cyrilzakka/clinical-trials huggingface dataset:
The UFIM (Ultraprocessed Foods In Breast Milk) Project

In last decades, a change in dietary habits has been observed in industrialized countries characterized by a drastic increase in the consumption of ultra-processed foods (UPF, Ultra-Processed Foods). As defined by the NOVA classification, UPFs are industrial formulations of food substances added with colourings, flavourings, emulsifiers, thickeners and other additives. Among the main compounds of UPFs are the advanced glycation end-products (AGEs). Increasing evidence suggests an association between dietary exposure to AGEs and the development of chronic non-communicable diseases, such as obesity and allergies, in the general population, through increased oxidative stress and inflammation. Preliminary evidence suggests that a maternal diet rich in AGEs during pregnancy and lactation could negatively influence the composition of breast milk and have a negative impact on the infants health. However, data regarding the presence of derivatives of UPFs in breast milk are not available. The UFIM (Ultraprocessed Foods In Breast Milk) study aims at evaluate the presence of UPFs-derivatives compounds in breast milk.


Eligibility Criteria:
Inclusion Criteria:

Caucasian women who are breastfeeding full-term infants

Exclusion Criteria:

* Non-Caucasian ethnicity;
* Age \<18 and \>35 years;
* Mothers of preterm children;
* Non-exclusive breastfeeding;
* Mothers suffering from chronic, malignancies, immunodeficiencies, chronic infections, autoimmune, inflammatory bowel disease, celiac disease, genetic-metabolic diseases, cystic fibrosis and other chronic lung diseases, cardiovascular / respiratory / intestinal malformations, neuropsychiatric disorders and pathologies neurological, vegetarian and vegan diet;
* Mothers with tattoos, scars, moles or skin lesions on both forearms.
Ultrasound Evaluation of Gastric Emptying in Diabetic Patients: a Comparison With Non-diabetic Controls

This is a prospective cohort study. The main objective is to compare the prevalence of a "full stomach" using gastric ultrasound technique, in elective surgical patients with diabetes mellitus compared to non-diabetic controls following the present fasting guidelines (2 h after clear liquid and 6h after a light meal). For patients with a full stomach or intermediate stomach, an consecutive ultrasound scan is performed every 10 min,until empty stomachstomach contents are detected to determine the mean gastric emptying time for clear liquid and light meal, and to investigate the risk factors for delayed stomach emptying in diabetic patients by logistic regression analysis .


Eligibility Criteria:
Inclusion Criteria:

* diabetes (two fasting plasma glucose concentration≥7mmol/L or casual plasma glucose concentration≥11.1mmol/L);
* age≥18 yr; ASA physical status I-III;
* body mass index \<35kg/m2;
* who are admitted to the surgical department;
* who are able to understand the rationale of the study and provide informed consent.

Exclusion Criteria:

* pregnancy;
* a history of upper gastrointestinal disease or previous surgery on the oesophagus, stomach or upper abdomen;
* documented abnormalities of the upper gastrointestinal tract such as gastric tumors;
* recent upper gastrointestinal bleeding (within the preceding 1 month);
* taking medicines that may delay gastric emptying(e.g., anticholinergic agents).
* hypothyroidism.
cSMART Liquid Biopsy and Dynamic Monitor of NSCLC Patients in Inner-Mongolia China

The purpose of this study is to evaluate the mutation pattern of epidermal growth factor receptor (EGFR) and other TKI targeted gene during TKI treatment of advanced NSCLC patient with liquid biopsy.

In the study, 200 advanced NSCLC patients will be recruited. All the patients will receive biopsy genotype assay and Circulating Single-Molecule Amplification and Resequencing Technology (cSMART) liquid biopsy. those patients who carry EGFR activating mutation and other TKI targeted activating mutation will receive TKI treatment. During the TKI treatment, every patients will take liquid biopsy assay to monitor the mutation status. the study will be ended when all the patients had a progressive disease (PD) in their targeted lesion

Eligibility Criteria:
Inclusion Criteria:

* NSCLC adenocarcinoma patients confirmed by pathologist
* Initial, non-operative patients with stage III \& IV adenocarcinoma
* Older than 18 years old
* Subjects have no major organ dysfunction. In detail, Liver Function: TBiL≤1.5 ULN ( Upper Limit of Normal); Serum GPT (Glutamate-Pyruvate Transaminase ):≤2 ULN, Renal Function: ScR≤1.2 ULN; BUN≤1.2 ULN, BM (Bone Marrow) Reserve: WBC (White Blood cell Count) ≥4.0×e9/L; ANC≥2.0×e9/L，PLT≥100×e9/L，HGB≥100g/L.

