cyrilzakka/clinical-trials huggingface dataset:
The Impact of Telemedicine to Support Palliative Care Resident in Nursing Home

Investigators hypothesize that telemedicine may be an effective tool to improve palliative care in nursing home, by providing on-site specialized and interprofessional consultation. The objective of this study is to assess the impact of telemedicine in decreasing the rate of hospitalization, compared with usual care, in nursing home resident with palliative care needs.

According to current statistics, approximately 12 % of all deaths in France occur in Nursing Home, with the number over 25% in USA. With the ageing of the population, this rate is expected to dramatically increase in the next years, to reach 40% in USA in 2020. Yet, there is some evidence that palliative care is often inadequate in Nursing Home: there is a difficulty to recognize residents who might benefit palliative care and their needs, an underassessment and under-treatment of pain and other end-of-life symptoms, and frequent burdensome treatments and hospitalizations. Several programs including palliative care consult service (with outside consultant), Nursing Home-based palliative care or Nursing Home-hospice partnerships, have succeeded in delivering high-quality palliative care in Nursing Home. But, to our knowledge, no studies examined the benefit of telemedicine for palliative care in nursing home.

During a 6 month-inclusion period, residents with palliative care needs will be included in both arms. In the intervention group, Telemedicine consultations involving Nursing Home staff and the palliative and/or geriatric unit from the University Hospital, will be organized systematically at inclusion and during the follow-up if needed. In both groups, hospitalizations and emergency hospitalizations, quality of life of the resident, satisfaction of the nursing home staff and health costs will be recorded during 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Residents with palliative care needs:

  * Diagnosis of advanced or terminal disease: advanced cancer, advanced congestive Hearth Failure, end-stage pulmonary disease, end-stage hepatic disease, end-stage neurologic disease, other end-stage medical diagnosis.
  * ≥ A unplanned acute hospital episodes within the past 6 months
  * Activity of daily life ≤ 1 and/or bed/chair ridden residents for at least 30 days.
  * Weight loss ≥ 10% of body weight in the last 6 months.
  * The " surprise question " approach: " Would I be surprised if this patient died within the next 6-12 months? "
* Informed and written consent by the patient or the legal representative or the reliable person when appropriate.
* General Practitioner agreement.

Exclusion Criteria:

* No agreement of study participation of patients or legal representative or the reliable person when appropriate.
A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease

The objective of this trial was to assess subject preference for PARCOPA, carbidopa/levodopa Orally Disintegrating Tablets (ODT), compared with conventional carbidopa/levodopa tablets, in subjects with stable Parkinson's disease.

See approved Package Insert for Adverse Event information.

Eligibility Criteria:
Inclusion Criteria:

* Stable Parkinson's Disease

Exclusion Criteria:

* Not using carbidopa/levodopa tablets
Postoperative and Opioid Free Anesthesia

Since the 1960's, intraoperative administration of opioids is considered a keystone of anesthesia as well as hypnotics and muscle relaxants. Synthetic opioids were introduced to achieve hemodynamic stability during anesthesia. They allow an inhibition of the sympathetic system without cardiovascular collapse and histamine release. Since then, anesthesia has changed from inhalation to multimodal anesthesia with lower doses of hypnotic. In 2017, the intraoperative objectives of hypnosis, hemodynamic stability, immobility and anticipation of postoperative analgesia can be achieved without opioids. Moreover, opioid administration consequences are neither scarce nor benign for the patient. Perioperative opioids are associated with nausea and vomiting, sedation, ileus, confusion/delirium, respiratory depression, increased postoperative pain and morphine consumption, immunodepression, hyperalgesia and chronic postoperative pain. Among these complications, hypoxemia, ileus and confusion/delirium are the most frequent.

