cyrilzakka/clinical-trials huggingface dataset:
Study of the Impact of Administering t the Scale of Brazelton on the Mother's Confidence in Her Newborn Born Premature at the Approach of Returning Home

In France, the last national perinatal survey show that 6.6% of live births are premature. For these infants, transfer in Neonatology sector may result in mother-child separation can last several weeks or months. This hospital can complicate the implementation of the attachment process that allows parents to recognize their children as their own, to gain confidence in their abilities to deal with them and establish a relationship with him.

A study of mothers of premature shows the interest of the Brazelton scale to help them identify the skills their child and adjust their own behavior.


Eligibility Criteria:
Inclusion Criteria:

* Mother: over the age of 18, affiliated to a health social security.
* Newborn: born to a term of less than 36 S.A., hospitalized in neonatology, said leaving in three days.

Exclusion Criteria:

Mother :

* Legally protected
* Inability to understanding and monitoring of the protocol's terms (not master the French language, intellectual impairment, psychotic disorder ...)
* Who have had a premature child born.

New born :

* Opposition of one of the holders of parental authority to the award of the Brazelton Scale
* Having withdrawal syndromes or malformation syndromes requiring oxygen therapy, gastrostomy or nasogastric tube
* Twins and more.
Randomized MicroPort's Firehawk DES Versus Xience V: TARGET I Trial

The purpose of this study is to evaluate new generation drug eluting stent (DES) of MicroPort of its safety, efficacy and delivery system in treating CAD.

The primary endpoint is in-stent late lumen loss after 9 months of the stent implantation. The secondary endpoint is in-stent percent diameter stenosis.This study is based on non-inferior assumption (vs. Xience V), requiring both endpoints reach statistical significance. Prespecified OCT follow-up is planned at 3-Year after index procedure at 3 chosen hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75, male or women who are not pregnant
* Evidence of non-symptomatic ischemia, stable or non-stable angina or past heart attack cases
* Target lesion is primary, single artery and single lesion of coronary artery
* Target lesion vessel length ≤24mm, diameter 2.25mm-4.0mm
* Lesion diameter stenosis ≥70%
* Candidates understand the study, willing to sign Consent of Agreement and to willing to accept follow-up For long lesion group, at least one target lesion length ≥28mm，diameter 2.5mm-4.0mm, and one lesion needs to implant 33mm 0r 38mm long stent

Exclusion Criteria:

* Acute heart attack within one week
* Chronic complete stenosis (TIMI 0), left main lesion, three branches need to treat, branch vessel diameter ≤2.5mm and bypass lesion
* Calcified lesion failed in pre-dilation and twisted lesion
* In-stent restenosis
* Stent implanted within one year
* Severe heart failure (NYHA above III) or left ventricle EF \<40%
* Renal function damage, blood creatinine \>2.0mg/dl
* Bleeding risk; allergic to drugs and agents used in procedure/treatment
* Life expectation \< 12 months
* No compliances to the protocol
* Heart implantation cases

Pre-specified OCT inclusion/exclusion criteria:

* Patients underwent 9-month angio F/U
* No binary restenosis at 9-month
* LLL between -0.01\~0.2mm
* No mix-implanted stent
* No more than one bail-out stent
* No TLR occurred at 3 years after PCI
* The target vessel able to deliver the OCT catheter
PrEP at a Syringe Services Program

The purpose of this study is to see if providing participants with pre-exposure prophylaxis (PrEP) medicine right away at the IDEA Exchange will help participants remain in HIV negative.


Eligibility Criteria:
Inclusion Criteria:

1. over the age of 18
2. speak either English or Spanish
3. ability to provide informed consent
4. currently enrolled in the syringe services program
5. have a negative HIV rapid test result
6. estimated creatinine clearance \> 30 ml/minute

Exclusion Criteria:

1. do not meet the above criteria of inclusion
2. decline to participate
3. test positive for HIV via rapid test
4. are pregnant or plan on becoming pregnant
5. have symptoms acute HIV.
6. Any other comorbidities that at the discretion of the investigator would prevent the participant from participating in the study.
The Risk Factors for Acute Radiation Pneumonitis in Patients With Prior Receipt of Immune Checkpoint Inhibitors

The purpose of this non-interventional study is to collect data on the risk factors for acute radiation pneumonitis in patients with prior receipt of immune checkpoint inhibitors.

