cyrilzakka/clinical-trials huggingface dataset:
Contribution of Actigraphy for the Evaluation of Elbow Range of Motion in the Joint Assessment in Gerontology

In this study, the investigators will measure range of motion of the elbow in a geriatric assessment in 85 subjects aged 65 years or over. These measures will be made by an actigraph and the software analysis BioVal. This technique will be compared with the standard technique (inclinometer). It will also be evaluated during this study, the ease of use and feedback.

The deterioration of the musculoskeletal system occurring in aging is a major cause of loss of autonomy and directly affects the quality of life of the individual.

Support and appropriate rehabilitation for the patient's return home is essential. It requires physiotherapy assessment, which includes, among other things, a joint assessment with a measure passive range of motion.

Physical therapists have different techniques to achieve these measures for each of them, the benefits (time, reliability) and disadvantages. Among them, the goniometer and inclinometer are technical references The main objective of the study is to validate the MotionPod and the software BioVal as valid tool for measuring range of motion of the elbow in a joint geriatric assessment.

Secondary objectives are the study of the reproducibility of the measurement time and ease of use The measurement range of motion in the elbow in degree, estimated by actigraphy and software BioVal will be compared to those obtained with an inclinometer.

The movements are examined successively flexion, extension, pronation and supination.

The proportion of valid measurements will be calculated for each movement. The confidence interval 95% partner will also be calculated.

Moreover, in order to judge the validity of actigraphy in all of these measures, the investigators will calculate the proportion of patients for which the measures are valid for all four movements and the confidence interval 95% partner.

85 patients aged 65 years or more will be recruited at the Cimiez hospital the CHU of Nice, in the services of short, medium and long geriatric stay

Eligibility Criteria:
Inclusion Criteria:

* Prescription of physiotherapy .
* Prescription of a passive joint assessment
* Consent to participate in the study signed
* person with a social security system

Exclusion Criteria:

* person with a pacemeker
* patient with the inability to position the wrist straightness
* patient with the inability to position the shoulder in neutral
* metal prosthesis or osteosynthesis
* patient with a joint debate \<20 °
* contraindicated warm up
Non-invasive Diagnostics of Iron Deficiency in Surgical Patients by Measuring Zinc Protoporphyrin-IX

* In approx. 40% of the incidences anemia is caused by iron deficiency (= ID). In turn, preoperative iron-deficiency anemia (= IDA) is associated with an increase in morbidity and mortality as well as with the need for a blood transfusion.
* A successful preoperative treatment of IDA via iron supplementation requires a timely screening of iron deficiency, typically done by analyzing specific blood parameters. This however of course requires drawing a blood sample which further reduces the patients' blood volume and is in many cases stated as an inconvenient procedure.
* Measured in blood zinc protoporphyrin-IX (= ZnPP) is an established parameter to detect ID.
* This study aims to evaluate a prototype device detecting ZnPP non-invasively in the intact oral mucosa of surgical patients.
* Results from the non-invasive measurement will be compared to reference measurements of ZnPP from residual blood samples (HPLC analysis) as well as to other parameters including Hb level and iron profile (MCH \[= mean corpuscular hemoglobin\], MCV \[= mean corpuscular volume\], ferritin, transferrin, transferrin saturation, soluble transferrin receptor, CRP).

The non-invasive measurements will be performed using a prototype device based on fluorescence spectroscopical techniques. In brief, light (restricted wavelengths: 407 / 425nm) will be used to excite ZnPP molecules within the blood of the oral mucosa by means of an optical fibre prob. The outgoing fluorescence emission of the excited molecules will be analyzed using a spectrometer and converted to a ZnPP value \[unit: µmol/mol heme\] using mathematical transformations as well as spectral fitting.

This study compares the diagnostic performance of iron deficiency based on non-invasive measurements of Zinc protoporphyrin with results based on standard laboratory procedure (i.e. ZnPP measured in whole blood sample using HPLC) and blood values assessed during clinical routine, respectively.

