cyrilzakka/clinical-trials huggingface dataset:
CERebrolysin in CADASIL

The objective of this trial is the global risk-benefit assessment of Cerebrolysin as compared to Placebo in patients with genetically proven CADASIL. In addition, a traditional approach will be taken based on an evaluation of the separate risk and benefit domains in comparison with placebo.

Safety data area collected throughout the study (adverse events, vital signs and laboratory tests) and thereafter in case of ongoing serious adverse events (SAEs) at study endpoint.

Optional secondary parameters include analyses of biomarkers (samples of blood, hair, urine, and saliva).

Eligibility Criteria:
Inclusion Criteria:

1. Patients of ≥18 years of age, all genders
2. Diagnosis of CADASIL based on clinical symptoms, MRI, and genetic analysis
3. MoCA \>11
4. Adequate visual, auditory, and language skills (no language interpreter required) to follow study procedures
5. Patient is not of childbearing potential (i.e. women are post-menopausal for two years, surgically sterile, or using adequate method of contraception)
6. Patient participates voluntarily and gave written informed consent

Exclusion Criteria:

1. Any significant neurological disease/conditions other than CADASIL
2. Focal lesions that may be responsible for the cognitive status of the patient (e.g.

   infectious disease, space-occupying lesion, normal pressure hydrocephalus)
3. Any other diseases/conditions that may affect compliance with the protocol, such as:

   1. severe psychiatric disorders within the last three months
   2. delusional symptoms
   3. history of schizophrenia, schizoaffective disorder, bipolar affective disorder
   4. major depressive disorder newly identified within eight weeks before screening
   5. history of alcohol or substance abuse or dependence within the past two years
4. Any circumstances that -in the investigator's opinion- may result in the patient's non-compliance with study procedures, e.g. fragile or thin veins that prevent many i.v. infusions
5. Any other disease/conditions that may affect the safety assessment, such as:

   1. history of systemic cancer within the past two years
   2. history of myocardial infarction in the past year or unstable or severe cardiovascular disease (including uncontrolled hypertension and/or history of unstable hypertension not compensated by antihypertensive therapy)
   3. any clinically significant laboratory abnormalities at screening
   4. uncontrolled insulin-requiring diabetes or non-insulin dependent diabetes mellitus (HbA1c \>87 mmol/mol)
6. Use of concomitant medication with neuroprotective/neurotrophic/nootropic effects (e.g. ginkgo biloba, erythropoietin, citicoline, amantadine, piracetam)
7. Any condition that would represent a contraindication for Cerebrolysin administration:

   1. hypersensitivity to one of the components of the drug
   2. epilepsy
   3. severe renal impairment (estimated Glomerular Filtration Rate \[eGFR\] \<30 ml/min/1.73 m2 as assessed at local laboratory within one month before screening)
Efficacy and Safety of Sorafenib as Adjuvant and Latter Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma

Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of RFA was not reported yet. There's a theoretical advantage of this combination. Hence in this study the efficacy and safety of pre-administrative Sorafenib and Latter radiofrequency ablation (RFA) in Recurrent HCC will be tested in a multicenter prospective cohort study.

Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of RFA was not reported yet. There's a theoretical advantage of this combination. Hence in this study the efficacy and safety of pre-administrative Sorafenib and Latter radiofrequency ablation (RFA) in Recurrent HCC will be tested in a multicenter prospective cohort study. Eligible cases will be assigned into the experimental group and the control group. For experiment group, sorafenib tablet will be given for two weeks, and then perform radiofrequency ablation. For the control group, RFA will be performed immediately.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 75 years old
* Without gender restriction
* With a favorable liver function of Child-Pugh A to B
* No contraindications to RFA and anesthesia
* Diagnosed with Recurrent HCC
* Signed informed consent.

