cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Nutritional Status and Fatigue in Patients With Multiple Sclerosis

Multiple sclerosis (MS) is a chronic progressive neurological disease, the leading cause of disability after injury accidents in young adults. Among the many symptoms, fatigue is very common with a significant impact on quality of life. Also, the disability caused by multiple sclerosis can alter food intake and can cause nutritional deficiencies. Nutrients such as proteins, minerals (iron, calcium, magnesium), some vitamins (B12, 25 OHD) are often deficient in this population with consequences in physical performance such as endurance and muscle strength. We propose to study the link between fatigue and shortcomings encountered in a defined population of MS patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 65 years old
* Expended disability status scale (EDSS) between 0 and 7
* Diagnosis of MS according to the revised criteria of McDonald
* Clinically stable patients in the past 3 months
* Coverage of the social insurance
* Informed consent to participate

Exclusion Criteria:

* Cognitive disorders that can hinder answering questionnaires
* Presence of uncontrolled metabolic disease(s)
* Malabsorption
* Patients with a gastrostomy
* Active cancer under treatment
* Anorexia
* Pregnancy or breast feeding
* Severe psychiatric disorder(s)
* No informed consent to participate
* No coverage by the social insurance
Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery

Statins have been used to low cholesterol to prevent and treat coronary artery diseases. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. The investigators recent found simvastatin reduced myocardial injury during noncoronary artery cardiac surgery in single medical center. The investigators further investigate that whether simvastatin can protect myocardium during noncoronary artery cardiac surgery with cardiopulmonary bypass and improve cardiac function with long term use postoperatively in two medical centers.


Eligibility Criteria:
Inclusion Criteria:

* More than 18-year-old,
* Congenital heart disease(not complex),
* Isolated heart valve disease,

Exclusion Criteria:

* Coronary artery disease
* Allergy for statins
* Poor liver function,Hepatitis
* Gestation women and Breast-feeding women
Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Unresectable Gastric Cancer

Exploratory the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients with Unresectable Gastric Cancer

To assess the effectiveness and safety of S-1 + Paclitaxel for the peri-operative chemotherapy in Chinese patients with unresectable gastric cancer, so as to further find out the optimal protocol for the peri-operative chemotherapy in the patients with gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

-Unresectable gastric cancer as proven histologically (AJCC, Version 7) under any following condition: Unable radical excision due to the local metastasis or invasion Metastasis to the lymph node beside the abdominal aorta Non-extensive metastasis to liver (not more than three metastatic foci of radical excision)

* Definitely diagnosed as above stage of stomach cancer before the operation via CT or MRI, ultrasonic endoscopy and blood tumor antigen test, or through the laparoscopy if necessary
* Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
* ECOG (Eastern Cooperative Oncology Group) : 0\~2
* Age: 18\~75 years old
* Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC\>4.0×109/L, NEU \>1.5×109/L, PLT\>100×109/L, BIL\<1.5 times of upper limit of normal reference value, ALT and AST\<2.5 times of upper limit of normal reference value, and CRE\<1.2mg/dl
* Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases
* Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver)
* Not participating in other study projects before and during the treatment
* Signed the Informed Consent Form

Exclusion Criteria:

* Not conforming to above inclusion criteria
* Distal metastasis to lung, brain and bone (except the liver)
* Ever operation on the stomach
* Operation intolerance due to other systemic basic diseases
* Ever administered other drugs (including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after the recruitment
* Allergy to the drugs in this protocol
* Pregnant or lactating women
* Women at childbearing age and of pregnancy desire during the study
Ultrasound Based Localization of Lumpectomy Bed in Anatomical Coordinate System

This is a pilot study. The main purposes for doing the study are to see if there is a relationship between lumpectomy volume and position as measured by USEI and by CT. This is not a study to see if the use of USEI is better than the current method of using CT for daily radiation therapy positioning.

1. Abstract The feasibility, toxicity and efficacy of Partial Brest Irradiation (PBI) are currently being studied by major cooperative groups such as the NSABP, and RTOG as well as by several major academic institutions. PBI entails definitive radiation to the lumpectomy site while minimizing radiation to the remaining breast tissue. The success of PBI is dependent in no small part to proper target localization. In radiation therapy, to treat an internal structure, external landmarks must be used to calculate the position of the internal target. These external landmarks can easily change in a non-rigid structure (e.g. breast), which would nullify their use as a reference. To address this problem, there have been recent advances in the application of ultrasound (US) technology in target localization especially with respect to the prostate. Transcutaneous tracked US emerged as the most suitable non-invasive daily prostate localization tool. In this procedure an US probe is tracked and spatially registered with respect to the treatment machine, linear accelerator. Thus if one localizes the target anatomy in the US images, then the position of the target is automatically known with respect to the linear accelerator, so that the accelerator can be correctly aimed.

