cyrilzakka/clinical-trials huggingface dataset:
Effects of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) Therapy on miRNAs Expression and Absolute Microvascular Resistance by Continuous Thermodilution in ST-segment Elevation Myocardial Infarction (STEMI) Patients: PiCSO-STEMI TRIAL

In this study we pretend to determine the molecular (miRNAs expression, angiogenic and inflammatory biomarkers) and microcirculatory (assessed by the innovative continuous intracoronary thermodilution technique) effects of PiCSO compared to a standard PCI control group in patients with high-risk anterior STEMI. Then, we aim to assess the efficacy of these molecular biomarkers as prognostic tools. Also, we will evaluate the impact of PiCSO on the coronary microcirculation beyond the acute phase in the follow-up six months after STEMI. Finally, we will assess PiCSO influence on Heart Failure (HF) clinical variables and patients' quality of life including a cost-effectiveness assessment in the mid-term follow-up one year after the STEMI event.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old.
2. Anterior STEMI (ECG with persistent elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial leads (V2, V3, V4) in men or ≥ 1.5 mm (0.15 mV) in women.
3. Culprit lesion in proximal or mid Left Anterior Descending Artery (LAD).
4. Pre-PCI TIMI flow 0-1.
5. Symptoms consistent with myocardial ischemia (persistent chest pain, dyspnea, nauseas/vomiting, fatigue, palpitations or syncope) present for ≤ 12 hours.
6. The patient is eligible for primary PCI.
7. Informed consent received and signed for study enrollment.

Exclusion Criteria:

1. Contraindication to coronary angiogram or PCI.
2. Implants or foreign bodies in the coronary sinus.
3. Known allergies to polyurethanes, Polyethylene Terephthalate (PET) or stainless steel.
4. Known pregnancy or breastfeeding.
5. Known coagulopathy.
6. Known severe kidney disease (eGFR \<=30 mL/min/1.73) and/or hemodialysis.
7. Known large pericardial effusion or cardiac tamponade.
8. Central hemodynamically relevant left-right shunt.
9. Previous MI or Coronary Artery Bypass Graft (CABG).
10. Previous history of stroke, transient ischemic attack (TIA) or reversible ischemic neurological deficit within last 6 months.
11. Cardiopulmonary resuscitated (CPR) cardiac arrest ≥ 5 minutes whom baseline neurologic status is not present.
12. Unconscious at presentation.
13. Need for circulatory support.
14. Need for invasive mechanical ventilation.
15. Need for temporal intravenous pacemaker.
16. Patient not suitable for femoral access.
17. Known contraindication for adenosine administration (severe asthma, complicated Atrioventricular (AV) block, critical aortic stenosis, severe cardiac arrhythmias, severe valve diseases).
18. Known epicardial stenosis greater than 50% distal to the culprit LAD lesion.
19. Active participation in another drug or device investigational trial.
20. Medical, social or psychological condition that limits the ability of patient to participate in the study.
21. Patients with definite or probable coronavirus disease 19 diagnosis within 2 weeks prior to STEMI.
Comparison of Glycemic Control Achieved With 2 Different Needles

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate if a 31 gauge x 6 mm needle will provide comparable blood glucose control to the 29 gauge x 12.7 mm needle in obese subjects with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus
* Current treatment with insulin or insulin analogues for the last 6 months
* BMI greater than or equal to 30.0 kg/m2
* Currently injecting in the thigh or abdomen
* HbA1c below 10%

Exclusion Criteria:

* Severe, uncontrolled hypertension
* Self-mixing insulin
* Unwillingness to monitor blood glucose
* Pregnancy, breast-feeding, intention to become pregnant, or inadequate contraceptive measures
Improving Lung Transplant Outcomes With Coping Skills and Physical Activity

This study evaluates the effectiveness of a coping skills and exercise (CSTEX) intervention among post lung transplant patients aimed to reduce distress and improve functional capacity. Half of the patients will receive CSTEX and half will receive the standard of care plus transplant education (SOC-ED).

