cyrilzakka/clinical-trials huggingface dataset:
Strategy of Early Detection and Active Management of Supraventricular Arrhythmia With Telecardiology (SETAM)

This study investigates if the early detection and treatment of supraventricular arrhythmia (SVA) may help to prevent the progression of the arrhythmia and improve the clinical outcome.

The primary endpoint investigates the delay to implement treatment in two groups of patients :

* Active group: Patients followed by telecardiology.
* Control group: Patients followed in the conventional manner.

It is assumed that the delay to implement treatment will be higher in the Control group.

Atrial fibrillation is the most commonly encountered sustained cardiac arrhythmia in medical practice and it is often associated with atrial flutter. In patients with the new pacemaker generation EVIA, the home-monitoring technology provides specific and clinical relevant notifications for detection of atrial arrhythmias. Combined with holters memories, this can help to optimize the treatment of supraventricular arrhythmia (SVA) such as atrial fibrillation or flutter.

This study will compare in the two groups the delay to implement for the first time a treatment for the supraventricular arrhythmia (antiarrhythmic drugs and/or an antithrombotic treatment).

Eligibility Criteria:
Inclusion Criteria:

* Dual chamber pacemaker with activated Telecardiology
* CHAD2DS2-VASc score ≥ 2
* Sinusal rhythm at enrollment
* Patient willing and able to comply with the protocol
* Patient has provided informed consent
* Men and women \> 18 years-old
* Patients geographically stable

Exclusion Criteria:

* Anticoagulation therapy
* Dual anti-platelet therapy
* Class I or class III anti-arrhythmic drugs
* Contraindication to antithrombotic therapy
* Participation in another clinical study
* Have a life expectancy \< 6 months
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia.

Secondary Objectives:

* To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points
* To evaluate the effect of alirocumab on other lipid parameters
* To evaluate the safety and tolerability of alirocumab

The maximum study duration was 34 weeks per participant, including a 24-week randomized treatment period.

Eligibility Criteria:
Inclusion criteria:

* Participants with hypercholesterolemia

Exclusion criteria:

* Age \< 18 or legal age of adulthood, whichever was greater
* LDL-C \< 100 mg/dL (\< 2.59 mmol/L) or \> 190 mg/dL (\> 4.9 mmol/L)
* Fasting serum triglycerides (TG) \> 400 mg/dL (\> 4.52 mmol/L)
* Known history of homozygous or heterozygous familial hypercholesterolemia

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Automated Geriatric Co-Management Program in Older Patients With Solid Mass or Nodule Suspicious for Cancer

The purpose of this study is to find out if it is possible to use the automated geriatric co-management program to manage the participants care before, during and after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Solid mass or nodule suspicious for cancer
* Aged 65 or older
* Being considered for surgical resection of the solid mass or nodule, with anticipated hospital length of stay of at least two days,
* Completed the eRFA per routine care

Exclusion Criteria:

* Unable to read or comprehend English
* Not having a completed electronic Rapid Fitness Assessment within 2 months of surgery\*\*Note) To avoid excluding patients based this item, patients have to complete another eRFA within two months of surgery.
* Being discharged in one day or earlier from the hospital.
Impact Evaluation of the Digital Connect Project for Homebound Older Adults

The goal of this study is to evaluate the impact of the Digital Connect Project on increasing functional capacity defined by the WHO-ICOPE and health-related quality of life (HRQL) among homebound older adults.

The Hong Kong Jockey Club Charities Trust is launching the Digital Connect project to increase the well-being and social connectedness of the homebound older adults. A total of 32 NGOs are applying for 7,500 tablets and data plan (in total) through this project. Different digital programs will be rolled out to enhance their well-being and social connectedness. This study aim is to capture the impact of this Digital Connect project on the health outcomes of the homebound older adults. The tablet intervention will be offered by the NGOs within a 2-year timeframe. Web-based multi-domain lifestyle training intervention will be conducted to promoted and focus three lifestyles: nutritional advice, exercise and cognitive training; chat communication with research team, and personalized agenda on daily activities and an information library.

The object of this study is to explore the dose-response relationship between online engagement in the different types of activity and the improvement in the corresponding health outcomes, including the five domains: (1) Physical function, (2) Cognitive function, (3) Psychological function, (4) Social function and (5) Health-related quality of life. One baseline assessment and four follow-ups will be arranged in every 3-month interval. To account for immortal time bias, each subject will be created with two clones at time zero and assigned each of the two clones to either treatment or control group, respectively.

The engagement experience will be explored by interviewing the participants and service stakeholders through the planning and delivery of the digital intervention for the homebound older adults.