Unfortunately, contemporary US imaging is not sufficiently sensitive to delineate the lumpectomy bed for PBI. We propose to supplant B-mode imaging with a novel US elasticity imaging (USEI) method to delineate the subtle and complex boundaries of the lumpectomy cavity. Our preliminary studies suggest that USEI may be superior to B-mode imaging (see statistical section and Ref. 6-7). However our work was only done in ex-vivo tissue models. In the literature, there are many studies showing the superior sensitivity and specificity of strain imaging compared to regular B-mode imaging7.

The benefit of developing a way to use ultrasound for target localization is clear. Identification of the target would no longer be dependent on unreliable external landmarks but now on direct internal information. As a consequence, targeting errors, most commonly associated with patient positioning, could be significantly reduced or practically eliminated. Thus, we propose to study the ability of USEI to detect and characterize the lumpectomy bed in-vivo using CT data as ground truth. We will pursue our work in two specific aims:

Aim 1: Describe the concordance between the lumpectomy bed's center-of-mass (COM) as determined by USEI and CT.

Aim 2: Describe the concordance between the lumpectomy bed volume as measured by USEI and CT.

Eligibility Criteria:
Inclusion Criteria:

* Women with breast cancer, who are status post lumpectomy and are scheduled to have radiation therapy, will be eligible.
Epidemiological Study of the Covid-19 Presto Test - The "COVIDOR" Study

The "COVIDOR" epidemiological study. Our study would be the first at the community level in Orleans Métropole, aiming to determine the link between a positive IgM level on the serological test and a healthy carrier of covid-19 in agents in contact with the public. It would provide epidemiological surveillance of anti-covid-19 immunity in the community

The metropolitan area of Orléans Métropole has 6,700 agents divided into 250 different trades and consequently multiple exposures and risks.

The global covid-19 pandemic has affected France and the Loiret, the sarscov-2 coronavirus, has infected several thousand people. On May 7, 2020, there were 75 deaths at the CHRO hospital in Orleans, excluding EHPAD. The contamination rate of the population of the Loiret department has been estimated at 5.6% of the population by Public Health France. This rate is very low and does not allow the use of serological screening tests because of too many false positives or false negatives, there should be a prevalence of the disease greater than 60%. The French health authorities do not recommend the use of a screening test at the present time in view of the uncertainties of the results of this test. The Loiret Management Center, the Department and Orléans Métropole have decided to offer a covid-19 serological screening test, the covid-19 presto test, to voluntary territorial agents regardless of their return to work following the national "deconfinement "on May 11, 2020 This can only be done through an epidemiological surveillance study validated as part of a research protocol.

Eligibility Criteria:
Inclusion Criteria:

* All the agents of the 3 local authorities (Loire Valley Region, CCTVL and Orléans Métropole) being voluntary to be tested for the COVID-PRESTO® test COVID-19 IgG / IgM rapid test (whole blood / serum / plasma) - Cassette
* Volunteer to get tested

Exclusion Criteria:

* Opposition to the participation of the study
* Covid-19 disease
Efficacy and Treatment Related Toxicity Study of a New Regimen for Lymphoma

This is an open label pilot study of 40 evaluable patients receiving vinorelbine-gemcitabine combination chemotherapy with filgrastim support in an outpatient setting. Participating patients at the time of registration will have measurable relapsed or primary refractory lymphoma.

Patients suffering from lymphoma (a type of cancer of the white blood cells called lymphocytes) have less chance of cure if they are refractory to initial chemotherapy or relapse after receiving initial chemotherapy when compared to patients who are responsive to and do not relapse following initial chemotherapy. The standard of care, therefore, for these patients is to undergo some form of bone marrow transplant procedure. However, before this can be considered most patients require chemotherapy to control the lymphoma and to determine whether the lymphoma is still sensitive to alternative types of chemotherapy (salvage chemotherapy). Currently used types of salvage chemotherapy require significant periods of inpatient hospitalisation and are associated with significant haematological toxicities (low blood counts with the associated risks of infection and bleeding and the need for blood and platelet transfusions). Two new chemotherapy drugs, vinorelbine and gemcitabine, have both shown encouraging efficacy against lymphoma when used alone for patients with heavily pretreated lymphoma. Furthermore, they can be given in an outpatient setting and are usually not associated with significant haematological toxicity. All the patients participating in this study have been diagnosed with relapsed or refractory lymphoma and have been offered treatment with vinorelbine and gemcitabine as an alternative to inpatient salvage chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 70 years
* relapsed or primary refractory non-Hodgkin's lymphoma (NHL) or Hodgkin's Disease (HD)
* measurable disease (clinically or radiologically)
* ECOG 0 - 2
* written informed consent