1. Incidence of acute radiation pneumonitis (aRPs) in in patients with prior receipt of immune checkpoint inhibitors.
2. Risk factors (especially analysis of the dosimetric risk factor) which may affect the product of aRPs events.
3. Establish a model to predict aRPs and guide clinical treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically or cytologically confirmed malignant tumor
2. Cancer patients with previously received ICIs underwent thoracic intensity-modulated radiotherapy

Exclusion Criteria:

1. Cancer patients did not receive immunotherapy before thoracic intensity-modulated radiotherapy
2. Non-thoracic radiotherapy patients
Correlating Ic/Pbs Symptoms With Urine Biomarkers

Completion of a brief survey tool and providing an urine specimen. The study purpose is to improve our understanding of interstitial cystitis and painful pelvic syndrome.

The purpose of the study is to improve our understanding of the IC/PBS and develop new treatments. Participation in the study will allow us to compare clinical information, obtained by completion of a brief survey, with substances found in the a urine specimen that is donated to the Beaumont Biobank.

Eligibility Criteria:
Inclusion:

1. Men and women with interstitial cystitis/painful bladder syndrome greater than 18 years old
2. Male and female controls without a history of IC/PBS diagnosis

Exclusion:

1. Unable to complete questionnaires and/or give informed consent
Longitudinal Virtual Reality Use in Pediatric Surgical Procedures

This study aims to investigate the use of virtual reality guided mindfulness meditation to reduce the pre and post-operative anxiety and pain of pediatric surgical patients.

Pre-procedural anxiety in pediatric patients has been previously shown to increase the likelihood of family stressors, agitation, sleep disturbances, and negative behavioral changes. Post-procedural pain has been shown to negatively impact future interactions with healthcare personnel. The purpose of this study is to determine the feasibility of using guided mindfulness meditation through a non-invasive device (virtual reality headset) to manage pre-procedure anxiety and post-procedure anxiety and pain.

Eligibility Criteria:
Inclusion Criteria:

* Have parental consent if under 18 or 18 and older but unable to provide own consent
* Can comprehend instructions in English language
* Is undergoing surgical procedure requiring general anesthesia at Lucile Packard Children's Hospital
* Children that are normally healthy (ASA I) or have a mild systemic disease (ASA II, III)

Exclusion Criteria:

* Children with significant cognitive impairment or developmental delays per parental report or H\&P
* Children with ASA IV (severe systemic disease that is a constant threat to life) or ASA V (unstable patients not expected to survive \>24hours or without operation)
* Children currently taking psychotropic mediations will be excluded from this study due to the affect emotion modulation
* Children with history of seizures related to photosensitivity.
Improving Infant Sleep Safety With the Electronic Health Record

This research is being done to find out if individualized feedback provided to parents on safe infant sleep can improve safety. This will be accomplished by having parents send photographs of their baby sleeping through the patient portal of the electronic health record (EHR).

The purpose of this study is to assess if photographs of infants sleeping at night sent by parents through the patient portal of the electronic health record (EHR) can be used to a) deliver individualized feedback on safe infant sleep surfaces and sleep health and b) improve parental knowledge of and adherence to guidelines for safe infant sleep surfaces and sleep health. The feasibility of this approach will also be assessed through a randomized, clinical trial involving 130 infants with primary care through Penn State Health. Participants will be randomized to receive personalized feedback on the infant sleep position and surface at age 1 month in addition to usual care or a usual care group. Both groups will receive personalized feedback on the infant sleep position and surface at infant age 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age: ≥37 weeks
* Singleton birth
* Newborns ages 0 days to 14 days old
* Newborn nursery stay \<=7 days
* English speaking mother
* Mother ≥18 years old
* Has email/internet access
* Willing to sign up for the Penn State Health Patient Portal through the Electronic Health Record (EHR)
* Owns a smart phone, digital camera, or tablet that can take pictures to be transmitted through the EHR
* Plan to follow with a Penn State Health Provider though the infant's 3-4 month well child visit

