cyrilzakka/clinical-trials huggingface dataset:
Interest of a Geriatric Intervention Plan Associated to a Comprehensive Geriatric Assessment on Autonomy, Quality of Life and Survival of Patients Aged 70 Years Old and More Surgically Treated for a Resectable Cancer (Thoracic, Digestive or Urologic). Randomized Multicentric Study

The curative treatment of thoracic (lung and oesophagus), digestive (gastric, pancreatic, hepatic, colorectal), and urologic (renal, bladder, prostatic) cancers needs a surgical resection. For patients aged of 70 years old and more, this surgery is associated to an increased morbid-mortality especially because of more frequent co-morbidities. Comprehensive geriatric assessment (CGA) allows distinguishing patients for whom a resection surgery can be complicated by high morbid-mortality or a loss of autonomy. It has been proved that for old patient population without cancer, CGA associated with a geriatric intervention plan (GIP) allows autonomy preservation, decrease of institution admission, and survival improvement. The reference study showed that a CGA associated to a GIP improves survival of old patients who had a cancer surgery. However this study included patients from 60 years old and the GIP consisted in 3 home visits and 5 phone calls during the 4 weeks following hospital discharge.

We propose to perform a prospective and randomized study to evaluate the impact of a CGA with GIP in 70 years old and more patients with a thoracic, digestive or urologic cancer resection, respectively 1, 3, 6 and 12 months after discharge. CGA and GIP will focus on 8 distinct fields: autonomy, co-morbidities, co-medication, mobility, nutritional status, depression, cognitive function and social status. The impact of such a strategy on autonomy and survival has never been studied.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 70 years old or more
* Patient with a resectable cancer( thoracic, digestive ore urologic);
* Patients who have to undergo a surgery with general anaesthesia;
* Patients treated in one of the partner programme unit ;
* Patient able to fill in an auto-questionnaire alone or with some help;
* Patient who have signed an informed consent and who commits himself or herself to respect the protocol instructions.

Exclusion Criteria:

* Patient younger than 70 years old;
* Patient who is not registered to the social ;
* Patient for whom surgery is performed under local anaesthesia;
* Patient unable to fill-in alone an autoquestionnaire (because of an inability to read French language or severe cognitive troubles);
* Patient treated with neuroleptic or lithium ;
* Patient with already known cognitive impairment (Alzheimer, dementia, neurologic sequel);
* Patient under legal protection;
* Patient who has not signed informed consent.
Tissue Oxygenation Measurements With Modulated Light (S-FLARE)

To perform a pilot study of the S-FLARE imaging system, which uses low levels of safe, invisible, near-infrared light to measure tissue oxygenation during breast reconstructive surgery and to compare S-FLARE measurements to the gold standard, FDA-approved, the ViOptix optical probe.

This pilot study will enroll three patients who have chosen to proceed with deep inferior epigastric perforator (DIEP) flap breast reconstruction. This type of reconstruction uses skin and fat from the abdomen to reconstruct a new breast shape. The construct is vascularized through perforating arteries and veins that provide a blood supply to this tissue.

Current techniques to evaluate vessel selection rely on a handheld Doppler used for confirmation of blood flow and perfusion; however, this modality is limited as it only assesses a specific point within the flap.

The S-FLARE imaging system will be used to visualize vascularization in the DIEP flaps, and this study will compare measurements by the S-FLARE imaging system and the standard-of-care ViOptix point probe.

Eligibility Criteria:
Inclusion Criteria:

* Women or men above the age of 21 who are undergoing unilateral breast reconstruction after mastectomy.
* Women of childbearing age must have a negative pregnancy test as confirmed by anesthesiologist.

Exclusion Criteria:

* BMI \> 30.
Comparison of the Effect of Warfarin and Direct Oral Anticoagulants

In this study, it was aimed to compare the frequency of new oral anticoagulants and warfarin usage, and to reveal the rates of recurrent upper gastrointestinal bleeding among patients who applied to our hospital with upper gastrointestinal bleeding

The data of all patients who applied to Samsun Training and Research Hospital Internal Medicine with a diagnosis of upper gastrointestinal bleeding and hospitalized by Internal Medicine and Gastroenterology clinics or who underwent outpatient endoscopy between 01.01.2021 and 31.12.2021 were included. The patients' data were analyzed from the patient files and hospital automation system retrospectively. Patients who had recurrent upper GI bleeding were detected by controlling them over the hospital software system and by reaching each patient again. The frequency of the new generation oral anticoagulants usage in patients with re-bleeding was determined, and data such as re-bleeding rate, length of hospital stay, need for transfusion, and mortality were analyzed in the groups who did not use this drug and those who used it. The patient demographics were also compared between the groups who were using the new generation oral anticoagulants, acetylsalicylic acid or warfarin.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Upper gastrointestinal bleeding
* 12 months follow-up

Exclusion Criteria:

* Age \<18 years old
* Lower gastrointestinal bleeding
* Esophageal variceal bleeding
Single Ascending Dose Study of MEDI1341 in Healthy Volunteers

This is a study of single ascending intravenous doses of MEDI1341 or placebo in up to 48 healthy volunteers, aged 18 to 65 years. The study will include up to 6 planned cohorts; each cohort will comprise 8 participants.

