cyrilzakka/clinical-trials huggingface dataset:
Titration of Oxygen Levels During Mechanical Ventilation With Electronic Alerts

Fractional oxygen during mechanical ventilation, is a life sustaining therapy in the intensive care unit , used for about a million patients annually. Oxygen therapy needs to be tightly balanced as both hypoxia and hyperoxia are harmful. Establishing precision in oxygenation has significant implications for improving patient outcomes, resource utilization and reducing iatrogenic harm to a vulnerable population. The investigators propose an approach using a oxygen titration protocol consisting of electronic health records based alerts to guide oxygen adjustment.

The investigators will conduct a prospective randomized, clinical trial in the Medical Intensive Care Unit at Ohio State University Medical Center. In the intervention arm, respiratory therapists' will conduct oxygen titration with the help of a novel, high fidelity, electronic health records based, protocol consisting of electronic alerts and decision support tool. Oxygen titration in the control arm will be done without alerts and will be per "current standard of care".

Participants for this study will be identified and recruited from patients admitted to the Ohio State University, Wexner Medical Center and James Cancer Hospital, Medical Intensive Care Unit.

Eligibility Criteria:
Inclusion Criteria:

• Critically ill subjects who require mechanical ventilation for at least 24 hours.

Exclusion Criteria:

* Subjects without research authorization,
* Pregnancy,
* Pneumothorax,
* Carbon monoxide poisoning,
* Hyperbaric oxygen therapy
* Acute ST elevation Myocardial Infarction
Adding Of Naxitamb In Induction Therapy For High Risk Neuroblastoma

To explore the efficacy of adding anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy for newly diagnosed high risk neuroblastoma patients. To investigate wether anding Naxitamab in the induction phase will improve the response rate at the end of induction therapy and further improve the overall survival rate.


Eligibility Criteria:
Inclusion Criteria:

Neuroblastoma patients who meet certain criteria are eligible for enrollment in the following stages of diagnosis:

1. Children with newly diagnosed stage 4 neuroblastoma according to the International Neuroblastoma Staging System (INSS) who meet the following criteria are eligible for enrollment: i. Age \> 18 months (\> 547 days) regardless of biological characteristics; or ii. Age 12-18 months (365-547 days), with one of the following three unfavorable biological characteristics (MYCN amplification, pathological type of poor histopathological prognosis, and/or DNA index = 1); or iii. MYCN amplification (MYCN signal increase \> 4 times compared to reference signal) regardless of age or other biological characteristics.
2. Children with newly diagnosed stage 3 INSS neuroblastoma who meet the following criteria are eligible for enrollment: i. MYCN amplification (MYCN signal increase \> 4 times compared to reference signal) regardless of age or other biological characteristics; or ii. Age \> 18 months (\> 547 days), with pathological type of poor histopathological prognosis regardless of MYCN status.
3. Children with newly diagnosed stage 2A/2B INSS neuroblastoma with MYCN amplification (MYCN signal increase \> 4 times compared to reference signal) regardless of age or other biological characteristics. The subject must be aged ≤ 21 years at the time of initial diagnosis, and must be aged \> 12 months at the time of enrollment.

Exclusion criteria:

Infants less than 1 year old, those aged 12-18 months, INSS stage 4, and all INSS stage 3 patients with favorable biological characteristics (i.e., non-amplified MYCN, good pathological histopathological prognosis, and DNA index \>1) are not eligible.

Subjects who have received immunosuppressive treatment (excluding local steroids) within the last 4 weeks prior to enrollment. Subjects who are currently receiving any investigational drug.

