cyrilzakka/clinical-trials huggingface dataset:
Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor Fluctuations

A 48-month open label multi-centered extension study to evaluate the long-term safety, tolerability and efficacy of E2007 in patients with Parkinson's Disease with "wearing off" motor fluctuations and "on" period Dyskinesias.


Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled in Study E2007-E044-204 and who either completed 12 weeks of study drug treatment or who withdrew from the study due to lack of efficacy.

Exclusion Criteria:

* Pregnant or lactating women.
* Women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (e.g. abstinence, IUD-intrauterine device, or barrier method plus hormonal method). These patients must also be willing to remain on their current form of contraception for the duration of the study. Postmenopausal women may be recruited but must be amenorrhoeic for at least 1 year to be considered of non-child bearing potential.
* Fertile men not willing to use reliable contraception and fertile men with partners not willing to use reliable contraception. These patients and their partners must also be willing to remain using reliable contraception for the duration of the study.
* Patients with a past or present history of drug or alcohol abuse.
* Patients with a past (within one year) or present history of psychotic symptoms requiring antipsychotic treatment. Patients may be taking anti-depressant medication, however the dose must have been kept stable for at least 8 weeks prior to baseline visit.
* Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, haematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.
* Patients with significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper normal limit).
* Patients with current or prior treatment (within 4 weeks prior to the Baseline visit) with medication known to induce the enzyme cytochrome P450 3A4 including but not limited to; carbamazepine; dexamethasone; ethosuximide; phenobarbital; phenytoin; primidone; rifabutin; rifampicin; and St John's Wort.
* Current or prior treatment (within 4 weeks prior to baseline visit) with methyldopa, budipine, reserpine or intermittent use of liquid forms of levodopa or as needed (prn) apo-morphine.
* Patients with previous stereotactic surgery (e.g. pallidotomy) for Parkinson's disease or who are likely to undergo surgery for Parkinson's disease while participating in this study.
* Patients receiving deep brain stimulation (DBS) or who are likely to undergo DBS for Parkinson's disease while participating in the extension study.
* Patients with clinically significant cognitive impairment (mini-mental state examination (MMSE) \<24 and /or fulfilling diagnostic and statistical manual of mental disorders (DSM IV) criteria for dementia due to Parkinson's disease).
* Patients with conditions affecting the peripheral or central sensory system.
Clinical Interventions in Respiratory Distress Syndrome and Neonatal Lung Injury - SCOR in Lung Biology and Diseases in Infants and Children

To conduct clinical interventions directed at neonatal lung disease and injury, with a focus on infants having surfactant-deficiency or inactivation as a component of pathophysiology. A major emphasis was on the surfactant-deficient Respiratory Distress Syndrome (RDS) of premature infants, and on acute neonatal respiratory failure in term infants with pulmonary edema and potential surfactant inactivation (ARDS-related).

BACKGROUND:

The study was a subproject within a Specialized Center of Research (SCOR) in Lung Biology and Diseases in Infants and Children. The clinical interventions studied had significance for respiratory distress syndrome of the newborn and for bronchopulmonary dysplasia, which is the chronic lung disorder of fibrosis, alveolar loss and reactive airway disease that often follows pulmonary disease requiring treatment with oxygen and mechanical ventilation in the newborn period.

DESIGN NARRATIVE:

A series of randomized, controlled trials/studies were conducted. In the first clinical study, full term infants with severe respiratory pathology where surfactant inactivation was important were assigned randomly to exogenous surfactant versus control groups to determine if surfactant was efficacious and safe in this kind of lung injury. In the second study, infants of less than 29 weeks gestation received prophylactic exogenous surfactant, but were assigned randomly to receive it immediately following birth or after initial stabilization at 10-15 minutes, to address a then critical current issue in surfactant therapy for RDS. In the third study, infants who had moderate RDS despite exogenous surfactant therapy were randomly assigned to high frequency jet or conventional ventilation groups to determine if this mode of ventilation therapy would reduce barotrauma and the incidence and/or severity of bronchopulmonary dysplasia (BPD). In addition to these three clinical trials, another study involved therapy using superoxide dismutase (SOD) along with surfactant as a multi-modal approach treating premature infants with RDS and lung injury secondary to hyperoxia and mechanical ventilation. This study depended on results of animal studies with SOD in Project 5. Finally, the study addressed the long term evaluation and surveillance of survival, rehospitalizations, health status, pulmonary sequelae, and school performance of those infants enrolled in the randomized clinical trials, as necessary for long-term outcome assessments.

