cyrilzakka/clinical-trials huggingface dataset:
Opioid Reduced Anesthesia With Parasternal CATheters on Postoperative Delirium After Cardiac Surgery

PostOperative Delirium (POD) is the most common neuropsychiatric complication following cardiac surgery and may be related to morphine consumption. PostOperative Delirium (POD) prolongs hospital and intensive care unit (ICU) length of stay (LOS) and increases morbidity and mortality. No study has been conducted to demonstrate the effect of regional anesthesia using catheters inserted before sternotomy.

This study investigate the effect of an enhanced recovery protocol using regional anesthesia on PostOperative Delirium (POD) onset.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Admitte for scheduled cardiac surgery with sternotomy under cardiopulmonary bypass (CPB) for coronary artery bypass grafting (CABG), surgical correction of valve disease (aortic, mitral or tricuspid) or combined surgery (coronary artery bypass grafting (CABG) and valve replacement).

Exclusion Criteria:

* Age over 85,
* emergency surgery or heart transplant,
* body mass index (BMI) more than 40 kg.m-2
* reoperation
* Renal insufficiency with glomerular filtration rate (GFR) less than 30 mL.min-1
* left ventricular ejection fraction less than 30%
* respiratory insufficiency with arterial pressure of oxygen less than 60 mmHg
* hepatic insufficiency with prothrombin rate less than 30% or cirrhosis
* chronic hyperglycemia not controlled
* pregnancy
* cognitive impairment chronic use of opioids or drug addiction
* epilepsy
* guardianship
* allergy to locals anesthesics or any drugs
Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity

Patients with spondyloarthritis, already treated by TNF blocker (adalimumab, etanercept or infliximab), and in stable low disease activity for at least 6 months, will be randomized into 2 groups: either keeping on their usual treatment with stable doses or progressive spacing of injections of their treatment. Follow-up will be done every 3 months during 12 months, with regular monitoring of disease activity and, in patients from the group "spacing", modification of the rhythm of injections according to health state and predefined protocol.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with spondyloarthritis according to ASAS criteria
* Stable low disease activity for at least 6 months
* Already treated by TNF blocking drug (adalimumab, etanercept or infliximab)

Exclusion Criteria:

* Raised acute phase reactants
* participation in another clinical trial
* Structural progression of peripheral joint damage
* Scheduled surgery within 12 months
* pregnancy
Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and epirubicin in treating patients who have malignant mesothelioma.

OBJECTIVES:

* Determine the antitumor activity of gemcitabine and epirubicin in patients with malignant pleural mesothelioma.
* Determine the toxicity of this regimen in this patient population.
* Determine the time to progression and overall survival of patients treated with this regimen.
* Assess quality of life in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and epirubicin IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond CR.

Quality of life is assessed at baseline, prior to course 3, at 3 months, and then at 1 year.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed malignant pleural mesothelioma
* At least 1 measurable lesion that can be accurately measured in at least one dimension

  * At least 20 mm (2 cm) in diameter

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* At least 12 weeks

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST no greater than 3 times ULN

Renal:

* Creatinine no greater than 1.5 times ULN

Cardiovascular:

* LVEF at least 50%
* No history of congestive heart failure
* No New York Heart Association class III or IV heart disease

Other:

* No uncontrolled infection
* No other severe underlying disease that would preclude study participation
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, noninvasive carcinomas, or localized prostate cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study participation

PRIOR CONCURRENT THERAPY:

Chemotherapy:

* No more than 1 prior chemotherapy regimen for malignant pleural mesothelioma
* No prior gemcitabine or anthracyclines

Other:

* No concurrent cimetidine
The Adverse Drug Reaction (ADRe) Profile for Polypharmacy

Polypharmacy, the use of multiple or inappropriate medications, has the potential to harm older adults by causing cognitive impairment, falls, and hospitalisations. The nurse-led intervention (The ADRe Profile) to review mental health medicines has demonstrated improved care quality by: identifying serious adverse drug reactions (ADRs); reducing prescription of mental health medicines; reducing the prevalence of pain and nausea; and, increasing non-urgent national health service (NHS) contacts. The investigators will develop ADRe to encompass medicines commonly prescribed in primary care and evaluate intervention implementation in care homes in Aneurin Bevan University Health Board.

