cyrilzakka/clinical-trials huggingface dataset:
Changes in Measured Plasma Volume, Glycocalyx and Atrial Natriuretic Peptide During Anaesthesia

The arterial blood pressure is thought to affect the ratio between filtration and reabsorption of fluids in the circulating blood volume and thereby the plasma volume. During induction of anesthesia blood pressure, hemoglobin level and hematocrits decreases and the plasma volume increases. The aim of the study is to evaluate weather a maintained blood pressure with norepinephrine during anesthesia induction reduces the increase in 125 iodine-labeled human serum albumine (125I-HSA) measured plasma volume.

24 patients scheduled for coronary artery bypass surgery will be included and randomized to receive either norepinephrine in the dose needed to maintain pre-anesthesia blood pressure or to a control group and receive norepinephrine only if mean arterial pressure decreases below 60 mmHg. Equal anesthesia in both groups will be monitored. No fluids will be infused.

Changes in vascular resistance and cardiac output will be measured with thermodilution and changes in plasma volume will be measured with 125I-HSA.

Endothelial cell function will be evaluated by measuring leakage of 125I-HSA and the plasma concentration of endothelial cell markers. Hormonal effects will be evaluated by measuring the plasma concentration of atrial natriuretic peptide (ANP). Shedding of glycocalyx will be evaluated by measuring heparan sulphate. The level of fibrinogen and platelet function will be evaluated by thromboelastography/multiplate.

Eligibility Criteria:
Inclusion Criteria:

* Elective coronary artery surgery patients

Exclusion Criteria:

* Age under 40 years
* Untreated hypertension
* A reduced left ventricular systolic ejection fraction of 45% or less
* Diabetes mellitus
* Former stroke and/or a known carotid artery stenosis
RinasciMENTE, An Internet-Based Self-Help Intervention for People With Psychological Distress Due to COVID-19

This study aims is the evaluation of the efficacy and feasibility of RinasciMENTE, the Randomized Controlled Clinical Trial compared with a waiting list control group.

A sample of 128 participants, who experience psychological discomfort due to COVID-19, will be recruited. After initial screening, participants will be randomly assigned to either an experimental group or a waiting list group. Measures will be taken at the baseline (T0), at the end of the treatment (T1) and 12 months follow-up (T2).

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or over and both gender
* Italian mother-tongue
* Score 14 or less on Patients Health Questionnaire-9 (PHQ-9)
* Internet access and basic informatic ability to navigate the internet platform
* Must be able to complete a phone interview

Exclusion Criteria:

* Having severe and mental impairments, psychiatric condition and neurological disorder
* Not be able to use a computer or do not have internet access
* Not be able to complete a phone interview
* Score 15 or more on PHQ-9
Observation of the Gait Cycle in Patients With Hemiplegia in Order to Improve the Triggering of Functional Electrical Stimulation

The main objective of this study is the estimation and comparison of the dephasing between the switch heel and the inertial placed on the paretic foot compared to the events of the gait cycle determined by a Gaitrite system (beginning and end of the swing phase) in conditions without stimulation.


Eligibility Criteria:
Inclusion Criteria:

* patient has had a first ischemic or hemorragic stroke (supratentorial) within the last 6 months for the "recent stroke" group, or more than a year ago for the "old stroke" group
* the patient can walk 10 m without human help, with or without a cane, and a deficit of the foot levator requiring the use of technical assistance to remedy this or involving walking problems
* electrostimulated contraction of the anterior tibialis is possible
* patient has been informed and has signed the consent form

Exclusion Criteria:

* cognitive disorder making participation in the study difficult
* fixed plantar flexion, knee extended below 0°
* patient refuses to sign consent
* patient is not covered by a social security system
* patient is under any kind of guardianship
Mentalization-Based Group Therapy for Adolescents

This is a prospective parallel group design of group-based Mentalization-Based Therapy for Adolescents (MBT-A) through a pilot randomised controlled trial comparing group-based MBT-A plus treatment as usual (TAU) to TAU alone. As a pilot study, we aim to determine: the effectiveness of our recruitment strategies; compliance with protocol/procedures; trends towards reduced self-harm.