Eligibility Criteria:
No eligibility criteria
Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease

The hypothesis of this study is that participation in a formal cardiopulmonary rehabilitation program improves aerobic exercise capacity and quality of life over the medium term for patients with congenital heart disease with reduced exercise capacity. To test this hypothesis, subjects will be randomized to either receive a 12-week cardiopulmonary rehabilitation program or standard of care, with interval testing of aerobic capacity and other physiologic markers improved fitness, as well as assessment of quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to participate in a 12-week cardiac rehabilitation program and repeated cardiopulmonary exercise testing
* pVO2≤80% predicted (impaired aerobic capacity) on baseline exercise test
* congenital heart disease of at least moderate complexity

Exclusion Criteria:

* Cardiac intervention (cath/surg) within prior 6m
* Planned cardiac intervention (cath/surg) within 12m
* Formal cardiac rehabilitation within 24m
* Current/recent (delivery\<90d prior) pregnancy, planned pregnancy within 12m
* Active heart failure, hospitalization or major change in clinical status over prior 30d
* Other recent or planned events expected to have a significant impact on exercise capacity
* Baseline oxygen saturation \<92%
Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After DES Implantation

The objective of this randomized control trial is to gain clinical insight on the use of POT PTCA balloon dilatation catheter for the optimal dilation after drug-eluting stent implantation.

The current study is designed as a multicenter, randomized and prospective study aiming to compare the change in minimal stent area (MLA) of POT PTCA balloon dilatation catheter on patients with drug-eluting stent (DES) implantation. Based on the previous studies, the MLA in the proximal and distal 3mm segments was 7.38 mm\^2 and 8.08 mm\^2 before non-compliant balloon (NCB) dilation, respectively. After NCB dilation, that MSA in the proximal and distal 3mm segments was 7.53mm\^2 and 9.55mm\^2, respectively. As a result, a total of 48 patients with DES implantation are randomized at a ratio of 1:1 to either POT PTCA balloon dilatation catheter group (POT group) or Quantum Maverick balloon catheter group (NCB group) using a randomization schedule blocked by site.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures;
2. Men and women 18 years and older;
3. Patients with asymptomatic myocardial ischemia, stable or unstable angina, or acute myocardial infarction with symptoms lasting more than 12 hours;
4. The target lesions was de novo lesion;
5. Reference vessel diameter of target lesion is between 2.25-4.0mm, and the lesion length is less than 15mm(visual inspection);
6. Diameter stenosis of target lesion diameter ≥70% or ≥50%(visual) with ischemia evidence;
7. DES was successfully implanted in target lesions;
8. TIMI 3 blood flow of target vessel before post-dilation.

Exclusion Criteria:

1. Subjects had clinical symptoms and/or ECG changes consistent with ST-elevation myocardial infarction within 12 hours;
2. Allergies to concomitant medications required by the balloon/stent system or protocol used in the study;
3. Cannot tolerate dual antiplatelet therapy;
4. Life expectancy is less than 6 months;
5. Pregnant or lactating women;
6. Participating in another clinical trial and has not completed the primary endpoint observation of the trial;
7. Planned multiple operations, failed to follow the treatment prescribed in the protocol or affected data analysis and interpretation;
8. Restenosis disease;
9. Target lesions with severe calcification require rotary grinding treatment.
Interest of the Reborn® Doll as a TO in the Care of Residents With Alzheimer's Disease or a Related Disorder

The primary objective of this study is to evaluate the benefits of the Reborn®doll as an OT for the care of residents with Alzheimer's disease or related disorders, by assessing the frequency of resident agitation.

