cyrilzakka/clinical-trials huggingface dataset:
A Novel Conditioning Regimen for Myelodysplastic Syndrome With Moderate High IPSS-M Score

Figure out the Efficacy and Safety of Azacitidine Combined with BUCY2 Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome with Moderate High IPSS-M Score

This study is a prospective, single-center, single-arm clinical study, which plans to enroll 40 patients with high-risk myelodysplastic syndrome (MDS) to be given azacitidine (AZA) combined with busulfan and cyclophosphamide (BUCY2) conditioning regimen to evaluate 18-month progression-free survival (PFS), aiming to evaluate the efficacy and safety of azacitidine plus BUCY2 pretreatment regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patients fully understand this study, voluntarily participate and sign the informed consent form
* Age equal or more than 18 years old
* Patients with moderate high-risk MDS with an IPSS-M score which is higher than 0
* Patients planning to undergo allogeneic hematopoietic stem cell transplantation, HCT-CI ≤ 3 or KPS ≥ 80%

Exclusion Criteria:

* Patients who refuse to participate in this clinical study
* Patients with central nervous system involvement
* Patients with HIV seropositive
* Patients with other serious medical conditions with a life expectancy of less than six months
* Patients with severe psychiatric or psychological disorders
EMail Reminder to Follow up With Primary Physician

The purpose of this study is to see if patients who receive an email reinforcing their discharge instructions after being discharged from the emergency department will have an affect on follow-up care with their primary physician.

When a patient is treated in the emergency department (ED), they experience a whirlwind of care involving multiple diagnostics and treatments. They are often discharged home with instructions to follow up with their primary care physician. This follow up care is crucial to ensuring optimal patient outcomes and re-establishing continuity of care. Despite efforts to communicate clearly and effectively, ED patients often have difficulty understanding their follow-up care instructions. Several different methods have been employed to attempt to improve the follow-up rates after emergency department care, including providing patients with an easily read, printed copy of discharge instructions, having a nurse or mid-level provider call patients days after discharge from the ED to ensure that they understood discharge instructions. One medium for communication that has become increasingly relevant in recent years is electronic mail (email). Because of its pervasiveness and relative ease of use, email offers a potentially valuable resource for augmenting and improving communication between physicians and patients. This study will assess whether an email reminder with follow up instructions one day after ED visit occurs will increase follow up rates and timely follow up rates.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients triaged to category 2, 3, and 4 and placed in a room for care at St. Joseph Mercy Hospital-Ann Arbor Emergency Department 2. Primarily English speaking. 3. \>18 years of age 4. Have a primary physician who is part of Integrated Health Associates 5. Have access to an email account

Exclusion Criteria:

* 1. Patients triaged to category 1 or 5 placed in a room at Stl Joseph Mercy Hospital-Ann Arbor (category 1 patients are not typically discharged home from the hospital. Category 5 patients could potentially be interfered with if attempting implementation of the communication instrument. Category 5 patients are typically very straightforward visits with minimal requirement for follow-up appointments) 2. Patients \< age 18 3. Prisoners or institutionalized persons 4. Patients with a mental-health related chief complaint 5. Not primarily English speaking (the potential language barriers could interfere with ability to communicate via email which will be written in English) 6. Under temporary or permanent custodianship (used as a surrogate for ongoing lack of mental competence or consciousness) 7. Prior participation in this study. (A patient may only participate once).
BD Veritor™ At-Home and BD Veritor™ Professional

The BD Veritor™ System is a rapid test that is testing for both COVID-19 and for Influenza This study will try to determine if the BD Veritor™ system can assist in the diagnosis of someone who has upper respiratory infection symptoms. There is both an At-Home self test and test completed by a health care professional that will be completed during this study.

This is a prospective, multi-country, multicenter, comparative study to assess the performance of the BD Veritor™ At-Home SARS-CoV-2 \& Flu A+B test and the BD Veritor™ System for Rapid Detection of SARS-CoV-2 \& Flu A+B (Professional use) compared to an FDA approved Flu A/B reference assay (RT-PCR) and FDA authorized molecular SARS-CoV-2 comparator reference method assays.