Each participant will receive a single 60 minute intravenous infusion of MEDI1341 or placebo and will undergo scheduled assessments over a period of 13 weeks.

The main aim of the study is to assess the safety and tolerability of single doses of MEDI1341 in healthy volunteers.

This is a randomized, double-blind, placebo-controlled study of single ascending intravenous doses of MEDI1341 in male and nonfertile female healthy volunteers, aged 18 to 65 years.

The study will include up to 6 planned cohorts; each cohort will comprise 8 participants. Within each cohort, 6 participants will be randomized to receive MEDI1341 and 2 will be randomized to receive placebo. A Safety Review Committee will review data from each cohort before progression to the next higher dose cohort occurs. On Day 1, each randomized participant will receive a single 60 minute intravenous infusion of MEDI1341 or placebo and will undergo scheduled safety, pharmacokinetic, pharmacodynamic, and immunogenicity assessments. Additional study assessments will occur on Days 2, 4, 8, 15, 22, 29, 43, 57, and 92.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be healthy, with no clinically significant abnormality identified on the medical or laboratory evaluation at screening
* Participants must weigh ≥50 kg and must have a body mass index between 18 and 32 kg/m\^2, inclusive
* Participants must have a 12-lead electrocardiogram recorded at screening that is normal for the appropriate age group and shows no abnormalities that will compromise safety in this study
* Participants must have no clinically significant findings on the clinical neurological examinations at screening and at baseline or on the ophthalmic examination at screening.

Exclusion Criteria:

* Nicotine use within 6 months before screening
* Considered to be at a high risk of developing a stroke
* Significant medical history of dizziness, blackouts, fainting, or vaso-vagal attacks
* History of any significant ophthalmic disorder, including congenital, genetic or acquired conditions affecting the retina or choroid
* History of severe allergy or history of hypersensitivity to immunizations or immunoglobulins
* History of any significant psychiatric disorder
* History of alcohol abuse
* History of cancer within 5 years of screening
* History of drug abuse
* Any contraindication to Lumbar Puncture
* Any clinically significant abnormality in ECG rhythm, conduction or morphology
* Positive serologic findings at screening for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies
* Use of prescription or non-prescription drugs
* For female participants, a positive serum or urine pregnancy test result at screening
Comparison of a Classical Rehabilitation Method and a Specific Rehabilitation Method of the Cervical Spine

In more than 90% of cases, victims of fall are elderly people over 65. Nearly the third of those people fall at least 1 time by year. The incidence substantially increases for people over 80 and women are at higher risk than men.

The value of balance rehabilitation no longer needs to be demonstrated in Gerontology. Nevertheless, a more specific therapy based on the aged-related cervical problems seems to be essential. Indeed, those problems are numerous (arthrosis-like pains, joint stiffness, muscular contractures...) and often lessen vestibular and/or proprioceptive afferents. The cervical spine is a link between different systems which regulate balance, as the visual, vestibular and cervical systems (muscular, articular afferents...), and this role is key to balance control. Indeed, the cervical spine owns an exceptional function thanks to Ruffinian corpuscles, muscle and neurotendinal spindles.

Many studies point up the importance of the relation between balance, cervical spine and vestibular system, and others between tissue changes and postural adaptations in elderly people. Nevertheless, the take into consideration of all these data and their impacts in rehabilitation has not been reported yet.

