
* American Society of Anesthesiology (ASA) from I to III

Exclusion Criteria:

* Presence of local or systemic infection
* Coagulopathy
* Body mass index \> 35
* Cervical spine fracture
* Myelopathy
* Malignancy
* Pregnancy
* Patients unable to communicate with the operator during the procedure or report their pain diary after it.
* Patients not responding to previous cervical transforaminal steroid injection or had any untoward effects.
* Allergy to any one of the used medications.