The investigators will introduce medicines' monitoring using the PADRe Profile into up to 7 care homes, each with up to 26 residents prescribed \>4 medicines (estimated \~90% residents).

Each home will identify a nurse lead and a deputy. Nurses will be asked to administer the PADRe Profile with all patients prescribed \>4 medicines.

Barriers, facilitators, and feasibility of the Profile will be explored. This will identify how, in which contexts medicines' monitoring can be integrated into routine care, relate the Profile to improved processes and outcomes of care, and inform implementation strategies (see logic model in cited papers).

Data collection:

* Record review before and after each of 3 administrations of the intervention to identify clinical and prescription changes. Narrative accounts of problems causing moderate or severe harm will be prepared.
* Serial interviews and debriefs with nurses: three per nurse.
* Stakeholder interviews with patients, participating pharmacists and prescribers for an overview of implementation.

Eligibility Criteria:
Inclusion Criteria:

* • Resident at the care home and expected to continue to live there for 1 year

  * Currently taking \>3 prescribed medicines daily
  * Willing and able to give informed, signed consent themselves, or where capacity is lacking, a consultee is willing to give advice and assent to the resident participating.

Exclusion Criteria:

* age \<18

  * Prescribed \<4 medicines daily;
  * Receiving active palliative care
  * Not well enough to participate, as screened by their nurses
Perfusion Computer Tomography: Imaging and Clinical Validation Following Reperfusion Therapy in Acute Ischaemic Stroke

CT perfusion (CTP) of the brain is an innovative technique to identify rapidly regions which are only partially or insufficiently perfused during an acute ischemic event. The differentiation between the core infarct and the still viable penumbra is its major clinical application. CTP helps directly in the decision-making process in the event of acute ischemic stroke by increasing the potential of success in patient who can benefit from thrombolytic/endovascular treatment.

The use of CTP in patient selection for thrombolytic/endovascular treatment was never evaluated in a prospective randomized study. Yet, clinical experience well demonstrated a good correlation between the size of the penumbra and the clinical outcome when done in early as well as late stages of the event.

The importance of identifying the penumbra in the acute phase of the ischemic stroke is widely accepted. But crucial evidence to support the predictive value of CTP to predict the clinical and anatomical/structural outcomes in the late phases (90 days after) is lacking.

Currently, the use of CTP is based on theoretical assumptions and expert opinions but a randomized prospective study to validate its use is lacking.

The current guidelines restrict the use of CTP trials and to patients that can't performed MRI scan.


Eligibility Criteria:
Inclusion Criteria:

* NIHSS\>=8
* up to 6 hours from event onset

Exclusion Criteria:

* mRS\>= 3 before the start of the event
* life expectency \<1 year because other disability disease
An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

To determine the safety profile of Androxal in men with secondary hypogonadism.

This study is an open-label, multi-center Phase 3 extension study to evaluate the safety on continued treatment with Androxal in subjects who completed either ZA-301 or ZA-302. The study requires 6 study visits (1 for an eye exam) and is approximately 7 months in duration. Subjects will be treated for 26 weeks, starting at a daily dose of 12.5 mg. At Visit 2 (Week 6) subjects who do not achieve morning T values ≥450 ng/dL will be up-titrated to 25 mg. Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy, refraction eye exams, clinical laboratory tests and adverse event reporting.