The secondary objectives are to study the frequency of treatments, evaluate the average time of exposure to the Reborn® doll, study the behavior of the residents, study the interest of this therapeutic workshop, thanks to an evaluation grid and finally study the repercussions of this OT on the nursing staff.

Dementia affects 50 million people worldwide, and this number is set to continue rising as the population ages. Indeed, the World Health Organization (WHO) expects this number to reach 82 million by 2030. At present, there is no cure for dementia. In order to limit the need for drug treatments for dementia-related symptoms (agitation, aggression), non-drug treatments can be used to improve residents' lives and soothe them. In the late 1960s, researchers turned their attention to non-medication therapies (snozelen concept, animal mediation, calinotherapy, Tovertafel, Carpe Diem, doll'therapy).

This doll is used by caregivers to calm anxiety attacks, aggression or apathy in residents with MND. The doll helps to calm the elderly by focusing them on an object. Several studies have shown that residents are calmed and feel valued by taking care of the doll. This also helps to avoid physical or chemical restraints, as well as the use of drug therapies in cases of agitation. Reborn® dolls are an evolution of Doll'therappy.

Eligibility Criteria:
Inclusion Criteria:

* Resident aged 65 and over
* Moderate to severe cognitive impairment diagnosed using the NPI-ES scale
* Behavioral disorders (agitation, aggression, anxiety, apathy) assessed using the NPI-ES scale
* Covered by a social security plan
* Written consent of representative (tutor/ curator/trusted person)

Exclusion Criteria:

* Resident or representative refusing to participate
* Resident under judicial protection
Expression of the Inhibitory Receptors on Lymphocytes T Cells After Lung Cancer Surgery.

Postoperative pneumonia is one of the most common complications after lung cancer surgery and associated with a morbidity and mortality. Postoperative lymphopenia has been recently identified as one of risk factors for postoperative pneumonia. According to recent studies in polytrauma, cancer or septic shock, T cells dysfunction may be related to high expression of inhibitory receptors on lymphocytes.

This study will investigate prospectively TIM-3, PD-1 and CTLA4 expression on lymphocytes T cells before and after lung cancer surgery. Patients ≥ 18 years with no history of immunosuppressive state will be included.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years undergoing lung cancer surgery by thoracoscopy

Exclusion Criteria:

* Patient under guardianship/curatorship
* Patient who received of radiotherapy or chemotherapy in the last 6 months
* Patient under immunosuppressive treatment or dose of corticoids over 10 mg/day prednisolone or equivalent
* Patient with history of malignant blood disease or auto-immune disease
* Patient suffering from HIV infection and
* Patients with pre-operative infection
* Patient with an empiric antibiotic therapy introduced at operating room
Levosimendan Versus Dobutamine in Shock Patients

The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine in patients with unstable hemodynamics (shock).


Eligibility Criteria:
Inclusion Criteria:

* Reduced left ventricular systolic function
* Hypotension
* Anuria or oligouria

Exclusion Criteria:

* Less than 18 years old
* Pregnant
* Uncorrected valvular stenosis
* Hypertrophic obstructive cardiomyopathy (HOCM)
* Third degree AV block
Iron Long-Term Labelling Study Switzerland

Conventional indirect indicators of iron status, using serum and red blood cell biomarkers, are confounded by inflammation from common infections and are therefore of limited use in populations carrying a high burden of infection and inflammation, as for example women of reproductive age in malaria endemic areas in developing countries. Even without the confounding effect of inflammation, current markers of iron status are insensitive to small changes in dietary iron and do not allow to establish associations between dietary, lifestyle and genetic factors and iron balance. With a new method based on the dilution of a previously administered and equilibrated stable isotope signal, an accurate measurement of long-term oral iron balance and absorption is possible, allowing the estimation of iron requirements and potentially providing fundamental guidance for supplementation and fortification programs in both healthy and chronically inflamed/infected patients. In the current study the novel methodology will be validated in generally healthy subjects with low iron status. The technique will be used to assess dietary and lifestyle determinants of iron status and to compare the effect on iron balance and iron status of three distinct, commonly used iron interventions: food fortification with iron; oral iron supplementation, and intravenous iron infusion.