The study will aim to evaluate the effectiveness of the CSTEX intervention in (i) reducing distress and (ii) improving functional capacity. It is hypothesized that compared to SOC-ED, the CSTEX intervention will result in 1) greater reductions in global distress measured by an established psychometric test battery; and 2) greater improvements in functional capacity assessed by distance walked on a standard Six Minute Walk test (6MWT).

Eligibility Criteria:
Inclusion Criteria:

* Single or bilateral first lung transplant recipient; discharged from the hospital and at least 6 weeks post-transplant; completed post-transplant pulmonary rehabilitation within the past 18 months; on stable medication regimen; proficient in the English language

Exclusion Criteria:

* Illness such as malignancies that are associated with a life-expectancy of \< 12 months; current pregnancy; inability to read or to provide informed consent; multi-organ transplant recipient or repeat lung transplant.
Management of Diabetic Patients With Neuropathic Osteoarthropathy (Charcot Foot) : Descriptive Study in Diabetic-foot Centers

Despite the prominence of diabetes prevalence (more than 8% of the world population in 2012) and its expected increase in the next 15 years, Charcot foot remains a widely unknown diabetes complication. At this day, there is no national guidelines about diagnosis and treatment of this complication, which is known to alter life quality and to increase risk of foot ulceration and mortality in diabetics. Through this descriptive multicentric study, we will investigate the Charcot foot cares in diabetic-foot centers in France and Belgium.


Eligibility Criteria:
Inclusion Criteria:

* The patient has received written information about the study and did not oppose to participate
* The patient is affiliated to a health insurance programme
* The patient is at least 18 years old
* The patient is admitted to hospitalization or consultation
* The patient is diagnosed with type 1 or type 2 diabetes mellitus
* The patient is diagnosed with acute or chronic osteo-neuroarthropathy

Exclusion Criteria:

* The patient participates in another interventional study
* The patient refuses to participate
Development of an Atlas of Respiratory Host-microbiome Interactions in Healthy Volunteers

The role of the pulmonary microbiome in the pathophysiology of lung disease is becoming increasingly well understood. Studies on murine models have highlighted the immunomodulatory and antibacterial activity of certain commensal bacteria, such as S. mitis, and have led to an understanding of their potential therapeutic impact. The investigators will therefore couple their analyses of the respiratory microbiome with an in-depth analysis of mucosal immunity. In particular, they will characterize immune cell types and frequencies using high-dimensional (spectral) flow cytometry and single cell RNA-sequencing. Finally, they will study the mediators exchanged between the microbiome and the host using proteomic and metabolomic analyses of respiratory fluids.


Eligibility Criteria:
Inclusion Criteria:

* Male or female.
* Age from 18 to 70.
* Indication for scheduled general anesthesia with orotracheal intubation for non-thoracic, non-carcinological, non-septic surgical procedures such as prosthesis (knee or hip), spinal surgery, digestive hernia surgery, gall bladder surgery, maxillofacial surgery (non-exhaustive list).
* Membership of a social security scheme or beneficiary of such a scheme.
* Written informed consent.

Exclusion Criteria:

* Persons under guardianship or trusteeship.
* Pregnant or breast-feeding woman.
* Antibiotic treatment received within 28 days prior to surgery, regardless of the site of infection.
* Acute respiratory pathology within the last 28 days (pneumothorax, bronchitis or pneumonia including Covid).
* History of chronic respiratory disease (asthma, chronic obstructive pulmonary disease, emphysema, lung cancer, cystic fibrosis, etc.).
* Immunosuppression (cancer active or within the last 5 years, HIV, radio-chemotherapy within the last year, organ transplant).
* Chronic inflammatory disease (digestive, osteoarticular, neurological or cutaneous) requiring or having required specific treatment in the last 12 months.
* Type I or II diabetes.
* Steroid treatment within the last 30 days (regardless of dose or duration).
Evaluation of the Effect of Hydration About Orthostatic Hypotension in the Elderly. Difference With Venous Compression

Primary objective: To compare the decrease in systolic blood pressure between hydration and venous contention when switching to a standing position. Hypothesis in that hydration is better than venous contention.