Eligibility Criteria:
Inclusion Criteria:

* Self-harm behaviour in the past 6 months
* In receipt of treatment from local Child and Adolescent Mental Health Services
* Competent and willing to provide written, informed consent.

Exclusion Criteria:

* Severe learning disability or pervasive developmental disorder
* Acute psychotic episode
* Eating disorder in the absence of self-harm.
* Non-English speaking
* Current involvement in other ongoing treatment research
Trial of Early Noninvasive Ventilation for Amyotrophic Lateral Sclerosis (ALS)

The goal of this trial is to determine the feasibility of conducting a randomized, double-blind, placebo-controlled trial of nocturnal noninvasive positive pressure ventilation in persons with amyotrophic lateral sclerosis with an forced vital capacity greater than or equal to 50 percent.

Amyotrophic lateral sclerosis (ALS) is an untreatable neurodegenerative disorder characterized by the progressive loss of motor neuron function. Respiratory failure is the most common cause of death in persons with ALS. Treatment of respiratory muscle weakness with nocturnal noninvasive positive pressure ventilation (NIPPV) when forced vital capacity (FVC) is less than 50 percent-but prior to the development of respiratory failure-has prolonged survival in observational studies. Despite the association of NIPPV use and survival, it is unknown whether earlier NIPPV treatment will benefit people with ALS. Also, no placebo-controlled studies of NIPPV treatment and people with ALS have been conducted.

The goals of the this trial are to assess the feasibility of conducting a prospective, randomized, double-blind, clinical trial of NIPPV versus control (sham) NIPPV in people with ALS who have a FVC greater than 50 percent, and to gain preliminary data on outcome effects.

In the trial, the investigators will test the following hypotheses: (1) People with ALS who have a FVC greater than 50 percent can tolerate active NIPPV and control NIPPV, and will find control NIPPV to be a believable treatment; (2) Initiation of active NIPPV in people with ALS who have a FVC greater than 50 percent will have better clinical outcomes with respect to measures of quality of life, rate of pulmonary function decline, and functional outcome; and (3) People with ALS who start active NIPPV early will have improved tolerance later when respiratory weakness has progressed. These aims will enable planning of a subsequent, large-scale and definitive clinical trial of early NIPPV (FVC greater than 50 percent) in people with ALS.

If the benefits of early NIPPV can be confirmed, then a new treatment may be established for this progressive, fatal disease.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Probable or possible ALS by El Escorial criteria
* If of child-bearing potential, has a negative urine or serum pregnancy test

Exclusion Criteria:

* FVC \< 50% predicted for age
* Previous pneumothorax
* Bullous emphysema
* Requirement for oxygen
* Previous use of any positive pressure ventilation equipment (continuous positive airway pressure, or bilevel positive airway pressure)
* Current involvement in a clinical treatment trial
* Any unstable medical condition thought likely to interfere with participation
Prospective Randomized Comparison of Zymar(Gatifloxacin) and Vigamox (Moxifloxacin) in Killing Conjunctival Bacterial Flora Following a One-hour Application

Topical ophthalmic antibiotics are common prescribed just prior to eye surgery to lower the risk of infection. Previous studies have suggested that antibiotics containing a preservative (Zymar) kill bacteria much quicker than those without a preservative (Vigamox). The purpose of this research is to compare how quickly to the two commonly prescribed antibiotics eliminate bacteria from the eye surface.