Any other medical condition that, in the opinion of the investigator, may interfere with the interpretation of results or affect the subject's ability to provide informed consent, the legal guardian's ability to provide informed consent, and the subject's cooperation and participation in the study, including but not limited to malabsorption syndrome, mental illness, or substance abuse. Subjects with significant comorbidities (any serious medical condition unrelated to cancer or its treatment that is not covered by the detailed exclusion criteria and is expected to interfere with the investigation drug(s) action or significantly increase the severity of the trial treatment toxicity)
Clinical Trial of Aplidin® in Patients With Primary Myelofibrosis

This is an open-label, Phase II Clinical Trial of Aplidin® (plitidepsin) in Patients with Primary Myelofibrosis and post polycythemia vera/essential thrombocythemia (Post-PV/ET) Myelofibrosis.

This trial tries to assess response rate (ORR) of plitidepsin in patients with:

primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF). Besides, the study results will allow to evaluate the effect of plitidepsin on bone marrow (BM) or peripheral blood histology and to determine the quality of life (QoL) and symptoms or participant patients.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Primary Myelofibrosis (PMF) or Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis(post-ET/PV MF) as per revised World Health Organization (WHO) criteria.
2. High-risk or intermediate-2 risk Myelofibrosis (MF) as defined by the International Prognostic Scoring System (IPSS); or intermediate-I risk MF associated with symptomatic splenomegaly/hepatomegaly and/or unresponsive to available therapy.
3. At least 18 years of age, with life expectancy of ≥12 weeks.
4. Able to provide informed consent and being willing to sign an informed consent form (ICF).
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
6. Evidence of acceptable organ function within seven days of initiating study drug

Exclusion Criteria:

1. Previous treatment with plitidepsin.
2. Any of the following therapies within two weeks prior to initiation of study drug:

   * chemotherapy (e.g., hydroxyurea),
   * immunomodulatory drug therapy (e.g., thalidomide),
   * immunosuppressive therapy,
   * corticosteroids \>10 mg/day prednisone or equivalent, or
   * erythropoietin.
3. Incomplete recovery from major surgery within four weeks of study entry.
4. Radiation therapy within four weeks of study entry.
5. Women of childbearing potential
6. Women who are pregnant or are currently breastfeeding.
7. Myopathy grade \> 2
8. Known positive status for human immunodeficiency virus (HIV).
9. Active hepatitis B or C virus (HBV or HCV) infection
10. Diagnosis of another invasive malignancy
11. Any acute active infection.
12. Known hypersensitivity to the study drug or any of its formulation components (e.g., Cremophor®).
13. Treatment with any investigational product in the 30 days before inclusion in the study.
Prenatal Diagnosis and Treatment of Flat, Inverted and Retracted Nipples

The objectives of this study are to determine the population occurrence rate of flat, inverted, or retracted nipples (FIRN) in pregnant women in our obstetrical practice through prenatal evaluation at the NOB visit and re-evaluation at the 28th-30th week of gestation, to determine the benefit of using Supple Cups as treatment for FIRN for 6-8 weeks in the third trimester to evert the nipples prior to delivery, and to evaluate the effect of prenatal diagnosis and treatment of FIRN on establishment of latch and breastfeeding rates in the postpartum period.

It is well established that breastfeeding is the most clinically optimal method of feeding for infants through the first year of life, however exclusive breastfeeding rates in the United States remain low. Many women have difficulty establishing breastfeeding in the first few weeks after birth which leads to the use of formula supplementation. For approximately 10% of women this difficulty is caused by flat, inverted or retracted nipples (FIRN) which make it very difficult to latch when attempting to breastfeed. Many women are not diagnosed with FIRN until after the baby is born.