Exclusion Criteria:

* Cancer thrombosis in major vessels/ extrahepatic metastasis
* Uncontrollable ascites or variceal bleeding
* Impairment in liver function
* Severe disorders in vital organ
* Accompanied with other tumors or infectious disease except hepatitis.
Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates

The purpose of this study is to determine whether using electrocardiograms (ECGs) during resuscitation of preterm infants (less than 31 weeks gestation) will decrease the amount of time it takes from birth for heart rate (HR) to be above 100 beats per minute and oxygen saturations to be in the goal range, in other words to stabilize the infant. A few studies have been conducted which showed that ECGs are faster at detecting HR than pulse oximetry (PO). Sample sizes, however, have been small and only few extremely low birthweight infants have been included. It is unclear if use of ECG in these tiny preterm infants in addition to traditional techniques to determine HR will be beneficial and impact resuscitation and outcomes. The investigators propose a study where infants will be randomized to either using ECG in addition to PO ± auscultation versus PO ± auscultation only to assess HR during neonatal resuscitation. The investigators hypothesize that the group of infants randomized to ECG will be able to stabilize faster, i.e. achieve HR \> 100 beats per minute and oxygen saturation in goal range faster.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants less than \<31 weeks gestation born at Parkland hospital vaginally or by C/S
* Infant with congenital heart disease, congenital anomalies, or chromosomal abnormalities will be included unless comfort care has been agreed upon beforehand
* Resuscitation team present to attend delivery before birth

Exclusion Criteria:

* Any infant with prenatally agreed upon comfort care since resuscitation will not be provided
* Any precipitous delivery since resuscitation team will not be in attendance prior to delivery
CoreValve® System Australia/New Zealand Clinical Study

To evaluate the performance, efficacy and safety of the percutaneous implantation of the CoreValve® prosthetic aortic valve in patients with severe symptomatic native aortic valve stenosis that have an elevated surgical risk

Prospective, non-randomized, single-arm multi-center trial conducted under a common protocol at 10 centers in Australia and New Zealand.

Eligibility Criteria:
Inclusion Criteria

1. Documented severe aortic valve stenosis
2. Access vessel diameter \>6 mm as defined pre procedure via angiographic measure
3. Aortic valve annulus diameter ≥ 20 mm and \< 29 mm as defined pre procedure by echocardiographic measure
4. Ascending aorta diameter ≤ 43 mm at the sino-tubular junction
5. Native aortic valve disease, defined as valve stenosis with an aortic valve area\<1cm2 (\<0.6cm2 /m2) as defined pre procedure by echocardiographic measure

   AND (Assessment of Surgical Risk)

   Age ≥ 80 years

   AND/OR

   Surgical risk calculated with logistic EuroSCORE ≥ 20%,

   AND/OR

   Age ≥ 65 years with one or two (but not more than 2) of the following criteria:
   * Cirrhosis of the liver (Child class A or B)
   * Pulmonary insufficiency : VMS \< 1 liter
   * Previous cardiac surgery (CABG, valvular surgery)
   * Porcelain aorta
   * Pulmonary hypertension \> 60 mmHg and high probability of cardiac surgery for other than valve replacement
   * Recurrent pulmonary embolus
   * Right ventricular insufficiency
   * Thoracic burning sequelae contraindicating open chest surgery
   * History of mediastinum radiotherapy
   * Severe connective tissue disease resulting in a contraindication to surgery
   * Cachexia (clinical impression)
6. Study subjects must be willing and able to attend all follow-up visits within specified visit windows, and agree to undergo all protocol evaluations at each visit

Exclusion Criteria:

1. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, porcine products, or contrast media which cannot be adequately pre-medicated
2. Any sepsis, including active endocarditis.
3. Recent myocardial infarction (\<30 days)
4. Any left ventricular or atrial thrombus as determined pre procedure by echocardiography
5. Uncontrolled atrial fibrillation
6. Mitral or tricuspid valvular insufficiency (\> grade II)
7. Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve)
8. Evolutive or recent CVA (cerebrovascular accident), (\<3 months)
9. Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make impossible insertion and endovascular access to the aortic valve
10. Symptomatic carotid or vertebral arteries narrowing (\> 70%) disease
11. Abdominal or thoracic aortic aneurysm
12. Bleeding diathesis or coagulopathy, or patient will refuse blood transfusion
13. Evolutive disease with life expectancy less than one year
14. Creatinine clearance \< 20 ml/min
15. Active gastritis or known peptic ulcer disease
16. Pregnancy
Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia

Cardiovascular disease (CVD), especially its management and associated costs, remains a major concern globally. There is a direct correlation between circulating levels of low-density lipoprotein cholesterol (LDL-C) and the incidence of CVD.

