cyrilzakka/clinical-trials huggingface dataset:
Delayed Cold-Stored Platelets -PLTS-1

PLTS-1 is a multicentre, randomized, controlled, pilot trial, using a conventional, parallel group, two-armed design at 2 cardiac surgery centres in Canada. The study is designed to assess the feasibility of a future, definitive RCT to determine the non-inferiority of cold-stored platelets compared to conventional platelets with respect to hemostatic effectiveness (total number of allogeneic blood products transfused within 24 hours after CPB), as well as safety.


Eligibility Criteria:
Inclusion Criteria:

Adult (≥18 years old) patients undergoing elective cardiac surgery with CPB will be eligible for inclusion if they are planned to undergo at least moderately complex surgery or have a preoperative platelet count ≤150,000 x106/L (this is a group at high risk of requiring platelet transfusions post-CPB).

Moderately complex index surgery is defined as:

1. repair/replacement of more than one valve;
2. aorta (root/ascending/arch) replacement;
3. any combination of coronary artery bypass grafting, valve repair/replacement, or aorta (root/ascending/arch) replacement; or
4. re-do procedures consisting of a repair or revision of a prior cardiac intervention.

Exclusion Criteria:

Patients will be excluded if cold-stored platelets are not going to be available at the time of surgery or if the patient:

1. has a congenital or acquired hemostatic disorder (including platelet refractoriness due to anti-platelet and anti-human leukocyte antigen \[HLA\] antibodies) and/or requires specially matched platelets (including patients with anaphylaxis to blood due to Immunoglobulin A \[IgA\] deficiency),
2. has known contraindications to heparin, thereby excluding cases where non-reversible anticoagulants (i.e. argatroban) are used,
3. is on warfarin or direct oral anticoagulants (dabigatran, rivaroxaban, apixaban or edoxaban) within 3 days prior to surgery,
4. is on antiplatelet drugs within 5 days prior to surgery (excluding acetylsalicylic acid \[ASA\]),
5. refuses allogeneic blood products,
6. has a known pregnancy,
7. has already enrolled in this study,
8. is enrolled in another interventional clinical trial where routine care and management are altered,
9. has hemodynamic instability defined as critical care admission, vasopressor, or inotrope dependence prior to index surgery, or
10. has pre-operative requirement for, or expected post-operative dependence upon mechanical circulatory support (i.e., intra-aortic balloon pump, ventricular assist device).
Effect of Semi-recumbent Position on Treatment of Shoulder Pain Seen After Laparoscopic Cholecystectomy

This study was carried out to determine the effect of placing the semi-recumbent position in reducing pain in patients who developed shoulder pain after laparoscopic cholecystectomy.

HO: The application of the semi-recumbent position to patients who develop shoulder pain after laparoscopic cholecystectomy has no effect on reducing pain.

H1: The application of semi-recumbent position in patients who develop shoulder pain after laparoscopic cholecystectomy has an effect on reducing pain.

In addition to pharmacological interventions for the relief of postoperative complications such as pain in patients undergoing laparoscopic cholecystectomy, non-pharmacological applications; It is evaluated that it will be beneficial in increasing patient satisfaction, reducing the need for analgesic drugs, reducing the cost of hospitalization due to the side effects of drugs and increasing the quality of care. With the results of this research, it is evaluated that the effect of positioning, which is one of the independent activities of nurses who base their care on evidence-based practices, on pain will be beneficial to increase the evidence-based nursing knowledge in the literature.

Eligibility Criteria:
Inclusion Criteria:

* Those who had surgery with laparoscopic cholecystectomy
* Those between the ages of 18-65,
* Patients in ASA I-II group
* Patients undergoing general anesthesia

Exclusion Criteria:

* Epidural analgesia after surgery
* Patients with reactive airway diseases such as chronic obstructive pulmonary disease (COPD), Bronchitis, Emphysema
* Conversion to open abdominal surgery during laparoscopic cholecystectomy
The TELENEO Trial: a Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals

The purpose of this study is to evaluate the impact of real-time audio-video telemedicine consults with a neonatologist (termed teleneonatology) on the early health outcomes of at-risk neonates delivered in community hospitals.

