cyrilzakka/clinical-trials huggingface dataset:
Self Treatment with an Electronic Device for Cognitive Rehabilitation in Patients with Subacute Stroke

The objective of this study is to evaluate whether the independent use of an electronic device by a patient with stroke outcomes can enhance the effectiveness of rehabilitative treatment for attentional functions compared to standard treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ischemic or hemorrhagic stroke;
* Age between 18 and 90 years;
* First stroke event;
* Time since the stroke greater than 30 days;
* Adequate level of comprehension;
* Presence of one or more of the following cognitive disorders: Memory disorders; Attention disorders; Executive function disorders
* Availability of internet access at the patient's home, necessary for telemedicine procedures.

Exclusion Criteria:

* Presence of other neurological conditions;
* Presence of pre-morbid cognitive decline;
* History of psychiatric disorders;
* Alcohol and/or drug abuse;
* Presence of severe uncorrected visual impairments.
Balloon-expandable DES for ICAS Registry Study (BDES-ICAS Registry)

To study the clinical outcomes after implantation of balloon-expandable drug-eluting stents in patients with symptomatic intracranial atherosclerotic stenosis in prevention of composite event of any stroke and death within 30 days and ischemic stroke in the territories of the responsible artery from 31 days to 1-year.

This study is a prospective, multi-center, real world, registry study. This study aimed to evaluate the effectiveness of balloon-expandable drug-eluting stents in treating stenosis in the C2-C7 segments of the internal carotid artery and V4 artery which with high prevalence of calcified plaques in ICAD.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. According to clinical and angiographic evidence, symptomatic intracranial arteries stenosis within 3 months include vertebral artery V4 segment or internal carotid artery C2-C7 segment, and the degree of diseased arterial stenosis is between 70%\~99% (WASID method).
3. Patients have more than 1 episode of symptoms including stroke or transient ischemia attack (TIA) after intensive medical treatment (including antiplatelet therapy, antihypertensive, hypoglycemic and lipid-lowering treatments).
4. Patients have at least 1 risk factor for intracranial atherosclerosis, including previous or existing hypertension, hyperlipidemia, diabetes mellitus, smoking, alcohol consumption, obesity, underlying heart disease, family history of atherosclerotic vascular disease, hyperhomocysteinemia and so on.
5. Baseline mRS score ≤3.
6. Patient or guardian signs informed consent.

Exclusion Criteria:

1. Patients who cannot receive dual antiplatelet therapy due to existing diseases or with server coagulation dysfunction, uncontrolled serious infections, serious systemic diseases, uncontrollable hypertension and other conditions are not suitable for surgery.
2. Patients with aneurysm that cannot be treated in advance or at the same time or are not suitable for surgery.
3. Gastrointestinal disease with active bleeding.
4. Myocardial infarction or massive cerebral infarction within 2 weeks.
5. Patients with known severe allergies or contraindications to heparin, rapamycin, anesthesia and contrast media.
6. Life expectancy \&lt;12 months.
7. According to the judgement of the investigator, other situations that are not suitable for enrollment.
Determination of a Minimal Clinically Important Difference of the "Functional Reach Test" in the Elderly.

The main objective of the study is to determine the Minimal Clinically Important Difference of the "Functional Reach Test" in the Elderly by a statistical method.

The first secondary objective of the study is to determine the Minimal Clinically Important Difference by the Anchor method based on a qualitative assessment by the patients of their own response. The second secondary objective is to determine the Minimal Clinically Important Difference by the Delphi method, based on the search for a consensus between physiotherapists specializing in geriatrics.

The French population is aging, and geriatric rehabilitation care must adapt to this growing population. The functional reach test is a common clinical test in geriatrics. It helps to determine the risk of falling. However, its metrological qualities are not all determined. The Minimal Clinically Important Difference (MCID) is in particular unknown for this test. The MCID of a test makes it possible to personalize in a way more in-depth evaluation of physiotherapy treatment. So it is necessary to characterize this essential metrological determinant of a common balance skills assessment tool.

Eligibility Criteria:
Inclusion Criteria:

* People over 65 years old
* People in care with balance problems

Exclusion Criteria:

* People in an emergency situation
* People unable to give their consent (including people under guardianship)
* Patients already involved in another study.
Assessing Sleep in Blackfeet Families With K-3rd Grade Children

This project will investigate traditional sleep routines and the current sleep environment in American Indian children to develop a culturally appropriate and novel sleep intervention to increase total sleep time for families with K-3rd grade children. The outcomes of this study will provide a comprehensive understanding of a relatively unknown behavior (sleep) in American Indians, show results from a novel sleep intervention in a high risk and underserved population, and will also contribute to the research and training development of an American Indian investigator, all defined missions of NHLBI.

