cyrilzakka/clinical-trials huggingface dataset:
Graft Patency of QFR-guided Versus Angio-guided Coronary Artery Bypass Grafting

Coronary artery bypass grafting(CABG) is the golden standard for severe coronary artery disease(CAD), the current surgery strategy is mainly based on coronary angiography(CAG), but many trials of PCI have shown that visually stenosis in CAG may not have functional significance. The aim of this study is to investigate if the Quantitative Flow Ratio (QFR) can be adopted in CABG and achieve a better graft patency.

CABG is the major treatment of three vessels or left main disease. CAG is the main basis on choosing the vessels to graft, however, some of the grafts occluded shortly after surgery due to competitive flow, these vessels may not be significantly stenosis in functional assessment such as Fractional Flow Reserve (FFR). Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. Comparing to FFR, there is no need for pressure wire or ATP when performing QFR. This study plan to investigate the clinical effect of QFR in CABG, all patients included will be allocated 1:1 into two groups: QFR-guided and Angio-guided, QFR-guided group will be performed a CABG based on the result of QFR, the other group will be based on heart team discussion of CAG, CTA will be adopted to evaluate the 1 year graft patency.

Eligibility Criteria:
Inclusion Criteria:

* patients with evidence of angina pectoris
* left main or three vessels disease, have the indication for CABG after discussion of the heart team
* at least one main vessels stenosis on 40%-70%

Exclusion Criteria:

* former cardiac surgery patients
* need to perform other cardiac or major surgery( i.e. valve surgery, carotid endarterectomy
* emergent CABG
* acute myocardial infarction time less than 7 days
* life expectancy less than 3 years
Bevacizumab Plus EGFR-TKIs in Chinese Patients With EGFR-mutant NSCLC: a Real-world Study

This study is a prospective, multicenter, real-world study to investigate the efficacy and safety of bevacizumab plus epidermal growth factor (EGFR) Tyrosine Kinase Inhibitors in Chinese Patients With Stage IIIB/IV EGFR-mutant Non-small Cell Lung Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet the following criteria for study entry:

  1. Signed Informed Consent Form.
  2. Age≥18 years.
  3. Histologically or cytologically documented inoperable, locally advanced (Stage IIIB, IIIC), metastatic (Stage IV) or recurrent non-squamous NSCLC.
  4. An exon 19 deletion mutation or exon 21 L858R mutation in EGFR has been found clinically, with or without EGFR T790M mutation
  5. Eastern Cooperative Oncology Group performance status 0-2 or KPS ≥60
  6. Previous EGFR-TKIs or anti-angiogenic agents or systemic cytotoxic chemotherapy for locally advanced, metastatic or recurrent disease has not been performed.

     Exclusion Criteria:
* Patients who meet any of the following criteria will be excluded from study entry:

  1. Squamous carcinoma or mixed non-small cell lung cancer with squamous component.
  2. Potential hazard for receiving EGFR-TKIs or bevacizumab by clinical evaluations
  3. Previous history of receiving EGFR-TKIs or bevacizumab treatment prior to study enrollment
  4. Suspected or diagnosed leptomeningeal metastases
  5. Chest radiotherapy within 3 months prior to study enrollment
  6. Open surgery within 4 weeks prior to study enrollment
Diffusion MRI in Heart Failure

The development of symptomatic heart failure is frequently preceded by a pre-clinical period of structural remodeling in the heart. The remodeling process driving this transition, however, remains poorly understood. The investigators hypothesize that imaging the diffusion of water in the heart with MRI will allow its microstructure to be resolved. The investigators further hypothesize that the characterization of microstructural changes in the heart will help elucidate the pathogenesis of heart failure and the transition from a compensated to a decompensated state. Patients with recent myocardial infarcts and left ventricular hypertrophy, who are at risk for the development of heart failure, will be enrolled. The participants will undergo serial diffusion tensor MRI (DTI) imaging of the heart to characterize changes in myocardial microstructure over time.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults with no history of hypertension, diabetes or heart disease
* Patients with ST Elevation MI within last 6-10 weeks who are angina free, and have been seen by a cardiologist since discharge
* Patients with episode of heart failure within last 12 months and left ventricular hypertrophy, documented by echocardiogram or MRI.