If results of non-invasive and reference measurement techniques yield coinciding results, the non-invasive method could provide an improved mean to detect iron deficiency and thereby to improve treatment of patients suffering from iron deficiency anemia.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years

Exclusion Criteria:

* Patients who received a blood transfusion less than 8 weeks before examination
* Pregnancy
Imaging Tau in Alzheimer's Disease and Normal Aging

This study is being done to learn about tau tangles in Alzheimer's disease. A type of positron emission tomography (PET) scan is used to measure the abnormal accumulation of protein called tau in the brain. These are thought to be involved in Alzheimer's disease. The investigators will also perform brain MRI and to tests to measure the participant's memory and thinking.

This study is being done to determine the relationship between tau tangles and cognitive impairment in elderly subjects with and without Alzheimer's disease (AD). Subjects will undergo screen that includes neuropsychological testing and brain MRI. This study uses a special type of scan called a PET scan to take pictures of the brain. During the PET scan, a special radioactive dye called 18F-MK-6240 is injected into the body. 18F-MK-6240 sticks to abnormal tangles made of the protein tau. Subjects will have the option to have lumbar puncture performed to measure CSF concentrations of biomarkers.

Eligibility Criteria:
Inclusion Criteria:

1. Age 50 and older.
2. Meet criteria for either

   1. amnestic mild cognitive impairment (MCI) (single or mixed domain) or mild Alzheimer's disease (AD), or
   2. have no cognitive impairment, based on history, exam, neuropsychological testing, and consensus diagnosis. MCI and mild AD patients must have Clinical Dementia Rating scale score of 0.5 or 1. Unimpaired subjects must have Clinical Dementia Rating scale score of 0.
3. Subjects unable to provide informed consent must have a surrogate decision maker.
4. Written and oral fluency in English or Spanish.
5. Able to participate in all scheduled evaluations and to complete all required tests and procedures.
6. In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.

Exclusion Criteria:

1. Past or present history of certain brain disorders other than MCI or AD.
2. Certain significant medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries.
3. Contraindication to magnetic resonance imaging (MRI) scanning.
4. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
5. History of kidney disease or presence of impaired kidney function based on laboratory tests at screening visit.
6. History of liver disease or presence of impaired liver function based on laboratory tests at screening visit.
7. Participation in the last year in a clinical trial for a disease modifying drug for AD.
8. Inability to have a catheter in subject's vein for the injection of radioligand.
9. Inability to have blood drawn from subject's veins.
Mediterranean Diet and Protein-Sparing Modified Diet for Metabolic Syndrome in Liver Transplant Recipients

Many metabolic complications can develop after liver transplant including: diabetes, high blood pressure, obesity, heart attacks and stroke. The goal of this study is to look at the safety and effect of 2 well known and established diet regimens on the people who had a prior liver transplant and investigate whether it helps with the control of these comorbidities.

The Mediterranean diet has been shown to be effective in improving hepatic steatosis, insulin sensitivity, diabetes control and reducing cardiovascular risk in adult patients, but there is no data available for patients who underwent liver transplant. The protein-sparing modified fast (PSMF) diet has been used for years at the Cleveland Clinic to treat adult patients with obesity-related medical problems, but its safety and efficacy has not been established in liver transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

Adult patients \> 18 years old who had a successful liver transplant at least 1 year prior to enrollment who also have a BMI\>30 with previous failed attempts at weight loss via conventional methods. In addition to one of the following:

1. Triglyceride (TG)\>150 mg/dl or specific treatment for this lipid abnormality
2. HDL \<40 mg/dl in females and \<50 mg/dl in males or specific treatment of this lipid abnormality
3. Systolic BP \>130 or diastolic BP \>85 mm Hg or treatment for previously diagnosed hypertension
4. Fasting plasma glucose \>100 mg/dl or previously diagnosed type 12 diabetes

Exclusion Criteria:

* Significant behavioral issues that would interfere with compliance
* Lack of readiness to change (pre-contemplation, contemplation or preparation stages)
* Previous bariatric surgery
* Pregnant or planning to become pregnant
* History of a documented eating disorder (e.g. bulimia)
* History of kidney stones
Quadriblock Versus "IPACK + Femoral Triangle Block + Obturator Nerve Block" in Total Knee Arthroplasty

Total knee arthroplasty (TKA) is one of the most common orthopedic surgical procedure and is associated with severe pain in the immediate postoperative period, thus limiting early recovery.