Children sleep less now than ever before. Despite a growing body of literature in understanding child sleep patterns, sleep interventions are limited. To date, there are no sleep intervention studies that have been done in AI tribal communities. Elders and community members play a critical role in identifying culturally adaptive solutions to address problems in tribal communities. Because of the prevalence of historical trauma and mistrust of outsiders, I am uniquely positioned to do this work in my own tribal community. Preliminary data of sleep patterns showed that Blackfeet children age 2-5 and age 12-15 averaged 10.15 hours and 7.5 hours of weekday sleep. Despite this understanding, evidence-based solutions to increase TST in tribal communities are unknown. Thus, I propose to explore traditional sleep routines coupled with asking Blackfeet families about the current sleep environment in their home to develop a culturally specific sleep intervention with one child and one adult dyad. I hypothesize that the sleep intervention will increase TST (primary outcome) in the dyads. The intervention may also result in improved physical activity and diet, and decreased stress and screen time (secondary outcomes). Data will be measured at 0 and 9 weeks and then at 3 month follow-up. This hypothesis will be tested in the following specific aims:

Specific Aim 1: Develop a culturally appropriate sleep intervention for Blackfeet families with K-3rd grade children using surveys, focus groups, interviews, community input, and evidence-based strategies on sleep.

Specific Aim 2: Feasibility test of the 9-week sleep intervention with K-3rd grade Blackfeet families.

The work proposed in these aims is designed to develop a comprehensive understanding of traditional sleep strategies and the child sleep environment to develop and pilot-test a novel culturally appropriate sleep intervention in the Blackfeet community. Developing culturally specific interventions to increase TST will address two significant gaps in the literature; understanding sleep problems in AI children and pilot-testing culturally adaptive sleep intervention strategies that will inform future research for investigators doing similar work in AI communities and provide direction for an R01 proposal that is one of the outcomes of this work.

Eligibility Criteria:
Inclusion Criteria:

• Blackfeet families with K-3rd grade children

Exclusion Criteria:

• Blackfeet families living off the Blackfeet Indian Reservation in Montana
Isolated Rectal Bleeding in Newborns : Allergic Proctocolitis or Neonatal Colitis Transient - COLON Study

Prospective observational pilot study evaluating the frequency of cow's milk protein allergic prococolitis in newborns hospitalized in neontal medicine at the university hospital of Nice who presented rectal bleeding.

Inclusion of all newborns in the neonatal medicine department at Nice University Hospital with isolated rectal bleeding.

A note of information and non-opposition will be presented and given to the biological mother. She has the right to object to this study, on her own initiative, at any time.

Collection of data relating to the newborn during hospitalization, the results of the clinical examination and the systematic check-up carried out in accordance with standard practice, and data at discharge.

Follow-up of the newborn to determine the cause of rectal bleeding and therefore the frequency of procolitis allergic to cow's milk proteins.

Prospective observational study of current practices without any intervention.

Eligibility Criteria:
Inclusion Criteria:

1. All newborns ≤ 28 days corrected age or ≤ 44 amenorrhea weeks corrected age hospitalized in neonatal medicine with isolated rectorrhagia;
2. Affiliated to social security ;
3. Presenting isolated rectorrhagia defined as rectorrhagia without hematemesis/ repeated vomiting/ tense or distended abdomen/ apathy/ apnea/ bradycardia or signs of severity (tachycardia, desaturation, poor coloration);
4. After obtaining the biological mother's non-objection;

Exclusion Criteria:

1. All newborns with ulcerative enterocolitis, congenital digestive malformations or rectorrhagia following digestive surgery;
2. Opposition to participation in research involving the human person.
Microvolt T-wave Alternans in Cardiac Surgery Patients

The purpose of this study is to measure MTWA in the patients undergoing cardiac surgery and to investigate the relation between MTWA and adverse clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* All patients underwent cardiac surgery including coronary artery bypass graft surgery with or without cardiopulmonary bypass, cardiac valve surgery, cardiac mass excision, thoracic aorta surgery, etc.

Exclusion Criteria:

* unavailability of the recording equipment
Efficacy and Safety of Colquhounia Root Tablet in Patients With Rheumatoid Arthritis

This study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate whether Colquhounia Root Tablet combined with methotrexate (MTX) might be better than MTX alone for patients with active rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

1. Subject understood the whole process of the trial and signed the informed consent voluntarily.
2. Subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR RA classification criteria.
3. Subjects aged between 45-70years who were the males without fertility requirements or menopausal women.
4. Subject has a DAS28 CRP disease activity score greater than 2.6 and less than 5.1.
5. Subject did not participate in any drug trials within 1 month before enrollment.

