cyrilzakka/clinical-trials huggingface dataset:
Reporting Usual Physiotherapy Care in Stroke Survivors in Catalonia

Stroke is one of the major leading causes of death and disability globally and presents a high interest of research around all its branches, including rehabilitation. There are published recommendations and clinical guidelines to guide the care of stroke patients with regard to physical therapy. However, the status of current clinical practice is unknown.

This study aims to identify and describe the therapeutic approaches most used by physiotherapists in Catalonia in the care of stroke survivors in different phases of evolution.

An observational study will be carried out through an anonymous survey of physiotherapists in Catalonia. Through the College of Physiotherapists of Catalonia, all members will be invited to answer a survey on current clinical practice in the care of stroke survivors. The survey will collect data related to the physiotherapist's training and experience, the most frequently used therapeutic approaches, user profiles and institutions. It is intended to collect the data between October 2022 and February 2023. The data will be analyzed by the team of researchers


Eligibility Criteria:
Inclusion Criteria:

* Physiotherapists who are currently working in Catalonia with patients who have suffered a stroke.

Exclusion Criteria:

* Physiotherapists do not currently work with at least one stroke patient
PRESERFLO® MicroShunt Extension Study

This prospective, concurrent controlled, open-label, multicenter study is designed to collect additional safety data through 5 years of follow-up for subjects randomized to either the treatment arm (PRESERFLO® MicroShunt with MMC) or the control arm (Trabeculectomy with MMC) of the INN-005 clinical study.

The objective of this study is to evaluate the long-term safety of the PRESERFLO® MicroShunt in subjects with Primary Open-Angle Glaucoma who have completed their Month 24 Follow-Up Visit in the INN-005 clinical study, by collecting safety data through 5 years post-operative follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has completed their Month 24 Follow-Up Visit in the INN-005 clinical study conducted under IDE G130028.
2. Subject was randomized into the INN-005 study and received the PRESERFLO® MicroShunt device or trabeculectomy. (Subjects who have had the device explanted, or replaced with another device, may be included).
3. Subject is willing and able to comply with all study requirements, including signing an informed consent form.

Exclusion Criteria:

1. Subject has exceeded the timeframe for the Month 60 Follow-Up Visit prior to enrollment for participation in this long-term follow-up study.
Self-operated Endo-vaginal Telemonitoring (SOET), an Economic and Patient-empowered Method for Ovarian Stimulation for In-vitro Fertilization (IVF)

The SOET project introduces a new strategy for routine follow-up of follicle growth during the hormonal treatment phase of an in-vitro fertilization (IVF) treatment cycle. After a learning instruction and demo, patients should be able to perform most of their vaginal echoes at home. The images can be sent to the medical center over the internet. These images are analyzed by the expert.


Eligibility Criteria:
Inclusion Criteria:

* Woman, suffering from subfertility.
Central Venous to Arterial CO2 Difference and Low Cardiac Output Syndrome Related Outcomes in Children After Cardiac Surgery

The goal of this clinical trial is to compare the capability of 3 different bedside surrogates in children who underwent cardiac surgery and were admitted in intensive care unit. These test are lactate, oxygen saturation from central venous and the carbon dioxide gap between central venous and arterial.

The main questions is which one is the best prognostication for post operation poor outcomes Participants will be taken routine blood test for post cardiac care (at ICU arrival, 6, 12, and 24 hour post operation) and follow the their outcomes. There is no any intervention or drug in this research


Eligibility Criteria:
Inclusion Criteria:

* Children aged 0-18 years old with either congenital or acquired cardiac disease
* Undergone cardiopulmonary bypass for cardiac surgery
* Be admitted in PICU for post-operative care

Exclusion Criteria:

* Preterm infant (GA \< 37 weeks) or weight less than 2 kg
* Patient who weaned off cardiopulmoanry bypass and required extracorporeal membrane oxygenator (ECMO) before leaving the operating room
* Patient who required emergency cardiac operation within 24 hour after hospitalization
* Patient who had significant residual left side outflow tract obstruction (e.g., coarctation of aorta, interrupted aortic arch) which defined by difference of SBP between upper and lower extremities more than 10 mmHg
* Patient who had already participated in another research project
* Patient who does not have both arterial line and central line catheter back from operating room
* Parents or legal guardian refuse to inform consent.
Impact of Atelectasis on RVEDP Following Orthotropic Heart Transplantation

Following orthoptopic heart transplantation (OHT), children undergo surveillance cardiac catheterizations to assess for signs of rejection including muscle biopsy as well as pressure measurements to guide post transplant treatment regiments. These procedures are done under general anesthesia which promotes lung tissue collapse (atelectasis). What is not known is the effect of atelectasis on intracardiac pressures which are a critical area of monitoring post-transplant patients for rejection.

Following orthoptopic heart transplantation (OHT), children undergo surveillance cardiac catheterizations to assess for signs of rejection including muscle biopsy as well as pressure measurements. These procedures are done under general anesthesia which promotes lung tissue collapse (atelectasis). Atalectaisis is known to alter intra-thoracic pressures and cardiac loading conditions. What is not known is the effect of atelectasis on intracardiac pressures which are a critical area of monitoring post-transplant patients for rejection. Therefore, the aim of this study is to identify if atelectasis impacts the pressure measurements obtained during cardiac catheterization.

Eligibility Criteria:
Inclusion Criteria:

* Patients having undergone orthotropic heart transplantation
* Patients requiring routine heart catheterization for post-transplant surveillance
* General anesthesia

Exclusion Criteria:

* Patient/parental refusal
* Patients with suspected or known acute rejection
* Known anti-rejection medication non-compliance
* Patients within 1 year following heart transplant
* Home oxygen requirement
* Previous lung surgery (e.g., lobectomy) other than biopsy
* Lung transplantation
* Known pulmonary fibrosis
* Known pulmonary hypertension (\>1/2 systemic)
* Sedation without the use of an airway device
* Active respiratory infection -Inability to provide recruitment breaths \>25mmHg -Cardiomegaly
* Recipient/donor size mismatch
Buprenorphine Disposition and CYP3A

To evaluate role of CYP3A in buprenorphine disposition and effect

Subjects will be studied during a maximum of seven occasions.

Study drugs are intravenous buprenorphine (0.025-0.2 mg infused over 1 hr) and sublingual buprenorphine (2-4 mg), with 1-3 week washout between sessions.

Sessions 1\&2: Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV)

Sessions 3\&4: Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine

Session 5: Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine

Sessions 6\&7: Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and sublingual buprenorphine

Eligibility Criteria:
Inclusion Criteria:

Each subject must meet all of the following criteria:

1. Male or non-pregnant female volunteer, 18-50 yr old
2. Good general health with no known major medical conditions
3. BMI \< 33
4. Provide informed consent

Exclusion Criteria:

Subjects will not be enrolled if any of the following criteria exist:

1. Known history of liver or kidney disease
2. Use of prescription or non-prescription medications, herbals or foods known to be metabolized by or affect CYP3A activity (this includes the use of oral contraceptives).
3. Females who are pregnant or nursing
4. Known history of drug or alcohol addiction (prior or present addiction or addiction treatment)
5. Direct physical access to and routine handling of addicting drugs in the regular course of duty (this is a routine exclusion from studies of drugs with addiction potential)
Aging and Frailty Study

The purpose of this research study is to compare methods to help personalize the prediction of chemotherapy side effects for older adults and to evaluate whether chemotherapy causes changes in the body that are associated with aging.

Primary Objective: Describe mean and variation of the electronic frailty index-cancer, geriatric measures, patient reported outcomes, and biomarkers of aging of chemotherapy, and their change.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years and older
* Planned to initiate a new chemotherapy regimen
* Solid tumor malignancy of any stage or lymphoma
* Any performance status
* Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
* Life expectancy of ≥3 months

Exclusion Criteria:

* Initiating biologic, endocrine or immunotherapy only.
* Hematologic malignancy other than lymphoma.
* Concurrent radiation therapy.
* Planned inpatient chemotherapy.
Drug Intervention in Chronic Fatigue Syndrome

Based on pilot patient observations,the investigators anticipate that chronic fatigue syndrome (CFS) patients may benefit from B-cell depletion therapy.