Postoperative pain management requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA). For optimal pain management, several peripheral nerve blocks should be associated. Thus, a recent study shows that the combination of IPACK, femoral triangle and obturator nerve blocks (ITO blocks) provides an effective pain control after TKA.

The hypothesis of this study is that a quadruple nerve block combining femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks (quadri-block) could improve analgesia after TKA.

The main objective of this monocenter, prospective, randomized, open-label, controlled trial is to assess the effect of quadri-block on morphine consumption after TKA compared to ITO blocks.

In the pre-anaesthesia room, after the implementation of classical monitoring with an oxygen mask and a peripheral venous catheter, all patients will receive an antibioprophylaxis according to SFAR (French Society of Anesthesia \& Intensive Care Medecine) recommendations and injection of 10 mg of IV dexamethasone.

The patients will be then randomized in 2 groups:

* ITO group (usual technique): IPACK combined to femoral triangle and obturator nerve blocks
* Quadriblock group (experimental technique): femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks.

An experienced anesthetist will perform ultrasound-guided blocks 30 minutes before surgery with ropivacaine 0.3%, total volume of 70 ml.

In the operating room, general anesthesia will be induced by intravenous ketamine (0.4 mg/kg) and propofol (3 mg/kg). Anesthesia will be maintained with propofol.

Postoperative analgesia protocol :

* Multimodal analgesia will be instituted from the end of the surgery by the administration of paracetamol (1 g) and ketoprofen (100 mg).
* In post-anesthesia care unit (PACU): oxynorm titration if VRS (pain score) \>3 according to the centre's usual care.
* In ward: systematic per os analgesia with paracetamol (1 g, 4 times a day) and ibuprofen (400 mg, 3 times a day); oxynorm (10 mg, lockout interval: 4 h) if VRS (pain score) \>3.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older,
* Primary total knee arthroplasty
* Consent for participation,
* Affiliation to a social security system

Exclusion Criteria:

* Preoperative morphine use
* Chronic pain syndrome
* Contraindication to any drugs used in the protocol (paracetamol, ketoprofen, oxynorm, propofol, ketamine, ropivacaine)
* Valgus \> 9°
* Pregnant or breastfeeding women
* Patients under protection of the adults (guardianship, curators or safeguard of justice)
Prevention of Depression in Spouses of People With Cognitive Impairment

This study evaluates the effectiveness of a problem-solving training program in preventing depression in the spouses or family caregivers of persons with mild cognitive impairment or early dementia.

People with a diagnosis of mild cognitive impairment (MCI) have an estimated 12% probability each year of progressing to a dementing disorder. Pilot data suggest that the spouses of people with MCI begin to adopt the caregiver role and its burdens as they cope with this condition. Although levels of caregiver burden and psychiatric illness are lower than those typically observed in family dementia caregiving samples, our findings suggest that MCI spousal caregivers have already begun to experience distress associated with elevated caregiver burden. In order to protect the mental health and well-being of caregivers as they cope with their spouses' current and future health care needs, it may be ideal to implement selective preventive strategies while they are in the very earliest stages of caregiving. This study evaluates the effectiveness of a problem-solving training program in preventing depression in the spouses or significant others of people with MCI.

Participants in this open-label study are randomly assigned to receive either a self-management intervention targeted at problem-solving training or an attention-matched intervention targeted at nutritional education. The self-management intervention trains participants to effectively use problem-solving skills with the aim of strengthening their ability to cope with burdens of caregiving and preventing the onset or worsening of depression. The nutritional education program is based on the new United States Department of Health and Human Services 2005 dietary recommendations. All participants attend weekly individual training sessions, either in their home or another convenient location for a total of 6 weeks. At the end of 6 weeks, participants receive a weekly phone call for an additional 3 weeks to support the training they received. Follow-up data is collected at Months 1, 3, 6, and 12 post-intervention. If a participant's spouse is diagnosed with dementia during the study, additional follow-up data is collected after the Month 12 visit.

