cyrilzakka/clinical-trials huggingface dataset:
Sorafenib for Residue Disease After Resection With Curative Intent

Radical hepatic resection represents one of the treatment options offering a prospect for cure with 5-year survival rates up to 50%. However, unintentionally, quite a proportion of these "radical resection" actually turned out to be non-radical in nature. For these patients who actually received non-radical resection, their by year survival rates were much lower than those who received radical hepatectomy. In this prospective, non-interventional, multi-center study, we are planning to observe the patient characteristics of Hepatocellular carcinoma (HCC) patients who have residual disease after resection with curative intent, as well as treatment pattern, safety and effectiveness of sorafenib for these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed HCC and have residual disease after resection with curative intent and for whom a decision to treat with Sorafenib has been made.

The definitions of non-radical resection are as follows:

Liver tumor rupture or adjacent organ invasion, confirmed by intra-operative or post-operative pathology; Positive resection margin, confirmed by post- operative pathology; Lymph node metastasis confirmed by intra-operative or post- operative pathology; Residue lesion confirmed by post-operative digital subtraction angiography (DSA); Macroscopic/microscopic tumor thrombi of vein and/or bile duct, confirmed intraoperative / post-operative pathology; Number of tumors \>=3, confirmed by preoperative radiographic inspection (CT, MRI or BUS), intraoperative BUS, or post-operative pathology.

AFP alpha fetoprotein(AFP) remains higher than Upper Limits of Normal (according to local lab's range), confirmed by local laboratory test at least 2 months after surgery.

* Confirmation of complete response (no visible residual tumor), on the eligibility scan (CT or MRI) by local radiological review, performed \>2 weeks after surgery;
* Patients must be followed up regularly after surgery (time interval and method based on physician's daily practice), have no documented tumor recurrence by eligibility scan (CT or MRI) before Sorafenib treatment;
* Patients must have physically/mentally recovered from surgery and considered to be able to tolerant Sorafenib therapy, by investigator's judgment;

Exclusion Criteria:

* The approved local product label must be followed for the exclusion criteria
IMPACT of AspireSR® for VNS Therapy on Healthcare Resource Utilisation and Clinical Outcomes.

This is a retrospective non-interventional study to describe the HCRU and clinical outcomes before and after AspireSR® device implantation in subjects with drug resistant epilepsy at the Queen Elizabeth Hospital, Birmingham (QEHB).

Real-world data on healthcare resource use (HCRU) for subjects with treatment-resistant epilepsy and their clinical outcome prior to- and post-VNS device implantation in the UK are limited.

The current study aims to describe and compare the secondary HCRU and clinical outcomes prior to and following AspireSR® device implantation in subjects with drug resistant epilepsy.

Retrospectively-collected data from hospital medical records (paper-based and/or electronic, as appropriate) will be used to describe subject characteristics, disease control and clinical outcomes. All secondary HCRU data will be extracted from the Hospital Episode Statistics (HES) database by Harvey Walsh Ltd (HW, trading under OPEN VIE). Primary HCRU data will be requested from the subjects' general practitioners (GPs).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years at AspireSR® device implantation.
* VNS device AspireSR® implantation for the first time or battery change from a previous model to AspireSR® at least 24 months prior to the start of retrospective data collection from medical records.
* Subjects for whom written informed consent has been provided for researcher access to their medical records and extraction of data from HES (if the subject is living and has capacity to consent) or advice from a consultee (if the subject is living but lacks capacity to consent).
* Subjects with available medical history for at least 24 months prior to Aspire SR® implantation.

Exclusion Criteria:

* Living subjects for whom consent for researcher access to medical records and extraction of data from HES has not been obtained.
* Deceased subjects.
Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Node-Positive Breast Cancer Patients

The purposes of this study are the following:

1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75)
2. To determine maximum tolerated dose (MTD) and optimal biologic dose (OBD) for the peptide vaccine
3. To evaluate the in vivo cellular immune response to the peptide vaccine
4. To evaluate time to recurrence in the vaccinated patients vs. matched controls

Breast cancer is the most common malignancy and second most common cause of cancer-specific death among women in the United States. Despite advances in the diagnosis and treatment of breast cancer, one third of the women who develop the disease will die of the disease, accounting for approximately 46,300 deaths/year. While good primary therapies are available to treat early stage breast cancer, there is a substantial failure rate to these therapies in more advanced disease.

