cyrilzakka/clinical-trials huggingface dataset:
The State of Play in Picardy of the Knowledge of the Elderly at Risk of Falling at Home in Terms of Prevention and Evaluation.

In 2010, the French population over 75 years of age was 9%; It will be 13% in 2030 and 19% in 2050 according to estimates. The incidence of falls is high in the elderly population, with at least one fall per year for one-third of the over-65s and for half of the over-80s. These data are consistent with the international medical literature, particularly in Japan, the United States and France, with a high rate of recurrence from the first fall. Falling is a complex phenomenon that is of great importance in terms of morbidity and mortality since it can be followed by serious complications: failure to recover, recurrences, trauma (fractures, hematomas, wounds), complications of decubitus and ulcers, Immobilization, loss of autonomy, hospitalization, institutionalization, psychological complications (post-fall syndrome, depressive syndrome), death.

Fall risk factors are well known and described and relayed by learned societies of geriatrics and medical literature. In addition, HAS reported on this issue in 2009.

The French Society of Geriatrics and Gerontology (SFGG) defines fragility as a clinical syndrome that reflects a decrease in reserve physiological capacities that alters the coping mechanisms of stress. Its clinical expression is modulated by comorbidities and psychological, social, economic and behavioral factors. Frailty syndrome is a risk marker for mortality and pejorative events, including disability, falls, hospitalization and institutionalization. The fall and its complications are closely related to the fragility syndrome. The very fragile patient must take an active part in his own care. He is the first advocate of fall prevention.

On the other hand medical desertification and the low number of geriatricians makes this implication problematic even more so if the person is isolated or has cognitive impairment. Nevertheless, it is important to make the patient actor of his own prevention. This is the first study to describe the knowledge of older adults about their own risk of falling.


Eligibility Criteria:
Inclusion Criteria:

* male or female over 75
* considered by their attending physician as a fall arrester or at risk of falling and living at home
* presenting themselves to the office of their attending physician for a consultation for whatever reason.

Exclusion Criteria:

* EHPAD resident
* patient not affiliated to a social security scheme
* under legal protection
Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery

Patients (pts) with stable coronary artery disease (CAD) requiring coronary artery bypass graft surgery (CABG) may be physically inactive during the waiting period to avoid further risks. Aim of this study is to investigate the feasibility and safety of a preoperative aerobic exercise training in these pts during the waiting period and to analyze its effects on pre-, peri and postoperative outcomes

Pts with stable coronary artery disease (CAD) and indication for elective CABG will be prospectively randomized into a preoperative training group (TG) or a non active control group (CG). Pts in TG have to perform six sessions of aerobic endurance training within two weeks prior to CABG. The following investigations will be performed at baseline, one day before surgery and at the beginning and at the end of cardiac rehabilitation: a maximal symptom limited ergospirometry, assessment of endothelial function (analysing the reactive hyperaemic index (RHI) via a finger-tonometry), assessment of quality of life (QoL) using the MacNew Heart Disease Questionnaire, laboratory testing of ischemic and inflammatory Parameters. Baseline, peri- and postoperative characteristics will be collected.

Eligibility Criteria:
Inclusion Criteria:

* stable Angina
* indication for elective CABG surgery
* functional capacity \> 50 watts
* willingness to participate in the study

Exclusion Criteria:

* unstable Angina
* comorbidities precluding performance of aerobic exercise training (e.g. neurological disorders, orthopedic disorders etc)
* functional Status NYHA IV
* relevant ventricular arrhythmias
* hemodynamic significant heart valve disease
* myocarditis
* cardiomyopathies
* left main coronary artery disease \> 50%
* peripheral obstructive disease (Fontaine \> IIb)
* reduced life expectancy \< 12 months
* CABG surgery during the last six months
* participation in another trial
Emergency Medical Technician Treat-and-leave Patients Receiving Telemedicine Consultation With Emergency Medical Dispatch Physician - a Controlled Before and After Pilot-study

A large part of acutely ill patient's access to the health care system starts by calling the emergency number 1-1-2 and thereby getting in touch with the emergency medical dispatch center (EMDC). In most cases an ambulance is dispatched and the patient is brought to the hospital. These patients are not referred by a physician (eg. a GP) and represent an unselected subpopulation of the acutely ill patients. At present, all non-critically ill patients not evaluated by a pre-hospital physician are normally be transported to hospital as category 2 (without activated emergency lightning and sirens).A part of this patient population, however, is not critically ill and a proportion of these may not need hospital admittance . Emergency medical technicians (EM) are not allowed to treat - and- leave patients without a physician's involvement. If the EMT had 24/7 online access to medical control i.e. in form of a physician present in the EMDC , the number of patients transported to hospital for assessment may be reduced as well as response times for patients actually needing ambulance transportation. This could potentially reduce the workload on the whole healthcare system involved in the management of these patients - thereby potentially reducing costs.

