cyrilzakka/clinical-trials huggingface dataset:
Rapid Exchange Devices Observational Registry.

This registry is designed to assess the clinically relevant benefits of balloon angioplasty and stenting in superficial femoral and popliteal artery, using rapid exchange technology.

This registry is designed to assess the clinically relevant benefits of balloon angioplasty and stenting in superficial femoral and popliteal artery, using rapid exchange technology

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic one or two legs ischemia, requiring treatment of SFA or popliteal artery
* Rutherford classification 2-5
* Single lesion with recoiling/dissection/restenosis after balloon angioplasty or de novo lesions with stenosis or occlusion,
* Target vessel reference diameter ≥4mm and ≤7mm (by visual estimate)
* At least one patent (less than 50% stenosis) tibioperoneal run-off vessel confirmed by baseline angiography
* Patient is suitable candidate for femoral-popliteal artery bypass surgery

Exclusion Criteria:

* Female of child-bearing potential.
* Previous bypass surgery
* In stent restenosis as a target lesion
* Scheduled staged procedure of multiple lesions within the ipsilateral iliac or popliteal arteries within 30 days after index procedure.
* Co-existing aneurysmal disease of the abdominal aorta, iliac or popliteal arteries
* Acute thrombophlebitis or deep venous thrombosis
* Hemodynamic instability
* Untreated inflow disease of the ipsilateral pelvic arteries (more than 50 percent stenosis or occlusion),
* Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
* Known intolerance to study medications, contrast agents or nitinol.
Observational Study of Apremilast in Patients With Psoriasis in The Netherlands

This is a multicenter, prospective, non-interventional, observational single arm study.

Two-hundred patients will be recruited in the Netherlands over a one year period. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into this study. Treatment will be according to routine clinical practice and based on recommendations as per the SPC of apremilast (Otezla®). Recruitment will continue until 200 patients have entered the study. Each patient will be followed for 12 months.

Baseline Demographics, disease characteristics and medication history prior to start of treatment with apremilast will be collected. Patients will be asked to complete baseline DLQI, SF36, EQ5D, TSQM,WPAI and PBI questionnaires. Photographs of the finger nails will be taken.

Follow-up visits Follow-up assessments will take place at the regularly scheduled outpatient visits at 6 and 12 months (+/- 1 month) after initiation of apremilast.

* Skin-specific disease measures (Psoriasis Activity and Severity Index (PASI), (static) Physician Global Assessment (sPGA), Body Surface Area (BSA))
* Patients will be asked to complete the following questionnaires:
* DLQI
* TSQM
* EQ5D
* SF36- Itch Visual Analog Scale (VAS)
* WPAI Work Productivity and Activity Index
* Patient Benefit Index PBI

End of treatment Upon discontinuation of treatment with apremilast, the date, the dose and reason for discontinuation will be documented.

AE monitoring All patients will be monitored for adverse events throughout the study.

From the time of the patient signing informed consent until treatment with apremilast is permanently abrogated, all non-serious adverse events that are considered related to apremilast and all Serious Adverse Events (SAEs) regardless of causality will be reported.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age who understand and voluntarily sign an informed consent form.
* Patients starting treatment for psoriasis with apremilast in clinical practice.

Exclusion Criteria:

* Refusal to participate in the study.
* Women who are pregnant or breast-feeding.
* Hypersensitivity to the active substance or to any of the excipients.
* Prior exposure to apremilast
* Psoriatic arthritis treated by a rheumatologist in the previous year
A Study of Octave System for Improving Lines and Wrinkles of the Décolleté

To demonstrate the safety and effectiveness of the Octave System for improving lines and wrinkles of the décolleté.


Eligibility Criteria:
Inclusion Criteria:

- Moderate to severe fine lines, wrinkles, laxity, and crepiness of the décolleté that is amenable to improvement with non-invasive intervention and is not severe enough for surgical intervention.

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Scarring in area(s) to be treated.
* Active implants (e.g., pacemakers or defibrillators), ports, or metallic implants in area(s) to be treated.
* Breast implants or is planning to receive breast implants during the study.
* Inability to take pre-treatment medications due to a pre-existing condition, medication allergy, or medical issue that, at the discretion of the treating investigator, is contraindicated.
COGnitive Outcomes and WELLness in Survivors of Critical Illness

As survival rates from critical illness improve, strategies to return patients to their baseline cognitive and functional status are important research priorities. Up to 100% of ICU survivors will suffer some degree of cognitive impairment at hospital discharge and approximately 50% will have decrements that persist for years. While the mechanisms for this newly acquired brain injury are poorly understood, several risk factors have been identified. Unfortunately, it is unclear how to accurately predict long-term cognitive impairment.

