cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Heidelberg Engineering SPECTRALIS with Flex Module for In-vivo Imaging in the Supine Position

This is a prospective clinical study conducted at one clinical site in the United States.

The conducted study is an observational study for an imaging device used in the aid of ophthalmology diagnosis.

Eligibility Criteria:
Adult Normal Eyes Population (AN)

Inclusion Criteria for AN Population

1. Age ≥ 22 years
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
3. Physically able to be positioned in all required imaging positions (upright at chinrest and supine).
4. Able to fixate.
5. Best corrected visual acuity ≥ 20/40 in both eyes.

Exclusion Criteria for AN Population

1. Eye with ocular media not sufficiently clear to obtain acceptable study-related imaging.
2. Subjects who cannot tolerate the imaging procedures.
3. Clinically significant ocular disease in either eye as determined by an Investigator.
4. Ocular surgical intervention (except for refractive laser surgery or cataract surgery) in either eye.

Adult Posterior Segment Abnormality Eye Population (AD)

Inclusion Criteria for AD Population

1. Age ≥ 22 years
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
3. Physically able to be positioned in all required imaging positions (upright at chinrest and supine).
4. Able to fixate.
5. Eye with a structural and vascular posterior segment abnormality due to ocular disease and/or trauma.

Exclusion Criteria for AD Population

1. Eye with ocular media not sufficiently clear to obtain acceptable study-related imaging.
2. Subjects who cannot tolerate the imaging procedures.
PEEP Vs. ZEEP in Out-of-Hospital-Cardiac-Arrest

Out-of-hospital cardiac arrest (OHCA) remains a major cause of mortality, with low survival probabilities to hospital discharge. Despite the frequent use of airway management and mechanical ventilation during resuscitation, there is limited evidence regarding the optimal ventilation strategy to improve oxygen delivery and patient outcomes. The present study aims to investigate the effects of positive-end-expiratory-pressure (PEEP) set at 5 mbar compared to zero-end-expiratory-pressure (ZEEP) on the return of spontaneous-circulation (ROSC) in adult patients with OHCA.

This is a prospective, multicenter, cluster-randomized controlled trial conducted across emergency medical services (EMS) in the regions of Guetersloh, Minden-Luebbecke and Osnabrueck. Adult patients (\>= 18 years) with OHCA who are undergoing mechanical ventilation through an airway device will be enrolled. The clusters (regional district) will be randomized into two groups: one group will receive ventilation with PEEP set at 5 mbar (intervention group), while the other group will receive ventilation with ZEEP (control group). The study's primary endpoint is the rate of ROSC. Secondary endpoints include rate of re-arrest, death during pre-hospital care phase, hospital admission during ongoing resuscitation, hospital admission with spontaneous circulation, peripheral oxygen saturation and end tidal CO2 at hospital admission.

Eligibility Criteria:
Inclusion Criteria:

* Adults \>= 18 years
* non-traumatic OHCA
* mechanical ventilation via airway device

Exclusion Criteria:

* Patients \< 18 years,
* traumatic cause of OHCA,
* no cardiac arrest, withholding of resuscitation (e.g. Do-Not-Resuscitate orders)
Telephony Or Videophony for Isolated elDerly in Maine-Et-Loire 49 During COVID-19

The current health crisis at COVID-19 is forcing us to profoundly rethink our social organizations, especially towards our most fragile seniors. Prohibitions on visits to Nursing Homes and care services, although essential to control the epidemic, are also becoming a major source of social isolation and loneliness for these fragile populations. The only source of residual social ties during a period of confinement remains dematerialised communication via the various existing communication channels (in particular telephone calls or video telephony).