The hypothesis is that at least a subset of CFS patients have an activated immune system involving B-lymphocytes, and that B-cell depletion may alleviate symptoms.


Eligibility Criteria:
Inclusion Criteria:

* verified chronic fatigue syndrome (CDC-criteria)
* age \>18 and \<60 years
* informed consent

Exclusion Criteria:

* pregnancy or lactation
* previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ
* previous long-term use of immunosuppressive drugs
* previous exposure to rituximab
* endogenous depression
* multi-allergy with risk of serious drug reaction
* reduced renal function (creatinin \> 1.2 x UNL)
* reduced liver function (bilirubin or transaminases \> 1.5 x UNL)
* known HIV infection
* signs of active viral infection by pretreatment investigations
Medico-economical Evaluation on Buccodental Teleexpertise in Nursing Home

Oral care in medical and social institutions is a real public health problem. The impact of poor oral health on the general state of residents but also on their overall quality of life is significant.

The development of a precise regulatory framework for telemedicine in France aims to transform experiments into sustainable medical activities. Odontology often set aside in this reflection, must be reintegrated. The use of tele-expertise for the oral care of nursing home residents should make it possible to replace oral health in medico-social institutions. The investigators will assess in a cluster randomized controlled study whether the buccodental telemedicine has a viable economic model and a significant impact on the overall health of facility for dependent elderly persons residents.

The medico-economic impact of the buccodental telexpertise is fundamental for the development of this innovative activity.


Eligibility Criteria:
Inclusion Criteria:

* Be resident of a facility for dependent elderly persons involved in the study
* Have given their Free, informed and signed consent
* Beneficiary or member of a social security scheme

Exclusion Criteria:

* incapacity to open the mouth
* contrary opinion of the medical team (end of life)
* Change of nursing home planned within 6 months
* Subject in a period of relative exclusion from another protocol
* Subject's participation in another study
* Subject deprived of liberty by judicial or administrative decision
Evoked Potential Response to Full-endoscopic Cervical Foraminotomy

Cervical foraminotomy is used to treat recalcitrant foraminal stenosis in the cervical region. This foraminotomy can be performed under endoscopy. The irrigation pressure used to allow adequate visualization of the anatomical structures is usually between 40 and 50 mmHg. This pressure has no adverse effect intraoperatively on motor evoked potentials but its effect on somesthetic evoked potentials has not yet been studied. The purpose of this study is to validate the absence of disruption of somatosensory evoked potentials by endoscopic cervical foraminotomy


Eligibility Criteria:
Inclusion Criteria:

1. Cervical radiculopathy due to foraminal stenosis
2. Age \> 18 years
3. Radicular arm pain that were refractory to optimal medical therapy for a minimum of 3 months.
4. Persistent pain despite 3 types of pharmacological treatments (paracetamol, non-steroidal anti-inflammatory drugs, opioids, antidepressant medications, and anticonvulsant medications, etc.).
5. Intact Llemniscal pathways must remain at least partially intact

Exclusion Criteria:

1. History of coagulation disorders; Lupus erythematosus; diabetic neuropathy; rheumatoid arthritis; Morbus Bechterew; Active malignancy; immune deficiency
2. Presence of myelopathy
3. Addiction to drugs, alcohol (5 units/day) and/or medications
Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation

This study is the extension of the CLARINET study \[NCT00396877 -EFC5314\] in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt.

The primary objective was to assess the safety up to 18 months of age of the extended use of Clopidogrel 0.2 mg/kg/day in patients for whom the shunt was still in place at one year of age.

The secondary objective was to assess the efficacy on the occurrence of shunt thrombosis requiring intervention or any death.

