cyrilzakka/clinical-trials huggingface dataset:
Acetylcholine Receptors From Human Muscles as Pharmacological Target for ALS

Amyotrophic lateral sclerosis (ALS) is a fatal disease leading to motor neuron degeneration and progressive paralysis. Other studies have revealed defects in skeletal muscle even in absence of motor neuron anomalies, focusing on acetylcholine receptors (AChRs) and supporting the so-called "dying-back" hypothesis. Outcome of this study will be to understand if the endocannabinoid palmitoylethanolamide (PEA) can reduce the rundown of AChRs currents in ALS muscle, and if it can modify ALS patients' clinical and electrophysiological parameters.

Outcome:

Monitoring the efficacy and safety of PEA in the treatment of patients with ALS. Analysis of AChR currents and description of the composition of AChRs subunits in ALS muscles

Design of the Study:

A randomized controlled blinded study. Patients with sporadic ALS will receive riluzole alone or riluzole+PEA in order to investigate the clinical and electrophysiological effects of treatment. The expected number of enrolled patients will be 50.

All patients satisfying the selection criteria will be randomized into two groups: a first group will be treated only with riluzole, the second group with riluzole associated with PEA (Normast 600 mg microgranular, 2 sachets/day). The randomization will be done stratifying patietns according to type of clinical onset (bulbar vs. spinal). The patients will be enrolled in the Department of Neurology and Psychiatry, University of Rome "Sapienza".

The visits will be performed at 0 (randomization), 3 and 6 months. At each visit the ALS Functional Rating Scale-Revised (ALSFRS-R), the percentage of predicted forced vital capacity (FVC%), the Medical Research Council (MRC) score for muscle strength limited to the right upper limbs, and the compound muscle action potentials (CMAP) from right ulnar and phrenic nerves will be assessed. A muscle biopsy will be done at the end of the study. The obtained results will be compared with those observed in muscle samples from denervated (non-ALS) control patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ALS according to the El-Escorial criteria;
* Age\> 18 years;
* ALS Functional Rating Scale-Revised (ALSFRS- r) score\> 20;
* Forced Vital Capacity (FVC)\> 30%;
* Treatment with Riluzole.

Exclusion Criteria:

* Other diseases motor neurons;
* Experimental treatments in the previous three months;
* Pregnant or breast-feeding;
* Contraindications to the use of riluzole;
* Patients undergoing tracheostomy, enteral or parenteral supply;
* Severe psychiatric disorders.
China Nutrition Fundamental Data 2020

Malnutrition caused by reduced food intake or assimilation and varying degrees of acute or chronic inflammation is a serious and underappreciated risk factor for adverse clinical outcomes. Despite the substantial health and economic burden, malnutrition remains to affect a considerable proportion of hospitalized patients worldwide. Nationally representative studies from the USA, Australia, and European countries have reported prevalence figures in the range of 8.9% to 80.4%. However, national data in some resource-poor countries, such as China, the largest developing country in the world, are scarce.

We did the China Nutrition Fundamental Data 2020 in a large, nationally representative sample of Chinese adult inpatients to 1) Explore the relationship between nutrition and health; 2) Understand the capacity of nutrition services in Chinese medical institutions.

This project adopted a multistage, stratified, cluster-sampling procedure based on administrative divisions in China. For each participant, a structured interview was done by trained nutritionists or clinicians. The following data were acquired: weight change within and beyond six months, food intake change within two weeks, nutrition therapy during this hospitalization, and laboratory tests. We also collected information on participants' sociodemographic characteristics and medical history. We took physical measurements, including height, weight, waist circumference, hip circumference, mid-arm circumference, calf circumference, handgrip strength, and blood pressure following standard protocols. Body composition was measured using bioimpedance analysis (BIA). In total, 54677 inpatients from 291 project hospitals completed information collection.

In addition, we collected information on the number of beds, the nutrition support team, the nutrition treatment plan and the construction of a full-time nutrition physician or nutrition nurse, the routine monitoring methods, interventions, and distribution of brochures for patients with malnutrition or nutritional risk in each project hospital and 37 other hospitals based on the principle of voluntary participation. A total of 328 hospitals completed information collection.

This project will establish standards for nutrition risk assessment, diagnosis, and treatment of inpatients in China, promote the construction of clinical nutrition departments, and improve the nutritional status of inpatients.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Admitted to hospital within 24-48 hours (not emergency) due to tumor or digestive system, respiratory system, cardiovascular system, endocrine system, nervous system, and urinary system disease.

