cyrilzakka/clinical-trials huggingface dataset:
PREdiction of succeSSful weanING From Continuous Renal Replacement Theraphy: the Possible Role of Delta C-cistatin

The goal of this observational study is to know if, in patients with acute kidney injury, naive for renal injurie, admitted to different ICUs, the change in plasma concentration of c-cistatin, between initiation and discontinuation of CRRT, is a predictive finding to optimize the withdrawal time of renal support


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years;
* diagnosis of acute kidney injury (defined according to KDIGO 2012 criteria)
* need for support with CRRT according to the indications of the nephrologist consultants and Clinical Practice
* Obtaining informed consent

Exclusion Criteria:

* CRRT already ongoing (in another department not participating in the study) at the time of transfer/admission to intensive care;
* need for RRT (any type and modality) in the 14 days prior to enrolment;
* diagnosis of AKD/CKD/ESRF on admission;
* Discontinuation of CRRT under conditions that do not comply with the criteria established by the study;
* Need for CRRT not associated with AKI condition (e.g. elimination of toxicants);
* pregnant women;
* presence of known thyreopathy
* Continuous use of corticosteroids
* patient with known neoplastic disease.
Implementing Physical Activity Guidelines for Adults With MS

The proposed project will evaluate two methods of implementation of the new Physical Activity Guidelines (PAGs) for Adults with Multiple Sclerosis (MS) living in two Ontario communities. The investigators will also determine if following the PAGs will improve aspects of fitness, function, quality of life and risk for cardiometabolic disease in this population. The investigators hypothesize that adherence to the PAGs will be higher in people who have been referred directly to a community-based exercise program, and that this greater adherence to physical activity will be associated with greater improvements in fitness, function and quality of life.

This randomized controlled trial will provide important information on how best to implement physical activity recommendations within the community setting; this information will be translated to key stakeholders during the final stages of the project.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS with mild-moderate disability (EDSS 1-7)
* Aged 18-60
* Medical clearance to participate in physical activity

Exclusion Criteria:

* current participation in regular physical activity (at least twice-weekly)
* other serious medical condition that might impair ability to participate in strength or aerobic exercise
Effectiveness of Clozapine Versus Olanzapine for Treatment-resistant Schizophrenia

This study will determine the effectiveness of clozapine versus olanzapine in treating people with schizophrenia that has not improved with treatment.

This is a two-year open-label, randomized trial of the comparative effectiveness of clozapine versus olanzapine in patients with treatment refractory schizophrenia. The objective is to determine whether in a naturalistic setting olanzapine is a logical treatment choice (before using the more toxic clozapine) for some treatment refractory patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-60 years;
* Diagnosis of treatment refractory schizophrenia or schizoaffective disorder;
* BPRS score \> 21 (0-6) scale;
* Either two 6-8 week trials of typical neuroleptics given at a dosage of 600 mg/day of CPZ or its equivalent or one 6-8 week trial of an atypical antipsychotic at a reasonable dose (i.e. risperidone 4-6 mg/day);
* The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent;
* Clinically appropriate for clozapine or olanzapine

Exclusion Criteria:

* Current substance abuse;
* Suicide or homicide risk;
* Pregnancy or lactation;
* History of seizures or blood dyscrasias
Eyenovia MiDD Usability Study

This study is to evaluate the usability and patient tolerability for microtherapeutic dosing of commercially available ocular medication via the Eyenovia microdose delivery system (MiDD)


Eligibility Criteria:
Inclusion Criteria:

* Healthy patients without significant ocular pathology and mean unmedicated diurnal intraocular pressure (IOP) in the range of of 17-27 mmHg
* Willing to forego use of contact lenses during study period
* Presence of cognition an dexterity necessary to follow MiDD drug administration instructions
* Female subjects must be 1-year postmenopausal, surgically sterilized, or if of childbearing potential, have a negative serum pregnancy test

Exclusion Criteria:

* Prior clinically significant ocular history or abnormal eye exam
* Use of ocular medication within 30 days of screening
* Use of oral steroid within 30 days of screening, or anticipated need for ocular steroid treatment during study period
* History of drug or alcohol abuse within 1 year of screening
* Lid squeezer
* Presence of disabling arthritis or limited motor coordination that would limit self-handling of the MiDD
* Participation in any interventional study of an investigational drug or device within 30 days of screening
Modeling the Impact of Inbound Call Distribution Virtualization in Emergency Medical Communication Centers (EMCCs) on Their Service Level

Fast access to the Emergency Medical Communication Center (EMCC) is essential for the population in emergency situation. It is therefore essential that these call centers operate quickly and provide good quality service. However, in recent years, EMCCs have experienced a constant and increasing demand from the population. Thus, maintaining the current organization of emergency medical communication centers raises questions about both the volume of incoming calls to EMCCs and the economic constraints, which make it difficult to manage call peaks, especially in periods of crisis.