PS (Performance Status) Score: less than 2, Expected Survival Time: More than 3 months;

* Have a clear measurable tumor lesion in lung,under RIEST.
* Without severe drug allergy
* Patients participate in this trail must sign the informed consent

Exclusion Criteria:

* Patients with brain metases related syndrome
* Patients with bone metases related complication
* Patients with cognitive disorder
* Patients with major organ dysfunction and severe cardiopathy include congestive heart-failure, uncontrolled arrhythmia, angina with long term treatment, VHD (Valvular Heart Disease), myocardial infraction, RHTN (Resistant Hypertension).
* Patients with other severe complication and excluded by the researcher.
* Patients who are allergy with the TKI in this trail.
* Patients who participated in other trails or with anti-tumor treatments
* Patients who receive radiotherapy at the site of curative effect observation
* Patients who receive allogenic blood transfusion within 14 days
Physical EXercise as an Adjunct Treatment for Depression

35 participants diagnosed with major depressive disorder were randomized in 3 intervention groups: (1) aerobic exercise (AE) ; (2) placebo (stretching) exercise (ST); and (3) no intervention (control group; NI). The intervention length was 10 consecutive days. In groups 1 (aerobic exercise) and 2 (sham exercise), participants exercised for 30 minutes each day. Depressive symptoms were assessed the day before the beginning of intervention and the day after the end of intervention for participants of both groups.

In the aerobic exercise (AE) group, the intervention consisted of 30 minutes of daily brisk walking or jogging. This was done individually and supervised. Participants who missed \> 2 training sessions were considered as non-completers. Exercise intensity had to be maintained within 65%-75% of age-predicted maximal heart rate, as commonly prescribed in studies using aerobic exercise to alleviate depression. Heart rate monitoring devices were used.

Participants in the stretching (ST) group also performed a daily 30 minutes exercise program but this was "sham" exercise, consisting of stretching exercises. Several muscle groups (thighs, calves, gluteal, shoulders, back) were stretched for 60 seconds, with equivalent resting intervals between stretching series. These activities were also individual and supervised. As was the case for the AE intervention, participants who missed \> 2 training sessions were considered as non-completers.

Participants in the control (NI) group received no intervention other than prescribed medication.

All participants started antidepressants within less than 2 weeks before study entry.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of major depressive disorder (MDD)
* antidepressant drug therapy initiated for less than 2 weeks
* score of 29 or more on the Beck depression inventory

Exclusion Criteria:

* medical contraindication for exercise practice
* inability to understand written French
* beta-blocking drugs or another forms of antidepressant therapy (sleep deprivation, electroconvulsive therapy)
Combination of Ketogenic Diet and Exercise on Prediabetes in Female With Normal Weight

Individuals with prediabetes have a high risk of developing type 2 diabetes. The purpose of this study was to compare the effect of combination of ketogenic diet and aerobic exercise interventions versus ketogenic diet alone on the glucose level in prediabetes female with normal weight.

Pre-diabetes is the preceding condition of diabetes, where the blood sugar level is higher than normal but lower than the diagnostic criteria of type II diabetes and in most of the cases, this ultimately leads to the development type II diabetes. It has been estimated that the number of pre-diabetic cases will increase to more than 470 million people worldwide, and this is understandably a worrying trend . Many studies have been done on diabetes patients. However, little is known about the pre-diabetic conditions.

Diagnosed Prediabetes was stated as any participants who did not have diabetes but who had fasting plasma glucose level of 100 - 125 mg/dL, an HbA1c level of 5.7% - 6.4%, or 2-hour plasma glucose level of 140 - 199 mg/dL.

