cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Sacral Foam Pad in Preventing Pressure Injury in Surgical Patients With Supine Position

In surgical patients, prevention of pressure injury is a challenge because of the high risk for multiple comorbid conditions, hemodynamic instability, and long duration of immobility.

The objectives of our study is to compare the difference in incidence rates of sacral pressure injury in surgical patients with supine position more than 3 hours between those treated with usual preventive care and a sacral foam pad versus a control group receiving usual care.

The incidence of pressure injury in surgical patients about 12% to 45%, though these patients were treated with "gel pad" as routine. Based on the nutritional status of patients, long-term surgery, surgical posture, and anesthesia-induced hypotension, pressure injury still occurred. Sacral foam pad (Mepilex(®) Border Sacrum) is an unique 5-layer design, was designed to protect sacral pressure injury. In this study, we enrolled surgical patients who need to supine over ≧ 3 hours to evalute the effectiveness of sacral foam pad in preventing sacral pressure injury. The patients will randomized to control and intervention groups, both groups recruited 105 patients. In control group, patients use gel pad during surgery; whereas patients use gel pad in addition to sacrum foam pad (Mepilex(®) Border Sacrum) in intervention group. After surgery, the occurrence and severity of sacral pressure injury was evaluated. The results of this study can provide evidence to improve the awareness of operating room medical staff on surgical pressure injury, and find out the risk factors in avoiding of pressure injury, and offer an effective strategy to enhance the quality of surgery throughout the perioperative care.

Eligibility Criteria:
Inclusion Criteria:

1.20-99 years old surgical patients who need to supine position over ≧ 3 hours 2.Patients have no any skin lesion.

Exclusion Criteria:

1. under 20 years
2. Patients have any skin lesion.
Verification of Shear Wave Elastography for DEtection of Prostate Cancer

1. Objective To provide evidence that adding shear wave elastography during sono-guided prostate biopsy can increase prostate cancer detection rate and to demonstrate that shear wave elastography of the prostate can discriminate malignant lesions to reduce the number of unnecessary prostate biopsies.
2. Overview Patients who are indicated for prostate biopsy in suspicion of prostate cancer will be assigned to a control group and an intervention group under double blinded randomization.

   * Control group : Patients will undergo prostate biopsy guided by conventional ultrasonography (B mode, gray scale).
   * Experimental group : Patients will undergo prostate biopsy guided by shear wave elastography in addition to conventional ultrasonography.

A comparative statistical analysis of the two groups will be performed.

The study is planned to be conducted for 3 years, with 2 years for patient enrollment and 1 year of follow-up. Three hospitals will participate in the study to enroll 85 patients for each group and a total of 170 patients.

3. Inclusion and Exclusion criteria

* Male patients with suspected prostate cancer must meet at least one of the following three criteria.

  1. PSA level over 4ng/dl
  2. Suspicious hard prostatic nodule on digital rectal examination.
  3. Hypoechoic lesion on ultrasound of the prostate suspicious for cancer.
* Patients who (1) are less than 20 years old, (2) have a history of surgery on the prostate such as HoLEP, (3) have moderate cognitive impairment, or (4) have medical conditions precluding transrectal procedures such as rectal cancer are excluded from the study.

  4. Research method
* Patients who wish to participate in this study and meet the inclusion/exclusion criteria are randomly assigned to the 2 groups as described above.
* The biopsy results are checked one week after the procedure.

  * Patients confirmed to have prostate cancer are provided proper treatment according to generally accepted treatment methods.
  * Patients with negative biopsy results are followed according to general follow-up protocol for suspected prostate cancer patients. After 6 months from the biopsy the patients are re-evaluated and if cancer is still suspected based on PSA level or other clinical symptoms, prostate MRI or additional biopsy is be performed.
* Patients are followed again after 12 months since the initial biopsy with identical methods from the 6 months follow-up protocol.


Eligibility Criteria:
Inclusion Criteria:

1. PSA level over 4ng/dl
2. Suspicious hard prostatic nodule on digital rectal examination.
3. Hypoechoic lesion on ultrasound of the prostate suspicious for cancer.

Exclusion Criteria:

1. Less than 20 years old
2. History of surgery on the prostate such as HoLEP
3. More than moderate cognitive impairment which limits understanding of the study
4. Medical conditions precluding transrectal procedures such as rectal cancer
PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study

The goal of this study is to investigate the feasibility and toxicity of using prostate-specific membrane antigen-positron emission tomography (PSMA-PET) and multi-parametric magnetic resonance imagining (mpMRI) with PET-MR technology to define radiotherapy targets, while meeting all the current planning criteria.