Exclusion Criteria:

* Maternal morbidity or pre-existing condition that affects ability to care for the newborn (e.g. narcotic drug use, chemotherapy, uncontrolled depression etc.)
* Child is being adopted or will not be in the care of the mother
Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)

This investigator-initiated, multicenter, international, retrospective registry aims to investigate outcomes of patients with atrial functional mitral regurgitation, as treated in clinical routine.


Eligibility Criteria:
Inclusion Criteria:

* functional mitral regurgitation
* left ventricular ejection fraction ≥50%

Exclusion Criteria:

* age under 18 years
* known regional wall movement disorders
Gesture Behavior and Knowledge on Low Back Pain Among Nurses

The aim of the proposed study is to evaluate knowledge on low back pain and gesture behavior among nurses with low back pain using validated measures and compare the findings to those from nurses without back pain.

A controlled, cross-sectional study will be carried out with 100 nurses (50 with low back pain and 50 without low back pain). The following assessment measures will be employed: Visual analogue scale (VAS) for pain, Gesture Behavior Test (GBT), Low Back Pain Knowledge Questionnaire (LKQ), Roland Morris Questionnaire and the SF-36.

Eligibility Criteria:
Inclusion Criteria:

* Non-specific chronic low back pain,
* Performance in the hospital sector (hospitals, emergency rooms and/or intensive care units,
* Hourly load of at least 6 hours per day,
* Low back pain on most days in the last three months,
* Pain greater than 3 cm in visual analog scale (VAS).

Exclusion Criteria:

* Dispute,
* Previous surgery of the spine,
* Pregnant.
A Phase II Study to Evaluate the Efficacy and the Safety of Flumatinib in CML-AP or CML-BP Patients

Multi-center, single stage, phase II study to evaluate the efficacy and safety of Flumatinib in accelerated or blastic Phase chronic myelogenous leukemia patients.

Multi-center, single-arm, open-label,phase II study to investigate efficacy and safety of Flumatinib in Chinese patients with accelerated or blastic Phase chronic myelogenous leukemia. The starting daily oral dose of Flumatinib is 600mg，core test is six cycles (each cycle is 28 days), collecting the core test data for primary efficacy analysis. The longest treatment time is 12 cycles.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients age 18-75 year-old;
* ECOG 0 - 2;
* Newly diagnosed or previously treated Ph+ CML patients in accelerated or blastic Phase;
* Adequate organ function;
* Written informed consent prior to any study procedures being performed.

Exclusion Criteria:

* Patients in Chronic and Blastic Phases;
* Previously treated with Flumatinib;
* Previously documented T315I mutations;
* Previous therapy within protocol defined timeframe, including:

  * hydroxyurea within 24 hr,
  * Imatinib or Nilotinib or Dasatinib within 28 days)
* Cardiac dysfunction ;
* History of congenital or acquired bleeding disorders unrelated to CML;
* Central nervous system leukemia;
* Previous malignancy except CML;
* Acute or chronic liver or severe kidney disease unrelated to CML;
* Pregnant, breastfeeding, child bearing potential but failed to take effective contraception.
The Effects of Glucocorticoids on Glucose Metabolism in Patients With Interstitial Lung Disease

This study is aimed at exploring the effects of glucocorticoids on glucose metabolism in patients with interstitial lung disease. Patients with interstitial lung disease who is on the medication of 15mg prednisolone and 7.5mg prednisolone conduct the continuous glucose monitoring (CGM). The data attained from the CGM are used to define the glycemic characteristics in patients using glucocorticoids and the difference of glucose features due to different doses.

