cyrilzakka/clinical-trials huggingface dataset:
BEVERLY-C: An Observational Study of Avastin (Bevacizumab) in First-Line Treatment in Elderly Patients With Metastatic Colorectal Cancer

This observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy in elderly patients (\>/= 65 years of age) with newly diagnosed metastatic colorectal cancer. Patients will be followed until disease progression, death, withdrawal of consent, discontinuation of physician-patient relationship or study closure, whichever comes first.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 65 years of age
* Patients with newly diagnosed metastatic colorectal cancer starting first-line treatment with Avastin in combination with fluoropyrimidine-based chemotherapy according to the approved Hungarian Summary of Product Characteristics
* Patients suitable for Avastin treatment as assessed by the treating physician

Exclusion Criteria:

* Any contraindications to Avastin treatment according to the Hungarian Summary of Product Characteristics
Interferon Lambda Therapy for COVID-19

The main purpose of this research study is to test the safety and effectiveness of an investigational drug peginterferon lambda-1a in treating COVID-19.

Primary Objective: Determine efficacy of pegylated interferon lambda as measured by clinical improvement. This will be defined as improvement in supplemental oxygen requirement.

Secondary Objectives:

* Determine safety and tolerability of pegylated interferon lambda
* Days with fever
* Time to resolution of fever
* Rate of progression to requiring critical care
* Overall survival
* Time to discharge

Exploratory Objectives: Determining the effect systemically on inflammatory markers in the blood, as well as viral load.

Diagnosis and Main Inclusion Criteria: Patients must have a confirmed diagnosis of infection with SARS-CoV-2 and be receiving supplemental oxygen. Many patients may be receiving hydroxychloroquine with or without other antimicrobials.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of SARS-CoV-2
* Hospitalization due to diagnosis with SARS-CoV-2
* Sp02 \< 93% on ambient air or PaO2/FiO2 \< 300 mmHg and requires supplemental oxygen

Exclusion Criteria:

* Patients must not be pregnant or nursing
* Patients cannot be admitted to intensive care unit at time of admission or require positive pressure ventilation
* Patients cannot be requiring continuous supplemental oxygen normally (pre-SARS-CoV-2)
* Patient is receiving steroids \>1mg/kg
* Has diagnosis of primary immunodeficiency
* Has active autoimmune disease that has required systemic treatment in the past year
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial
* Patients with ferritin \>2000ng/mL and/or C-reactive protein \>100mg/L
* History of allogeneic hematopoietic cell transplantation or solid organ transplantation
* Childs-Pugh class B or C cirrhosis or class A if portal hypertension is present
* Documented allergic or hypersensitivity response to protein therapeutics
* No serious disease requiring mechanical ventilation at time of enrollment
Short Message Service in Colonoscopy Preparation (PERICLES-II-SMS)

The purpose of this study is to analyze if integration of new media (SMS) could improve the quality of colonoscopy preparation.

The study approach is the implementation of new media into colonoscopy preparation. As most of our patients already use mobile phones the study should evaluate if time adjusted information about diet recommendation, laxative intake and behavioral recommedation improve the patient compliance and the quality of colonoscopy preparation. In total 14 SMS wil be sent to the study participants starting 4 days prior the colonoscopy appointment. No additional or different information is provided in comparison to regular colonoscopy preparation for out-patient colonoscopy.

Study participant are randomized when included into the study. Group 1 receives a SMS- supported colonoscopy preparation, group 2 receive no SMS and prepares regularly.

Primary endpoint is bowel cleanness measured by Boston Bowel preparation scale, secondary endpoints are patient satisfaction, adenoma detection rate and compliance.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* written informed consent
* mobile phone user
* appointment for outpatient colonoscopy

Exclusion Criteria:

* no outpatient colonoscopy
* no mobile phone
IXO+A in mCRC With Liver-only Metastases

The percentage of patients with defined unresectable metastatic disease who will benefit from a first-line treatment enabling secondary complete metastasectomy is unknown but limited. Definition of optimized treatment algorithms is difficult due to very inhomogeneous patient populations.

This open label, multicentre Phase II study primarily aims to assess the resection rate achievable in a selected patient population with initially unresectable metastatic disease limited to the liver only in order to evaluate feasibility, safety and efficacy with regards to secondary resection of hepatic lesions in these patients.

The trial aims to enrol only patients meeting defined criteria of unresectability with regards to their hepatic lesions and will exclude patients with extrahepatic lesions in order to examine the most appropriate, highly active treatment regimen for this group of unresectable patients with the highest probability of a successful secondary metastasectomy with curative intent. The trial will be conducted in highly specialized centres with a track record of successful interdisciplinary treatment approaches in the field of metastatic colorectal cancer to allow the precise assessment of the peri-operative safety parameters as well as an evaluation of the surgical treatment approaches.