Supple Cups are promising as a prenatal and postnatal intervention to elongate nipples in cases of FIRN, allowing women with these biological variations to successfully breastfeed. If women are diagnosed in the early prenatal period with FIRN, Supple Cup use can be initiated to elongate and prepare the nipples for breastfeeding postpartum. Pre-natal diagnosis of FIRN is critical to enable breastfeeding immediately postpartum.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 18 years of age
* Pregnant at time of enrollment
* Plan to breastfeed their infant following birth
* Plan delivery at Mayo Clinic Hospital
* One or more flat, inverted or retracted nipple diagnosed by a healthcare professional

Exclusion Criteria:

* History of breast surgery or nipple piercings
* History of significant low milk supply requiring discontinuation of breastfeeding prior to six weeks postpartum
* History of preterm labor and/or birth
* History of high-risk medical condition that increases patient risk for preterm labor and/or birth
* History of Raynaud's syndrome and/or hypersensitivity to palpation of breasts
* Current multiple gestation pregnancy
* Active rash, infection, or lesions on the nipple at time of initiation of Supple Cups
NUTRI-HAB - Posttreatment Rehabilitation of Nutrition Impact Symptoms in Head and Neck Cancer Survivors

The study is a randomised controlled trial that aims to test the effect of a residential rehabilitation program with a focus on eating problems after treatment in head and neck cancer survivors. The study will furthermore investigate whether selected nutrition screening and assessment tools can be used to identify head and neck cancer survivor who benefit from the program.

This study is a randomised controlled trial with following objectives:

1. To test the effect of a targeted residential rehabilitation program with focus on the physical, psychological and social aspects of eating problems on body weight, health-related quality of life and physical function in curatively treated head and neck cancer survivors 1-5 years after completion of radiation therapy
2. To test whether a potential effect of the program is associated with/dependent of the participants' score in Scores Patient-Generated Subjective Global Assessment Short Form (PG-SGA-SF), Nutrition Risk Screening 2002 (NRS 2002) or M.D. Anderson Dysphagia Inventory (MDADI) at baseline

Eligibility Criteria:
Inclusion Criteria:

* Cancer of the larynx, pharynx or oral cavity
* Treatment with radiation therapy completed 1-5 years before inclusion
* Curatively treated
* Expression of interest in participating in the rehabilitation program in a preceding survey
* Self-reliant and no need for assistance with personal hygiene etc.

Exclusion Criteria:

* Active cancer disease at the time of recruitment
* Not being able to speak and understand Danish
* No permanent residence in Denmark
CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia

CAR-T cell therapy targeting CD19 has been shown to be effective in heavily-pretreated B-cell ALL or NHL, but relapses post-CAR-T are common, and CD19 antigen loss is one of the reasons. Thus, we supposed that CD19/CD22 bispecific CAR-T cell therapy would be more effective and less relapses would occur in B-ALL or NHL. In this prospective phase 2 clinical trial, we aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T cell therapy in relapsed/refractory B-ALL or Large B cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* 14 years to 85 years, expected survival \> 3 months;
* CD19/CD22 positive B-cell lymphoma or B-ALL;
* relapsed or refractory to standard first-line treatment;
* ECOG-PS score=0-2;
* Having at least one measurable lesions;
* Cardiac function: 1-2 levels;
* Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN;
* kidney: Cr≤1.25ULN;
* bone marrow: WBC ≥ 3.0×10e9/L, Hb ≥80 g/L, PLT ≥ 50×10e9/L;
* No serious allergic constitution;
* No other serious diseases that conflicts with the clinical program;
* No other cancer history;
* No serious mental disorder;
* Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

* Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test);
* Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
* Active hepatitis B or hepatitis C infection;
* Recent or current use of glucocorticoid or other immunosuppressor;
* With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
* Participate in other clinical research in the past three months;
* previously treatment with any gene therapy products;
* Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results.
A Comparison of Optimal PEEP Determination Guided by EIT and Conventional Protective Ventilation Tool in ARDS Patients

The study of positive end-expiratory pressure(PEEP) in the setting mode has not yet been conclusive. there are several ways to choose the best positive end-expiratory pressure(PEEP) mode for ARDS patients. In this study ,the investigators selected two best positive end-expiratory pressure(PEEP) assessment methods to compare:

First is using the conventional postive ventilator to choose positive end-expiratory pressure(PEEP) and the new non-invasive electrical impedance tomography(EIT) guided method and evaluation the treatment outcome in moderate and severe acute respiratory distress syndrome patients by using pressure-volume curve guided and electrical impedance tomography guided positive end-expiratory pressure setting. In this project, we utilize a newly available non-invasive method- electric impedance tomography (EIT) and Protective Ventilation to determine the optimal PEEP on ARDS patients required invasive mechanical ventilator support at a medical center medical ICU (MICU) and cardiovascular ICU (CVICU)- the Far Eastern memorial hospital, Taiwan.