Eligibility Criteria:
Inclusion Criteria:

* 1. Participants symptomatic of an acute respiratory illness within 7 DOSO
* 2. ≥2 years of age at the time of study participation
* 3. Symptomatic subjects with
* a. Any one of the following symptoms (with or without additional symptoms):
* i. Fever
* 1. Oral/temporal artery: ≥100.4 °F / ≥38.0 °C
* 2. Rectal/Ear: ≥101.2 °F / ≥38.5 °C
* ii. Cough
* iii. Malaise (fatigue/extreme tiredness)
* b. Or two of the following symptoms:
* i. Sore throat,
* ii. Shortness of breath/difficult breathing
* iii. Rhinorrhea (runny or stuffy nose),
* iv. Myalgia,
* v. Headache,
* vi. Sneezing,
* vii. New loss of taste or smell,
* viii. One or more GI symptoms (nausea, vomiting, diarrhea)

Exclusion Criteria:

* 1. Participants currently undergoing treatment and/or within the past thirty (30) days of the study, with medication to treat novel Coronavirus SARS-CoV-2 viral infections, which may include but is not limited to Remdesivir (Veklury)
* 2. Participants receiving convalescent plasma therapy for SARS-CoV-2.
* 3. Participants who have received antiviral medications for influenza within the previous 30 days.
* 4. Participants who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit.
* 5. The participant is currently receiving or has received within the past thirty (30) days of the study visit, an experimental biologic or drug including either treatment or therapy.
* 6. Participants who have been previously enrolled in the study.
* 7. History of frequent or difficult to control nosebleeds within the last fourteen (14) days.
* 8. Participants who have tested positive for Flu A/B or SARS-CoV-2 within the last 28 days (excluding the day of enrollment in the study).

Exclusion criteria for the participation in the At-Home portion of the study would include all of the criteria previously listed and include the following

* 1. Participants without the ability to read or write in the English Language
* 2. Participants with prior medical or laboratory training.
Interest of Levosimendan Preconditioning for Cardiac Surgery Under CEC in Heart Failure Patients With Impaired Ejection Fraction

Levosimendan, a drug with inotropic, vasodilatory and myocardial protective properties, has been proposed for the prevention and treatment of postoperative low cardiac output syndrome in cardiac surgery. Despite preliminary studies with promising results, large randomized controlled trials aimed at demonstrating the benefits of levosimendan did not show superiority over placebo in this indication. However, in these studies, the infusion was neither performed at the maximum dosage nor during the 24 hours preceding the surgery, but mainly at the very beginning of the operation. However, post hoc analyses showed a reduction in mortality and in the occurrence of low cardiac output syndrome in the subgroup of patients who had undergone isolated coronary artery bypass grafting, in contrast to those who had undergone valvular or combined surgery. Another recent study suggests that under similar conditions, preconditioning with levosimendan started 48 hours before surgery reduces the length of stay in intensive care and the average cost of hospitalization. There are no formal recommendations on the prophylactic use of levosimendan in cardiac surgery for heart failure patients with impaired LVAS. However, the France-Levo registry, a multicenter observational study requested by the HAS, has shown that in real practice there is a place for preconditioning with levosimendan, which is used in this indication for 7% of the patients in the registry. The Cardiovascular Surgery and Transplantation Department of the Nancy Brabois University Hospital, which actively participated in the France-Levo registry, is one of the cardiac surgery centers that uses this practice, as is the University Hospital of Rouen. It is interesting to be able to evaluate retrospectively whether levosimendan preconditioning has a positive impact on the postoperative prognosis of patients and more particularly on the reduction of the length of stay in critical care and in hospital compared to standard management.


Eligibility Criteria:
Inclusion Criteria:

* Patients with heart failure impaired LVEF (\< 40%), who have undergone left heart surgery (coronary artery bypass grafting and/or mitral and/or aortic valve replacement) under extracorporeal circulation between 01/01/2018 and 28/02/2022 at different University Hospital in France

Exclusion Criteria:

* Initiation of levosimendan \> 48 hours or \< 24 hours before surgery ECMO pre- or post-op
Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia

Radiation-induced xerostomia (dry mouth) is one of the most common and severe toxicities experienced by patients undergoing radiation treatment for head and neck cancer. Radiation-induced dry mouth is a frequently experienced symptom and persists after treatment, potentially indefinitely. Current practice does not specifically attempt to spare the parotid ducts, where stem/progenitor cells are believed to preferentially reside, and considers the entire salivary gland to have equal function. New radiation therapy planning and conducting strategies are needed to reduce this toxicity and maximize patient quality of life post-treatment.

This randomized Phase II study explores the contribution of magnetic resonance imaging (MRI) guided salivary gland duct definition to decrease patient-reported xerostomia in patients with oropharynx cancer receiving radiation therapy. The severity of xerostomia will be measured by patient-reported (PRO) symptoms, saliva secretion, saliva pH, and buffering.


Eligibility Criteria:
In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Eligibility must be maintained up for the subject to be considered eligible for treatment.