The IXO regimen selected for this study has shown in a phase I/II study promising efficacy and a favourable safety profile. Bevacizumab has demonstrated a significant survival benefit in combination with chemotherapy in metastatic colorectal cancer. Therefore the study will allow evaluation of its potential benefit in combination with the two most active current chemotherapy regimens in the first-line and post-operative treatment setting.


Eligibility Criteria:
Inclusion Criteria:

* Primary colorectal cancer with unresectable metastatic lesion(s)
* At least one measurable lesion, confirmed by CT scan
* Male and female patients, aged ≥ 18 years
* ECOG performance score of 0 or 1 (within 1 week of study treatment start)
* Written informed consent
* Adequate general condition, cardiopulmonary functions and performance status
* Liver metastases no initially foreseen R0 resection of all hepatic lesions, but deemed potentially resectable after response to downsizing therapy

Exclusion Criteria:

* Extrahepatic metastatic disease
* Prior systemic or local treatment for metastatic disease, prior therapy with a biologic agent, prior adjuvant or neo-adjuvant chemotherapy, prior radiotherapy to the liver, other concurrent chemotherapy
* Inadequate bone marrow, liver, renal function, uncontrolled hypertension
* Pregnancy or lactation
The Biopsychosocial Burden of Prostate Biopsy

Prostate biopsy was offered to 47 consecutive patients with prostate-specific antigen (PSA) over 4 ng/dl or suspicious digital rectal examination (DRE) of whom 16 had undergone a biopsy. Comprehensive validated questionnaires at TIME 0 (pre-biopsy), TIME 1 (before diagnosis, 20 days after biopsy) and TIME 2 (after diagnosis, 40 days after biopsy) accessed patients' erectile (IIEF-5) and voiding (IPSS) functions, Beck scales measured anxiety (BAI), hopelessness (BHS) and depression (BDI), added to the emotional thermometers including five visual analog scales for distress, anxiety, depression, anger and need for help. Mann-Whitney or Friedman tests were obtained among times and studied variables.

A prospective, longitudinal and observational study in which the sexually active patients were evaluated in the Urology Department of the city of Paulínia, submitted to biopsy guided by transrectal ultrasound after ethics committee approval (355.357).

Consecutive patients who were attended by urologist and present prostate cancer suspicions (PSA\> 4 ng / dL and/or rectal examination (TR) were submitted a BXP. They were evaluated at three different moments of the biopsy:

* Seven days before the biopsy procedure (T0);
* 20 days after the biopsy, upon receiving the histopathological result, before becoming aware of it (T1);
* 40 days after the biopsy, 20 days after being aware of the test result (T2). Sixty-one consecutive patients were invited to participate in the study, 10 of them had no active sexual life and 9 answered the questionnaires only at the first moment, were excluded; 47 responded at three times (T0, T1, and T2).

Validated instruments were applied - IIEF-5 (erectile function); - IPSS (voiding function); - Beck scales - BAI (anxiety), BHS (hopelessness), BDI (depression); and - Emotional thermometers.

The comparison among the moments (T0, T1, and T2) was performed through Friedman (analysis of variance) for repeated measures with the variables transformed in stations. The comparison between patients and variables was performed using the Mann-Whitney test. The sample power was calculated and the level of significance considered was 5%.

Eligibility Criteria:
Inclusion Criteria:

* prostate cancer suspicion (PSA \> 4 ng / dL, digital rectal examination)

Exclusion Criteria:

* not agree to participate
Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction

Meibomian gland dysfunction (MGD) is among the leading causes for dry eye syndrome (DES), affecting millions of people worldwide. We have shown in a previous study that tear film thickness (TFT) is reduced in patients with DES and that this reduction correlates with tear break up time (BUT) as well as with the severity of subjective symptoms. Even though systemic tetracyclines as well as topical azithromycin can be used for the treatment of MGD, it seems that topical azithromycin is more effective than tetracyclines and also has the advantage of better tolerability. The hypothesis of the present study is that topical treatment with azithromycin leads to a more pronounced increase in TFT compared to oral doxycycline in patients with DES caused by MGD.