Eligibility Criteria:
Inclusion Criteria:

* age \> 65
* consent to participate
* able to participate in the impact assessment as evidence by a test score of \> 6 on the Abbreviated Mental Test
* has the functional ability to engage in the digital intervention

Exclusion Criteria:

-
Assessing the Time Demands of Cancer

A total of 80 individuals receiving treatment for metastatic breast or advanced stage ovarian cancer will be asked to complete a baseline survey and install the mobile app on their smartphone; carry the smartphone for 28 consecutive days while outside the home; keep smartphone location and motion services active; confirm and correct (if needed) smartphone-detected activities and trips; use the app interface to provide additional information on activities and trips related to cancer treatment tasks; complete daily surveys regarding well-being; and at the end of the 28 day period, complete an online survey.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosed with advanced stage (III, IV) ovarian (ovarian, fallopian tube or prmary peritoneal) or metastatic breast cancer \[do not need to be newly diagnosed\]
* Currently receiving any type of therapy for their cancer \[can be front-line, maintenance therapy, or treatment for recurrence\]
* Able to complete study tasks in English
* Able to provide voluntary informed consent
* Own an Android or iOS smartphone on which the operating system is version 9.0 or higher for Android or 10.0 higher for iOS; or willing to use a researcher-provided smartphone

Exclusion Criteria:

* Those who are currently incarcerated
* Have opted out of research contact
Can Fish Oil and Phytochemical Supplements Mimic Anti-Aging Effects of Calorie Restriction?

The purpose of this study is to determine if a combination of 10 nutritional supplements provide health benefits that are consistent with protection against age-related disease. All supplements have been shown in previous studies to have health benefits when administered alone. The hypothesis is that 6 months of taking 10 nutritional supplements each day will provide beneficial changes in healthy related measures.


Eligibility Criteria:
Inclusion Criteria:

* age 40-60 yr
* body mass index of 21 - 30 kg/m2
* sedentary to moderately active
* eating a typical US diet

Exclusion Criteria:

* history of any chronic disease other than mild osteoarthritis
* use of medications other than occasional use of non-steroidal anti-inflammatory drugs, antihistamines, antacids or laxatives
* use of nutritional supplements
* smoking
* alcohol intake greater than two drinks per day for women and three drinks per day for men
Intratumoral and Peritumoral Habitat Radiomics of MRI Predict Pathologic Complete Response to Neoadjuvant Chemoimmunotherapy in Oral Squamous Cell Carcinoma

Background：Neoadjuvant chemoimmunotherapy (NACI) shows promise in oral squamous cell carcinoma (OSCC), but reliable noninvasive biomarkers for predicting pathologic complete response (pCR) remain scarce. Radiomics integrating intratumoral and peritumoral heterogeneity across multi-sequence MRI may offer novel insights into treatment response evaluation.

Methods: The data of 212 patients with OSCC after NACI were retrospectively collected and analyzed. Among these patients, 56 (26.4%) achieved pCR after NACI. Intratumoral and peritumoral habitat imaging (HI) was achieved using the K-means clustering algorithm applied to T1-weighted imaging (T1WI), axial T2-weighted imaging with fat suppression (T2WI), and contrast-enhanced T1-weighted imaging with fat suppression (T1C). Moreover, intratumoral and peritumoral HI models were constructed and compared using the receiver operating characteristic (ROC) curve. Five-fold cross-validation was performed to mitigate model overfitting.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed OSCC at the initial diagnosis;
* No treatment received prior to the first MRI examination;
* Receipt of NACI;
* Underwent MRI examination after NACI;
* Underwent surgical intervention.

Exclusion Criteria:

* Absence of clinical data and postoperative pathological results;
* MRI image artifacts significantly affecting image quality.
ABlative Radiotherapy (for) Unfavorable Prostate Tumors

Published clinical evidence confirms that a single dose of 24 Gy provides unprecedented long-term local control in primary and metastatic prostate cancer with safe toxicity profiles, provided that exposure of surrounding healthy tissues is critically assessed with fulfillment of strict constraints and dose distribution is accomplished using image guidance and tracking tools. In the present trial, intermediate unfavorable and selected high-risk organ-confined prostate cancer patients will undergo Single Dose Radiation Therapy (SDRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume by means of image-guided volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures. Androgen Deprivation Therapy (ADT) type and duration has been set as per standard of care, in accordance with current recommendations and guidelines.

Patients enrolled in this observational prospective trial will be offered image-guided, volumetric modulated radiotherapy (IGRT-VMAT) in a single session (SDRT) of 21 Gy to the whole gland with a simultaneous boost of 24 Gy to the macroscopic PI-RADS driven (4-5) tumour(s). ADT will be prescribed concomitantly, as per standard of care. A real time non-ionizing prostate monitoring will be used to account for intra-fractional errors. If the dose constraints to the normal tissues are at risk, these will be prioritised over the aimed boost dose. The primary endpoint of the trial is the treatment related toxicity measured by the CTCAE v5.0. Secondary endpoints are quality of life in different domains (sexual, rectal , urinary) and biochemical outcome.