Advances in the understanding of the immune response to cancer have lead to the genesis of immunotherapeutic approaches. Specifically, the development of anti-cancer vaccines holds promise as an adjuvant and preventive therapy for patients after both primary surgical and medical treatment for breast cancer, but who are at a high risk for recurrence. Patients with greater than four lymph nodes positive have an 87% chance of recurrence post standard surgical and medical therapies at 10 years. While patients with hormone receptor positive tumors have the option to undergo hormonal therapy, recurrence is especially high among estrogen receptor/progesterone receptor (ER/PR) negative patients. For these patients, currently there is no good treatment option after completion of primary therapy; close surveillance and watchful waiting is the standard.

It is this population of patients that a vaccine strategy to induce cellular immunity would target. We propose to vaccinate these patients with an immunogenic peptide from the HER2/neu protein. If successful, this vaccine strategy could be utilized as an adjuvant to currently accepted first line therapy in future clinical trials.

Eligibility Criteria:
Inclusion Criteria:

1. HER2/neu expressing tumor
2. HLA-A2+ and/or HLA-A3+ to receive the vaccine. HLA-A2- and/or HLA-A3- patients will be eligible to be included in the control group.
3. Immunologically intact with a good performance status
4. Identified as being high or intermediate risk for recurrence
5. Without evidence of disease
6. Completion of all standard first-line therapies (but may still be on hormonal therapy)

Exclusion Criteria:

1. Tumor does not express HER2/neu
2. Not HLA-A2+ and/or HLA-A3+
3. Anergic
4. Receiving immunosuppressive therapy
5. In poor health (Karnofsky \<60%, ECOG \>2 and Tbili \>1.5 and creatinine\>2)
6. Pregnant (beta HCG+)
7. Metastatic disease or have refused standard therapies
8. Patients enrolled in other experimental protocols may enroll to this study only with the permission of the other study PI.
Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males

Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a proprietry testosterone replacement product - Testosterone-MD Lotion, and this study will evaluate the efficacy and safety of this product.


Eligibility Criteria:
Inclusion Criteria:

* Hypogonadal males between 18-70 years old with qualifying general medical health

Exclusion Criteria:

* Disqualifying concurrent conditions or allergy/sensitivity to testosterone replacement therapy
Impact of Exercise on Prognostic Biomarkers Related to Prostate Cancer

The goal of this study is to demonstrate the impact of a home based exercise program versus wait-list control to modulate circulating prognostic biomarkers in men with prostate cancer under active surveillance.

Prostate cancer (PCa) is the most common non-skin cancer effecting American males. Several reports suggest that physical activity after cancer diagnosis is associated with better cancer- specific and overall survival in individuals diagnosed with PCa. There is a growing body of evidence for lifestyle interventions that aim to promote physical activity as having the potential to counter some of the adverse effects of cancer treatments, disease progression and other health outcomes. Exercise performed 2-3 times a week has been shown to improve physical fitness, functional performance, and quality of life in men with PCa; however, few men with PCa exercise regularly and do not meet national physical activity guidelines. A potential explanation on the lack of exercise in men with PCa is the absence of a structured, home-based, exercise program. While studies have shown positive effects of exercise in men with PCa, little is known about how physical activity effects tumor physiology in men with PCa. The primary objective of this pilot study is to gather preliminary data regarding the impact of a novel, home-based exercise program on PCa biomarkers associated with recurrence and metastasis of PCa in men under active surveillance.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 40 or older
* Ambulating male
* Diagnosed with low grade prostate cancer
* Subjects willing and able to provide consent to participating in the study Exclusion Criteria
* prostatectomy
* severe cardiac disease (New York Heart Association class III or greater)
* angina
* severe osteoporosis
* uncontrolled hypertension (blood pressure \> 160/95mm Hg)
* uncontrolled sinus tachycardia (\> 120 beats per minute)
* uncontrolled congestive heart failure third-degree atrio-ventricular heart block, active pericarditis or myocarditis, recent embolism, thrombophlebitis, deep vein thrombosis, resting ST displacement (\> 3mm), uncontrolled diabetes, uncontrolled pain, cognitive impairment, history of falls due to balance impairment or lost of consciousness,
* severe neuromusculoskeletal conditions that limit their ability to perform walking exercise (including ataxia, peripheral or sensory neuropathy, unstable bone lesion, severe arthritis, lower limb fractures within 6 months, lower limb amputation).
Clinical Trial to Assess the Efficacy and Safety of MUCOLASE Tablet(Streptokinase • Streptodornase)