This study will assess bempedoic acid/FDC in a real-world clinical setting in adult patients in Spain with hypercholesterolaemia or mixed dyslipidemia.

This non-interventional study will be conducted in order to further understand the potential risks and benefits of bempedoic acid/fixed dose combination (FDC) with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia and to gain insight into the effectiveness (managing plasma levels of LDL-C) as well as safety (clinical events associated with the treatment modalities). No study medication will be provided as part of this protocol to the patients. Medications will be as prescribed by the treating physician in line with clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent to participate
* At least 18 years of age
* Participants suffering from documented primary hypercholesterolemia or mixed dyslipidemia
* Part 1: For participants treated to a maximum of 6 months or intended to be treated with bempedoic acid/FDC under usual clinical practice conditions and as long as the decision of the physician to start treatment is prior to the inclusion of the participant in the study at the discretion of the physician under no reimbursement conditions at enrollment
* Part 2: For participants treated or intended to be treated with bempedoic acid/FDC under usual clinical practice conditions and as long as the decision of the physician to start treatment is prior to the inclusion of the patient in the study under reimbursed conditions at enrollment
* No contraindications exist according to the SmPC of bempedoic acid/ FDC
* No concurrent participation in an interventional study (Simultaneous participation in other non-interventional studies is possible)
* Life expectancy \> 1 -year

Exclusion Criteria:

* As this is a non-interventional study, no explicit exclusion criteria exist in order to avoid selection bias and to allow for documentation of routine clinical practice.
Clinical Evaluation of the i-STAT TBI Test

The goal of this study is to evaluate the i-STAT TBI test to assist determining the need for a computed tomography (CT) scan in patients with suspected mild traumatic brain injury (TBI).

Patients will be asked to provide a blood sample.

The purpose of this study is to evaluate the clinical performance of the i-STAT TBI test for the proposed intended use; to assist in determining the need for a computed tomography (CT) scan in patients presenting with suspected mild traumatic brain injury (TBI) who are 18 years of age or older.

The secondary objective of this study is the collection of additional data and specimens from all study subjects that may support other purposes related to the understanding of TBI.

Eligibility Criteria:
Acute Blood Biomarker Branch Subject Inclusion Criteria:

1. 18 years of age or older.
2. Subject or Legally Authorized Representative (LAR) provided informed consent for the Acute Blood Biomarker Branch (waiver of consent may be acceptable, per IRB).
3. Subject presented to a health care facility or emergency department with a suspected TBI resulting from an insult to the head by an external force within 12 hours of the injury.
4. Subject has a CT scan of the head with all sequences (bone and soft tissue) ordered as part of standard of care at the enrolling facility or are transferred to the enrolling facility with a head CT scan sent from the originating facility.
5. As a result of this head injury, the subject has sustained a traumatically induced physiological disruption of brain function, as manifested by at least one of the following.

   1. Any period of loss of consciousness
   2. Any loss of memory for events immediately before or after the injury
   3. Any alteration of mental state at the time of the injury
   4. Focal neurological deficits that may or may not be transient

Acute Blood Biomarker Branch Subject Exclusion Criteria.

