cyrilzakka/clinical-trials huggingface dataset:
Relationship Between Protein Biomarkers in Cerebrospinal Fluid and Alzheimer&Apos;s Disease in Patients With Depression

It is currently accepted that depression during midlife is a risk factor for Alzheimer's disease (AD). Furthermore, several prospective population studies have demonstrated that depression is an independent risk factor for incident dementia of different types (e.g. vascular, mixed, Alzheimer's disease). However, it is not clear, what are the mechanisms that link depression and dementia, and if depression can be a prodromal manifestation of AD. There are also studies that suggest that depression could be an initial sign of AD.

Objective:

1. Demonstrate that late life depression (over 60 years of age) constitutes the first manifestation of AD.
2. Define by rating scales and life stressors have differential risk profiles evolutionary AD.
3. To study the relationship between the subtypes of depression and CSF biomarkers, neurophycological test and evolution to AD.

Groups of subjects: patients with recent apparition of late life depression without fulfilling the dementia criteria (Global Deterioration Scale, GDS, stages 1, 2 and 3). A longitudinal, prospective population study with two years follow-up. A cohort of will be included in the study. The patient's depression will be defined and categorized according to its severity (Yesavage Scale), whether it's endogenous or reactive (Holmes and Rahe scale) and taking into account the patient's medical history of depression.

There will be a prospective follow-up of conversion to dementia (starting from GDS Stage 4). It will be considered that dementia corresponds to AD if the biological markers of LCR present typical changes of AD at the moment of inclusion (Beta amyloid low and P-tau high).

It will be studied if there's any correlation between the clinically defined depression types and a high risk of progression to dementia and especially to AD.

Eligibility Criteria:
Inclusion Criteria:

* \>= 60 years.
* GDS (Reisberg Gobal Dementia Scale) of 2 to 3.
* Geriatric Depression Scale of Yesavage \>=12.
* History of previous depressive episodes resolved, but the emotional situation 15 months before inclusion, necessarily have to be normal.

Exclusion Criteria:

* Established dementia of any cause, or secondary degenerative dementia of any origin
* Primary diagnosis of cognitive impairment with psychiatric illness (schizophrenia , bipolar disorder, personality disorders ... )
* Dual diagnosis of chronic depression, dysthymia more than 15 months duration, or major depression with psychotic or atypical symptoms
* Neuroimaging with significant chronic vascular involvement
* To take drugs with known side effects on cognition and it is suspected that the neuropsychological deficits.
* Moderate or severe sensory deprivation or functional illiteracy in the neuropsychological study can not be performed
* Neoplastic diseasesContraindication to performing a lumbar puncture
Effects of Game-based Virtual Reality Intervention on Senior Fitness, Fall Prevention and Balance Function Among Older Adults

The purpose of this study is to explore the effectiveness between game-based virtual reality intervention and conventional health education in improving older adults' balance knowledge, and let them know how to prevent falling. The intervention group will receive virtual reality games in person and read the health education flier, while the control group was assigned to read the health education flier and follow suit the video of balance exercise.

Falls can lead to disability, sickbed and even death of the elderly, and it ranks second among the top ten which causes death in Taiwan. In the past, when multifaceted exercise interventions were conducted for the elderly, most of them focused on group strength training and aerobic exercise, but lacked individualized balance training, resulting in a low degree of cooperation.

Eligibility Criteria:
Inclusion Criteria:

* Elderly people over the age of 65-99.

Exclusion Criteria:

* cognitive impairment
* neurological diseases
* severe osteoporosis
* lower limb joint surgery
* discomfort symptoms during exercise
Effect of Omega-3 Fatty Acid Supplementation on Dry-AMD Progression

This multi-center, randomized, double-blind (subjects and doctors), placebo controlled study will evaluate the effect of krill oil on dry-AMD progression. The pilot study will observe biochemical and hematologic biomarkers changes after 3-month treatment between the krill oil group and placebo group


Eligibility Criteria:
Inclusion Criteria:

* Dry-AMD patients in either early, intermediate, or intermediate-to-late stage confirmed by fundus photography and FFA.
* Willing to stop supplementation of omega-3 fatty acids, choline, or astaxanthin.
* Willing to sign the informed consent, and willing to attend follow-up visits for at least 5 years.

