cyrilzakka/clinical-trials huggingface dataset:
A Study to Describe the Characteristics, Health Care Interventions and Outcomes of Patients With Major Bleedings in the Presence of Factor Xa Inhibitor Treatment

REVERXaL study aims to increase the understanding of the patient characteristics, bleeding presentation, health care interventions provided, and the clinical as well as self-reported health outcomes of patients with major bleeding in the presence of Factor Xa inhibitor treatment. The generation of insight on treatment approaches and associated outcomes in hospitalized patients with Factor Xa inhibitor-related major bleeds may inform clinical guidelines, health system decision making and streamline treatment pathways in this population.

REVERXaL is a multinational observational study incorporating 2 patient cohorts (historical and prospective) with major bleeds during Factor Xa inhibitor use. This study will be mainly descriptive in nature without any pre-specified statistical hypotheses. Variables will be collected according to routine medical practice either through primary data collection directly from patients, or from secondary data collection via data extraction from electronic or paper medical records into electronic case report forms (eCRFs). Patients will undergo clinical assessments and receive standard medical care as determined by their treating physicians. Patients will not receive any experimental disease management intervention or experimental treatment because of their participation in the study. As part of routine care, study investigators will evaluate patients about their medical history, medication history, bleeding presentation, and any adverse event (AE) or severe adverse event (SAE) experiences since the previous clinical visit and the related information. No additional or pre-defined site visits will be scheduled outside of the patient's routine clinical visits.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years on the index date
* Admitted to the hospital with an acute major bleeding or developed an acute bleeding while already in hospital
* Ongoing treatment with a Factor Xa inhibitor before the index date
* Provided signed and dated informed consent or able to obtain a waiver

In addition, for cohort B:

- Administered reversal or replacement therapy

Exclusion Criteria:

* Pregnant women
* Patients enrolled in any interventional trial that includes reversal/replacement agents

In addition, for cohort B:

* Use of vitamin K antagonists, dabigatran, prothrombin complex concentrates or recombinant factor VII, or transfusion of whole blood or plasma within the preceding 7 days of the index event
* As judged by the investigator, if it is deemed undesirable for the patient to participate in the study or participant is unlikely to comply with study procedures, and requirements
* Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
Contralateral Strength-training After Anterior Cruciate Ligament (ACL) Reconstruction

The main aims of the study are (1) to examine the impact of contralateral strength training on the quadriceps muscle function after ACL surgery and (2) to compare the magnitude of cross-education induced by NMES versus eccentric strength training.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for ACL reconstruction surgery

Exclusion Criteria:

* Concomitant lower limb injury or disorder
* previous lower extremity open surgery on the contralateral lower limb
* cardiac disease
* pregnancy
EMLA Topical Cream for Treatment of Pain in Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Skin Cancers

This phase II trial tests how well EMLA topical cream works in treating pain in patients with skin cancers receiving Technetium 99 injections for a lymphoscintigraphy mapping procedure. A lymphoscintigraphy mapping procedure is used to find the main or lead lymph node (tissue that fight infection) so it can be removed and checked for tumor cells. Using lymphoscintigraphy to highlight and then surgically remove lymph nodes is standard way to treat skin cancer for many patients. The Technetium 99 injections used for lymphoscintigraphy can be briefly painful due to the sensitivity of the nerve endings in the skin. The EMLA topical cream, which contains a numbing medicine to block pain from nerve endings, has been studied in breast cancer patients with a difference in pain reported, but this is the first time it has been studied in patients undergoing lymphoscintigraphy for skin cancer. This study may help researchers learn whether the use of EMLA cream may improve the associated pain at the time of the lymphoscintigraphy procedure.

PRIMARY OBJECTIVE:

I. Evaluate if the application of eutectic mixture of local anesthetics (EMLA) topical cream (2.5% lidocaine mixed with 2.5% prilocaine) prior to intra-dermal Technetium 99 sulfur colloid (Tc99 injection) for lymphoscintigraphy can improve associated pain.

OUTLINE: Patients are randomized to 1 of 2 cohorts.

COHORT 1: Patients apply EMLA cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure.

COHORT 2: Patients apply placebo cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure.

Eligibility Criteria:
Inclusion Criteria:

* Biologic males or females
* 18 - 99 years of age
* Histologically confirmed cutaneous melanoma, Merkel cell carcinoma, squamous cell carcinoma, or other cutaneous malignancy for which lymphoscintigraphy and sentinel lymph node biopsy has been recommended.