Exclusion Criteria:

1. Presence of metallic foreign bodies/objects
2. Selected medical devices and implants
3. Pacemakers, implantable defibrillators, life vests
4. Coronary artery stent within last 6 weeks (unless the stent is a MRI-inert chromium-cobalt stent)
5. Known untreated ventricular arrhythmia such as sustained ventricular tachycardia within last 12 months
6. Atrial fibrillation that is not well rate controlled (heart rate \>125)
7. Unstable angina within last 2 months that has not been fully evaluated by a cardiologist
8. Syncope within last 6 weeks
9. Hemodynamic instability (Systolic BP less than 100 or greater than 180)
10. Decompensated heart failure (inability to lie flat and perform a breath-hold).
11. Glomerular filtration rate (GFR) \< 60 for those receiving gadolinium.
12. Labile GFR that is not stable/similar on last 2 measurements (for those receiving gadolinium).
13. Patients with GFR \< 20 or on any form of dialysis.
14. Infiltrative cardiomyopathy (amyloid, sarcoid, hemachromatosis)
15. Recent surgery (within the last 3 months)
16. Prior stroke with large residual deficit
17. Presence of liver or respiratory failure
18. Pregnancy and nursing mothers
19. Claustrophobia
20. Known seizure disorder
Adult Pulmonary Valve Replacement: A Simple and Reproducible Technique

Pulmonary valve replacement in the adult population is an uncommon operation. The majority of native valve pathology in adults involves the mitral, aortic, and occasionally tricuspid valves. On the other hand, right ventricular outflow tract and pulmonary valve disease is quite common in children, especially with tetralogy of fallot, truncus arteriosus, pulmonary atresia/ventricular septal defect, and double outlet right ventricle. Unfortunately, right ventricular pathology often develops in adulthood as a result of pulmonary insufficiency or pulmonary stenosis created by previous childhood operations. Without the valve size constraints present at prior operations, these patients can be well-served by the placement of adult-sized bioprosthetic valves. There are limited descriptions in the adult cardiac literature of the actual technique of pulmonary valve replacement. We present our current technique and the pitfalls encountered when performing pulmonary valve replacement in adults.

This will be primarily a technique paper. The only clinical data points I am interested in are the presence of pulmonary stenosis, pulmonary insufficiency or perivalvular leak on the initial post-operative echocardiogram. I estimate reviewing 50 patients' charts dated March 22.2003 through and including March 22.2006 at Emory Hospital .

Primary Aim: Present an effective technique for pulmonary valve replacement

Secondary Aim: Present our excellent technical results of PVR in our adult congenital patients

Eligibility Criteria:
Inclusion Criteria:

* Adults undergoing pulmonary valve replacement
* at Emory Hospital
* between 3.22.03 amd 3.22.06

Exclusion Criteria:

* those charts that do not fall under inclusion criteria
Effect of Intrathorathic Oscillations on Pulmonary Functions in Children With Cerebral Palsy

Aim: To investigate the effect of intrathoracic oscillations on forced expiratory volume at first second and peak expiratory flow in the children with cerebral palsy.

Methods and Procedures: Children were randomly assigned into two groups (study group and control group). Each child was evaluated before and after 6 successive weeks.

Methods and Procedures: 24 children with spastic cerebral palsy from both sexes, There ages from 6 to 8 years old. Children were randomly assigned into two groups (study group and control group). Each child was evaluated before and after 6 successive weeks. The children of the control group received traditional chest physiotherapy. while, the children of the study group received 4 sessions per week for 6 weeks with quake device.

Eligibility Criteria:
Inclusion Criteria:

* children with cerebral palsy
* Age from 6 to 8 years old
* the degree of spasticity from 2 to 2+
* grade 4, 5 according to GMFCs

Exclusion Criteria:

* Uncontrolled convulsions
* Any psychiatric disorders
Effectiveness of Physiotherapy Interventions for Patients With Parkinson's Disease

Parkinson's Disease is an incurable and progressive disease. Treatment includes medication and non-pharmacological intervention such as physiotherapy. Physiotherapy is a main component of non-pharmacological interventions. It includes exercise to strengthen the muscles; improves balance and walking, and adopts the use of visual cue training. Treatment has been found to be effective in patients with mild impairment up to 6 months post-treatment. The present study will investigate the effectiveness of treatment for patients with mild to moderate impairment for short term (3-month) and long term (1 year). The hypothesis is that compared to patient education alone, physiotherapy intervention for patients with Parkinson's disease leads to improve function and quality of life.