Immediate opportunities to improve cognitive outcomes through risk reduction exist. The investigators propose to comprehensively study the prevalence of sleep abnormalities and their association with cognitive impairment, as it may yield potential targets for effective therapy. Moreover, the investigators will examine for gene x environment associations \[APOE ε4\] that may allow for genetic risk stratification of individuals at greatest risk of cognitive impairment. The investigators hypothesize that EEG \[a sensitive longitudinal marker of brain dysfunction\] is a novel and independent predictor of long-term cognitive impairment, and possibly a candidate intermediate end point for future clinical trials.

This study has the potential to identify novel biomarkers and risk factors for post-critical illness cognitive impairment, and may lay the foundation for rational interventions to mitigate risk in high-risk individuals.


Eligibility Criteria:
Inclusion Criteria:

* ≥16 years of age
* Admission to study ICU for invasive mechanical ventilation \[minimum of 72 hours\]

Exclusion Criteria:

* Advanced cognitive impairment or unable to follow simple commands before their acute illness \[e.g. end-stage Alzheimer's disease\]
* Primary neurological injury \[e.g. anoxic brain injury, stroke or traumatic brain injury\]
* Anticipated death within 3 months of discharge \[e.g. palliative\]
* Uncontrolled psychiatric illness at hospital admission
* Not fluent in English
* Unlikely to adhere with follow-up \[e.g. no fixed address\]
* Residence greater than 300 kms from referral centre
AI-based Frailty Assessment Tool for Patients Undergoing Cardiac Surgery

The main purpose of this study is to establish a frailty automatic evaluation index "AI frailty index" based on artificial intelligence multi-modal non-contact monitoring information analysis. At the same time, the study will explore the correlation between ' AI weakness index ' and perioperative and long-term prognosis and quality of life.

This is a prospective cohort study. Patients who undergoes elective cardiac surgery will be enrolled. We collect frailty scales, clinical information and multi-modal, non-contact monitoring information during hospitalization. One-year follow-up will be done. The non-contact monitoring information are used to predict the frailty scales to establish and validate an AI-based frailty assessment model "AI frailty index". The AI frailty index will be further used to predict perioperative and long-term outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Elective cardiac surgery

Exclusion Criteria:

* Emergency surgery
* Age ≤ 18 years
* The clinical situation is unstable, such as frequent occurrence of coronary ischemia events, unstable heart failure, or acute events leading to severe discomfort symptoms or changes in vital signs
* Unable to cooperate in completing research data collection due to severe neurological and psychiatric abnormalities or other reasons
* Duration of postoperative ventilation \> 48 hours or inability to obtain scale data on the first day after surgery
Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA)

Describe the proportion of patients who underwent cardiac surgery in France and benefiting from a monitoring cardiac output, describe the use of positive inotropic and vasoactive agents for cardiac surgery patients operated (type of catecholamines, their duration), describe the fluid replacement and transfusions of first 24 hours, describe the incidence of postoperative complications in patients undergoing cardiac surgery.

The perioperative management in cardiac surgery patients has changed dramatically in the last fifteen years with the development of new cardiac output monitoring devices, the availability of new inotropic molecules, and a modern treatment for cardio-circulatory failure.

However, few studies report the possible changes in practice. The last French national survey was conducted in 2001. Since then, the literature is poor on the subject, and the impact of new approaches has been only marginally addressed. Recently, a German postal survey was conducted among cardiac surgery anesthesiologists, but on purely declarative elements and without patient data.

The investigators offer a type of national prospective observational study to evaluate professional practices, morbidity and mortality in cardiac surgical patients. This study must include all patients undergoing cardiac surgery at the participating centers during 7 weeks.

The main objective of this work is to assess the proportion of patients undergoing cardiac surgery receiving a cardiac output monitoring.

Secondary objectives are to describe the relationship between the use of cardiac output monitoring and the use of positive inotropic agents and vasoactive (type molecules, duration), volume expansion and transfusions the first 24 hours, and the incidence postoperative complications for patients undergoing cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old undergoing cardiac surgery during the study period

Non-inclusion Criteria:

* age under 18 years old
* Extracorporeal life support and others cardiac assistance
* congenital cardiac surgery
* TAVI procedures
* Pericardium surgical drainages
* Sternal sepsis surgery
Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children

The investigators aim to address the following specific aims:

* Determine the efficacy of Prog in preventing postpartum smoking relapse and reducing smoking relapse risk factors.
* Examine the effects of this maternal smoking intervention on infant health.
* Examine racial and ethnic differences in intervention outcomes.