The objective of this study is to evaluate if a systematic telemedical assessment by an EMDC-physician of all patients who receive an ambulance but are not critically ill and would have a category 2 transport to hospital can reduce the number of the patients that are transported to hospital and save costs and time.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving an emergency ambulance after calling the EMDC Patients who are going to be admitted to a Hospital in the Central Denmark Region.
* Patients who are going to be transported as category 2 patients (non-critical illness, not requiring transport with activated lightning and sirens.

Exclusion Criteria:

* Critically ill patients (Patients who are going to be transported as category 1 patients (critical-illness, requiring immediate transport with activated sirens and warning lights )
* Patients who are not supposed to be admitted to a hospital in the Central Denmark Region
A Premarket, Prospective, Randomized, Single-Blind Study to Compare the Veriset™ Hemostatic Patch to TachoSil® as an Adjunct to Hemostasis in Subjects Undergoing Cardiovascular Surgery

The objective of this study is to assess the safety and effectiveness of Veriset™ Hemostatic Patch in cardiovascular procedures by comparing Veriset™ Hemostatic Patch to TachoSil® in subjects undergoing open cardiovascular surgery involving the aorta (e.g., aortic valve replacement (AVR), David procedure, Bentall procedure, abdominal aortic aneurysm repair, etc.), or CABG.


Eligibility Criteria:
Inclusion Criteria:

* Subject has provided informed consent.
* Subject is ≥18 years of age.
* Subject is scheduled for surgery involving the aorta (e.g., aortic valve replacement (AVR), David procedure, Bentall procedure, abdominal aortic aneurysm repair, etc.), or coronary artery bypass graft (CABG) where a topical hemostatic agent would be used to control bleeding via an open approach.
* Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
* Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death.
* Subject has a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin.
* Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding.
* Subject has an estimated life expectancy of less than 6 months.
* Subject is unwilling to receive blood products.
* Subject is scheduled for another planned cardiovascular surgery, and subsequent surgery would jeopardize previous application of study treatment.
* The subject has participated in another investigational drug or device research study within 30 days of enrollment.

Exclusion Criteria:

* Subject has an appropriate Target Bleeding Site (TBS) defined as an area of bleeding on the aorta or coronary vessels where hemostasis by conventional methods is ineffective or impractical, and thus necessitates the use of a topical hemostatic agent.
* TBS Bleeding is Type 2 (Oozing/Mild) or 3 (Moderate).
* It is possible to hold pressure on Veriset™ Hemostatic Patch or TachoSil® for at least 3 minutes.
* Incidental finding of any other pre-operative exclusion criteria
* Subject does not have an appropriate TBS.
* TBS Bleeding Assessment is Type 1 (No bleeding) or 4 (Severe/Surgical/Life Threatening).
* Subject has an active local infection at the surgical site.
* Investigator determines that participation in the study may jeopardize the safety or welfare of the subject.
Treatment of Acetabular Fracture: the Contribution of the 3D Impression

Acetabular fracture are common in elder patients and high energy trauma in younger one.

However, the fracture deplacement induces incongruity between cotyloid cavity and femoral head. Anatomic reduction and osteosynthesis of these fracture are technically difficult .

3D printing ease the process of operating planification or implant fabrication. The 3D impression allows to obtain a model on the scale of the pond of the patient allowing to pre mold plates on the anatomy of the patient before he is operated with the aim of decreasing the surgical time and improving the quality of the reduction.


Eligibility Criteria:
Inclusion Criteria:

* age \>18
* acetabulum fracture within one month
* anterior access or double access

Exclusion Criteria:

* acetabulum fracture more than one month
Drug-drug Interaction Study of CTP-543 and Oral Contraceptives in Healthy Female Subjects

This is a Phase 1, fixed sequence, multiple dose, open-label study of the effect of CTP-543 on oral contraceptive pharmacokinetics in healthy female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female participants of non-childbearing potential, or adult females of childbearing potential who agree to use birth control methods described in the protocol
* If of reproductive age, willing and able to use a medically highly effective form of birth control 28 days prior to first dose, during the study and for 28 days following last dose of study medication. Examples of medically highly effective forms of birth control are:

  1. Surgical sterilization of the partner (via vasectomy, hysterectomy, bilateral tubal ligation or bilateral salpingectomy) at least 4 months prior to first dose or post-menopausal with amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels (\> 40 IU/L) consistent with postmenopausal status
  2. Sexual partner is sterile, or of the same sex
  3. Double-barrier method (any combination of physical and chemical methods)
  4. Non-hormone releasing intrauterine device in females
* Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dosing and throughout the study
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
* Medically healthy with no clinically significant medical history, physical examination, laboratory tests, vital signs, or ECGs
* Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol

Exclusion Criteria:

* Positive pregnancy test
* History or presence of clinically significant medical or psychiatric condition or disease
* History of any illness that might confound the results of the study or pose an additional risk to the subject by their participation in the study
* History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
* A positive tuberculosis test at screening or history of incompletely treated or untreated tuberculosis
* Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
* Donation of blood or significant blood loss within 56 days prior to dosing
Fatigue, Quality of Life, Cognitive Function and Physical Ability in Patients Suspected of Colorectal Malignancy

The aim is to investigate if iron deficiency at the time of colorectal cancer diagnosis has an influence on fatigue, quality of life, cognition and physical ability.

Around 60% of newly diagnosed colorectal cancer patients suffer from iron deficiency at the time of diagnosis. The study hypothesis is that, besides leading to anemia, iron deficiency might be associated with impaired patient report outcomes in the domains of fatigue, quality of life, cognitive impairment and lower physical ability. No previous studies on colorectal cancer patients and iron deficiency are available.

The participants (patients suspected of colorectal cancer after endoscopy) will be tested on these parameters. The participants and the investigators are blinded to the patients iron status. The study takes place before any preoperative iron treatment. Multivariate analysis will be used taking into account, gender, age, hemoglobin, tumor stage.

Eligibility Criteria:
Inclusion Criteria:

* patients in whom endoscopy has raised suspicion of colorectal malignancy

Exclusion Criteria:

* non fluent in Danish language
* cerebral impairment (ex severe dementia) so that informed consent can not be obtained
Abnormal Expression Proteins, Mitochondrial DNA and miRNA of Irritable Bowel Syndrome

In the investigators study, the investigators will focus on the screening of the related proteins and miRNA to IBS in order to reveal the possible clues or molecular mechanism for this disorder.

For the proteomic procedures, Our study groups extracted proteins from the cecum and sigmoid colon samples and ran on the two-dimensional gel electrophoresis (2-DE). The proteins on 2-DE were visualized by the silver stain, and then gel maps were scanned and analyzed with the Image Master 2D Elite. The obvious abnormal protein spots were identified by the mass spectrometry. Western blot 、 immunohistochemistry 、 mRNA and miRNA were also performed for further verification of the proteins.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptoms meeting Rome III criteria for diagnosis of IBS-C and IBS-D

Exclusion Criteria:

* Patients with organic illnesses or a history of major abdominal surgery
* Major psychotic episode, mental retardation or dementia
* Pregnant women and lactational women
* Postinfectious IBS, PI-IBS
The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)

The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) \[PEG+RBV=PR\] is effective in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. The primary hypothesis is that the percentage of participants achieving sustained virologic response in the BOC + PR group is superior to that in the Placebo (PBO) + PR group.


Eligibility Criteria:
Inclusion criteria:

* body weight ≥40 kg and ≤125 kg
* previously documented CHC genotype 1 infection;
* must have a liver biopsy with histology consistent with CHC and no other etiology
* if cirrhosis present, must have an ultrasound within 6 months of the screening visit (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC)
* agree to use acceptable methods of contraception with partner
* previously untreated with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV or failing prior treatment with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV

Exclusion criteria:

* co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen \[HBsAg\] positive).
* required discontinuation of previous interferon or ribavirin regimen for an adverse event (possibly or probably related)
* treatment with ribavirin within 90 days and any interferon-alpha, based on the amendment, should be within 1 month prior to screening
* treatment with any investigational drug within 30 days of the screening visit in this trial
* evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
* diabetic and/or hypertensive with clinically significant ocular examination findings
* clinical diagnosis of substance abuse of specified drugs within specified timeframes
* any known pre-existing medical condition that could interfere with the participant's participation in and completion of the trial
A Study of LY3556050 in Healthy Participants

The main purpose of this study is to learn more about the safety of LY3556050 after it is given by mouth to healthy participants. Blood tests will be performed to check how much LY3556050 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive multiple doses of LY3556050 or placebo and will remain in the study for up to 31 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females of nonchild bearing potential, as determined by medical history
* Have safety laboratory results within normal references ranges
* Weight at least 50 kilograms (kg)

Exclusion Criteria:

* Have known allergies to LY3556050, iodine, metformin and related compounds
* Abnormal electrocardiogram (ECG) or blood pressure at screening
* Significant history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or endocrine disorders
* Show evidence of active renal disease with estimated glomerular filtration rate (GFR) \<90 milliliters per minute per 1.73 meters squared
NGAL, an Early Predictive Marker of Acute Kidney Injury After Cardiac Surgery in Neonates and Infants

Urinary NGAL has been shown to be an early marker of acute kidney injury (AKI) following paediatric cardiac surgery (2 hours off pump). Previous studies showed that an early increase of urinary NGAL following cardiopulmonary bypass was predictive of AKI. Several studies included heterogeneous populations of children undergoing cardiac surgery, but NGAL has not been studied in neonates after open heart surgery, neither has been identified the threshold for accurate prediction of severe AKI requiring renal replacement therapy.