Parkinson's disease (PD) is an incurable and progressive disease (Rubenis 2007). Current management include medical, neuro-surgical and non-pharmacological intervention. Physiotherapy is a major component in non-pharmacological interventions. Effective interventions including visual or auditory cues improves gait (Nieuwboer et al. 2007), exercise is effective in improving balance (Hirsch et al 2003); intense treadmill training improves motor control, quality of life and walking speed so as to sustain improvement in gait speed and motor control post 4 weeks of treatment (Herman et al 2007). Patient with PD attending physiotherapy twice weekly, one and half hour for 12 weeks showed improvement in walking speed and Activities of Daily Living (Ellis et al 2005). However, the majority of focus on patients in the Hoehn and Yahr stage of 2 to 3 and long term effect is lacking (Kwakkel et al 2007). A knowledge gap is present in the effectiveness of physiotherapy training of patients with Parkinson's disease in the more advanced stage of disease and long term effect is lacking. The aim of the study is to investigate the immediate, short-term \& long-term clinical effects of physiotherapy training of patients with Parkinson's disease. The hypothesis is that compared to patient education alone, physiotherapy intervention for patients with Parkinson's disease leads to improve function and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Stable medication usage
* Hoehn and Yahr stage II to IV
* At least 1 score of 2 or more for at least 1 limb of either the tremor, rigidity, or bradykinesia item of the Unified Parkinson's Disease Rating Scale (UPDRS)
* Able to walk independently
* No severe cognitive impairments (Mini-Mental State Examination - Chinese Cantonese version) score greater than 24

Exclusion Criteria:

* Other severe neurological, cardiopulmonary, or orthopedic disorders
* Having participated in a physiotherapy or rehabilitation program in previous 2 months
ACCELERATE: Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Pegfilgrastim and Darbepoetin Alfa Support for the Treatment of Women With Breast Cancer

This is a study of dose dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel (Taxol; T) with pegfilgrastim (Neulasta) and darbepoetin alfa support in the adjuvant breast cancer setting.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer diagnosis node-positive or high risk node negative
* Estrogen receptor (ER) negative or ER positive (stage IIA, IIB or IIIA) disease.

Exclusion Criteria:

* Metastatic breast cancer
* Clinically significant cardiac disease
Dose Escalation TTHX1114 Ophthalmic Solution

Dose escalation 3+3 design with accelerated titration 4 dose levels

This is a 28-day open-label dose-escalation study. TTHX1114(NM141) Ophthalmic Solution: 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days. Four planed dose levels, accelerated titration DL1 and DL2, standard 3+3 design.

Eligibility Criteria:
Inclusion Criteria:

* Female or male, 18 to 65 years of age, Female subjects of child-bearing potential must be non-pregnant
* Able to provide voluntary written informed consent
* Normal ocular function (BCVA 20/20) and anatomy
* Available for and agree to all study procedures including inpatient monitoring, follow-up visits, sample collection, study treatment administration
* Body mass index 18.5 to 35 kg/m\^2
* Demonstrated ability to self-administer eye drops

Exclusion Criteria:

* Clinically significant co-morbid ocular conditions
* Co-morbid medical conditions requiring treatment
* Active ocular infection within the 2 weeks prior to Day 1
* Active non-ocular infection requiring antibiotics within the 2 weeks prior to Day 1
* Use of systemic or dermatological cytotoxic chemotherapy within the 1 month prior to Day 1
* Planned contact lens use during the study period
* Use of any investigational product within the 1 month prior to Day 1
* Corticosteroid use in the 1 month prior to Day 1
* Major surgery within the 3 months prior to Day 1
* History of dependence on alcohol or drugs of abuse
* History of intolerance, hypersensitivity, or significant allergy to any drug compound, food, or other substance
* Any other reason (e.g., serious systemic disease or uncontrolled medical condition) that, in the opinion of the Investigator could increase the subject's risk, interfere with the interpretation of the study results, or affect the subject's ability to provide informed consent or comply with the study
Characterization of Clinical Skeletal and Cardiac Impairment in Carriers of DMD and BMD

Longitudinal prospective observational study. This is a 24-month study with the possibility of extending the data time points. Initially baseline, then 12 and 24 months follow up studies will be completed.