This Good Clinical Practice clinical trial will be implemented by an experienced, transdisciplinary, and productive team of investigators to enhance the diversity of the study sample and generalizability of results. We will enroll healthy pregnant women (following enrollment, all subsequent study procedures will be completed postpartum) or postpartum women on hormonal birth control or no hormonal birth control with either a recent history of smoking and a desire to remain abstinent after childbirth, or who are currently smoking and motivated to quit smoking. Participants will be recruited throughout the continental United States (US) and will participant in an observational arm of the study. Participants living in Minnesota (our clinical site) will receive a 12-week course of exogenous progesterone. All participants will be followed for six months with remote visits, self-administered surveys, and self-collection of dried blood spots to measure hormones and smoking-related biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent,
* Aged 18 to 45 years old
* Self-reported stable physical and mental health

  1. self-report uncomplicated pregnancy at gestational week 30 or beyond, or
  2. self-report the birth of a child within the past 6 months
* History of ≥ 4 cigarettes per month during the six months prior to pregnancy
* At enrollment, self-report of motivation to become and/or remain abstinent after delivery ≥ 6 on a 10 point Likert-type scale
* Willingness to protect against pregnancy following day 0 to week 12 of the study
* Participants must live in the continental US and have a device to fully participate in the protocol

Exclusion Criteria:

* Current daily use of nicotine replacement therapy or smoking cessation medications, with the exception of e-cigarettes
* Current major depressive disorder based on the Patient Health Questionnaire-9 (PHQ-9) and the Beck Depression Inventory
* Contraindication to progesterone treatment (e.g., current use of drugs that may inhibit CYP3A4; current or history of deep vein thrombosis, pulmonary embolus, clotting or bleeding disorder, hypertension, stroke, heart disease, or liver dysfunction or disease; or peanut allergy),
* Current or within the past 3 months treatment for illicit drug use or alcohol use
* Any condition or issue that, in the opinion of the clinical team, precludes participation in the trial.
Study of Platelet-rich Plasma in Treating Patients With Tibiofemoral Cartilage Degeneration

Recently an articular cartilage repair has been given much attention in the orthopaedic field. Cartilage regeneration capacity is very limited. Optimal approach seems to be a delivery of natural growth factors. Autologous platelet-rich plasma (PRP) contains proliferative and chemoattractant growth factors. The objective of the present study was to determine if PRP can increase tibiofemoral cartilage regeneration and improve knee function.

Fifty consecutive and strictly selected patients, affected by Grade II or III chondromalacia, underwent one year treatment (9 injections) with autologous PRP in a liquid form with 2,0 to 2,5-fold platelets concentration. Outcome measures included hte Lysholm, Tegner, IKDC, and Cincinnati scores. Magnetic resonance imaging was used to evaluate cartilage thickness and degree of degeneration.

Eligibility Criteria:
Inclusion Criteria:

* isolated Grade II or Grade III nontraumatic chondromalacia according to Outerbridge grading scale

Exclusion Criteria:

* Grade I (only softening) or Grade IV (exposed subchondral bone) tibiofemoral chondromalacia;
* patellofemoral chondral damage;
* associated intraarticular lesions confirmed during arthroscopy (menisci, ligaments, osteochondral defects);
* associated extraarticular lesions confirmed by magnetic resonance imaging (ligaments, tendons, bursae);
* lower limb axial deviation confirmed by whole leg weight-bearing radiograph; knee trauma in patients history;
* body mass index (BMI) higher than 35;
* hyaluronic acid intraarticular injection 6 months prior the arthroscopy and up to last follow-up control;
* steroids intraarticular injection 3 months prior the arthroscopy and up to last follow-up control;
* symptomatic slow acting drugs for osteoarthritis (SYSADOA) and/or non-steroidal anti-inflammatory drugs (NSAID) administration during the PRP treatment;
* systemic autoimmune rheumatic and/or polyarticular disease; gout, pseudogout and hyperuricaemia.
* Other exclusion criteria included: non-informed consent; treated knee injury during the PRP therapy; PRP injection cycle not completed; impediments to fill out the questionnaires; blood disease and/or immunosuppressant treatment and/or dicoumarol therapy; immunosuppressant and/or neoplastic and/or infectious diseases.
Popliteal Sciatic Nerve Block: Intraneural or Extraneural?

