cyrilzakka/clinical-trials huggingface dataset:
The COMPLETE Study

The COMPLETE study is a single-centre, investigator-initiated study of patients with an indication for invasive coronary angiography with CCTA performed during the diagnostic evaluation. After identifying the presence of a coronary stenosis, defined as an epicardial lesion \>50% stenosis on CCTA, patients eligible for the study will be invited to participate.

The main aim of this trial is to assess the accuracy of coronary CT angiography to quantify total atheroma volume with intravascular ultrasound as reference.

Patients will be divided into 2 sub-groups:

Cohort 1: Patients with stable coronary artery disease or stabilized acute coronary syndromes with a clinical indication for invasive coronary angiography.

Cohort 2: Patients previously revascularized with a metallic stent with a clinical indication for invasive coronary angiography.

In both cohorts, patients should have undergone coronary CT angiography as part of the standard of care.

Patients included in the study will be managed according to the standard of care for the assessment of coronary artery disease. Clinical follow-up will be collected until 3 years follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Epicardial stenosis more than 50% by visual assessment.

Exclusion Criteria:

1. STEMI.
2. Hemodynamic instability.
3. Rapid atrial fibrillation, flutter or arrhythmia (HR \> 80 bpm).
4. Insufficient CCTA image quality.
5. Age \<18 years.
6. Chronic obstructive pulmonary disease.
7. Contraindication to adenosine.
8. NYHA class III or IV, or last known left ventricular ejection fraction \<30%.
9. Uncontrolled or recurrent ventricular tachycardia.
10. History of recent stroke (≤90 days).
11. Prior myocardial infarction.
12. History of ischemic stroke (\>90 days) with modified RANKIN score ≥ 2.
13. History of any hemorrhagic stroke.
14. Previous coronary artery bypass surgery.
15. Active liver disease or hepatic dysfunction, defined as AST or ALT \> 3 times the ULN.
16. Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2.
17. BMI \>35 kg/m2.
18. Nitrate intolerance
19. Contra-indication to heart rate lowering drugs.
20. Unable to provide written informed consent.
Molecular Signature From Tumor to Lymph Nodes

Mediastinal lymph node (LN) involvement (N2) in non-small cell lung cancer (NSCLC) concerns 15% of resectable tumors and is associated with a poor prognosis and an overall survival reaching 9 to 49%. Literature fails to provide any definitive consensus regarding the management of these patients, except for the platinum-based doublet chemotherapy. The N2 involvement remains a matter of debate because of its not yet well-classified heterogeneity. Regarding anatomy, the Mountain and Dresler's regional LN classification for lung cancer staging remains the reference. Different studies classified IIIA-N2 disease into 4 groups, in addition to the skip-N2 phenomenon: minimal-N2, N2 single station, N2 multiple stations, and bulky-N2. Other subgroups were recently proposed for the 8th edition of the TNM: N2a1 - single station skip, N2a2 - single station non-skip, N2b - multiple stations.

The French National Cancer Institute (INCa) proposed guidelines, but in case of cN2 staging without mediastinal infiltration, guidelines remained imprecise ("resectability should be discussed for each case") and suggested surgery first, or induction chemotherapy, or concomitant chemoradiation.

Thus, optimal management of cIIIA-N2 remains controversial but complete tumor resection can be related to long-term survival in some patients, including 10 years after surgery \[1\]. In this situation, the identification of markers that will help select IIIA-N2 patients who will benefit from surgical resection is mandatory.

We planned a comprehensive molecular characterization of tumors and lymph nodes to evaluate the impact of molecular signatures and molecular heterogeneity on disease-free survival after surgery in IIIA-N2 NSCLC patients. Identification of specific molecular profiles in primary tumors and evolution profiles in nodes might provide clues to the potential risk of metastatic evolution and trigger specific management.

