cyrilzakka/clinical-trials huggingface dataset:
Coroflex ISAR NEO "All Comers" Post Market Clinical Follow-up (PMCF)

The aim of the study is to assess the safety and efficacy of the device to treat coronary de novo and restenotic lesions.

Post-authorisation / after Conformité Européene (CE) marking Coroflex® ISAR NEO is a drug eluting stent system which is an improved version of the predecessor device Coroflex® ISAR which was extensively studied in the ISAR 2000 Registry. The rationale of this observational, post-market, single-armed study is to confirm the safety and efficacy of Coroflex® ISAR NEO, also as part of the manufacturer's post-market surveillance obligations in particular for the re-certification of the device.

Eligibility Criteria:
Inclusion Criteria:

Coroflex® ISAR NEO is intended to be used for

* All common significant coronary lesions
* Target lesion length \>34mm need to be covered with at least 2 stents
* Patients eligible for this study must be at least 18 years of age.
* The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment.

Exclusion Criteria:

* Intolerance to sirolimus and/or probucol
* Allergy to components of the coating
* Pregnancy and lactation
* Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized
* Cardiogenic shock
* Risk of an intraluminal thrombus
* Hemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy
* Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior
* Severe allergy to contrast media
* Lesions which are untreatable with PCI or other interventional techniques
* Patients with an ejection fraction of \< 30 %
* Vascular reference diameter \< 2.00 mm
* Treatment of the left stem (first section of the left coronary artery)
* Indication for a bypass surgery
* Contraindication for whichever accompanying medication is necessary
Non-invasive Treatment for Long COVID (Post COVID-19 Condition) Brain Fog

This study aims to assess the effects of both acute and chronic exposures to hypoxia and hypercapnia in patients with Long COVID syndrome.


Eligibility Criteria:
Inclusion criteria:

* English speaking
* Diagnosis of Long COVID

Exclusion criteria:

* Any history of:

  * Coronary artery dissection or aortic dissection
  * Neurological disease (e.g. dementia, Alzheimer's disease, or other brain-related disease)
  * Cerebrovascular disease or stroke
  * Aneurysm
* If currently has:

  * Moderate-severe chronic obstructive pulmonary disease
  * Uncontrolled moderate-severe asthma
  * Moderate-severe bronchiectasis
  * Moderate-severe interstitial lung disease, requiring the use of supplemental oxygen
  * A necessity to use supplemental oxygen, for any reason
  * New or worsening symptoms (decompensation) of heart failure
  * Right heart disease due to chronic pulmonary disease/sleep apnea
  * Uncontrolled myocardial ischemia or angina
  * Uncontrolled heart arrhythmias
  * Heart or lung infection (e.g. myocarditis or pericarditis)
  * Left main coronary artery stenosis
  * Moderate-severe aortic stenosis
  * Pulmonary embolism, pulmonary infarction, or other blood clots
  * Severe respiratory disease
  * Chronic kidney disease
  * Chronic liver disease
* Females of childbearing potential will complete a urine pregnancy test at their baseline visit to rule out pregnancy
* BMI \>40
* Study staff unable to obtain adequate signal for cerebral blood flow
Optical Frequency Domain Imaging for Assessing Colonic Polyps

The goal of this research is to conduct a pilot clinical study to image colonic polyps with the intent to evaluate the potential use of Optical Frequency Domain Imaging (OFDI) to identify the extent of invasion (if present), differentiate between hyperplastic polyps and adenomas, and identify serrated polyps.

The colon OFDI catheter will be used in conjunction with a sigmoidoscope. If a sigmoid polyp is identified, the colonoscope will be removed and a sigmoidoscope inserted. The colon OFDI catheter will be advanced through the sigmoidoscope accessory port and positioned adjacent to the colon wall. Imaging will be performed with the OFDI system across the polyp's surface and the base/stalk if pedunculated. The investigators anticipate that on average the investigators will utilize 4 helical scans per polyp. Each of the scans will take less than 30 seconds.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a screening colonoscopy
* Patients must be over the age of 18
* Patient must be able to give informed consent

Exclusion Criteria:

* Patients with hemostasis disorders
* Patients taking any anti-coagulants such as Coumadin or Plavix,
Effect on Post-operative Pain of Tranexamic Acid Injection During Shoulder Surgery

Arthroscopic shoulder surgery is a commonly performed minimally invasive surgery in which a camera (an arthroscope) is inserted inside the shoulder joint.

This surgery is responsible for moderate to severe pain. It may require the use of opioid analgesics in the acute phase. One of the components of this pain may be the postoperative hematoma.

Pain is one of the main causes of patient satisfaction failure after shoulder surgery. Finding ways to reduce this pain is a primary principle in the management of this surgery. Until now, this management requires the frequent use of morphine. However, this use of morphine may conduct to adverse effects (nausea/vomiting, constipation, malaise, sweating), and even public health problems such as addiction.

It is therefore interesting to look for ways to increase the patient's analgesia by other means, which will thus increase patient satisfaction and make his management more fluid. The effect on pain of hematoma reduction is rarely described in the scientific literature.

The hypothesis of this study is that the intraoperative administration of intravenous (IV) tranexamic acid can reduce the hematoma and thus decrease postoperative pain.The aim of this study is to demonstrate that the use of IV tranexamic acid intraoperatively, compared to a placebo (sodium chloride 0.9%), reduces postoperative pain after arthroscopic shoulder surgery.


Eligibility Criteria:
Inclusion Criteria:

1 - Male or female aged 18 years old or more; 2- Patient requiring shoulder arthroscopy; 3 - Patient affiliated to a social security scheme; 4 - Patient informed on the study and who has signed the informed consent form.

Exclusion Criteria:

1. - Tranexamic acid contraindications (Hypersensitivity to the active substance or to any of the excipients, Acute venous or arterial thrombosis, Severe renal impairment, History of convulsions);
2. - Pregnant or breastfeeding patient;
3. - Patient under legal protection;
4. - Patient taking part simultaneously to another clinical trial.
Artificial Tears Study in Mild to Moderate Dry Eye Patients

The mean change in the subjective comfort score from baseline of the test group is at least 2.0 units less than that of the control group.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate dry eye
* over 18

Exclusion Criteria:

* No concurrent ocular disease or meds
Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia

20 to 30% of the general population suffers from chronic insomnia. Cognitive behavioral therapy (CBT) is the first-line treatment, but unfortunately its implementation is complex. Long waiting times for a consultation / exploration, too short a consultation period, non-reimbursement of specialists and a lack of trained staff make the current care of insomniac patients difficult. Patients are thus treated late, often with heavy drug treatment, dependence on sleeping pills, difficult withdrawal and / or reactive mood disorders. The treatment is therefore limited to advice on sleep hygiene and a restriction of time spent in bed without ultimately intervening in the cognitive domain. Therapeutic education consists of empowering the patient in the management of chronic insomnia through group education workshops. The patient learns the principles of normal sleep, the way in which sleep evolves with aging, the dangers of treatments as well as the rules of sleep hygiene and the behaviors to modify to sleep well. In addition to benefiting from sharing of experience with other patients, therapeutic education makes the care pathway smoother and considerably reduces the long waiting times of the traditional care pathway in consultation.

The study investigators hypothesize that therapeutic education is more effective as a treatment for chronic insomnia than traditional management in individualized consultation (IC). Thus, therapeutic education could constitute an effective alternative to CBT.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent
* The patient must be a member or beneficiary of a health insurance plan
* Patient must understand and read French
* Patient with ICSD-3 diagnostic criteria for chronic insomnia: ISI score \> 14/28.

Exclusion Criteria:

* Patient with cognitive impairment as assessed by the investigator
* Patient with shift work
* Patients scoring \> 10/24 on the Epworth sleepiness scale
* Patient suffering from medical or psychiatric illnesses which may, in the opinion of the investigator, compromise the subject's state of health or ability to participate in the study.
* Patient with chronic alcohol consumption or drug abuse
* Patient unable to express consent.
* Pregnant, parturient or breastfeeding patient.
* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
Tear Film Break-Up Time Evaluation of FID 114657

To evaluate the effects of FID 114657 on tear film break-up time in dry eye patients.


Eligibility Criteria:
Inclusion Criteria:

1. The informed consent document and HIPAA privacy document must be read, signed and dated by the patient or legally authorized representative before conducting any procedures.
2. Patients (minimum age 18) with dry eye. Criteria for the diagnosis must include the following characteristics at Visit 1 (Screening): Patients' self-assessment of dry eye status (answer of at least Some of the time to the question, "How often have your eyes felt dry enough to want to use eye drops?");TFBUT \<5 seconds in at least one eye; \> Grade 1 for Meibomian Gland Expression in both eyes; Evidence of missing meibomian glands in both eyes.
3. Able and willing to follow study instructions.
4. Patients must have best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart at Visit 1.
5. Patients must not have used any topical ocular drops for approximately 24 hours prior to Visit 1.

Exclusion Criteria:

1. History or evidence of ocular or intraocular surgery in either eye within the past six months.
2. History or evidence of serious ocular trauma in either eye within the past six months.
3. Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
4. History of intolerance or hypersensitivity to any component of the study medications.
5. History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
6. Use of any concomitant topical ocular medications during the study period.
7. Patients using systemic medications that may contribute to dry eye (e.g. cold and allergy medications, tricyclic antidepressants, hormone replacement therapies) may not be enrolled in the study unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1. In addition, the dosing regimen must remain stable throughout the study.
8. Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude safe administration of the test article.
9. Individuals unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1.
10. Enrollment of investigator's office staff, relatives, or members of their respective households; or enrollment of more than one member of the same household.
11. Participation in an investigational drug or device study within 30 days of entering this study.
Fibromyalgia in Patient With Impaired Fasting Glucose

To assess the frequency of fibromyalgia among women with impaired fasting glucose.

Objective: To assess the frequency of fibromyalgia among women with impaired fasting glucose.

Materials and Methods: The sample was selected from the patients who applied to the Internal Medicine clinic and whose fasting blood glucose level were ≥100 and \<126 mg/dL in their routine examination \[Group1 \] and patients whose fasting blood glucose were less than 100 constituted the control group \[Group2 \]. Oral glucose tolerance test \[OGTT \] has been applied to patients with impaired fasting glucose and whose 2nd hour OGTT levels were under 140 has been included. Patients were evaluated in terms of fibromyalgia according to modified 2010 ACR Fibromiyalgia Criteria. Functional status was assessed by using the Fibromyalgia Impact Questionnaire \[FIQ \].

Eligibility Criteria:
Inclusion Criteria:

* the study group subjects: fasting blood glucose level was between 100 and 126 mg/dL;
* the control group subjects: fasting blood glucose level was \< 100 mg/dL.

Exclusion Criteria:

* Patients with a severe systemic disease (chronic kidney disease, liver disease etc. ),
* psychiatric disease,
* hypothyroidism or hyperthyroidism,
* any connective tissue disease
* patients who used medications that influenced the fibromyalgia symptoms, such as analgesics, antidepressants, and anticonvulsive medications
Validity of Lung Ultrasound in Diagnosis of Acute Respiratory Distress Syndrome

To evaluate the validity of lung ultrasound compared to CT chest and chest radiograph for diagnosis of ARDS and prediction of successful weaning from mechanical ventilation in those patients compared to traditional methods.

57 patients will be diagnosed as ARDS by CT chest and clinical criteria, then will be compared between the findings by lung ultrasound and chest radiograph to detect the sensitivity of both imaging to CT chest as gold standard in diagnosis of ARDS patients

Eligibility Criteria:
Inclusion Criteria:

Patients or legal guardian's consent .All patients with suspicious criteria of acute respiratory distress syndrome .Hemodynamically stable in the absence or minimal of vasopressors.

Exclusion Criteria:

Pregnant women. patients with traumatic lung injury or pneumothorax. surgical dressings over the right lower rib cage which would preclude ultrasound examination. presence of ascites. presence of lung collapse, fibrosis, or pleural effusion.

-presence of any mass or mechanical factor in the chest or the abdomen interfering with the diaphragmatic mobility.
Mifepristone at Same Time Multicenter Study

This is a multicenter, randomized study. 564 healthy women, age 18 years or older, with an intrauterine pregnancy, and requesting a medical abortion, will be recruited to participate in this prospective clinical trial. This study will provide an evaluation of oral mifepristone 200 mg and vaginal misoprostol 800 mcg administered simultaneously in women up to 63 days gestation. The aims of the study are to compare the complete abortion rates, at 7 and 14 days after misoprostol administration, when using mifepristone 200 mg orally and misoprostol 800 mcg vaginally are administered simultaneously and 24 hours apart in women up to 63 days gestation. Assessment of side effects (nausea, vomiting, pain) as well as acceptability will be done using pre and post-study questionnaires, and visual analogue scales. Complete abortion rate within 24 hours is expected to be 90%

This is a multicenter, randomized study. 564 healthy women, age 18 years or older, with an intrauterine pregnancy, and requesting a medical abortion, will be recruited to participate in this prospective clinical trial. This study will provide an evaluation of oral mifepristone 200 mg and vaginal misoprostol 800 mcg administered simultaneously in women up to 63 days gestation. The aims of the study are to compare the complete abortion rates, at 7 and 14 days after misoprostol administration, when using mifepristone 200 mg orally and misoprostol 800 mcg vaginally are administered simultaneously and 24 hours apart in women up to 63 days gestation. Assessment of side effects (nausea, vomiting, pain) as well as acceptability will be done using pre and post-study questionnaires, and visual analogue scales. Complete abortion rate within 24 hours is expected to be 90%.

Eligibility Criteria:
Inclusion Criteria:pregnancy equal to or less than 63 days at enrollment -

Exclusion Criteria:abnormal pregnancy diagnosed by ultrasound

-
Electro-Acupuncture Treatment in Patients With Osteoarthritis Of The Knee (EATOAK)

The purpose of this study is to assess the efficacy of electroacupuncture (EA) on pain control, perception of pain, plasma cortisol and beta-endorphins levels, patient-perceived quality of life and use of pain medications, in people with chronic knee pain.

Previous randomised trials and meta-analyses have shown certain efficacy of acupuncture in some chronic painful conditions, in spite of methodological weaknesses. The hypothalamic-pituitary-adrenal (HPA) axis and the endogenous opioid (EO) system are the mechanisms appear to explain how acupuncture works in part. These systems have been shown to be important mediators of stress, pain and other stimuli. The Osteoarthritis Research International suggest that osteoarthritis (OA) treatment should be multidisciplinary and recommended acupuncture as one of 12 possible non-pharmacological modalities for treating OA.

This study is a randomized, double-blind, placebo-controlled trial, parallel design. 128 out-patients over 50 years with OA of the knee will be recruited from Mallorca, Spain. Participants will be randomly allocated into two groups: placebo/sham acupuncture, non insertion technique, and EA. Acupuncture treatments will be used the Traditional Chinese Medicine (TCM) style. The patients will be evaluated after a period of one month (2 sessions weekly), three months (1session monthly), six months (1 session every 45 days) and again one year later (1 session every 2 months), at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex with primary osteoarthritis of one or both knees fulfilling diagnostic criteria for osteoarthritis knee laid down by American College of Rheumatology.
* Patients also had to have a Kellgren-Lawrence (radiologic criterion) score of at least 2 and chronic pain in the knee joint for more than 3 months.

Exclusion Criteria:

* The patients with secondary osteoarthritis of knees
* Associated systemic arthropathies, e.g. rheumatoid arthritis and gout
* Patients on steroids
* Disease modifying drugs, e.g. methotrexate and azathioprine
* Patients with recent trauma in the area of acupuncture
* History of intra articular injection of steroid within last two months
* Patients missing two or more sessions of electro-acupuncture consecutively were excluded from the study
Multicomponent Exercise in the Functionality of the Elderly in the Community

Evaluate the results of the implementation of a multicomponent exercise program (16 weeks) for elder community dwelling population on their functionality (via cognitive, balance and mobility status).

A quasi-experimental study, of the pre-test-post-test type, with a sample for convenience from in a cohort of elderly community dwelling people, carried out between 2009 and 2011. The general objective is to verify the impact of a physical exercise program organized in classes, under the supervision of physiotherapists.The specific objectives are to analyze the effect after 8 and 16 weeks, on the functionality of the elderly person, discriminating three conditions: cognitive state, balance and functional mobility.

Eligibility Criteria:
Inclusion Criteria:

* be supported by day centers or collective residences linked to the "Project + City",
* not having regular exercise habits,
* ability to walk (with or without assistance).

Exclusion Criteria:

* not being collaborative,
* missing the classes three times.
Femoral and Epidural Block After Total Knee Arthroplasty

Total knee prosthetic replacement causes severe postoperative pain. Various analgesic techniques have been used in pain control. Comparison of epidural and femoral nerve block is lacking, furthermore effect on chronic pain is unclear. The investigators aimed to compare the effects of epidural and femoral block on acute and chronic postoperative pain.

Background and aim Total knee prosthetic replacement causes severe postoperative pain. Various analgesic techniques have been used in pain control. Comparison of epidural and femoral nerve block is lacking, furthermore effect on chronic pain is unclear. The investigators aimed to compare the effects of epidural and femoral block on acute and chronic postoperative pain.

Methods The study was of randomized, prospective, and double-blind design and was conducted with 80 patients who had undergone total knee prosthetic replacement surgery with the insertion of a femoral nerve block or epidural block catheter to initiate postoperative analgesia. One-sided spinal anesthesia was performed in all the patients. Postoperative pain control was achieved with the administration via catheter using bupivacaine for patient-controlled analgesia. Acute postoperative pain was evaluated in the first 24 hours and chronic postoperative pain in the 1st and 3rd months following surgery. The anxiety/depression scale was used to assess anxiety and depression, the SF 12 test was used to evaluate quality of life, and the DN4 test was employed at patient visits at the 1st and 3rd months.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of total knee arthroplasty

Exclusion Criteria:

* Patients with pain syndromes
* Patients using routinely medications for pain