cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of the HF-ACP Website Study

This study evaluates the effectiveness of an interactive website on advance care planning for patients living with heart failure (HF-ACP website). The investigators will randomize patients to either the HF-ACP website or usual care to determine if the participants who use the HF-ACP website have higher advance care planning completion rates than participants assigned to usual care.

Advance care planning is a process that supports adults at any age or stage of health to understand and share their personal values, life goals and preferences in order to prepare for future decisions regarding medical care. Public awareness campaigns to promote ACP have been taking place for about 10 years without significant improvements in ACP completion rates. Content intended for use by the general public may be too vague for those living with a chronic illness. Framing ACP within the context of a specific disease may provide the impetus for a person to engage in ACP. The investigators believe the HF-ACP website will improve patient understanding of the life-limiting nature of HF, the ACP process and the need to plan ahead to help ensure the care they receive matches their treatment preferences.

Eligibility Criteria:
Inclusion Criteria:

* over the age of 18,
* a regular patient in our clinic,
* able to read and write English,
* familiar with the use and have access to a personal computer, email and the internet.

Exclusion Criteria:

* ineligible for participation in the trial if they do not meet the inclusion criteria described above.
Surgeons' Mental Distress and Risks After Severe Complications Following Emergency Surgery

Surgeons experience higher levels of work stress, even under normal circumstances. Many can suffer from substantial levels of mental health issues, especially when faced with severe complications. However, due to a variety of reasons, many surgeons are reluctant to disclose mental health issues or seek psychological help.

Patients in need of emergency surgery are usually characterized by critical conditions and high surgical risks. Emergency surgeons always do not have enough time to clearly explain the ins and outs of the disease to the family members of the patients, only tell the key issues and risks that need to be paid attention to during the operation. The tone of the explanation maybe direct and blunt, which also could cause the incomprehension and dissatisfaction of the patients and their families. Due to the lack of communication, although the patient is in critical condition, the family members always think that the disease should be cured after arriving at the hospital. Therefore, once severe complications occur after the operation, the family members often find it difficult to accept the reality. This is also one of the important reasons for medical disputes in emergency surgery.

In addition to delaying patients' recovery courses, severe complications also place enormous pressure on chief surgeons who performed the operations. Such pressures may bring great risks of psychological distress. Surgeons are also the victims when they encounter severe complications following emergency surgery. Their mental distress should not be minimized. Until now, little has been known about the effects of surgical complications on surgeons. In the current study, based on a large-scale questionnaire survey in China, the investigators aimed to investigate incidences of surgeons' mental distress following severe complications after emergency surgery. The investigators also aimed to identify independent risk factors which could help develop strategies to improve the mental well-being of these surgeons after such incidences.


Eligibility Criteria:
Inclusion Criteria:

* Emergency surgeons who experienced severe complications after Emergency Surgery.

Exclusion Criteria:

* Other conditions that do not meet the inclusion criteria.
Aqualase Versus Torsional ip. A Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity

Objective of this study is the comparative assessment of the impact of torsional and liquefaction technologies on endothelial cells (ECC), corneal edema (CCT) and corneal sensitivity (CCS) in a sample of cataract patients.

Participants were recruited from the Cataract Service of the UHA in a consecutive-if-eligible basis. Eligibility criteria included diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale \[10\]. By means of a custom computer randomization program all participants randomly populated two study groups according to the cataract-extraction technology used: a) Torsional group (TG) and b) Liquefaction group (LG).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale

Exclusion Criteria:

* Endothelial cell count less than 1900,
* glaucoma,
* IOP-lowering medications,
* former incisional surgery,
* former diagnosis of corneal disease,
* diabetes or autoimmune diseases
Project Impact: An Innovative Approach to Weight Loss Maintenance

The major goal of this project is to evaluate an innovative approach to obesity. This study will determine if behavioral treatment can be improved by 1) implementing a primary focus on PA following initial weight loss treatment, and 2) using a novel, acceptance-based approach to the promotion of PA.

Most adults who engage in lifestyle modification find it difficult to maintain a high level of PA over the long-term, and most also find that weight regain is inevitable. The current portfolio of available interventions does not adequately address these challenges. This project is designed to test the effectiveness of an intervention that is specifically designed to enhance the ability to maintain, in the long-term, a level of PA high enough to achieve long-term weight loss maintenance.

In the study, 300 obese adults will be recruited from the community and provided with 6 months of group-based, standard behavioral treatment for induction of weight loss (Phase I). A 6-month Phase I was chosen so that all participants will have sufficient time to accomplish initial weight loss before Phase II begins, allowing Phase II to truly be a test of weight loss maintenance. In Phase II, participants will receive one of three interventions, to be delivered for an additional 12 months: 1) behavioral treatment, with the standard emphasis on maintaining changes in diet and PA (BT), 2) behavioral treatment, with a primary emphasis on using these skills to maintain PA (BT-PA), or 3) acceptance-based behavioral treatment, with a primary emphasis on using these skills to maintain PA (ABT-PA).