Eligibility Criteria:
Inclusion Criteria:

* Age- older than 50 years of age
* Diagnosis- Cataract or had cataract surgery

Exclusion Criteria:

* Systemic or topical antibiotic treatment within 30 days
* Use of systemic or topical steroids
* Active ocular infection
* Ocular surgery in the past 6 months
* Allergy to fluoroquinolones
Artificial Intelligence in Breast Cancer Screening in Region Östergötland Linkoping

The purpose of this observational study is to assess whether the use of AI (Transpara®) can lead to an improved quality of a double reading mammography screening program. This is investigated by performing AI as a third reader and as a decision support during the consensus meeting, compared with conventional mammography screening (double reading and consensus without AI).

The AI cancer detection system will act as a 3rd reader and will recall additional cases to the consensus conference: the exams that were not recalled by double reading but are classified as the 3% most suspicious exams, based on AI derived cancer-risk scores. Secondly, AI is used as a decision support during consensus. AI risk scores and Computer-Aided Detection (CAD)-marks of suspicious calcifications and soft tissue lesions are provided to the reader(s).

The hypothesis of this study is that the use of AI has the potential to improve the quality of the screening program by increasing the cancer detection rate without affecting the recall rate.

Eligibility Criteria:
Inclusion Criteria:

* Women participating in the regular Breast Cancer Screening Program in Region Östergötland Linkoping

Exclusion Criteria:

* Women with breast implants or other foreign implants in the mammogram
* Women with symptoms or signs of suspected breast cancer
Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant

RATIONALE: Lithium carbonate may be an effective treatment for intestinal graft-versus-host disease caused by a donor stem cell transplant.

PURPOSE: This clinical trial is studying lithium carbonate in treating patients with acute intestinal graft-versus-host-disease after donor stem cell transplant.

PRIMARY OBJECTIVES:

I. To evaluate the effects of lithium on functional and mucosal anatomic recovery in the small or large bowel of patients with acute GVHD.

II. Functional recovery will be evaluated according to changes in clinical manifestations of gastrointestinal GVHD. III. Mucosal anatomic recovery will be evaluated by review of results from clinically indicated endoscopic evaluations.

SECONDARY OBJECTIVES:

I. To assess the tolerability of lithium administration in allogeneic hematopoietic cell transplant recipients.

OUTLINE: Patients receive oral lithium carbonate once or twice daily. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a diagnosis of severe intestinal GVHD that is not improving at any time after initial treatment with glucocorticoids for at least 7 days are eligible for enrollment; measures indicating severity of GVHD will include: a) persistent diarrhea with average daily stool volumes \> 500 mL per day; or b) persistent hemorrhage that is detectable by visual inspection of the stool
* Patients with denuded mucosa caused by GVHD are eligible for enrollment, regardless of prior treatment for acute GVHD; denuded mucosa is defined as loss (i.e., erosion or sloughing) of the epithelium in: a) at least one-third of the surface area in a 30 cm colonic segment (i.e., rectosigmoid, descending or transverse colon); or b) at least one fifth of the surface area of the second portion of the duodenum, as estimated by endoscopic evaluation; denuded mucosa must be documented by images of the duodenum and colon and by histologic evaluation of the colon
* All subjects must provide written informed consent with the use of forms approved by the Fred Hutchinson Cancer Research Center (FHCRC) Institutional Review Board (IRB)

Exclusion Criteria:

* Significant renal dysfunction (estimated creatinine clearance \< 30 mL/min)
* Persistent or recurrent malignancy
* Secondary malignancy
* Patients who had autologous or syngeneic marrow transplantation
* Presence of any cause of intestinal symptoms or ulceration other than GVHD
* Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol will be excluded
Semmelweis Sport Study

The aim of the present proposal is to investigate the development of distinct morphological, functional, biochemical and molecular aspects of short- and long-term sport-induced changes in the heart, to get a better understanding on the (patho)physiology of athlete's heart. The main goal of our research is to deepen our knowledge on the proper differentiation between beneficial (physiological) and harmful (pathological) consequences of professional sport, thereby effectively preventing potential cardiovascular complications of athletes.

