cyrilzakka/clinical-trials huggingface dataset:
The Strategy of "Pulmonary Opening by Titration of Positive End-expiratory Pressure" Means of a Pulmonary Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome: for Which Patients?

Pulmonary recruitment maneuvers open these lung areas and appropriate adjustment of positive expiratory pressure (PEP) helps to stabilize recruitment and reduce the stress associated with alveolar opening and closing. Its beneficial effects in the lung affected by Acute Respiratory Distress Syndrome (ARDS) remain unclear. The hypothesis is that there is a heterogeneous effect of the recruitment maneuver according to the phenotype of ARDS. It is important to be able to define responder patients from non-responders to this recruiting maneuver.

It will be a prospective interventional study in resuscitation patients with severe or moderate ARDS. This study will be multicentric between the University Hospital of Amiens and intensive care of Lens, intensive care of Bethune and intensive care of Arras. All patients in intensive care and severe, moderate ARDS will be included in this study. All patients will benefit from Lung ultrasound (LUS) with a mapping of each lung looking for normal or pathological lung profiles, as well as a measurement of esophageal pressure (Peso) at rest. A "PEP titration pulmonary opening" (PEP-OP) test using a recruitment maneuver was then performed in all patients followed by a new LUS and Peso measurement.

Eligibility Criteria:
Inclusion Criteria:

Will be included in the study, patients:

* Major patient (age ≥18 years)
* Controlled assisted ventilation, sedation and curarization adapted to the respirator.
* Within the first 72 hours of an ARDS (PaO2 / FiO2 ≤ 200 mmHg, FiO2 ≥ 60% and PEEP of ≥5 cmH20) (as recommended by the Berlin criteria)
* Decision of intensivist in charge of the patient to put an oesophageal probe
* After hemodynamic optimization (evaluation of the preload dependence and need for catecholamines)
* Decision of the intensivist in charge of the patient to perform a pulmonary opening test by titration of PEEP by means of a pulmonary recruitment test.

Exclusion Criteria:

* Patients under the age of 18
* Pregnant women, women who are parturient or breastfeeding
* Patients with pulmonary broncho-emphysematous pathology or at risk of presenting it.
* Patients with a history of barotrauma or at risk of presenting it.
* Patients with a history of intracranial hypertension
* Patients with suspected or proven right ventricular dysfunction or uncontrolled hemodynamic instability after hemodynamic management.
* Patients with a contraindication to the placement of an oesophageal tube (esophageal surgery, severe esophageal pathology)
* Patients under guardianship or curatorship or deprived of liberty.
* Patients who are legally protected
* Patient not covered by French national health insurance
Losartan in Prevention of Radiation-Induced Heart Failure

This study is being done to see if losartan affects the chances of developing radiation-induced heart failure in patients who are receiving radiation therapy as part of standard of care treatment for breast cancer.

The interventions involved in this study are:

* Losartan
* Radiation Therapy (standard of care)

This is a pilot study examining whether losartan prevents radiation therapy-induced myocardial fibrosis (thickening of the heart tissue), which can cause heart failure, in breast cancer patients receiving radiation therapy.

Losartan is an U.S. Food and Drug Administration (FDA) approved drug used to treat hypertension (high blood pressure) and heart failure. The U.S. Food and Drug Administration (FDA) has not approved losartan for use in the treatment of breast cancer.

The FDA has approved radiation therapy as a treatment option for breast cancer.

The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. It is expected participants will be on the study for 1 year.

It is expected that about 10 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

-\>18 years of age

* Non-metastatic Breast Cancer patients who are scheduled to receive conventional left breast/chest wall RT inclusive of treatment to the internal mammary lymph nodes (IMNs)
* Prior chemotherapy is permitted
* Patients must have Left-sided Breast Cancer
* Ability to understand and the willingness to sign a written informed consent document
* No contraindication to MRI

Exclusion Criteria:

* Person who is pregnant or breastfeeding.
* Patient unable to swallow oral medication.
* Patients receiving any other investigational agent will not be excluded from study eligibility, unless the patient is already enrolled in an interventional study evaluating cardiac toxicity
* Patients already receiving ACE/ARBs.
* Patients with a history of allergic reactions to Losartan biosimilars.
Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus

The purpose of the study to prove benefits of adding metformin to insulin for controlling presentational and gestational diabetes mellitus and improving neonatal outcome.