Assessments will be conducted at baseline, 6 months, 18 months (end of treatment), 24 months (6-month follow-up), and 36 months (18-month follow-up).

Eligibility Criteria:
Inclusion Criteria:

* Have a BMI between 27 and 45 kg/m2
* Have the ability to engage in at least 15 minutes of moderate physical activity (e.g. brisk walking)
* Successfully complete all steps in the enrollment process, including attendance at all pre-randomization clinic visits and providing physician clearance

Exclusion Criteria:

* Have a medical condition that prevents safe engagement in moderate-to-vigorous physical activity
* Are lactating, pregnant, or planning to become pregnant in the next three years
* Report recently beginning a course of or changing the dosage of prescription medications that can cause significant weight loss or weight gain
* Are participating in or plan to participate in another weight loss program in the next three years
* Have a primary family member or member of their household participating in the study
Using the Active Breathing Control Device to Reduce Radiation Side Effects to Critical Structures in Breast Cancer

The purpose of this study is to evaluate the use of a device that helps coordinate the breathing cycle in the radiation treatment of the breast in order to minimize the radiation dose to the normal structures around the breast.

The Active Breathing Coordinator (ABC) allows for temporary and reproducible immobilization of internal thoracic structures by monitoring the patient's breathing cycle and implementing a breath hold at a predefined lung volume level. While ABC is FDA approved and commercially available, only preliminary dosimetric data is available on a small number of patients with breast cancer. There is some data using ABC for intrathoracic malignancies, which shows that it is feasible and safe to use. ABC can be used to optimize the distance between chest wall, heart and liver. This allows adequate treatment of the breast and underlying chest wall while minimizing irradiated cardiac and liver volume.

Eligibility Criteria:
Inclusion Criteria:

* Requiring adjuvant or post mastectomy radiation therapy with tangential fields or 3-fields
* Adequate pulmonary function
* Presence of 5 cc of the heart or liver with the simulation fields
* Karnofsky Performance Status (KPS) equal to or greater than 70

Exclusion Criteria:

* Pregnant women
* Patients who have had previous ipsilateral breast or thoracic radiation therapy
Nosocomial Influenza Surveillance 2018 - 2022

Hospital-acquired influenza is associated with significant morbidity and mortality in hospitalized patients notably elderly patients. Furthermore, it is also associated with a large economic impact for the hospitals.

The transmission of influenza has been mostly reported in pediatric and long-stay units. The chains of transmission of influenza in acute-stay units have to be describe in order to prevent and control potential outbreaks. Furthermore, to know clinical symptoms seems to be important in order to identify potential sources of virus as soon as possible and to set up appropriate hygiene prevention measures. Moreover, the definition of the hospital-acquired influenza has to be harmonized for all over the studies, especially concerning the delay between the admission in the hospital and the symptoms onset.

The aim of this study is to describe the hospital-acquired influenza in a french university hospital of around 800 beds


Eligibility Criteria:
Inclusion Criteria:

* Adult patients and health-care workers in a participating unit in the study,
* more than 18 years old,
* volunteers,
* who present an influenza-like illness defined by fever \> 37,8°C or/and cough or sore throat.

Exclusion Criteria:

-Everyone who does not present the inclusion criteria.
Biological and Psychological Health Effect of Ramadan Study

This observational study collects data on blood neurotransmitter and neuromodulator levels of subjects observing Ramadan. Additional information collected are a diet record, mood and perceived stress using validated surveys at three time points: a) before starting Ramadan, b) at the midpoint evaluation, and c) at the end of Ramadan. Three additional dispositional factors collected at the beginning and at the end are: a) sense of belonging, b) purpose in life (sense of coherence), and c) empathy (interpersonal reactivity index). The subjects are also individually interviewed on their experience of Ramadan as narrative data.