A phase 4 study to evaluate efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase)

Double-blind, randomized, placebo controlled, multicenter, phase 4 clinical trial to assess the efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase) in patients with acute upper respiratory infection or acute bronchitis

Eligibility Criteria:
Inclusion Criteria:

* 19≤ age
* Patients with acute upper respiratory infection or acute bronchitis
* Patients with cough and phlegm within 48 hrs as of Visit 1
* Patients understood the consents and purpose of this trial and signed consent form

Exclusion Criteria:

* Patients with high fever (≥39℃)
* Patients with severe respiratory diseases (ex) bronchial asthma, pneumonia, pulmonary tuberculosis, bronchiectasis, mucus sticking, chronic obstructive pulmonary disease (COPD), etc.
* Patients with a history of hypersensitivity to drug
* Patients with abnormal blood coagulation
* Patients with thrombocytopenia
* Patients with uncontrolled hypertension
* Patients with a severe liver disorder(AST or ALT level exceeds 2 times more than normal upper range)
* Patients woth a clinically significant renal failure(MDRD eGFP \< 60 mL/min/1.73m2)
Effect of Dapagliflozin on VT in Patients With Heart Failure.

This project plans to design a randomized controlled clinical trial to evaluate the effect of dapagliflozin on ventricular arrhythmia in the participants with heart failure with reduced ejection fraction after ICD implantation by collecting and analyzing the data of ECG, cardiac ultrasound and ICD programming. This project will explore the anti-ventricular arrhythmia effect of dapagliflozin in HFrEF patients.

This is a single-center, randomized, controlled, double-blind study in Chinese heart failure participants with ICD implantation. This trial aims to investigate the effect of dapagliflozin on ventricular arrhythmias in participants with HFrEF. This trial includes a screening period, a treatment period and a follow-up period. Total duration of each subject's participation in the trial is approximately 1 year. During the screening period, 120 participants with HFrEF with ICD implanted in the investigator's department were recruited. The participants should sign the informed consent and be randomly divided into 2 groups. All participants will receive the best anti-heart failure treatment for 6 months before enrollment, including ACEI/ARB/ARNI, β-blockers, spironolactone, diuretics, and digitalis. One group was randomized to receive dapagliflozin (10 mg qd) and another group received place. Participants were then enrolled in a 1-year clinical trial and investigators will record the participants' QT interval, QTc interval, frequency and mode of ICD electrical therapy, cardiac function, symptoms, signs and other indicators before and after treatment to evaluate the occurrence of ventricular arrhythmia.

Eligibility Criteria:
Inclusion Criteria:

patients received ICD therapy with HFrEF, including: ischemic cardiomyopathy, non-ischemic cardiomyopathy, LVEF ≤35% and optimized anti-HF therapy for at least 6 months.

Exclusion Criteria:

1. Type 1 diabetes or a history of repeated diabetic ketoacidosis.
2. Those who strictly restrict carbohydrate intake.
3. Genital infection.
4. Low blood pressure.
5. SGLT2i allergy.
6. Severe renal impairment or end-stage renal disease (eGFR\<30ml/(min•1.73m\^2)) or dialysis.
7. The water-electrolyte and acid-base balance disorders have not been corrected.
8. Bladder cancer.
9. Those taking other antiarrhythmic drugs except beta-blockers.
10. Other diseases cause the patient's life expectancy to be less than 1 year.
Study Evaluating Preference, Satisfaction And Correct Use Of Inhalers In COPD Patients

This study compared the correct use of and patient preference for two drug delivery systems (inhalers) in patients with COPD