Efficacious multimodal analgesia and anesthesia are the basis of successful fast-track surgery. These multidrug regimens aim at decreasing postoperative pain, intra- and postoperative opioid requirements, and subsequently, opioid-related adverse effects and to fasten recovery. Opioid-free postoperative analgesia has been recommended for more than 10 years. Opioid-free anesthesia (OFA) is based on the idea that hemodynamic stability can be achieved without opioids during anesthesia. OFA is multimodal anesthesia associating hypnotics, N-methyl-D-aspartate (NMDA) antagonists, local anesthetics, anti-inflammatory drugs and alpha-2 agonists (Dexmedetomidine).

Proofs of the effect of OFA on reducing opioid-related adverse effects after major or intermediate non-cardiac surgery are still scarce. We hypothesized that the reduced opioid consumption during and after surgery allowed by OFA compared with standard of care will be associated with a reduction of postoperative opioid-related adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing a scheduled major or intermediate non-cardiac surgery,
* Benefiting from the health insurance system,
* Having signed an informed consent.

Exclusion Criteria:

* Pregnant or breast feeding women,
* Allergy to dexmedetomidine or one of its excipients,
* Allergy to one of the drugs used for anesthesia or one of their excipients,
* Urgent surgery,
* Intracranial surgery,
* Transplant surgery or transplanted patients,
* Surgery with planned regional anesthesia,
* Outpatient surgery,
* Atrioventricular block, intraventricular or sinoatrial block,
* Treatment by chronic betablockers and HR \< 50 bpm,
* Heart failure with LVEF \< 40%,
* Adam-Stokes syndrome,
* Epilepsy or seizures,
* Uncontrolled hypotension,
* Acute cerebral pathology,
* Obstructive sleep apnea syndrome,
* Severe hepatic insufficiency (Prothrombin Ratio \< 15%),
* Patients in whom the CAM-ICU cannot be performed (deaf patients for example)
* Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty.
STUDY INCIDENCE AND CHARACTERISTICS OF MALIGNANT NEOPLASIES IN PATIENTS WITH HEMOGLOBINOPATHY FOLLOWED IN ITALY

The Trial aims to increase the information available on the relevance of tumor pathology in hemoglobinopathies, updating the data relating to hepatocarcinoma and investigating which other tumors are more frequent in patients with hemoglobinopathies. Still, in relation to tumor pathology, the study will evaluate any differences between the different types of hemoglobinopathy and will investigate the association between the appearance of neoplasms and risk factors such as age, sex, iron accumulation markers, history of bone marrow transplant, and others.

By providing targeted screening strategies, these data may contribute to the early identification of tumor pathology in hemoglobinopathies, and, by contributing to the identification of risk factors, to its prevention. They will also be able to contribute to understanding which therapeutic approaches in the case of cancer are most appropriate in this category of subjects.

To be able to go even deeper into understanding the possible link that exists between tumors and hemoglobinopathy, a further data collection (substudy) has been prepared in which additional and more detailed information will be collected in order to evaluate which is the percentage of patients who develop tumors compared to all those with hemoglobinopathy.

The risk of developing tumors will also be assessed for each hemoglobinopathy (transfusion-dependent beta-thalassemia, transfusion independent beta-thalassemia, hemoglobin H disease, sickle cell disease, microdrepanocytosis)

Eligibility Criteria:
Inclusion Criteria:

* Transfusion-dependent or independent beta-thalassemia, hemoglobin H disease, sickle cell anemia and microdrepanocytosis
* Current or previous malignant tumor pathology
* Availability of medical history including the most relevant clinical and instrumental data before the onset of cancer

Exclusion Criteria:

* - Other haematological diseases other than hemoglobinopathies
* Absence of neoplastic events in the clinical history
* Non-availability of relevant clinical and instrumental data
Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients

The overall objective of this study is to collect data relevant to the tolerability of Novantrone® therapy in patients with multiple sclerosis (MS) using dosing and monitoring recommendations specified in the package insert.