The objective of this study is to compare the effect of treatment with topical azithromycin or oral doxycycline on tear film thickness in patients with DES caused by MGD.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 18 years
* Signs of meibomian gland plugging or expressibility of the meibomian glands.
* DES most likely caused by MGD, no other cause identifiable which is more likely (e.g. intake of concomitant medication that could induce DES, systemic diseases such as systemic arthritis or diabetes), as judged by the investigator
* Signed and dated written informed consent.
* History of dry eye syndrome for at least 3 months
* Normal ophthalmic findings except dry eye syndrome and MGD, ametropia \< 6 Dpts
* BUT ≤ 10 seconds

Exclusion Criteria:

* Participation in a clinical trial in the 3 weeks before the screening visit
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
* Sjögren's syndrome
* Stevens-Johnson syndrome
* Presence or history of a severe ocular condition that will interfere with the study aim as judged by the clinical investigator
* Treatment with corticosteroids in the 4 weeks preceding the study
* Wearing of contact lenses
* Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants Ocular infection
* Ocular surgery in the 6 months preceding the study
* Pregnancy, planned pregnancy or lactating
* Contraindication against the use of topical azithromycin or oral doxycycline
Effect of Monosaccharides on Intestinal Barrier Function

The aim of the present study is to determine the effect of monosaccharides on intestinal barrier function in healthy subjects.

In the intervention study normal weight participants will receive defined amounts of monosaccharides for several days. Before and after intervention parameters of intestinal barrier function will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* BMI \<25 kg/m2
* no kown history of metabolic disorders or fatty liver

Exclusion Criteria:

* food allergies or intolerances (esp. fructose intolerance and malabsorption)
* renal insufficiency
* chronic disease of the gastrointestinal tract
* taking drugs affecting lipid or glucose metabolism
High-frequency nrTMS on the Contralateral Broca Mirror Area for Glioma Patients With Early Postoperative Aphasia

The goal of this randomized clinical controlled trial is to determine whether the application of high frequency neuronavigated repetitive transcranial magnetic stimulation (nrTMS) on the contralateral of Broca's area can ameliorate glioma patients's non-fluent aphasia after tumor resection.

The questions this trial is aiming to answer are:

1. Whether the nrTMS can ameliorate glioma patients' postoperative language impairements.
2. if yes, how effective nrTMS is for improving glioma patients' postoperative language function.

The including criteria:

A. Right-handed, age: 20\~65 years old, tumor involves left language function area, no previous history of treatment of neurological diseases, and preoperative cognitive and language function assessment is normal B. Access to formal education at the primary level and above C. Postoperative pathology is primary low-grade glioma D. Language function assessed as motor aphasia on days 7-10 after surgery E. Willing to receive nrTMS rehabilitation F. The patient and family sign informed consent

The excluding criteria:

A. Tumor grows across the midline to the opposite side B. Undergoing unplanned surgery after the first tumor resection C. Patients request to withdraw from the study during treatment D. During the treatment period, the patient is unable to continue treatment due to force majeure E. Patient loss or refusal of follow-up during the study F. Patients are considered by the investigator to be unsuitable for participation in this study

All patients will receive nrTMS treatment or nrTMS sham treatment for 7 sessions within 10 days (one session per day), start at the 7th - 10th day after glioma resection. The effects of nrTMS treatment will be determine by using the Western Aphasia Battery to evaluate patients' language function after each session and each follow-up interview (every 7-10 days after the whole treatment session finished until the end of the 3rd month after tumor resection or patients' language evaluation shows the language function recoveried to the normal level).

Eligibility Criteria:
Inclusion Criteria:

A. Right-handed, age: 20\~65 years old, tumor involves left language function area, no previous history of treatment of neurological diseases, and preoperative cognitive and language function assessment is normal B. Access to formal education at the primary level and above C. Postoperative pathology is primary low-grade glioma D. Language function assessed as motor aphasia on days 7-10 after surgery E. Willing to receive nrTMS rehabilitation F. The patient and family sign informed consent

Exclusion Criteria:

A. Tumor grows across the midline to the opposite side B. Undergoing unplanned surgery after the first tumor resection C. Patients request to withdraw from the study during treatment D. During the treatment period, the patient is unable to continue treatment due to force majeure E. Patient loss or refusal of follow-up during the study F. Patients are considered by the investigator to be unsuitable for participation in this study
Prevalence of Lactose Intolerance Following Stem Cell Transplantation

It is currently assumed that all patients are lactose intolerant post bone marrow transplantation. This pilot study is to assess what the incidence of lactose intolerance is after bone marrow transplantation in children. This will be done using a lactose breath test.

All pediatric patients over the age of 4 years who are scheduled for a stem cell transplant will be approached to assess whether what the incidence of lactose intolerance is in the post transplant period and how quickly recovery occurs. A baseline lactose and lactulose breath test will be performed followed by repeat lactose breath tests starting 2 weeks after day 0 and repeated every fortnight for 10 weeks. Stool pH and reducing substances will be checked at the time of the breath tests to see if there is any correlation.