For patients included prospectively, we planned to analyze cell free circulating tumor DNA (ctDNA) as prognostic marker. Because multiple biopsies are not always available in care settings, ctDNA could also be analyzed as a surrogate marker of molecular heterogeneity. Next generation sequencing (NGS) that was validated in our lab to screen ctDNA using a specific bio-informatics workflow allows accurate and cost effective ctDNA screening

Eligibility Criteria:
Inclusion Criteria:

* Adult patient, men and women age \>18 years
* Patients operated with a curative intent for an IIIA-cN2 NSCLC
* Social security affiliation
* Written informed consent for patient included in part 2 (prospective) or not opposing the use of this data for patient included in part 1 (retrospective)

Exclusion Criteria:

* Patient with T4, R1 or R2 surgical resection, sublobar resection, no radical lymphadenectomy
* Patient under protectives measures
* Pregnancy or breast-feeding
Frenkel's Exercises for Sub-Acute Ischemic Stroke Patients

This single-blinded, randomized controlled was aimed to compare the efficacy of Frenkel's and Conventional Balance Exercises in improving balance and quality of life in patients with subacute ischemic stroke. The participants of Group A received 'Frenkel's Exercises'. In contrast, Group B participants received 'Conventional Balance Exercise' interventions three days/week for 30-60 minutes for four weeks. The data was collected pre and post-treatment on the Berg Balance Scale and Stroke Specific-Quality of Life.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between 35 to 75 years.
2. First-ever ischemic stroke and hemiparesis within 7 to 30 days of onset.
3. Reduced proprioception of the lower limb with a score of ≤12 on the NSA (kinesthetic and tactile sensation test),
4. Able to comprehend tasks and follow directions with a score of ≥21 points on the Mini-Mental State Examination (MMSE).
5. Able to independently perform standing motions for ≥1 minute.

Exclusion Criteria:

1. Patients with lower limb fractures within 6 months.
2. Severe pain.
3. Limited range of motion.
4. Cerebellar ataxia.
5. Medically unstable.
Efficacy of School-Based, Peer-Led Asthma and Smoking Prevention Program on CO1 Levels and Smoking Behavior Among Early Adolescents in Jordan

Study Hypotheses:

1. adolescents in intervention schools who are given Triple A program plus ASP will show more awareness in regards to cigarettee smoking health effects and less nicotine dependencethan those in the control schools who are given Triple A alone.
2. adolescents with asthma in intervention schools who are given Triple A program plus ASP will show less asthma symptoms and better control than those in the control schools who are given Triple A alone.
3. adolescent smokers and passive smokers will exhibit higher levels of carbon monoxide (CO) in their breath than those who are not active or passive smokers.
4. there is a positive correlation between self-report questions regarding student smoking status and levels of CO in their breath


Eligibility Criteria:
Inclusion Criteria: students in grades 7 and 8 in Irbid city high schools, can speak and read in both Arabic and English, obtain parental agreement, attend regular school.

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Exclusion Criteria:students with other chronic diseases (rather than asthma),

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Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient

Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient

This treatment protocol will serve as a mechanism to continue to provide ficlatuzumab to patient 0001-000412, who was previously enrolled under protocol P05538 and whom the investigator believes is deriving clinical benefit from ficlatuzumab treatment.

Eligibility Criteria:
Inclusion Criteria:

* Per original P05538 protocol

Exclusion Criteria:

* Per original P05538 protocol
Protective Effect of Biodegradable Collagen Implant (Ologen) in Scleral Thinning After Strabismus Surgery

This study is to investigate protective effect of biodegradable collagen implant in scleral showing after lateral rectus recession in patients with exotropia.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with intermittent exotropia or constant exotropia
2. Alternate prism cover test showed 20 prism diopters or more than 20 prism diopters exotropia
3. Subjects who want to do strabismus surgery

Exclusion Criteria:

1. Subject who had previous strabismus surgery or other ocular surgery history
2. Thyroid eye disease or other connective tissue disease
3. Significant bleeding or scleral perforation during operation
4. Subjects who need to do medial rectus resection, not lateral rectus recession
5. Subjects who had a plan to do other intra or extraocular surgery within 3 months
Multimodal Assessment of Frailty in Acute Stroke Patients

The goal of this study is to investigate the influence of frailty on clinical and stroke characteristics, treatment and outcomes in patients with acute stroke.