1. Previous enrollment in this study
2. Current (on-going) enrollment in a therapeutic or interventional clinical trial (drug or device)
3. Primary diagnosis at the enrolling facility of ischemic or hemorrhagic stroke
4. Time of injury is unknown and cannot be estimated
5. Presented with penetrating head trauma or spinal cord injury (American Spinal Injury Association \[ASIA\] score of C or worse) at the enrolling facility
6. Standard of care head CT scan procedures not completed prior to Emergency Department (ED) discharge
7. Prisoners or patients in custody
8. Patients on psychiatric hold
Racial Variation in Response to Music Interventions for People With Alzheimer's Dementia

This project will study the efficacy of a personalized receptive music intervention on neuropsychiatric symptoms and general cognitive function in patients with mild and moderate Alzheimer's disease (AD) by race.

Music interventions have become a popular treatment option to be used alongside medicinal treatment for many chronic conditions including Alzheimer's disease. Healthcare providers and researchers have found that when patients who have chronic conditions engage with music that is patients' preference or most familiar to patients, the patients display positive changes in mood regulation and thinking overall. The investigators are trying to understand to what extent these music interventions could be useful for patients with Alzheimer's disease and for which populations the intervention is more effective for. To do this, the investigators are looking to recruit participants with a diagnosis of Alzheimer's disease to complete a four (4) week personalized music intervention where patients listen to a one-hour playlist created from patients' described preferences and songs.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Alzheimer's disease
* English speaking

Exclusion Criteria:

* Deaf or hard of hearing
Reported Time Between Onset and Diagnosis of Alzheimer's Disease: Correlation With Objective Parameters

The early diagnosis of Alzheimer's disease is essential to enable patients to have access to the available treatments. However, there is a delay between the diagnosis and the onset of symptoms, which can range from 1 year to more than 5 years. In clinical practice, the hippocampal volume, measured by the Scheltens index, is currently used as a marker of the progression of the disease.

The purpose of this study is to determine whether the patient's sex, age and ethnicity can influence the delay in the expression of cognitive troubles reported by the family at the first medical consultation, as well as to determine if there is a correlation between the delay reported by the family and the Scheltens index.


Eligibility Criteria:
Inclusion Criteria:

Alzheimer Disease patients admitted in the 'Memory Clinic' of the CHU Brugmann Hospital between 01-01-2010 and 31-01-2013. Diagnose according to the Dubois criteria

Exclusion Criteria:

None
Stereotactic Body Radiotherapy Based Treatment for Hepatocellular Carcinoma With Extensive Portal Vein Tumor Thrombosis

Macrovascular invasion (MVI) is common in HCC, Portal vein tumor thrombus (PVTT) is the most common form of MVI in HCC, with an incidence ranging from 44 to 62.2%. About 10% to 60% of HCC patients have PVTT at the time of diagnosis. the prognosis for those with PVTT remains poor, as their median survival is only 2-4 months via supportive care. There is currently no widely-accepted consensus for the management of HCC with PVTT. According to some guidelines in Europe and America, HCC with PVTT is regarded as Stage C per Barcelona Clinic Liver Cancer (BCLC) Staging system, and sorafenib alone is recommended as the treatment of choice. This study is to analyze the safety and efficacy of radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis.


Eligibility Criteria:
Inclusion Criteria:

1. tumor thrombus involving the main trunk and/or first branches of the portal vein, unsuitable for surgery or TACE;
2. an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2; 3. no refractory ascites;

4. Child-Pugh class A and B, or class C with good performance status; 5. no previous radiotherapy to the liver; 6. more than 700 cc of uninvolved liver

Exclusion Criteria:

1. Have received local or systemic treatments in the past, including but not limited to TACE, immunotherapy, targeted therapy, radiotherapy, radiofrequency therapy, etc.;
2. Diffuse HCC or accompanied by distant metastasis;
3. Severe bleeding tendency or coagulation dysfunction within the previous 6 months;
4. Patients with a history of hepatic encephalopathy
Intercalated Combination of Chemotherapy and Tyrosine Kinase Inhibitors as First-line Treatment for Patients With Non-Small-Cell Lung Cancer

Objective: To compare the efficacy and safety of chemotherapy plus intercalated EGFR-tyrosine kinase inhibitors (TKI) combination therapy with TKI alone therapy as first-line treatment for patients with non-small-cell lung cancer (NSCLC).