The current study was conducted at Ain Shams university maternity hospital during the period between June 2016 to December 2016.

All patients were subjected to:

1. History taking:
2. General and Abdominal Examination:

   With particular emphasis on :
   * Body mass index
   * Blood pressure.
   * Fundal height .
   * Estimated fetal weight .
3. Insulin and metformin doses :

   Insulin dose:

   0.7 IU/Kg (at the second trimester of pregnancy). 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.

   Metformin dose :

   Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.

   If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day.
4. Investigations:

Fasting and two hours postprandial blood glucose levels were measured in two groups of pregnant women:

1. Group I: pregnant women who received oral metformin in addition to insulin therapy.
2. Group II: pregnant women who received insulin therapy only.

Eligibility Criteria:
Inclusion Criteria:

1. Age 20 - 35 years.
2. Gestational age: 20- 36 weeks gestation.
3. Singleton pregnancy.
4. Women with pregestational or gestational diabetes mellitus

Exclusion Criteria:

1. Pregnant women with secondary diabetes (e.g. those on chronic steroid therapy).
2. Hypertensive patients.
3. Women with impaired liver or renal function
4. Non-compliant patients.
Uninterrupted Direct-acting Oral Anticoagulation in Patients Undergoing Transradial Percutaneous Coronary Procedures

Up to 20-30% of patients who are candidates for direct oral anticoagulation (DOAC) present with concomitant ischemic heart disease and often require coronary angiography with or without percutaneous coronary intervention (PCI). The decision whether to continue the DOAC throughout periprocedural period or interrupt DOAC before planned procedure represents a substantial challenge in daily clinical practice.

The objective of this study is to evaluate the safety of uninterrupted direct-acting oral anticoagulation in patients undergoing trans-radial percutaneous coronary procedures.

The study design is an investigator-initiated, single-arm, open-label, pilot study in patients treated with DOAC undergoing trans-radial percutaneous coronary procedures.

Because of the exploratory nature of this study, no formal sample size calculations are required. On the basis of previous pilot studies with similar designs, a sample of 200 patients is planned; with a safety stopping rule based on the occurrence of BARC type 3 or 5 bleeding. In the present trial, if during the enrollment period more than 3 cases of BARC 3 or 5 bleeding occur up to 30-day follow-up, patient recruitment will be terminated. This number is based on the reported 1.6% BARC type 3 or 5 bleeding in patients undergoing transradial percutaneous coronary procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patients under anticoagulation with DOAC and any indication for diagnostic or therapeutic trans-radial percutaneous coronary procedures. At least 25% of the population undergoing PCI will be included.

Exclusion Criteria:

1. Aged \< 18 years
2. Cardiogenic shock
3. Major active bleeding at the time of the procedure
4. Use of mechanical circulatory support
5. Chronic total occlusions
6. Pre-planned vascular access different from radial artery access (i.e. femoral, brachial, ulnar)
7. Inability to provide informed consent
8. Unable to understand and follow study-related instructions or unable to comply with study protocol
9. Currently participating in another trial
10. Pregnant women
The Study to Evaluate Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients (MYLT1)

Efficacy and safety of MY-REPT capsule in primary, liver transplantation recipients

Open label, Multicenter, Non-comparative Study to evaluate the efficacy and safety of MY-REPT capsule in primary, liver transplantation

Eligibility Criteria:
Inclusion Criteria:

* Patient with primary liver transplantation recipients
* Male and Female aged ≥19 and ≤65
* Patient with ABO blood type correspond with Donor's blood type
* Patient who agreement with written informed consent
* Patient who Women if had childbearing potential must have a negative serum or urine pregnancy test at the screening visit and agreement with contraception