CLINICAL METHODS

1. Sport specific questionnaire, patient history and physical examinations - In our detailed questionnaire, specific information is collected about quantity and quality of training, personal and family history and presence of sport specific and general symptoms.
2. Laboratory biochemical examination - Besides the regular routine laboratory parameters, several specific parameters associated with physical exercise are planned to be measured, such as cardiac biomarkers.
3. 12-lead ECG - Resting standard 12-lead digital ECG will be recorded. Extended analysis will be performed according to the latest recommendations.
4. Holter ECG - 24 hour Holter ECG will be recorded. Extended Holter ECG analysis will be performed.
5. Detailed echocardiography
6. Detailed CMR examination
7. Body composition analysis - With a sophisticated bio-electrical impedance analysis, comprehensive whole body composition and hydration analysis will be performed.
8. Cardiopulmonary exercise testing - Sport specific protocols will be used on both treadmill and bike ergometers.

Eligibility Criteria:
Inclusion Criteria:

* age
* no known cardiovascular disease
* history of sport activity (athletes)
* no history of competitive sport (controls)

Exclusion Criteria:

* History of known relevant cardiac disease (including cardiomyopathies)
* Contraindication to MRI or cardiopulmonary exercise testing
A Prospective Non-interventional Study to Evaluate the Safety of Methylene Blue Plasma

The objective of this non-interventional study is to gather data on adverse reactions occurring with Methylene Blue plasma administered in a routine clinical practice environment; to know more about their characteristics and behaviour and the possible factors that may influence their presentation and evolution.

This is an open label, multi-centre, non-controlled, non-randomized, non-interventional study to evaluate the safety of Methylene Blue (MB) plasma. One centre per country will participate from United Kingdom, Belgium, Greece and Spain.

The haemovigilance Case Report Form (CRF) will be completed for all patients who receive a Methylene Blue plasma transfusion and experience an adverse reaction. The patients will be monitored for the occurrence of possible adverse reactions within 24 hours after start of the transfusion. If the patient experiences an adverse reaction, information about the adverse reaction will be documented. Serious adverse reactions will be collected within a 7-day period after the transfusion.

Each adverse reaction or serious adverse reaction will be followed up for 28 days after the occurrence of the reaction.

Each centre will provide the number of transfused Methylene Blue plasma units and the number of transfused Methylene Blue plasma patients every three months.

Information collected on the haemovigilance CRF will include:

* Details about the transfusion (transfused units, volume, other non-plasma blood components transfused)
* Details about the plasma (collected from whole blood, aphaeresis or both, filter using, type of reference used, illumination device model)
* Demographic data
* Transfusion history (including hospital department)
* History of previous transfusion reactions
* Details about the adverse reaction (date and time of reaction)
* Signs and symptoms and allocation to a diagnosis
* Classification of the adverse reaction (severity, imputability, non-serious or serious)
* Actions taken
* Outcome
* Time to recovery

Eligibility Criteria:
Inclusion Criteria:

* Patients, who have received a transfusion with Methylene Blue plasma produced using the THERAFLEX MB-Plasma procedure from MacoPharma and experience an adverse reaction.

Exclusion Criteria:

* Patients receiving transfusion with other plasma types during the same transfusion episode
Gamification in Knee Replacement Rehabilitation

After total knee arthroplasty (TKA), knee is usually swollen, painful, and stiff. The main goal of post-operative physical rehabilitation is to achieve full extension and flexion of the knee to avoid contractures and stiffness. Also strengthening of quadriceps muscle and balance to help activities of daily living and overall mobility are important. The post-operative knee replacement rehabilitation includes the standard protocol in hospital phase and the standard home exercise instructions. Computer based exercising games (exergames) may be new method to increase training adherence and volume after TKA and thus improve results and effectiveness of the rehabilitation. However, evidence of effectiveness of rehabilitative exergaming on physical functioning is sparse and more research is needed to conduct evidence-based rehabilitation practices.