This is an observational study seeking research volunteers during Ramadan in the Pacific Northwest. We plan to recruit 10 female and 5 male volunteers. Each subject will donate her/his blood (20 milliliters) at three time points: a) before initiation of Ramadan, b) 14 days later, and c) 30 days later (60 milliliters total over one month). Because the dates of Ramadan in 2021 occur on April 12th through May 11th, the three days of the blood collection will be April 10th, April 27th and May 11th ± 1 day. Due to current COVID-19 restrictions, mass gatherings at mosque do not happen. This study deploys a mobile phlebotomist who is a licensed healthcare practitioner who will set up a droplet barrier phlebotomy station. The time of phlebotomy is determined based on the hydration status of each individual. The specimens will be packed in an ice cooler and processed (centrifuged and divided into aliquots) at Bastyr University Tierney laboratory and stored in a -80 degree Celsius freezer until analyzed at the same time for the three time points. Narrative data will also be collected through individual conversations (phone or in-person) at the completion of Ramadan, reflecting on the study and any heightened sense of spirituality.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age at the time of baseline blood draw, up to 65 years old
* Community member who observe Ramadan during April 12 (Monday evening) through May 11, 2021 (Tuesday sundown)
* Understand and sign the informed consent form and have ability to comply with the requiremnets of the study
* Vaccinated for COVID or having a history of a positive PCR test which was resolved

Exclusion Criteria:

* Anticubital vein is not accessible
* Pregnant, breastfeeding, recovering from major illness or surgery that influences quality of life
* Who reside more than 14 miles away from the city limits
* Unavailable to meet in-person and donate blood for any of three measurement days (basline, 15th day, post Ramadan)
* Smoking, drinking aclohol or using recreational drug
* Presence of a condition that in the opinon of the Investigator would compromise the safety of the participant or the quality of the data
Changes in MTX-PG Concentrations During Subcutaneous MTX Therapy in Patients With Rheumatoid Arthritis(COSMOS Study)

Methotrexate is known to exist intracellularly as methotrexate polyglutamate, which is formed by the addition of glutamic acid after absorption into the body.

The objective of this study is to measure the concentration of methotrexate polyglutamate in red blood cells and peripheral blood mononuclear cells after initiating methotrexate treatment in patients with rheumatoid arthritis who have no prior history of using methotrexate (either subcutaneous or oral formulations). Additionally, we aim to examine changes in methotrexate polyglutamate concentrations when switching from oral methotrexate to subcutaneous Metoject, as well as to investigate the relationship between methotrexate polyglutamate concentration and the efficacy and safety of the treatment. Another objective of this study is to evaluate whether switching to subcutaneous Metoject allows for an increased maximum tolerable dosage while maintaining safety.


Eligibility Criteria:
Inclusion Criteria:

* 1) Patients who were previously untreated with MTX, regardless of route of administration 2) Patients aged \>=18 years at the time of informed consent 3) Patients who meet 2010 EULAR/ACR criteria 4) Patients who have disease activity of SDAI \>11 at screening 5) Patients who were previously untreated with JAK inhibitor or bDMARDs 6) Female of child-bearing potential who can use appropriate contraceptive during the study and for at least one menstrual period after completion of MTX administration, female in whom time from menopause to informed consent is \>=1 year, or female of no child-bearing potential through sterilization 7) Virile male who can use appropriate contraceptive during the study and for at least three months after completion of MTX administration 8) Patients who can adequately understand this study procedures, and voluntarily consent in writing to take part in this study

Exclusion Criteria:

* 1) Pregnant women or women who may be pregnant 2) Patients with a history of hypersensitivity to any ingredient of the study drug 3) Patients with serious hematologic and lymphatic disorders
* Patients with a history of myelodysplastic syndrome, aplastic anemia, or erythroblastoma
* Patients with a diagnosis or treatment of lymphoproliferative disease within the past 5 years
* Patients with significant leukopenia (white blood cell count \<3000/mm3) or thrombocytopenia (platelet count \<50000/mm3millimeter) 4) Patients with significant hepatic impairment
* Patients with acute or chronic active viral hepatitis B or C
* Patients diagnosed with cirrhosis
* Patients with other significant hepatic impairment (AST \>150 U/L or ALT \>150 U/L) 5) Patients with severe renal impairment The following criteria should be used as a reference.
* Dialysis patients or renal dysfunction correspon ding to renal glomerular filtration rate (GFR) \<30 mL/min/1.73 m2 6) Patients who have pleural effusion or ascites 7) Patients who have active tuberculosis 8) Patients otherwise whom principal investigator/sub- investigator considered medically ineligible to participate in the study
Phase I Study on Multiple Oral Dosing of CG100649

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of 3 escalating loading and maintenance dose regimens of CG100649 administered orally for 7 total days in healthy volunteers.

Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used CTCAE and normal ranges if relevant.

