cyrilzakka/clinical-trials huggingface dataset:
Acute Post-Radiation Hyperbaric Oxygen (HBO2) for Breast Cancer Patients Who Have Recently Completed Radiation Therapy

This study aims to compare patients that receive hyperbaric oxygen or Trental and Vitamin E immediately after completion of radiation therapy to evaluate which treatment best reduces radiation fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Patient is currently undergoing treatment for breast cancer and is on one of two pathways:

  * Pathway 1 involves lumpectomy with radiation therapy, recurrence years later, mastectomy and tissue expander with further radiation therapy
  * Pathway 2 involves mastectomy and tissue expander, 6 weeks of radiation therapy, and an implant in 6 months
* Undergone mastectomy with expander or implant reconstruction \> 2 weeks before starting radiation therapy
* Completed chest wall irradiation in the past 3 days
* Willing to stop herbal medications as directed by provider
* Willing to stop daily use of supplemental vitamin E (Multivitamin with vitamin E component is acceptable, vitamin E cream is also acceptable)
* Willing to have photographs of chest area taken for research purposes only
* Therapeutic PT-INR for participants taking Coumadin
* If tissue expanders remain intact during radiation, plan for conversion to the final implants must occur \> 4 months after completing radiation
* Willing to travel to a Legacy Health facility for study related visits
* Agree to attend study visits outside of standard of care visits, if needed
* Willing to engage in pre/post testing and survey/phone calls
* Willing to attend all 6 weeks of HBOT if randomized to that group

Exclusion Criteria:

* \< 18 years of age
* Pregnant or lactating
* Have final implant placed \< 2 weeks before start of radiation therapy
* Plan to place final impacts \< 4 months from the completion of radiation therapy, if tissue expanders are intact during radiation therapy
* Have evidence of ongoing infection or implant exposure before start of radiation therapy
* Radiation completed more than 3 days prior to study start
* Unable to comply with protocol
* Unable to provide written informed consent
* Unwilling or unable to stop oral supplemental Vitamin E
* PT-INR outside of acceptable range for participants taking Coumadin
* Any delay in radiation treatment greater than 14 days
* Investigator does not believe study participation is in the best interest of the patient
* History of a seizure within the last 5 years
Anal Fistulae Internal Opening Closure by OTSC Clip After Video Assisted Tract Fulguration

This study is expected to recruit 20-25 cases treated with video assisted anal fistula treatment. Additionally the internal opening of the fistulae will be closed by an OTSC clip.

Sphincter damage after anal fistulae surgery is the most important cause of incontinence in adults. Surgeons are gradually gradually getting more reluctant for creating any damage to sphincter for this reason. Anteriorly located, high and trans-sphincteric fistulae are at more risk.

Ablating the fistula tract by laser or diathermy has been in use for a long time. Recently a rigid thin camera to visualize all side tracts and branches for ablating them under direct vision has also been in use especially in Europe. Recently, closing the internal opening after ablating the fistula tract was reported to offer higher success rates for healing with less recurrence. The success rate was higher when the opening was closed by a stapler device.

Our aim in this study is to use o novel technique by using OTSC clip for water tight closure of the internal fistula opening after diathermy ablation of the tract under direct vision and compare the healing and recurrence rates with other methods.

Eligibility Criteria:
Inclusion Criteria: Patients with trans-sphincteric and inter-sphincteric perianal fistulae

-

Exclusion Criteria:

* Presence of acute abscess, Inflammatory Bowel Disease, Myeloproliferative disease, established incontinence, Recto-vaginal fistula
A Study on the Effect of Renal Impairment on the Pharmacokinetics of RO4917838

This open-label, single-dose, parallel-group study will investigate the pharmacokinetics and safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single dose of RO4917838.