This brings us to question the added-value of a cervical mobility management in balance rehabilitation in Gerontology.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 75 hospitalized in rehabilitation department and long-term unit of Cimiez Hospital
* With MMSE \> 20
* In need of balance rehabilitation
* Who can stand Bipodal position for \>1 minute
* Who can walk for more than 10 meters without walking aid
* Having signed an informed consent
* Affiliated to a health insurance plan

Exclusion Criteria:

* Motor neurological deficit, specific vestibular pathologies
* Patient hospitalized for traumatological pathology or who has been hospitalized for traumatological pathology within 3 months
* Vulnerable people: adults under guardianship, deprived of freedom
Study of the Cutaneous Microcirculation in Elderly People

Pressure ulcers are a common and frustrating problem and their treatment is critical in elderly people. The interaction between external pressure and the skin vascular is central to the prevention of pressure ulcers. It is only through understanding of the physiology of cutaneous perfusion and its relation to external pressure or different stimuli that effective preventive measures to reduce skin beakdown can be adapted in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* volunteers

Exclusion Criteria:

* pregnancy
Dietary Intake in Adults From the GA2LEN Folow-up Survey

The Nutrition Study of the GA2LEN Follow-Survey was designed to investigate the association between usual dietary intake and allergic and respiratory outcomes in adults across Europe. Within this framework, a food frequency questionnaire (FFQ) was designed to ascertain usual dietary intake of 250 food items, which was translated into the languages of the participant centres. Information on daily intake of foods, nutrients, and flavonoids was derived.

Within the GA2LEN Follow-up Survey, the Nutrition Survey was aimed at assessing dietary intake in adults across European countries and its association with various outcomes of allergy and respiratory health. In absence of an internationally comparable dietary questionnaire to ascertain usual dietary intake, a single and standardized food frequency questionnaire (FFQ) was design to be used as a common instrument in all participant countries. The FFQ is comprised of 32 food sections and 250 food items. The FFQ sections were designed following the recommendations by the EFCOSUM Group, which facilitate international comparisons of dietary intake. It also included several staple foods to capture locally representative dietary intake.

Participants reported how often they had consumed each of the foods over the previous month, using eight predefined options (rarely or never, 1-3 times per month, once, 2-4, or 5-6 times per week, once, 2-3 times per day). Standard food portion sizes were used to quantify the intake following the recommendations from the UK's Food Standards Agency. Daily intake of foods (g) were estimated and macro- and micronutrient and flavonoid intakes were derived. The GA2LEN FFQ was validated in five EU countries, namely Finland, UK, Portugal, Germany, Poland, and Greece, and demonstrated to be a good tool to assess mid-term intake of foods, specifically essential polyunsaturated fatty acids (PUFAs). The instrument has also been demonstrated to be an accurate tool to assess dietary sources of flavonoids.

Various approaches were planned to derive dietary exposures and to examine their association with respiratory and allergic outcomes. These included the use of dietary patterns derived from Principal Component Analysis (PCA), a dietary inflammatory index (DII), as well as single antioxidants, and individual food items.

Eligibility Criteria:
Inclusion Criteria:

Participants aged 15-75 years old, who had responded to the GA2LEN Baseline survey and who met the definition of cases or controls (as described below)

Exclusion Criteria:

Participants who did not answer the baseline survey
Relative Bioavailability Of Two Formulations Of Moroctocog Alfa (AF-CC)

This study is being conducted to compare how moroctocog alfa (AF-CC) acts in the body when administered as 2 different dose presentations. The first is the current product vials with prefilled diluent syringes and the second is a new dual-chamber syringe dose presentation.

This study is being conducted in order to satisfy a post-approval EMA commitment to compare the pharmacokinetics of the 2 dose presentations used in this study.

Eligibility Criteria:
Inclusion Criteria:

* Male patients at least 18 years old with severe or moderately severe hemophilia A (facto VIII concentration less than or equal to 2%).
* Negative test for facto VIII inhibitor.
* If applicable, HIV or hepatitis treatment is stable at the time of enrollment.
* Ability to abstain from use of FVIII products for 72 hours at a time.

Exclusion Criteria:

* History of any positive test result for factor VIII inhibitor.
* Presence of any bleeding disorder in addition to Hemophilia A.
* Body weight less than 50 kg.
* History of alcoholism.
* Treatment with investigational drug or device within 30 days prior to the Screening visit.
Radiofrequency Ablation Versus Balloon Cryoablation in Elderly Patients With Atrial Fibrillation

This study compares the procedural characteristics and effectivity of radiofrequency ablation and cryoablation in patients with atrial fibrillation that are 75 years or older.

Radiofrequency and cryoballon ablation have been shown to be comparable to each other in terms of safety and effectivity in patients with atrial fibrillation. However, elderly patients have been underrepresented in the previous studies. The number of older patients with atrial fibrillation is high and the number of who undergo an ablation procedure for atrial fibrillation increases steadily. This prospective randomized trial compares the effectivity (recurrency of atrial arrhythmias) and periprocedural characteristics of the two established ablation methods in patients who are 75 years or older.

Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrent symptomatic paroxysmal or persistent atrial fibrillation
* At the day of their inclusion in the study the patients have to have completed the 75th year of life

Exclusion Criteria:

* Dementia
* Presence of left atrial thrombus
* Left atrial volume\> 50 ml/m²
* Renal failure (GFR≤ 30 ml/min)
* Comorbidity with an expected survival of 12 months or less.
Weight Changes After Incretin-mimetics

The goal of this study is to identify people at risk of weight regain after stopping an injectable weight loss drug. The main question the investigators aim to answer is: Can weight regain be predicted by measuring circulating Agouti-related peptide, a small protein coming from the brain?

This study will enroll people who are taking an injectable weight loss drug, have lost weight with the help of this drug, and are required by their health insurance plan to discontinue treatment. Participants will first be screened for health conditions that would prevent them from entering the study. Once enrolled, participants will be asked to have the following testing while still on the injectable weight loss drug: body weight measurement, body composition (fat and lean mass), resting energy expenditure (calories burned), multiple blood draws after overnight fast and after drinking and nutritional shake urine collection, urine collection, measurement of heart rate, measurement of physical activity and sleep, questionnaires. Participants will then stop taking the injectable weight loss drug when the prescription runs out, and the same tests will be repeated 3 months later.

Eligibility Criteria:
Inclusion Criteria:

* adults 18 years or older
* men and women
* prescribed an incretin-mimetic for weight loss and for whom insurance coverage for this specific drug will lapse
* any ethnicity

Exclusion Criteria:

* weight \> or = 400 lb
* type 1 or type 2 diabetes
* patients taking steroid medications
* anemia
* heart disease
* advanced kidney disease (CKD stage 4 and 5)
* decompensated liver disease
* hyperthyroidism
* untreated hypothyroidism
* active cancer
* post solid organ or bone marrow transplant
* HIV/AIDS
* pregnancy/plan for pregnancy in the next 6 months
* breastfeeding
* post-menopausal women
* current smoker
* current recreational drug use
* night shift or rotating shift workers
Camostat Mesilate Treating Patients With Hospitalized Patients With COVID-19

To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will increase the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Laboratory confirmed SARS-CoV-2 infection
* Admitted to hospital for management of SARS-CoV-2
* Age ≥18
* Subject or legal representative able to give informed consent
* Ability to take all study drugs
* Respiratory status of 3 or greater on the WHO ordinal scale
* ALT or AST ≤5 x ULN
* Creatinine clearance ≥50 mL/min using the Cockroft-Gault formula
* Willingness to provide mandatory specimens for correlative research and banking

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Known hypersensitivity to the study drug, the metabolites or formulation excipient
Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)

The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis chronic obstructive pulmonary disease
* Relatively stable airway obstruction with post FEV1 \>=30 and \< 80% predicted normal and post FEV1/ FVC \< 70%
* Male or female patients, 40 years of age or more
* Smoking history more than 10 pack years

Exclusion criteria:

* Significant diseases other than COPD
* History of asthma
* COPD exacerbation in previous 3 months
* Completion of pulmonary rehabilitation program within previous 6 weeks or current participation in pulmonary rehabilitation program.
* Pregnant or nursing women
* Patients unable to comply with pulmonary medication restrictions
Risk Analysis Interview IVDR 2023

The objective of this research project is to design a risk-based model to decide when clinical performance studies should be performed on in-house developed in vitro diagnostic tests (IH-IVDs) in compliance with the European in vitro diagnostics regulation (EU IVDR 2017/746). To construct the dataset, semi-structured interviews will be conducted to assess the clinical hazards of the in-house in vitro diagnostic test assessments, their degree of significance and their importance with respect to clinical performance, as determined by the opinions of field specialists.

The project's intervention involves conducting semi-structured interviews with clinical laboratory managers and medical professionals. The estimated number of participants for this study is 30. Various In-house in vitro diagnostic tests (IH-IVDs) will be selected, that are classified under different categories according to the risk management in the new IVDR. Two interviews will be conducted for each test. These interviews will engage a laboratory technician and a medical expert specialized in that particular test. The purpose of these interviews is to gather data on the variables that contribute to the risks of IH-IVDs and their impact on clinical diagnosis and patient outcomes. The obtained results will be applied in creating a decision tree using a pre-validated algorithm. The semi-structured interviews feature pre-determined questions that allow participants to share their experiences and opinions within their area of expertise. Each interview is expected to last between thirty minutes to an hour. If consent is given, the interviews will be recorded but not published or shared. In accordance with the confidentiality policy, all data collected will be kept anonymous.

Eligibility Criteria:
Inclusion Criteria:

* Work relation with the medical field/hospital
* Achieved a master degree or higher
* Compatible to take an interview independently

Exclusion Criteria:

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