Eligibility Criteria:
Inclusion Criteria:

• Successful completion of either ZA-301 or ZA-302

Exclusion Criteria:

• Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study
Soft Mist Spray Device for Airway Anaesthesia During Awake Videolaryngoscopy

Rationale:

Effective and fast topical anaesthesia of the upper airway is of paramount importance in awake (conscious) videolaryngoscopy of the airway in order to avoid patient discomfort. Different methods of anesthetizing the airway have been described. Conventional topical airway anaesthesia is not always effective due to non-optimal flow patterns and generation of ineffective local anaesthetic aerosols. Other methods of anaesthetizing the airway are more invasive. In order to optimize topical anaesthesia of the airway a soft mist spray device (Trachospray) for topical anaesthesia of the airway has been developed, in which optimal airflow patterns are obtained and local anaesthetic aerosols are generated which will reach the target zone for anesthetizing the airway.

Objective: In this study, the Trachospray will be used for awake videolaryngoscopy, to evaluate its use, effectiveness and comfort level for patients and anaesthesiologist.

Study design: Interventional study.

Study population: 20 healthy human volunteers, ASA 1, 18-60 years old.

Intervention: Subjects will be asked to inhale 4 ml lidocaine 4% via the Trachospray device

Main study parameters/endpoints:

Anaesthesia of the airway as evaluated with successful awake videolaryngoscopy with minimal discomfort for the subject.

Nature and extent of the burden and risks associated with participation:

Risk management on the Trachospray device shows that all user risks are mitigated and no residual risks remain for the use of the device. Testing of the device and the application of the device in daily practice has no additional risks than the present technique of performing anaesthesia of the airways.There may be some discomfort during the procedure, mainly airway irritation which may cause coughing or gag reflex.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-60 years
* Lean body weight \>= 50 kg
* ASA physical status 1

Exclusion Criteria:

* Inability to cooperate with adequate airway assessment,
* History of hepatic, renal and coagulation diseases,
* Respiratory tract pathology
* Pregnancy
* Risk of regurgitation or aspiration
* Allergy to amide type of local anaesthetics
* No written informed consent by subject
Stroke and Rehabilitation in North of Norway and Central Denmark

Post-stroke prospective multicenter cohort study. The objectives of the study was to compare functioning and health related quality of life in the two study regions, in relation to known predictors and to differences in organization of treatment- and rehabilitation. The inclusion was of consecutive acute stroke patients with ICD10 diagnosis I.63 and I.61 from a regional part of Northern Norway and Jylland Denmark. All were referred to stroke units. At baseline national stroke registry data were collected in each country. A questionnaire package was mailed to the participants 3- and 12-months post stroke. Telephone interviews at 3 months post stroke added information on functioning and rehabilitation.

Post-stroke prospective multicenter cohort study. The objectives of the study was to compare functioning and health related quality of life in the two study regions, in relation to known predictors and to differences in organization of treatment- and rehabilitation. The inclusion was of consecutive acute stroke patients with ICD10 diagnosis I.63 and I.61 from a regional part of Northern Norway and Jylland Denmark. All were referred to stroke units. At baseline national stroke registry data were collected in each country. Telephone interviews at 3 months post stroke added information on functioning and rehabilitation. A questionnaire package was mailed to the participants 3- and 12-months post stroke. These included validated Questionnaires like QOLIBRI-OS, HADS, SS-QOL and EQ5D.

Validity studies on QOLIBRI-OS and SS-QOL has been published, along with several other papers. Synne Garder Pedersen and Guri Heiberg have finished their PhDs.

Eligibility Criteria:
* Clinical diagnosis acute ischemic or hemmorhagic stroke
* Inclusion period Mars 2014 to January 2016
* Hospitalised in Stroke Units
* Living in a defined geographic area in North of Norway or in Central Denmark
DePuy Attune Total Knee Arthroplasty RSA Study

The DePuy Attune knee system incorporates several key features aimed at improving kinematics of the knee joint, range of motion, and smoothness of use compared to existing total knee replacement technologies. As this is a newly approved medical device, clinical testing in patients using high precision diagnostics is important to evaluate the stability of implant fixation and in vivo function. We propose a multi-centre consecutive series study examining the stability of the Attune posterior-stabilized knee design in 30 patients undergoing total knee arthroplasty for a follow-up period of 2 years. Radiostereometric analysis (RSA) will be utilized to identify the micromotion of the tibial tray with respect to the surrounding bone. Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at follow-up intervals.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
* Between the ages of 21 and 80 inclusive
* Patients willing and able to comply with follow-up requirements and self-evaluations
* Ability to give informed consent

