cyrilzakka/clinical-trials huggingface dataset:
On-line Cognitive Training for Parkinson's Disease

Application of online cognitive training in patients affected by Parkinson's disease and mild cognitive impairment. The treatment consists of a 6-week on-line cognitive training preceded and followed by neurological, neuropsychological and motor assessment.

At the recruitment, participants will undergo a neurological visit, a neuropsychology assessment (2 tests for each considered cognitive domain: memory, attention, visuospatial, executive function, language) and a motor assessment with wearing sensors under supervised conditions.

In the treatment arm only, patients will have the Neuronation application installed on their personal technology device (smartphone or tablet) and are asked to complete 4 training session three times a week. Each session is composed of 5 exercises from one out of 4 cognitive domains: Memory, Attention, Speed and Reasoning. The training is tailor made, the complexity of the exercises is adjusted online, based on the patient's performance.

Participants are re-assessed at the end of the 6-week cognitive training (T1) to find out its effects on cognition and motor ability. The same assessment is administered also after 1 (T2) and 3 (T3) months from the end of the cognitive training to test long-term effects.

Eligibility Criteria:
Inclusion Criteria:

* Ease of use of at home internet connection
* Active presence of a caregiver to help with the use of the App
* Sufficient physical ability to use a technological device
* Signature of informed consent

Exclusion Criteria:

* Presence of systemic pathologies potentially responsible for cognitive deficits
* Presence of pathologies of the Central Nervous system potentially associated with cognitive deficits
* No access to internet connection
* Cognitive rehabilitation within the previous 6 months
* Major depression (assessed by Beck Depression Inventory at baseline)
A Randomized Phase III Study Comparing Maintenance Treatment With Fluoropyrimidine + Bevacizumab Versus Fluoropyrimidine After Induction Chemotherapy for a Metastatic Colorectal Cancer

The aim of BEVAMAINT is to improve benefic effect of maintenance therapy after a first line of induction chemotherapy for patients with colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic colorectal adenocarcinoma before induction treatment
* Measurable or non-measurable lesion before the induction treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
* Metastatic, unresectable disease according local practice after induction treatment
* ECOG performance status ≤ 2
* Disease control (complete response, partial response or stable disease) after 4-6 months of frontline induction chemotherapy with doublet (fluoropyrimidine + irinotecan or oxaliplatin) or triplet (fluoropyrimidine + irinotecan + oxaliplatin) +/- (cetuximab, panitumumab, bevacizumab) or IAH chemotherapy
* Life expectancy \> 3 months
* Age ≥ 18 years
* Patient is at least 4 weeks from any major surgery
* Total bilirubin \< 25 µmol/L, ASAT \< 3 x ULN, ALAT \< 3 x ULN (ASAT , ALAT \< 5 x ULN in case of hepatic metastasis) , PT \>60% , PAL\<2.5 x ULN ( \< 5 x ULN in case of hepatic metastasis) - Neutrophils \> 1500/mm3, platelets \> 100 000/mm3, haemoglobin ≥ 9 g/dL
* Creatinin clearance \> 30 ml/min (MDRD) - if creatinin clearance comprised between 30 and 50 ml/min, see smPCs for dose adjustments
* Proteinuria ≤ 2+ (dipstick urinalysis) (if more than 2+, so proteinuria at or ≤1g/24hour must be ≤1g)
* Patient is able to understand, sign, and date the written informed consent
* Evidence of post-menopausal status or negative urinary or serum pregnancy test for premenopausal female patients
* Male and female patients of childbearing potential agree to use a highly effective contraceptive measure
* Patient affiliated to a social security system

Exclusion Criteria:

* Myocardial infarction, severe coronaropathy or severe cardiac dysfunction less than 6 months prior randomization
* Follow-up impossible
* Patients with all metastases resected (R0/R1) after induction chemotherapy
* Patient with a hand-foot syndrome \> 1 before maintenance treatment
* Known brain or leptomeningeal metastases
* Other concomitant or previous malignancy, except: adequately treated in situ carcinoma in complete remission for \> 5 years
* Uncontrolled hypertension (defined as systolic blood pressure \>140 mmHg and/or diastolic blood pressure \>90 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy
* Pregnancy or breast feeding
* Treatment with sorivudine or analogs (brivudine)
* Treatment with phenytoin or analogs
* Partial or complete DPD deficiency (Uracilemia ≥ 16 ng/ml)
* Peptic ulcer not healed after treatment
* Any contraindication to bevacizumab or fluoropyrimidine treatments according to the updated SmPC
* Intestinal perforation or intestinal fistula
* Previous or active gastrointestinal bleeding
* Thromboembolic event and/or history of thromboembolic event
* Severe hepatic insufficiency
Comparison Between Celution Preparation and Manual Preparation of Adipocyte Derived Regenerative Cells, Using Stromal Vascular Fraction Cell Counts (COMPARE)

This scientific study is meant to establish correlation in Stromal Vascular Fraction (SVF) cell counts between our manual method of harvesting and Cytori's Celution automated system.

Future scientific studies involving Adipocyte Derived Regenerative Cells (ADRCs) will be based on SVF cell counts from the more economical manual method of harvesting if this study shows good correlation.

This study requires lipoaspirate obtained from liposuction. Lipoaspirate is typically discarded in the biohazard waste disposal system. We will be using the lipoaspirate (which would otherwise be discarded) in this study.

Lipoaspirate contains adipose tissues. With a suitable enzymatic separation method, stromal vascular fraction (SVF) can be separated from the adipose cells (adipocyte).

Adipocyte derived regenerative cells has been isolated from the stromal vascular fraction (SVF) of adipose tissues. There are two methods of obtaining the SVF from the adipose tissue in this study. One is called the manual preparation and the other the Celution preparation. The Celution preparation is an automated system, providing a constant standard by which to compare the manual preparation of SVF. This study aims to establish correlation between the manual preparation and Celution preparation.

The purpose of establishing correlation is to allow the manual preparation of SVF to be used in future scientific studies. The manual preparation has the advantage of being more economical than the Celution automated system.

In future scientific studies, we hope to establish correlation between survival rates of fat graft and SVF cell counts. Currently fat grafting is an accepted List A aesthetic procedure in Singapore to enhance facial features and in breast augmentation. However results vary widely among patients, and seems unpredictable. A possible hypothesis is that the survivability of the fat graft is dependent on the number of naturally occurring ADRCs found in the fat graft. In the future we hope to conduct a scientific study on this hypothesis using the manual preparation.

The secondary purpose for this study is to correlate SVF cell counts with the age, sex, weight, BMI and anatomical area of liposuction.

Eligibility Criteria:
Inclusion Criteria:

* patients who already opted for liposuction
* patients who consents to donate the lipoaspirate after liposuction
* patients more than 21 years of age

Exclusion Criteria:

* patients with history of organ failure
* patients with history of carcinoma
* patients who are pregnant
High Flow Nasal Cannula vs NPPV in Moderate Chronic Obstructive Pulmonary Disease Exacerbation

For moderate AECOPD(pH\<7.35), several guidelines have strongly recommended NPPV as standard therapy, which can reduce the rate of intubation and mortality. A few previous studies have shown that HFNC can efficiently improve alveoli ventilation and breathing pattern in some severe AECOPD patients. Therefore, we hypothesize that HFNC is not inferior to NPPV for preventing endotracheal intubation in moderate AECOPD patients. To assess this hypothesis, we performed a multicenter, randomized, noninferiority trial of HFNV vs NPPV in moderate AECOPD patients.