Exclusion Criteria:

* With mental illness or memory disorder who were unable to answer questions correctly
* Critically ill patients
* Lack behavioral ability
A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

This study is to compare and evaluate the efficacy and safety of the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and chemotherapy in chemotherapy-naïve participants with HER2- negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).


Eligibility Criteria:
Inclusion Criteria:

* Patients with gastric or esophagogastric junction cancer histologically diagnosed as adenocarcinoma
* Patients have not been treated with systemic chemotherapy as first-line therapy
* Patients who can provide tumor tissue samples

Exclusion Criteria:

* Patients unable to take oral medicines
* Patients with HER2-positive
* Patients with contraindications to nivolumab, oxaliplatin, S-1, or capecitabine
* Patients who have a history of severe drug-related adverse reactions caused by non- steroidal anti-inflammatory drugs (NSAIDs) or who have complications caused by NSAIDs requiring treatment
* Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, such as rheumatoid arthritis
* Patients with headache and/or nausea associated with brain metastasis
Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics

This trial will evaluate whether a particular type of circulating white blood cell, monocytes, from type 2 diabetics with high blood pressure and vitamin D deficiency vs. sufficiency will induce hormones that increase blood pressure.

More than half of patients with type 2 diabetes mellitus develop hypertension, which doubles their risk for cardiovascular disease. Inflammation plays a role in the development of these diseases, and monocytes, a type of white blood cell, may be critical. This study will isolate monocytes from blood samples of patients with type 2 diabetes and high blood pressure who have either high levels of vitamin D or low levels of vitamin D, and determine what their effects are on stimulating production in kidney cells of a hormone that increases blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes (T2DM)
* Age: 25-80 years old
* Vitamin 25(OH)D3 levels \<20 or \>30 ng/ml.
* HbA1c: 5.5%-9.5%
* Blood Pressure: \<160/100 mm Hg on BP lowering medications and
* Blood Pressure: \>120/80 to 160/100 mmHg without BP lowering medications

Exclusion Criteria:

* Recent weight loss of more than 5% within 3 months prior to screening
* Current Pregnancy
* Hypercalcemia
* Previous heart attack and stroke
* Heart failure
* Atrial fibrillation
* Heavy alcohol consumption
* Extreme diets (Atkins, South Beach)
* Chronic renal failure: stage 4 or worse
* \>2 + proteinuria on urine sample
* Chronic diseases known to affect immunity
Study of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type

The purpose of this study is to assess xaliproden's potential capacity of slowing the deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's disease. The patients participating in this study will take orally once daily xaliproden or placebo (inactive substance pill).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable Alzheimer's disease using NINCDS-ADRDA criteria

  * Mild to moderate degree of severity of dementia as assessed by the Mini-Mental Status Examination score of 16 to 26 (inclusive)
  * Potential participant may be treated with conventional Alzheimer's disease therapy and must be on a stable dose for at least 6 months prior to the randomization and during the entire study period
  * Potential participant must have a reliable caregiver and must be living in a community or in an assisted living facility
  * Mother tongue is English, Spanish or French (oral and written fluency)
  * Signed informed consent from potential participant or legal representative and identified caregiver

Exclusion Criteria:

* Potential participant with any other cause of dementia.
* Potential participant with serious health problems other than Alzheimer's disease
* Use of an investigational drug within two months prior to randomization or during this study
A Phase I Pharmacokinetics and Safety Study of Two Dapivirine Intravaginal Gels

IPM 012 is a double-blind, randomized, placebo-controlled phase I study conducted at one research center in Belgium among 36 healthy, HIV-negative women of 18-40 years of age, randomized in a 1:1:1 ratio to assess plasma, vaginal fluid and vaginal tissue levels and the pharmacokinetics of dapivirine when applying either Dapivirine Gel 4750, 0.05%, 2.5g or Dapivirine Gel 4789, 0.05%, 2.5g intravaginally for 11 days (1 day followed by a 3 day washout period and then 10 consecutive days); and to assess the safety of these gels as compared to the intravaginal HEC-based universal placebo gel.


Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 40 years of age, inclusive
* Willing and able to give written informed consent
* Available for all visits and consent to follow all procedures
* Healthy, based on medical history, vital signs, physical examination, urinalysis, laboratory evaluations for genital infections and laboratory evaluations for hematology, liver and renal function
* HIV-negative as determined by a HIV-1 ELISA test at enrollment
* Willing to abstain from sexual activity for the duration of the study
* On stable oral contraceptive regimen for 2 months prior to enrollment and willing to continue
* Upon pelvic/speculum examination, the cervix and vagina appear normal
* Willing to refrain from the use of vaginal products from 14 days prior to enrollment and for the duration of the study

Exclusion Criteria:

* History of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact adherence with protocol requirements
* History of sensitivity/allergy to any component of the study product or to latex
* Currently pregnant or breast-feeing, or within 3 months of last pregnancy outcome
* Currently or within one month of participating in any other clinical research study
* History or current diagnosis and/or treatment for a STD within the last three months prior to enrollment
* Current vulvar, vaginal or cervical symptoms/abnormalities as determined by pelvic/speculum exam or colposcopy that could influence the study results
* History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last 3 months
* Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption
* Smoking more than 10 cigarettes a day
Evaluating the Safety of Myfortic (Mycophenolate Sodium) in Patients With Lupus Nephritis

This is an open-label, prospective, single-arm, observational study in patients with Lupus nephritis (LN) who newly (i.e.,for the first time) received treatment of Enteric-coated Mycophenolate Sodium (EC-MPS).

This is an observational study. Patients will be treated and followed according to routine medical practice in terms of visit frequency and type of assessment performed. Only endpoint related data will be collected as part of the study. Patient demographic information, disease characteristics, treatments and laboratory data will be collected retrospectively.

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 20 years and ≤ 75 years at screening.
2. Patients with written informed consent form.
3. Male or female diagnosed with SLE.
4. Confirmed diagnosis of LN by physician. Diagnosis of LN is defined as:

   a. Kidney biopsy within 1 year, with histological diagnosis of LN (class III/IV/V)
5. Laboratory evidence of active nephritis: spot UPCR\>0.5, and/or proteinuria \> 0.5 g/24 hours, and/or greater than 3+ by dipstick, and/or cellular casts.
6. Patients with LN who received EC-MPS for the first time. The patients who switched from other treatment and treatment naive patients (did not received any treatment before) can be included in this study.
7. Women of childbearing potential must use effective contraception before beginning EC MPS therapy, during therapy, and for six weeks after their last dose of EC MPS.

Exclusion Criteria:

1. Previous or planned kidney transplant.
2. Currently receiving continuous dialysis or GFR \< 30 mL/min/1.73 m2 within 3 months prior to the start of study.
3. Patients with active serious digestive system disease, including infrequent cases of gastrointestinal tract ulceration with hemorrhage or perforation.
4. Patients currently with life threatening conditions including malignancies, or severe infection in recent 6 months prior to start of study
Assessment of the Benefit of Teleconsultations for Children With Autism Spectrum Disorders

The purpose of this study is to determine whether Teleconsultation would a)be effective and cost-effective by increasing the proportion of patients with Autism Spectrum Disorders having a correct follow-up, and less transportation, and b) get a high satisfaction from the parents and from the professionals


Eligibility Criteria:
Inclusion Criteria:

* All residents of medico-social structures accepting children and adolescent with autism disorders

Exclusion Criteria:

* Refusal of parents that their child use telemedicine
* Refusal of parents that their child participate to the research
Metabolic Effects of Alcohol

The hypotheses to be tested are 1) the use of alcohol in the form of wine with the evening meal will lower plasma glucose during the night and result in lower fasting plasma glucose the next morning; 2) the chronic use of alcohol in moderation in the form of wine will have beneficial effects on plasma lipids in type 2 diabetic subjects.

The use of alcohol in moderation has been associated with reduced mortality rates, reduced risk of cardiovascular disease and reduced risk for type 2 diabetes. However, the effects of alcohol in persons with type 2 diabetes have not yet been defined. Moreover, the possibility of alcohol induced hypoglycemia remains a safety concern. Finally, little is known about the effects of alcohol on plasma lipids in people with diabetes. To address these issues, two substudies are proposed. The first substudy will examine the acute effects of alcohol in the form of wine at supper on postprandial and nocturnal glucose levels. The second substudy will examine the effects of alcohol in the form of wine consumed regularly for one month on plasma lipids.

To test these hypotheses, 20 type 2 diabetics will be studied. In substudy 1, subjects will be admitted to the Clinical Research Center for a two day inpatient stay. Blood samples for plasma glucose and serum insulin will be obtained every two hours from 5:00 pm to 7:00 am. On one day, subjects will recieve 8 ounces of wine with dinner. On the other day, subjects will recieve 8 ounces of fruit juice with dinner. The primary endpoint of substudy 1 will be fasting plasma glucose. In substudy 2, subjects will be asked to consume 4-8 ounces of wine in the evening for one month and to abstain from wine and alcohol containing beverages for one month. Fasting blood samples will be obtained after the month of wine consumption and after the month of abstention from alcohol for measurement of fasting lipids. The primary endpoint of substudy 2 will be fasting HDL cholesterol.

Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetes HbA1c 6.0-8.0% age \> 40 years

Exclusion Criteria:

History of alcoholism or alcohol abuse liver disease blood pressure \> 150/90
Cyberdyne HAL, TecnoBody D-Wall, and Walker View 3.0 SCX Combined Treatment

Mosaicplasty is a procedure where grafts taken from almost non-load-bearing areas of the joint are used to reconstruct lesioned areas. Hangody and his team developed this method using small cylindrical grafts and named it mosaicplasty (1). With the adoption of this approach, both the morbidity of the donor area has decreased, and a better joint surface has been achieved in the grafted area. Some studies have shown that 80% of this newly formed composite cartilage has a hyaline structure (2).

The Cyberdyne Hybrid Assistive Limb (HAL) - Single Joint (SJ) (HAL-SJ, Cyberdyne Inc., Tsukuba, Japan) is a wearable exoskeleton that facilitates voluntary control of knee joint movement. This exoskeleton processes signals from muscle action potentials detected by electrodes on the skin surface and assists the patient with joint movements. The knee joint power unit includes angular sensors and actuators, and the control system consists of Cybernetic Voluntary Control (CVC) and Cybernetic Autonomous Control (CAC) systems (3). HAL has been found to be effective in the functional improvement of various mobility disorders (4-7).

The TecnoBody Walker View (Bergamo, Italy) is used to analyze asymmetries and changes in joint range of motion. It can also be used to provide gait training, supporting weights ranging from 20% to 80%, and offers a safe walking rehabilitation option. The TecnoBody D-Wall is an assessment and rehabilitation device designed to improve movement quality with auditory and visual feedback. This device evaluates individuals' balance in seconds/mm² with eyes open (EO) and eyes closed (EC) conditions (8).

Although studies to date have reported successful outcomes for acute or chronic mobility disorders, there is limited literature on the use of HAL-SJ for cartilage rehabilitation or related postoperative recovery. Therefore, this study aims to investigate the effects of a combined treatment protocol involving HAL-SJ-based knee extension and flexion exercises with TecnoBody D-Wall and Walker View devices on gait parameters and balance during the acute recovery phase following mosaicplasty cartilage surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male patient aged 33 years.
* Body weight of 70 kg and height of 180 cm.
* Underwent knee mosaicplasty surgery on the right knee in November 2023.
* Presence of postoperative complications, including affected gait, reduced range of motion (ROM) in the knee joint, and edema.
* Ability to participate in intensive rehabilitation sessions (5 days a week, 2 hours per day) for 3 months.

Exclusion Criteria:

* Patients with severe cardiovascular, pulmonary, or neurological disorders that could affect participation in the rehabilitation program.
* Presence of any other musculoskeletal conditions that could interfere with the study outcomes.
* Patients with uncontrolled metabolic disorders such as diabetes.
* Inability to follow the prescribed rehabilitation protocol due to personal or logistical reasons.
* Participation in any other physical therapy or rehabilitation program during the study period.
A Predictive Model for Oropharyngeal Dysphagia in Non-hospitalized Older Patients

Oropharyngeal dysphagia (OD) is a highly prevalent and growing condition in the older population. It affects approximately one in three community-dwelling elderly, almost half of the geriatric patients, and even more than half of elderly nursing home residents.

The main complications of OD are respiratory infections such as aspiration pneumonia, malnutrition, and dehydration. It supposes substantial costs for the healthcare system, increases the risk for (re)admissions and length of stay, and has an important impact on the quality of life of people who suffer from it.

The aim of this study is to develop a predictive model to identify non-hospitalized older patients at risk for oropharyngeal dysphagia, quantify that risk, and facilitate decision-making according to personal, clinical, and socio-emotional characteristics.

Given the high prevalence of Oropharyngeal Dysphagia (OD) in older people and the difficulty to detect it, the investigators purpose to develop a predictive model to identify non-hospitalized older patients at risk for OD, quantify that risk, and facilitate decision-making.

Objectives:

Main objective:

- Develop a predictive model for oropharyngeal dysphagia in non-hospitalized older patients (≥ 65 years).

Secondary objectives:

* Identify predictive factors for OD among the studied population.
* Contribute to the characterization of OD in older people through a retrospective analysis of videofluoroscopic studies and clinical evaluations.
* Define different models of intervention from a multidimensional approach.

Eligibility Criteria:
Inclusion Criteria:

* Older people between 65 and 99 years.
* Swallowing assessed with Videofluoroscopy
* Non-hospitalized patients (swallowing assessed on an outpatient basis)

Exclusion Criteria:

* There are no exclusion criteria in relation to the gender or ethnicity of the participants. Failure to meet one of the inclusion criteria will result in the participant's exclusion from the study sample.