Exclusion Criteria:

* Any eye with disease that would interfere with the fundus examinations
* Eye with CNV, GA or high myopia
* Surgeries that may interfere with AMD evaluation
* Long-term use of any medications that are associated with retinal or neural toxicities.
* Supplementation history with more than 2 mg lutein or 500 mg omega-3 fatty acid/day s (can be included if wash-out phase for 8 weeks before the trial)
* Omega-3 index \> 6
* Intraocular pressure more than 26 mmHg
* Received cataract surgery in 3 months.
* Other conditions: diseases that causes less than 5 years survival; any condition that causes high risk of drop-out, or low compliance, for instance cognition disorder; have been involved in other trial that interfere with the current visit plan; taking other angiogenesis Inhibitors drugs for treating cancer.
* Other conditions not suitable for the current study
Gastric Volume and Colorectal Surgery

Postoperative ileus (POI) is a serious complication after colorectal surgery. One of its most frequent consequences is the replacement of nasogastric tube because of the vomiting. Vomiting is due to the distension of the stomach and information on the evolution of gastric filling after surgery could help to better understand the physiopathology of POI. It could also give indication to help the physician in the management of POI.

The ultrasonography has been shown to be a reliable technic to assess the gastric emptying.

To date, there is no indication in the literature about the evolution of the gastric filling after colorectal surgery while these information could help to identify patients at risk for POI and to predict the need for POI replacement.


Eligibility Criteria:
Inclusion Criteria:

* patient undergoing colorectal resection whatever the surgical access

Exclusion Criteria:

* contra-indication to ultrasonography performance
* history of gastrectomy
Necrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis Mono- or Multi-microbial Streptococcus Beta-haemolytic

The aim of the study is to evaluate streptococcal carriage by swab, pharyngeal, anal and perineal in patients with DHBN-FN, in the entourage living under the same roof as well as patients with erysipelas

The main hypothesis is the major role of chronic porting of patients and entourage in DHBN-FN to SBH.

Indeed, the chronic pharyngeal / anal / perineal carriage could be a gateway following a transient bacteremia for a DHBN-FN.

The transmission of germs from the surrounding to the patient plays a major role:

At the gateway level in the case of exogenous DHBN-FN At the origin of chronic carriage in the case of endogenous DHBN-FN Transmission of germs from the patient to the surrounding area also plays an important role in increasing the risk of invasive SBH infections in the surrounding area.


Eligibility Criteria:
Inclusion Criteria:

* Patient:
* Major patient hospitalized for a DHBN-FN or erysipelas (clinical diagnosis determined at the entrance).
* Signed informed consent.

Case contact

* person of major age living under the same roof as a patient who has had a DHBN-FN.
* Signed informed consent

Exclusion Criteria:

* Patient:
* Minor patient
* Immunosuppressed patient: active hematology, poorly controlled HIV, neutropenia (PNN \<1000 / mm3).
* Patient under guardianship or curatorship
* Patient deprived of liberty by judicial or administrative decision
* Patient not affiliated to a social security scheme and not a beneficiary of such a scheme

Case contact

* Minor person
* Person under tutorship or curatorship
* Person deprived of liberty by judicial or administrative decision
* Person not affiliated with a social security
A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)

An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults with Mild to Moderate Atopic Dermatitis.

Multi-center, prospective, randomized, vehicle-controlled, investigator-blinded, stable lesion design.

Eligibility Criteria:
Inclusion Criteria:

* Subject with mild to moderate AD
* Four comparable TAs
* TSS of at least 5 on all TAs
* Difference in TSS not greater than 2 between the TAs
* Sign score erythema ≥ 2 between the TAs
* TAs should be at least 2 cm apart

Exclusion Criteria:

* Investigator's opinion
* Fitzpatrick skin type \>5
* Topical (i.e. on the TAs) treatment with prohibited medications
* Systemic treatment with prohibited medications
* Phototherapy within prohibited timeframe
* Use of emollients within prohibited timeframe
Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter

The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary infections is studied.

This study is an open randomized controlled trial of 4 weeks duration. The intervention is a novel urinary catheter with an electromagnetic therapy to prevent catheter associated infections. The catheter is used in patients which require longterm urinary catheterization over at least 1 month.

The endpoint is bacteriological exam and the laboratory is blinded to the therapy status. Weekly urinary cultures are drawn and a sonication culture of the catheter tip is performed to detect and characterize the biofilm. A colonization rate of \>95% is anticipated in the control arm. Therefore a 50% reduction in colonization can be detected with 54 patients, a 90% reduction in colonization can be detected with 20 patients with a power of 0.9.

Eligibility Criteria:
Inclusion Criteria:

* Patient with need for an indwelling urinary catheter to be placed at least for 4 weeks, which are willing and capable to provide informed consent. Most patients have spinal cord injury and are treated by the prinicpal investigator.

