cyrilzakka/clinical-trials huggingface dataset:
Preoperative Marking of the Oral Resection Margin in Esophageal Cancer With a Surgical Fiducial Marker - First Experiences

This study aims to evaluate if BioXmark™, a surgical marker, may efficiently and safely be used to preoperatively mark the proximal and distal resection line 5 cm proximal and distal to the tumor margin of gastroesophageal-junction adenocarcinoma (GEJ AC).

Furthermore, to determine if placing the resection margin according to the resection margin defined by BioXmark™ is superior to the current standard of a proximal resection line estimation by the individual surgeon based on the intraoperative findings.

In Denmark, the national guidelines for GEJ AC surgery are an R0 resection with a minimum 5 cm proximal and distal resection margin, measured in vivo. During the operation, the primary surgeon sets the resection margin according to the guidelines, with 5 cm on either side.

The Danish national guidelines are clear, but the literature behind them is not, and the recommendations for resection margins vary worldwide. With the lack of a strong literature-backed guideline and a surgical approach that is heavily dependent on the individual surgeon's estimate, the risk of a microscopic positive resection margin (R1 resection) increases. Both problems, namely resectability at the definitive surgery and the incidence of microscopic positive resection margins after resection, may be improved by preoperatively marking the tumor margins in vivo. This could be achieved with an endoscopically placed surgical marker.

One such surgical marker is BioXmark™, a liquid injectable and adherent fiducial marker that has shown promising results for image-guided adaptive radiotherapy in lung, bladder, and esophageal cancer. BioXmark™ is implanted during endoscopy and has appropriate visibility with good positional stability on CT, CBCT, and MRI. Furthermore, no adverse reactions or events have been reported yet.

The study will be performed as a feasibility study of BioXmark™ at the Department of Surgery \& Transplantation, Centre of Cancer and Organ Diseases. The investigators plan to include 10 patients who are scheduled to undergo curatively intended surgery for GEJ AC. The patients will be drawn from the existing operating program.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred with gastroesophageal adenocarcinoma to the Department of Surgery \& Transplantation, Centre of Cancer and Organ Diseases, Rigshospitalet, and who are candidates for curatively intended surgery.

Exclusion Criteria:

* Patients under the age of 18.
* Patients diagnosed with disseminated disease during surgery.
* Patients with impaired cognitive ability, making obtainment of informed consent impossible
A Study of Participants in China With Non-Small-Cell Lung Cancer That is Unable to be Treated With Surgery

This is a multicenter, observational cohort study in China with both primary prospective data collection and retrospective collection of prior treatment information from medical records, which enrolls and follows patients who are newly diagnosed with unresectable stage IIIB/IIIC/IV Non-Small-Cell Lung Cancer (NSCLC) in the selected sites.

This study aims to describe the clinical practice and long-term survival benefits of patients newly diagnosed with unresectable stage IIIB/IIIC/IV NSCLC. The study also seeks to explore the condition of biomarker tests utilization, and to assess potential economic impact on patients in the real world. The safety related events will also be summarized in this study.


Eligibility Criteria:
Inclusion Criteria:

Cohort 1:

* Participants who have diagnosed with unresectable stage IIIB/IIIC/IV NSCLC
* Participants who have been diagnosed six months before the start of the study were required to have two complete tumor assessments within at least 6 months intervals after the diagnosis
* Participants who were newly diagnosed within six months before the start of the study were required to have complete baseline information (see section 6.4.1)
* Participants who have received standard first-line treatment defined by guideline CSCO (https://www.csco.org.cn/cn/index.aspx) and NCCN (https://www.nccn.org/)

Cohort 2:

* Participants who are newly diagnosed with unresectable Stage IIIB/IIIC/IV NSCLC after the start of the study
* Participants who are able to be followed up by the participating site
* Participants planned to receive first line anti-cancer treatment targeting unresectable stage IIIB/IIIC/IV NSCLC in the study site after study initiation