This phase IV, multicenter, prospective, open-label tolerability and safety monitoring study will enroll a select cohort of 500 multiple sclerosis patients receiving commercially available Novantrone®. The patients will be assessed every 3 months during treatment followed by annual assessment for a total of five (5) years.

The select cohort of MS patients enrolled will have secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting disease (i.e., patients whose neurological status is significantly abnormal between relapses).

The overall objective of this study is to collect data relevant to the tolerability of Novantrone® therapy in patients with multiple sclerosis (MS) using dosing and monitoring recommendations specified in the package insert.

Eligibility Criteria:
Inclusion Criteria:

* To be eligible for inclusion into this study, the subjects must fulfill all of the following criteria:
* Platelet count \>100,000 cells/µL
* Granulocyte count \> 2000 cells/µL
* Age 18-65 years
* Negative pregnancy test for female patients who are biologically capable of becoming pregnant, even if they are taking birth control
* For patients of reproductive age, agreement to practice effective contraception throughout the study and for 6 months following the last administration of Novantrone®
* Signed Inform Consent.

Exclusion Criteria:

* To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
* Presence of cardiac risk factors:
* History of congestive heart failure
* LVEF \< 50% determined by echocardiography or MUGA
* Previous treatment with Novantrone®, other anthracenediones, or anthracyclines
* Prior mediastinal radiotherapy or total lymphoidal irradiation
* AST, ALT, bilirubin \> 2x upper limits of normal
* Severe untreated infection (including current urinary tract infection)
* Nursing or pregnant women)
Cognitive Impairment in Parkinson's Disease Categorised in Accordance to Motor Symptoms

Background: Approximately 40% of patients with Parkinson's disease (PD) have cognitive impairments. There is a lack of consensus as to the extent to which psychiatric symptoms, depression, age at disease onset, disease duration, and medication is related to the type and severity of cognitive impairment. This discrepancy can in part be caused by the lack of distinction between patients with different motor symptoms and disease severity.

Objective: To identify the extent to which psychiatric symptoms, depression, age at disease onset, disease duration, and medication is related to the severity and type of cognitive dysfunction in patients with idiopathic PD categorized according to motor symptoms and disease severity.

Methods: the population of patients with PD in the old county of Aarhus is described on the background of medical records, and stratified in accordance to age, sex and cardinal symptoms. Through proportional allocation a sample of a minimum of 50 patients with PD is drawn from the population. The patients and 30 healthy matched controls will undergo comprehensive neuropsychological assessment including tests of language, memory, executive function, and visuospatial function. Furthermore, all participants will be screened for depression (Geriatric Depression Scale) and psychiatric symptoms (Neuropsychiatric Inventory and Symptom Checklist). The patients will be categorized in accordance with their motor symptoms via cluster analysis for the purpose of analyzing the effect of psychiatric symptoms, depression, and age of disease onset, disease duration, and medication on cognition.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's in accordance to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria,
* Born and raised in Denmark ,
* \>50 years

Exclusion Criteria:

* Cerebrovascular disease,
* Dementia not caused by Parkinson's Disease,
* Metabolism anomaly,
* Abuse of drugs, medication or alcohol,
* History of head injuries,
* Severe psychiatric disorder, excluding depression,
* Resident outside the region of Aarhus h) DBS -
Running Title: Walking to Music and in Silence on a Treadmill

This work is embedded in the context of auditory-motor coupling, which entails the engagement of two systems; the interaction between the music (or repetitive auditory stimuli) and a walking individual (repetitive movements of footfall). In previous studies, the investigators have shown that synchronising steps to beats in music have shown to be feasible in persons with multiple sclerosis, showing increase of step frequency and reduced perceived fatigue\[1, 2\]. In this current work, The investigators expand previous findings with a pilot intervention study, to investigate if synchronisation is necessary to improve cognitive and motor functions.