Exclusion Criteria:

* Need for antibiotic treatment for any infections
* Urological intervention or need for catheter change within study duration of 4 weeks
Biomarkers in Giant Cells Arteritis

Giant cells arteritis or Horton disease is a vasculitis that affects great vessels. This is the most frequent vasculitis of the population over the age of 50. This vasculitis is at the origin of an inflammatory infiltrate of arterial tunics, essentially composed of lymphocytes. Clinical signs are a deterioration of general state, unusual cephalgias, jaw pain, scalp hyperesthesia, but can also be serious ischemic complication, especially ophthalmologic with the possibility to go blind. Until now, the standard treatment is a high dosage corticosteroid therapy.

Diagnosis is based on criterias of the American College of Rheumatology, dating back to 1990. The relapse rate is important, ranging from 10 to 64 % according to studies. There are also issues of becoming dependent on steroid.

So it is important to determine new diagnosis markers and a therapeutic following of giant cells arteritis.

With this study several biomarkers of inflammation will be studied in order to determine if one ore many of them have a good sensitivity and special feature for diagnosis and following of giant cells arteritis.

The main goal is to determine a new diagnosis marker for giant cells arteritis.


Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from giant cells arteritis.
* Inclusion while discovery of symptoms, or during relapse.

Exclusion Criteria:

* Healthy volunteer
* Treatment with corticosteroid since more than 8 days for a patient suffering from giant cells arteritis, exept for patients under corticosteroid for a polymyalgia rheumatica.
* Other diseases than giant cells arteritis that could introduce an inflammatory symptom, especially a tumoral process in progress or a chronic inflammatory disease (any other one than giant cells arteritis)
Clinical Evaluation of the SportWelding FijiAnchor® in Hand and Hand Wrist Surgery

The SportWelding FijiAnchor is an absorbable suture anchor which is inserted by applying ultrasonic energy. This provides an intimate bond between implant and bone delivering immediate stability.

The purpose of this study is to evaluate the surgical and clinical outcome of the SportWelding Fiji Anchor in ligament repair of the hand and hand wrist.


Eligibility Criteria:
Inclusion Criteria:

* Having a condition requiring (re)fixation or (re)construction of ligaments in the hand or hand wrist
* Being able to comprehend, sign, and date the written informed consent form (ICF)); and
* Being able to visit the hospital to be examined the repaired region after the procedure.

Exclusion Criteria:

* Having serious concomitant disease
* Being pregnant
* Having the control hand not suitable to serve as comparator
Magnetic Resonance Imaging and Spectroscopy Biomarkers for Facioscapulohumeral Muscular Dystrophy

The purpose of this research study is to identify and study changes in muscle in people with facioscapulohumeral muscular dystrophy using magnetic resonance imaging and spectroscopy.

This research study is being done to study changes in muscle imaging over time in people with facioscapulohumeral muscular dystrophy (FSHD). Whole-body magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) will be used to evaluate skeletal muscle in study participants. This research is being done to assess how changes in muscle imaging correspond to muscle strength and function. Qualified participants will be asked to complete 5 study visits over 21 months. Each visit will include muscle strength and function testing in addition to the MRI/MRS scan. The investigators plan to use MRI and MRS in developing outcome measures that can be used in future clinical trials for FSHD.

Eligibility Criteria:
Inclusion Criteria:

* Ability to give written informed consent for study participation (a parent or guardian will be asked to provide informed consent for participants younger than 18 years old)
* Confirmed diagnosis of FSHD through genetic testing (participants will be asked to provide copies of genetic testing results)

Exclusion Criteria:

* Any contraindication to MRI scanning
* Inability to complete a physical examination, including strength measurements
Exercise in Women With Fibromyalgia

Background The Al-Andalus physical activity intervention study is a randomised control trial to investigate the effectiveness of a land- and water-based exercise intervention for reducing the overall impact of fibromyalgia (primary outcome), and for improving tenderness and pain-related measures, body composition, functional capacity, physical activity and sedentary behaviour, fatigue, sleep quality, health-related quality of life, and cognitive function (secondary outcomes) in women with fibromyalgia.

Methods One hundred eighty women with fibromyalgia (age range: 35-65 years) will be recruited from local associations of fibromyalgia patients in Andalucía (Southern Spain). Patients will be randomly assigned to a usual care (control) group (n=60), a water-based exercise intervention group (n=60) or a land-based exercise intervention group (n=60). Participants in the usual care group will receive general physical activity guidelines and participants allocated in the intervention groups will attend three non-consecutive training sessions (60 minutes each) per week during 24 weeks. Both exercise interventions will consist of aerobic, muscular strength and flexibility exercises.