Four cohorts are enrolled in this study. The target population is the cohort of genetically confirmed DMD/BMD female carriers (Cohort A). This cohort will consist of 150 DMD/BMD mothers who are somatic carriers of a mutation in the DMD gene. The data collected for this cohort will be compared to three control groups; Control Group B is a cohort of 50 DMD/BMD mothers who are NOT somatic carriers, Control Group C is a cohort of 50 age-matched healthy controls and Control Group D is a cohort of 25 genetically confirmed carriers who do not have an affected child. The inclusion of a Control Group B allows for a comparison to a group of mothers that share the emotional and cognitive burden of caring for an affected male without having the physical or cognitive risks of being a female carrier. The Control Group C offers robust data from an age-matched healthy cohort for purposes of comparison. Control Group D allows for comparison to a group of women that have the same physical or cognitive risks as the Cohort A female carriers, but do not have the same burden of care giving.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Cohort A requires a genetically confirmed mutation in the DMD gene with an affected child
* Cohort B includes DMD/BMD mothers with NO somatic mutation in the DMD gene
* Cohort C age-matched healthy controls with a normal CK level
* Cohort D requires a genetically confirmed mutation in the DMD gene without an affected child
* Able to complete testing in English
* Able to consent

Exclusion Criteria:

* Subjects with a contraindication to cardiac or skeletal muscle MRI
* Subjects on heart failure medication at time of enrollment
* Subjects on steroid treatment
* Presence of an inherited neurologic disease or comorbidity that may affect their ability to complete this study
* Has a medical condition or extenuating circumstance that, in the opinion of the investigator, might compromise the subject's ability to comply with the protocol required testing or procedures or compromise the subject's wellbeing, safety, or clinical interpretability
Early Assessment of Response to Treatment of Metastatic LUng Tumors Based on CIrculating Tumor DNA

In patients with locally advanced or metastatic tumors, first-line therapeutic management is based on the use of targeted therapies (EGFR, BRAF ALK and ROS1 inhibitors), immunotherapies (anti-PD1/ anti-PDL1-antibodies or chemotherapy.

Despite patient selection based on histo-pathological and molecular criteria, not all patients respond to treatment. There are currently no markers to definitively guarantee a patient's response.

An alternative is to identify early patient response to treatment. The investigator hypothesize that change in circulating tumor DNA concentration (ctDNA) allow to early identify patients' therapeutic response (and non-response) of patients, regardless of the type of treatment used in the first line setting.

The primary objective is to determine whether early evolution (between baseline and week 3) of circulating tumor DNA concentration predicts the radiological response to first-line treatment of advanced or metastatic NSCLC patients, regardless of treatment

Eligibility Criteria:
Inclusion Criteria:

* Metastatic or locally advanced non-small cell lung cancer (stage III or IV)
* At least one measurable target according to RECIST criteria
* Identification of at least one molecular alteration in the tissue sample analyzed in the framework of patient management
* Performance Status 0 to 2
* Affiliated to a social security system
* Patient who can be followed under the protocol
* Patient agreed to participate in the study and gave his/her express consent

Exclusion Criteria:

* Minor
* Small cell or mixed bronchial cancer
* Radiotherapy (except radiotherapy for antalgic purposes) during the last 7 days
* Patient who has already started a first line of treatment
* Patient already included in an interventional research protocol that may have an impact on the results of the ELUCID study
* History of cancer (with the exception of non-melanoma skin, cervical cancer in situ, adequately treated) with sign of illness during the last 5 years
* Patient which, does present a substantial risk of recurrence.
* Major under guardianship, curators or deprived of liberty
* Pregnant or lactating woman, or of childbearing age without effective contraception
* Not affiliated to a social security system
* Inability to understand the protocol and / or to give express consent
18F-DPA-714 PET/MR in Dysfunctional Brain Diseases