Methods: Patients with untreated, stage IIIB/IV, EGFR mutation-positive NSCLC will be randomly assigned to combination therapy group (receiving four cycles of docetaxel or pemetrexed (on day 1) plus platinum (on day 1) with intercalated TKI (gefitinib, erlotinib or Icotinib, on day 2-15) every 3 weeks) or TKI alone therapy (gefitinib, erlotinib or Icotinib, daily). All patients were continued to receive TKI until progression or unacceptable to toxicity or death. The primary endpoint was progression-free survivial (PFS).

Expected results: PFS of combination therapy group will be prolonged to nineteen months while PFS of TKI alone therapy group is ten months. Overall survival (OS) of combination therapy group will be prolonged to 36 months while OS of TKI alone therapy group is 26 months.

Hypothesis: Platinum-based chemotherapy plus intercalated TKI combination therapy as first-line treatment will prolong PFS and OS for patients with NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>=18 years of age;
* Advanced (stage IIIB/IV) non-small-cell lung cancer;
* Although stageⅠ-ⅢA, have contraindications to surgery;
* EGFR mutation-positive (EGFR exon-18, exon-19 or exon-21);
* Measurable disease;
* ECOG Performance Status 0 or 1 or 2.

Exclusion Criteria:

* Wild-type EGFR;
* Prior exposure to agents directed at the HER axis;
* Prior chemotherapy or systemic anti-tumor therapy after advanced disease;
* Unstable systemic disease;
* Any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
* Brain metastasis or spinal cord compression.
Descriptive Study of the Incidence of Malignancy in Severe Asthma Patients Receiving Benralizumab and Other Biologic Therapy, a Post Authorization Safety Study

This is a real-world, observational, prospective cohort study in patients with severe asthma recruited into the International Severe Asthma Registry (ISAR) and the US severe asthma registry (CHRONICLE) and followed-up for occurrence of new malignancies. The primary objective is to measure the incidence of malignancy in the overall severe asthma population as well as its relevant subgroups, including patients receiving benralizumab, patients receiving non-benralizumab biologics, and patients not receiving biologics. The secondary objective is to describe the clinical characteristics of new malignancy cases that develop in severe asthma patients and relevant subgroups.


Eligibility Criteria:
Inclusion Criteria:

* The study population includes patients with severe asthma recruited into ISAR and CHRONICLE. Severe asthma patients are defined as those receiving treatment consistent with Global Initiative for Asthma (GINA) Step 5 or who are uncontrolled on GINA Step 4 treatment regimens.

Exclusion Criteria:

- Patients who are not willing and able to sign written informed consent
Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity

Kaposi sarcoma remains the most common malignancy among persons with HIV.

Lesions localized to the airway may cause bleeding, pain and dyspnea.

New therapeutic approaches for local disease are needed.

The purpose of this study is to compare the effectiveness of intralesional bevacizumab + HAART vs HAART alone in treating localized Kaposi´s sarcoma of the airway in patients with AIDS.

Once disseminated disease is excluded, histologically confirmed HIV-positive patients with localized Kaposi's sarcoma of the airway will be randomized to receive HAART only or HAART + intralesional bevacizumab.

The primary outcome will be the size of lesions according to RECIST criteria. Patients in the HAART + bevacizumab arm will undergo series of 3 bevacizumab injections of 5 mg/cm3. Follow-up will be carried out through scheduled meetings for office setting examination every week for the first 8 weeks, then every 15 days for two months and finally every month for eight months.

Size of the lesions will be assessed by an independent observer and adverse events will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected
* KS of the oral cavity, pharynx and larynx, histopathologically confirmed
* HIV treatment-naïve

Exclusion Criteria:

* Airway obstructive lesions
* Actively bleeding lesions
* Tumor-associated oedema or ulceration
* Gastrointestinal KS
* KS in other nonnodal viscera