Eligibility Criteria:
Inclusion Criteria:

General criteria

* Body mass index (BMI) between 18 and 32 kg/m2

Criteria applying to renal impaired subjects

* Adult subjects, 18-65 years of age
* Part 1: Subjects with end stage renal disease (ESRD), not on dialysis
* Part 2: Subjects with severe, moderate or mild renal impairment
* Stable renal function

Criteria applying to healthy subjects

* Adult subjects, 18-70 years of age

Exclusion Criteria:

General criteria

* Any condition or disease (other than renal impairment for the renal impaired subjects only) that would render the subject unsuitable for the study, or would place the subject at undue risk
* Any condition which could relapse during or immediately after the study
* History of alcohol or drug abuse

Criteria applying to renal impaired subjects

* Evidence of unstable clinically significant disease other than renal impairment
* Clinically significant liver disease
* Any other major illness (with the exception of renal impairment) within 4 weeks prior to study start

Criteria applying to healthy subjects

* History of any clinically significant disease (e.g., cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic disease)
ESPB Combined With Intercostal Nerve Block in VATs

A randomized prospective trial to test the effect of additional Erector Spinae Plane Block (ESPB) with intercostal nerve block during video assisted thoracoscopic surgery.

A prospective randomized trial which aims to evaluate effect of peripheral nerve block for pain management, the Erector Spinae Plane Block (ESPB) in patients undergoing video assisted thoracoscopic surgery with intercostal nerve block.

Eligibility Criteria:
Inclusion Criteria:

* Wedge Resection or Lobectomy under VATS approach.

Exclusion Criteria:

* Age \< 20 years
* Patients who has anatomical abnormality in any spine
* Patients who has skin infection near to be the present procedure site
* Intercostal nerve block is not performed during surgery
* Previous lung surgery history of affected side
Therapeutic Variables in Cataract Surgery

The purpose of this study is to compare patient outcomes in following cataract surgery in patients randomized to one of two surgical kits.


Eligibility Criteria:
Inclusion Criteria:

* Males or females scheduled to undergo cataract surgery
* Patients can be receiving monofocal IOLs only
* Likely to complete all study visits and able to provide informed consent
* Visual potential of 20/25 or better

Exclusion Criteria:

* Known contraindications to any study medication or ingredients
* Active ocular diseases or uncontrolled systemic disease
* Active ocular allergies
Comparison of Transversus Abdominis Plane Block and Ilioinguinal / Iliohypogastric Nerve Block

the aim of this study is to compare the effects of Transversus abdominis plane block and ilioinguinal / iliohypogastric block combined with sedation in pediatric surgeon on the anesthesia and analgesia contributions during surgery without general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesia score I-II
* To undergo elective lower abdominal surgery
* between 2-6 years old

Exclusion Criteria:

* Patients with psychiatric disease
* Patients whose weight is more than 40 kg
* Patients with cardiac-pulmonary-neurological disease
* Patients with bleeding disorder
* Patients with infection or scar on the injection area
* Patients with known allergies to local anesthetics
SMS 2: Impact of Cancer Therapy on the Somatic Mutational Landscape of Normal Tissues

Recently technology has been developed at the Wellcome Sanger Institute to allow clusters of cells with mutations to be detected in normal and diseased tissues. The researchers wish to determine how the number and nature of these mutant cell clusters change in response to treatments given to cancer patients (such as chemotherapy, radiotherapy, immunotherapy, and drugs targeted at specific mutations in tumours). As such the researchers wish to collect research samples of blood, cheek cells (via swabs) and urine from adult cancer patients receiving the above-mentioned treatments as part of their standard care. The researchers also wish to access any leftover tissue following surgery that is undertaken as part of these patient's treatment.

Disease and tissue aging are thought to be influenced by genetic changes, or mutations, acquired throughout life. These mutations provide clues regarding the genetic damage that occurred through the lifetime of the patient, and include mutations caused by environmental factors such as ultraviolet light from sunlight or tobacco smoke affecting the skin or internal tissues, respectively. Other mutations may occur due to errors in copying the genome as cells divide. Once a cell has acquired a mutation, the cell's daughters may inherit it. Eventually clusters of cells carrying the same mutation may form within tissues. If the mutations alter cell behaviour this may impact how cells behave and influence how a whole tissue functions.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Due to commence systemic treatment for histologically confirmed cancer at a - participating site
* Age over 18 years
* Able to give informed consent.
* Able to give urine, blood and cheek swab samples on two occasions.
* Likely to complete 3 months of treatment