Patients remained in the treatment group to which they were originally allocated for the CLARINET study and continued blindly their treatment (0.2 mg/kg/day of clopidogrel or placebo) up to the occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first. The maximum treatment duration were 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients randomized in the CLARINET study,
* Still receiving the study drug,
* Palliative systemic-to-pulmonary artery shunt still in place at 1 year of age,
* Investigator's decision to continue based on his/her judgment of the expected benefit / risk of continuing treatment with study drug,
* Signed informed consent to participate in the long-term safety study.
Continuous Glucose Monitor Application After Hospital Discharge for the Improvement of Outcomes in Patients With Poorly Controlled Type 2 Diabetes and Active Cancer

This clinical trial studies the effect of a continuous glucose monitor application in improving outcomes in patients with poorly controlled type 2 diabetes and active cancer. Patient satisfaction with type 2 diabetes management influences medication-taking behavior as well as health outcomes. Adding continuous glucose monitor application to diabetes treatment plan after hospital discharge plan may improve patient satisfaction and reduce diabetes distress.

PRIMARY OBJECTIVE:

I. Evaluate if addition of continuous glucose monitor (CGM) to diabetes treatment plan following inpatient hospitalization is associated with improved patient satisfaction with DM management in patients with cancer and poorly controlled type 2 diabetes mellitus.

SECONDARY OBJECTIVES:

I. Evaluate feasibility of CGM initiation upon hospital discharge. II. Evaluate effect of CGM on recognition of post-hospitalization hypoglycemia. III. Evaluate patient reported outcome of CGM incorporation into patient diabetes care burden.

IV. Evaluate effect of CGM on depression score before and after CGM use.

OUTLINE:

Prior to hospital discharge, patients receive CGM application and education on how to apply the CGM, and how to use the sensor and its associated smart phone application (app). Patients also receive basic diabetes mellitus education. After hospital discharge, patients use CGM for up to 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Insulin use \> 10 units per day
* Hemoglobin A1c \> 8.5%
* Smart phone compatible with LibreView App

Exclusion Criteria:

* Type 1 diabetes mellitus (DM)
* Inability to consent
* Pregnancy
* Prisoners
* Discharge to skilled nursing facility
Proteome Remodelling

The purpose of the project is to investigate the proteome signature dynamics and remodelling in human skeletal muscle induced by exercise training


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* VO2max \> 55 mL/min/kgLM for men and \> 50 for women (only applicable for endurance and sprint training interventions)
* BMI \< 26

Exclusion Criteria:

* Chronic disease deemed by the medical doctor to pose a risk or to affect study outcomes
* smoking
* Use of prescription medicine deemed by the medical to affect study outcomes
* Pregnancy
Investigation of the Cerebrospinal Fluid and Further Tissue Samples for Biomarker Indicating Spinal Ischemia and Organ Failure in Patients With Thoracoabdominal Aortic Aneurysm

Patients with a thoracoabdominal aortic aneurysm in need of an endovascular or open operative restructuring will be asked to participate in this study. After obtaining written consent a central venous catheter and a liquor drainage will be routinely placed during surgery. The catheter and the drainage will stay in the patients for at least 72 hours postoperatively. In total, nine measurements of the liquor and serum will be performed within a week in order to determine the following parameters: neuropeptide P, neuropeptide Y, neurofilament triplet protein (NFL), S100B, glial fibrillary protein (GFAp), lactate, glucose, or oxygen.

Patients with complex aortic diseases receiving an operative treatment are under risk of spinal cord damage due to insufficient blood circulation of the spinal cord during surgery. The risk depends on comorbidities, extent of surgery, and the perioperative management. Despite an adequate preoperative imaging, assessment of the blood circulation of the spinal cord during endovascular or open operative restructuring is struggling. Beside the monitoring possibilities of the spinal cord functions during surgery, insufficient approaches regarding early detection of spinal ischemia by using laboratory parameters exist. Several biomarker, e.g. neuropeptide P, neuropeptide Y, neurofilament triplet protein (NFL), S100B, glial fibrillary protein (GFAp), lactate, glucose, or oxygen, will be evaluated singularly or as a bundle of markers in small patient groups. Surgeries of thoracoabdominal aortic aneurysms are associated with high risks despite already existing high standardized procedures (Cowan et al. 2003). The major complications are cardiovascular, renal, pulmonary, gastrointestinal complications, and ischemias of the spinal cord. Especially, the ischemia of the spinal cord is a feared complication caused by the irreversibility and the small time frame.