Secondary objective: To evaluate the effect of hydration on lowering systolic blood pressure during the passage standing in elderly patients with orthostatic hypotension.

Inclusion criteria: Patient aged over 75 years old with orthostatic hypotension proved to 1 and / or 3 min

Day 0: confirmation of the orthostatic hypotension, without prevented measures

Two groups randomized :

* Group 1: First day (day 1), Orthostatic Hypotension test after hydration by three large glasses of clear liquid (33cl). Second day (day 2), Orthostatic Hypotension test with venous contention in the morning.
* Group 2: First day (day 1), Orthostatic Hypotension test after implementation of venous contention in the morning. Second day (day 2), Orthostatic Hypotension after hydration by three large glasses of clear liquid (33cl).

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 75 and older with orthostatic hypotension proved to 1 and / or 3 minutes.
* Written consent of the subject
* Hospitalization or stay expected minimum 3 days
* Affiliation to a social security scheme

Exclusion Criteria:

* bedridden patient or without possibility of verticalization
* Patient who can't stand up (pulmonary embolism with high risk)
* Patient who refuse to participate in the study
* Patient with legal protection
* State or condition that may affect the stability of blood pressure during the study (hyperthermia, modification antihypertensive treatments less than 48 hours before inclusion...)
* Pathology preventing hydration: Heart failure with less than 1 Liter water restriction, swallowing disorders preventing hydration orally, inability to nutrition and hydration orally
* Intravenous or subcutaneous hydration (intravenous or subcutaneous treatments not included)
* Patient who can't have venous contention: Blue phlebitis, septic thrombosis, arteritis with score less than 0.6, varicose ulcers during treatment
Post-marketing Study in Femoral Popliteal Artery of Drug Coated Balloon Used for Treatment of Lower Limb Ischemia

The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Drug-coated Balloon catheters in the treatment of the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old and ≤85 years old
2. Rutherford clinical category classification：2-5
3. Significant stenosis (≥50%) or occlusions of lesion(s) located in the superficial femoral artery an /or the popliteal artery
4. At least one patent native outflow artery to the ankle free from significant lesion as confirmed by angiography
5. Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.

Exclusion Criteria:

1. Aneurysms near target lesions or popliteal aneurysms.
2. The guide wire cannot pass smoothly through the target lesion.
3. Known allergy to contrast agents, heparin or paclitaxel.
4. Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints or may enroll in other studies after enrollment in this clinical trial.
5. Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating.
6. Other comorbidities, which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up.
Similarities and Differences of Biological Therapies for Severe Asthma.

This is an ambispective multicenter longitudinal observational study to evaluate the efficacy and safety profile of biological therapies in patients diagnosed with severe asthma in real life conditions.

The use of biologicals to treat severe asthma has been implemented in a regular basis while information on long term effectiveness and safety is lacking. It is necessary to establish strategies to closely monitor the possible occurrence of reactions, adverse effects of innovative biological medicines used to treat severe asthma.

In this study the investigators want to evaluate the comparative effectiveness, utilization patterns, long-term safety, and use in special groups in real-life conditions in severe asthma.

Eligibility Criteria:
Inclusion Criteria:

* Individuals of any age: adults and children.
* Diagnosis of severe asthma as given by the treating physician, and defined as an asthma that remains uncontrolled in despite adherence with maximal optimized therapy and treatment of contributed factors, or asthma that worsens when high dose treatment is decreased.
* Being treated or not (control group) with biological drugs.
* Signed Informed Consent.

Exclusion Criteria:

* None.
Comparison of Two Marketed Silicone Hydrogel Lenses

The purpose of this study is to evaluate cholesterol sorption by AIR OPTIX® AQUA lenses compared to ULTRA lenses after 30 days of wear.


Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent document;
* Vision correctable to 20/40 Snellen (feet) or better in each eye at distance with both study contact lenses;
* Willing to wear study lenses on a daily basis (minimum 5 days/week, 8 hours/day) and attend all study visits;
* Successful wear of single-vision spherical, 2-week/ monthly replacement silicone hydrogel contact lenses in both eyes daily wear during the past 2 months for a minimum of 5 days/week, 8 hours/day. (Note: Monovision is included);
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current);
* History of herpetic keratitis, corneal surgery or irregular cornea;
* Any use of systemic or ocular medications within the past 30 days for which contact lens wear could be contraindicated as determined by the investigator;
* Monocular (only 1 eye with functional vision) or fit with only one lens;
* Current or past AIR OPTIX® AQUA or ULTRA lens wearers;
* Other protocol-specified exclusion criteria may apply.
Youth Nominated Support Team

This study aims to adapt the current Youth-Nominated Support Team (YST) manual used to treat suicide risk for people at clinical high risk for psychosis.

Psychotic disorders are characterized by high rates of suicidal ideation and behavior, and the risk for suicide appears to be greatest during the earliest stages of psychosis. A recent meta-analysis showed that the majority of youth at clinical high-risk (CHR) for psychosis experience suicidal ideation, and that approximately one in five make at least one suicide attempt. There are, however, no suicide prevention interventions specifically tailored to the needs of transition-aged youth at CHR, and no current best practice guidelines for how to respond to suicide risk in this population. The Youth-Nominated Support Team (YST) intervention has recently been shown to reduce mortality among adolescents and is potentially highly adaptable within the context of existing CHR services. YST is intended as an adjunctive treatment and is primarily delivered towards support persons rather than the youth themselves, and therefore would not interfere or overlap with the already extensive direct services provided in CHR treatment settings. The proposed project intends to adapt the YST intervention for CHR populations. Specifically, the investigators aim to: (1) adapt YST for CHR based on stakeholder input (i.e., clients, family/friends, clinicians) and to develop a new treatment manual and submit an additional IRB to cover the next two aims -- (2) to implement YST in a single CHR clinic and to revise the intervention based on input from clients, providers, and support person and (3) conduct a pilot randomized clinical trial at four SAMHSA funded CHR sites to test the efficacy of the adapted YST intervention and to identify underlying mechanisms of change. The investigators hypothesize that the revised intervention will be superior to existing practice for the reduction of suicidal ideation and behavior.

Eligibility Criteria:
Inclusion Criteria:

* A person with suicidal ideation in the past 3 months or suicidal attempt in the past year
* A person who is receiving or has received treatment for psychosis risk symptoms
* Between the ages of 12-25

Exclusion Criteria:

* Cannot have participated in the first 2 phases of the study (focus groups and adaption of the YST-CHR manual)
Comparison of Glucovance to Insulin for Diabetes During Pregnancy

Pregnant women with gestational or Type 2 diabetes who require medication are placed in one of two groups: Insulin injections or Glucovance (oral administration). Blood glucose is checked 5 times per day, and medication adjusted by perinatologist according to glucose levels. The hypothesis is that patients will have similar or improved blood glucose control on an oral agent as compared to control on insulin.