Exclusion criteria:

* bilirubin \> 50μmol/litre unless secondary to lymphoma
* creatinine \> 2 x upper limit of normal unless secondary to lymphoma,
* absolute neutrophil count \<0.5 x 109/litre and / or platelets \< 50 x 109/litre unless secondary to lymphoma
* isolated bone marrow disease
* known sensitivity to E coli derived preparations
The Effect of Virtual Reality on Patients With Anxiety Over Surgeries Under Spinal Anesthesia

The main purposes of this study are as follows:

First, to understand the effect of virtual reality on the subjective feelings of anxiety in patients with orthopaedic lower limb surgery for spinal anesthesia.

Second, to understand the effects of virtual reality on the systolic blood pressure, diastolic blood pressure, mean arterial pressure, heartbeat, respiration and other physiological parameters in the operation of orthopedic lower extremity surgery patients with spinal anesthesia.

Third, to understand the effect of using virtual reality in surgery to reduce the use of sedative drugs and the degree of pain in patients with orthopedic lower extremity surgery.

Surgery is a serious source of stress for the general patient and can increase the patient's anxiety. which is It is normal to show obvious anxiety in patients undergoing surgery, but if the degree of anxiety is serious, it may lead Negative physiological manifestations, such as slow wound healing, increase the risk of infection and may affect the induction of anesthesia It requires more anesthesia dose during surgery, which hinders recovery time. Most studies have confirmed surgery Playing music in the room can alleviate the anxiety and pain of the patients, but the music preference is subjective and some people like it.

There must be people who hate it, and the operating room is not a quiet space. There are many sound sources in the operating room., such as the sound of surgical instruments, the warning sound of physiological monitors, the voice of the staff, these It will be a source of anxiety for patients. Instrument noise averages up to 60 decibels, including neurosurgery, orthopedics It can even exceed 100 decibels. Foreign scholars believe that playing music at this time will only aggravate the noisy environment.The attention of the staff. Therefore, it is hoped that by using virtual reality to provide images and sounds during surgery, hijacking The patient's auditory, visual, and proprioception creates an immersive, distracting approach that reduces the cause of the ring Anxiety brought by the environment helps spinal anesthesia patients to reduce anxiety during surgery and increase psychological comfort To reduce the use of sedative drugs during surgery.

Eligibility Criteria:
Inclusion Criteria:

1. population: acceptance of lower extremity fractures in patients with spinal anesthesia.
2. Anesthesia classification (ASA): I-III.
3. Age: 20 years old to 70 years of age.

Exclusion Criteria:

1. Mental illness and taking related drugs.
2. Visually impaired and hearing impaired.
3. Being unable to communicate or illiterate.
4. The condition changes or is critical, and the intensive care unit is admitted after the operation.
5. Contact isolation.
6. Trauma of the head and wounds on the head.
7. History of motion sickness and vertigo.
Cytometric Immunodiagnostics of Latent Tuberculosis Infection (LTBI)

TB-reactive immune cells will be tested in a multiparametric flow cytometry to distinguish an immune response for antigens of Mycobacterium spp. in TB disease/latent infection or a reaction after BCG vaccine.

The goal of this project is the verification of current cytometric panel of detection antibodies in a wider panel of stimulative immunodominant antigens for CD4+ and CD8+ T cells in combination with adjuvants 2 in a in vitro activating test.

Eligibility Criteria:
Inclusion Criteria: active TB, contact with TB infection in previous 3 months before the study

-

Exclusion Criteria:

* HIV positive patients
Low Fat Milk Intake and Cardio Vascular Risk (CVR) Indicators in Children

Substituting whole milk intake for defatted milk will improve indicators of cardiovascular risk, i.e. total cholesterol, triglycerides, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL)cholesterol, apolipoproteins: ApoB100, Lp(a) and ApoA in a sample of Mexican children 6-13 years of age.