Treatment of pre-diabetes and prevention of the development of pre-diabetes to T2DM,through lifestyle intervention mainly includes nutritious dietary and exercises.

Combining a ketogenic diet with exercise is a powerful way to reducing insulin resistance, control blood glucose levels and achieve weight loss. As ketogenic diets are nowadays predictable as being useful, there is presently a shortage of research studies examining just how useful the combination of exercise and a ketogenic diet

Eligibility Criteria:
Inclusion criteria:

1. female with their age ranged from 40-60 years
2. body mass index (BMI) from 20-25 kg/m2
3. fasting serum glucose range 5.6 to 6.9 mmol/L
4. hemoglobin A1C value fell within the prediabetes range (5.7%-6.4%) without medications, or treatment with oral hypoglycemic agents and/or insulin.

Exclusion criteria:

1. renal insufficiency
2. liver disease
3. abnormal cardiovascular function
4. diabetes
5. untreated hypertension
6. dyslipidemia
7. abnormal thyroid function
8. anyone who has undergone gallbladder removal
9. musculoskeletal constraint preventing them from fully participating in the exercise intervention
Schizophrenia Treatment With Photoneuromodulation

Abstract: Randomized clinical trial that aims to see the efficacy of photoneuromodulation for the treatment of negative symptoms of schizophrenia in patients refractory to transcranial direct current stimulation. In this group of 30 refractory volunteers, magnetic resonance spectroscopy will be performed before and after photoneuromodulation in a cross-over design.

Objectives: Effectiveness of photoneuromodulation in patients with schizophrenia. . Analysis of glutamate, Gaba and lactate in spectroscopy before and after stimulation (secondary) Sample: 30 volunteers with negative symptoms of schizophrenia refractory to treatment.

Method: clinical trial, cross-over randomized, double-blind, sham-controlled. PANSS negative symptoms subscale evaluation before and after the 10 photoneuromodulation sessions. Participants who are in the active group after the 10 photoneuromodulation sessions will go to the sham group and vice versa. They will perform magnetic resonance spectroscopy before the beginning, after the 10 sessions and again after the inversion of the groups (3 resonances per volunteer). The study will be a cross-over: half of participants will start at sham group and the other half at active group and invert groups after 10th day of stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 55 years
* Diagnosis of schizophrenia according to DSM-IV criteria and confirmed by the SCID (Structured Clinical Interview for DSMIV), which will be applied by a psychiatrist, will be included.
* Minimum score of 20 points in the sum of negative PANSS
* Stable antipsychotic medications
* There is a need for at least one trial with at least one antipsychotic in adequate dose and time to enter the study.

Exclusion Criteria:

* Unstable or uncontrolled clinical diseases,
* Psychiatric comorbidities,
Blood Lactate Level for Pre-hospital Orientation of Septic Shock

In the pre-hospital setting, the severity assessment of septic shock is essential to decide the optimal initial in-hospital level of care. As clinical signs can be faulted, there is a need for an additional element in order to enhance the severity assessment and to decide in-hospital admission in the intensive care unit (ICU) or in the emergency department (ED). Point of care medical device yielding blood lactate levels since the pre-hospital setting may give an easy and valuable element for the severity assessment and the decision-making.

The aim of this study is to provide clinical evidence that the pre-hospital blood lactate level predicts the 30-day mortality of patients with septic shock.

This trial is a prospective, observational, non-randomized controlled study. A total of 1000 patients requiring mobile intensive care unit intervention for a septic shock in the pre-hospital setting will be included. Pre-hospital blood lactate levels will not be taken into account to decide patients treatments and/or ED or ICU admission. In the pre-hospital setting, each patient will benefit from 2 measurements of blood lactate level: initial measurement at the first contact, and final measurement at the hospital admission with a specific point of care medical device.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years either sex
* Severe sepsis according to the French anesthesiology and intensive care society (SFAR) and intensive care society (SRLF) conference 2005 defined by the existence of an infectious disease and at least one the following:

  * Low blood pressure prior to volume expansion
  * Glasgow coma scale \< 13
  * Skin mottling score \> 2
* Septic shock according to the French anesthesiology and intensive care society (SFAR) and intensive care society (SRLF) conference 2005 definition

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Serious comorbid conditions with a not to be reanimated status known since pre-hospital setting
* Patients with guardianship or curator
Study to Assess the Safety and Efficacy of Multiple Doses of VB-201 on Biomarkers

The purpose of this study is to assess the safety and tolerability of multiple doses of VB-201 administered for 4 weeks and its efficacy on biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, ≥18 to ≤75 years of age;

Exclusion Criteria:

* Presence of, or history of cancer, with the exception of completely excised, non-metastatic squamous cell or basal cell carcinomas of the skin;
* Has a clinically significant systemic infection (e.g., chronic or acute infection, UTI, URI) within 30 days of Day 0, or a history or presence of recurrent or chronic infection (e.g. viral infections, \[including hepatitis B or C, HIV\], bacterial infections, systemic fungal infections, or syphilis);
* Subjects with a history of coronary events within the last 6 months;
The Efficacy of Watch and Wait Strategy or Surgery After Neoadjuvant Immunotherapy for Locally Advanced Colorectal Cancer With dMMR/MSI-H Guided by MRD Dynamic Monitoring: A Single-center, Open-label, Prospective, Phase II Clinical Trial.

This study is a single arm, single center, phase II, prospective clinical study aimed at exploring the effectiveness and safety of watch and wait strategy guided by dynamic minimal disease residual (MRD) monitoring to achieve clinical complete response after neoadjuvant immunotherapy for locally advanced colorectal cancer with deficient mismatch repair/ microsatellite instability-high (dMMR/MSI-H).


Eligibility Criteria:
Inclusion Criteria:

* ( 1 ) Disease characteristics 1. Histologic confirmation for colorectal adenocarcinoma; 2．Immunohistochemical identified as dMMR and/or pCR and/or NGS detection for MSI-H; 3．According to UICC/AJCC TNM staging system (in 2017 version 8) assessment for locally advanced colorectal cancer (II - III, namely cT3-4 and/or N + ）； 4.\* clinical staging methods: colon CT staging, approved by pelvic magnetic resonance imaging (MRI) and the rectum rectum cavity ultrasound combined with staging, 5．No signs of intestinal obstruction;Or intestinal obstruction after proximal colon obstruction has been relieved after colostomy surgery; 6．No distant metastasis was confirmed by comprehensive examination (distant organs or (and) the distant lymph node metastasis); ( 2 ) Previous treatment 1．No colorectal cancer surgery before; 2. No previous chemotherapy or radiotherapy ; 3. had not received biological treatment ; 4. Previous endocrine therapy : no restriction.

Exclusion Criteria:

* 1.Immunohistochemistry of tumor biopsy specimens suggested pMMR or microsatellite instability detection suggested MSS ; 2. Chronic hepatitis B or C ( high-copy viral DNA ) with a history of HIV infection or active phase ; 3.Autoimmune diseases ; 4.Other active clinical severe infections ( \> NCI-CTC3.0 version ) ; 5. patients with clinical stage I ; 6.Preoperative evidence of distant metastasis ; 7. cachexia, organ dysfunction ; 8. Have a history of pelvic or abdominal radiotherapy ; 9. Patients whose seizures require treatment ( e.g. steroids or antiepileptic treatment ) ; 10.5 years have a history of other malignant tumors, except for cured cervical carcinoma in situ or skin basal cell carcinoma ; 11. Chronic inflammatory bowel disease, intestinal obstruction ; 12. Drug abuse and medical, psychological or social conditions may interfere with patient participation in the study or have an impact on the evaluation of the results of the study ; 13.Known or suspected allergies to the study drug or any drug related to this test ; any unstable condition or condition that may endanger patient safety and compliance ;
Using Tablets for Upper Extremity Rehabilitation Post Acquired Brain Injury

The purpose of the study is to test the effectiveness of training using novel tablet applications for hand function, compared to traditional hand exercises. In addition, we aim to examine brain plasticity following treatment with the new tablet applications. We hypothesize that training with a tablet would prove to be more effective than traditional exercises. We expect to observe neuroplastic changes in the brain in patients who practiced finger movements using the tablet.