This is a diagnostic pilot study that recruited 25 normal volunteers and 40 patients with dysfunctional brain diseases and performed 18F-DPA-714 PET/MR imaging to evaluate the correlation between the multimodal imaging features of dysfunctional brain diseases, to explore the potential pathological mechanisms of neuroimmune activation, and to further analyse the value of PET/MR-based multimodal imaging in the diagnosis and differential diagnosis of dysfunctional brain diseases. and further analyse the diagnostic and differential diagnostic value of PET/MR-based multimodal imaging in dysfunctional brain diseases.


Eligibility Criteria:
Inclusion Criteria:

* Dysfunctional disorders diagnosed according to the guidelines include: cognitive disorders, movement disorders, disorders of consciousness-like disorders, and autoimmune encephalitis. Signing the PET/MR informed consent form to volunteer for this study

Exclusion Criteria:

* Minors, pregnant women, nursing mothers, those with severe liver or kidney insufficiency, history of allergy to contrast media or other drugs. Diagnosis of viral encephalitis, acute myelitis, idiopathic epilepsy, antibody-negative AIE; diagnosis of any major disease; history of alcohol or drug abuse/dependence; history of cardiorespiratory disease, oncology, haematological disorders, poorly controlled chronic diseases; contraindications to PET/MR examination. History of head trauma, history of surgery. History of other neurological disorders.
The Dutch STRIDER (Sildenafil TheRapy In Dismal Prognosis Early-onset Fetal Growth Restriction)

Rationale: Severe, early-onset fetal growth restriction (FGR) due to placental insufficiency is associated with a high risk of perinatal morbidity with long-lasting sequelae and mortality. Placental insufficiency is the result of abnormal formation and function of the placenta (placentation) with inadequate remodelling of the maternal spiral (uteroplacental) arteries. There is currently no therapy available with demonstrated effectiveness. Evidence suggests Sildenafil citrate improves uteroplacental blood flow, growth, and meaningful outcomes.

Objective: To evaluate the effectiveness of sildenafil (versus placebo) in achieving healthy perinatal survival.

Study design: Multicenter nationwide randomized placebo-controlled clinical trial.

Study population: Women with a singleton pregnancy between 20 and 30 weeks with severe fetal growth restriction of likely placental origin, and with estimated significant likelihood of perinatal death.

Intervention: Sildenafil 25mg or placebo tablet orally three times daily. Main study parameters/endpoints: Perinatal healthy survival, i.e. survival without severe neonatal morbidity at term age.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Taking tablets three times daily. No additional ultrasounds, other than standard clinical protocol, one extra blood sample at inclusion. No risks anticipated, unexpected medication-associated risks can't be excluded on beforehand.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria ((I OR II) AND III):

* At 20+0-27+6 weeks: an ultrasound measurement of the fetal abdominal circumference (AC) \<3rd percentile for gestational age or an ultrasound estimate of fetal weight (EFW) \<5th percentile OR
* At 28+0-29+6 weeks: an ultrasound estimate of fetal weight (EFW) \<700 grams using Hadlock C formula AND
* Likely placental origin defined by (a AND/OR b AND/OR c AND/OR d)

  * The presence of uterine artery notching
  * Abnormal flow velocity patterns of the umbilical artery or middle cerebral artery
  * Maternal hypertensive disorders
  * Low PlGF in point-of-care assessment

Exclusion Criteria:

* Plan to terminate pregnancy for maternal or fetal indication within days
* Known multiple pregnancy
* Identified congenital anomalies or congenital infection
* Maternal age at eligibility \<18 years
* Cocaine use
* Current use of sildenafil
* Current use of cyp3A5 inhibitors: amiodaron, azitromycine, ciclosporine, claritromycine, diltiazem, erytromycine, fluconazol, itraconazol, ketoconazol, verapamil, voriconazol.
* Recent myocardial infarction or stroke