Exclusion Criteria:

* Patient with secondary liver transplantation(LT) recipient or other organ transplantation recipient in past or current
* Patient with multi-organ transplantation recipient
* Patient with dual-graft transplantation recipient
* Patient who used body artificial liver before LT
* Cr level \>2.0mg/dL in screening
* WBC \<2,000/mm3 or ANC \<900/mm3 or PLT \<30,000/mm3 in screening
* Patient who experienced severe gastrointestinal disorder so investigator judge the man's participation impossible
* Patient who experienced severe infection (need to treatment)
* Patient or Donor with HIV positive
* Patient who need to treat with immunosuppressant or chemistry therapy
* Patient who had taken immunosuppressant within 30days before LT (except to take Corticosteroids and Tacrolimus due to protocol)
HLA-haploidentical Hematopoietic Stem Cell Transplantation for Children and Adolescents With Acute Leukemia, Myelodysplastic Syndrome and Solid Tumors

RATIONALE: Conditioning with total body irradiation (TBI) and fludarabine, cyclophosphamide and anti-thymocyte globulin may induce the engraftment cross the immunologic barrier in the setting of HLA-haploidentical allogeneic hematopoietic cell transplantation. In addition, T-cell depletion may contribute to prevent developing severe acute graft versus host disease (GVHD) in haploidentical transplantation.

PURPOSE: This phase I/II trial is to evaluate the safety and efficacy of TBI, fludarabine, cyclophosphamide and antithymocyte globulin with T-cell depleted graft from haploidentical donors in treating patients with acute leukemia and myelodysplastic syndrome.


Eligibility Criteria:
Inclusion Criteria

1. Disease characteristics

   * Acute lymphoblastic leukemia (first remission, high risk; beyond first remission; refractory)
   * Acute myeloblastic leukemia (first remission, high risk; beyond first remission; refractory)
   * Myelodysplastic syndrome
   * Solid tumors (Refractory/relapse)
2. No HLA-identical family member or closely matched (8 or 7 of 8 HLA-locus match) unrelated marrow donor available
3. HLA-haploidentical related donor available

Exclusion criteria

1. Active fungal infections
2. HIV positive
3. Pregnant or nursing
SCI&U Peer Health Coaching Program for Individuals Newly Discharged from Inpatient Rehabilitation

The goal of this clinical trial is to learn if the online program and web-based platform for delivery of self-management services to people with spinal cord injury (SCI) called "SCI \& U" can support transitions from hospital to the community after injury. Specifically, can providing support from trained peer health coaches via the SCI \& U web-based self-management program increase health self-management among those within two years of a spinal cord injury with a planned discharge to or living in the community with SCI for less than two years in the province of British Columbia, Canada or the state of Connecticut, United States.

The main question it aims to answer is:

• Does the SCI \& U web-based self-management program lower emotional distress and increase self-efficacy Researchers will compare those who participate in SCI \& U with those who receive usual peer support after 6 months to see if the SCI \& U program improves self-management knowledge, skills and self-efficacy and decreases secondary complications

Participants will:

* engage in up to 14 online sessions, each of which lasts about an hour with a peer health coach trained in motivational interviewing, goal setting and brief action planning. During sessions, they may also review resources and create follow up plans on the online platform on health management topics
* complete an interviewer administered survey at baseline, 6 and 12 months


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older, with a planned discharge to or living in community with SCI for no more than two years since injury and with the ability to speak and understand English

Exclusion Criteria:

* not a resident of British Columbia or Connecticut
Verification of Appropriate Insertion Depth of Endotracheal Tube Placement

The investigators are trying to evaluate the efficacy of ultrasonographic determination of depth of endotracheal tube placement in infants and young children by using the pleural sliding sign.