Patients will be followed at one month, then every 3 months for the first 12 months and every 6 months thereafter. Quality of Life will be prospectively evaluated through validated tools (ECOG, EPIC, IIEF-5, IPSS, ICIQ-SF) at various timepoints. Percentage or total mean score will be reported according the questionnaires, whether they grade values in a scale or use descriptive statistics. Kaplan-Meier curve analysis of biochemical relapse free survival (b-RFS) at 2 and 5-year bRFS for all patients will be estimated.

Eligibility Criteria:
INCLUSION CRITERIA

* Histologically proven prostate adenocarcinoma;
* Intermediate and High risk disease, as per the NCCN definition;
* N0M0 at staging with standard techniques (Bone Scan and Abdominal CT) or (preferably) Choline or PSMA PET-CT;
* ECOG performance status between 0 and 2;
* Life expectancy of \> 5 years, in the opinion of the investigator;
* IPSS score must be ≤ 19 (alpha blockers allowed);

EXCLUSION CRITERIA:

* ≥T3b disease according to the 8th AJCC classification;
* PSA\>20 ng/ml at any time point;
* Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy);
* Previous radiotherapy to the pelvis;
* Previous invasive malignancy unless disease free for a minimum of 5 years;
* Active Crohn's Disease or Ulcerative Colitis;
Fabry Cardiomyopathy: Identification of Early Myocardial Structural and Tissue Abnormalities Using Multiparametric MRI

This study will evaluate whether cardiac MRI T1 and T2 mapping improves our ability to detect early abnormalities in the heart in patients with Fabry disease and identify patients at increase risk of adverse events.

Fabry disease is an inherited disorder that affects many organs in the body, including the heart. Men and women are both affected, with average life expectancy reduced by 10-20 years. The heart muscle can become thick and scarred in over half of patients, eventually resulting in heart failure, abnormal rhythm and death. The focus of this study will be on improving the detection of early heart disease before irreversible damage has occurred in order to improve patient outcomes.

It is hypothesized that new cardiac MRI techniques called T1 and T2 mapping will improve the ability to detect early abnormalities in the heart. Early detection of cardiac disease may enable a personalized treatment approach, potentially improving patient outcomes. The results of the study will identify which patients might benefit from early initiation of treatment to prevent bad outcomes in the future by using cardiac MRI to identify those at higher risk.

Eligibility Criteria:
Inclusion Criteria:

* Fabry disease;
* Age ≥ 18 years.

Exclusion Criteria:

* History of myocardial infarction;
* Contraindication to MRI.
Cimex Lectularius or Bed Bugs : Vector of Infectious Agents and Pathogenic Role

During the last years, the investigators were the witness to the increase of a old emerging pest due to bed bugs (Cimex lectularius) in the world. Insecticides resistances apparitions and internationals transports increases seem to be the reasons of the pest. Cimex lectularius as vector of parasites, bacteria or virus was often suggested although not much observation are recently investigated in France. This study intends to examine the vectorial ability and the direct pathogenicity of Cimex lectularius.


Eligibility Criteria:
Inclusion Criteria:

* On the site of takings presence of insects and eggs evoking bedbugs of beds. The identification of certainty will be made in the laboratory. All the insects not apartment to the family of Cimicidae (Criterion of exclusion) are thrown(cast) in trash cans of laboratories for organic products.
* voluntary Patients after reading of the information sheet and the signature of the consent
* Membership of the patient in the national insurance scheme

Exclusion Criteria

* On the site of takings absence of insects and eggs evoking bedbugs of beds
* During the identification of certainty in the laboratory, the captured insects do not make parties of the family of Cimicidae
* The subjects deprived of freedom.
* Patients cancelling their consent.
* Patients violating the protocol of search(research)
A Trial to Investigate the Impact of Nocturnal Hypoglycaemia on Sleep in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the impact of low blood sugar during the night on sleep in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (diagnosed clinically) for at least 24 weeks prior to screening
* Currently treated with any anti-diabetic treatment (incl. diet and exercise) except insulin with a stable dose for more than 4 weeks prior to screening
* Body mass index below 35 kg/m\^2

Exclusion Criteria:

* Severe hypoglycaemic event during the past 6 months or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Any other chronic disorder or severe disease by clinical information (including chronic obstructive pulmonary disease (COPD), sleep apnoea and epilepsy) which, in the opinion of the investigator might jeopardise subject's sleep, safety or compliance with the protocol, or subjects with mental incapacity or language barriers precluding adequate understanding or co-operation or who, in the opinion of the investigator, should not participate in the trial
* Use of antidepressants, antipsychotics, hypnotics, sedatives or other drugs known to influence sleep within 12 weeks prior to screening
A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer

This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed colon carcinoma, AJCC/UICC Stage III (Dukes stage C)
* Complete tumor resection; Patients operated with curative intent and with no macroscopic or microscopic evidence for remaining tumor who can be randomized to either treatment arm within 8 weeks after surgery. As this is an adjuvant trial patients should never have had any evidence of metastatic disease (including presence of tumor cells in the ascites).
* Have a life expectancy of at least 5 years

Exclusion Criteria:

* Pregnant or lactating women
* Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study
* Previous cytotoxic chemotherapy, radiotherapy or immunotherapy, for the currently treated colon cancer
* Patients who have not completely recovered from surgery
Study to Evaluate Long Term Performance and Safety of the Knee Prosthesis (HLS KneeTec Deep Dish)

The aim of this study is to assess the long-term performance and safety of HLS KneeTec Deep Dish knee prosthesis when used in standard medical practice

It is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in a single French site where Total Knee Arthroplasty with HLS Kneetec Deep Dish prosthesis is performed routinely

All patients treated with HLS KneeTec Deep Dish implant will be included. All eligible patients seen in consultation and who agree to participate in the study should be included, systematically and consecutively, since the initiation of the study.

Patients will be assessed according to the usual practice of the investigator at each participating site before surgery and then at the follow-up (FU) visits as following: 3 months (+/- 1 months); 15 months (+/- 3 months); 5 years (+/- 6 months) and 10 years (+/- 6 months).

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 - 80 years old at the time of the surgery
* Implanted with an HLS KneeTec Deep Dish TKP according to the Instructions for Use (IFU) after the 1st of february, 2017
* Patients agree to consent to collect data from their medical records and agree to answer questionnaires for the purposes of the study.

Exclusion Criteria:

* Patients under guardianship and/or those who, according to the investigator or his delegated research team, will not be able to comply with the study procedures. (e.g. illiteracy, recent psychotic or manic disorders and/or inability to comply with routine follow-up visits.)
Internet-Based Cognitive Behavioral Therapy for Depressive Symptoms in Adolescents With Type 1 Diabetes Mellitus

This study evaluates the use of an established internet-based cognitive behavioral therapy intervention in a group of adolescents with type 1 diabetes and mild to moderate depressive symptoms. Half of the participants will receive the internet-based intervention while the other half will receive usual care.

Adolescents with diabetes have a higher incidence of subclinical and clinical depression compared to healthy adolescents. Patients with diabetes who are clinically or subclinically depressed are at high risk for poor glycemic control.

Studies evaluating prevention and treatment strategies for depression in patients with type 1 diabetes have shown that group cognitive-behavioral therapy (CBT) and individual interpersonal psychotherapy (IPT) can reduce the risk of depressive illness in adolescents with diabetes. Computerized interventions show evidence of being efficacious, and have been recommended as the "first line" intervention.

The Competent Adulthood Transition with Cognitive Humanistic and Interpersonal Teaching (CATCH-IT) internet program has shown positive results with adolescents at risk for depression, but has not been used in patients with a chronic illness like diabetes. CATCH-IT is based on established CBT and IPT treatment models. It includes a) an innovative and effective brief practitioner-provided motivation enhancement component (in person at enrollment and through phone calls) and b) self-directed modules for the adolescent that can be accessed on the internet.

Eligibility Criteria:
Inclusion Criteria:

* Age 13-17 receiving ongoing medical care in the Diabetes Clinic at Children's Medical Center Dallas.
* Patients must be fluent in English (the materials on the site have not been validated in any other language), be in at least the 8th grade, report/demonstrate comfort with use of a computer, and regular, convenient and discreet access to the internet.
* Patients must experience at least sub-threshold depression (CES-D score \> 15).
* Patients must have had the diagnosis of type 1 diabetes for at least 12 months.

Exclusion Criteria:

* Patients who are medically unstable during their diabetes clinic visit will be excluded (i.e. diabetes ketoacidosis, symptomatic hypoglycemia).
* Patients who are too severely depressed for this form of intervention (i.e. meet criteria for MDD, endorse suicidal intent, PHQ-A score ≥ 20), those with a diagnosis or symptoms of severe mental illness (schizophrenia, bipolar disorder), prior psychiatric hospitalization, prior self-harm attempt.
* Patients receiving ongoing counseling or therapy services within the last year, by a licensed professional (counselor, psychologist or psychiatrist).
* Patients who are currently taking or begin taking psychotropic medications during study participation will be excluded/withdrawn.
Drug-drug Interaction of BI 201335 and Microgynon

This study will investigate possible effect of multiple oral doses of BI 201335 on the steady state pharmacokinetics of ethinylestradiol and levonogestrel


Eligibility Criteria:
Inclusion criteria:

1. Healthy female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions