cyrilzakka/clinical-trials huggingface dataset:
Long-Term Follow-Up Study of Psoriasis Patients

The purpose of this study is to evaluate the long-term safety and profile of psoriasis patients who have completed participation in a previous study and who received treatment with MEDI-507.

This study will evaluate the long-term safety and lymphocyte repletion profile of psoriasis patients who have completed participation in a previous study and who received treatment with MEDI-507. Patients must have had an ALC \> 30% lower than baseline (defined as baseline prior to any MEDI-507 exposure); or an absolute CD4 count of \< 250 cells/uL. This study will also evaluate the development and durability of anti-MEDI-507 antibodies.

Eligibility Criteria:
Inclusion Criteria:

* The patient has previously completed participation (i.e., completed per protocol, including any long term follow-up; or discontinued from the study due to withdrawal of consent, loss to follow-up, or other reason) in a Medimmune, Inc. study of MEDI-507 in psoriasis in which they received MEDI-507 (or placebo for patients who participated in a blinded placebo-controlled study of MEDI-507, and for whom the treatment assignment in that study has not been unblinded at the time of entry into this study)
* The patient had an absolute lymphocyte count (ALC) \> 30% lower than baseline (defined as baseline prior to any MEDI-507 exposure; or, for patients whose treatment assignments have not been unblinded at the time of entry into this study, drug exposure) at his/her final visit (excluding any long-term follow-up visits) in the most recent Medimmune, Inc. study in which the patient participated; or the patient had an absolute CD4 count of \< 250 cells/uL at his/her final visit (including any protocol-specific long-term follow up) in the most recent Medimmune, Inc. study in which the patient participated.
* Written informed consent obtained from the patient

Exclusion Criteria:

* There are no exclusion criteria.
Evaluating Changes in Middle Ear Pressure Caused by CPAP

This study is an investigation into the effect that CPAP has on the pressure in the middle ear. It will evaluate the middle ear pressure and ear drum appearance at multiple levels of CPAP pressure delivered via a full face mask. These measurements will be used to determine optimal levels of CPAP to affect individual's middle ear pressure, particularly those with negative middle ear pressure due to Eustachian tube dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* No use of CPAP within past 30 days
* Individuals presenting to the UVA otolaryngology clinic who are otherwise healthy

Exclusion Criteria:

* Pre-existing cardiopulmonary disease that presents a risk with CPAP use
* Inability to tolerate CPAP
* Recent otologic surgery
Post-market Follow Up Study on Paragon CRT® 100 (Paflufocon D)

The main objective of this post market clinical study is to evaluate the effectiveness and safety of the Paragon CRT®100 Contact Lens.

This clinical study has two phases: prospective and retrospective.

Prospective Phase - evaluates the post-market long-term effectiveness and safety of the Paragon CRT® 100 Contact Lenses, for temporary myopic refractive power reduction with minimum 12-month period follow-up.

Retrospective phase - evaluates the post-market long-term safety of the Paragon CRT® 100 Contact Lenses, for temporary myopic refractive power reduction.

Eligibility Criteria:
Inclusion Criteria:

1. Patient contact lens refraction should fit within the available parameters of the study lenses (spherical power within -4.00D and the cylinder power within 1.50D).
2. Is willing to comply with the wear and visit schedule.
3. Is willing to participate and signed the informed consent form.

Exclusion Criteria:

1. Age under 8 years old
2. Any ocular abnormalities, undergone corneal surgery, or history of ocular trauma, active corneal infections (corneal inflammation), corneal curvature less than 40.00D or more than 46.00D
3. Best corrected visual acuity less than 1.0D
4. Pregnant, lactating or near-pregnancy
5. The eye has the following conditions:

   1. Acute and subacute inflammations or infection of the anterior segment of the eye
   2. Any eye disease, injury, or abnormality that affects the cornea, conjunctiva or eyelids, e.g. dacryocystitis, conjunctivitis, blepharitis and other inflammation, glaucoma, etc.
   3. Severe insufficiency of tears (TBUT≤5s).
   4. Allergy to any ingredient, such as mercury or thimerosal, in a solution which is to be used to care
   5. Any active corneal infection (bacterial, fungal or viral).
6. Manifested strabismus
7. Abnormal intra-ocular pressure
8. Suffering from systemic diseases, resulting in low immunity, or affecting corneal re-shaping (such as acute and chronic sinusitis, diabetes, Down syndrome, rheumatoid arthritis, mental patients, etc.)
9. Under medications or long-term medications that lead to dry eye with clinical signs or affects vision and corneal curvature.
10. Examination result indicate any contraindication or not suitable for OrthoK lens wear
11. Participated in pharmaceutical clinical study 3 months before the date of the screening or participated any other medical devices research study within 30 days of the screening
12. Only eye fulfills inclusion criteria
13. History of any ocular operations
14. Unable to follow investigator's instruction
15. Any other condition not suitable for the study per investigator's judgement
AcuSleep in Mild Traumatic Brain Injury (TBI)