Exclusion Criteria:

* Participants who have received prior systematic treatment for unresectable Stage IIIB/IIIC/IV NSCLC
* Participants who have participated in any anti-cancer, regimen-specified clinical study of first-line treatment for unresectable Stage IIIB/IIIC/IV NSCLC
A Controlled Breathing Course for Social & Emotional Health for Vietnam Veterans With Chronic PTSD-RCT

The main aim of this project is to evaluate the use of a specific Yoga technique of controlled breathing in Vietnam War Veterans with chronic posttraumatic stress disorder. This method is currently the subject of a United States grant application to formally test American War Veterans from Afghanistan and Iraq. Drs Gerbarg and Brown are collaborating with The Bay Pines Veterans Administration Medical Center in Florida to develop a study of this course for treatment of American veterans returning from Afghanistan and Iraq. Elements of this method have been used on a variety of populations. Whilst this is a multi-component intervention, it is postulated that the most active ingredient in the program is a specific Yoga breathing technique called Sudarshan Kriya (SK).

The main aim of this project is to evaluate the use of a specific Yoga technique of controlled breathing in Vietnam War Veterans with chronic posttraumatic stress disorder. This method is currently the subject of a United States grant application to formally test American War Veterans from Afghanistan and Iraq. Drs Gerbarg and Brown are collaborating with The Bay Pines Veterans Administration Medical Center in Florida to develop a study of this course for treatment of American veterans returning from Afghanistan and Iraq. Elements of this method have been used on a variety of populations. Whilst this is a multi-component intervention, it is postulated that the most active ingredient in the program is a specific Yoga breathing technique called Sudarshan Kriya (SK).

This program has been developed by Sri Sri Ravi Shankar, chief yoga teacher and Head of The Art of Living Foundation (Ravishankar 2002). Further, this method has been applied widely for the treatment of Acute Stress Disorder and Posttraumatic Stress Disorder in individual cases (Gerbarg and Brown 2005Direct communication). For example, this controlled breathing program has been reported to have relieved posttraumatic stress disorder (PTSD) in large groups of people affected by mass disasters such as war (Kosovo, Bosnia, Iraq and Sudan) (Biswas 2004; Joseph 2004; Luedemann 2004), terrorism (New York City 9/11) (Anonymous 2001b), (Kashmir, India, Israel) and natural disasters (Gujurat earthquake, 2000) (Anonymous 2001a) Iran flood, Asian Tsunami. This controlled breathing program is reported to have also helped police (Slovenia, India, Washington, DC) and military personnel (Iraq) (cited in Gerbarg and Brown 2004), (Gerbarg 2005Personal communication). Pilot studies conducted by the Principal Investigator using similar techniques showed positive health results for Vietnam Veterans with PTSD in Australia (Carter and Byrne 2004). However, although randomized clinical trials have been performed for depression with good effect

Eligibility Criteria:
Inclusion Criteria:

* suffering chronic post traumatic stress disorder tested by CAPS
* Vietnam Veteran
* Adequate Cognition

Exclusion Criteria:

* Inadequate cogition
* suicidality
* psychosis
* substance abuse other than alcohol
Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain Birthmark at High Fluences

The purpose of the study is to improve the efficacy of pulsed dye laser treatment of port wine stain birthmarks. Involvement in the protocol will involve formal documentation of the level of treatment pain, duration of post-treatment purpura and incidence of side effects. In addition, measurements will be taken of blood substances that promote blood vessel formation/regrowth and non-invasive reflectance measurements and photographs will be taken before and after treatment.

The objective of this study is to document the degree of port wine stain lightening, the incidence of side effects and the presence of angiogenic factors induced during treatment with the pulsed dye laser in association with cooling agent. This information ultimately lead to improved treatment.

The flashlamp-pumped pulsed dye laser has offered the best results with the lowest incidence of side effects. The yellow light is preferentially absorbed by hemoglobin allowing more selective destruction of the ectatic capillaries in the dermis.

