cyrilzakka/clinical-trials huggingface dataset:
Nurse-led Consultations in Heart Failure Within the 'FIL-EAS' Evaluation and Support Care Pathway for Heart Failure Patients

The management of chronic heart failure, following current guidelines, requires the implementation and adjustment of therapies to limit mortality and morbidity associated with disease progression. However, this period of treatment titration remains challenging due to the need for multiple, closely spaced consultations. The difficulty in maintaining this consultation frequency, coupled with the current decline in medical demographics, largely explains the lack of treatment titration or even initiation and the existing therapeutic inertia. Concurrently, medical telemonitoring is emerging as an essential tool in heart failure management, offering significant benefits for both patients and healthcare professionals.

In this context, new forms of nursing practices have emerged, such as advanced practice nursing, aimed at improving the care of patients with chronic diseases. However, only limited data are currently available regarding the functioning and impact of these consultations in France.

The "Evaluation and Support Pathway for Heart Failure Patients (FIL-EAS ic)" has systematically integrated this new model of consultations provided by heart failure nurse specialists. Given their significant and growing role within the pathway, it appears necessary to thoroughly evaluate these consultations to propose improvements and maximize their effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years old or over
* Patient seen in nurse-led consultations for heart failure between January 1, 2023 and December 31, 2023

Exclusion Criteria:

* Patient opposition to participate in the study
Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy

The purpose of this study is to examine whether orotracheal intubation in morbidly obese patients is faster, gentler and safer using the GlideScope videolaryngoscope than with the Macintosh direct laryngoscope.


Eligibility Criteria:
Inclusion Criteria:

* Approved for elective bariatric surgery at Glostrup University Hospital, Copenhagen.
* Body Mass Index at least 35 kg/m2
* Written informed consent to participate

Exclusion Criteria:

* Mental illness
* Abuse of alcohol or other substances
* Previous difficult tracheal intubation
* Considered non-eligible for safety-reasons by the anesthetist in charge
Immediate Lymphatic Reconstruction After Lymphadenectomy in Melanoma Patients: a Parallel Cohort Pilot Study

To learn if LBP can help to prevent lymphedema when it is performed at the time of surgery rather than after a patient has already developed the disease.

To examine if performing lymphovenous bypass (LVB) at the time of axillary lymph node dissection (ALND) or inguinal lymph node dissection (ILND) in the melanoma participant population impacts the period prevalence of lymphedema occurrence one year from surgery. To assess wound complications rates occurring in first 30-days post operatively from the time of surgery. To estimate time to drain removal. To estimate the point prevalence of LE following surgery at 3 months, 6 months, and 1 year following surgery. To estimate the cumulative incidence associated with the first appearance of LE. To assess quality of life and survivorship, using Lymphedema Quality of Life (LYMQOL) questionnaire over the study follow-up domain.

Eligibility Criteria:
Inclusion Criteria:

1. Participants greater than or equal to 18 years of age.
2. Participants willing to participate.
3. Participants able to complete informed consent.
4. Participants with a diagnosis of Melanoma undergoing ALND or ILND.

Exclusion Criteria:

1. Participant staking anticoagulants within 7 days prior to surgery.
2. Participants that are known to be pregnant at the time of surgery.
3. Participants with BMI greater than 50.0
Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity

Patients with sleep apnea are at increased risk of developing cardiovascular disease - with women at potentially greater risk than men. Contributing mechanisms are not well understood, but may be related to how women respond to low oxygen and, given over 70% of patients with sleep apnea are obese, the impact of obesity. This project seeks to increase our understanding of mechanisms that may contribute to sex differences in the cardiovascular response to low oxygen with the hope that this knowledge will improve the efficacy of current therapies and support the discovery of novel therapeutics.