As soon as the COVID-19 crisis began and the first visiting restrictions were imposed on patients in the geriatric department of the Angers Univesity Hospital and the Retirement Home / long-term care unit, acute care geriatric unit of Angers offered patients and residents the opportunity to organize communication with their relatives via videophone calls. Initial feedback from the field shows us that, contrary to our intuition, patients and residents are not necessarily asking for communication to the outside world and, when they are, the preferred channel is not necessarily video telephony but often a simple phone call with relatives. Even though the vast majority of projects aimed at setting up communication aids for the elderly now rely on videophonic support, these initial observations in everyday care situations raise questions about the directions taken in this area. Also, the investigators ask themselves the following question: in the absence of a physical meeting, what is the preferred means of communication for elderly people in isolation in hospital or in Retirement Home? This study will make it possible to propose the most appropriate solutions for breaking isolation for the hospitalized or institutionalized geriatric population in order to limit as much as possible the increase in social isolation imposed by restrictions on movement during epidemics.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalisation in the acute care geriatric unit (Angers UH) or institutionalization in St Nicolas during the isolation measures linked to the SARS-CoV-2 epidemic.

Exclusion Criteria:

* Refusal to participate.
* Contraindication posed by the medical team to proposing dematerialized communication.
Mindfulness-Based Stress Reduction for Psycho-socially Vulnerable Pregnant Women.

The aim of the study is to address the need for a wider array of evidence-based and non-pharmacological options to improve mental health in a psycho-socially highly vulnerable group of pregnant women. In more detail, the primary outcome is to estimate the effect of prenatal Mindfulness-Based Stress Reduction (MBSR) as an add-on to usual care on mental well-being when compared to usual care alone. Second, to estimate the effect of prenatal MBSR on perceived stress and symptoms of depression and anxiety, and third to explore the effect on maternal bonding and childbirth, e.g. gestational age and experience of childbirth. Finally, to examine the mediating effect of mindfulness and self-compassion on the primary outcome.

Background A history of psychopathology or psychosocial adversities are risk factors for mental disorders in the perinatal period. Mental disorders in pregnancy can adversely affect the developing fetus, which call for early prevention. Mindfulness-Based-Stress-Reduction (MBSR) is an acceptable intervention for pregnant women and has a growing evidence-base with meta-analyses consistently pointing to reductions in symptoms of stress, anxiety and depression. The aim of this study is to address the need for a wider array of evidence-based and non-pharmacological options to improve mental health in a psychosocially highly vulnerable group of pregnant women.

Methods/design Pregnant women (n = 238) referred to an outpatient clinic at Copenhagen University Hospital, Amager and Hvidovre, Denmark will be recruited for the study. The design is a single-center, parallel group, randomized controlled trial, with an adapted MBSR program as add on to usual care. The primary outcome is mental wellbeing. Secondary and exploratory outcomes include stress, anxiety, depression, mindfulness, compassion, antenatal attachment and childbirth experience. Participants will be randomized in a 1:1 ratio to prenatal MBSR or usual care.

Implications for perinatal mental health Teaching the skills of mindfulness meditation to a psychosocially vulnerable group of pregnant women could prove a viable and non-pharmacological approach to improve mental health during pregnancy, reduce stress and support the transition to parenthood. The MBSR program does not target a particular group, and results from the study is thus of potential relevance for pregnant women in general as a means of reducing stress and improving perinatal mental health.

Eligibility Criteria:
Inclusion Criteria:

* Estimated due date no sooner than three months from start of the intervention. This criterion is included in order for the women to be able to complete the intervention before their due date.
* Eighteen + years of age.
* Speak and write Danish.
* Available for group intervention scheduled sessions. Being unavailable for two or more sessions is reason for exclusion from study participation.
* Written informed consent to study criteria.

Exclusion Criteria:

* Active substance dependence.
* Psychotic disorders (e.g. schizophrenia or bipolar disorder).
* Suicidality.
Trial of Sunitinib for Refractory Malignant Ascites

The study is to see whether treatment with Sunitinib decreases the accumulation of ascites in patients with refractory malignant ascites.