Exclusion Criteria:

* Active or prior infection
* Medical condition precluding major surgery
Randomized Study of Sequential Orbital Radiotherapy for Graves' Ophthalmopathy

OBJECTIVES: I. Evaluate the effects of 20 Gy of external-beam radiotherapy to 1 orbit vs. the untreated orbit at 3 and 6 months after therapy in patients with Graves' ophthalmopathy.

II. Evaluate whether 20 Gy of external-beam radiotherapy delivered to the second orbit 6 months later in the course of the disease produces effects of equal magnitude to those observed when the first orbit was treated.

III. Relate the magnitude of treatment effects to the time since onset of eye symptoms.

IV. Evaluate whether characteristics of radiation retinopathy are present 3 years after orbital radiotherapy.

PROTOCOL OUTLINE: The posterior region of 1 orbit is irradiated over 2 weeks with supervoltage equipment. The other orbit is treated 6 months later. The sequence of therapy is randomly assigned.

The untreated eye receives a simultaneous sham treatment during each radiotherapy session.

Patients are followed at 3, 6, 9, 12, and 36 months.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Firm diagnosis of Graves' disease with normal thyroid function, i.e.: Thyroid-stimulating immunoglobulin positive Thyroxine 5-12.5 micrograms/dL Tri-iodothyronine 80-180 nanograms/dL Thyroid-stimulating hormone 0.2-8 milli-International unit (mIU/L) Euthyroid due to therapy acceptable Ophthalmopathy meeting at least 3 of the following criteria: Chemosis or lid edema Lid lag, lid retraction, or restrictive lagophthalmos Proptosis at least 20 mm by Krahn exophthalmometry in at least 1 eye Less than 4 mm discrepancy between eyes Patient perception of "stare" or "bulge" Extraocular muscle motion restriction in 1 or both eyes on clinical exam or by patient report of diplopia at extremes of gaze Extraocular muscle enlargement on computerized tomography (previous study results acceptable) Mild to moderate ophthalmopathy, i.e.: Orbital pain Lacrimation Photophobia Visual blurring or diplopia No optic neuropathy, i.e.: Afferent pupillary defect Impaired color vision on D-15 testing (unless congenital color perception deficiency) Visual field defect Impaired visual acuity No corneal ulcers --Prior/Concurrent Therapy-- No prior external-beam radiotherapy to the head and neck At least 2 weeks since corticosteroids --Patient Characteristics-- No prior head and neck tumors No diabetes No pregnant women
Durability of Combination of Insulin and GLP-1 Receptor Agonist or SGLT-2 Inhibitors Versus Basal Bolus Insulin Regimen in Type 2 Diabetes (BEYOND)

BEYOND represents an open-label, parallel, three-arm randomized controlled trial, aimed at evaluating the effects of combination therapy of fixed ratio basal insulin/GLP-1 receptor agonist (GLP-1RA) or basal insulin/SGLT-2 inhibitors (SGLT-2i) on the durability of the glycemic control, as compared with the basal bolus insulin regimen, in people with type 2 diabetes failing to achieve glycemic targets with injective therapy. The potential benefits for participants in the study include the possibility of improving the glyco-metabolic control with drugs that have been evaluated as safe and protective for the heart and the kidneys. The primary outcome of the study is the mean HbA1c change between groups at six months. Participants in the study will be followed for subsequent 18 months in order to evaluate the durability of glycemic control and the chenge of other secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Poor glycemic control (HbA1c ≥7.5%)
* Stable basal bolus insulin regimen for almost a year, eventually associated with metformin.