The aim of this observational cohort study is to describe postoperative kinetics of urinary NGAL in neonates and to identify the threshold for accurate prediction of severe AKI requiring renal replacement therapy in neonates and infants undergoing cardiac surgery

Urinary NGAL has been shown to be an early marker of AKI following paediatric cardiac surgery (2 hours off pump). Previous studies showed that an early increase of urinary NGAL following cardiopulmonary bypass was an excellent predictor for a later \>50% increase in serum creatinine concentration in children undergoing cardiac surgery. Increased urinary concentrations of NGAL were found following open heart surgery. When defining AKI as an \>50% increase of serum creatinine from baseline, the increase of urinary NGAL concentration two hours off pump appeared to be an excellent predictor of AKI. Several studies included heterogeneous populations of patients aged one month to 21 years undergoing cardiac surgery. Besides, NGAL concentrations have not been studied in neonates after open heart surgery, neither has been identified the threshold for accurate prediction of severe AKI requiring renal replacement therapy (RRT). If such a threshold was identified, urinary NGAL could be provided for intervention.

The aim of this observational cohort study is to describe postoperative kinetics of urinary NGAL in neonates and to identify the threshold for accurate prediction of severe AKI requiring RRT in neonates and infants undergoing cardiac surgery with cardiopulmonary bypass.

The study is entirely observational, the decision to initiate RRT continues to be based on clinical evidence of fluid overload, low cardiac output and oliguria. Urine samples are collected during the early postoperative period, stored, than NGAL concentrations are measures on the ARCHITECT platform.

Eligibility Criteria:
Inclusion criteria :

* term neonates and infants undergoing heart surgery with cardiopulmonary bypass
* parents received written information

Exclusion criteria :

* preoperative documented kidney injury
* parents not informed, opposed
What is the Gold Standard of Airway Management in the Anticipated Difficult Airway

A prospective Observationalstudie to analyze the current significance of the awake flexible endoscopy in German hospitals.

The aim of the study is to analyze the current significance of the awake flexible endoscopy in German hospitals, to identify strategies to securing the airway in patients with a anticipated difficult airway. The participants complete a pre-prepared questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* experience in anesthesia or intensive care

Exclusion Criteria:

* no
Nightmare Rescripting and Rehearsal

This study aims to test the efficacy of an abbreviated version of Imagery Rehearsal Therapy administered by non-mental health professionals in a Primary Care setting. This treatment, to be called 'Nightmare Rescripting and Rehearsal Therapy' (NRRT) would arm Primary Care medical personnel with a nonpharmacologic, ten minute intervention for treating recurring nightmares.

The study will provide sleep hygiene education to both the control and experiment groups, NRRT to the experiment group only, and compare their Nightmare Distress Questionnaire and Nightmare Frequency Tool at two (2), four (4), and six (6) week intervals.

This is a prospective Randomized Controlled Trial to determine if a standard of care sleep hygiene handout plus a brief 10 minute intervention for recurring nightmares (Nightmare Rescripting and Rehearsal Therapy) reduces scores on the Nightmare Distress Questionnaire and Nightmare Frequency Tool, when compared to patients solely receiving a handout outlining sleep hygiene techniques. Individuals with a minimum score on the Nightmare Distress Questionnaire and Nightmare Frequency Tool of 15 out of a possible 52 who meet all other inclusion criteria will be invited to participate.

A clinically significant reduction will be considered if a decrease in Nightmare Distress and Frequency measures is greater than or equal to 25% from baseline. Secondary outcomes will include PCL-5 (PTSD), PHQ9 (Depression), GAD7 (Anxiety), ISI (Insomnia Severity Index) scores.

Eligibility Criteria:
\*\*Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study\*\*

Inclusion Criteria:

* Active Duty members and DoD beneficiaries.
* Aged 18 years or older
* Recurring disturbing dreams (at least three times per month for the past one month)
* Participants must score a 15 out of a possible 52 on the Nightmare Distress Questionnaire and Nightmare Frequency Tool in order to qualify.

Exclusion Criteria:

* Aged less than 18 years old
* Unwilling to refrain from taking an over the counter or prescription medication for the purpose of improving sleep during the course of the study.
* Participants that score less than a 15 out of a possible 52 on the Nightmare Distress Questionnaire and Nightmare Frequency will be excluded