This is a single arm, non-randomized, phase II pilot study in patients who have stopped cytotoxic and biologic therapy for their neoplasms and are suffering from malignant ascites that requires drainage for comfort. The study will employ a Simon 2-stage optimal design. Initially up to 17 patients would be enrolled. If there are no responses among the first 12 patients, the study would be terminated. Otherwise the trial would be expanded by 23 to a total of 37 patients. If there are 3 or fewer responses by the end of the trial, then no further investigation would be warranted.

Eligibility Criteria:
Inclusion Criteria:

* Solid tumor malignancy and failure of at least one biologic or cytotoxic regimen, or the inability to receive standard treatment due to performance status (PS\>2).
* Ascites based on paracentesis or CT scan within one month prior to enrollment
* Life expectancy \> 3 months
* Indwelling paracentesis catheters are permitted, paracentesis is permitted at the investigators discretion
* Negative urine pregnancy test for females
* All subjects must agree to use birth control
* All subjects must abstain from eating grapefruit and grapefruit juice. They must tell their physicians about any changes in their medication including over-the-counter and herbal supplements.

Exclusion Criteria:

* History of congestive heart failure
* Creatinine \> 2.0
* Pregnant or nursing
* ALT \> 2.5 times the upper limit of normal
* Blood pressure \> 160/90 (antihypertensives permitted)
* Gastrointestinal or intra-abdominal hemorrhage within the last 6 months
* History of QTc \> 450 milliseconds
* Brain metastasis
Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure

The main purpose of this research study is to evaluate the safety and dosing of CG0070.

Cohorts of three to six patients will be assigned to receive intravesical (into the bladder) administration of CG0070 either Weekly or Every 4 Weeks for up to a total of 6 doses.

Eligibility Criteria:
Inclusion Criteria:

* High grade non-muscle invasive bladder cancer (stages Ta, T1 and/or CIS - carcinoma in situ). High grade being defined as G2 or G3 disease.
* Failure of at least one prior treatment with BCG, defined as evidence of TCC on cystoscopic exam and biopsy or cystoscopic exam and urine cytology at least 6 weeks from last BCG treatment
* ECOG performance status 0-1
* Adequate bone marrow, renal, liver and coagulation function

Exclusion Criteria:

* Pregnant or nursing
* HIV positive
* Use of anticoagulants such as coumadin or heparin
* History of bleeding disorder
* Active systemic autoimmune disease or chronic immunodeficiency
* Prior gene therapy
* Uncontrolled cystitis, bladder pain, bladder spasms, urinary incontinence, or reduced bladder volume
Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study

The objective of this study is to investigate the safety, tolerability, and antitumor activity of novel combination therapies administered in participants with advanced EGFRm NSCLC.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
3. Weight ≥ 35 kg
4. Diagnosed with histologically or cytologically confirmed locally advanced/metastatic NSCLC with EGFRm

   * For Arm A (Oleclumab + Osimertinib arms): must have received 1 prior line of therapy with an EGFR tyrosine kinase inhibitor (TKI) and confirmed T790M negative
   * For Arm B (Oleclumab + AZD4635 arms): must have received at least 2 but not more than 4 prior lines of therapy.

Exclusion Criteria:

1. Receipt of an EGFR TKI within 14 days of the first dose of study treatment
2. Receipt of any conventional or investigational anticancer therapy not otherwise specified within 21 days of the planned first dose
3. Prior receipt of any investigational immunotherapy. Participants may have received agents that have local health authority approval for the disease indication
4. Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed.
5. Participants with a history of venous thrombosis within the past 3 months
6. Participants with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 6 months
7. Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
8. Other invasive malignancy within 2 years
9. Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression
10. Current or prior use of immunosuppressive medication within 14 days prior to the first dose

Additional Exclusion Criteria for Arm A

1. Concurrent treatment (or inability to stop therapy) with medications or herbal supplements known to be potent inducers of cytochrome P (CYP) 3A4
2. Participants has a history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD
3. Participants requires continuous supplemental oxygen for any reason