Discussion The investigators study attempts to reduce the impact of fibromyalgia and improve patients' health status by implementing two types of exercise interventions. Results from this study will help to assess the efficacy of exercise interventions for the treatment of fibromyalgia. If the interventions would be effective, this study will provide low-cost and feasible alternatives for health professionals in the management of fibromyalgia. Results from the Al-Andalus physical activity intervention will help to better understand the potential of regular physical activity for improving the well-being of women with fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* Age: 35-65 years.
* Meeting the American College of Rheumatology criteria: widespread pain for more than 3 months, and pain with 4 kg/cm of pressure reported for 11 or more of 18 tender points.
* Not to have other severe somatic or psychiatric disorders, or other diseases that prevent physical loading (Answer "no" to all questions on the Physical Activity Readiness Questionnaire-PAR-Q ).
* Not to be engaged in regular physical activity \>20 minutes on \>3 days/week.
* Planning to stay in the same Association during the study.
* Able to ambulate, with or without assistance.
* Able to communicate.
* Informed consent: Must be capable and willing to provide consent.

Exclusion Criteria:

* Acute or terminal illness.
* Myocardial infarction in the past 3 months.
* Not capable to ambulate.
* Unstable cardiovascular disease or other medical condition.
* Upper or lower extremity fracture in the past 3 months.
* Severe dementia (MMSE\<10).
* Unwillingness to either complete the study requirements or to be randomised into control or training group.
* Presence of neuromuscular disease or drugs affecting neuromuscular function.
Prevention of Ischemic Conditions in Non-disabling Stroke/Transient Ischemic Attack With Remote Ischemic Conditioning

This is a single-arm, open-labeled and phase II futility study. Application of Remote ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the study. The study is to test whether RIC is effective in preventing ischemic evens after a minor ischemic stroke/transient ischemic attack within 3 months and to explore the safety and compliance of chronic RIC. Medication strategy is based on physician's best judgement.

This is a single-arm, open-labeled and phase II futility study. Application of Remote ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the study. RIC consisted of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. The study is to test whether RIC is effective in preventing ischemic evens after a minor ischemic stroke/transient ischemic attack within 3 months and to explore the safety and compliance of chronic RIC. Medication strategy is based on physician's best judgement.

Eligibility Criteria:
Inclusion Criteria:

1. Eighteen years old or older of any gender or race;
2. Diagnosed with a non-cardiogenic MIS/TIA within 14 days; MIS is defined by an ischemic stroke of score of 3 or less on the NIHSS at the time of inclusion, TIA is defined as neurologic deficit attributed to focal brain ischemia, with symptoms resolution within 24 h of symptom onset, Symptom onset is defined by the "last see normal" principle;
3. Stable vital signs, normal cardiac, hepatic and renal functions;
4. Able to consent by himself/herself or by legally authorized representative.

Exclusion Criteria:

1. Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other non-vascular diseases, based on brain CT or MRI;
2. Modified Rankin Scale score \> 2 at inclusion;
3. Received iv. recombinant tissue plasminogen activator (rtPA) therapy or interventional treatment for the current event;
4. Contradiction for aspirin or clopidogrel (known allergy, severe asthma or heart failure et al.) ;
5. Clear indication for anticoagulation therapy ( cardiac source of embolus);
6. Hemorrhagic tendency of any reason （including but not limit to Hemostatic disorder, platelet count \<100 × 109/L, history of drug-induced hepatic dysfunction）;
7. Any hemorrhagic transformation;
8. Gastrointestinal bleed or major surgery within 3 months of symptoms onset;
9. Stroke or TIA induced by interventional therapy or surgery;
10. Any upper extremity soft tissue, vascular injury or peripheral blood vessel disease which may contraindicate RIC;
11. Systolic blood pressure greater than 200 mmHg after medication;
12. Planned revascularization (any angioplasty or vascular surgery) within the next 3 months ；
13. Scheduled for surgery or interventional treatment requiring RIC cessation within next 3 months;
14. Severe noncardiovascular comorbidity with life expectancy \< 3 months;
15. Pregnancy;
16. Currently receiving an investigational drug or device by other studies.
Early Procalcitonin Kinetics During Empirical Antibiotic Therapy in Critically Ill Patients

To investigate the value of procalcitonin (PCT) kinetics between 0-8-16-24 hours after starting empirical antibiotic therapy in critically ill patients, to predict appropriate or inappropriate antibiotic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical signs of infection
* Suspected or proven acute infection requiring empiric antibiotic therapy as decided by the attending ICU physician
* Suspected site of infection has to be present and documented
* Microbiological sample sent for staining
* Inflammatory markers available at the start of the therapy

Exclusion Criteria:

* Patients younger than 18 years
* Who received prophylactic or empiric antibiotic therapy 48 hours before inclusion
* Whose receiving acute renal replacement therapy in the first 24 hours following antibiotic treatment
* Following cardiopulmonary resuscitation
* End stage diseases with a "do not resuscitate" order
* Immunocompromised patients (human immunodeficiency virus infection, bone marrow transplantation, malignant haematological disorders and chemotherapy)
* Post cardiac surgery patients