Eligibility Criteria:
Key Inclusion Criteria:

1. Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure.
2. Co-operative outpatients with a diagnosis of moderate COPD as classified by the GOLD Guidelines 2010 or grade A in GOLD 2011and including:

   * Smoking history of at least 10 pack years
   * FEV1/FVC \< 70%

Key Exclusion criteria:

1. Previous diagnosis of asthma
2. Pregnant or nursing women
3. Hospitalization or emergency room attendance due to COPD exacerbation within 3 months prior to visit 1
Transcranial Doppler in Children With Hemoglobinopathies

Transcranial Doppler ultrasonography (TCD) is a noninvasive, portable technique for evaluating the intracranial vasculature.

TCD ultrasonography is performed placing a low frequency (≤ 2 MHz) transducer on the scalp of the patient, in order to visualize the intracranial arterial vessels through specific acoustic windows, where bone is thinner, and evaluate cerebral blood flow velocity (CBFV) .

Patients diagnosed to have hemoglobinopathy conditions with its most common forms thalassemia and sickle cell disease manifest both biochemical and clinical evidence of hypercoagulability conditions include deep venous thrombosis, pulmonary emboli and recurrent arterial occlusion .

Cerebrovascular accidents can be identified using transcranial Doppler ultrasonography which enables evaluation of cerebral artery blood flow velocity with a sensitivity of 90% and specificity of 100 % when compared with cerebral angiography .

According to the stroke prevention trial in sickle cell anemia (STOP) study ,TCDs were classified based on blood velocity in the circle of Willis, expressed as time averaged mean of the maximum velocity (TAMMV). Children with abnormal, high velocities (\>200cm/s) were at increased risk of stroke, which was reduced by 90% after starting regular blood transfusions. TAMMVs less than 170cm/s were classified as normal with annual TCD scanning recommended, whereas velocities between 170 and 200cm/s were called conditional, and followed up more closely without starting transfusion.


Eligibility Criteria:
Inclusion Criteria:

* children diagnosed with hemoglobinopathies

Exclusion Criteria:

* Children before two years old .
* Hemoglobinopathy patients more than 18 years .
* Uncooperative patients .
Liver SBRT in Combination With Immune Checkpoint Inhibition in Patients With Metastatic Non-small Cell Lung Cancer

Determine the feasibility of liver stereotactic body radiation therapy (SBRT) given in combination with systemic therapy (immune checkpoint inhibitors) in adult patients with metastatic NSCLC with liver metastases.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years of age)
* Histologically or cytologically confirmed NSCLC with liver metastases
* Eligible for immune checkpoint inhibitors per treating medical oncologist
* Disease must be measurable per RECIST criteria
* ECOG Performance status of 0 - 2
* Adequate organ function per protocol.
* Allowable prior therapy includes adjuvant durvalumab, prior radiotherapy outside the upper abdomen.
* Patients must be willing and able to sign an informed consent form.
* Participants of childbearing potential willing to undergo pregnancy test and use contraception per Appendix.

Exclusion Criteria:

* Liver tumor burden which cannot be targeted with SBRT per treating radiation oncologist
* Presence of uncontrolled intercurrent illness or significant comorbidities precluding participation in a clinical study as determined by investigator
* Diagnosis of underlying parenchymal end stage liver disease (cirrhosis) or biliary disease (primary biliary cirrhosis).
* Other invasive malignancy active within 1 years, excluding in situ cancers
* Presence of psychiatric or substance abuse disorders that would interfere with compliance or safety
* Has a known history of active Bacillus Tuberculosis (TB), Hepatitis B or Hepatitis C infection
* Has received a live (active) vaccine within 30 days of enrollment.
* Active autoimmune disease that has required systemic treatment in the past 1 years aside from hormone replacement therapy (ie. thyroxine, insulin, or physiologic corticosteroid replacement therapy)
* Baseline corticosteroid use (\>10 mg prednisone daily or equivalent) at study entry
* Pregnancy or breast feeding
A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit

The ReWalk enables people with lower limb disabilities to carry out routine ambulatory functions (stand, walk, climb stairs etc.). It can be used by people with disabilities such as spinal cord injury, brain injury, stroke, multiple sclerosis, cerebral palsy and other severe walking impairments. The device promises to restore the dignity of disabled persons, enabling them to work and improve their general health and quality of life, as well as significantly reduce medical and other related expenses.