The proposed experiment includes 30 participants, randomised to three arms of a pilot intervention (10 participants per arm). With the intention of a further case-study analysis, the inestigators request to include 4 additional participants (2 PwMS with cognitive impairment, and 2 persons with cerebellar lesion) to only follow the intervention arm 1.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of MS if \>1,
* no relapses \>1 month,
* ability to walk for 12minutes,
* ability to walk independently on a treadmill
* walking speed between 0.8-1.2m/s.

Exclusion Criteria:

* amusia,
* deafness,
* cognitive impairment hindering understanding of study instructions,
* pregnancy.
Motivational Enhancement Therapy's Impact on d COPD Outcomes in Geriatric Patient

Motivational Enhancement Therapy (MET) is a systematic intervention that focuses on eliciting and strengthening a person's intrinsic motivation to change. MET is rooted in motivational interviewing principles, emphasizing empathy, autonomy, and the evocation of the patient's own motivations for change. The therapy typically involves several sessions where therapists help patients identify personal goals, explore ambivalence towards change, and develop actionable plans to achieve their desired outcomes.

Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of morbidity and mortality worldwide, particularly among the elderly. Managing COPD effectively in geriatric patients requires addressing not only the physiological aspects of the disease but also the psychological and motivational factors that can influence treatment adherence and overall well-being. Motivational Enhancement Therapy (MET) is a counseling approach designed to help individuals enhance their motivation to change and engage in healthier behaviors. This study explores the impact of MET on motivation, resilience, anxiety reduction, and COPD outcomes in geriatric patients.

Eligibility Criteria:
Inclusion Criteria:

* more than 60 years

Exclusion Criteria:

* more than 80 years
Oral Self Medication Versus IV Administration of Pain Killers After Caesarian Delivery

C-section deliveries are painful and need adequate analgesia. In the same time, mothers need early rehabilitation to take care of the baby.

Hypothesis: Early oral self administration of painkillers could be as effective as usual IV administration by nursing staff.

Purpose of the study: Evaluation of the efficacy of a program of self administration of painkillers postoperatively of C-section delivery.

Two Arms: PCOA group receiving oral self administered multimodal analgesic protocol and IV group receiving same multimodal analgesic protocol administered by nursing staff.

Eligibility Criteria:
Inclusion Criteria:

* planned caesarian section

Exclusion Criteria:

* delivery bleeding which requires general anaesthetic and other surgical treatment
* contraindication of the targetted anaesthetic because of hemostatis dysfunctionments
* Signed consent form
* under 18 years old, toxicomania
* do not french speacking
* allergia or contraindication to IMPs
* suffer from chronicle disease
* do not affiliate to a health protection
* do not want to cooperate with the medical staff
Neurobiological, Neuropsychological,Linguistic and Gestural Processes and Phenomena in Individuals With Alexithymia

The syndrome of extremely restricted emotional competence, alexithymia, was originally conceptualized in psychoanalytic research and is now empirically and experimentally studied in clinical psychology and psychological medicine within the context of emotion regulation using neuroscientific techniques. Alexithymia refers to an individual's inability or impaired ability to name or express feelings and to distinguish them from the physical consequences of an acute or chronic stress reaction. Modern "brain-body-interface" research suggests that alexithymia represents a complex deficiency in cognitive processing and emotional regulatory processes. The neurobiological basis is assumed to be a preconscious, automatic and involuntary information transfer to the amygdalae of acquired representations of emotional contents stored in ventromedial prefrontal cortical areas.

Alexithymia is not just "emotional coldness", i.e. a limited emotionality, but essentially the detachment of feelings from language. In alexithymia the link between affective phenomena and language, understood as media-supported sign practices, is insufficient or even absent.