This prospective, multicenter trial will use a stepped wedge cluster randomized study design to evaluate the impact of real-time audio-video telemedicine consults with a neonatologist (termed "teleneonatology") on the risk of early mortality, early morbidity, and delivery room care for at-risk neonates delivered in community hospitals.

Eligibility Criteria:
Inclusion Criteria:

GROUP 1: Community hospital clinicians

To be eligible to participate in this study, an individual must meet all of the following criteria:

1. A clinician who attends newborn resuscitations at a participating community hospital spoke site.
2. Provision of informed oral consent prior to any mandatory study specific procedures and analyses.

GROUP 2: At-risk outborn neonates To be eligible for this study, a neonate born in a participating community hospital spoke site must meet \*at least one\* of the following inclusion criteria

1. Preterm birth at less than 32 weeks' gestation at delivery; OR
2. Need for advanced resuscitation defined as:

   1. positive pressure ventilation (PPV) initiated soon after birth and continued for at least 10 minutes; OR
   2. placement of an alternative airway (endotracheal tube or laryngeal mask) to provide PPV; OR
   3. chest compressions.

Exclusion Criteria:

GROUP 1: Community hospital clinicians None

GROUP 2: At-risk outborn neonates

A neonate born in a participating community hospital spoke site who meets any of the following criteria will be excluded from the study:

1. Birth outside of the hospital birthing center.
2. Neonatal transport team present at time of birth and providing resuscitative care.
3. Severe congenital anomaly necessitating intensive care or surgery in the first two weeks of life.
4. Plan for comfort care (non-resuscitation) following delivery.
5. In-person neonatology-trained physician present for the resuscitation.
Effects of a Low Glycemic Load Diet on Fatty Liver in Children

There has been a recent increase in incidence of obesity and its associated morbidities, including T2 DM, hypertension and hepatic steatosis. Hepatic steatosis is a precursor to non-alcoholic steatohepatitis, cirrhosis and end-stage liver disease. The 1st reported case of pediatric hepatic steatosis was in 1980 and it is now affects 30-77% of overweight children. In addition to its association with obesity, hepatic steatosis has been associated with the metabolic syndrome, insulin resistance, and post-prandial hyperglycemia. Current treatment of hepatic steatosis includes weight loss with a hypocaloric low fat diet. Given the association with insulin resistance and post-prandial hyperglycemia, adult patients with hepatic steatosis that does not respond to weight loss are placed on insulin sensitizing drugs. We hypothesize that weight loss with a diet designed to decrease insulin resistance and post-prandial hyperglycemia, a low glycemic load diet, will provide a safe and effective way to decrease hepatic fat content in the pediatric population. This hypothesis will be tested with a randomized control trial comparing the effect of a low fat diet with a low glycemic load diet.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>95th percentile for age and sex
* Weight \<300 pounds
* Ability to lie quietly in the MRI for approximately 45 minutes
* Willing and able to attend all sessions.
* Working telephone
* Greater than or equal to 10% hepatic steatosis on nMR spectroscopy

Exclusion Criteria:

* Any other medical condition besides obesity that may predispose to liver disease
* Medications that affect liver metabolism
* Any causes of chronic hepatitis
* Diabetes
* Inability to adhere to prescribed diets
* Currently on high-dose vitamins and not willing to discontinue
* Weight loss/gain in the past 6 months of \>10% of total body weight.
* Sibling of any subject who is already enrolled
* Any alcohol consumption
Adjuvant Protontherapy of Cervical and Endometrial Carcinomas

The APROVE study is a prospective single-center single-arm phase-II study. Patients with cervical or endometrial cancer after surgical resection who have an indication for postoperative pelvic radiotherapy will be treated with proton therapy instead of the commonly used photon radiation. A total of 25 patients will be included in this trial. Patients will receive a dose of 45-50.4 Gray in 1.8 Gray fractions 5-6 times per week using active raster-scanning pencil beam proton radiation. Platinum-based chemotherapy can be administered if indicated. The primary endpoint of the study is the evaluation of safety and treatment tolerability of pelvic radiation using protons defined as the lack of any CTC AE Grade 3 or 4 toxicity. Secondary endpoints are clinical symptoms and toxicity, quality of life and progression-free survival. The aim is to explore the potential of proton therapy as a new method for adjuvant pelvic radiotherapy to decrease the dose to the bowel, rectum and bladder thus reducing acute and chronic toxicity and improving quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed cervical or endometrial cancer
* Indication for postoperative radiotherapy
* Karnofsky Index ≥ 70
* Age between 18 and 80 years
* Written informed consent