The aim of our study is to assess the impact of incoming call distribution virtualization in EMCCs on their service quality.

France is facing political decisions on the evolution of Emergency Medical Communication Center organization to improve population accessibility. Regarding the performance targets requested by the French government (MARCUS report: http://www.urgences113.fr/marcus/Rapport_MARCUS3.pdf), the virtualization of inbound call distribution could improve EMCC service quality indicators.

The Virtualization is a process that consists of centralizing calls from different territories before distributing them to the centers concerned according to their availability. The objective through this process is to improve the population' access to the EMCC by reducing waits time. And on the other hand, to optimize the activity rate of dispatchers and physicians.

Eligibility Criteria:
Inclusion Criteria:

* All incoming calls passing through the five Emergency Medical Centers in the Pays de la Loire region (Loire-Atlantique, Maine-et-Loire, Mayenne, Sarthe and Vendée). In each center, an advanced telephone system automatically keeps track of all inbound calls.

Exclusion Criteria:

According to the French national consortium, incoming calls that hung up in less than 10 seconds are considered as dialing errors and are excluded
MK0952 in Patients With Mild-to-Moderate Alzheimer's Disease (0952-004)(COMPLETED)

MK0952 is a phosphodiesterase type IV (PDE4) inhibitor in development for improvement of cognitive impairment in mild-to-moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or females
* Age \>/= 55 years, With mild-to-moderate AD, with MMSE between 18 and 26, inclusive, MHIS score \</= 4, Global CDR score of 1 or 2
* Who have a reliable informant/caregiver to accompany patient to all clinic visits
* If using a symptomatic AD treatments, patients must be on stable dose for \>/= 6 months

Exclusion Criteria:

* Patients must not be living in nursing home or skilled nursing facility
* Patients must not have current evidence and/or history of Crohn's disease, ulcerative colitis, proctitis, GI bleeding, mesenteric arteritis
* Patients must not have current evidence and/or history of poorly-controlled hypertension, clinically significant cardiac arrhythmia, angina, or CHF
* Patients must not have current evidence and/or history of a psychotic disorder or major untreated depressive disorder
* Patients must not have current evidence and/or history of stroke or multiple lacunar infarcts, or neurological or neurodegenerative disorder (other than AD)
* Various concomitant therapy restrictions
Probiotic Supplementation in Children Affected by Upper Respiratory Infections

The goal of this randomized non-pharmacological Intervention study is to evaluate the effects of probiotic supplements (Bifidobacterium breve M-16V, Bifidobacterium lactis HN019, Lactobacillus rhamnosus HN001) on children affected by upper respiratory tract infections.

The main questions it aims to answer are:

* probiotic formulation can reduce intensity and duration of fever in children affected by upper respiratory tract infections
* probiotic formulation can influence the gut microbiota composition in children affected by upper respiratory tract infections

Participants will be asked to take probiotic supplements or placebo for 14 days and to collect three fecal samples: before probiotic supplementation (T0), 14 days after probiotic supplementation (T1), and 12 months after the enrollment (T2).


Eligibility Criteria:
Inclusion Criteria:

* Access to the Emergency room with fever and upper respiratory tract infection
* Age \> 28 days and ≤ 4 years
* Signature of informed consent by parents or guardian

Exclusion Criteria:

* Presence of pathologies associated with immunosuppression or ongoing immunosuppressant treatments
* Hospitalisation/hospitalisation
* Diarrhea at enrollment
* No signed informed consent
Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19

Feasibility trial investigating the potential higher frequency of robotic assisted early mobilization in intubated COVID19 patients on the ICU.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Invasive mechanically ventilated and expected to be ventilated for another 24 hours
* Cardiovascular stability, allowing mobilization
* Respiratory stability, allowing mobilization

Exclusion Criteria:

* Bed-bound before ICU admission
* Bed-rest order or contraindication of weight load of the lower extremity or spine
* Severe skin lesions or fasciitis in the area of contact with the device or rhabdomyolysis
* Fresh SAB, ICB or elevated ICP
* Status epilepticus
* Acute intoxication
* Shock with catecholamine doses \>0.3μg/kg/min or acute bleeding including organ ruptures
* Multiorgan failure with lactate \> 4 mmol/l
* Body height outside the range 150-195 cm
* Body weight outside the range 45-135 kg
* pAVK IV°
* Pacemakers or other electrical stimulators
* Implanted medical pumps
* Pregnancy
* Life expectancy below 7 days or acute palliative care situation
* Death inevitable or maximum therapy is not carried out by the treating physicians or due to patient's request
* Unable to understand the official language
Atrial Fibrillation Ablation Pilot Study

This is a prospective, non-randomized, multicenter, multi-country pilot study to evaluate the safety and effectiveness of the Ablation Frontiers Cardiac Ablation System for the ablative treatment of symptomatic permanent atrial fibrillation.

The study shall be conducted according to ISO 14155. Results of this research study will be used to assess the performance and safety of the System and its components. Data may be combined with similar research at additional sites to create a greater understanding of the endpoints. Up to sixty (60) patients (including "roll-in" or training patients) will be enrolled in a non-randomized study to assess the safety and efficacy of the Ablation Frontiers Cardiac Ablation System. Further studies may be performed to gather additional data regarding the safety and efficacy of the system.

Patients with a history of symptomatic permanent AF, willing and able to sign an informed consent, and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study. Comparative and descriptive statistics will be used to summarize patient outcomes for the specified study endpoints.

Eligibility Criteria:
Inclusion Criteria:

* History of symptomatic permanent atrial fibrillation
* Age between 18 and 70
* Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study

Exclusion Criteria:

* Structural heart disease of clinical significance
* Any prior ablation for atrial fibrillation
* Prior ablation for arrhythmias other than AF within the past three months
* Enrollment in any other ongoing arrhythmia study protocol
* Any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study
* Active infection or sepsis
* Any history of cerebral vascular disease including stroke or TIAs
* Pregnancy or lactation
* Left atrial thrombus at the time of ablation
* Untreatable allergy to contrast media
* Any diagnosis of AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
* History of blood clotting (bleeding or thrombotic) abnormalities
* Known sensitivities to heparin or warfarin
* Severe COPD (identified by an FEV1 \< 1)
* Severe comorbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
Whole-body Vibration Versus Aerobic Exercise on the Inflammatory Status and Hormonal Parameters Premenstrual Syndrome

The purpose of this study is to investigate and compare the effect of whole-body vibration to aerobic exercise on inflammatory status in females with premenstrual syndrome.

Premenstrual syndrome (PMS) is a complex disorder characterized by moderate to severe symptoms taking place during the luteal phase of the menstrual cycle. It has a negative impact on females' lives, which can affect their relationships, educational efficiency, social activities, and quality of life. Despite previous studies reported that physical exercise improves the symptoms of PMS, the effects of physical exercise on inflammatory status in females with PMS are not clear yet. sixty females allocated to three groups randomly to group (A) that will receive whole-body vibration+supplementation, group (B) that will receive aerobic exercises+supplementation, and group c that will receive supplementation only

Eligibility Criteria:
Inclusion Criteria:

1. Females suffering from PMS (as determined by PMS scale).
2. Their ages will range from 18 to 25 years.
3. Having regular menstrual cycle.

Exclusion Criteria:

1. Smoking.
2. Taking any medications.
3. History of chronic disease.
4. Having any psychiatric or gynecological problems
Biological Therapy in Treating Patients With Glioblastoma Multiforme

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: Phase II trial to study the effectiveness of biological therapy in treating patients with glioblastoma multiforme.

OBJECTIVES: I. Determine the time to progression in patients with glioblastoma multiforme or anaplastic astrocytoma (primary presentation) treated with surgical resection, radiotherapy, and T cell immunotherapy as initial therapy. II. Determine the toxic effects of this therapy in these patients.