Eligibility Criteria:
Inclusion Criteria:

1. 19-55 years old. Body weight is over 50 kg (male) and over 45 kg (female). Body weights must be within 20% of ideal body weight for their height according to the ideal body weight table.
2. No significant congenital/chronic disease. No symptoms in physical examination.
3. Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
4. Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria:

1. History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
2. History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
3. History of known hypersensitivity to drugs including CG100649.
4. After taking a rest in sitting position for 3 minutes, subjects who have low blood pressure (Systolic BP ≤ 90 mmHg or Diastolic BP ≤ 50 mmHg) or high blood pressure (Systolic BP ≥ 150 mmHg or Diastolic BP ≥ 100 mmHg).
Use of an Interactive 3D Tool During Consultation for Breast Reconstruction Surgery

The purpose of this study is to find out whether using an interactive 3D tool during a standard surgical consultation can lead to greater patient satisfaction with the information provided about breast reconstruction options than the standard consultation alone. The study researchers will also assess whether women whose surgical consultation includes the use of the 3D tool are more satisfied with their breasts and with the decisions they made about their reconstruction procedure.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Presenting at MSK for initial breast reconstruction consultation
* Planning to undergo mastectomy at time of consultation
* English spoken as primary language
* Able to provide informed consent without a legally authorized representative

Exclusion Criteria:

* Prior breast reconstruction
* Prior breast reconstruction consultation with a plastic surgeon
Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia

The objective of the study is to evaluate armodafinil as a wakefulness-promoting therapy as a means of improving residual daytime sleepiness in patients with treated nocturia.


Eligibility Criteria:
Inclusion Criteria:

1. Receiving standard-of-care therapy for nocturia based on assessment by study physician
2. Evaluation by study physician indicates that the patient meets criteria for either overactive bladder diagnosis, or nocturnal polyuria diagnosis.
3. Mean number of nocturia episodes at least 2 per night based on day sleep/bladder diary
4. Epworth Sleepiness Scale Score of at least 10
5. Clinical Global Impression of Sleepiness at least Moderate
6. Age 18-90 years inclusive

Exclusion Criteria:

1. Medications affecting urinary or sleep-wake function other than therapy for OAB o or NP within 5 half-lives of baseline assessment
2. Sleep disorders other than nocturia based on history and screening assessment
3. Unstable medical or psychiatry conditions
4. Medical or psychiatric conditions affecting sleep/wake or urologic function
5. Apnea-Hypopnea Index (AHI) ≥ 15 on screening polysomnogram
6. Periodic Leg Movement Arousal Index (PLMAI) ≥ 15 on screening polysomnogram
7. History of substance abuse or dependence in the last year
8. Regular consumption of over 800 mg of caffeine use
9. Shift-work in the 3 months prior to or during the study
COVID-19 Related Lockdown Effects On Chronic Diseases

The containment associated with the VIDOC-19 pandemic creates an unprecedented societal situation of physical and social isolation. Our hypothesis is that in patients with chronic diseases, confinement leads to changes in health behaviours, adherence to pharmacological treatment, lifestyle rules and increased psychosocial stress with an increased risk of deterioration in their health status in the short, medium and long term.

Some messages about the additional risk/danger associated with taking certain drugs in the event of COVID disease have been widely disseminated in the media since March 17, 2020, the date on which containment began in France. This is the case, for example, for corticosteroids, non-steroidal anti-inflammatory drugs but also for converting enzyme inhibitors (ACE inhibitors) and angiotensin II receptor antagonists (ARBs2). These four major classes of drugs are widely prescribed in patients with chronic diseases, diseases specifically selected in our study (corticosteroids: haematological malignancies, multiple sclerosis, Horton's disease; ACE inhibitors/ARAs2: heart failure, chronic coronary artery disease). Aspirin used at low doses as an anti-platelet agent in coronary patients as a secondary prophylaxis after a myocardial infarction can be stopped by some patients who consider aspirin to be a non-steroidal anti-inflammatory drug. Discontinuation of this antiplatelet agent, which must be taken for life after an infarction, exposes the patient to a major risk of a new cardiovascular event.

The current difficulty of access to care due to travel restrictions (a theoretical limit in the context of French confinement but a priori very real), the impossibility of consulting overloaded doctors, or the cancellation of medical appointments, medical and surgical procedures due to the reorganization of our hospital and private health system to better manage COVID-19 patients also increases the risk of worsening the health status of chronic patients who by definition require regular medical monitoring.

Eight Burgundian cohorts of patients with chronic diseases (chronic coronary artery disease, heart failure, multiple sclerosis, Horton's disease, AMD, haemopathic malignancy, chronic respiratory failure (idiopathic fibrosis, PAH) haemophilia cohort) will study the health impact of the containment related to the COVID-19 pandemic.


Eligibility Criteria:
Inclusion Criteria:

* patients with one of the following chronic diseases: chronic coronary syndrome, heart failure, multiple sclerosis, Horton's disease, AMD, malignant haemopathy, chronic respiratory failure (idiopathic fibrosis, PAH, haemophilia) and already registered in one of the 8 Burgundian registries/cohorts.

Exclusion Criteria:

* deceased patient, patient cannot be reached after \>3 telephone calls, patient or caregiver does not speak French to carry out telephone interviews