Exclusion Criteria:

* Anyone outside of the inclusion criteria plus individuals who Lack the capacity to provide informed consent and those who do not have a good command of the English language.
* Any participant who is known to have Hep B, Hep C or HIV
Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008)

This is a phase 3, multicenter, prospective, randomized study of intravenous (IV) ceftolozane/tazobactam versus IV meropenem in the treatment of adult participants with either ventilator-associated bacterial pneumonia (VABP) or ventilated hospital-acquired bacterial pneumonia (HABP). The primary objective is to demonstrate the non-inferiority of ceftolozane/tazobactam versus meropenem in adult participants with ventilated nosocomial pneumonia (VNP) based on the difference in Day 28 all-cause mortality rates in the Intent-to-treat (ITT) population using a non-inferiority margin of 10%.


Eligibility Criteria:
Key Inclusion Criteria:

* Adult participants diagnosed with either VABP or ventilated HABP requiring IV antibiotic therapy;
* Intubated and on mechanical ventilation at the time of randomization;
* New or progressive infiltrate on chest radiography consistent with pneumonia;
* Presence of clinical criteria consistent with a diagnosis of ventilated nosocomial pneumonia.

Key Exclusion Criteria:

* History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics;
* Prior non-study antibiotics for \> 24 hours;
* Gram stain of lower respiratory tract specimen showing only gram positive bacteria;
* Active immunosuppression;
* End-stage renal disease or requirement for dialysis;
* Expected survival \< 72 hours;
* Severe confounding respiratory condition (i.e., chest trauma with paradoxical respiration);
* Known or suspected community-acquired bacterial pneumonia.
* Anticipated concomitant use of any of the following medications during the course of study therapy: valproic acid or divalproex sodium. Anticipated concomitant use of serotonin re-uptake inhibitors, tricyclic antidepressants, or serotonin 5-HT1 receptor agonists (triptans), meperidine, or buspirone during the course of linezolid treatment.
* Receipt of a monoamine oxidase inhibitor within 14 days prior to the first dose of study drug or anticipated concomitant use during the course of linezolid therapy.
A Safety and Efficacy Study of Vitreosolve® for Non-Proliferative Diabetic Retinopathy Subjects

The purpose of this study is to determine the safety and efficacy of Vitreosolve in diabetic retinopathy patients.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a history of systemic diabetes (type I or II)
* Subject with a documented history of Non Proliferative Diabetic Retinopathy (NPDR)
* Subjects with no PVD at baseline exam in the study eye.

Exclusion Criteria:

* Subjects with Retinal pathology in the study eye other than (NPDR)
* Subjects with high myopia in the study eye
* Subjects who have monocular vision or contra lateral vision of 20/200 or worse BCVA in the non-study eye.
* Subjects with an aphakic study eye or if pseudophakic, cataract extraction surgery less than 6 months prior to study enrollment
* Subjects that have had either vitrectomy surgery, intravitreal injections, or laser treatments in the study eye.
Comparison of Vascular Findings Between Symptomatic and Asymptomatic Postmenopausal Women Before and During Hormone Therapy (HRT)

Recent large randomized, placebo-controlled studies assessing the health effects of HT question the overall benefits of long term HT, especially with respect to cardiovascular disease. However, recently menopausal women with severe hot flushes were mostly excluded from these trials. This was unfortunate since vasomotor symptoms may reflect different vascular sensitivity to estrogen or its deficiency, and therefore, the vascular responses to HT in women with and without hot flushes can differ.

Aims of the present project are

1. to compare vascular, cardiac and sympathetic function in recently menopausal women with or without severe vasomotor symptoms
2. in a randomized placebo controlled clinical trial investigate vascular response to oral and trans-dermal HT.

We recruit 160 healthy postmenopausal women between ages 48-55. Eighty women must have severe vasomotor symptoms (at least seven severe or moderate hot flush attacks per day) whereas 80 comparators must be symptomless (no hot flushes). Thorough vascular function and risk factor assessments will be done, including clinical assessment of autonomic nervous system, endothelial function measurements, 24-hour ECG and blood pressure evaluation, and lipid and various other vascular surrogate marker measurements. In the first part of the study we compare these baseline measurements between women with or without severe vasomotor symptoms. In the second part of the study the women are randomized to receive placebo, oral estrogen, oral estrogen plus progestin or transdermal estrogen for 6 months. After the treatments the baseline assessments are repeated.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women between ages 48-55
* Minimum of 6 months and maximum of 36 months from last menstrual period
* Postmenopausal status of these women will be confirmed by level of FSH that should exceed 30 U/l
* Eighty women must have severe vasomotor symptoms (at least seven severe or moderate hot flush attacks per day) whereas eighty comparators must be symptomless

Exclusion Criteria:

* smoking
* hysterectomy
* dyslipidemia
* overt hypertension (blood pressure \> 140/90)
* diabetes
* any regular medication
* HT in the previous 3 months
* body mass index over 27
A Clinical Trial to Evaluate the Sensitivity of a Number of Clinical and Psychological Outcome Measures for Cancer Patients Being Treated at the Hospital Day Care Unit or (Partially) at Home

This pilot study aims to evaluate the sensitivity, variability and responsiveness of a number of predefined clinical and psychological outcome measuring tools in an ambulant cancer treatment setting (home vs. hospital). The measuring tools will be evaluated in two patient cohorts. One cohort is treated as per standard of care at the outpatient hospital, the other cohort is receiving (partial) cancer treatment at home. A second objective is to create a costs inventory representing total costs for an ambulant treated cancer patient.


Eligibility Criteria:
Inclusion Criteria:

* Starting new oncological treatment at the outpatient hospital.
* ECOG ≤ 2
* Living within 30 minutes of drive from the hospital

Exclusion Criteria:

* Important comorbidity (ECOG \> 2)
* Simultaneous radiotherapy treatment
* Language barriers or communication difficulties
* Problematic venous access
* Known problems with administration of the therapy
Medical Abortion Self-Confirmation (MASC)

This study aims to investigate the ability of participants to perform and accurately interpret the multi-level pregnancy test and the low sensitivity pregnancy test following medication abortion, without routine provider contact.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age of less than or equal to 63 days
* English speaking
* Determined by the site investigator or designee to be fully eligible for medical abortion with mifepristone followed by misoprostol according to the site's standard criteria
* In the judgement of the site investigator, she is capable of giving informed consent and she has signed the study informed consent or assent form

Exclusion Criteria:

* Allergy to mifepristone and/or misoprostol
* Non-english speaking
* Inability to access internet
Study of BN83495 in Post-menopausal Women With Endometrial Cancer Post-chemotherapy

The purpose of the protocol is to determine the effect of BN83495 on the progression of endometrial cancer with estrogen receptor in post menopausal women who had previously received chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent prior to any study related procedures.
* postmenopausal or ovariectomised female patient over 18 years of age.
* histologically confirmed diagnosis of ER positive endometrial carcinoma in the primary tumour or metastatic disease
* patient has received one line of chemotherapy prior to enrolment in the adjuvant or in the metastatic setting (including chemoradiotherapy) and progressed after this line of chemotherapy
* patient has at least one measurable disease site (RECIST criteria version 1.1)

Exclusion Criteria:

* patient has received hormone therapy for endometrial cancer in the adjuvant or metastatic setting
* patient has received more than one line of chemotherapy in the adjuvant or metastatic setting
* patient was treated with any other investigational agent within the 3 weeks before study entry.
* patient has ongoing cardiac dysrhythmias grade ≥2, atrial fibrillation of any grade (NCI CTCAE) or QTcF interval \>460 msec.
Monocyte Profiles in Critically Ill Patients With Pseudomonas Aeruginosa Sepsis

The present study focuses on patients with Pseudomonas aeruginosa (PSA) sepsis. The aim of the present study is to find out whether the M1 (pro-inflammatory) or M2 (anti-inflammatory) phenotype predominates in blood monocytes in critically ill patients with PSA-sepsis, and whether the severity of sepsis and outcome is associated with distinct monocyte phenotype and function.

During bacterial related sepsis, one of the key playing cells are macrophages, monocytes and T-lymphocytes (Hotchkiss et al., 2003). Macrophages and monocytes are supposed to be essential for the septic reaction to Gram-negative bacteria (Hotchkiss et al. 2003). Generally, there are two dominant types of macrophages: the pro-inflammatory M1 macrophage and the anti-inflammatory M2 macrophage (Mantovani et al., 2006). Similar to this macrophage characteristics, monocytes can also be categorized into pro-or anti-inflammatory. These macrophage/monocyte phenotypes can be differentiated in vitro from freshly isolated human blood monocytes using either GM-CSF giving raise to M1 macrophage/monocyte or M-CSF resulting in M2 macrophage/monocyte (Mantovani et al., 2006; Neu et al., 2013). Brunialti et al. (2012) have already demonstrated that the population of antiinflammatory M2 monocytes in septic patients is bigger than the pro-inflammatory M1 population. However, the authors did not further analyze the underlying mechanisms of M2 polarization nor did they identify the sepsis-causing pathogens.

In the present study, monocytes and macrophages of patients with Pseudomonas aeruginosa (PSA) sepsis are characterized by their surface marker expression profile via flow cytometry and cytokine pattern by ELISA in vivo and after ex-vivo LPS stimulation. In addition, an ex-vivo model system for PSA induced sepsis is validated. Blood of critically ill patients in the ICU infected with PSA is sampled to isolate peripheral blood mononuclear cells (PBMCs). Blood monocytes are analyzed for surface marker expression to determine the relative proportions of M1 and M2 monocytes in these patients and in healthy controls by flow cytometry

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* critically ill patients with sepsis
* microbiologically proven infection with Pseudomonas aeruginosa

Exclusion Criteria:

* life expectancy \< 24 hours
* participation in other studies
Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in HIV-infected Adults

A four-site intradermal rabies booster vaccination in HIV - infected patients who have ever received primary rabies vaccination could improve their immune response to this kind of vaccine.

A four-site intradermal rabies booster vaccination has shown higher immune response than conventional intramuscular rabies booster vaccination in healthy persons. So, the investigators hypothesized the same outcome in HIV - infected patients.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected patients
* Age 18 - 60 years
* Received primary rabies immunization

Exclusion Criteria:

* Have any active opportunistic infections
* Received blood or blood product within 3 months
* Allergy to vaccine or any vaccine components
* Received anti-malarial drugs
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18 years of age
* Documentation of any of the following clinical criteria:

  * CHA2DS2-VASc ≥ 4 with age ≥ 65
  * CHA2DS2-VASc ≥ 4 with significant left atrium enlargement or elevated NT-proBNP
  * CHA2DS2-VASc = 3 with age ≥ 75
  * CHA2DS2-VASc = 3 with significant left atrium enlargement or elevated NT-proBNP
  * CHA2DS2-VASc score = 2 with age ≥ 65 and significant left atrium enlargement or elevated NT-proBNP

Exclusion Criteria:

* Clinically significant atrial fibrillation or atrial flutter:

  * Anytime in the past and
  * Documented by an electrocardiographic recording and
  * Episode lasting 6 minutes or longer1\*
* Prior procedure involving opening the pericardium or entering the pericardial space
* Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)
* Planned cardiac surgical procedure using non-sternotomy approaches

  o Partial sternotomies will be allowed.
* Patients whose planned procedure is a heart transplant or implantation of any ventricular assist devices
* Active endocarditis
* Active systemic infection at the time of cardiac surgery requiring antibiotics, including known SARS-CoV2 infections regardless of symptoms
* Known allergy to Nitinol or nickel sensitivity
* Known medical condition with expected survival of less than 1 year
* Other comorbidities that in the investigator's opinion make the subject unsuitable candidate to complete the protocol required visits.
* Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial.
* Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial.
* Pregnancy
* Known severe symptomatic carotid disease