OUTLINE: Patients are vaccinated with irradiated, autologous tumor cells plus sargramostim (GM-CSF) intradermally near draining lymph nodes in the groin or axillary regions. This is then followed by 3 consecutive days of intradermal injections of GM-CSF only, directly into the vaccine sites. Enlarged lymph nodes are then removed 7-10 days later and activated with staphylococcal enterotoxin A (SEA) and interleukin-2 (IL-2). T cells are expanded ex vivo over approximately 10 days. 1-2 days prior to infusion, oral cyclophosphamide is administered as a one time dose. The lymphocyte infusion is then administered intravenously. Based on availability, patients may receive vaccine boosts with additional injections of irradiated autologous tumor cells thawed from the original, cryopreserved collection. Patients are followed at 1 month and then every 2 months thereafter.

PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven glioblastoma multiforme or anaplastic astrocytoma Prior surgical resection and radiotherapy completed approximately 1 month prior to study

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 OR Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC greater than 2000/mm3 Platelet count greater than 100,000/mm3 Hepatic: No active infection with hepatitis B Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 1 month after study No active collagen vascular or autoimmune disease No prior severe reaction to any blood product No other prior malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer, carcinoma in situ or the cervix, or stage I or II cancer in complete remission Not immunologically compromised due to chronic conditions Not allergic by standard skin testing HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy with immunomodulatory effects (e.g., interleukin-2, interferon alfa) Chemotherapy: No prior or concurrent local or systemic chemotherapy Endocrine therapy: At least 1 week since prior corticosteroid therapy No concurrent corticosteroid therapy Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No concurrent antiproliferatives or immunosuppressants
The Impact of Udenafil on Exercise Capacity in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients

Pulmonary hypertension (PH) is a serious complication of COPD which is associated with shorter survival, more frequent exacerbation, and increased use of health resources. There is no effective pharmacological treatment for COPD-associated PH. Therefore, the investigators wanted to evaluate the effect of udenafil, a phosphodiesterase- 5 (PDE-5) inhibitor, on exercise capacity of severe COPD patients.

Study design

* prospective, single arm, open-label study
* Udenafil 50mg qd po for 8 weeks

Eligibility Criteria:
Inclusion Criteria:

* Severe COPD who showed post-bronchodilator forced expiratory volume in 1 second (FEV1) less than 50% of predicted value

Exclusion Criteria:

* Acute exacerbation within 4 weeks of the study entry
* Coronary heart disease
* History of adverse event on PDE-5 inhibitors
A Study to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Patients 6 to 17 Years of Age

The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of chronic migraine (CM).

Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of CM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of CM and to evaluate the immunogenicity of Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to Fremanezumab

The total duration of the study is planned to be 75 months.


Eligibility Criteria:
Inclusion Criteria:

* The participant has a clinical history of recurrent headache consistent with the diagnosis of migraine for at least 6 months before screening, consistent with ICHD-3 criteria (Headache Classification Committee of the IHS 2013), and a history of ≥15 headache days per month on average during the 3 months prior to screening (visit 1).
* The participant or parent/caregiver maintain a prospectively collected headache diary

NOTE: Additional criteria apply; please contact the investigator for more information.

Exclusion Criteria:

* The participant is using medications containing opioids (including codeine) or barbiturates (including Fiorinal®, Fioricet®, or any other combination containing butalbital) for the treatment of migraine during the 3 months prior to the day of the screening visit.
* The participant has used an intervention/device (eg, scheduled nerve block or transcranial magnetic stimulation) for the treatment of migraine or in the head or neck area for any condition during the 2 months prior to the day of the screening visit.
* The participant has a current history of a clinically significant psychiatric condition, at the discretion of the investigator. Any prior history of a suicide attempt, or a history of suicidal ideation with a specific plan within the past 2 years must be excluded.
* The participant has an ongoing infection or a known history of human immunodeficiency virus infection, tuberculosis, Lyme disease, or chronic hepatitis B or C, or a known active infection of coronavirus disease 2019 (COVID-19).
* The participant has a past or current history of cancer.
* The participant is pregnant or nursing.
* The participant has a history of hypersensitivity reactions to injected proteins, including mAbs, or a history of Stevens-Johnson Syndrome or toxic epidermal necrolysis syndrome, or the participant is concomitantly using lamotrigine.
* The participant received a live attenuated vaccine (eg, intranasal flu vaccine, and measles, mumps, and rubella vaccine) within the 12-week period prior to screening. Note: If a medical need arises during the study, the participant may receive a live attenuated vaccine.
* The patient has a current or past medical history of hemiplegic migraine.

NOTE: Additional criteria apply; please contact the investigator for more information.