Aim of this study is to demonstrate the advantages of intraneural injection over extraneural injection in terms of onset and duration on peripheral block. In addition we will evaluate the frequency of possible adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II

Exclusion Criteria:

* Neurological diseases
* Diabetes
* Allergies to used drugs
* Chronic pain in treatment
* Electrophysiological alterations at time zero analysis
Clinical Study of the Presence of Trichomonas Tenax and Entamoeba Gingivalis in Patients With Periodontitis

The buccal cavity presents microorganismes whose the number and composition vary with oral hygiene and medical context (pathologies and associated drug therapies) of the patient. More than 1200 bacterial species have been identified, and among them, 400 are inhabitants of the sub-gingival biofilm. Among all these microorganismes, only 20 species participate to the etiopathogenesis of periodontal diseases.Some are recognised as major periodontopathogens other play unclear role in this pathology. They belong respectively to the red and orange complex of Socransky et al. (1998).

Other microorganismes such as virures, yeasts and protozoans could potentially impact the emergence and development of periodontal diseases. The presence of protozoans in periodontitis have been investigated in this study.


Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years-old
* Consulting in periodontal department of CHU, Nancy
* Patient with moderate to severe periodontitis
* At least 2 periodontal sites with PPD≥ 4mm and One healthy site
* No scaling root planning in the last 6 months
* Patients insured under the French social security system

Exclusion Criteria:

* Pregnant patients
* Patients with antibiotic therapy, and/or all medecines which could modify the buccal microbiota in the last 6 months
* Tooth with endodontic periapical lesion
* Patients having a scaling root planning in the last 6 months
* Patient with guardianship
Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fed Conditions

The purpose of this study is to determine the pharmacokinetics and bioequivalence of amlodipine besylate formulations under fed conditions.

This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Tablets 10 mg of Dr. Reddy's versus Norvasc 10 mg tablets administered as 1 x 10 mg tablet in healthy volunteers with a washout period of 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects between 18 and 45 years of age inclusive.
* Informed of the nature of the study and given written informed consent.
* Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weigh at least 115 (Appendix I and Appendix II).

Exclusion Criteria:

* If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the three treatment periods. Females must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of themselves or their partners or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
* Hypersensitivity to amlodipine besylate (Norvasc®)or related calcium channel blockers).
* Any history of a clinical condition that might affect drug absorption, metabolism or excretion.
* Recent history of mental illness, drug addiction, drug abuse or alcoholism.
* Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
* Received an investigational drug within the 4 weeks prior to study dosing.
* Currently taking any prescription medication, except for oral contraceptives, within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or -herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
* Regular tobacco use in the 6 months prior to study dosing.
BMP-2 and ALP Levels Following Laser Therapy With Scaling and Root Planing in Periodontitis- RCT.

Patients with periodontitis will be treated by either SRP only or SRP in combination with laser.

Samples from GCF will be collected immediately after treatment and at 3 months follow-up time. Levels of BMP-2 and ALP will be assessed at these time points.

Statistical analysis to compare the results will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Periodontitis

Exclusion Criteria:

* Uncontrolled medical condition
Observational Study of Allergic Rhinitis in Children

Observational, cross-sectional, prospective, multicentric study in France with private paediatricians to describe the management of allergic rhinitis in children.

Data collected about diagnostic, comorbidities, clinical history, management of allergic rhinitis using a patient paper case report form. There is only one visit per patient and investigators can include up to 10 patients.

Eligibility Criteria:
Inclusion Criteria:

* Under 18 years of age
* With allergic rhinitis
* Who's representative of the parental authority did not object to his child's participation after oral and written information and who agrees to participate

Exclusion Criteria:

* Child or adolescent opposed to participate or collect his personal data
Effects of Fatigue and Foot Orthoses on Lower Extremity EMG and Biomechanics for Individuals With Flat Foot

Determine the effects of non-custom made foot orthoses on the kinematics, muscle activity and joint contact force after fatigue and compare the rate of fatigue in flexible flat foot with and without foot orthoses


Eligibility Criteria:
Inclusion Criteria:

* Bilateral flexible flatfoot( navicular bone drop greater than 10 mm)

Exclusion Criteria:

* History of foot and ankle surgery, inflammatory joint disease
* History of lower extremity injury in six months
* Known pathological or neurological disorders that could affect gait pattern