Inclusion Criteria

1. Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
2. Subjects is willing and able to comply with study procedures based on the judgment of the investigator.
3. Age ≥ 18 years at the time of consent.
4. T0-4, N0-3, M0 disease American Joint Committee on Cancer (AJCC 7th or 8th edition) of the oropharynx (this includes patients with head and neck cancer of unknown primary origin, often categorized as T0 disease, who will be treated with radiotherapy to the oropharynx) planned for definitive radiotherapy +/- chemotherapy

5 No contraindications to receiving MRI such as implanted electrical devices, pregnancy, and significant quantities of metal in the head/neck

Exclusion Criteria

1. Patients with Sjogren's syndrome or baseline xerostomia (CTCAE \> 0 for the question regarding dry mouth)
2. Patients with lesions grossly involving the salivary glands
3. Patients with an allergy to lemon juice
4. Prior history of radiation therapy to the head and neck
The Effect of Presbyphagia on Urinary Incontinence and Quality of Life in Healthy Elderly People in Nursing Homes

Urinary incontinence in the elderly and health-related quality of life due to urinary incontinence is a common problem in nursing homes. Another problem that occurs in elderly individuals is swallowing disorder. Swallowing disorders that occur with aging are called presbyphagia. Additional health problems such as impaired fluid intake balance, fetal incontinence and sarcopenia may occur after presbyphagia. However, the effect of presbyphagia on urinary incontinence is not known. In this study, we aimed to determine the effect of presbyphagia on urinary incontinence and quality of life in healthy elderly individuals living in a nursing home.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who have been living in the nursing home for at least 1 year and volunteer to participate in the study
* a mini metal test score of 24 and above

Exclusion Criteria:

* Those who cannot provide information on urinary function and quality of life,
* Those with a history of disease and surgery with mechanisms directly related to swallowing and urinary incontinence,
* Those with a mini mental test score of 23 or less were excluded
Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis Comparing to Traditional Treatment of Troches

Background: Oral candidiasis is most frequently found among the elderly .It is accompanied with oral pain, irritation, burning sensation. In addition, the altered taste sensation may cause nutrition compromise, which may affect ones diet. Management of superficial oral Candida is usually achieved by treatment with clotrimazole, a fungi static drug which is given five times per day with instruction to slowly suck on it with out the dentures.

Working hypothesis and aims: Management of oral candidiasis is feasible. The major disadvantage of the mode of action now days is the substantively of the drug in the oral cavity and patient compliance. A sustained release varnish which is easily applied on the dentures, which also release the anti fungal drug for at least a day, may overcome some of the pit falls of the treatment applied today.

Based on our past experience, in developing local sustained release varnishes for dental use, we anticipate that we can also formulate a special anti fungal sustained release varnish which will fit the special and unique needs of the elderly population.

Methods: Sustained release varnish will be developed in our laboratory. The kinetics of release (using HPLC) and antifungal activity (Bioassays) will be examined in vitro. The formulation showing the optimal results will be tested on human subjects with oral candidiasis. The efficacy of the varnish will be examined clinically (reduction in symptoms), microbiology (reduction of oral fungal), pharmaceutically (release kinetics in vivo).

Expected results: The clinical out come of one time varnish application will be improved compared to the five times application of lozenges (used today). The severity of the disease should decrease and the healing period should be shorten drastically.

Importance: This is a novel pharmaceutical development of a local application of a dental varnish designed specially to the elderly population


Eligibility Criteria:
Inclusion Criteria:

* adults
* removable denture in mouth
* diagnosed oral candida

Exclusion Criteria:

* allergy to clotrimazole
* immunosuppressed
* using other antifungi treatment
* have an active oral ulcerative disease
* impaired kidny or live functions
Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal Carcinoma

A Phase II Open-Label, Multi-Center Study of MEDI4736 Evaluated as Single Agent or in Combination with Tremelimumab in Patients with Metastatic Pancreatic Ductal Adenocarcinoma.

This is a Phase II, open-label, multi-center study to determine the efficacy and safety of MEDI4736 evaluated as single agent or in combination with tremelimumab in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) whose disease has progressed on fluoropyrimidine containing or gemcitabine-containing first-line chemotherapy.This study will consist of Part A, lead-in, as well as a possible expansion Part B.