Exclusion Criteria:

* patient refusal or patient incapable of consent
* implanted active medical devices with no approval for ion beam radiation
* metallic implantations in the radiation field like hip prothesis
* prior pelvic irradiation
* participation in another clinical trial which might influence the results of the APROVE trial
A Pilot Feasibility Study of Fibroblast Calcium and Glucoregulation in Health and Disease

The purpose of this research is to better understand how calcium and glucose may play a role in people developing diabetes. By doing this study, the investigator hopes to learn whether abnormal calcium and glucose responses in skin biopsies from healthy patients and patients with Type 2 diabetes can identify and predict patients at greatest risk for later complications.

The overall goal of this proposal is to establish a pathophysiological index of a patient's status through imaging of calcium and glucose in skin fibroblasts. The investigator will obtain skin samples from patients in the Barnstable Brown Obesity and Diabetes Center at the University of Kentucky to test the hypothesis that calcium and glucose dysregulation are present in fibroblasts from patients with Type 2 diabetes, and are exaggerated in more difficult-to-treat patients or those with poor glucose control. The innovation of the project focuses on results that can potentially lead to earlier treatment for patients with diabetes and thereby reduce the risk for long-term complications.

Three levels of analyses will be conducted to assess the relationship between Ca2+ and glucose homeostasis in four patient groups (lean non-diabetics, obese non-diabetics, Type 2 Diabetics with good glucose control, and Type 2 Diabetics with poor control.

Participants will be required to attend only one study visit that will last approximately 2-3 hours. During the study subject will undergo the following: 1. Collection of two 4 ml tubes of blood for adiponectin analysis, 2. A skin biopsy, 3. Collection and review of medical history and current/past medication use 4. Collection of demographic information, 5. Height and weight measurement 6. Body mass index evaluation, 7. Vital signs assessment (blood pressure, pulse).

Follow-up for all enrolled patients will occur on a yearly basis through a phone interview.

The punch biopsy will be performed under local anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Type 2 Diabetes

Exclusion Criteria:

* Under 40 years of age
* Over 55 years of age
* Pregnant or breastfeedig
* Will not agree to a skin biopsy
* Talking calcium channel blockers
Dual Energy Computed Tomography (CT) in Finding Bone Metastases in Patients With Cancer

This clinical trial studies dual energy computed tomography (CT) in finding cancer that has spread from the original (primary) tumor to the bone (bone metastases) in patients with cancer. Diagnostic procedures, such as dual energy CT, may help find and diagnose bone metastases and may be more accurate compared to single energy CT alone.

PRIMARY OBJECTIVES:

I. Compare the accuracy of single energy CT (SECT) with virtual non-calcium (VNC) double energy CT (DECT) to standard SECT alone in the detection of metastatic bone lesions using positron emission tomography (PET)-CT as the reference standard.

OUTLINE:

Computed tomography (CT) scans are routinely used in the evaluation of oncologic patients for initial diagnosis and subsequent disease staging. Detection of bone metastasis on standard CT, however, is limited in sensitivity, particularly in case of osteolytic intramedullary lesions. Recent studies have shown the ability to detect bone marrow edema using CT with the use of a virtual non-calcium (VNC) dual energy CT (DECT) technique. Because bone marrow edema is similar in composition to intramedullary bone metastases (i.e. both are of soft tissue composition as opposed to calcium or fat), VNC DECT may also be helpful in the detection of bone marrow metastasis. Cancer patients obtaining a Positron Emission Tomography (PET) CT and a separate diagnostic CT scan as part of their routine clinical care will be enrolled into the study. The diagnostic CT scan will be performed on a DECT scanner and the images will be reconstructed as SECT images for routine clinical interpretation as well as VNC DECT images. The SECT images alone will be evaluated and scored, and then the VNC DECT images will be added to the SECT images for a second evaluation (consecutive reading session). Multiple readers blinded to the PET-CT findings for detection of bony metastatic disease will participate.