Eligibility Criteria:
Inclusion Criteria:

* Have participated in a former absorption study in our lab,
* Signed written informed consent to participate in the new study,
* Serum ferritin \< 25 µg/L

Exclusion Criteria:

* Anaemia (Hb \< 117 g/L),
* Any metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement),
* Allergic or similar reactions against iron supplements,
* Known fructose intolerance, glucose-galactose malabsorption or saccharase-isomaltase deficiency,
* Known hypersensitivity to ponceau R4 and ponceau R4 aluminium salt (E124)
* Continuous/long-term use of medication during the whole study (except for contraceptives),
* Regular consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration (more than 3 consecutive days or more than 5 times within 14 days),
* Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 6 months,
* pregnancy or breast feeding,
* Intention to become pregnant during the course of the study,
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Enrollment of the investigator, his/her family members, employees and other dependent persons
Effects of Omega-3 Fatty Acids on Muscle Wasting

The risk of muscle wasting, and sarcopenia is high in the intensive care unit patients and associated with adverse clinical outcomes. The etiology of muscle wasting is multifactorial and medical nutrition therapy plays a key role in treatment and prevention. The purpose of this study is to evaluate the effect of omega-3 fatty acids in the treatment and/or prevention of muscle wasting in critically ill trauma patients.

Low skeletal muscle mass and loss of lean tissue in critically illness have been associated with negative clinical outcomes. Critically ill patients may lose about 25% of their skeletal muscle mass within 7 days of admission to the intensive care unit. Besides increased protein catabolism, other factors inherent to the ICU environment contribute to muscle loss, including patient immobility and interruptions in nutrient delivery. This combination of factors is especially debilitating in patients with preexisting low muscle stores due to sarcopenia, chronic illness, or malnutrition. Although preservation of skeletal muscle mass is important for recovery in critically ill patients, the mechanism of muscle wasting is not unknown. Muscle wasting is a multifactorial process and it may be the consequence of several events, including oxidative stress, inflammatory conditions and muscle remodeling. Omega-3 fatty acids with their anti-inflammatory, antioxidant and anabolic effects can be a key factor for an effective treatment.

Eligibility Criteria:
Inclusion Criteria:

Age ≥18 years and ≤80 years, Expected ICU stay of seven days or longer Written informed consent or requirements of local/national ethical committee

Exclusion Criteria:

Pregnancy or breastfeeding Neuromuscular conditions (e.g., multiple sclerosis, muscular dystrophy, spinal cord injury, Guillain-Barre syndrome) Current cancer or chemotherapy End-stage of renal failure or dialysis treatment or renal transplantation prior to ICU admission Burn injury History of transplantation Pretibial edema Uncontrolled hemorrhage Uncontrolled hyperlipidemia Acute pancreatitis Acute thromboembolic diseases Severe heart failure Septic shock Concurrent enrolment in a nutrition-related interventional study at the time of screening
Cognitive Behavioral Therapy and Light Therapy

Cognitive behavioral therapy (CBT-I) is a common treatment for insomnia that does not use medications. While CBT-I is effective for insomnia, it does not tend to improve the waking symptom of fatigue. Another treatment, Bright Light Therapy, is used for treating seasonal depression and sleep disorders, and may improve fatigue and physical activity in individuals with PAH. The purpose of this study to assess the effects of Bright Light Therapy compared to CBT-I to treat insomnia and fatigue in patients with PAH.

In a single site, 3-arm (Cognitive Behavioral Therapy \[CBT-I\] group; Bright Light Therapy group; Standard of Care group), parallel, randomized controlled trial we will enroll 36 subjects (n=12 per group) to assess the feasibility of Bright Light Therapy compared to CBT-I in subjects with pulmonary arterial hypertension (PAH) to treat insomnia (difficulty initiating sleep or maintaining sleep) and fatigue.