Eligibility Criteria:
Inclusion Criteria: -

1. Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior chemotherapy regimen
2. Eastern Cooperative Oncology Group 0 or 1
3. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) scan and that is suitable for accurate repeated measurements

Exclusion Criteria:

1. Any concurrent chemotherapy, investigational product , biologic, or hormonal therapy for cancer treatment.
2. History of leptomeningeal carcinomatosis
3. Ascites requiring intervention
4. Brain metastases or spinal cord compression.
Study to Evaluate the Safety and Efficacy of High Dose IVIG in Hospitalized Participants With Coronavirus Disease (COVID-19)

The purpose of the study is to determine if high dose Intravenous IVIG plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29 versus SMT alone in hospitalized participants with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized male or female subject ≥ 18 years of age at time of Screening who is being treated for COVID-19.
2. Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by qualitative Polymerase Chain Reaction (PCR) (reverse transcriptase \[RT\]-PCR), or other commercial or public health assay (of any type) in any specimen during the current hospital admission prior to randomization.
3. COVID-19 illness (symptoms) of any duration with radiographic infiltrates by imaging (Chest X-Ray, Computed tomography (CT) scan, etc.).
4. PaO2/FIO2 ratio \> 300 to ≤ 450 mmHg (i.e., arterial oxygen in mmHg divided by fraction inspired oxygen concentration \[e.g., 0.21 for room air\])
5. Any one of the following related to COVID-19: i. Ferritin \> 400 nanogram per milliliter (ng/mL), ii. Lactate dehydrogenase (LDH) \> 300 units per liter U/L, iii. D-Dimers \> reference range, or iv. C-reactive protein (CRP) \> 40 milligram per liter (mg/L).
6. Subject (or a legal representative or a nearest relative or a relative by marriage, as appropriate) provides oral informed consent prior to initiation of any study procedures.

Exclusion criteria:

1. Subject requires invasive mechanical ventilation or ICU admission.
2. Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator may place the subject at undue medical risk.
3. The subject has had a known (documented) serious anaphylactic reaction to blood, any blood-derived or plasma product or commercial immunoglobulin.
4. Subject has known (documented) hereditary fructose intolerance (HFI).
5. A medical condition in which the infusion of additional fluid is contraindicated.
6. Shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered by the Principal Investigator not able to be reversed.
7. Subject with known (documented) thrombotic complications to polyclonal IVIG therapy in the past.
8. Subject with current or prior (within the past 1 month) myocardial infarction, stroke, deep vein thrombosis, or thromboembolic event.
9. Subject with limitations of therapeutic effort (eg, 'do not resuscitate' status).
10. Female subject who are pregnant or of child-bearing potential with a positive test for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at Screening/Baseline.
11. Subject participating in another interventional clinical trial with investigational medical product or device.
Post-Traumatic Brain Injury (Post-TBI) Fatigue and Its Treatment

Randomized clinical trial of modafinil vs. placebo for treatment of fatigue after TBI.

Purpose: The purpose of this study is to examine the efficacy of the drug modafinil as a treatment for fatigue post TBI.

Background: After TBI, fatigue is one of the most common complaints, as documented in our work and that of many other researchers. People with TBI experience fatigue that seems to them out of proportion to whatever work they are doing or effort they are making. Fatigue after TBI is associated with decreased participation in normal activities in the community and has been linked to depression.

Need for Research: Research on use of drugs to treat post-TBI fatigue is inadequate. While studies of fatigue in people with other chronic conditions suggest that modafinil helps relieve fatigue and has fewer side effects than some other drugs used in treating fatigue, the use of modafinil has not yet been tested in people with TBI.

Current and Future Research Activity: More than 100 men and women volunteers who complain of post-TBI fatigue will be randomly assigned to a 4-week period of taking modafinil or a placebo. At the beginning and end of the study, the severity of their fatigue and associated symptoms (e.g., cognitive function, mood, pain, daytime sleepiness, sleep quality, health status) will be assessed, as well as their participation in activities and perceived quality of life. It is hypothesized that modafinil will reduce the symptoms of fatigue and will increase level of activity and perceived quality of life to a significantly greater extent than will the placebo.

Eligibility Criteria:
Inclusion Criteria:

- Individuals who sustained a TBI with a documented loss of consciousness or evidence of a TBI on neuroimaging studies and who are at least 12 months post-injury, who complain of fatigue and who have scores of 22 or above on the Barroso Fatigue Scale will be eligible to participate in this study. Subjects must not meet criteria for alcohol or substance abuse using the Structured Clinical Interview for DSM-IV (SCID) for at least six months prior to study enrollment.

Exclusion Criteria:

- Diagnosis of chronic neurological disease (including Lyme disease), narcolepsy, current infectious disease, chronic fatigue syndrome, fibromyalgia, anemia, hypothyroidism not adequately controlled with medication, blood pressure greater 150/100 mm Hg, or clinically significant major systemic disease. In addition, individuals taking medications which are known to cause fatigue will be excluded from participation in the study.