PSMA-PET is highly sensitive and specific for detecting prostate cancer. PSMA-PET and mpMRI can potentially help guide target volumes for patients with unfavorable-risk prostate cancer receiving radiation by designing a radiation treatment plan so that the entire prostate receives the prescribed dose of radiation in addition to the visible tumor in the prostate as detected by mpMRI and/or PSMA-PET receiving any inevitable intrinsic plan "hot spots" or areas of dose above the prescription.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
* Histologically confirmed prostate adenocarcinoma
* Unfavorable intermediate or high-risk, based on the National Comprehensive Cancer Network (NCCN) criteria, with appropriate staging (e.g. bone scan) as defined in the protocol.
* Subject has adequate performance status as defined by ECOG performance status of 0-2.
* Subject is willing and able to comply with the protocol as determined by the Treating Investigator.
* Subject speaks English (quality of life instrument is validated in English).

Exclusion Criteria:

* Contraindications for MRI
* Other prior or concomitant malignancies with the exception of:

  * Non-melanoma skin cancer
  * Other cancer for which the subject has been disease free for ≥5 years before the first study treatment and of low potential risk for recurrence.
* Inflammatory bowel disease
* Absolute contraindications to brachytherapy per American Brachytherapy Society: unacceptable operative risk, absence of rectum, large TURP defects
Safety and Efficacy of Three Different Loading Doses of Clopidogrel, in Patients With Acute Myocardial Infarction

The aim of this study is to determine both safety and effectiveness of three different loading dose regimens of clopidogrel in patients with acute myocardial infarction undergoing primary angioplasty.

This study will enroll STEMI patients, who were planned to undergo PCI, and will randomize them to three different clopidogrel loading dose regimens at first medical contact: no pre-treatment, 600 mg or 900 mg. Platelet activity after administration of clopidogrel will be evaluated by VerifyNow™ P2Y12 point-of-care system.

The study is powered to demonstrate significant differences in the primary end point (the rate of TIMI Myocardial Perfusion Grade=3).

Eligibility Criteria:
Inclusion Criteria:

* ST-elevation myocardial infarction:

  * chest pain lasting more than 30 minutes
  * not responsive to nitrates
  * ST-segment elevation of more than 0.1 mV in two or more leads on the ECG, or new Left Bundle Branch Block
* With indication to primary PCI, presenting within 12 hour from symptoms onset
* Age \> 18 years
* Planned PCI
* Informed Consent

Exclusion Criteria:

* bleeding diathesis
* allergy to study drugs
* pregnancy
* the performance of a rescue PCI after thrombolysis
* known existence of a disease resulting in a life expectancy of \<6 months
* lack of informed consent
Comparing the Sleep Strip OTC™ Accuracy in Screening for Sleep Apnea Syndrome Against the Reference Method, an In-lab Full Night Polysomnographic (PSG)

The primary purpose of this study is to demonstrate the equivalence of the new Sleep Strip OTC(TM) compared to the reference method of an in-lab, attended full-night polysomnographic (PSG) study.

A prospective, single center two phase study to evaluate the validity and the predictability of the SleepStrip OTCTM in screening for SAS, as compared to the reference method, an in-lab, full night, attended Polysomnographic (PSG) Study.

The study will consist of two phases:

I: Optimization Phase:will be performed at the Clinic; 20 participants will be enrolled. Each participant will be connected simultaneously to the SleepStrip OTC(TM) and to the standard lab sensors and recorder. This phase is intended to allow SLP to optimize the analysis parameters for optimal performance and will be considered as a pilot phase.

II: Equivalence phase: At least 180 participants will be enrolled. All participants will receive the SleepStrip OTC(TM) for a night test at home, before or after undergoing an independent PSG test at the Sleep lab. Out of 180 participants, at least 26 participants will receive two SleepStrip OTC(TM) devices for two consecutive night tests at home. The remaining participants will receive one SleepStrip OTC(TM) for one night test.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female participants, 18 years of age or older at time of enrollment.
* Participants who present at the Technion Sleep Disorder Center for a PSG test, and who are willing comply with study procedures.
* Participants who are willing to sign a Written.

Exclusion Criteria:

* Participant has a clinically significant untreated chronic disease which may unable him/ her to participate in the study.
* Participant has facial hair or any other skin problem that may hinder proper application of the device on destined facial area.
* Participant is suffering from a respiratory-track infection or a runny nose at enrollment.
* Participant is unable to comprehend the purpose of the study as stated in the participant consent form.
* Participant is unable to comply with the technical requirements of the study.
Zinc Status and Growth in Cystic Fibrosis

The purpose of this study is to improve the understanding of the relationship of zinc status and growth in infants and young children who were diagnosed with cystic fibrosis via newborn screening.