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years of age (premenopausal)
* Healthy weight (BMI ≥18 and ≤25 kg/m2)
* Obese (BMI ≥30 kg/m2)

Exclusion Criteria:

* Pregnancy, breastfeeding, oral hormonal contraceptive use
* Diagnosed sleep apnea or Oxygen desaturation index \>10 events/hr
* Current smoking/Nicotine use
* Increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy
* Nerve/neurologic disease
* Cardiovascular, hepatic, renal, respiratory disease
* Blood pressure ≥140/90 mmHg
* Diabetes, Polycystic ovarian syndrome
* Communication barriers
* Prescription medications, Sensitivity to lidocaine
Research Study of a New Medicine (NNC9204-1706) in People With Overweight or Obesity

The study is testing a new medicine for weight control in people with overweight or obesity. The aim of the study is to find out how safe the study medicine is and how it works in the body. Participants will either get NNC9204-1706 (the new study medicine) or placebo (a dummy medicine) - which treatment participants get is decided by chance. NNC9204-1706 is a new medicine which cannot be prescribed by doctors. Participants will get an injection under the skin of participants' stomach each morning for 10 weeks. A medical tool called NovoPen®4 will be used for the injection. Participants must change the part of the pen including the medicine (the cartridge) each day. The study will last for about 16 weeks. Participants will have at least 17 clinic visits and 10 phone calls with the study doctor. At certain times during the study, participants will have blood drawn and 3 different kinds of heart tests (electrocardiograms). Study doctor will ask participants to answer mental health surveys.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body mass index (BMI) between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

Exclusion Criteria:

* Female subject who is of childbearing potential (pre-menopausal and not surgically sterilised) and is sexually active with male partner(s) who are not surgically sterilised (vasectomy) or who is not using highly effective contraceptive methods (Pearl Index less than 1%) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), or are pregnant, breast-feeding or intend to become pregnant.
* Male subject who is not surgically sterilised (vasectomy) and is sexually active with female partner(s) and who is not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their nonpregnant female partner(s) (Pearl Index less than 1%), and/or intend to donate sperm in the period from screening until 90 days following administration of the investigational medical product.
* Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
Study of XL228 Administered Intravenously to Subjects With Advanced Malignancies

The purpose of this study is to assess the safety and tolerability of the multi-targeted protein kinase inhibitor XL228 (active against IGF1R, Src, FGFR, and BCR-Abl) administered as a once- or twice-weekly 1-hour intravenous infusion in subjects with advanced malignancies.


Eligibility Criteria:
Inclusion Criteria:

* The subject has a histologically confirmed solid tumor that is metastatic or unresectable, lymphoma, or multiple myeloma, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival. Subjects treated at the MTD (once-weekly) must have a diagnosis of metastice colorectal carcinoma, relapsed or refractory multiple myeloma, non-small-cell lung cancer (NSCLC), or small cell lung cancer (SCLC). Certain other eligibility requirements must also be met.
* The subject has disease that is assessable by tumor marker, clinical laboratory, physical, or radiologic means.
* The subject is ≥18 years old.
* The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
* The subject has adequate organ and marrow function.
* The subject is capable of understanding the informed consent document and has signed the informed consent document.
* Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study.
* Female subjects of childbearing potential must have a negative serum pregnancy test at screening.

Exclusion Criteria:

* The subject has received anticancer treatment (eg, chemotherapy, radiotherapy, cytokines, investigational agent, or hormones) within 14 days before the first dose of study drug.
* The subject has received radiation to \>25% of his or her bone marrow within 30 days of treatment with XL228.
* The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 from adverse events (AEs) due to investigational or other agents administered more than 14 days prior to study enrollment.
* The subject has a primary brain tumor. Subjects with brain metastases are considered eligible if the subject has not received radiation therapy for brain metastasis within 2 weeks of enrollment and has been on a stable dose of steroids for 2 or more weeks.
* The subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* The subject has a psychiatric illness or social situation that would limit compliance with study requirements.
* The subject is pregnant or breastfeeding.
* The subject is known to be positive for the human immunodeficiency virus (HIV).
* The subject has a known allergy or hypersensitivity to components of the XL228 formulation.
* The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
Acetazolamide in Central Sleep Apnea Patients Using Medication for Opioid Use Disorder

Patients with opioid use disorder treated with either methadone or buprenorphine are at risk of developing central sleep apnea (CSA) from these medications. Investigators will conduct a mechanistic trial using acetazolamide, a medicine known to improve CSA in other settings, to determine if acetazolamide can improve CSA due to medication for opioid use disorder and whether this leads to physiologic changes that might lead to reduced drug craving. Patients treated with medication for opioid use disorder and who have central sleep apnea will be randomized to treatment with acetazolamide or matching placebo for 7 days. At the end of the 7 days, they will undergo an overnight sleep study to assess the impact on breathing during sleep as well as sleep quality. In addition, measures of sympathetic tone, anxiety, arousal, cognition, and drug craving will be measured to determine if treatment of CSA with acetazolamide can produce physiologic changes that might contribute to improved health.