Exclusion Criteria:

1. Pregnant women, women planning to become pregnant or breastfeeding.
2. Severe systemic involvement, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, autoimmune liver disease.
3. Active liver disease or abnormal liver function, ALT and AST are more than 1.5 times the upper limit of normal.
4. Renal impairment, serum creatinine greater than the upper limit of normal.
5. Bone marrow hematopoietic dysfunction, peripheral blood leukocytes \<3.0×109/L, or definite anemia (hemoglobin less than 80g/L), or platelets \<80×109/L, or other blood system diseases.
6. Active gastric and duodenal ulcers.
7. Uncontrolled severe hypertension, metabolic diseases.
8. malignant tumors.
9. Acute and/or chronic infectious diseases.
10. Severe cardiac arrhythmia found on electrocardiogram.
11. Mental illness, history of alcoholism, drug or other substance abuse.
12. Diagnosed with other connective tissue disease.
13. Those who have used immunosuppressants, biological agents, Colquhounia Root Tablet or drugs containing Tripterygium wilfordii within 1 month before enrollment.
14. Those who have previously used methotrexate or preparations containing tripterygium wilfordii for 12 weeks or more ,but their condition is not under control.
15. Adverse reactions have occurred in the past using Colquhounia Root Tablet or drugs containing Tripterygium wilfordii.
Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe)

Nocturia, or waking during the night to pass urine, is a multifactorial disease. An important cause of nocturia are peripheral edema due to accumulation of fluid in the lower limbs. Venous insufficiency is an important cause of peripheral edema. The investigators hypothesize that, as a result of the lying position during the night, the accumulated fluid in the lower limbs returns to the systemical circulation leading and is excreted during nighttime. This will lead to a higher voiding frequency during the night.

With this trail the investigators wanst to prove the difference in leg edema between healthy volunteers and volunteers with venous insufficiency (Type 1 or 2).


Eligibility Criteria:
Inclusion Criteria:

* Age between 25 years and 60 years
* For the volunteers with venous insuffiency: clearly visual venous insufficiency (CEAP 1 and 2)
* BMI between 24 and 30

Exclusion Criteria:

* Volunteers using medication (exception for contraception)
* Volunteers having comorbidities
* Pregnant women
* Women who menstruate on the test date
* Volunteers with an implanted elektronical device (IPG, Pacemaker)
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 653048 BS H3PO4 Capsule Multiple Rising Doses in Healthy Male Volunteers

The objectives of the trial were to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of BI 653048 BS H3PO4 compared with prednisolone.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects based on a complete medical history, physical examination, vital signs (blood pressure and pulse rate), 12-lead ECG, and clinical laboratory tests
* Age of 18 to 50 years
* Body mass index (BMI) of 18.5 to 29.9 kg/m2
* Signed and dated written informed consent in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

* Any clinically relevant deviation from normal in the medical examination including blood pressure, pulse rate, and ECG
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Chronic or relevant acute infections
* History of relevant allergy or hypersensitivity (including allergy to drug or its excipients)
* Intake of drugs with a long half-life (\>24 h) within at least 1 month or less than 10 half-lives of the respective drug before first treatment with study drug or during trial
* Use of drugs which might reasonably influence the results of the trial or which prolong the QT/QTc interval within 10 days before first treatment with study drug or during trial
* Participation in another trial with an investigational drug within 30 days before first treatment with study drug or during trial
* Smoker (more than 10 cigarettes, 3 cigars, or 3 pipes per day)
* Inability to refrain from smoking beginning from 1 day before first treatment with study drug until discharge from the clinical unit
* Alcohol abuse (more than 60 grams per day)
* Drug abuse
* Blood donation of more than 100 mL within 4 weeks before first treatment with study drug or during trial
* Excessive physical activities within 1 week before first treatment with study drug or during trial
* Any laboratory value outside the reference range and of clinical relevance
* Inability to comply with dietary regimen of trial site
* A marked baseline prolongation of the QT/QTc interval (e.g. QTc intervals that are repeatedly longer than 450 ms)
* A history of additional risk factors for torsades de points (e.g. heart failure, hypokalaemia, or family history of Long QT syndrome
Quality of Life After Open Heart Surgery in Older Patients

Long term follow-up of nonagenarians who have undergone open heart procedures.