Double blind trial in 600 children 6-13 years of age residing in 12 boarding schools. Schools will be randomized to distribute three types of milk namely: full fat milk (3% fat), partially defatted milk (2% fat) or defatted milk (1% fat) for 90 days of effective exposure (4 months total duration). Subjects will receive 400 mL of the corresponding milk every day (200 mL breakfast and 200 mL night meal) from Monday through Friday. During week ends they will eat a freely chosen diet at home. Milk intake will be measured every day. Diet by 24 h-recall. will be evaluated every month. Blood samples will be obtained at the beginning and at the end of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Attending selected boarding schools

Exclusion Criteria:

* No lactose intolerance
In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment

This study aims to develop and evaluate new in-home supportive technology that is designed to alleviate anxiety, burden, and loneliness in spousal and familial caregivers of individuals with Alzheimer's disease, other dementias, or mild cognitive impairment.

This study aims to develop, refine, and evaluate a new hardware/software system designed to integrate in-home sensors and devices, Internet-of-Things technologies (i.e., devices that can be controlled and communicated with via the internet), and social networking to create a more safe and supportive home environment for caregivers and people who have Alzheimer's disease, other dementias, or mild cognitive impairment. The system monitors troublesome behaviors in people with dementia or mild cognitive impairment (e.g., wandering), and targets mechanisms (e.g., worry, social isolation) thought to link behavioral symptoms in people with dementia or mild cognitive impairment with adverse caregiver outcomes (declines in health and well-being). The system is designed to minimize demands on caregivers' limited time and energy and to provide a platform for data collection that can be used by researchers and care professionals.

Hypotheses:

1. Caregivers in the full operation condition will have fewer negative effects of caregiving (lower burden, better mental and physical health, higher well-being) than those in the control condition.
2. Greater use of the social networking features of the system will be associated with fewer caregiver depressive symptoms.
3. Greater utilization of the home safety features of the system will be associated with fewer caregiver anxiety symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Caregivers are fluent/literate in English
* Caregivers currently reside with spouse/family member who has received a diagnosis of Alzheimer's disease, other dementias, or mild cognitive impairment
* Caregivers primarily use a smartphone (e.g., iPhone, Android)
* Caregiver has wireless internet in home

Exclusion Criteria:

* Caregivers providing care for individuals with known non-neurodegenerative conditions affecting behavior and cognition
* Caregivers providing care for individuals with longstanding Axis I psychiatric disorder
* Caregivers providing care for individuals with metabolic disorder or major organ dysfunction
* Caregivers providing care for individuals with alcohol abuse or dependence (within 5 years of dementia onset)
* Caregivers providing care for individuals with head trauma with loss of consciousness greater than 30 minutes
* Caregivers providing care for individuals with contraindications to MRI imaging
* Caregivers providing care for individuals with large confluent white matter lesions
* Caregivers providing care for individuals with significant systemic medical illness
* Caregivers providing care for individuals who use a medication likely to affect central nervous system functions adversely
Functional Outcome Comparison of Implant-Free Bone-Patellar Tendon Autograft in Arthroscopic ACL Reconstruction

The use of implants for conventional anterior cruciate ligament (ACL) graft fixation has been associated with several problems including graft injury, implant osteolysis, implant migration and soft tissue irritation. Implantless ACL surgery offers additional benefits involving lower cost, improved graft incorporation and ease of revision surgery. The investigators aimed to compare the functional outcome of implantless bone-patellar tendon autograft using press-fit fixation technique and hamstring autografts using implant.

Purpose: The use of implants for conventional anterior cruciate ligament (ACL) graft fixation has been associated with several problems including graft injury, implant osteolysis, implant migration and soft tissue irritation. Implantless ACL surgery offers additional benefits involving lower cost, improved graft incorporation and ease of revision surgery. The investigators aimed to compare the functional outcome of implantless bone-patellar tendon autograft using press-fit fixation technique and hamstring autografts using implant.

Materials and Methods: A prospective cohort study design was used. Between March 2013 and March 2014, 12 patients underwent implantless ACL reconstruction using press-fit femoral technique, while 24 patients underwent implant ACL reconstruction. Objective functional outcome were measured using rolimeter, and subjective functional outcome were measured according to IKDC, Tegner-Lysholm and KOOS.

Eligibility Criteria:
Inclusion Criteria:

* total rupture of ACL on a single knee

Exclusion Criteria:

* increased knee laxity according to Beighton Hypermobility Score
* previous history of knee surgery