Medications used to treat opioid use disorder (MOUD) such as methadone and buprenorphine have been found to cause central sleep apnea (CSA), but the clinical ramifications are unclear. It has been hypothesized that the sleep fragmentation and intermittent hypoxemia caused by CSA from MOUD may lead to sympathetic activation, nocturnal arousal, increased anxiety, and cognitive impairment that may in turn increase drug craving and drug relapse. This mechanistic study will evaluate the potential adverse effect of CSA in patients on MOUD by evaluating the impact of acetazolamide to improve CSA and thereby lead to downstream physiologic changes in measures of sleep quality, sympathetic tone, nocturnal arousal, anxiety, cognitive functioning, and drug craving.

Eligible individuals will undergo an overnight research visit including overnight polysomnography, assessments of autonomic tone, sleep quality, nocturnal arousal, emotional distress, cognitive testing, and drug craving. Individuals with opioid-induced CSA will be randomized into a parallel-arm trial of acetazolamide vs. placebo with overnight research visit for outcome assessment at 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients on Medication for Opioid Use Disorder (MOUD) with central sleep apnea.

Exclusion Criteria:

* Sleep-related Hypoventilation.
* Other causes of Central Sleep Apnea besides Opioid Use.
* Pregnancy.
* Contraindications for Acetazolamide.
A Study in Healthy Men and Women Who Are Either Between 18 - 45 Years or Between 65 - 80 Years to Test How Different Doses of BI 474121 Are Tolerated

The main objectives of this trial are to investigate safety and tolerability of BI 474121 in healthy male and female young and elderly subjects following oral administration of multiple rising doses per day over 14 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
* Age of 18 to 45 years (inclusive) for young or 65 to 80 years (inclusive) for elderly healthy volunteers
* BMI of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 100 to 140 mm Hg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* A positive Poly-chain reaction (PCR) test for SARS-CoV-2 and clinical symptoms suggestive for this disease at screening or on Day -3
* Further exclusion criteria apply
Pharmacokinetics Study of Liposomal Paclitaxel in Humans

The purpose of this study is to determine whether there is any difference of the pharmacokinetics of two taxane formulations, paclitaxel injection and liposomal paclitaxel in Chinese cancer patients with solid tumors.

The pharmacokinetics of a new formulation of taxane (liposomal paclitaxel) has never been studied in Chinese cancer patients. This clinical trial is designed to find out the pharmacokinetics of liposomal paclitaxel at the dose of 175mg/m2 and whether it has a different pharmacokinetic profile to paclitaxel.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients must have histologically confirmed solid tumors of advanced stages
* Patients who are suitable for being treated with liposomal paclitaxel only
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* Patients who are expected to be alive for at least 3 months
* Adequate hematologic, hepatic and renal functions
* Adequate other organ functions as defined by the protocol
* No prior systemic chemotherapy at least 4 weeks before the recruitment
* No previous anaphylactic reaction to hormone.

Exclusion Criteria:

* Allergy to any study medication
* Serious complication that would compromise the patient's ability to complete the study
* Grade ≥1 neuropathy using NCI CTCAE version 3.0 criteria
* Pregnancy or breast feeding
Stress, Diurnal Cortisol, and Breast Cancer Survival

The purpose of this study is to learn about the effects of stress on hormones, the relationship between these hormones and cancer progression.

The purpose of this study is to investigate stress and tonic activation of diurnal cortisol in aging metastatic breast cancer patients; feedback inhibition \& activation of cortisol; and stress-induced phasic activation of cortisol.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of recurrent or metastatic breast cancer.
2. Karnofsky of 70% or greater.
3. Proficient enough in English to be able to take questionnaires and participate in the required tasks.
4. Living within the Greater Bay Area.
5. Age 35 or older .