The main questions it aims to answer are:

1. How prevalent is frailty in patients with stroke?
2. Which impairments (e.g. undernutrion, impaired mobility, laboratory markers) contribute to frailty?
3. Is the outcome of frail patients worse than those without?
4. Are in-hospital complications more frequent in frail patients than those without?

Stroke is one of the most common causes of disability and mortality worldwide. A recognized complication in stroke patients is frailty, which is associated with increased costs, poorer prognosis, and higher mortality rates. However, there is currently no uniform definition or diagnostic criteria for frailty in stroke patients, and there is a need for standardized frailty assessments in this patient population.

The aim of this study is to determine the prevalence of frailty in stroke patients at the Stroke Unit of the University Hospital Giessen and to analyze the associated characteristics and impacts on clinical outcomes. A multimodal frailty assessment will be conducted to capture a wide range of frailty features and investigate their significance. The study includes all stroke patients admitted to the certified stroke- unit of the University Hospital Giessen within a 3-month period. There are no inclusion criteria related to age, gender, or type of stroke.

The multimodal frailty assessment encompasses determining appropriate blood values (e.g., CRP, albumin), assessing muscle strength/mass through handheld dynamometry and sonographic muscle diameter, utilizing scores like the Clinical Frailty Scale (CFS) and the Groningen Frailty Indicator (GFI), evaluating nutritional status (BMI), collecting image-based frailty data (e.g., sarcopenia, cerebral white matter lesions, lacunar strokes, brain atrophy), and conducting suitable one-year follow-ups. Additionally, demographic and clinical data such as age, gender, type of stroke, and treatment details will be recorded.

The primary outcome is the prevalence of frailty among stroke patients. Secondary outcomes include the characteristics and impacts of frailty in stroke patients, including correlations between various frailty features and clinical outcomes such as length of hospital stay, mortality, and functional outcome.

Eligibility Criteria:
Inclusion Criteria:

* treated at the certified stroke-unit of the Dpt. of Neurology, University Hospital Giessen
* diagnosis of ischemic (including transient ischemic attack) or hemorrhagic stroke

Exclusion Criteria:

* withdrawal of care within 24 hours after admission
Effects of General Anesthesia and Spinal-Morphine Anesthesia on Recovery and Comfort After Benign Abdominal Hysterectomy

The purpose of this study is to determine whether spinal anesthesia combined with intrathecal morphine in abdominal hysterectomy on benign gynecological indications gives better outcome concerning duration of hospital stay and postoperative patient comfort than general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Female between 18 and 60 years of age.
* Scheduled for abdominal hysterectomy - total or subtotal -on benign gynecological indication.
* At least one ovary planned to be preserved at the hysterectomy.
* Can understand and communicate in Swedish
* Accept participation after written and verbal information and after signed informed consent.
* Has supervision at home after discharge from hospital during the first couple of days and has access to a telephone.

Exclusion Criteria:

* Contra-indications against spinal or general anesthesia or the standard dosage of the study drugs
* ASA classification ≥ Class 3
* Postmenopausal women without HRT (hormone replacement therapy).
* Suspected gynecological malignancy
* Previously undergone bilateral oophorectomy
* Substantial physically disabled so that a normal recovery with early physical mobilization can not be anticipated.
* Mentally or severly psychic disabled
The Effects of Night Shift Work on Health Across the Menstrual Cycle

The study aims to investigate the effects of sleep deprivation on women's health across different phases of the menstrual cycle.

Modern society demands around-the-clock services, with an estimated 20% of workers involved in night shifts. Shift work disrupts the circadian rhythm and has been linked to increased risks of obesity, metabolic syndrome, glucose dysregulation, and immune system issues. Sleep deprivation, especially during wakeful nights, is associated with elevated levels of central nervous system biomarkers like Tau and Amyloid-β proteins, which are implicated in brain disorders such as Alzheimer's disease.

However, the effects of sleep deprivation on women, particularly in relation to hormonal fluctuations during the menstrual cycle, remain largely unexplored. The menstrual cycle, which occurs in cis-women of childbearing age, involves significant fluctuations in estrogen, a hormone known for its neuroprotective properties. Estrogen impacts memory, executive function, and may play a role in protecting against neurodegenerative conditions like Alzheimer's disease. Previous studies have largely focused on men or women using hormonal contraceptives, leaving a gap in understanding how natural hormonal cycles impact the response to sleep deprivation.