The flashlamp-pumped pulsed dye laser has become the treatment of choice for port wine stain birthmarks; however, therapeutic challenges remain. The epidermis is not totally spared due to partial absorption of energy therein by melanin which presents an optical barrier through which the light must pass to reach the underlying blood vessels. Absorption of laser energy by melanin causes localized heating in the epidermis, which may, if not controlled, produce permanent complications such as hypertrophic scarring or dyspigmentation.

Clinical studies have demonstrated the efficacy and safety of cryogen spray cooling during pulsed laser treatment of port wine stain birthmarks. This technology allows the use of higher incident laser light dosages and has been demonstrated to improve treatment results. cryogen spray cooling also decreases treatment pain and the duration of post-laser treatment purpura.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PWS birthmark or age and sex matched control of a subject with a PWS birthmark
* Apparent good health as documented by medical history and physical examination
* Ability to understand and carry out subject instructions

Exclusion Criteria:

* Pregnancy
* History of cutaneous photosensitivity
* History of photodermatoses, skin cancer or other cancer
* Any therapy to the proposed treatment sites within the previous two months
* Current participation in any other investigational drug evaluation
* Concurrent use of known photosensitizing drugs
* Inability to understand and carry out subject instructions
MELD ESAS Evolution: Assessment of the Symptomatic Burden of Patients With Advanced Chronic Liver Disease

The goal of this observational study is to understand if there is a correlation between the evolution of MELD-Na and symptomatic burden of patients with advanced chronic liver disease.

All patients with chronic liver disease will be invited to participate in the study. Patients will be followed prospectively with assessment of their MELD-Na score and symptom burden, according to the Edmonton Symptom Assessment System scale.

1. Methodology - Prospective observational study
2. Population - All patients with chronic liver disease followed in the Matosinhos Local Health Unit after their first episode of decompensation or are diagnosed with hepatocellular carcinoma in stage C or D of the Barcelona Liver Clinic Cancer will be invited to participate in the study.

   All patients who do not sign consent to participate, patients under 18 years of age and patients who present a recurrent degree of encephalopathy, according to the West-Haven scale, equal or greater than 2, will be excluded.
3. Sample - Non-probabilistic for convenience
4. Data collection instrument - Patients will be followed prospectively with quarterly assessment, or after each episode of decompensation, of their MELD-Na score and symptom burden, according to the Edmonton Symptom Assessment System scale (ESAS), with introduction of 3 other symptoms prevalent in patients with chronic liver disease: sexual dysfunction sexual, cramps and pruritus. The minimum analysis for each patient will be 2 assessments.

   All symptoms greater than 5 points will be considered moderate to severe and formal referral to the palliative care team will be discussed with the patient and their attending physician. Subsequently evaluating its effectiveness in symptomatic control.
5. Aims - This observational study will try to understand if there is a correlation between the evolution of MELD-Na and symptomatic burden of patients with advanced chronic liver disease. As well as the influence that the implementation of palliative care have on symptom burden of advanced chronic liver disease patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients with chronic liver disease

Exclusion Criteria:

* do not sign consent to participate
* patients under 18 years of age
* patients who present a recurrent degree of encephalopathy, according to the West-Haven scale, equal or greater than 2
Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients

Posterior Reversible Encephalopathy Syndrome prospective (PRES) registry. Data collection using a standardized form : demographic data and data related to the PRES, including circumstances of onset, dates and times of onset and of symptoms control, on-scene clinical findings, clinical and radiological features of PRES, pre-hospital and hospital care providers, timing of antiepileptic, antihypertensive drugs and supportive treatments, results of etiological investigations, cause of PRES, type and dosage of antiepileptic and antihypertensive drugs. Dates and times of EEG monitoring, EEG results, radiological and biological investigations. Outcomes including vital status and Glasgow Outcome Scale score at ICU and hospital discharge, day-90 and 1-year after SE and determined based on data in the ICU and/or neurologist charts and/or patients phone interview


Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 years
* Posterior Reversible Encephalopathy Syndrome defined as:

  * combination of consciousness impairment, seizure activity, headaches, visual abnormalities, nausea/vomiting, and focal neurological signs AND
  * cerebral imaging abnormalities involving the white matter (brain CT scan hypodensities AND/OR Brain MRI hypoT1, hyper T2 FLAIR)
* intensive care unit admission

Exclusion Criteria:

* normal cerebral imaging
Restoring Skill in Walking

The purpose of the study is to examine the effect of an intervention to improve walking based on motor learning (skill-based) compared to the usual intervention (strength, flexibility and balance-based) on clinical, psychological and laboratory measures of walking and balance of older adults with mobility disability (walking problems).

While therapeutic exercise to improve mobility and balance appears to improve physical performance and may reduce falls, less is known about the responsiveness to specific interventions or the relation between response to intervention and the underlying problems or impairments. Therapeutic approaches for improving mobility and reducing fall risk are heterogeneous, but do not consistently focus on problem solving as a method of enhancing motor control or skill, an approach that has been found to be important for motor learning in animal models.

This two-year pilot study will allows us to compare the clinical, psychological and laboratory outcomes after a motor-learning based and an impairment-targeted exercise intervention to improve walking in older adults. All subjects will participate in pre and post intervention testing and a 12 week exercise intervention for gait involving either a motor learning (skill enhancement) or impairment-targeted (lower extremity strengthening, flexibility and gait cues).

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age and older
* Ambulatory (with or without a straight cane, and without the assistance of another person)
* Have written approval/clearance of their physician to participate in low to moderate intensity, supervised exercise as is characteristic of the interventions for improving gait.
* Difficulty with walking or balance as indicated by the following two criteria during baseline testing:

  * mild to moderate slowing of walking speed (walking speed ≥ .6m/s and ≤ 1.0m/s) and,
  * gait variability (step length coefficient of variability, CV \> 4.5%, or step width CV \< 7% or \> 30%)
Energy Expenditure of People Living With HIV/AIDS

Background: Several studies have reported increased resting energy expenditure (REE) in people living with HIV/AIDS possibly due to changes in body composition that occurs in HIV lipodystrophy syndrome.

The aim of this study was to evaluate the influence of the use of lipid-lowering drugs in resting energy expenditure (REE) and total energy expenditure (TEE) in patients seropositive for HIV in treatment of lipodystrophy.

REE was measured by indirect calorimetry.

TEE was measured by doubly labeled water (DLW) technique and an activity monitor based on accelerometry (AM).

Eligibility Criteria:
Inclusion Criteria:

* Use of antiretroviral therapy for at least 4 months
* A cluster of differentiation 4 (CD4) T-cell count of \>200 cells/mm3
* Use of lipid-lowering drugs for at least 1 month (group HIV-seropositive with lipodystrophy and use of lipid-lowering)

Exclusion Criteria:

* Signs or symptoms of opportunistic infections
* Thyroid disease
A Study of Avonex to Determine the Effects of Dose Titration on the Incidence of Flu Like Symptoms in Healthy Volunteers

The primary objective of the study is to determine whether titration of Avonex reduces the severity of flu-like symptoms (FLS). Secondary objectives of this study are to determine whether titration of Avonex reduces the incidence of FLS and to evaluate the overall safety and tolerability of Avonex intramuscular (IM) injections.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have a Body Mass Index of 19 to 30 kg/m2, and a minimum body weight of 50.0 kg at Screening.
* Female participants of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

Key Exclusion Criteria:

* Known history of or positive test result for human immunodeficiency virus (HIV), hepatitis C virus (test for hepatitis C virus antibody \[HCV Ab\]) or hepatitis B virus (test for hepatitis B surface antigen \[HBsAg\] and hepatitis B core antibody \[HBcAb\])
* Known history of chronic fatigue syndrome or fibromyalgia
* Within one month, flu-like illnesses (e.g., gastroenteritis, upper respiratory infection, common cold)
* History of severe allergic reactions to any drug or anaphylactic reactions
* Known allergy to Avonex or any of its components
* Serious infection (e.g., pneumonia, septicemia) within the 3 months prior to Screening or active bacterial or viral infection
* History of alcohol or substance abuse (as defined by the Investigator)
* Female participants who are pregnant or currently breastfeeding
* Any previous treatment with any interferon product.10. Vaccinations within 2 weeks or 5 half-lives, whichever is longer, prior to Day 1
* Blood donation within 30 days prior to Screening
* Use of any tobacco product more than 5 times within 30 days prior to Screening

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Efficacy and Tolerability of Enstilar® in Daily Practice

This study aims to assess how the Enstilar® aerosol foam performs in daily real-life practice with regards to effectiveness and convenience of application to psoriasis plaques on body and extremities. In addition the profiles of patients prescribed Enstilar® will be described, and preceeding, concomitant and follow-up management will be mapped. The study will be conducted in about 100 dermatology clinics all over Germany,


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Psoriasis vulgaris
* Lesions on trunk and/or extremities of at least mild severity
* Treatment with Enstilar® planned
* Signed informed consent to participate

Exclusion Criteria:

* Enrolled in any interventional clinical trial
* Ongoing or recent treatment with any systemic psoriasis
* Ongoing or recent treatment with UV-therapy
* Ongoing or previous treatment with Enstilar®
* Psoriasis of scalp only
* Other forms of psoriasis, e.g. erythrodermic or pustular psoriasis
* More than 30% of surface area affected by psoriasis
* Any contraindications or known allergies to Enstilar® or its ingredients
* Incapacitated patients under institutionalized care
A Study of PRO95780 in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer (APM4074g)

This is a randomized, double-blind, Phase II, placebo-controlled trial adding on to a background of effective treatment designed to evaluate the efficacy, safety, and pharmacokinetics of PRO95780 combined with paclitaxel + carboplatin + bevacizumab therapy in patients with previously untreated Stage IIIB, Stage IV, or recurrent non-small cell lung cancer (NSCLC). Approximately 120 patients will be randomized to one of two treatment arms.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and willingness to sign a written informed consent
* Histologically or cytologically confirmed NSCLC
* Advanced NSCLC
* Measurable disease
* ECOG performance status of 0 or 1
* Age ≥ 18 years
* Use of accepted and effective method of contraception, i.e., double barrier contraceptive methods (e.g., diaphragm plus condom) or abstinence during the course of the study and for 6 months after the last study treatment administration for women, and 1 month for men

Exclusion Criteria:

* Squamous cell histology
* Prior malignancy other than NSCLC (except in situ basal cell carcinoma or in situ cervical cancer), unless it has been treated with curative intent and there is no evidence of disease for ≥ 3 years prior to randomization
* Untreated or unstable CNS metastases
* Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function within 1 year prior to randomization
* Uncontrolled hypertension
* History of arterial thrombosis, stroke, or serious hemorrhagic disorder within 1 year prior to randomization
* Major surgical procedure within 28 days prior to randomization
* Serious non-healing wound ulcer, or bone fracture within 21 days prior to randomization
* Persistent history of gross hemoptysis relating to the patient's NSCLC
* Known HIV infection
* Known to be positive for hepatitis C or hepatitis B surface antigen
* Chronic daily treatment with aspirin or nonsteroidal anti-inflammatory agents known to inhibit platelet function
* Use of anticoagulation therapy
* Participation in clinical trials or undergoing other investigational procedures within 30 days prior to randomization
* Pregnancy (e.g., positive HCG test) or breast feeding
* Known sensitivity to any of the products to be administered during the study
* Any disorder that compromises the ability of the patient to provide written informed consent and/or to comply with study procedures