Exclusion Criteria:

* Known allergy or intolerance to EMLA cream, lidocaine, prilocaine, or any other local anesthetic
* History of adhesive allergy
* Contraindication to Tc99 injection for sentinel lymph node mapping
* Incarcerated patients
* Patients incapable of independently providing consent
* Mucosal or genital lymphoscintigraphy site
* Pregnancy
* Participant self-declared or Ohio State University (OSU) medical chart listing chronic pain as a pre-existing diagnosis
* Participants with chronic pain as defined by the Centers for Disease Control and Prevention (CDC):"pain lasting 3 months or more that can be caused by a disease or condition, injury, medical treatment, or unknown reason" excluding those with stable co-morbid conditions such as peripheral neuropathy, fibromyalgia, arthritis, and cancer-related pain who do not require narcotics. Patients who require narcotics at any time within the 7-day period leading up to the procedure
Evaluation of Cavernous Sinus Invasion by Pituitary Adenoma Using Deep Learning Based Denoising MR

Preoperative evaluation of cavernous sinus invasion by pituitary adenoma is critical for performing safe operation and deciding on surgical extent as well as for treatment success. Because of the small size of the pituitary gland and sellar fossa, determining the exact relationship between the pituitary adenoma and cavernous sinus can be challenging. Performing thin slice thickness MRI may be beneficial but is inevitably associated with increased noise level. By applying deep learning based denoising algorithm, diagnosis of cavernous sinus invasion by pituitary adenoma may be improved.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing preoperative brain MR for pituitary adenoma

Exclusion Criteria:

* Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulates, electronic infusion pumps, etc), because such devices may be displaced or malfunction
* Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
* Poor MRI image quality due to artifacts
Effectiveness of the Nicotine Patch in Suppressing Nicotine Withdrawal Symptoms in Women Versus Men - 1

Women typically have a more difficult time quitting smoking than men. Little research has been done to understand the differences between men and women that may cause this distinction. This study will assess whether the reduced effectiveness of nicotine replacement therapy in women is caused by gender differences in the withdrawal suppression induced by nicotine replacement therapy.

Smoking can cause a variety of cancers, cardiovascular disorders, and other health problems. Quitting smoking greatly decreases one's risk for these problems. Studies have shown, however, that quitting smoking is more difficult for women than men. Despite that knowledge, little research has been done to try to understand the mechanistic differences between men and women that may cause this distinction. This study will assess whether the reduced effectiveness of nicotine replacement therapy in women is caused by physical and psychological gender differences in the withdrawal suppression induced by nicotine replacement therapy.

Participants in this double-blind study will attend 4 treatment sessions, each approximately 6.5 hours long and each corresponding to one of four transdermal nicotine replacement patch doses (0, 7, 21, or 42 mg). Sessions will be separated by at least 48 hours to avoid carryover effects. Immediately following arrival at each session, participants' expired air carbon monoxide (CO) levels will be measured to verify that the participant has not smoked for at least 8 hours prior to the visit. If the CO level meets the necessary criteria to proceed, a baseline blood sample will be obtained, followed by additional blood samples every 30 minutes. Baseline nicotine withdrawal levels will be assessed using questionnaires. Computerized recordings of physiological responses will also commence and will continue throughout the session. These response measures will include heart rate, percent oxygen saturation, skin temperature, systolic and diastolic blood pressure, and mean arterial pressure. Upon completion of baseline measures, participants will receive a randomly assigned dose of nicotine replacement therapy, in the form of three patches placed on the participants' back. The patches will be removed after 6 hours and the participant will be assessed for any residual effects from the medication.

Eligibility Criteria:
Inclusion Criteria:

* Smokes at least 15 cigarettes a day for at least 2 years prior to enrollment
* Has an afternoon carbon monoxide level of at least 15 ppm
* Agree to use an effective form of contraception for the duration of the study

Exclusion Criteria:

* History of chronic health problems
* History of psychiatric conditions
* History of or active cardiovascular disease
* History of or active high or low blood pressure
* History of or active seizure condition
* History of or active peptic ulcers
* History of or active diabetes
* Pregnant
* Score of greater than 17 on the Beck Depression Inventory
Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant

A point-of-care bleeding management protocol based on global viscoelastic test (thromboelastometry) can change the amount of blood products used during orthotopic liver transplant.