This study addresses this gap by focusing on healthy young women with regular menstrual cycles who do not use hormonal contraceptives. Participants will undergo an adaptation night followed by a sleep condition and a wake condition experiment. The goal is to better understand how hormonal changes throughout the menstrual cycle influence the body's response to sleep deprivation and stress, particularly in areas such as metabolism, brain function, and immune, system, and microbiota.

Eligibility Criteria:
Inclusion Criteria:

- Healthy

Exclusion Criteria:

* Use of hormonal contraceptives
* Chronic disease
* Regular use of nicotine
* Use of medication
* Consumes excessive amounts of alcohol or coffee
Determine AF Burden With PPG Trial - Detection and Quantification of Episodes of Atrial Fibrillation

In this prospective single-center trial, a wearable photoplethysmographic (PPG) sensor coupled with a cloud analytics service will be used to detect and quantify atrial fibrillation (AF) episodes in patients with known paroxysmal AF. Patients will simultaneously receive the PPG sensor in form of a smartwatch or bracelet and a Holter ECG for 48 hours. Correctly identified AF episodes and AF burden determined by both methods will be compared.

Atrial fibrillation (AF) is the most common cardiac arrhythmia and a major risk factor for cerebrovascular insults. Paroxysmal AF is defined as an episode of AF that terminates spontaneously or with intervention within 7 days. Patients with AF may present with palpitations, shortness of breath or sensation of light-headedness but asymptomatic episodes are also possible, especially in paroxysmal AF. The lack of continuous heart rate monitoring options makes early diagnosis of paroxysmal AF challenging. In this prospective single-center trial, the PPG wearable Corsano CardioWatch 287 sensor will be used to conduct continuous heart rate and -rhythm monitoring in patients with known paroxysmal AF. Collected data will then be analysed using a Cloud Analytics Service (Preventicus Heartbeats algorithm) and compared with data from simultaneously obtained 48-hour Holter ECG. Correctly identified AF episodes, their cumulative duration per 48 hours (AF burden) and the number of asymptomatic episodes will be assessed. In the primary analyses, the sensitivity of the PPG analysing algorithm to detect AF episodes is estimated by performing a logistic regression on detection (yes/no) with only an intercept as predictor, which is then translated to a proportion (the sensitivity). In the secondary analyses we are comparing the cumulative duration of AF episodes over 48 hours (AF burden) obtained with the PPG-sensor and Holter-ECG. In summary, the purpose of the study is to evaluate the performance and efficacy of the wearable PPG sensor and the cloud analytics service in detecting and quantifying AF episodes in patients with known history of paroxysmal AF.

Eligibility Criteria:
Inclusion Criteria:

* Known paroxysmal atrial fibrillation
* Patient ≥ 18 years old
* Written informed consent as documented by signature from the patient

Exclusion Criteria:

* Cardiac implanted electronic device (Pacemaker, ICD)
* Smartwatch/Bracelet and/or ECG device cannot be worn due to comprehensible reasons (allergic reactions, wounds, amputations, other)
* Patients unable or not willing to sign informed consent Significant mental or cognitive impairment
Vitamin D Supplements on Markers for Cardiovascular Disease and Diabetes: an Individual Participant Data Meta-analysis

This meta-analysis will be conducted to study the effect on vitamin D supplements on markers for cardiovascular disease and diabetes using individual participant data from 12 RCTs. Given that previous data suggest that vitamin D supplementation might be most effective in those individuals with very low 25-hydroxyvitamin D (25(OH)D) and potentially harmful in those achieving very high levels after vitamin D supplementation, this meta-analyses will be performed in subgroups according 25(OH)D levels.

Large randomized controlled trials (RCTs) are currently on-going to evaluate non-skeletal effects of vitamin D supplementation in the general older population. The results of these studies can be expected in 2017 to 2020 and while they will report important data, they may still leave knowledge gaps on the effects of vitamin D on clinically relevant surrogate parameters in specific groups. Recent data indicate that the association of vitamin D status and outcome is U- or reverse J-shaped and may be modified by the presence of certain risk factors or genetic variations of the vitamin D receptor.