Based on population studies, life expectancy at age 80 is 8.5 years, and at the age of 85 years, it is 6.3 years (US Bureau of Census 2000). There are currently 1.6 million nonagenarians and roughly 72,000 centenarians living in the United States. With this increasing elderly population, knowledge of the special management issues and long-term sequela are imperative. Bacchetta and coworkers from our institution presented a 10-year outcomes experience in nonagenarians undergoing cardiac surgery. In 42 consecutive patients, in-hospital mortality was 7%, and 30-day mortality 5%. Postoperative morbidity was documented in 67% with arrhythmias accounting for 31% of the cases, followed by respiratory complications, infections, and strokes. While this is mostly in-hospital data, long-term follow-ups have not been performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent open heart procedures and who were 90 years or greater between 1995 and 2004 at The New York Presbyterian Hospital

Exclusion Criteria:

* Patients who refuse follow-up
Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer

The study will evaluate how safe and effective abemaciclib is when given to participants whose metastatic prostate cancer progresses after they had received several previous treatments.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have metastatic prostate cancer for which castration (medical or surgical) is no longer effective (castration-resistant).
* Participant must have disease spread to soft tissue that is measurable.
* Participant must have documented evidence of progressive disease by PSA test or imaging.
* Participant must have previously received at least one of the following treatment: abiraterone acetate, apalutamide, darolutamide or enzalutamide.
* Participant must have previously received chemotherapy with docetaxel and cabazitaxel.
* Participant must be willing and amenable to undergo a biopsy of tumor tissue (or able to provide adequate archived tumor tissue sample) and to provide blood for research.
* Participant must have good physical functioning ability and adequate organ function.

Exclusion Criteria:

* Participant must not have received more than 3 therapy regimens for metastatic castration-resistant prostate cancer (NOTE: GnRHa, first-generation antiandrogens (flutamide, nilutamide, or bicalutamide), diethylstilbestrol (DES) (or other estrogens), corticosteroids, ketoconazole, and bone loss-prevention will not count as systemic therapy regimens.
* Participants must not have previously received abemaciclib or any cyclin-dependent kinase (CDK)4 and/or CDK6 inhibitors.
* Participants must not have serious and/or uncontrolled preexisting medical condition(s) including but not limited to severe renal impairment, severe hepatic impairment, interstitial lung disease (ILD)/pneumonitis, severe dyspnea at rest or requiring oxygen therapy or other serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
* Participants must not have, or suspected to have, brain metastasis.
* Participants must not have untreated spinal cord compression, evidence of spinal metastases with risk of spinal compression or structurally unstable bone lesions suggesting impending fracture.
Prostate Cancer Prospective Cohort

The overall purpose of this research is to determine if certain genes increase the chance of developing prostate cancer and once diagnosed increase the chance of the prostate cancer spreading to other parts of the body.

DNA will be isolated from each person and then studied for the presence of certain genes that may increase the chance of developing prostate cancer. Certain genes will also be studied in patients with known prostate cancer to determine if they increase the chance of cancer spreading to other parts of the body and decrease one's chance of being cured. Small differences in genes can slightly affect their ability to function. While these differences are normal, they may influence the way the cancer responds to therapy. An understanding of which genes increase (or decrease) the chance of being cured of a disease, such as prostate cancer, will improve our ability to take care of patients more effectively.

A second purpose of this study is to collect blood and cancer tissue for future studies. While the small differences in genes may be the best marker of bad cancer, it is also possible that proteins in blood or tumor may be a better marker.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients: 1. newly diagnosis of prostate cancer 2. untreated except for neoadjuvant systemic therapy.

Exclusion Criteria:

* Newly diagnosed patients: 1. inability to give informed consent
Interest of 18F-FDG Positron Emission Tomography in the Management of Fevers and Inflammatory Syndromes

Patients aged 75 and over represent a heterogeneous population with fragile subjects who have a higher risk of poor tolerance to many tests and especially who have a risk of major functional loss in the event of hospitalization. It is therefore necessary to adapt our prescriptions and not to impose on these patients an examination that is unnecessary. Or on the contrary, not to do without, out of ignorance, a minimally invasive examination that could be useful to these patients.

In this study, the investigators wish to evaluate the interest of the Pet-Scan in the therapeutic management of these elderly patients


Eligibility Criteria:
Inclusion criteria:

* Patient aged 75 years and over,
* Patients cared for at the HUS, in hospital or in consultation, during the defined period (from 01/05/2013 to 31/12/2018)
* Having had an 18FDG-PET/TDM
* For fever or inflammatory syndrome check-ups, regardless of the duration of the evolution and the examinations already carried out
* Patient who has not expressed opposition to the reuse of their data for the purposes of this research.

Exclusion criteria:

* Patient who has expressed opposition to participating in the study
* Known explanation for fever or inflammatory syndrome
* Subjects under legal protection
* Subject under the protection of justice
* Subject under guardianship or curatorship

Translated with www.DeepL.com/Translator