The purpose of our observational study is to better understand the neurobiological and neuropsychological as well as linguistic and gestural processes and determinants of this phenomenon


Eligibility Criteria:
Inclusion Criteria:

* scoring high on the TAS-20

Exclusion Criteria:

* personal history of a mental disorder
* currently mentally ill
Clinical Trial to Study the Safety Tolerability, Pharmacokinetics, Food Effect & Pharmacodynamics of a New Compound P7435 in Healthy, Overweight and/or Obese Subjects

Clinical trial to study the safety tolerability, pharmacokinetics, food effect and pharmacodynamics of a new compound P7435 in in healthy, overweight and/or obese subjects

* A phase I, randomized, double-blind, placebo-controlled, dose escalating study of P7435 to determine the safety, tolerability, pharmacokinetics, food effect and pharmacodynamics of single and multiple ascending doses of P7435.
* Subjects participating will be either healthy subjects or healthy overweight and/or obese subjects. In this study, overweight/obese are defined as subjects having a BMI of 23 kg/m2 and above.
* The study will be conducted in 3 parts as follows: Part A will consist of the Single Ascending Dose (SAD) study, Part B will consist of the Multiple Ascending Dose (MAD) study and Part C will consist of the Food Effect study.

Eligibility Criteria:
Inclusion Criteria:

* Willingness and are able to provide a written informed consent to participate in the study.
* Healthy adult male subjects aged between 18 and 45 (both inclusive) years old
* BMI between 19 and 23 kg/m2. Overweight (BMI between 23 and 25kg/m2) and/or obese (BMI between 25 and 35 kg/m2) but otherwise healthy subjects in PartB .
* Healthy as determined by the investigator
* Smoking less than 10 cigarettes per day and able to refrain from smoking during confinement.
* Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, coke, chocolate, "power drinks") and grapefruit juice to admission.

Exclusion Criteria:

* Employees of the sponsor or clinical sites.
* Female subjects.
* No past or current serious diseases of any organ will be allowed. Exceptions may be non-malignant skin diseases, childhood asthma and other conditions as per the Investigator's discretion and discussed with the Sponsor a priori. History of significant gastrointestinal disease or other significant diseases including cardiac, renal or liver impairment.
* History of sleep apnea, irregular sleep/wake cycle or working in night shifts.
* Acute disease state
* History of hypo/hyperthyroidism or repeated abnormal TSH values at screening or obesity of endocrine origin.
* History of alcoholism for more than 2 years
* Positive serology for human immunodeficiency virus (HIV-1/2) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
* Positive findings in urine drug screen / alcohol breath test.
* Participation in another clinical trial within 90 days of the first drug administration.
* Intake of more than 8-10 cups of coffee and/or tea per day and consumption of methyl xanthine-containing beverages (tea, coffee, cola drinks, chocolate) within 48 hours prior to study.
* Donation of blood (i.e. 350 ml) within 90 days before Day -1 of the first treatment period.
Sonographic Imaging of Oral and Dental Anatomical Structures (A Pilot Study)

The overall purpose of this study is to establish an ultrasound technique to aid in oral and dental examination of soft and hard tissues. Ultrasound is currently not used in Dentistry and associated oral examinations and its usefulness for clinical practice will be explored. This study will investigate the use of ultrasonic imaging for planning and placing dental implants, as well as evaluate the use of ultrasonic imaging for monitoring marginal bone loss around dental implants.

This study will involve two different groups of subjects: Patients scheduled for a dental implant procedure, and patients scheduled for a revision surgery after developing infection after implant surgery.

Twenty subjects examining only specific aim one is funded and will be studied. If future funding is granted and additional 30 subjects for aim one and 40 for aim two will be studied Subjects in both groups will receive an ultrasound examination of the oral cavity prior to their clinically-scheduled dental surgery. Subjects in group 1 also may receive a CBCT scan if not previously clinically-ordered.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years of age and older who will be scheduled to have an implant surgery from premolar to premolar with bilateral adjacent teeth present will be recruited.

Exclusion Criteria:

* Patients under 18 years of age.
* Unwilling or unable to read and sign this informed consent document.
* Do not have a tooth on each side of the implant that will be placed.
* Women who are pregnant or unsure of their pregnancy status.