It is difficult to determine the adequate depth of endotracheal tube placement in infants and young children. It is usually determined by an equation according to the patient's age (12 + age/2, cm) or auscultation method. The auscultation method is to intentionally place the tip of the endotracheal tube into the right main stem bronchus and then withdraw it until breath sounds are equal. The tube is fixed 1 or 2 cm proximal to the point where breath sounds become equal. However, in small children or infant, as the breadth sound in unilateral lung transmits the contralateral lung field and is often difficult to listen in a noisy operation room, it is often difficult to determine the depth by auscultation method. Pleural sliding sign, or sliding lung sign is a ultrasonographic finding that the visceral pleura moves against the parietal pleura. It is used to identify whether the lung is ventilated by ultrasound. The investigators are trying to use this pleural sliding sign to determine the depth of endotracheal tube, and compare this method with auscultation method.

Eligibility Criteria:
Inclusion Criteria:

* Infants or young children (less than body weight of 20 kg) undergoing elective surgery (general surgery, urology, plastic surgery, cardiac surgery) under general anesthesia with endotracheal intubation

Exclusion Criteria:

* Patients with pneumothorax, pleural effusion, atelectasis, pneumonia
* hemodynamic unstable patients (inotropics use)
* History of difficult intubation
* Combined upper airway anomaly
Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients

The purpose of this study was to assess the efficacy and safety of vildagliptin 50 mg bid add-on therapy to improve overall glycemic control in patients with T2DM inadequately controlled by insulin, with or without concomitant metformin treatment. It was agreed with PMDA to conduct a postmarketing clinical trial to further collect the efficacy and safety data of vildagliptin especially in Japanese patients when it iwas used on top of insulin.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of T2DM by standard criteria.
* HbA1c ≥ 7.0 to ≤ 10% at Visit 1.
* Age: ≥ 20 to \< 75 years old at Visit 1.
* BMI ≥ 20 to ≤ 35 kg/m2 at Visit 1.

Exclusion Criteria:

* FPG ≥ 270 mg/dL (≥15 mmol/L) at Visit 1.
* Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.
* Significant heart diseases
* Hepatic disorder

Other protocol defined inclusion/exclusion criteria may apply
A Study to Assess Growth in Children With Idiopathic Short Stature

Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must be \> 2 years old, and ≤ 14 years old (female) or ≤ 16 years old (males) at the time of signing the informed consent.
2. A height assessment corresponding to a height Z-score of ≤ -2.25 SDs in reference to the general population of the same age and sex, as calculated using the Centers for Disease Control and Prevention (CDC) growth chart (https://www.cdc.gov/growthcharts/zscore.htm).
3. Participants who have either never received hGH, or who are currently receiving hGH treatment.
4. Historic stimulation test result with serum or plasma GH level greater than 10 μg/L.
5. Parent(s) or guardian(s) are willing and able to provide written, signed informed consent.

Exclusion Criteria:

1. Diagnosis of systemic disease or condition that may cause short stature, eg renal, neoplastic, pulmonary, cardiac, gastrointestinal, immunologic and metabolic disease. Children with such diagnoses can be considered for inclusion if their condition is well controlled, at the discretion of the Medical Monitor.
2. Known presence of one or more pituitary hormone deficiencies
3. Bone age advanced over chronological age by more than 3 years.
4. For hGH naïve participants, historic stimulation test result with serum or plasma GH level greater than 10 μg/L or serum IGF-1 in the normal range for age (between -1.00 SDs and +2.00 SDs).
5. For participants currently on hGH treatment, historic results before GH treatment of stimulation test with serum or plasma GH level greater than 10 μg/L or serum IGF-1 test between -1.00 SDs and +2.00 SDs.
6. Have received an investigational product (IP) or investigational medical device for any purpose within 6 months before the Screening visit. .
Texting Atopic Dermatitis Patients to Optimize Learning and EASI Scores

The purpose of this study is to determine if sending text messages with treatment reminders and facts regarding atopic dermatitis (AD) to caretakers of children with AD will have a positive effect on the disease severity.