Therefore the present study examines the effectiveness of a 16-week gamified physiotherapy on physical functioning, life satisfaction and pain for patients after TKA compared to treatment as usual home exercise. The second objective is to validate the psychometric properties of WHODAS 2.0 (WHO Disability Assessment Schedule) and brief ICF (International classification of functioning, disability and health) core set of osteoarthritis questionnaire. Other objectives are to find out, what kind of understanding and experiences the participants have about the rehabilitation with exergames and to evaluate the usability and user experience of exergames.


Eligibility Criteria:
Inclusion Criteria:

* first primary (M17.0, M17.1) unilateral TKA
* mechanical axis of the limb in varus
* model of the TKA is posterior stabilizing (PS) or cruciate retaining (CR) prosthesis
* normal vision with or without eyeglasses

Exclusion Criteria:

* fractures, rheumatoid arthritis, or other biomechanical disruptions in affected lower limb within one year before operation
* diagnosed memory disorder or cognitive impairment
* neurological condition as Parkinson's disease, multiple sclerosis or stroke
Development and Validation of a Language Screening Test in Acute Right Hemispheric Strokes

This is a bi-centric study whose main objective is the validation of a rapid screening test for language disorders in the acute phase of right hemisphere stroke.

Primary objective

The main objective is the validation of a rapid language disorder screening tool that will be used in the acute phase of right hemispheric stroke.

Secondary objectives

Secondary objectives are:

* Characterize the "atypical crossed aphasia" since the acute phase of stroke with a large cohort of patients , which, to our knowledge, has never been done.
* Re-evaluate the number of patients with acute language disorder in right hemisphere stroke.
* Validate the use of R-LAST by different categories of carers

The R-LAST (Right Language screening test) comprises 8 subtests and a total of 15 items.

Validation will focus on the internal validity (no ceiling or floor effect, no redundancy, internal consistency), the external validity (against a "gold standard" in order to evaluate its specificity and its sensitivity) and the interclass agreement of R-LAST. The median time to administrate de scale will be calculated.

The investigators will validate the scale by administering it to 300 consecutive patients within 24 hours after admission to our 2 stroke units (Centre Hospitalier de Versailles and Centre hospitalier du sud francilien) and to 100 stabilized patients with and without atypical crossed aphasia using the MEC-P evaluation as a reference.

Patients must be 100% right-handed (Edinburgh test), be of French mother tongue, have no history of neurological disease, have no sensory disturbances (blindness, deafness) and no mirror crossed aphasia detected by the LAST (minimum score of 14/15 with a loss point granted for the "automatic speech" subtest, potentially stranded in right strokes)

Eligibility Criteria:
Inclusion Criteria:

* patients must be the age of majority
* Patients with right hemispheric stroke in the acute phase (internal validation + inter-examiner validation) or stabilization phase (external validation) confirmed by MRI or CT when MRI contraindicated
* Patient with no "mirror" crossed aphasia detected by the LAST procedure (A or B): LAST\> 14
* Patients who read the newsletter
* Affiliation to a social security scheme

Criteria Exclusion:

* Minor patients
* No French speakers
* Patients with a history of stroke
* Patients with dementia
* Patients with sensory impairment: deafness, blindness
* Patient not 100% right handed in the Edinburgh questionnaire
* Inability to answer the Edinburgh Laterality Questionnaire and absence of any person to fill in the questionnaire.
* Patient with a left-handed person in its family
* Illiterate patients
* Patient presenting a "mirror" crossed aphasia detected by LAST A or B (score tolerated: 14/15 with error accepted to the automatic speech)
* Inability to receive the information letter about the protocol and to read the newsletter
* Refusal of the patient
Mobile Phone in Hypertension Management

The purpose of this study is to examine if a mobile phone-based self-report system, using the patient's own mobile phone, will improve adherence to treatment of hypertension and lead to personal involvement of the patient in the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of arterial hypertension
* Prescribed antihypertensive treatment
* Alert and oriented
* Swedish-speaking
* Access to a functioning cell phone
* Agreeing to regular controls at the National Prescribed Drug Register of drugs