The objective of this study is to improve the understanding of the relationship of zinc (Zn) status and growth in infant and young people with cystic fibrosis (PWCF). The investigators hypothesize that Zn deficiency in infant and young PWCF is associated with poor growth.

Aim #2: To study the association between Zn levels in red blood cells and nutritional status in PWCF at 3 months to 3 years of age and compare it to the association between serum Zn and nutritional status in the same population. Hypothesis: Lower Zn levels in red blood cells is associated with poorer nutritional status in infant and young PWCF and is a better measure of Zn status compared to serum Zn.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients ages 3 months to 3 years with CF identified via new born screening

Exclusion Criteria:

* History of meconium ileus
* History of prematurity (born prior to completing 36 weeks 6 days gestation)
Early Diagnosis of Malignant Transformation of Pigmentary Skin Lesions

Malignant Melanoma is a deadly skin cancer that can be cured if diagnosed early. To date atypical pigmented skin lesions are diagnosed by appearance alone and many moles and lesions are excised unnecessarily and on the other hand malignant lesions are missed and diagnosed too late. In this study a protein conjugated to a florescent dye is spread on a suspicious pigmented lesion, the hypothesis is that this protein binds to malignant cells only and thus with a special camera that picks up the dye we can find pigmented lesions with early malignant transformation.


Eligibility Criteria:
Inclusion Criteria:

* pigmented lesion indicated for surgical excision
* over 18 years of age

Exclusion Criteria:

* pregnancy
The Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies

To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.


Eligibility Criteria:
Inclusion criteria Participation in study EPO906A2120E1

* Age ≥ 18 years of age
* Life expectancy ≥ 3 months
* Histologically documented advanced solid tumors which have progressed after standard systemic therapy or for which standard systemic therapy does not exist
* Completed all PK sampling in the core study

Exclusion criteria

* Known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis
* Female patients who are pregnant or breast feeding
* Patients with a severe and/or uncontrolled medical disease

Other protocol-defined inclusion/exclusion criteria may apply
A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels

Celsior® is an organ preservation solution used for the harvesting and the preservation of solid organs. Its use as a crystalloid cardioplegia solution has been established recently. Its main advantage is the long duration of myocardial protection. Compared to the other cardioplegia solutions, it allows a reduced amount of solution administered during the surgery and fewer interruptions during the intervention for the administration of supplemental doses of cardioplegia for long and complex operations.

The objective of this register is to compare the safety and the efficacy of Celsior® to the old cardioplegia solution Saint-Thomas used as cardioplegia solution in surgery of the transposition of great vessels, the arterial switch operation.


Eligibility Criteria:
Inclusion Criteria:

* Patient of neonatal age at the time of the intervention
* Patients with a transposition of the great vessels with intact septum and with the arterial switch operation performed as a corrective procedure
* CELSIOR® used as cardioplegia solution between 2012 and 2019
* Saint-Thomas used as cardioplegia solution (control group) between 2005 and 2011

Exclusion Criteria:

* Major cardiovascular malformations needing correction during the surgery for the transposition of great vessels including : interventricular communication, coarctation of the aorta, interruption of the aortic arch
* Significant anomalies of coronary arteries origin or paths including : intramural course, single coronary ostium
* Opposition to participate in this retrospective research
Evaluating ABX-EGF Extended Therapy in Subjects With MetastaticColorectal Cancer

The purpose of this study is to examine the safety of ABX-EGF administered as monotherapy in subjects with metastatic colorectal cancer who were previously randomized to best supportive care (BSC) in protocol 20020408 and subsequently determined to have progressive disease.


Eligibility Criteria:
Inclusion Criteria: - Subject previously randomized to BSC in protocol 20020408 and subsequently determined to have progressive disease - ECOG performance status of 0, 1 or 2 - Adequate hematologic, renal and hepatic function Exclusion Criteria: - Myocardial infarction in time interval between completing 20020408 and enrollment in study - History or evidence of interstitial pneumonitis or pulmonary fibrosis - Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics during the time interval between completing 20020408 protocol and enrollment in this study - Use of systemic chemotherapy or radiotherapy during the time interval between completing 20020408 protocol and enrollment in this study
Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus

Patients with newly diagnosed gestational diabetes will be recruited. The control group with get routine diet and exercise counseling. The intervention group will be instructed to get moderate-to-vigorous intensity exercise; they will walk on a treadmill one time with supervision in order to be instructed how hard to work. All participants will keep an exercise log for 3 weeks and will wear an accelerometer for 1 week. The primary outcome is glucose control, specifically the need for medication in treatment of their diabetes. The hypothesis is that moderate or greater intensity exercise will better control glucose and lead to less need for medication management.