Recently, many clinical studies have showed that HFNC can be successfully used in patients with hypoxemic respiratory failure to improve the comfort, to attenuate respiratory failure and to decrease the rate of tracheal intubation and mortality. Although theoretically HFNC is a potential and ideal treatment for AECOPD patients, the related clinical researches are very few. It still needs to further evaluate the safety and efficacy of HFNC in patients with AECOPD. For moderate AECOPD(pH\<7.35), several guidelines have strongly recommended NPPV as standard therapy, which can reduce the rate of intubation and mortality. A few previous studies have shown that HFNC can efficiently improve alveoli ventilation and breathing pattern in some severe AECOPD patients. Therefore, we hypothesize that HFNC is not inferior to NPPV for preventing endotracheal intubation in moderate AECOPD patients. To assess this hypothesis, we performed a multicenter, randomized, noninferiority trial of HFNV vs NPPV in moderate AECOPD patients.

Eligibility Criteria:
Inclusion Criteria:

* AECOPD; 7.35\>pH≥7.25，PaCO2\>50 mmHg

Exclusion Criteria:

* contraindications for NPPV, such as thick sputum, cough weakness, hemodynamic instability, etc.; need to be intubated immediately; refuse to engage in the study; severe organ dysfunction
Endoscopic vs. Suction Device Calibration in Sleeve Gastrectomy

This study aims to compare the difference in staple usage and post-operative GERD (heartburn) between patients that had an endoscope used versus patients that had a suction calibration system used on them during "laparoscopic sleeve gastrectomy" (LSG).

There are multiple choices for a surgeon and their patient when it comes to weight loss surgery. One of those options is a procedure called a "laparoscopic sleeve gastrectomy" (LSG). In this procedure the majority of the patient's stomach is removed leaving behind a stapled "sleeve" about the same size as the patient's esophagus.

During this procedure there are three main devices that surgeon inserts through the mouth and in to the stomach to calibrate the size of the "sleeve". They can use a standard weighted bougie, an endoscope, or a suction calibration device. This study aims to compare the difference in staple usage and post-operative GERD (heartburn) between patients that had an endoscope used versus patients that had a suction calibration system used on them during LSG.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* agreed with a surgeon that laparoscopic sleeve gastrectomy (LSG) is the best choice

Exclusion Criteria:

* Had prior gastric surgery or bariatric surgery (including prior adjustable gastric band and/or sleeve gastrectomy)
* Concomitant hiatal surgery
* Paraesophageal hernia at time of surgery
* Any subject with prescribed immunosuppressive drugs.
* In the opinion of investigator, subject is not eligible to participate in the study.
* If patient is a female and becomes pregnant at any time during the study duration
Study to Learn More About the Benefits and Side-effects of Drugs Rivaroxaban and Apixaban Compared to the Drug Warfarin for Stroke Prevention in Patients With Rapid and Irregular Heartbeat Which is Not Due to a Heart-valve Fault (Non-valvular Atrial Fibrillation) in the UK Routine Clinical Practice

This population-based study will identify patients with rapid and irregular heartbeat which is not due to a fault with the heart valves (non-valvular atrial fibrillation) who initiate rivaroxaban, apixaban or warfarin as treatment for Stroke Prevention in Atrial Fibrillation (SPAF). Purpose of the study is to learn more about the safety and how well the drugs rivaroxaban, apixaban and warfarin work in patients appropriately and inappropriately receiving standard and reduced doses of each drug for reducing the risk of stroke in atrial fibrillation. Real world data from routine general practice stored in the primary care database in the UK, The Health Improvement Network (THIN), will be used for investigation.