Acute respiratory distress syndrome (ARDS)，over the years in the treatment policy has been confirmed that: with low tidal volume to achieve lung protection strategy and high positive end-expiratory pressure (PEEP), both can effectively reduce the mortality rate. And increase PEEP，the alveolar pressure is greater than the atmospheric pressure when exhaled，So that can be effective expansion of the lungs to avoid spitting at the end of the alveolar collapse.

The study of PEEP in the setting mode has not yet been conclusive. Currently in the clinical situation，there are several ways to choose the best PEEP mode for ARDS patients. In this study the investigators selected two best PEEP assessment methods to compare:

First is using the conventional postive ventilator to choose optimal and the new non-invasive electrical impedance tomography guided method and evaluation the treatment outcome in moderate and severe acute respiratory distress syndrome patients by using pressure-volume curve guided and electrical impedance tomography guided positive end-expiratory pressure setting. In this project, the investigators utilize a newly available non-invasive method- electric impedance tomography (EIT) and Protective Ventilation to determine the optimal PEEP on ARDS patients required invasive mechanical ventilator support in ICU at the Far Eastern memorial hospital, Taiwan.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe ARDS patient on mechanical ventilation from ER or word transfer ICU. (P/F≦ 200 with PEEP ≥ 5cmH20) (PEEP greater than or equal to 5 cm H2O and Berlin criteria for ARDS)

Exclusion Criteria:

* On pacemaker
* Pregnant
* Thoracic or spinal cord trauma
* Pneumothorax
* Hemodynamic instability
* IICP
TAP Block vs LAWI for Analgesia Post-cesarean Section

Adequate pain control after cesarean delivery is a significant concern both for parturients and obstetric anesthesiologists. Transversus Abdominis Plane (TAP) block and local Wound infiltration with anesthetics are alternatives for reducing the severity of pain, total analgesic consumption, and opioid side effects. Both the TAP block and wound infiltration are superior to placebo; however, it is unknown which provides better analgesia after cesarean delivery because of a scarcity of randomized clinical trials. So, we hypothesized that the TAP block would decrease postoperative pain and postoperative cumulative opioid consumption at 24 hours


Eligibility Criteria:
Inclusion Criteria:

1. Women who underwent cesarean section under spinal anesthesia.
2. Aged ≥19 years and less than 40 years.
3. Gestational age ≥ 37 Weeks.

Exclusion Criteria:

1. Body mass index (BMI) ≥40 kg/m2.
2. History of recent opioid exposure
3. Hypersensitivity to any of the drugs used in the study.
4. Significant cardiovascular, renal, or hepatic disease
Patient Controlled Tissue Expansion for Breast Reconstruction

This study is designed to compare the performance and safety of the AirXpander tissue expander to standard saline expanders in patients undergoing two-stage breast reconstruction following mastectomy.

This is a pivotal, prospective, multi-center randomized, controlled, open-label clinical study designed to compare the performance and safety of the AirXpander Tissue Expander System to currently cleared saline tissue expanders. Subject who meet the inclusion and agree to participate in the study will be enrolled and randomized to either the investigational arm (AirXpander Tissue Expander) or the control arm (standard saline tissue expander) using a 2:1 (AirXpander to saline) permuted block randomization stratified by investigational center and procedure (unilateral or bilateral). If the subject is having a bilateral procedure, the same type of expander will be implanted in each side. Subjects in both arms will be followed in the same manner until the explantation of the tissue expander(s) and exchange for permanent implant(s).