Additional Exclusion Criteria for Arm B

1. Herbal preparations/medications are not allowed throughout the study
2. History of seizures excluding those that occurred due to previously untreated CNS metastasis
Ex-vivo Examination of Excisions of Skin Tumors by Confocal Optical Coherence Tomography (LC-OCT) With Integrated Dermoscopy and Comparison With Histology (DERMOCTAV)

This project aims to validate ex vivo the use of the OCTAV® prototype integrating the "dermoscope" function before an in vivo application, by comparing images obtained by the OCTAV® prototype integrating the "dermoscope" function with the histological sections of a skin tumor excision corresponding to them exactly, at the same level.

There are mainly 3 types of skin cancer: melanoma, basal cell carcinoma and squamous cell carcinoma. The diagnosis of skin cancers is now based on anatomo-pathological evidence. However, given the progress made, imaging is a technique that now has a full role in the diagnosis of these pathologies. This is particularly the case of confocal optical coherence tomography (LC-OCT), which is a recent imaging technique that has proven itself in ophthalmology with the obtaining of precise images of the retina.

LC-OCT can be applied in dermatology according to the following principle: the low intensity laser beam delivered by the LC-OCT device interferes with the melanin, is reflected and makes it possible to instantly acquire a 3D cross-sectional image of the skin, with a resolution of the order of a micrometer. It is finally an "optical echography", the light allowing a tissue definition much higher than the ultrasonic waves. It is therefore possible to obtain sections of histological resolution, and to scan the entire area studied.

Based on this principle, DAMAE has created OCTAV®, a class 1 medical device intended to allow "an in-depth study of skin pathologies", which is currently being evaluated in vivo as part of a clinical trial ( OCTAV - NCT03731247).

The device evaluated in the OCTAV trial does not include the "dermoscope" function. However, coupled with an image capture and processing system, it would increase the magnification obtained from 10 times to 20 or 30 times, allowing precise targeting of the lesion. As a result, a new prototype of OCTAV® has been developed which integrates the "dermoscope" function.

In this context, this project aims to validate ex vivo the use of the OCTAV® prototype integrating the "dermoscope" function before an in vivo application, by comparing images obtained by the OCTAV® prototype integrating the "dermoscope" function with the histological sections of a skin tumor excision corresponding to them exactly, at the same level.

Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, at least 18 years old
* Patient with a skin lesion suspected of a cancerous pathology (basal cell carcinoma - BCC, squamous cell carcinoma - SCC and melanoma) and for whom surgery is planned at Antony Hospital
* Affiliated patient or beneficiary of a social security scheme
* Patient having signed the free and informed consent

Exclusion Criteria:

* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant or breastfeeding women
* Patient hospitalized without consent
Risk Factors of Radiation Pneumonitis

A prospective observational study to evaluate clinical, dosimetrical, functional, and biological factors in predicting radiation pneumonitis.