Objective: To evaluate real acupuncture, as compare to sham acupuncture, in improving persistent sleep difficulties in veterans with mild traumatic brain injury (mTBI) Design: Randomized, blinded, sham-controlled clinical trial Setting: Outpatient clinic at a major VA medical center in Southeast USA Participants: Sixty veterans aged 24-55 (mean 40) with history of mTBI at least 3-month and beyond, suffering from sleep difficulties refractory to regular care and sleep education, as indicated by a global Pittsburgh Sleep Quality Index (PSQI) score of 14.25 + 3.23 pre-intervention (baseline). They were randomized into 2 groups, real acupuncture versus sham acupuncture, and stratified by Post-traumatic stress disorder (PTSD) diagnosed by PTSD CheckList - Military Version (PCL-M).

Intervention: Real or sham acupuncture with both standardized and individualized acupoints selection. All subjects were informed that the treatments, if effective, may improve symptoms such as pain, anxiety or depression other than sleep; real acupuncture may not be effective in some individuals, and sham acupuncture may as well be effective by mind-body interactions.

Outcome Measures: Primary outcome measure was global PSQI score change after intervention as compared to baseline. Secondary outcome measure was wrist-actigraphy sleep latency, sleep efficiency, wake after sleep onset (WASO), and sleep duration. PTSD was analyzed as a co-variant.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 55; and,
* Meeting the diagnosis criteria for mild traumatic brain injury as listed above at the time of injury; and,
* At or over 3 months post injury; and,
* With untreated sleep complaints (Pittsburgh Sleep Quality Index \[PSQI\] \> 8, sleep difficulties at least 4x per week in the past month, average sleep duration of 6 hours or less); and,
* Has the capacity to give informed consent.
* Agree to attend 13 clinic visits

Exclusion Criteria:

* Same sleep complaints present prior to traumatic brain injury; or,
* Diagnosis of obstructive sleep apnea (OSA) by prior sleep study; or,
* With a non-daytime work-schedule; or,
* With prior acupuncture experience for the treatment of sleep difficulties or with acupuncture treatment within 3 months; or,
* History of bleeding diathesis or currently on anticoagulation with international normalized ratio (INR) over 2.5; or,
* Severe depression with Beck Depression Score of 29 and above; or,
* Moderate and severe alcohol users.
* Does not have a permanent address
What Treatment for Patients With Phlebitis or Pulmonary Embolism ?

The objective of the "anticoagchoice" study is to analyze the preferences of people suffering from phlebitis, in terms of anticoagulant, to improve adherence to these treatments, to adapt the medical prescriptions.

Venous thromboembolism (VTE) is the third leading cause of cardiovascular death, with an increase in annual incidence with age. With the advent of direct oral anticoagulants, the management of deep vein thrombosis and pulmonary embolism has evolved in recent years and these treatments are widely prescribed. There are studies comparing the different anticoagulant treatments used in venous thrombosis, which show no inferiority of treatment (injectable or oral) compared to others. Drug delivery modalities have been shown to affect adherence, and thus treatment efficacy. It seems fundamental to focus on patients' drug preferences in VTE to ensure the best possible compliance. These preferences seem to depend on the personal history of each patient. In addition, no studies have been conducted on patient preferences for anticoagulant therapy for VTE: this is the goal of the "anticoagchoice" study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with deep vein thrombosis, superficial vein thrombosis, muscle vein thrombosis or pulmonary embolism, over 18 years of age.

No Exclusion Criteria
Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms

Assess the safety and performance of the Miami InnFocus Drainage Implant in patients suffering from glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg.

Unicentric, non-randomized, single arm safety and performance study which will be conducted in accordance with the applicable parts of CFR 21 and Standard EN-ISO 14155 I \& II: 2003 on clinical investigations with medical devices on human subjects and recommendations guiding physicians in biomedical research involving human subjects adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 and later revisions

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 to 85 years, inclusive
* Glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg.
* Patient must have signed informed consent form

Exclusion Criteria:

* Unwilling or unable to give informed consent or unable to return for scheduled protocol visits
* Pregnant or nursing women
* No light perception
* Active iris neovascularization or active proliferative retinopathy
* Iridocorneal endothelial syndrome
* Epithelial or fibrous downgrowth
* Aphakia (without pseudophakia)
* Vitreous in anterior chamber for which a vitrectomy is anticipated
* Chronic or recurrent uveitis
* Severe posterior blepharitis
* Unwilling to discontinue contact lens use after surgery
* Previous ophthalmic surgery, excluding uncomplicated phacoemulsification (cataract) surgery or corneal refractive surgery
* Need for glaucoma surgery combined with other ocular procedures other than cataract surgery (i.e., penetrating keratoplasty or retinal surgery) or anticipated need for additional ocular surgery
* Known allergy to Mitomycin C (MMC) drug.
Sacubitril/Valsartan in Left Ventricular Assist Device Recipients