Patients diagnosed of interstitial lung disease and treating with glucocorticoids could be enrolled in this clinical trial. Those who is in an acute inflammatory phase and diagnosed with hemorrhagic disease should are excluded, so are those unwilling to carry the continuous glucose monitoring (CGM) device. When the dose of prednisolone is applied 15mg per day steadily and is going to be decreased, the CGM is conducted. At the same time, blood tests evaluating the glucose metabolism are measured, including HbA1c, GA, fasting insulin and fasting glucose. After taking 7.5mg prednisolone per day for 3 months, participants do the CGM and blood tests again to evaluate the glucose metabolism during this period. The CGM data could be used for the glucose evaluation, which can manifest the glucose characteristics in the circumstances of glucocorticoid use. By comparing the CGM data and the blood tests, the investigators hope to find the different features of the glucose metabolism due to different doses.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with interstitial lung disease

Exclusion Criteria:

* Patients who are in an acute inflammatory phase
* Patients who are diagnosed hemorrhagic disease
* Patients who are unwilling to carry the continuous glucose monitoring device
Study to Test the Usability of a New Injector to Administer Contrast Media Into Humans for Diagnostic Purposes

This study investigates if a new medical device, which injects contrast media and flushing solution into humans to increase the visibility of images taken of the human body for diagnostic purposes, is easier to handle, quicker and cheaper than an older injector.

The study compares an investigational injection system (Centargo) for computed tomography (CT) to a currently marketed injection system (Stellant MP) in terms of efficiency, cost, performance and user satisfaction (Part 1). In addition, the reliability of the new injection system Centargo is tested (Part 2).

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects referred for contrast-enhanced computer tomography using a power injector

Exclusion Criteria:

* Pregnant and lactating women
* Subjects with know hypersensitivity to iodinated contrast media
* Subjects with unacceptable renal function per local guidelines
Exercise Preconditioning and Breast Cancer Cardiotoxicity

The purpose of this study is to determine whether a supervised exercise-training program, initiated prior to chemotherapy induction (pre-conditioning) and continued throughout chemotherapy treatment, can preserve short- and long-term cardiovascular performance, skeletal muscle function, cognitive ability and quality of life better than current standard or care recommendations for exercise during chemotherapy.

The primary aim of this study is to determine the efficacy of a novel, high-intensity aerobic interval exercise preconditioning protocol to ameliorate anthracycline-mediated cardiac and skeletal muscle toxicity in women with breast cancer undergoing de novo chemotherapy.

Research Design:

Women with breast cancer scheduled to undergo de novo chemotherapy with anthracyclines will be enrolled. Qualified patients will be randomized to either 1) a high-intensity interval exercise group, or 2) an attention-control group.

Supervised exercise training will be carried out at the Mayo Clinic Cardiac rehabilitation center in Arizona on cycle ergometers using Electrocardiogram (EKG) telemetry. Patients in the high-intensity interval exercise group will perform four, 4-min intervals at 85-90% peak heart rate (PHR), separated by 3 min at 50% PHR. Each training session will begin with a 10-minute warm-up at 50% of PHR and end with a 5-min cool down at 50% PHR.

The attention-controls will receive counseling consistent with standard of care regarding physical activity during chemotherapy. Attention-control group will receive a weekly phone call to maintain physical activity during chemotherapy and compliance will be verified using physical activity diaries and pedometers.

Treatment for each group will commence 1-week prior to chemotherapy induction. The first dose of chemotherapy will be given within 16-18 hours of the last bout of exercise. High-intensity intermittent exercise (HIIE) training will be continued throughout four, 2-week cycles of chemotherapy (total training time = 9 weeks, 3 days/week).