During the study samples of liquor and tissues (serum, urine) will be drawn pre-, peri- and postoperatively. Patients will receive a routinely placed liquor drainage due to the temporal duration in surgery. The liquor drainage stays in the patient also in the early postoperative phase. Hence, the patient will not be bothered with additional examinations. Additionally, biomaterial (blood) will be drawn routinely and used for the biomarker measurement as well as biobanking.

Eligibility Criteria:
Inclusion Criteria:

* presence of thoracoabdominal aortic aneurysm
* endovascular or open operative restructuring
* age\>18 years
* given written consent
* subjects, who are mentally and legally capable to understand the scope of the trial and comply with the protocol

Exclusion Criteria:

* local skin infection (cutaneous fungus, acne)
* pregnant or lactating females
* parallel participation in another clinical trial
* incarcerated subjects
* subjects, who are in an interdependency with the sponsor or investigator
Prehospital Stroke Study at the Universitair Ziekenhuis Brussel I (PreSSUB I)

The PreSSUB trial I will focus on prehospital telemedicine for patients with suspicion of acute stroke. The study is designed as a prospective monocentric observational trial on the safety, feasibility and reliability of in-ambulance telemedicine for patients with suspicion of acute stroke during transportation by the Paramedic Intervention Team of the Universitair Ziekenhuis Brussel.

As part of the Prehospital Stroke Study at the Universitair ziekenhuis Brussel (PreSSUB) project, the investigators have developed and tested several prototypes for prehospital telemedicine. The current system consists of commercially available hardware and a Web-based telemedicine platform. The data are transmitted to a multimedia server unit over a mobile (ultra)broadband connection (3G or 4G). Data privacy is secured by password-protected logins, role-based access control, and hypertext transfer protocol secure encryption.

The results of a feasibility study using the 4G network in healthy volunteers have been reported and feasibility data using the 3G network in healthy volunteers are available (unpublished data). The investigators recently evaluated the safety, technical feasibility and reliability of in-ambulance telemedicine in patients during emergency missions by a Paramedic Intervention Team of the Universitair Ziekenhuis Brussel (Feasibility study on AmbulanCe-based Telemedicine, FACT) and yielded satisfactory results (paper under review, trial registered at clinicaltrials.gov: NCT02119598).

Telestroke consultations should include standardized evaluation of key stroke features, which can be obtained by application of validated clinical scales (e.g. Glasgow Coma Scale for evaluation of consciousness). Prehospital assessment of stroke severity remains challenging and inspired researchers to develop adapted scales, among which the Unassisted TeleStroke Scale (UTSS). The UTSS has shown to be a rapid, simple, quantitative measure for the evaluation of stroke severity through telemedicine, without need for assistance from a third party at the patient's bedside. Moreover, it has been shown that this scale can be used for ambulance-based telemedicine for emergent patient transportation.

The PreSSUB trial I builds further on the reassuring data obtained in a general patient population during emergency missions in the FACT study and will focus on prehospital telemedicine for patients with suspicion of acute stroke only.

Eligibility Criteria:
Inclusion Criteria:

* Emergency transportation by the Paramedic Intervention Team of the Universitair Ziekenhuis Brussel
* Age \>= 18 years
* Suspicion of acute stroke with symptom onset \<12 h or unknown, based on any of the symptoms mentioned in the Belgian manual for medical regulation of pre-hospital care: Hemiparesis, Facial asymmetry, Speech disturbance, Sudden, severe headache, or Confusion.

Exclusion Criteria:

* Patients for whom telemedicine consultation would delay any diagnostic or therapeutic intervention.