Eligibility Criteria:
Inclusion Criteria:

* All patients planned to undergo a stem cell transplant.

Exclusion Criteria:

* Refusal to participate
* Unable to perform breath tests on request (generally under the age of 4 years.)
GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients

The purpose of this study is to evaluate the efficacy and safety of GX-I7 in combination with bevacizumab in subjects with recurrent glioblastoma.

This is a phase 2 study designed to evaluate the efficacy and safety of GX-I7 in combination with bevacizumab in subjects with recurrent glioblastoma.

A total of 20 patients will be enrolled in the study and administered bevacizumab GX-I7. The study treatment will be continued for up to 6 cycles or until a progression of disease or unacceptable toxicity is confirmed.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 19 years
2. Histologically diagnosed glioblastoma patients who have been confirmed the progression of disease after attempting standard therapy (RT/CCRT and/or adjuvant chemotherapy (TMZ))
3. Karnofsky Performance Status; KPS ≥ 60 or ECOG status 0-2
4. Life expectancy \> 12 weeks
5. Adequate hematologic and end organ function

Exclusion Criteria:

1. Malignancies other than disease under study within 5 years prior to the first dose of study drug
2. Subjects who have received bevacizumab or other VEGF inhibitors prior to study participation
3. Body Mass Index (BMI) ≥ 30 kg/m2
4. Subjects confirmed intracranial hemorrhage with non-contrast CT or MRI
5. Clinically significant cardiovascular disease
6. History of arterial or venous thromboembolism 6 months prior to study participation
7. Uncontrolled hypertension (blood pressure ≥ 150/90 mmHg with appropriate antihypertensive therapy)
8. History of hypertensive crisis or hypertensive encephalopathy
9. Subjects receiving therapeutic anticoagulation (except low molecular weight heparin or warfarin)
10. Pregnancy or breastfeeding.
11. Subjects with active virus infection
12. Subjects with autoimmune disease/ syndromes
13. Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study
14. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
15. Severe infections during the screening period, including but not limited to complications of infection, bacteremia or severe pneumonia
16. Prior allogeneic bone marrow transplantation or prior solid organ transplantation
Irreversible Electroporation(IRE) For Unresectable Gallbladder Neoplasms

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Gallbladder Neoplasms.

By enrolling patients with unresectable Gallbladder Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Gallbladder Neoplasms.

Eligibility Criteria:
Inclusion Criteria:

* Gallbladder Neoplasms diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial

The purpose of this study is to gather clinical information on the hemodynamic performance of the Contour 3D® and Tri-Ad® Tricuspid Annuloplasty Rings in a post-market environment.

The primary goal of the TV repair procedure is to relieve patients from TV insufficiency or reduce TV stenosis. This study will evaluate the hemodynamic efficacy of the Contour 3D® and Tri-Ad® ring and characterize the effect of the TV repair through assessment of right atrial size and right ventricular function. Additionally, this study will characterize the patient population for whom a Contour 3D® or Tri-Ad® ring is chosen to repair TV insufficiency. Health status and adverse events (AE) will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Subject or legal guardian willing and able to sign and date the Informed Consent Form (and Authorization to Use and Disclose Health Information Form, if applicable)
* Subject indicated for a concomitant surgical repair of the TV
* Subject is willing to return for required follow-up visits to the hospital where the implantation originally occurred

Exclusion Criteria:

* Subject with a degenerative TV condition
* Subject with primary TV regurgitation
* Subject with a previous TV repair or replacement
* Subject indicated for a stand-alone TV repair
* Subject currently participating in an investigational drug or another device study
* Subject with life expectancy of less than one year
* Subject is pregnant or desires to be pregnant within 12 months following implantation
* Subject is under 18 or over 85 years of age
* Subject with active endocarditis
* Subject with valvular retraction with severely reduced mobility
* Subject with a heavily calcified TV
Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis B

The aim of our study is to evaluate liver fibrosis using biochemical markers, FibroScan, and radiology methods in patients with chronic hepatitis B in mainland China.

Up to Nov, 2015, total of 818 patients with chronic HBV infection had been enrolled in the study. Paired blood and liver biopsy specimen had been collected. The serum samples stored at -80 degree Celsius. All the liver biopsy samples were judged by three pathology experts, according to Ishak standard.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of chronic hepatitis B or compensated cirrhosis due to chronic hepatitis B virus infection
* agree to have liver biopsy

Exclusion Criteria:

* clinical diagnosis of decompensated cirrhosis due to hepatitis B virus or inactive carrier
* liver diseases due to other origin