Primary objectives are to assess the safety and effectiveness of rivaroxaban, apixaban and warfarin based on the risk of intracranial hemorrhage and hemorrhagic strokes (safety) and ischemic stroke, systemic embolism and myocardial infarction (effectiveness). Secondary objectives comprise the assessment of the mentioned risks in subpopulations of patients with renal impairment or diabetes, mortality rates, and drug utilisation as well as patient characteristics before and after the first intracranial hemorrhage or ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-valvular atrial fibrillation
* New users of rivaroxaban, apixaban or warfarin
* At least one year enrollment with the general practice (GP)
* One year since first health contact recorded in THIN prior to the first prescription of a study drug

Exclusion Criteria:

* Patients with other recent indications of oral anticoagulant initiation
* Individuals on more than one oral anticoagulant on the start date
* Users of rivaroxaban apart from 15 / 20 mg daily dose
* Users of apixaban apart from 5 / 10 mg daily dose
Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers

OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost ophthalmic solution are administered once daily for 7 days and the effect on the blood concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating the combination drug will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are considered medically healthy per investigator's judgment

Exclusion Criteria:

* Subjects with ocular conditions as defined by the protocol
* Subjects with intraocular pressure: \<10 or ≥22 mmHg
Follow-up of Psychological and Neurocognitive Gulf War Outcome: Relation to Stress

This is the follow-up to an observational epidemiological study of psychological and neuropsychological outcomes of deployed and non-deployed Gulf War-era veterans.

Approximately 800 deployed and 250 nondeployed veterans were originally administered psychological assessment instruments shortly after the cessation of the Gulf War. These veterans are currently being followed to evaluate longer-term psychological outcomes in relation to war-zone stress, intervening life stress, and individual difference factors and personal resources, such as coping and social support.

Approximately 75 of these veterans, oversampled for post-traumatic stress disorder, were administered a specialized neuropsychological battery emphasizing attention and memory. This sample will also be followed to evaluate longitudinal neuropsychological outcome in relation to PTSD status.

A cross-sectional study will also be conducted examining visual, hierarchical attention in relation to PTSD diagnosis.

Eligibility Criteria:
Participation in Time 1 data collection
Recovery of Ventilation After Anesthesia for Laparoscopic Nephrectomy

The purpose of this randomized, controlled feasibility investigation is to characterize pharmacologically induced ventilatory depression after anesthesia and examine how is affected by the amount of supplemental oxygen patients are receiving in the immediate postoperative period.

The purpose of this study is characterize pharmacologically induced ventilatory depression after anesthesia and examine how is affected by the amount of supplemental oxygen patients are receiving in the immediate postoperative period, since hyperoxemia (ie., higher than necessary partial pressure of oxygen in the arterial blood) has been associated with ventilatory depression via suppression of the hypoxic ventilatory drive.

In this feasibility randomized controlled trial, the investigators plan to estimate and compare the cumulative segment of time during which the transcutaneous partial pressure of carbon dioxide will exceed an upper limit of 45 mmHg (i.e., TcPCO2 \> 45 mmHg) for the 90-min-long post-anesthesia period, between the conventional (titrated to an oxygen saturation \> 96%) and the conservative (titrated to O2 saturation 90 -94%) O2 supplementation interventions.

Hypothesis: Conservative use of O2 (titrated to an SpO2: 90 - 94%), will be associated with less hypoventilation (i.e., less time spent with an TcPCO2 \> 45 mmHg) during recovery from general anesthesia, compared to liberal O2 supplementation (SpO2 \> 96%).

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-III
* Body mass index (BMI) less than 40 kg/m2
* Scheduled to undergo robotic-assisted radical laparoscopic nephrectomy.

Exclusion Criteria:

* Patients with a diagnosis of chronic obstructive pulmonary disorder (COPD), severe neurological, cardiopulmonary, psychiatric, or untreated thyroid disorder
* Chronic pain condition that is being treated with opioids
* Patients with a hematocrit lower than 30% at the end of surgery, or those with an excessive blood loss, requiring transfusion of blood products during their surgery, will be also excluded from the study.
Computer Assisted Volumetric Analysis of CT-Identified Metastatic Pulmonary Or Hepatic Lesions

The purpose of this study is to evaluate the ability of a new type of CT computer program(MeVis™)to accurately analyze and measure the size and changes in metastatic Liver and Lung tumors. This study will evaluate the data from current CT evaluation methods using the MeVis™ 3-D software.