* To assess the recruitment and retention rates of CBT-I and Bright Light Therapy.
* To compare the effects of CBT-I and Bright Light Therapy to Standard of Care on (insomnia and fatigue severity) and secondary (wake after sleep onset and sleep onset latency) outcomes.
* To test the effects of CBT-I and Bright Light Therapy to Standard of Care on the secondary outcome physical activity.
* To test the effects of CBT-I and Bright Light Therapy to Standard of Care on the secondary outcomes: depression, dyspnea and QOL.

Eligibility Criteria:
Inclusion Criteria:

* PAH diagnosis
* Insomnia
* Fatigue

Exclusion Criteria:

* Untreated obstructive sleep apnea
* Subjects with left-sided valvular disease
* Hospitalized or acutely ill
* Any eye disease such as, but not limited to, cataracts, glaucoma, retinal disorders (e.g. macular degeneration), or previous eye surgery
* Subjects with photosensitivity (e.g. epilepsy)
* Manic-depressive psychosis or Bipolar Disorder
Reasons of Transfer in Emergency Units of Patients in End of Life Situation.

This qualitative study aimed to describe and understand the factors leading to the admission in emergency unit of patients coming from their home, in an end of life situation.

This study was conducted in the university hospital of Besançon, France. Semi-structured interviews were conducted with general practitioners and family members in order to understand the factors leading, from their points of view, to the admission in emergency unit whereas this hospitalization wasn't necessary.


Eligibility Criteria:
Inclusion Criteria:

* FOR PATIENTS :
* aged of 18 yo or more
* Admitted in the emergency unit of the university hospital of Besançon
* who died within the 3 days following their admission in the emergency unit
* who died of a chronic disease in terminal phase
* for whom therapeutic goals were only focused on comfort
* living at their home or at their family's home before their transfer in emergency unit
* accompanied by at least one main carer (family member or friend) and one general practitioner during the last weeks before death
* FOR MAIN CARERS :
* Family members or friends of the patient
* who were the main carers of the patient during his/her last weeks
* speaking easily in french
* who agreed for being interviewed and whom psychic and emotional state is compatible with a interview
* living within 80km from Besançon
* FOR GENERAL PRACTITIONERS :
* who were the main medical actor for the patient during his/her last weeks
* who agreed for being interviewed
* working within 80km from Besançon

Exclusion Criteria:

* FOR PATIENTS :
* Patients who expressed a wish to not die at home
* Patients who died because of any other medical event than predictable death following the terminal phase of a chronic disease
* minors
* FOR MAIN CARERS AND GENERAL PRACTITIONERS :
* refusal to participate to the interviews
The London COPD Exacerbation Cohort

The London COPD exacerbation (EXCEL) cohort builds on an established cohort started in 1995 and designed to study COPD exacerbations and their impact on health-status and disease progression.

Our intentions are to phenotype Chronic Obstructive Pulmonary Disease (COPD) patients on the basis of factors that a related to (a) exacerbation frequency which will include (b) lung function to assess disease severity, (c) baseline therapy, (d) airway and systemic inflammatory markers, (e) health status, (f) gene expression, (g) airway bacterial and viral load and (h) co-morbidity including cardiovascular disease, diabetes and psychological disease, (i) psychological factors,(j) mortality, (k) nasal susceptibility to rhinovirus infection, (l) heart rate variability (m) exhaled hydrogen sulphide.

Eligibility Criteria:
Inclusion Criteria:

* Forced Expiratory Volume in 1 sec (FEV1)/Forced Vital Capacity (FVC) ratio of \<0.70
* Able and willing to give informed and written consent

Exclusion Criteria:

* Patients with a history of asthma, bronchiectasis, carcinoma of the bronchus, or other significant respiratory disease were excluded.
* Patients on Immunosuppressive medications or with active cancer
* Long term steroid therapy
* Age \<40 years at recruitment