Eligibility Criteria:
Inclusion Criteria:

* Spouse or non-married partner of a patient being treated at the University of Pittsburgh Alzheimer's Disease Research Center (ADRC) for a new or subsequent diagnosis of MCI

Exclusion Criteria:

* Does not speak English
* Cohabitating adult child of a person with MCI
* Resides in an institutional or assisted-living setting
Efficacy and Safety of Oral Sulfate Solution on Bowel Preparation for Colonoscopy

To evaluate whether oral sulfate solution used for colon cleaning in adults prior to colonoscopy was not inferior to 3-liter polyethylene glycol in the proportion of subjects with BBPS score (total colon) ≥6 after colonoscopy

Polyethylene glycol (PEG) is the most widely used laxative at present, but volume of oral PEG liquid is large and the taste of PEG is not good, so some patients could not take enough laxative to complete bowel preparation. Oral sulfate solution containing sodium sulfate, magnesium sulfate, and potassium sulfate as active ingredients was developed as osmotic laxative for bowel cleansing preparation. The OSS works on the principle that sulfate is a poorly absorbed anion. Compared to traditional magnesium sulfate solution, OSS not only tastes better, but also reduces the occurrence of electrolyte disturbances.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily participate and sign informed consent;
* Scheduling screening, surveillance, and diagnostic colonoscopy;
* Necessary body fluid and blood electrolyte balance (the test values of potassium, sodium, chlorine, calcium and magnesium in blood biochemistry during screening period should not exceed 10% of the normal range).

Exclusion Criteria:

* Subjects who used drugs that affect gastrointestinal dynamics, affect kidney function, or increase the risk of fluid retention or electrolyte disorders within 7 days before the start of the trial;
* Subjects with serious cardiac and cerebrovascular diseases, bronchial and lung diseases, suffering from metabolic disease or endocrine disease, abnormal blood clotting mechanism, malignant tumor, electrolyte abnormalities, epilepsy, Renal or liver dysfunction;
* Subjects with confirmed or suspected gastrointestinal obstruction, gastric retention, gastroparesis, gastric emptying disorder or acute gastrointestinal bleeding;
* Subjects with acute severe colitis (such as active severe inflammatory bowel disease, acute bacterial dysentery, diverticulitis, etc.);
* Subjects with a history of major gastrointestinal surgery (e.g. gastric bypass, gastric septal surgery, colostomy, colectomy, etc.);
* Subjects with constipation or suspected severe gastric motility disorder;
* Women with positive pregnancy tests or pregnancy plans, and women in lactation;
* Subjects who have participated in any other clinical trials within the last 3 months;
* Subjects with any other conditions that the investigator considered inappropriate for inclusion.
A Study to Investigate the Impact of Abiraterone Acetate and Enzalutamide on Health-related Quality of Life, Participant-Reported Outcomes, and Medical Resource Use in Metastatic Castration-resistant Prostate Cancer Participants

The purpose of this observational study of metastatic castration-resistant prostate cancer (mCRPC) participants is to explore whether or not there are differences between participants treated with abiraterone acetate and enzalutamide on the health-related quality of life (HRQoL), Fatigue, Pain, Cognitive function and medical resource use (MRU).


Eligibility Criteria:
Inclusion Criteria:

* Male 18 years of age or older
* Participant with histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
* Participant with documented metastatic prostate cancer
* Participant with documented castration resistance with progression of prostate cancer on androgen deprivation therapy (ADT)
* Participant who will be initiated on either abiraterone acetate or enzalutamide for the treatment of metastatic castration-resistant prostate cancer (mCRPC) that is asymptomatic or mildly symptomatic (per physician's evaluation) after failure of ADT at the time of treatment initiation
* Participants who signed a participation agreement or Informed consent form (ICF) per local regulations
* The treatment decision (abiraterone acetate or enzalutamide) by the treating physician must have been taken before enrollment into the study
* Baseline patient-reported outcomes (PROs) must be captured before the first administration of abiraterone acetate or enzalutamide.

