cyrilzakka/clinical-trials huggingface dataset:
Eit in ArdS for Tcav Setting (EAST Study)

Acute respiratory distress syndrome (ARDS) is a severe form of acute respiratory failure. The therapeutic management is currently based on the treatment of the cause of ARDS, and on mechanical ventilation with positive expiratory pressure (PEEP). Another strategy that could be used is Time Controlled Adaptive Ventilation (TCAV) method based on ventilation using the airway pressure release ventilation (APRV) mode.

Electrical impedance tomography (EIT) allows individual, non-invasive, real-time, bedside, radiation-free imaging of an anteroposterior section of the right and left lungs, with global and regional dynamic analyses.

The aim of the study is to evaluate EIT for PHigh titration of TCAV.

Acute respiratory distress syndrome (ARDS) is a severe form of acute respiratory failure with a mortality rate of up to 35% for the most severe forms. The therapeutic management is currently based on the treatment of the cause of ARDS, and on mechanical ventilation with positive expiratory pressure (PEEP). Another strategy that could be used is Time Controlled Adaptive Ventilation (TCAV) method based on ventilation using the airway pressure release ventilation (APRV) mode.

The TCAV method is based on a prolonged THigh set at a constant pressure, creating a continuous positive pressure phase associated with a brief release during a TLow allowing the elimination of carbon dioxide and the creation of an intrinsic PEEP. With long high pressure phase this method could result in better recruitment but could also expose the patient to overdistention. While the TLow setting is well defined, level of PHigh is not standardized.

Electrical impedance tomography (EIT) allows individual, non-invasive, real-time, bedside, radiation-free imaging of an anteroposterior section of the right and left lungs, with global and regional dynamic analyses. Results of recent studies have highlighted the benefits of EIT, especially for ARDS patients in titrating PEEP in volume-controlled ventilation.

To date, no published study has evaluated EIT for PHigh titration using the TCAV method in patients with severe ARDS.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe ARDS patients with more than 24 hours of mechanical ventilation
* Under sedation with a Richmond Rating Scale less than or equal to -2.

Exclusion Criteria:

* Patients with a pacemaker or automatic implantable defibrillator
* Pregnant women.
* Contraindications to chest belt placement (e.g., spinal or thoracic recent surgery)
* Undrained pneumothorax, broncho-pleural fistula
* Hemodynamic instability (i.e., use of vasopressors at \> 2 ug.kg.min of norepinephrine)
* Patients on mechanical ventilation during more than 7 days
Effects of Video-recorded Role-play and Guided Reflection on Nursing Student Empathy, Caring Behavior, and Competence

Objectives: To examine the differences in nursing student empathy, caring behaviour, and competence between the experimental and control groups before and after educational intervention, and to predict the factors affecting their core competencies.

Design: The investigators used a two-group pretest and post-test quasi-experimental design.

Setting: The experiment was conducted at a college in northern Taiwan. Participants: First-year nursing students from medical schools in Taiwan participated in our study.

Methods: Data were collected between March and May 2022. The learning method used with the intervention group was role-playing with videos and guided reflection. The control group was exposed to classroom lectures without video-recorded role-play and guided reflection. Empathy, caring behaviour, and competence were measured using the Jefferson Scale of Empathy- Healthcare Providers, the Caring Behaviours Scale, and the Nursing Student Competence Scale.

Eligibility Criteria:
Inclusion Criteria:

* (1) Students who were first-year nursing students at college,
* (2) could communicate using Mandarin or Taiwanese,
* (3) were willing to participate in this study and agreed to cooperate with the completion of the questionnaire.

Exclusion Criteria:

* deafness or a diagnosis of cognitive disorder according to various information sources, such as school health information and notification from parents.
Is There a Difference in Oocyte Quality? A Comparison of Two Aspiration Needle Gauges

The aim of this study is to determine whether different needle gauges influences the quality of the aspirated oocytes during in-vivo fertilization (IVF).


Eligibility Criteria:
Inclusion Criteria:

* Fertility treatment
* Antral follicle count

Exclusion Criteria:

* Women who refuse to participate
A Study to Evaluate the Potential of Mesenchymal Stromal Cells to Treat Obliterative Bronchiolitis After Lung Transplantation

The primary aim of this study is to establish the safety of infusions of Mesenchymal Stromal Cells (MSC) from related or unrelated Human Leukocyte Antigen (HLA) identical or HLA mismatched donors in the management of bronchiolitis obliterans syndrome after lung transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with single, bilateral or heart-lung allografts
2. Patients with bronchiolitis obliterans syndrome (BOS) grades 2 \& 3 (defined and graded according to international criteria (Appendix 1)), with evidence of deterioration in allograft function (i.e. deteriorating FEV1 or worsening BOS grade) within the last 12 months.
3. Patients with BOS grade 1 and evidence of deterioration in allograft function (i.e. deteriorating FEV1 or worsening BOS grade) within the last 12 months and at least one of the following additional risk factors for subsequent death:

   * Single lung transplant
   * Rapid deterioration (\>20% fall in FEV1 in the previous 12 months)
   * A pre-transplant diagnosis of usual interstitial pneumonia (pulmonary fibrosis) or pulmonary hypertension

Exclusion Criteria:

1. Patients with active infection, acute allograft rejection, or airway anastomotic complications
2. Patients with \> 3 infective exacerbations of BOS in the last 12 months
3. Patients with a history of cytomegalovirus (CMV) pneumonitis
4. Patients with poor performance status and/or not expected to survive 3 months
5. Patients who are pregnant or breastfeeding
6. Patients with an allergy to beef products.
7. Any condition that in the opinion of the Investigator may interfere with the safety of the patient, his / her completion of required follow-up visits or evaluation of the study objectives.
Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery

Head and neck cancer care, including tumors of the mouth, nose, throat and voice box, often requires radiation for cure to be achieved. Despite advances in radiation, 40% to 60% of patients experience a significant dry mouth (xerostomia) following radiotherapy. Several factors are associated with severe xerostomia including older age, advanced stage disease and tumor location. Currently, no pragmatic treatment strategy exists to reduce the risk of radiation-related xerostomia in patients with head and neck cancer. The investigators propose the use of a botulinum neurotoxin injected into the at-risk salivary glands before radiation as a strategy to preserve salivary gland function during radiation treatments and reduce xerostomia.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosis AJCC 8th edition Stage III/IVa mucosal head and neck squamous cell carcinoma requiring definitive radiotherapy (with or without chemotherapy).

Exclusion Criteria:

* Previous radiation to the head and neck
* Previous treatment for head and neck cancer
* Personal history of xerostomia
* Hypersensitivity to onabotulinumtoxinA
* Previous major salivary gland surgery
* Previous exposure to radioactive iodine therapy
Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

Female patients with early onset (\<50 years old) pelvic malignancies such as uterine and rectal cancers are rising in incidence, which often requires pelvic radiation; many of these patients are premenopausal and at a high risk of premature ovarian failure from radiotherapy. Premature ovarian failure carries significant cardiac, musculoskeletal, sexual, and psychosocial morbidity. Ovarian transposition carries variable success rates, is not readily accessible to the general population, and can still be at risk of clinically significant radiotherapy doses. There is an unmet need for innovative techniques to protect ovarian function.


Eligibility Criteria:
Inclusion Criteria:

* Biologic female
* Age between 18 and 50 years old (inclusive)
* Clinically premenopausal (defined as having active, regular menstruation without vasomotor symptoms)
* At least one of two ovaries readily visualized on diagnostic CT or MR imaging as confirmed by radiologist
* Planning to receive radiation therapy (for any indication)
* Ability to understand and willingness to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Prior pelvic radiation
* Prior cancer therapies that are known to impact ovarian function
* Prior diagnosis of ovarian insufficiency/failure or menopause
* Clinically peri- or post-menopausal

  * For patients \> 45 years old, if there is a clinical history of vasomotor symptoms OR irregular periods, then the patient must be excluded.
  * For patients ≤ 45 years old, if there is a history of vasomotor symptoms consistent with menopause OR irregular menstruation for ≥3 months OR recent changes in their menstrual cycle \> 14 days, then the patient must be excluded.
* Surgically removed or transposed ovaries
* Pregnant and/or breastfeeding
Project AdaPT: An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain

In the proposed research, we will elucidate the comparative effectiveness of standalone physiotherapy (PT) vs. PT augmented with a self-guided, app-based Healthy Minds Innovation wellbeing program (PT+HMI) aimed at cultivating awareness, connection, insight, and purpose for people with chronic low back pain (CLBP).

The overall objective is to primarily elucidate differential changes in CLBP patients administered PT or PT+HMI across physical health domains (back disability, pain interference, actigraphy, gait performance). Secondarily, we will elucidate changes in patient-reported physical health outcomes for early non-responders who go on to receive an adaptive intervention that provides augmented treatment pathways.

