cyrilzakka/clinical-trials huggingface dataset:
EBV Positive Nasopharyngeal Carcinoma Treated With Concurrent Chemo-radiotherapy With or Without Anti-Viral Drug

PCR-DNA of EBV test is a good prognostic indicator for survival after treatment (report: Prognostic Impact of Plasma, Epstein-Barr Virus DNA in Patients with Nasopharyngeal Carcinoma Treated using Intensity-Modulated Radiation Therapy.

The chances of the local recurrence or metastasis are higher in the patients at same stage with positive PCR-DNA of EBV in Nasopharyngeal carcinoma after same treatment.(ref.) Antiviral drugs have been used to inhibit EBV replication and target viral DNA polymerase are Foscarnet and phosphonoacetic acid both interact directly with the pyrophosphate-binding site of the enzyme, where Acyclovir as antiviral drug act at two levels: as competitive alternative substrates, competing with GTP on the substrate-binding site, and as DNA chain terminators, by incorporating into the growing DNA chain and blocking its elongation due to their acyclic structure.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma, types WHO II-III.
* Stage II-IVB
* Requiring primary concomitant Radiotherapy and Chemotherapy.
* No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies.
* Positive PCR-DNA EBV
* ≥ 18 years of age
* ECOG performance status 0-1
* WBC ≥ 4,000/µl, platelets ≥ 100,000/µl; serum creatinine ≤ 1.6 mg/dl or 24 hr. calculated creatinine clearance ≥ 60 ml/min (see Section 3.1.6).
* Pre-treatment evaluation of tumor extent and tumor measurement.
* Nutritional and general physical condition must be considered compatible with the proposed radio-therapeutic treatment.
* Signed study-specific consent form prior to study entry Assessment.

Exclusion Criteria:

* Prior radiotherapy to the head and neck or any prior chemotherapy ≤ 6 months prior to study entry.
* Other malignancy except non-melanoma skin cancer or a carcinoma not of head and neck origin ≤ 5 years
* Evidence of distant metastasis.
* on any experimental therapeutic cancer treatment.
* major medical or psychiatric illness.
* pregnant females.
* Age ≤ 18 years old
Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer

The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.


Eligibility Criteria:
Inclusion Criteria:

* Patient has given written informed consent before any trial-related activity is performed.
* Has a confirmed prostate cancer in which this type of treatment is needed.

Exclusion Criteria:

* Previous treatment for prostate cancer
* Previous trans-urethral resection of the prostate
* Patients who are lymph node positive or have other metastatic disease
* Use of urethral catheter
* Current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
* History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
* Hypersensitivity towards any component of the investigational product
* Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
* Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
* Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.
An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment

The study will evaluate the physical impact of MS from participant's perspective, provide continued access to ocrelizumab and assess the safety and tolerability of ocrelizumab.


Eligibility Criteria:
Inclusion Criteria:

* Participants who were on ongoing ocrelizumab treatment on one of the following parent-studies \[Studies MN39159/CONSONANCE (NCT03523858), BN42082/MUSETTE (NCT04544436), BN42083/GAVOTTE (NCT04548999), BN44083/GLOBEAM, MN43978/CONSONANCE Ext., WA40404/O'HAND (NCT04035005), MN43964/OLERO (NCT05269004), GN41791/FENTREPID (NCT04544449), CN41144/OCARINA I-SC (NCT03972306), CN42097/OCARINA II-SC (NCT05232825)\] at the time of roll-over and who do not have access to the ocrelizumab treatment locally.
* The first dose of study treatment in this extension study will be received no earlier than 5 months after the last treatment in the parent study.
* Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in women of childbearing potential.

Exclusion Criteria:

* Study treatment is commercially marketed in the participant's country for the participant specific disease and is reasonably accessible to the participant.
* Study treatment is available via Post Trial Access Program (PTAP) in the participant's country and is accessible to the participant.
* Permanent discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable).
* Any condition that, in the opinion of the investigator, would interfere with the interpretation of participant safety or place the participant at high risk for treatment-related complications.
* Concurrent participation in any therapeutic clinical trial (other than the parent study).
* Immunocompromised state
* Known active malignancy or are being actively monitored for recurrence of malignancy.
* Known presence of other neurological disorders.
Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion

Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a noninvasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA™) to temporally and spatially map brain function, connectivity and synchronization.

The proposed study will provide additional evidence for the utility and contribution of the BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with concussion) in concussion management.


Eligibility Criteria:
Inclusion Criteria:

* Age 17-24, both genders, enrolled in a recognized college and members of a sport team of their school.

Exclusion Criteria:

Current or history of any of the following:

* TBI (i.e., Glasgow Coma Scale \<13) or brain surgery
* Any psychiatric disorder
* Any Neurological disorder
* Substance abuse
* Special education
* Any medication affecting CNS
* Significant sensory deficits such as deafness or blindness
* Residual symptoms or deficits related to a previous concussion
Transdermal Testosterone for Poor Responder Patients Undergoing Controlled Ovarian Stimulation Prior to IVF

This study evaluates the efficacy of pre- IVF treatment with transdermal testosterone to enhance ovarian response in poor responders.

a randomized controlled trial with two groups, treatment group with transdermal testosterone before IVF treatment and a control group with no treatment.

One of the major challenges of Assisted reproduction technology is treating women with low ovarian response,those women achieve very poor pregnancy rate with IVF.

in recent years there is a focus

Eligibility Criteria:
Inclusion Criteria:

* infertility patients undergoing ART regular menses normal function of thyroid, liver and kidney normal BMI (19.3-28.9) without use of any fertility drugs in the previous two months

Exclusion Criteria:

* patients with recurrent implantations failure (3 cycles and more) previous ovarian surgery uncontrolled medical illness severe endometriosis (stage 3-4) contraindication for testosterone use
Tiotropium in the Treatment of the Patients With Chronic Obstructive Pulmonary Disease

To collect post-marketing safety and effectiveness information on the use of Tiotropium Inhalation Capsules (18 μg) in patients with chronic obstructive pulmonary disease in daily clinical settings


Eligibility Criteria:
Inclusion Criteria:

- Patients with COPD

Exclusion Criteria:

-There is no exclusion criterion, because this post marketing study (PMS) is observational survey under condition of normal clinical practice
Buprenorphine in the Treatment of Osteoarthritis (OA) in the Elderly

The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).


Eligibility Criteria:
Inclusion Criteria:

* Either sex aged 65 or above
* Diagnosis of OA of the hip and/or knee
* Severe pain requiring step two medication
* Taking maximum dose of paracetamol

Exclusion Criteria:

* Painful disease of the joints other than OA
* Contraindication to buprenorphine, other opioids, patch adhesives or nonsteroidal anti-inflammatory agents (NSAIDS)
* Subjects taking cyclooxygenase (COX) II selective inhibitors
The Use of Tolvaptan to Prevent Renal Dysfunction in High Risk Patients With Heart Failure-Pilot Study

It is well known that the use of loop diuretics in acute setting may decrease glomerular filtration rate (GFR) and increase serum creatinine leading to renal dysfunction. Loop diuretic induced elevation in serum creatinine can lead to increase in length of hospital stay and possibly morbidity. Previous studies have suggested that tolvaptan unlike aggressive loop diuretic therapy may not activate neurohormonal system nor decrease renal blood flow. These properties may make tolvaptan a useful addition to diuretic therapy to prevent renal dysfunction in high-risk patients. Therefore the primary objective of this study is to determine if the use of tolvaptan in combination with diuretic therapy may prevent development of renal dysfunction in high risk patients with heart failure.

Hypothesis: Administration of tolvaptan in combination with continuous loop diuretic therapy in acutely decompensated heart failure patients at high risk for developing diuretic induced renal dysfunction will have a lower proportion of patients increasing their serum creatinine \> 0.3 mg/dL within a 96 hour time frame as compared to patients just receiving standard of care continuous infusion diuretic.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Prior clinical diagnosis of systolic heart failure (EF \< 40% within the past 18 months) with daily home use of oral loop diuretic for at least one month.
* Daily oral dose of furosemide ≥ 40 mg and ≤ 240 mg (or equivalent)
* Identified within 24 hours of hospital admission
* Heart failure defined by at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography)
* Anticipated need for IV loop diuretics for at least 48 hours
* Likely requires daily net urine output in the range of 1-3 L/day for over a 72-96 hour time period.
* Albumin level \< 3.5 g/dL
* Willingness to provide informed consent

Exclusion Criteria:

* Received or planned IV vasoactive treatment (inotropes, vasodilators) or ultra-filtration therapy for heart failure
* BNP \< 250 ng/ml or NT-proBNP \< 1000 mg/ml (if drawn for clinical purposes)
* Systolic BP \< 90 mmHg
* Serum creatinine \> 3.0 mg/dl at baseline or renal replacement therapy or creatinine clearances \< 10 mL/min
* Serum sodium \> 145 mEq/L
* Acute coronary syndrome within 4 weeks
* Anticipated need for coronary angiography or other procedures requiring IV contrast.
* Patients receiving any of the following drugs: clarithromycin, ketoconazole, itraconazole,ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, telithromycin, erythromycin, fluconazole, aprepitant, diltiazem, verapamil, cyclosporine, and grapefruit juice.
* Pregnant or nursing patients.
An Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) Subject

To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032 for 24 weeks treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects chronically infected with HCV Genotype 1
* HCV RNA viral load of ≥ 10\*5\* IU/mL (100,000 IU/mL) at screening

Exclusion Criteria:

* Subjects with evidence of liver cirrhosis
* Evidence of HCC
* Co-infection with hepatitis B virus, HIV
CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis.

This observational study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI).

To collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for TAVI in patients with failing surgical aortic bioprosthesis who are at high risk for redo surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patient is \> 18 years old
* Patient has a symptomatic degeneration of aortic bioprosthesis
* Acceptable candidate for elective treatment with the Medtronic CoreValveTM System (according to the most recent version of the Medtronic CoreValveTM Instructions For Use) and in conformity with the local regulatory and reimbursement context
* Logistical Euroscore \> 20% or STS \> 10% or presence of comorbidities responsible of contra-indication(s) for redo surgery as assessed by at least one cardiac surgeon or patients in whom heart team has assessed the redo surgery at high risk
* The patient or legal representative has been informed of the nature of the procedure and the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form ("Patient Informed Consent Form")
* The patient is willing and able to comply with requirements of the study, including the 24 months follow-up
* Patient will receive the CoreValveTM device in a degenerated surgical bioprosthesis

Exclusion Criteria:

* Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated
* Patient in whom heart team considers that risk of TAVI is too high with a particular attention for the risk of coronary occlusion
* Patient with prior endocarditis on failed bioprosthesis
* Patient has other medical illness associated with a limited life expectancy (i.e., less than 1 year)
* Patient with LVEF \<20%, cardiogenic shock, or hemodynamic compromise requiring pressors or inotropes or mechanical support devices
* Patient with severe mitral disease associated with severe pulmonary hypertension
* Acute coronary syndrome less than 7 days before intervention
* Currently participating in another investigational drug or device study.
* Patient with significant paravalvular regurgitation
* Patient in whom internal diameter prosthesis is equal to 17 mm
His-Bundle Corrective Pacing in Heart Failure

The investigators aim to prospectively evaluate the efficacy and mechanism of benefit of His-bundle pacing enhanced cardiac resynchronization therapy (His-CRT) vs. cardiac resynchronization therapy (BIV-CRT) in patients with heart failure and right bundle branch block (RBBB).

In this prospective, randomized, multi-center clinical trial, the investigators aim to prospectively evaluate the efficacy and mechanism of benefit of His-bundle pacing enhanced cardiac resynchronization therapy (His-CRT) vs. cardiac resynchronization therapy (BIV-CRT) in patients with Right Bundle Branch Block (RBBB) Electrocardiogram (ECG) Pattern by assessing the improvement in left ventricular ejection fraction (LVEF) in the His-CRT vs. BIV-CRT arm at 6 months, and by evaluating changes in ECG biomarkers, NT-pro-brain natriuretic peptide (NT-proBNP) levels, and echocardiography biomarkers (left ventricular volumes, strain contractility, and dyssynchrony), as well as temporal changes in functional status and quality of life in the His-CRT vs. BIV-CRT arm at 6, 12, and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older (no upper age limit)
* Optimal medical therapy for heart failure by current guidelines
* Class IIa or IIb guideline-based indication for CRT-D implant in RBBB patients, including one of the following:

  * New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS≥ 150 ms (IIb); OR
  * NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa); OR
  * NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration 120-149 ms (IIb)

Exclusion Criteria:

* Unable to obtain most recent imaging data from echocardiogram within 1 year prior to date of randomization
* Left bundle branch block (LBBB) or intraventricular conduction delay (IVCD) ECG morphology
* Unable or unwilling to follow study protocol
* Less than 12 months life expectancy at consent
* Pregnancy or planned pregnancy during duration of the study
* On heart transplant list or likely to undergo heart transplant
Augmentation of Neuronal Network Plasticity in Schizophrenia

Current pathophysiological models of schizophrenia focus on disconnectivity of distributed neuronal systems to explain the multitude of psychic symptoms. However, therapeutic strategies targeting this specific pathobiology are lacking. Our recent work provides strong evidence that complex video-game training interventions facilitate fronto-hippocampal structural and functional connectivity within 2 months in healthy subjects. The planned project transfers this knowledge into a training study in schizophrenic patients to counteract disease-related disconnectivity. Underlying mechanisms and behavioral effects are extensively parametrized by resting state functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI), spectroscopy and clinical short- and long-term outcome.


Eligibility Criteria:
Inclusion Criteria:

* clinically stabilized
* at least one schizophrenic episode in their lives
* International Classification of Diseases 10 (ICD-10) F20.x (and F25)

Exclusion Criteria:

* clinically relevant anemia
* MRI contraindication
* earlier electroconvulsive shock treatment
* significant somatic or neurological disease
* significant alcohol or substance abuse in the year before
* more than 1h video games per day more than 6 months before study start
* simultaneous major psychiatric disease (if symptomatic in the foreground)
Immobilization and Protein Supplementation (IM-PRO)

In the present study, the effects of 5 days of lower limb immobilization with or without twice-daily protein supplementation on muscle mass and muscle fiber characteristics will be determined. A young group will be included to compare the changes in muscle mass and muscle fiber characteristics between young and old men.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged from 18-35 years and from 65-75 years
* 18.5 \< BMI \< 30 kg/m2

Exclusion Criteria:

* Smoking
* Performing regular resistance training in the previous 6 months
* Hypertension (according to WHO criteria) \[52\] and/or cardiovascular disease
* Any back/leg/knee/shoulder complaints which may interfere with the use of crutches
* Systemic use of antibiotics within 3 weeks prior to the study visit
* Current systemic use of corticosteroids, growth hormone, testosterone, immunosuppressants or insulin
* Type 2 diabetes mellitus
* Any history of thrombosis
* Any family history (1st grade) of thrombosis
* All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis).
* Myocardial infarction within the last 3 years
* Use of anti-coagulants
* Any (history of) gastrointestinal disease that interferes with GI function
* Indications related to interaction with the study product:
* Known allergy to milk or milk products
* Known galactosemia
Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane

This registry is primarily aiming to demonstrate the correlation between good practices of anesthesiologists and patient related outcomes including decreased overall anesthesia cost. The investigators would also like to demonstrate how the training background, and experience in inhalational anesthesia of the anesthesiologist influence their daily practice. At the end of the registry, the investigators would be able to demonstrate the influence of different practice pattern on patient related outcomes between the sites at which anesthesiologists follow modern anesthesiology practice based on their training/experience background and at which anesthesiologists do not follow same type of practice due to lack of their inhalational anesthesia training/experience.


Eligibility Criteria:
Inclusion Criteria:

1. ASA (American Society of Anesthesiologists) physical status (a requirement of the patient's physical status): I to III
2. Age from 18 to 70 years
3. Surgery requiring general anesthesia with endotracheal intubation or laryngeal mask airway.

Exclusion Criteria:

1. History of significant cardiovascular, pulmonary, renal, hepatic or central nervous system disease or muscle disease.
2. Hypersensitivity or unusual response to any halogenated anesthetics.
3. Personal or familial history of malignant hyperthermia.
4. Female patients either pregnant or breast feeding.
5. General anesthesia is administered with total intravenous anesthesia (TIVA) of propofol.