Atopic dermatitis (AD) is a common, chronic, and debilitating disease that tends to present in children under age 2 and has a waxing and waning course. Poor adherence to treatment is the primary preventable contributor towards adverse outcomes such as infection, hospitalization, permanent disfigurement, and disruptions in normal childhood psychological development. The burden of care for these patients often falls upon parents, who may have difficulty incorporating the necessary daily treatments into the family's lifestyle. Thus, investigating ways of improving adherence could have a significant impact on a patient's long term prognosis and the family's ability to understand and adjust to the demands of AD.Text message reminders with embedded health literacy information have been shown to improve vaccination rates in children and caregivers have reported increased satisfaction with this means of communication.

This study aims to assess whether text message reminders with information about AD are an effective way to improve treatment adherence and provide disease specific information to caregivers of children with AD. The measure of AD severity will be the Eczema Area and Severity Index (EASI) score. Health literacy with regard to AD will be assessed via in-office survey.This study will involve children age 0-6 with newly diagnosed AD and their primary caregivers. The subjects will be randomized to standard care or text message reminder group. All study participants will be asked to complete a survey after their initial evaluation and after their follow up visit on the same day they are in the office. The text message group will receive text messages with information and treatment reminders. All participants will receive the standard of care with regard to AD.

If this study demonstrates that text message reminders can improve EASI scores in AD patients it could lead to a significant change in how these patients are managed. Fewer complications from episodic flares, infections, and other sequelae may lessen the burden of this disease for both patients and their caregivers. Text messaging is an inexpensive, noninvasive, and broadly applicable tool that is worth studying for the purpose of improving treatment adherence and disease literacy.

Eligibility Criteria:
Inclusion Criteria:

* New clinical diagnosis of atopic dermatitis
* New patient to Columbia University Medical Center, Department of Dermatology
* Caregiver has mobile that can send/receive text messages

Exclusion Criteria:

* Age over 7 years
* Caregiver is not fluent English speaker
* Those patients in which a definitive diagnosis of atopic dermatitis cannot be made
* Any individual who declines participation
Aspirin Resistance in Coronary Artery Disease

The purpose of this study is to evaluate possible mechanisms of aspirin resistance at a molecular level in aspirin-treated patients with coronary artery disease. We hypothesize that certain patient characteristics associate with aspirin resistance. In addition, we will compare the effects of enteric-coated aspirin and chewable aspirin.

Aspirin is commonly used for its antithrombotic effects in patients at risk for cardiovascular events. Its primary mechanism of action is the irreversible acetylation of platelet cyclooxygenase-1, thereby inhibiting platelet production of thromboxane A2, a potent vasoconstrictor and activator of platelets. Thromboxane A2, the major product of cyclooxygenase cytochrome oxidase (COX-1) in platelets, induces platelet aggregation. Thromboxane B2 is an inactive metabolite/product of thromboxane A2. This primary outcome measures the extent of inhibition of platelet COX-1 by measuring the amount of the metabolite thromboxane B2 in serum.

Previous studies have demonstrated that many patients have recurrent events despite treatment with aspirin, which has been termed "aspirin resistance" or "aspirin nonresponse." This study addresses some of the possible mechanisms for aspirin nonresponse; specifically, we will test the hypothesis that aspirin nonresponse results from states that produce high peroxide concentrations ("oxidative stress") in platelets. In addition, we will evaluate the effect of enteric coating on the pharmacologic efficacy of aspirin in patients with coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* On aspirin 81-325mg daily at time of enrollment
* Documented stable coronary artery disease or \> 6 months after coronary artery bypass grafting or interventional cardiac procedure
* Written informed consent

Exclusion Criteria:

* Pre-menopausal female
* Renal disease (creatinine \>= 2 mg/dl)
* Anemia (Hematocrit \< 30%)
* Thrombocytopenia (platelet count \< 135,000/ul)
* Use of NSAIDs or coxibs within the previous 2 weeks
* Concurrent use of other anti-platelet agents
* Uncontrolled hypertension (systolic BP \> 180 mmHg)
* Decompensated congestive heart failure
* Recent coronary syndrome (\< 6 months)
* History of significant GI bleeding