Patients with liver disease frequently acquire a complex disorder of hemostasis secondary to their disease.

The fundamental key to the management of coagulopathy of cirrhotic patient is the knowledge that hepatic dysfunction results in impairment of both pro-hemostatic factors as anti-hemostatic factors in a disproportionate manner which can lead to a clinical picture of both bleeding and thrombosis.

Routine tests of coagulation as prothrombin time (PT, INR) and activated partial thromboplastin time (APTT) although prolonged in cirrhotic patients cannot predict bleeding.

Global viscoelastic test of whole blood (TEG / ROTEM) produce a dynamic composite image of the entire coagulation process and have the potential to provide clinically relevant information in patients with liver disease allowing rational use of blood products during liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

* all patients from the national list of liver transplant assigned to have their transplant in Hospital Israelita Albert Einstein who gave free and clarified consent term.

Exclusion Criteria:

* acute liver failure
* age under 18
* combined transplant
* re transplantation less than 30 days
* incomplete medical records, more than 20% of missing data.
Motivational Interview and Nomophobia

A preparation session and a motivational interview consisting of 4 sessions will be applied to nursing students. Data collection tools will be applied before, after and at 3 months.


Eligibility Criteria:
Inclusion Criteria:

* being over 18 years of age
* being a first-year nursing student
* agreeing to participate in the research

Exclusion Criteria:

* having problems understanding and speaking Turkish
* having visual or hearing impairment
* having a neuropsychiatric disease
Changes in Inflammatory Markers During Pulmonary Rehabilitation Based on Exacerbation States in COPD

This study will examine the inflammatory response to exercise encompassed as part of a standard pulmonary rehabilitation programme in patients with chronic obstructive pulmonary disease (COPD). Patients will be split into two groups, frequent exacerbators or infrequent exacerbators, dependent upon exacerbation history to compare responses to pulmonary rehabilitation amongst phenotypes.

Pulmonary rehabilitation has been proven to benefit COPD patients in terms of quality of life and functional capabilities. The effects of pulmonary rehabilitation (exercise) on immune function are unclear despite clear benefits of exercise on immune function in healthy individuals being identified. Moderate-intensity and frequency of exercise has been shown to decrease the risk of upper respiratory tract infections in healthy individuals in comparison to sedentary individuals. Respiratory infections, also known as exacerbations, in COPD are the main cause of hospitalisation and mortality. Therefore, if exercise can modulate immune function in COPD, it can be encouraged further in COPD to reduce hospitalisation risk. However, it is important to compare the effects of exercise amongst different phenotypes as frequent exacerbators are known to have elevated inflammatory markers, and may consequently respond to exercise differently to infrequent exacerbators, paving a rationale for a different approach to this subset of patients.

Eligibility Criteria:
Inclusion Criteria:

* 58 frequent exacerbators and 58 infrequent exacerbators (116 in total) who have been diagnosed with any severity of COPD (according to BTS criteria, i.e. \>10 pack year smoking history and post bronchodilator spirometry FEV1/FVC ratio \<0.70 and FEV\<80%).

Exclusion Criteria:

* Inability or unwillingness to sign informed consent
* Any unstable ongoing cardiovascular events which may be exacerbated by exercise
* Inability to complete walk tests due to physical or mental impairment
* Other active inflammatory conditions e.g. rheumatoid arthritis, cancer.
* Known asthma, allergic rhinitis or other respiratory disease (bronchiectasis, pulmonary fibrosis)

Healthy control group - Patients who have not been diagnosed with COPD or any other respiratory condition and are characteristically (age (between 45-85 years old) \& smoking status) matched to recruited COPD patients.
Socio-ecological Intervention to Promote Active Commuting to Work

Background Cycling and walking to work is a natural way of increasing physical activity in a working population. However, the evidence on the effectiveness and cost savings of promoting active work commuting (ACW) is thin. This cluster-randomized, controlled study aims to promote ACW with environmental, social and behavioral strategies in two large workplace areas in Tampere, Finland. The paper de-scribes the protocol, evaluation and baseline findings of the study.