Eligibility Criteria:
Inclusion Criteria:

* gestational diabetes mellitus
* singelton pregnancy
* 18 years old or older
* no medical contraindications to exercise

Exclusion Criteria:

* multiple gestation
* non-English speaking
* unable to exercise
* preexisting diabetes
Efficacy and Safety of Electroacupuncture and Acupuncture in Postmenopausal Women With Overactive Bladder

The purpose of this study is to verify the efficacy and safety of electroacupuncture treatment of postmenopausal women with overactive bladder (OAB).

The investigators targeted the patients of menopausal women with OAB. After treatment in 2 groups - electroacupuncture treatment and acupuncture treatment - the investigators will compare the improvement of the urinary symptoms and the quality of life, and further the best treatment method. In addition, the investigators are going to evaluate the safety of abnormal reaction during the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Women over 40 years of age without the possibility of pregnancy
2. Have a history of amenorrhea for at least 1 year and have no previous history of hormone replacement therapy for the last 6 months
3. With symptoms of urinary frequency and urgency lasting more than three months
4. Who fit the diagnostic criteria for OAB, with a total score more than three points in Korean version overactive bladder symptom score (OABSS)
5. Who have average urinary frequency of more than eight times per day and urgency which is defined as urgency rating scale (URS) on bladder diary is more than two points and/or UUI on 3-day bladder diary during one week screening period
6. Who agree to this clinical study after sufficient explanation

Exclusion Criteria:

1. Diag¬nosed with UTI by urine examination
2. With stress urinary incontinence without symptoms of OAB
3. With suspected of having voiding dys¬function induced by neurological damage
4. With a medical history of cystocele, uterine pro¬lapse or similar
5. With a medical history of obstructive uropathy such as urinary stones and urinary tumors
6. With a surgical history of urethra or bladder
7. With a medical history of malignant tumors of urinary tract
8. With a medical history of neurologic disease or psychi¬atric illness
9. Have an artificial cardiac pacemaker or implantable cardioverter defibrillator in the chest
10. Have experienced a hypersensitivity reaction after an acupuncture treatment, or show any other contraindications;
11. Who participated in another clinical trial within the past three months
12. Who have taken therapeutic drugs that may affect blad¬der function within one month of the start of this study
13. With inadequate literacy to complete study documents
Stem Cell Transplantation for Fanconi Anemia

The purpose of this study is to determine whether thymic shielding during total body irradiation can be given and whether it will reduce the risk of infections in Fanconi Anemia patients undergoing alternate donor (not a matched sibling) stem cell transplants.

All subjects will be given the same treatment regimen of total body irradiation (TBI), Fludarabine, Cyclophosphamide, and anti-thymocyte globulin (ATG), followed by an alternate donor stem cell transplant. Since this treatment regimen has been given before, without thymic shielding, we will compare the outcomes of these patients with the historical data from subjects who did not receive thymic shielding.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be less than (\<) 18 years of age with a diagnosis of Fanconi anemia.
* Patients must have an HLA-A, B, DRB1 identical unrelated donor or less than or equal to (≤)1 antigen mismatched related (non-HLA-matched sibling) or \<1 antigen mismatched unrelated UCB donor. Patients and donors will be typed for HLA-A and B using serological or molecular techniques and for DRB1 using high resolution molecular typing.
* Patients with FA must have aplastic anemia (AA), myelodysplastic syndrome without excess blasts, or high risk genotype as defined below.

  * Aplastic anemia is defined as having at least one of the following when not receiving growth factors or transfusions
  * Platelet count \<20 x 10\^9/L
  * ANC \<5 x 10\^8/L
  * Hgb \<8 g/dL
  * Myelodysplastic syndrome with multilineage dysplasia with or without chromosomal anomalies
  * High risk genotype (e.g. IVS-4 or exon 14 FANCC mutations, or BRCA1 or 2 mutations)
* Adequate major organ function including

  * Cardiac: ejection fraction greater than (\>)45%
  * Hepatic: bilirubin, AST/ALT, ALP \<2 x normal
  * Karnofsky performance status \>70% or Lansky performance status \>50%
* Women of child-bearing age must be using adequate birth control and have a negative pregnancy test

Exclusion Criteria:

* Available HLA-genotypically identical related donor
* History of gram negative sepsis or systemic fungal infection (proven or suspected based on radiographic studies)
* Refractory anemia with excess blasts, or leukemia
* Active central nervous system (CNS) leukemia at time of hematopoietic cell transplant (HCT)
* History of squamous cell carcinoma of the head/neck/cervix within 2 years of HCT
* Pregnant or lactating female
* Prior radiation therapy preventing use of total body irradiation (TBI) 450 centigray (cGy)