The primary objective of this prospective randomised study is to assess the safety and tolerability of sacubitril/valsartan compared with standard of care used for treating BP in patients that have been implanted with the Heart Mate 3 LVAD (events of special interest - all cause death, right ventricular failure, bleeding events, deterioration in renal function, hyperkalemia, symptomatic hypotension).


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. ≥18 years of age, male or female
3. Recently implanted HeartMate 3 LVAD recipients, in stable condition and deemed ready for discharge or chronic, stable, ambulatory HeartMate 3 LVAD carriers implanted within 1 year prior to enrolment

1. Current acute decompensated HF (including right ventricular failure) requiring therapy with intravenous diuretics or vasodilators and/or inotropic drugs within the past 48 hours 2. History of hypersensitivity to sacubitril/valsartan or to drugs of similar chemical classes, patients with a known history of angioedema 3. Patients with mean blood pressure ≤75 mmHg (systolic blood pressure i.e. Doppler opening blood pressure ≤90 mmHg in those pulsatile and measured by Doppler method) or symptomatic hypotension 4. eGFR \< 30 mL/min/1.73m2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula at Visit 1 5. Patients with serum potassium \>5.4 mmol/L (mEq/L) at Visit 1 6. Hemodynamically unstable patients or those with ongoing MCS other than LVAD or those with planned biventricular support 7. Hemodynamically significant aortic insufficiency in the opinion of the investigator 8. Irreversible end-organ dysfunction 9. Previous sacubitril/valsartan use while on LVAD support 10. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within 30 days prior to enrolment 11. Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter with a resting ventricular rate \>110 bpm at enrolment 12. Any surgical or medical condition, which in the opinion of the Investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study 13. Active infection with hemodynamic compromise 14. hemoglobin (Hgb) \<8 g/dl 15. body mass index (BMI) \> 45 kg/m2 16. Congenital heart disease 17. Coronary or carotid artery disease or valvular heart disease likely to require surgical or percutaneous intervention within the 6 months after enrolment 18. Evidence of hepatic disease as determined by any one of the following: SGOT (AST) or SGPT (ALT) values exceeding 3x ULN, bilirubin \>1.5 mg/dl at Visit 1 19. Pregnant or nursing (lactating) women and women of child-bearing potential unless they are using highly effective methods of contraception
Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients

The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405FR01) to continue on the same treatment and to assess the long-term safety of EC-MPS


Eligibility Criteria:
Inclusion / Exclusion Criteria

- All patients who completed study CERL080A2405-FR01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

Other protocol-defined inclusion / exclusion criteria may apply
Covid-19 Effects on Arterial Stiffness and Vascular Aging (CARTESIAN)

The purpose of the study is to evaluate the presence of early vascular aging 6 months and 12 months after COVID-19 infection.

After being informed about the study and potential risks, all eligible patients giving written informed consent will undergo a comprehensive non-invasive assessment of vascular and cardiac function 6 months and 12 months after COVID-19 infection. Cardiovascular events and mortality will be collected 2, 5 and 10 years after inclusion

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years, both sexes;
* written informed consent;
* affiliation to a social security regime;
* a recent diagnosis of COVID19 (6±3 months) proven by PCR or serology (for group 1,2,3)
* hospitalization in intensive care unit for COVID19 (for group 1)
* hospitalization in a medicine unit for COVID19 (for group 2)
* no hospitalization for COVID19 or hospitalization less than 24h (for group 3)
* a negative test for SARS-nCOV2 infection (PCR or serology)(for group 4)

Exclusion Criteria:

* Age \<18 years
* Inability to express consent of the study
* Diseases carrying out a life -expectancy \<1 year according to clinical judgment
* Pregnancy and breastfeeding
* Foreseen inability to attend scheduled visits
The Intelligent Prevention And Control System And Strategy For The Whole Disease Cycle Of Diabetic Nephropathy

Diabetic nephropathy is one of the most severe microvascular complications of diabetes and a major cause of premature death and disability. It has become a leading cause of end-stage renal failure both in China and worldwide, consuming substantial medical resources. The establishment of a comprehensive regulatory system for the development and progression of diabetic nephropathy is a critical need for effective prevention and control. However, there is a lack of representative cohorts covering the entire disease cycle of diabetic nephropathy both domestically and internationally, creating technical bottlenecks in comprehensively describing its developmental patterns. This project aims to expand and integrate existing large-sample natural population cohorts and prospective follow-up cohorts covering the entire disease cycle of diabetes and diabetic nephropathy. It will construct a panoramic life database to identify risk factors, clinical phenotypes, and multimodal biomarkers at different disease stages. By integrating multi-organ interactions (e.g., kidney, eye), the project will establish novel imaging and functional assessment technologies for microvascular complications. Utilizing artificial intelligence to process multimodal medical data, it will build and validate risk prediction models and evaluation systems for the entire disease cycle of diabetic nephropathy. The project will develop effective intelligent prevention and treatment strategies for diabetic nephropathy, promote the adoption of new technologies, and establish a medical quality control system to provide services for medical institutions. Ultimately, it aims to improve and sustain medical quality, reducing the incidence of end-stage renal disease.


Eligibility Criteria:
T2DM

Inclusion Criteria:

* Age ≥18 years old, gender is not limited
* Diagnosed with type 2 diabetes
* A history of type 2 diabetes for more than 5 years
* Negative proteinuria
* Creatinine is normal
* Good compliance, voluntarily sign informed consent

Exclusion Criteria:

* Incomplete medical records
* Lack of fundus microvascular examination or new imaging technology examination results data
* Combined with autoimmune diseases and tumors

Type 2 diabetes patients undergoing renal biopsy

Inclusion Criteria:

* Age ≥18 years old, gender is not limited
* Diagnosed with type 2 diabetes
* Kidney damage (microalbuminuria or dominant albuminuria or renal insufficiency)
* Have undergone renal puncture biopsy and have complete renal pathological diagnosis data
* Sign informed consent voluntarily

Exclusion Criteria:

* Gestational diabetes mellitus, special type diabetes mellitus
* Patients with hereditary kidney disease
* Combined with autoimmune diseases
* Diabetic nephropathy The indicators in the comprehensive assessment model of the risk of renal progression could not be obtained
* There were pregnancy plans in the study period
High-activity Natural Killer Immunotherapy for Small Metastases of Pancreatic Cancer

The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of pancreatic cancer.

By enrolling patients with small metastases of pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Contribution Of Cognitivo-Behavorial Therapy In Shoulder Apprehension

Randomized controlled double-blind study aimed at studying the contribution of cognitive-behavioral therapy in the treatment of shoulder apprehension. Comparison of 2 physiotherapy techniques in the context of shoulder instability.

Control group: rehabilitation physiotherapy by physiotherapist using conventional technique alone.

Intervention group: rehabilitation physiotherapy by physiotherapist according to conventional technique, with the addition of techniques from cognitive-behavioral therapies.

Traumatic anterior instability of the shoulder is one of the most frequent lesions of the shoulder, the majority of cases of which occur in adolescents, with a risk of recurrence close to 90% if it occurs before the age of 20 years. It can be treated conservatively or surgically. Stabilizing surgery of the glenohumeral joint offers satisfactory results for people suffering from shoulder instability. Like subjects treated conservatively, patients undergoing stabilizing surgery remain apprehensive after the operation in 2 to 51% of cases. Currently, no rehabilitation program has demonstrated superior effectiveness, during instability treated conservatively or during postoperative rehabilitation. Recent studies have shown that cortical reorganization takes place, especially in areas of fear and anxiety. Faced with the need to develop physiotherapeutic management in post-traumatic unstable shoulder, this study aims to evaluate the contribution of cognitive-behavioral therapy, by including a neuropsychological axis in the rehabilitation of patients.

This study is randomized and controlled, multicenter, including 144 patients suffering from apprehension of the shoulder, divided into two treatment groups. Both groups will receive a conventional physiotherapy protocol including individual sessions and home exercises. The physiotherapists in the intervention group will also have received training in the use of techniques from Cognitive-Behavioral Therapies. Data will be collected before the introduction of physiotherapy, after 6, 12, 24 and 52 weeks of treatment. In the event of surgery, the data will also be collected preoperatively. The primary outcome is apprehension measured by the Rowe score. The secondary outcomes are apprehension measured by the apprehension and relocation tests, and the Tampa Scale for Kinesiophobia, as well as shoulder function, measured by the Simple Shoulder Test and the Subjective Shoulder Value.

Eligibility Criteria:
Inclusion Criteria:

* positive apprehension test;
* traumatic anterior dislocation of the glenohumeral joint requiring or not surgical stabilization according to Bankart or Latarjet;
* good oral and written comprehension of French;
* age between 15 and 45 years old.

Exclusion Criteria:

* associated tendon injury requiring surgical treatment;
* fracture other than Bankart fracture;
* multidirectional instability (MDI);
* peripheral neurological lesion in the upper limb;
* central neurological lesion;
* diagnosed psychosis, depression or epilepsy.