We propose a prospective observational study to investigate the combinational effect of radiotherapeutic dosimetric parameters \[mean lung dose \& percentage of lung volume receiving at least 20Gy (V20)\] and biological parameters \[interleukin-6(IL6) \& transforming growth factor beta (TGFB)\] in predicting radiation pneumonitis, fibrosis, and change of QoL among at least fifty-three lung cancer patients. Eligibility included pathological or cytological proven small cell or non small cell lung cancer, thoracic RT planned for more than 30Gy \[if fraction size \>= 3Gy/fx\] or 40Gy \[if fraction size \< 3 Gy/Fx\], ECOG performance status \[PS\] 0-2, body weight loss \[BWL\] \<=10% in previous 6 months, no prior thoracic RT and signed informed consent prior to study entry. Basic pre-radiotherapy information will be collected, which included BWL, ECOG PS, AJCC stage \[I-IV\], primary lesion site, history of smoking/coexisting lung disease/dosage of chemotherapy/surgical resection, albumin level, and pulmonary function test of FEV1/VC/DLCO(optional). Computed tomography \[CT\] of the whole lung in treatment position with reference mark will be done for calculation of V20 and mean lung dose. Blood test of IL6, TGFB by ELISA will be done before and after RT after storage at -80℃. Bronchial-alveolar lavage test of IL6, TGFB by ELISA will be done before and after RT if clinical available. Self-reported questionnaire \[EORTC C30 \& L13\] will be collected before and after RT and in every follow up visits after double-checked by trained assistants. RT must be given by photon energies \>=6MV. Radiation pneumonitis and fibrosis will be assessed according to common toxicity criteria 3 \[CTC-3\] weekly during RT and in every follow up visits. Chi-square test, logistic regression, and proportional hazard ratio method will be used to investigate whether the parameter(s) can be effective in predicting radiation related sequelae.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant adults (age \>=20 y/o)
* Pathological or cytological proven small cell or non small cell lung cancer
* Thoracic RT planned for more than 30Gy \[if fraction size \>= 3Gy/fx\] or 40Gy \[if fraction size \< 3 Gy/Fx\]
* ECOG PS 0-2
* Body weight loss \<=10% in previous 6 months

Exclusion Criteria:

* prior thoracic RT
Quitting Schedule Mobile Smartphone Application in Helping Participants to Quit Smoking

This trial studies how well a mobile smartphone application called Quitting Schedule works in helping participants to quit smoking. Quitting Schedule is based on WebCASSI, a computer-based initiative that offered state of-the-art smoking cessation treatment and counseling to MD Anderson Cancer Center (MDACC) patients and served as a portal for non-patients to find information regarding smoking cessation advice and treatments. Quitting Schedule may help participants to quit smoking.

PRIMARY OBJECTIVES:

I. To adapt the internal algorithms of the scheduled reduced smoking approach in Computer Assisted Stop Smoking Intervention for the World Wide Web (WebCASSI) into a smartphone application (app): Quitting Schedule.

II. Once the smartphone app is developed, a pretesting phase with smoker seeking care at MDACC Tobacco Treatment Program or another community service such as Equality Texas, Lesbian, Gay, Bisexual, Transgender, and Queer (LGBTQ) Advisory Board of the City of Houston, Montrose Center, Avenue 360 and Lesbian Health Initiative will follow.

III. To culturally and linguistically adapt Quitting Schedule app into Spanish language.

IV. To implement a feasibility trial in IDC (Colombia), INCan (Mexico), and INEN (Peru).

OUTLINE:

AIM I: Participants follow an individually tailored gradual reduction of smoking schedule for 5 weeks while MDACC eHealth adapts WebCASSI into a smartphone app: Quitting Schedule.

AIM II: Participants pre-test the Quitting Schedule mobile smartphone app for 5 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Current smokers (those who smoke at least 5 cigarettes a day; confirmed with carbon monoxide (CO) levels equal or above 7 parts per million ) newly enrolled in the Tobacco Treatment Program at MDACC (Aim 2 )
* Male or female (Aim 2)
* Adult cancer patients - 18 years or older (Aim 2)
* Current smokers seeking care at the Tobacco Treatment Program at MD Anderson and at Houston area community services who have smoked at least 100 cigarettes in lifetime
* Willing to download and use the app Quitting Schedule (Aim 2)
* Willing to set a quit smoking date within 5 weeks of the enrollment (Aim 2)
* Ownership of an iPhone or Android smartphone (Aim 2)

Exclusion Criteria:

* Unwillingness to participate in the study (Aim 2)
* Enrolled in another cessation program (Aim 2)
* Current use of NRT or other smoking cessation medications,e.g. Varenicline or Bupropion outside of the MD Anderson Institution (Aim 2)
* Expired CO levels below 7ppm (Aim 2)