Exclusion Criteria:

* Type 1 diabetes or secondary diabetes;
* Previous treatment for the last three months with GLP-1RA or DPP-4 inhibitors;
* Hypersensitivity towards active substances or other ingredients of the drugs used in the study
* Participation in other trial with experimental drugs within 30 days
* Diseases that represent contraindication to GLP-1RA use (pancreatitis, gallstones)
* Pregnancy or planned pregnancy within the time of the study
* Serum creatinine \> 1,3 mg/dL in women and \>1,4 mg/dL in men
* eGFR \< 30 mL/min
* Previous cancer or antineoplastic therapy for five years before randomization
* Current therapy with glucocorticoid (oral, topic or sistemic administration) or with antypsichotic drugs
* Previous ketoacidosis
* Any clinical, psychologic or psychiatric condition that is incompatible with the study according to the investigator
Metacognitive Therapy for Obsessive-Compulsive Disorder

The goal of this clinical trial is to learn if metacognitive therapy can be effective in a Chinese sample of obsessive compulsive disorder (OCD) . The main questions it aims to answer are:

Can metacognitive therapy significantly reduce participants' levels of obsessive-compulsive symptoms? Can metacognitive therapy significantly improve participants' metacognitive adaptations?

The researchers will compare metacognitive therapy to a control condition without psychotherapy to see if metacognitive therapy is effective in treating OCD.

Participants will:

Receive the metacognitive therapy intervention or under control conditions for 8 to 15 weeks.

Be assessed for symptoms and metacognitive beliefs at pre-intervention, post-intervention and 12 weeks post-intervention

This study will be a randomised controlled clinical trial. Participants who meet the enrolment criteria will be randomised into an experimental group and a control group. Participants in the experimental group will receive 8-15 weeks of metacognitive therapy, while participants in the control group will receive the same amount of time of regular treatment without psychotherapy components.

The researchers will assess participants' obsessive-compulsive symptoms and metacognitive levels before, after, and 12 weeks after the intervention. Assessment measures will be the Yale Brown Obsessive-Compulsive Scale (Y-BOCS) and the Metacognition Questionnaire (MCQ-30).

By comparing the assessment results of the two groups of participants, conclusions will be drawn as to whether metacognitive therapy can have a positive effect on a Chinese OCD sample.

Eligibility Criteria:
Inclusion Criteria:

* two psychiatrists with the title of Deputy Chief Physician or above jointly determine that the above diagnostic criteria were met
* education level of junior high school or above, without mental retardation or audio-visual disorders
* participation in the study is voluntary, and the informed consent is signed by the patient or his/her guardian

Exclusion Criteria:

* loss of or insufficient self-awareness, the presence of hallucinations, delusions, and other psychotic symptoms
* the presence of severe depression, or self-inflicted suicidal attempts and behaviors
* the presence of a history of alcohol or drug abuse
* refusal of psychotherapy, or the ineffectiveness of those who had been involved in a full course of psychotherapy.
Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.

The " CirB-RNA " cohort aims to create a biological collection associated with clinical and biological data from patients with hepatitis B infection. This project is part of a much larger program that aims to characterize and quantify circulating viral RNAs as a possible new biomarker of hepatitis B functional cure.


Eligibility Criteria:
Inclusion Criteria:

* Adults patients and minor children over 6 years of age (in Lyon) with acute or chronic hepatitis B or presenting with HBsAg loss (with/without HBs seroconversion). (Co-infected patients with HDV and/or HCV and/or HIV are eligible)
* Patients requiring blood sampling for medical care at the time of the medical appointment.
* Informed patients who do not refuse to participate.
* Persons not affiliated to a social security scheme and persons receiving medical assistance from the state may be asked to participate in the study

Exclusion Criteria:

* Patients participating at the time of the inclusion to an interventional trial evaluating a drug likely to interfere with this study.
* Persons deprived of their liberty by a judicial or administrative decision
* Adults who are subject to a legal protection measure
* Children less than 6 years old (in Lyon)