The ReWalk comprises light wearable brace support suit, which integrates DC motors at the joints, rechargeable batteries, an array of sensors and a computer-based control system. It is snugly fitted on the body and worn underneath the clothing, if desired. ReWalk is a new realization of the Powered Exoskeleton concept, first tried about fifty years ago with no success. Employing an innovative, non-robotic design approach, it uniquely matches the user's capabilities with the control mechanisms. Upper-body movements of the user are detected and used to initiate and maintain walking processes. User stability and safety during ambulation is secured by concurrent use of safety aids such as crutches for walking and railing for stairs.

Eligibility Criteria:
Inclusion Criteria:

* Chronic (at least 6 months after injury) complete cervical(C7-8) or thoracic (T1-T12) spinal cord injury
* Age between 18-55
* Male and non-pregnant non-lactating female
* Regular use of RGO or bing able to stand up using a device (e.g. EasyStand)
* under 100 kg and between 155-200 cm of height

Exclusion Criteria:

* History of severe neurological injuries other than SCI (MS, CP, ALS, TBI etc)
* Severe concurrent medical diseases: infections, heart or lung, pressure sores
* Unstable spine or unhealed limbs or pelvic fractures
* Psychiatric or cognitive situations that may interfere with the study
Prospective Cohort of Patients With Newly Diagnosed Glioblastoma: Analysis of MMP2 and MMP9 Expression and Correlation to Neuro-imaging Features.

Glioblastoma is the most frequent and aggressive primary brain tumor in adults. A team recently showed that baseline plasma levels of matrix metalloproteinase-2 (MMP2) and matrix metalloproteinase-9 (MMP9) were correlated to bevacizumab activity in patients with recurrent glioblastoma. To date, the biological rationale of this results remains unknown but MMP2 could be involved in classical angiogenesis while MMP9 could promote vasculogenesis.

The objectives are to correlate the plasma levels of MMP2 and MMP9 to their Ribonucleic acid (RNA) and protein tissue expression, activity and to patient neuro-imaging features. To analyze the changes of MMP2 and MMP9 plasma levels during peri-operative period and after radio-chemotherapy.

Methods: Plasmatic levels of MMP2, MMP9, vascular endothelial growth factor-A (VEGFA), vascular endothelial growth factor-R2 (VEGFR2), stromal cell-derived factor 1 (SDF1) and chemokine receptor-4 (CXCR4) will be analyzed by enzyme-linked immunosorbent assay (ELISA) in pre-, post-operative period, before radiotherapy, before adjuvant temozolomide and at relapse in newly diagnosed glioblastoma. RNA expression of these factors will be analyzed by reverse transcription-Polymerase chain reaction (RT-qPCR) on frozen tumor samples, whereas protein expression will be analyzed by ELISA and immunohistochemistry. Enzymatic activity of MMP2 and MMP9 will be analyzed by zymography. Tumor volume, infiltration and perfusion degrees will be analyzed on Magnetic Resonance Imaging (MRI) performed before and after surgery and before adjuvant temozolomide. Neuro-imaging characteristics will be correlated to plasma and tissue expressions of these factors.

The expected results are to better define the expression profile of MMP2, MMP9 and the change in their plasma level during treatment, a prerequisite for their clinical use.


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, aged 18 years or over
* Imaging suggestive of glioblastoma
* Patient eligible for excision surgery (partial, subtotal or macroscopically complete)
* Candidate for concomitant and adjuvant radiotherapy chemotherapy (Stupp protocol)
* Patient having signed an informed consent
* Patient having undergone a preoperative MRI

Exclusion Criteria:

* Existence of a contraindication to the MRI
* Nonoperable lesion
* History of radiotherapy and / or chemotherapy for this lesion
* Scalability of a low grade lesion
* Person in emergency situation, a legal person of legal age (guardianship, guardianship or legal guardianship), or unable to express his or her consent
* No affiliation to a social security scheme (beneficiary or beneficiary)
* Pregnant or lactating woman