Methods The enrollment of the workplaces took place in 2014-15. In Phase 1, the impacts of environmental strategies (improvements to the walking and cycling trails) were evaluated in Area1 including 11 workplaces. In Phase 2, five more workplaces were recruited from Area2 to evaluate the impacts of social and behavioral strategies accustomed for each workplace. The workplaces in both areas were then randomized into experimental (EXP, n=6+2) and comparison group (COM, n=5+3). EXP promoted ACW with social and behavioral strategies; COM participated in data collection only but will have the same support post-intervention. The primary outcome is the change in employees' self-reported and accelerometer-based ACW. The secondary outcomes include e.g. the changes in employees' self-rated health and subjective wellbeing at work, the change in the number of walkers and cyclists based on the traffic calculations and the change in the quality of walking and cycling trails based on camera auditing (Area1 only). External validity of the intervention is as-sessed with the compliance rates of the workplaces and employees as well as with the fidelity of the environmental, social and behavioral strategies. Health Economic Assessment Tool for Cycling and Walking (HEAT) is used to assess the cost savings of the multilevel intervention. In addition, environmental variables and types that promote ACW and mediate and moderate the effects of environmental strategies are examined.

Results and discussion This study is one of the first in Finland to combine interdisciplinary collaboration between practi-tioners and researchers working in the fields of transportation, urban design, physical activity and sustainable development to promote ACW. The findings benefit all stakeholders interested in pro-moting ACW in urban context. The study will also produce supportive material for promoting ACW at the workplaces.


Eligibility Criteria:
Inclusion Criteria:

All voluntary employees in the workplaces located in the specific area

Exclusion Criteria:

No exclusion criteria
The Influence of Needle Diameter on Post Dural Puncture Headache

The purpose of this study is to determine whether injection needle pen point type 'PP Gauge 25' should be recommended as a primary choice of needle (in stead of 'PP Gauge 27') for healthy pregnant women who at delivery (vaginal or cesarean section) get spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* healthy
* pregnant
* spinal anesthesia at delivery (vaginal delivery or cesarean section emergency grade 2-4)
* informed consent

Exclusion Criteria:

* chronic headache
* (attempt to) epidural anesthesia
A Mindfulness Mobile Intervention Targeting Reductions in Food Cravings

Participants will complete a 5-week smartphone app-based intervention that teaches mindful eating skills. One goal is to determine to what extent participants will enjoy using the app and complete the intervention. The investigators predict that after completing the intervention, participants will report fewer episodes of eating in response to food cravings. The investigators will also measure several other biological and behavioral outcomes.

In this prospective repeated-measures cohort study, participants will complete a 5-week smartphone app-based intervention that teaches mindful eating skills. The investigators will assess psychological and behavioral intervention targets using questionnaires and brief mobile assessments. The investigators will also measure BMI and adiposity. Assessments will occur at pre-intervention, post-intervention, and 1 and 2 months post intervention. At several times during the study, participants will also receive multiple daily text messages asking them to complete a brief food craving assessment on their phone. This "experience sampling" approach is critical as it allow the investigators to capture experiences and behaviors that are often brief and automatic, making them poorly suited to traditional retrospective questionnaires. The investigators will also assess acceptability and continued use of the app via anonymous usage logs.

Overall, the aims are to 1) assess feasibility of the protocol, 2) assess changes in food cravings and indulgence of cravings, and 3) determine the extent to which participants remain engaged with the app after completing the 5-week intervention period and whether this predicts maintenance of benefits at 1 month and 2 months post-intervention. An exploratory aim is to measure the effects of the intervention on body weight, bodyfat, and bodyfat distribution.

Eligibility Criteria:
Inclusion Criteria:

* Problems with controlling food intake as indexed by "yes" responses to the following two questions: "Do you have food cravings?" and "Do you eat in response to your food cravings more than you would like to?"
* Overweight or obese (BMI of 25.0 to 39.9 kg/m2)
* Score at or above the scale midpoint on the Readiness Ruler, a single-item visual analog scale measure of readiness for behavioral change (prompt is, "I have decided to give in to food cravings less")
* Have and use a smartphone (Android or iOS) with internet access.
* Report food cravings on most days and a desire to indulge in food cravings less

Exclusion Criteria:

* Current diabetes
* Pregnant or plans to become pregnant within 4 months
* Current diagnosis of anorexia or bulimia
* In the opinion of an investigator, meets any of the following criteria:

  1. Likely to drop out due to expressed ambivalence or lack of interest
  2. Likely to be harmed in any way by participating
  3. Likely to have provided untruthful answers to the screening questions (based on evidence such as unclear or inconsistent responses when talking to study staff vs. reporting online, or log data showing repeated attempts to "game" the screening questionnaire).