Eligibility Criteria:
Inclusion Criteria:

* At least one week post Brain injury or stroke
* Partial ability to open and close their hand (fingers)
* Full function of the hands prior to the injury or event
* Intact or Corrected vision
* Cognitively intact or mild impairment

Exclusion Criteria:

* Other neurological conditions besides the brain injury or stroke
* Orthopedic conditions of the upper extremity
Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents

This study is conducted in Europe. The aim of this study is to compare the easiness of use of Norditropin NordiFlex® device to the device previously used by patients or parents.


Eligibility Criteria:
Inclusion Criteria:

* Children who can receive Norditropin® (somatropin) treatment according to the product labelling
* Treated with growth hormone for at least one year

Exclusion Criteria:

* Contraindications to Norditropin® growth hormone therapy
* Known or suspected hypersensitivity to somatropin or related products
* The receipt of any investigational medicinal product within 3 months prior to study start
* Life threatening disease, for example cancer
* Pregnancy or the intention of becoming pregnant
Predictive Value of β2-microspheres for Postoperative Delirium

This study evaluated the predictive value of β2-microspheres for postoperative delirium (POD) in the elderly after orthopedic surgery. For this purpose, the levels of β2-microspheres in plasma and cerebrospinal fluid were compared between the POD and non-POD groups.

In this study, plasma and cerebrospinal fluid of the patients were collected to detect the levels of β2-microspheres before operation. Also, the patients were interviewed one day before the surgery and on postoperative days 1-3 by the Confusion Assessment Method and then divided them into POD and non-POD groups. The aim of the present study was to assess whether higher levels of β2-microspheres could predict the occurrence of POD.

Eligibility Criteria:
Inclusion Criteria:

* ≥65 years old, American Standards AssociationⅠ-Ⅲ, undergoing orthopedic operations under spinal anesthesia

Exclusion Criteria:

* decline to participate
Feasibility and Acceptability of Using Weighted Blankets to Prevent and /or Mitigate Delirium

The use of weighted blankets to avert or alleviate Delirium in Adult ICU patients.

To examine the feasibility and acceptability of weighted blankets as a single component, nonpharmacologic strategy to prevent and/or mitigate delirium in an adult medicine critical care patient population. To examine the feasibility and acceptability of videoconferencing (VCU Health Zoom), EHR screening, and VCU and VCU Health infrastructure (REDCap, OnCore) for rural participant recruitment and research participation, remote HealthCare provider protocol training and research engagement, and remote research monitoring and support for rural patient population. To collect preliminary descriptive data and examine trends related to the use of weighted blankets to prevent and/or mitigate delirium to inform future efficacy trials in an adult medicine critical care patient population (e.g., Agitation, Delirium, ICU length of stay, number ventilator days, sedation/opioid medication usage).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Requiring ICU level of care.
* Have a primary medical diagnosis.
* Proficient in English.

Exclusion Criteria:

* BMI less than 18.5.
* Significant deficit in cognitive functioning that is not expected to improve due to an end---stage disease stage or permanent injury (e.g., end-stage encephalopathy, traumatic or anoxic brain injury, dementia).
* Known pregnancy.
* Prisoners.
* Presence of skin injury (e.g., surgical wound, pressure injury, moisture injury) in an anatomical location where additional weight/pressure of blanket could prevent healing and /or lead to an expansion of the injury.
* Patients with skin injuries to areas easily left uncovered by the blanket (e.g., hands, feet) can be enrolled with additional communication to clinical team to leave areas uncovered to prevent additional injury.
* Paralysis effecting an area the weighted blanket will cover.
* Current neuromuscular blocking agent.
* Presence of recent/unhealed fractures on an area the blanket will cover (e.g., lower limb long bone, rib, pelvis, spine).
* History of claustrophobia reported by patient and/or their legally authorized representative (LAR).
* Fever of 37.5°C (99.5°F).
* Limited English proficiency.