Researchers hypothesize the addition of VNC DECT to SECT will be more accurate in the detection of metastatic bone marrow lesions compared to SECT alone.

Eligibility Criteria:
Inclusion Criteria:

* Patients being imaged with PET/CT for diagnosis and/or staging of disease at Case Comprehensive Cancer Center
* Patients with bone metastases on PET/CT
* Patients without bone metastases on PET/CT
* All cancer types and both newly diagnosed and previously treated patients will be included

Exclusion Criteria:

* Patients with intervening treatment during the time between diagnostic CT and PET/CT
* Time between the diagnostic CT and PET/CT greater than 30 days
Nicotinic Acid Composition of HDL and Arterial Endothelium Function in Premature Coronary Heart Disease and High HDL

Patients with premature ischemic heart disease (PIHD) and elevated levels of HDL-C present an altered composition of high-density lipoproteins (HDL) which is associated with a loss of their anti-atherogenic effects and of their arterial endothelium function.

Objectives: To analyse if the treatment with nicotinic acid (NA)/Laropiprant can correct the alterations of the HDL composition and endothelial function in patients with PIHD and elevated HDL-C.

Methods: A total of 46 subjects with PIHD who are stable in the 3 months prior to the Study, who continue in treatment with statins and have elevated concentrations of HDL-C (HDL-C ≥2.0mmol/L in females and ≥1.8mmol/L in males) and an LDL-C \<100mg/dL. This is a double-blind, randomised Study; after 6 weeks of lifestyle stabilisation, the subjects will be treated with NA or placebo for 16 weeks. At the start and end of treatment, HDL composition will be studied through density gradient preparative ultracentrifuge separation and FBLC (fast protein liquid chromatography) and through the changes in vasodilation induced by the endothelium through ultrasound. Primary endpoint: change in the apoA1 content associated to treatment. Secondary endpoints: variations in the change of the brachial artery diameter with reactive hyperaemia and changes in the content of other lipid and protein components of HDL including apoA2, paraoxonase, amyloid A and LCAT. The changes in HDL composition and endothelial function will be assessed with an analysis of variance with repeated measurements and a 2x2 design.


Eligibility Criteria:
Inclusion Criteria:

* Being male or female
* Age \> 25 years
* Have an episode of ischemic heart disease before 55 years in men and in women 65 years
* Serum HDL-C above the 90th percentile of the Spanish population: \>=2.0mmol/L in women and \>=1.8mmol/L in men (Gomez-Gerique JA, et al. Med Clin (Barc.). 1999, 113: 730-735.)
* Stable treatment with any statin in the past 6 weeks: simvastatin, atorvastatin, rosuvastatin, pravastatin or lovastatin.

Exclusion Criteria:

* Uncontrolled hypercholesterolemia or hypertriglyceridemia, LDL-C \>2.6mmol/L or triglycerides \>2.24mmol/L
* Patients with an episode of ischemic heart disease in the last 3 months
* Patients suffering from acute or chronic inflammatory diseases in the last 3 months
* Treatment with fibrates or omega-3 fatty acids.
* Treatment with steroids or immunosuppressive drugs
* Patients with a contraindication to Tredaptive (Hypersensitivity to the active substances or any of the excipients, significant or unexplained hepatic dysfunction, active peptic ulcer, arterial bleeding).
* Patients treated with drugs that may interact with Tredaptive (Midazolam).
Multi-site Decision Impact Study for Decipher

This prospectively designed retrospective clinical utility study will evaluate urologists' treatment recommendations before and after reviewing Decipher results for selected patient cases.

The clinical utility of Decipher will be evaluated at two time-points:

1. Post RP - within 6 months after surgery
2. PSA rise - defined as PSA detectable and rising on 2 or more subsequent determinations

Patient cases will be retrospectively selected from at least 5 sites. Participating urologists at each site will be asked to each identify a minimum of 10 to a maximum of 50 suitable cases retrospectively. The resulting cases will then be de-identified, aggregated and evenly randomly distributed among the participating urologists via a secure on-line survey platform . All study participants (ie: urologists) will be masked to the original actual treatment decision and patient outcome.