This work is part of the European Union-project 'Food-based solutions for eradication of vitamin D deficiency and health promotion throughout the life cycle' (ODIN). This individual patient meta-analysis of existing high quality vitamin D RCTs aims to evaluate whether there are beneficial or harmful vitamin D effects on surrogate parameters for clinical outcomes (i.e. blood pressure, lipids, parathyroid hormone (PTH), fasting blood glucose and glycated haemoglobin (HbA1c)). With data from almost 3000 randomized subjects from 12 RCTs that are available within this consortium, the investigators will have sufficient power to detect clinically relevant effects of vitamin D supplementation on risk factors for cardiovascular disease.

Subgroup analyses will investigate effect modifiers to evaluate whether certain groups of individuals experience pronounced or attenuated effects from vitamin D supplementation. Given that previous data suggest that vitamin D supplementation might be most effective in those individuals with very low 25(OH)D and potentially harmful in those achieving very high levels after vitamin D supplementation, this individual patient data meta-analyses will be performed in subgroups with serum 25(OH)D levels \<30, 40, and 50 nmol/L and \>100, 125 and 150 nmol/L. 25(OH)D levels will be re-measured to ensure comparability.

Eligibility Criteria:
Inclusion Criteria:

* Availability of quality bio-banked samples for uniform 25(OH)D re-measurement
* Prospective data on one or more of the outcomes
* Willingness to collaborate

Exclusion Criteria:

* Trials among pregnant women, children, or performed in patient populations.
Comparison of ANCA and Anti-GBM Auto-antibodies Removal Kinetics Between Plasma Exchanges and Immunoadsorption in Patients With ANCA-associated Vasculitis or Anti-GBM Disease

Anti-neutrophil cytoplasmic antibodies (ANCA), directed against myeloperoxidase (MPO) and against proteinase 3 (PR3), have a pathogenic role during ANCA (AAV) vasculitis. Glomerular basement membrane (MBG) antibodies also have a direct pathogenic role in Goodpasture's syndrome and anti-MBG antibody glomerulonephritis (GN). In some patients, the severity of renal and / or pulmonary involvement justifies the rapid purification of these autoantibodies by an apheresis procedure, while waiting for the effect of immunosuppressive treatments aimed at reducing their production. During vasculitis, plasma exchange (PE) is recommended in patients with severe renal impairment or intra-alveolar hemorrhage (2012 KDIGO Clinical Practice Guideline for Glomerulonephritis).

Given certain disadvantages related to plasma exchanges (low volume of purified plasma, non-selective technique for immunoglobulins (Ig), need for replacement solute, induction of coagulation disorders), immunoadsorption (IA), already used in transplantation, has been developed in these indications. IA has indeed greater selectivity for Ig with a probable better purification capacity due to higher volumes of plasma treated per session. The price of IA is however higher than that of EP.

These two apheresis techniques, EP and IA, are commonly used in France during severe forms of vasculitis ANCA or anti-MBG, without the superiority of one or the other has been demonstrated. As a result of higher plasma volumes being purified, AI may allow faster purification of pathogenic antibodies. No studies to date have specifically compared the purification kinetics of these antibodies between EP and IA.

The CINEVAS study (VAScularite Antibody Purification CINetic) is a multicentric pilot study whose main objective is to compare the purification kinetics of ANCA (anti-MPO or anti-PR3) and / or anti- MBG in patients treated with EP versus those treated with IA


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient with ANCA vasculitis with positive anti-MPO or anti-PR3 antibodies, or patient with Goodpasture syndrome or anti-MBG antibody glomerulonephritis
* Patient for whom the investigating physician retains the indication of apheresis
* Induction treatment with corticosteroids and cyclophosphamide or rituximab

Exclusion Criteria:

* Pregnancy or breastfeeding
* Vasculitis without anti-MPO, anti-PR3 or anti-MBG
* Severe anemia (hemoglobin \<7 g / dL) contraindicates additional blood sampling