Exclusion Criteria:

* Patient who has received any chemotherapy/cytotoxic agent to treat their mCRPC before abiraterone acetate or enzalutamide initiation; or ; treat their metastatic hormone-sensitive prostate cancer (mHSPC) \<12 months prior to abiraterone acetate or enzalutamide initiation.
* Participant who is not capable of completing a patient survey
* Participant who has received or is currently receiving abiraterone acetate or enzalutamide
* Patient receiving an investigational treatment for prostate cancer of any kind before or at the time of initiation of abiraterone acetate or enzalutamide
* Participant who is currently included in other observational studies with abiraterone acetate sponsored by Janssen
Solitaire FR Thrombectomy for Acute Revascularisation

The objective of this study was to obtain prospective clinical data on the safety and efficacy of the Solitaire™ FR device for patients diagnosed with acute ischemic stroke.

The Study was a multi-center, single-arm, prospective, observational evaluation. The Solitaire™ FR Device has been certified for CE mark. This protocol evaluated the safety and efficacy of the Solitaire™ FR Device when used in routine practice and according to its Instructions for Use.

Eligibility Criteria:
Inclusion Criteria:

1. Subject or subject's legally authorized representative has signed and dated an Informed Consent Form
2. Age ≥ 18 and \< 85
3. Clinical signs consistent with acute ischemic stroke
4. Thrombolysis in Cerebral Infarction (TICI) 0 or TICI 1 flow in the proximal anterior intracranial vasculature (M1 or M2 of Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA) intracranial, Internal Carotid Artery (ICA) terminal)
5. Presentation within 8 hours of stroke onset according to local stroke protocol
6. If stroke presentation within 4.5 hours, one of these conditions can be met:

   * Bridging protocol (starting intravenous and continuing with intra-arterial) (Up to maximum 0.9 mg/kg)
   * Failed intravenous thrombolysis
   * Direct Intra-arterial treatment (according to institution guidelines)
7. Subject is willing to conduct follow-up visits.
8. National Institutes of Health Stroke Scale (NIHSS) ≥ 8 and ≤ 30
9. Modified Rankin Scale (mRS) ≤ 2 prior to stroke onset

Exclusion Criteria:

1. Females who are pregnant or lactating
2. Known serious sensitivity to radiographic contrast agents
3. Neurological signs that are rapidly improving prior to or at time of treatment
4. Current participation in another investigational drug or device study
5. Life expectancy of less than 90 days
6. National Institutes of Health Stroke Scale (NIHSS) \> 30 or coma
7. Uncontrolled hypertension defined as systolic blood pressure \> 185 or diastolic blood pressure \> 110 that cannot be controlled except with continuous parenteral antihypertensive medication
8. Use of warfarin anticoagulation with International Normalised Ratio (INR) \> 3.0
9. Platelet count \< 30,000
10. Glucose \< 400 mg/dL
11. Previous stroke within 30 days
12. Time of symptom onset unknown
13. Seizure at the onset of stroke
14. Myocardial infarction or infection (sepsis or endocarditis)
15. Arterial tortuosity that would prevent the device from reaching the target vessel
16. Known hypersensitivity to nickel-titanium

    Imaging Exclusion Criteria:
17. Angiographic evidence of carotid dissection, complete cervical carotid occlusions, or vasculitis
18. Stenosis proximal to thrombus site that may preclude safe recovery of the device
19. Brain computed tomography (CT) with signs of hemorrhage, arteriovenous venous malformations, or aneurysm
20. Early ischemic changes greater than 1/3 of the middle cerebral artery (MCA) territory or according to brain computed tomography (CT) Alberta Stroke Program Early CT (ASPECT) score ≤ 6 or according to magnetic resonance diffusion weighted imaging (MR DWI) ASPECT score \<5