Our central hypothesis is that improvements in disability (primary outcome), i.e., responders to PT and PT+Well will be differentially associated with changes in physical activity levels, gait kinematics, psychological flexibility, and fear-avoidance. We further predict that initial non-responders who progress to augmented care will show improvements in the primary outcomes. We will conduct a two-armed RCT with 20 CLBP participants who will receive PT or PT+HMI and test our hypotheses in 3 specific aims. In Aim 1, we will use patient-reported measures of disability and pain interference to elucidate subjective physical health outcomes. In Aim 2, we will use actigraphy to measure physical activity levels, 3D trunk kinematic measures during gait, and a lifting task to reveal movement-based responders. In Aim 3, we will use patient-reported measures for indices of psychological flexibility and healthy emotionality to elucidate mental health processes that correlate with physical health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* A minimum age of at least 18 years; the ability to read and speak English; have visited a health care professional for back pain during the past 90 days with a physician referral for PT; have experienced back pain for at least 3 months duration and for at least ½ days in the past 6 months; and currently experiencing at least moderate back-related disability, which was operationalized as a score of ≥24% (12 out of 50 points) on the Oswestry Disability Index (ODI). Participants needed to have smart device access to engage with the HMI app.

Exclusion Criteria:

* Having undergone lumbar surgery within the past year; an ongoing disability or worker's compensation, or legal claim; informed by their physician the presence of a serious pathology causing their LBP; pregnancy or planning to become pregnant; and having previously received PT for LBP during the prior 6 months.
Clinical Trial to Compare TAPP (Transabdominal Preperitoneal) vs TEP (Totally Extraperitoneal) y Approach for Women's Inguinal Hernia on an Outpatient Basis

Open prospective randomised clinical trial enrolling women who suffer from inguinal or femoral hernia, to evaluate if TEP approach is superior to TAPP concerning postoperative development, principally postoperative pain, with no increase of recurrent hernia at the one-year follow-up visit.

Randomised phase IV clinical trial enrolling women suffering from inguinal hernia in Virgen del Rocío University Hospital influence area, from March 2019 to March 2021.

The aim of the study is to conclusively stablish whether there is real and significant benefit in using TEP approach over TAPP, in an outpatient basis, concerning postoperative evolution. Secondary objectives are the assessment of postoperative pain, using VAS (visual analogic scale), of both techniques, and evaluation of hernia recurrence during the first postoperative year The individuals will be assigned to each group according to simple random sampling.

Eligibility Criteria:
Inclusion Criteria:

* Inguinofemoral hernia, EHS (European Hernia Society) classification.
* Patient over 18 years old.
* Signed informed consent form.
* Female
* Meeting of outpatient discharge criteria, determined by Aldrete´s test

Exclusion Criteria:

* Loss of domain.
* Abdominal skin grafts.
* Previous preperitoneal (open or laparoscopic) prosthetic mesh.
* Incarcerated hernia.
* Previous complications such as infection, fistulae...
* Not candidate for ambulatory surgery
* Pregnancy or desire for pregnancy in the first postoperative year
Magnesium Injection Ensures Steroid Avoidance During Vaccine, Viremia or Immunocompromise

Steroid injections are used for interventional pain management. However, their side-effect of immunosuppression may increase the risk of infections. Magnesium is an alternative anti-nociceptive injection that may be used instead of steroids.

Prospective observational study of patients who received magnesium injection for interventional pain therapy, instead of steroid injection. Post-injection data collection includes numerical rating pain score, and sleep quality score. Pain is measured using the numeric pain rating scale. Sleep score is measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points is considered significant.

Corticosteroid injections are used for interventional pain management. The immunosuppression effect of steroid injection may increase the risk of infections. Magnesium is an alternative anti-nociceptive agent that may be used for interventional pain injection therapy, instead of steroids.

Prospective observational clinical study of pain clinic patients who received magnesium injection for interventional pain therapy, instead of steroid injection. Post-injection data collection includes numerical rating pain score, and sleep quality score. Pain is measured using the numeric pain rating scale. Sleep score is measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points is considered significant. Data analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value \<0.05 is considered significant.

Eligibility Criteria:
Inclusion Criteria:

* adult chronic pain patients
* previous interventional injection therapy
* consent for interventional injection therapy
* good treatment compliance
* regular sleep diary
* regular pain diary
* informed consent for diary review
* consent for clinical record quality assurance review

Exclusion Criteria:

* organ insufficiency
* cognitive disorder
* inability to provide consent
* major neuropsychiatric disorder
* unreliable diary
* poor treatment compliance
* previous adverse/allergic reactions to magnesium
PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children

Assess the safety and efficacy of polyethyleneglycol3350 laxative as compared to placebo therapy in pediatric patients with a history of constipation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients between the ages of 4 to 16 years.
* Adolescent female patients must not be pregnant or lactating.
* constipated according to ROME I definition
* Two or fewer bowel movements during the initial observation week.
* Absence of a stool impaction
* Bowel movement after receiving enema
* Are otherwise in good health, as judged by a physical examination.
* Parent or guardian is mentally competent to sign an instrument of informed consent

Exclusion Criteria:

* Patients with heme positive stool at baseline exam.
* Patients with fecal impaction at baseline, or after the observation period, as indicated by physical exam
* Patients with known or suspected perforation or obstruction other than fecal impaction.
* Patients who are breastfeeding, pregnant or intend to become pregnant during the study.
* Female patients of childbearing potential who refuse a pregnancy test.
* Patients with a known history of organic cause for their constipation.
* Patients with congenital malformations that produce constipation (Hirschsprung's disease, imperforate anus, children with cerebral palsy or other neurologic abnormalities, or systemic diseases).
* History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy.
* Use of concomitant medications that cause constipation
* Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.
* Patients with known allergy to polyethyleneglycol or polyethyleneglycol containing medications.
* Patients with clinically significant elevations of TSH or abnormal plasma electrolytes.
* Patients who, within the past 30 days have participated in an investigational clinical study
Posterior Capsular Opacification and Glistenings in Hydrophobic and Hydrophilic Intraocular Lenses

A prospective randomized controlled clinical study to measure posterior capsular opacification, objective measurement of glistenings and intraocular lens tilt and decentration as well as visual outcomes following insertion of a monofocal, aspheric, hydrophobic acrylic intraocular lens: the RayOne® Hydrophobic lens 800C and a monofocal aspheric, hydrophilic acrylic intraocular lens: the RayOne® Hydrophilic lens 600C


Eligibility Criteria:
Inclusion Criteria:

1. Unilateral or bilateral cataracts requiring surgical intervention
2. Age over 18 years
3. Able to understand informed consent and the objectives of the trial
4. Not pregnant, not breast feeding
5. No previous eye surgery
6. Corneal astigmatism less than 1 diopter in both eyes.

Exclusion Criteria:

1. age-related macula degeneration
2. glaucoma
3. previous retinal vascular disorders
4. previous retinal detachment or tear
5. any neuro-ophthalmological condition
6. any inherited retinal disorder or pathology
7. previous strabismus surgery or record of amblyopia
8. previous TIA, CVA or other vaso-occlusive disease
9. already enrolled in another study
Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma

Temozolomide (also known as TMZ) is a chemotherapy drug given by mouth. It is similar to DTIC, the only FDA-approved chemotherapy for melanoma, but because temozolomide is given by mouth, it can be given daily over a long period of time. We think that temozolomidemay work best if it is given every day for 6 weeks at a time. Temozolomide given by this extended schedule is experimental, although we have found that it is safe and can shrink melanoma in some patients.

One big advantage of TMZ is that it is given by mouth instead of by vein. This means that it can be given daily over a long period of time rather than off and on like DTIC. We think that TMZ may work better if it is given every day for 6 weeks. TMZ given by this extended schedule is experimental although we have found that TMZ given in this way is safe and can shrink melanoma in some patients. When extended dosing TMZ was given with either thalidomide or long-acting interferon-α, about 30% of patients had their tumors shrink. We think that this shrinkage was due mostly to the TMZ since neither thalidomide nor interferon-α alpha work in melanoma by themselves.

In this study, we will treat patients with TMZ alone using this extended dosing schedule to see how many patients experience tumor shrinkage.

We also want to learn more about which tumors are more likely to shrink from TMZ treatment. We will test samples of your tumor for whether or not a gene called MGMT has been turned on,


Eligibility Criteria:
Inclusion Criteria:

* Stage III (unresectable) or Stage IV melanoma from a cutaneous or an unknown primary.
* Histologic proof of melanoma reviewed and confirmed at MSKCC
* Measurable disease (RECIST criteria)
* No prior chemotherapy for melanoma. Prior interferon, interleukin-2 or vaccine therapy are allowed.
* No other concurrent chemotherapy, immunotherapy, or radiotherapy
* Karnofsky performance status ≥ 60
* Adequate organ function defined as follows: ANC \> 1500, Platelets \> 100,000, creatinine \< 2, Alkaline Phosphatase, AST and total bilirubin \< 1.5x upper limit of normal. For patients with suspected Gilbert's syndrome bilirubin will not be a requirement.
* Tumor tissue for MGMT promoter methylation analysis and/or IHC must be available. In most cases, this will be unstained slides from previously-obtained paraffin-embedded tumor material. If this is not available, patients must have an easily-accessable tumor for biopsy (e.g. skin or lymph node).

Exclusion Criteria:

* History of CNS metastases unless brain metastases have been resected and the patient has been free from CNS recurrence for 6 months.
* Uveal or mucosal melanoma primary
* Frequent vomiting or medical conditions that could interfere with oral medication intake
* Serious infection requiring antibiotics, or nonmalignant medical illnesses that are uncontrolled or whose control might be jeopardized by the complications of this therapy.
* History of HIV infection even if on HAART
* Immunosuppressive drugs
* High dose vitamins and herbs
* Other on-going investigational therapy, concurrent chemotherapy, immunotherapy or radiotherapy.