Exclusion Criteria:

1. Positive supraclavicular lymph nodes as the only metastatic lesion at the time of initial diagnosis.
2. Active cancers within the past 10 years other than breast cancer, basal cell or squamous cell carcinomas of the skin, or in situ cancer of the cervix.
3. Any other serious medical condition that will effect short term survival
4. History of major psychiatric illness for which patient was hospitalized or medicated, with the exception of depression or anxiety
5. A diagnosis of diabetes.
Evaluating the Effect of Neighborhood Environments on Cardiovascular Risk Factors

Cardiovascular disease (CVD) is one of the main causes of death in the United States. Research has shown that individuals who maintain an active lifestyle are less likely to develop CVD. This study will examine how neighborhood environments influence CVD risk factors of residents in and around the Stapleton community of Denver, Colorado.

CVD is a major health problem in the United States. Individuals who live in an environment in which it is difficult to maintain an active lifestyle may be more at risk for developing CVD. Because of an increased interest in healthy living, urban planners and architects are now developing neighborhoods that are designed to encourage physical activity. Parks, walking and bicycle trails, wider sidewalks, and community recreation facilities are examples of amenities that are being included in these neighborhoods. By incorporating these enhancements, the Stapleton community in Denver, Colorado has been redeveloped as a more active living environment. The purpose of this study is to determine the effect of the neighborhood environment on the cardiovascular health of residents in five racially, ethnically, and socioeconomically diverse neighborhoods in or near the Stapleton community.

In Years 1 and 2 of this study, 200 households from each of the five neighborhoods will be randomly chosen to complete a survey regarding their cardiovascular health, physical activity level, and use and perception of their neighborhood environment and facilities, for a total of 1,000 surveys. Interviews and focus groups with members of the community will also be used to gather information. Additionally, a neighborhood council composed of community members will be formed to study disparities among the five neighborhoods in their use of their neighborhood environments, their physical activity levels, and their cardiovascular risk factors. In Year 2, study researchers will analyze the collected data and distribute the findings within the communities. They will also begin testing culturally and community relevant programs aimed at reducing CVD risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Live in one of the following five neighborhoods in the Greater Stapleton Community: Northeast Park Hill, Greater Park Hill, East Montclair, Stapleton, or Original Aurora
* Speak either English or Spanish
Early Migration in a High Congruent Rotating Platform Total Knee Prosthesis Design

The aim of this study is to accurately assess the relationship between knee joint kinematics and migration of the tibial component of a high congruent, rotating platform total knee prosthesis by using fluoroscopy synchronised in time and space with a force plate, an external motion registration system and Electromyography (EMG).


Eligibility Criteria:
Inclusion Criteria:

* Patient is diagnosed with osteoarthritis and requiring primary arthroplasty
* Patient is capable of giving informed consent and expressing a willingness to comply with this study
* Patient has no major deformities
* The ability to perform a lunge and step-up motion without the help of bars or a cane.
* No or slight pain during activity according to the Knee Society Pain Score (Ewald, 1989; Insall et al., 1989)

Exclusion Criteria:

* The patient is unable or unwilling to sign the Informed Consent specific to this study
* The individual has a functional impairment of any other lower extremity joint besides the operated knee
* Patient has a flexion contracture of more than 15°
* Patient has a varus/valgus contracture of more than 15°
* Patients requiring revision arthroplasty
* The patient does not understand the Dutch or English language good enough to participate.
* The use of walking aids
* The inability to walk more than 500 meters
Effectiviteit en Beleving Van FooDIYou

Studies have shown that personalized nutrition advice is more effective compared to generic nutrition advice for weight loss purposes. However, since decentralization of clinical trials is on the rise, it of interest to test whether personalized nutrition advice is as effective when provided fully digitally. In the current study the investigators compare the effects of generic vs. personal nutritional interventions in a fully digital study. Three groups are included, a control group receiving generic nutritional advice, an intervention group receiving personalized nutrition advice and an intervention plus group receiving personalized nutrition advice plus personalized meals. The trial takes six weeks. Anthropometric data are collected every two weeks and data on changes in nutritional diet are collected at the beginning and end of the intervention. In addition, the opinion of the participants on trial participation is asked as well every two weeks during the trial.


Eligibility Criteria:
Inclusion Criteria:

* Age between 25-60 years
* BMI between 25 and 40
* Motivated to lose weight
* Can fill in a digital questionnaire
* Posses a smartphone, computer, weighing scale and measuring tape to perform anthropometric measurements.

Exclusion Criteria:

* Any food allergy
* Chronic diseases influencing food intake (e.g., IBD)
* Participating in another intervention study
* Females in menopausal transition
* Follow a specific diet