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent
* Subjects will have been recently diagnosed with breast cancer (stage I, II or III)
* Subjects must be scheduled by their oncologist to undergo anthracycline based chemotherapy (doxorubicin and cyclophosphamide) in the neoadjuvant/adjuvant setting

Exclusion Criteria:

* Unstable angina
* Myocardial infarction in the past 4 weeks
* Uncompensated heart failure
* New York Heart Association class IV symptoms
* Complex ventricular arrhythmias
* Medical orthopedic conditions precluding stationary cycling
* Medical conditions precluding neuropsychological assessment
* Symptomatic severe aortic stenosis
* Acute pulmonary embolus
* Acute myocarditis
* Untreated high-risk proliferative retinopathy
* Recent retinal hemorrhage
* Uncontrolled hypertension
* Sodium and/or Potassium ≥ Grade 2
* Pregnant Women
Effect of Dapagliflozin on Myocardial and Renal Function Following Aortic Valve Stenosis Intervention

Randomized, double-blinded, placebo-controlled study in AS patients with subclinical or clinical heart failure undergoing treatment with TAVR.

This is a randomized, double-blinded, placebo-controlled study in AS patients with subclinical or clinical heart failure undergoing treatment with TAVR. It evaluates the effect of Dapagliflozin versus placebo, given once daily in addition to background standard medical therapy. Patients who are scheduled for TAVR at Aarhus University Hospital (AUH) will be informed about the project and invited to participate if they fulfill the inclusion criteria prior to the TAVR procedure.

Patients will be randomized 1:1 in blocks of 6 patients to either Dapagliflozin 10 mg daily or placebo within 1 months prior to the scheduled TAVR therapy.

The total treatment period is 13 months with 6 scheduled outpatient clinic visits at baseline (before TAVR) and at 1, 3, 6, 9, 12 months after TAVR.

Cardiac magnetic resonance imaging (CMRI) is performed at baseline and 12 months follow-up. Echocardiography is performed at baseline, 1- and 12 months. 24-hour ambulatory blood pressure is measured at baseline and 12-months post-TAVR. Clinical status, HF questionnaire and blood samples will be performed at each visit. Drug accountability and adherence to the protocol is evaluated at each visit.

A sub study in 40 of the included patients (20 treated with Dapagliflozin and 20 placebo) is planned. This will include additional endomyocardial biopsies taken at baseline and 12-months follow-up for high resolution respirometry (mitochondrial function) and electron microscopy (mitochondrial structure and interstitial fibrosis) supplemented by right heart catherization (RHC) for hemodynamic assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Scheduled TAVR for significant symptomatic AS according to current guidelines
3. Age ≥ 18 years and \< 85 years.
4. \*

   * LVEF ≥ 40% and ≤ 50 % or LVEF ≥ 50% with at least one of the following:
   * LV GLS ≤ 15% by TTE
   * LV septum or posterior wall thickness ≥ 12mm by TTE or LV mass index ≥108/131 g/m2 for females/males (mild LVH)
   * LVEF ≥ 50 % and Nt-proBNP \> 600/900 ng/l (sinus rhythm/atrial fibrillation)
5. eGFR \> 30 mL/min/1.73 m2

Exclusion Criteria:

1. Medically treated type 1 or type 2 diabetes mellitus
2. Ongoing treatment with an SGLT2-inhibitor or intolerance to SGLT2-inhibitors
3. Life expectancy \< 12 months
4. Symptomatic hypotension or persistent SBP \< 100 mmHg
5. Contraindications to CMRI
6. HF due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis or hypertrophic obstructive cardiomyopathy
7. Additional other untreated severe valvular disease
8. Liver failure
9. Women who are pregnant or plan to be within the study period.
10. Allergy to any substance in the project medicine, both placebo and active medicine.
11. Previous renal transplantation.
12. Chronic dialysis treatment.
Role of Non-invasive Mechanical Ventilation and Diuretics in Improving Weaning Outcome of Patients With High Lung Ultrasound Score

patients who succeeded in SBT with high lung scores by ultrasound, non-invasive ventilation, and diuretic may have a role.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 21 years of age
* mechanical ventilation for more than 48 hrs
* patients successfully passed according to the traditional weaning criteria
* lung ultrasound score ≥ 17.

Exclusion Criteria:

* Significant obstructive lung diseases
* Obstructive sleep apnea
* Interstitial lung disease
* Neuromuscular disorders