The design of this study is such that any participating urologist may or may not review a patient originating from their own clinical practice, but will not review a case they themselves identified. Patient cases will be de-identified and randomized amongst participating urologists . By the retrospective nature of this study, cases may be several years post-RP. It is not expected that that participation in this study will have any impact on actual clinical management of patients.

Participants will be asked to complete two web-based electronic Case Report Questionnaires (eCRQ):

1. Pre-Decipher: will collect information on their recommended treatment decision and their decision confidence based on the de-identified clinical and pathological information provided for each patient case.
2. Post-Decipher: will collect their treatment recommendation and decision confidence for each de-identified patient case in the presence of the Decipher test results.

Eligibility Criteria:
Inclusion Criteria:

Patient cases eligible for this study were treated with radical prostatectomy and have one or more adverse features present as defined by AUA and NCCN guidelines:

* Pathological T3 stage of disease (i.e., ECE or SVI)
* Positive surgical margins, or
* Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent determinations

Exclusion Criteria:

1. Metastatic Disease (M+) prior to surgery
2. Failure of PSA to nadir after surgery
3. Received any neo-adjuvant prostate cancer treatment before radical prostatectomy
4. Received any adjuvant chemotherapy
5. Required patient clinical data (Section 5.3) is not available for evaluation of eligibility criteria
6. Lack of documented treatment or management recommendation on file
7. Tissue specimen is inadequate for sampling and analysis
Ankle Athletic Taping Fatigue After a Standard Tennis Warm up

Identify, quantify and compare the fatigue caused in two ankle athletic tapes after the completion of a tennis warm-up.


Eligibility Criteria:
Inclusion Criteria:

* There have been no ankle injury in the last 6 months (defined as any problem ankle injury that limited normal activity for more than 48 hours).
* Not having any neurological, circulatory or degenerative disease or to upset the balance in the lower limbs.
* Not having had any fractures or have undergone surgery on the lower limbs.
* No experience pain in the ankle at the time of the study.

Exclusion Criteria:

* Allergy to any of the materials used bandage
* Suffer an injury before taking the last measurement that prevented them from developing their sport normally.
Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy

This study was a single-arm, multi-center, prospective, phase 3 trial aimed to evaluate the efficacy and safety of icotinib in patients with locally advanced or metastatic NSCLC after failure of at least one platinum-based chemotherapy regimen.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced/metastatic (stage IIIB/stage IV, using the American Joint Committee on Cancer \[AJCC\] 6th edition of tumor-node-metastasis \[TNM\] staging system) NSCLC patients
* Progressed after at least one platinum-based chemotherapy regimen at entry
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* At least one measurable lesion by Response Evaluation Criteria in Solid Tumors version 1.0
* Adequate hematologic and biochemical values

Exclusion Criteria:

* Patients with symptomatic brain metastases
* Malignant tumor within the previous five years
* Severe infection; congestive heart failure
* Previous treatment with drugs targeting EGFR
* History of interstitial lung disease
ILF With/Without Cisplatin for Advanced Gastric Cancer

To compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.

Irinotecan, in combination with 5-FU or cisplatin, clearly demonstrated efficacy against gastric cancer. A previous randomized study of ILF regimen versus IP in patients with AGC showed that the ILF produced an overall response rate of 42% and a median survival of 10.7 months, which were significantly better than the results with IP regimen \[Pozzo C, et al. Ann Oncol 2004\]. However, since cisplatin is still considered one of the key drugs for the treatment of gastric cancer, a combination of these four drugs (irinotecan, leucovorin, FU and cisplatin) seemed to be a promising strategy for advanced AGC. We desinged this randomized phase II study to compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven gastric adenocarcinoma
* Advanced, metastatic or recurrent
* ECOG performance status 0 to 2
* No prior chemotherapy
* Measurable or evaluable indicator lesion(s)
* Normal marrow, hepatic and renal functions
* Provision of written informed consent

Exclusion Criteria:

* Active infection, bleeding or severe comorbidities
* Pregnant or breastfed women
* Active CNS metastasis