This is a Pilot Study that will evaluate if metastatic liver and lung tumor measurements made by the MeVis™ software program can provide more accurate information about the size and changes of the tumor compared to the current evaluation method, RECIST(Response Evaluation In Solid Tumors). This study will also collect information about the kind of treatment each subject receives.

Subjects will receive standard of care surveillance CT examinations(a baseline to document tumor size and interval CT exams as indicated by the Oncology Department Protocols); the tumor will be measured according to the current standard-RECIST by Radiology personnel not involved in the study. The CT data will then be analyzed by investigators using the MeVis™ software.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with cancer metastatic to either the liver or lungs
* Subjects Scheduled for regular CT surveillance examinations
* Subjects with life expectancy of at least 6 months

Exclusion Criteria:

* Age \<18 years
* No written informed consent
Acute Effects of Moderate Intensity Aerobic Exercise on Cognitive Functions in Young Adult Males

60 healthy male university students will be included in this study. Physical fitness parameters, fluid intelligence, and physical activity level will be measured at baseline. Participants will be randomised to one of two testing schedules, groups will complete either a 30-minutes aerobic exercise session or a resting control condition. Cognitive measures (simple reaction time task, go/nogo task, spatial cueing, n-back task) will be tested before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* No known psychiatric, cognitive or physical health problems
* No limiting issue for performing exercise according to Physical Activity Readiness Questionnaire (PAR-Q+)
* Physical activity level according to International Physical Activity Questionnaire (IPAQ) \< 3000 MET

Exclusion Criteria:

* Discomfort/illness that will interfere with physical activity
* Using any medication or stimulants
* Having limitations for performing exercise according to Physical Activity Readiness Questionnaire (PAR-Q+)
Verification of the Safety of Normal Food Before a Cerebral Arteriography

Fasting is currently required before elective cerebral angiography, despite numerous arguments against fasting (kidney toxicity, vasovagal reaction, discomfort) and seams unusefull regarding it's main goal : reducing nausea and vomiting. The investigators propose to assess frequency of nausea and vomiting among patients having taken their breakfast at home before day care angiography.

The investigators hypothesise that less than 1% of non fasting patients will suffer of vomitint.

Fasting is currently required before elective cerebral angiography, despite numerous arguments against fasting (kidney toxicity, vasovagal reaction, discomfort) and seams unusefull regarding it's main goal : reducing nausea and vomiting. The investigators propose to assess frequency of nausea and vomiting among patients having taken their breakfast at home before day care angiography.

The investigators hypothesise that less than 1% of non fasting patients will suffer of vomitint.

Eligibility Criteria:
Inclusion Criteria:

* Adult,
* non fasting,
* day care hosptilalisation

Exclusion Criteria:

* Childs,
* pregnancy,
* parenteral nutrition,
* nausea,
* vomiting before arteriography,
* arteriography under general anesthesia
Scale Up of Project Workout on Wheels Internet Intervention (WOWii)

This study is designed is to test the feasibility, fidelity, and effectiveness of scaling up an evidence- and theory-based virtually delivered physical activity intervention (WOWii) for individuals living with chronic SCI for delivery through other rehabilitation settings. The study outcomes address (1) feasibility based on participant enrollment, retention, and program engagement; (2) fidelity of intervention delivery; and (3) program effectiveness based on subjective and objective exercise data, and participant exercise perceptions regarding self-efficacy and barriers.


Eligibility Criteria:
Inclusion Criteria:

* more than 12 months post SCI
* requires use of wheelchair due to SCI
* receive signed approval from medical provider to initiate moderate-intensity exercise program
* have internet access via computer, tablet, or smartphone
* provide informed consent

Exclusion Criteria:

* already engaged in engaged in sufficient physical activity to meet CDCP guidelines
* cognitive of language impairments that would affect ability to participate
* presence of medical issue for which exercise is contraindicated
* pregnancy