According to ACOG guidelines, patients between 24 and 28 weeks gestation will be screened with a 1 hour glucose tolerance test (GTT) by their obstetrician. Those with elevated glucose levels will undergo a 3 hour GTT. According to routine OB standards, if the blood glucose is elevated on 2 or more of 4 parameters during this test (\> 95 fasting, \> 180 at 1 hour, \> 155 at 2 hours, \>140 at 3 hours), the patient will begin receiving dietary therapy using ADA guidelines. If blood glucose levels remain 20% above a fasting of 90 \& post parandial of 120 with diet alone during a period of 1-3 weeks after diagnosis, the patient will be invited to participate in this study. Type 2 diabetics who have been diagnosed prior to pregnancy will also be included. These patients may enroll in the study prior to 24 weeks gestation, entering at the time of referral. Patients who give consent for participation will be randomly assigned to either insulin therapy (the usual standard of care), or to oral Glucovance therapy (the experimental group). Glucovance will be started at 1.25mg/250mg BID. NPH \& regular Insulin will be started on a 1unit/kg basis BID. Both groups will receive care according to the current standard for gestational diabetics and pregnant Type 2 diabetics. The perinatologist and diabetes educator will evaluate the blood glucose record and assess the patient's adherence to the ADA diet weekly and will determine when the insulin or Glucovance needs to be increased. If the patients in the Glucovance group continue to be poorly controlled with 4 tablets/day (5mg/500mg), the therapy will be continued and insulin will be added to the management. Statistical analysis will compare the two groups for myriad factors including vaginal versus operative deliveries, hemoglobin A1C, fructosamine, and glucose at delivery, infant birth weight, infant complications, initial infant blood glucose.

Eligibility Criteria:
Inclusion Criteria:Gestational diabetes by ACOG definition or Type 2 diabetes in pregnancy Hyperglycemia despite following ADA diet English or Spanish speaking -

Exclusion Criteria:Already requiring Insulin Serum creatinine \> 1.3 or creatinine clearance \< 75ml/minute Liver disease

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Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2021/22

The primary objective of the study is to estimate the reporting rate of suspected Adverse Drug Reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, during the Northern Hemisphere (NH) influenza season 2021/22.

The secondary objectives of the study are:

* To estimate the reporting rates of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® according to the pre-defined age groups.
* To estimate the reporting rates of serious suspected ADRs after vaccination with VaxigripTetra®, and Efluelda®, respectively, at any time following vaccination, within the Enhanced Passive Safety Surveillance (EPSS) period.
* To compare vaccinees' reporting rates of suspected ADRs observed during the NH influenza season 2021/22.

Study duration per participant is maximum 2 months.

Eligibility Criteria:
Individuals who approach the site for vaccination and agree to receive a vaccination card will be included and vaccinated with the respective vaccine brand according to the country of their location, recommendations for the individual vaccines as well as national recommendations.
Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy

Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea.

single center, randomized trial

1. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) twice for 10 days
2. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) twice for 14 days
3. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 5 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 5 days
4. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 7 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 7 days

1st endpoint : Helicobacter pylori eradication rates (intention to treatment, per-protocol) 2nd endpoint : adverse event(nausea, vomiting, dizziness, bitter sense) drug compliance


Eligibility Criteria:
Inclusion Criteria:

* 20\~80 patients
* agreement of informed consent
* H.pylori positive (biopsy, CLO)
* Peptic ulcer disease, mucosa associated lymphoid tissue lymphoma, Post endoscopic submucosal dissection status due to early gastric cancer

Exclusion Criteria:

* H.pylori eradication history
* severe hepatic, renal, cardiac failure
* pregnancy, participant of other study
Cementless Triathlon 5YR Follow-Up

All artificial joint implants need to be solidly held (fixed) within the bone. Cementless fixation has become a popular method to achieve fixation for total knee replacements where the bone grows directly onto the implanted device instead of using bone cement. The primary purpose of this study is to assess long-term implant survivorship and clinical outcomes of a previous study cohort that received a cementless knee replacement. As this study cohort approaches 5 years post-operation, the investigators will re-examine the stability of participant implants using specialized x-rays, called "radiostereometric analysis". The study will use weight-bearing computed tomography (CT) to measure bone density and texture features and correlate that with implant stability. The investigators will collect stool samples to assess participant gut microbiomes for biomarkers of poor bone quality that could correlate to implant stability. All 33 participants from the original study cohort will be invited to participate in this study.


Eligibility Criteria:
Inclusion Criteria:

* Were in the originally investigated cohort
* Had successful imaging at 1-year post-operation
* Minimum of 5 years post-operation

Exclusion Criteria:

* Pregnancy
* Unable to follow-up