Eligibility Criteria:
Inclusion Criteria:

1. Subject is a woman between the ages of 18-70.
2. Subject needs to have tissue expansion as part of her breast reconstruction.
3. Subject is able to provide written informed consent.
4. Subject is able and willing to comply with all of the study requirements.
5. Subject is able to understand and manage at home dosing regimen.

Exclusion Criteria:

1. Subjects skin is not suitable for tissue expansion.
2. Subject has remaining tumor cells following her mastectomy.
3. Subject has a current or prior infection at the intended expansion site.
4. Subjects skin has been damaged by previous radiation treatments and the use of non radiated tissue from another part of her body will not be used.

4a. Subject had planned radiation therapy at the intended expansion site while the expander is implanted.

5. Subject has a history of failed tissue expansion or breast implantation at the intended expansion site.

6. Subject has any existing medical condition that the doctor thinks puts the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes).

7. Subject is taking any medications that the doctor thinks puts the subject at an increased risk of complications (e.g., prednisone, Coumadin).

8. Subject is currently participating in a concurrent investigational drug or device study.

9. Subject is a current tobacco smoker. 10. Subject is overweight (BMI \> 33). 11. Subject is unwilling to comply with the air travel or altitude restriction of not \> 3300 feet (1000 meters) from baseline during the time the AeroForm tissue expander is implanted.

12. Subject has a currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.

13. Subject is pregnant or planning on becoming pregnant during the study period.

14. Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.
Design and Validation of a German Language Questionnaire for Measuring Alarm Fatigue in Intensive Care Units

False-positive and non-actionable alarms can lead to staff desensitization ("alarm fatigue") and thus patient endangerment. With this study the investigators create a basic tool to survey alarm fatigue of intensive care staff: the first German language alarm fatigue questionnaire.

In intensive care units (ICUs), patients' vital signs are monitored automatically. As soon as one of the parameters indicates a critical or potentially critical condition, an alarm is triggered on the ward. However, if there are too many alarms, even most of which are false or require no treatment, ward staff may develop alarm fatigue and become desensitized to alarms. This puts patients at risk, especially by overhearing critical alarms. Overburdening staff with alarms is part of everyday life in most ICUs. Considering the demographic development as well as the COVID-19 pandemic, it is to be expected that the number of intensive care patients and thus also the alarm burden in intensive care units will increase. This will also be exacerbated by the increasing digitization of the ICU. Evidence-based and data-driven alarm management enables clinicians to trust alarms again. With this study the investigators create a basic tool to survey alarm fatigue of intensive care staff: the first German language alarm fatigue questionnaire. The questionnaire will be collected in two phases. With the data from the first phase (N ≈ 300), the investigators aim to uncover any structure that may be latent in the questionnaire data (by exploratory factor analysis) and reduce the number of questions from 27 to \~15. The reduced questionnaire will be collected in the second phase (N ≈ 300 - 400). With the data obtained, the investigators intend to test the structure postulated in the first survey in a confirmatory factor analysis.

Eligibility Criteria:
Inclusion Criteria:

* physicians of German intensive care units
* specialist nurses of German intensive care units
* respiratory therapists of German intensive care units

Exclusion Criteria:

- Refusal to participate
Short Term Outcome After Meniscectomy

Short term outcome after meniscectomy: a meniscectomy is a very frequent performed orthopedically procedure. The short term outcome is favourable, but some patients keep having residual lesions after surgery.

This prospective study examens the clinical outcome after meniscectomy using questionnaires (KOOS, VAS, SF-36, Tegner) (before the surgery, 3, 6 \& 12 months postoperative.) The investigators will also record the further treatment options for the people at risk.


Eligibility Criteria:
Inclusion criteria:

* all the meniscectomy patients (male \& female, all ages)

Exclusion Criteria:None