cyrilzakka/clinical-trials huggingface dataset:
Effects of Nasal Ventilation on Cerebral and Pulmonary Function in Orally Intubated Patients

The passage of air through the nasal cavity generates rhythmic oscillations transmitted by the olfactory bulb to the brain, which induces cerebral activation in functional areas and is associated with better cognitive performance compared to oral breathing. Consequently, the abolition of nasal ventilation in patients intubated via the orotracheal route could have deleterious effects on brain activity. Besides the loss of olfaction, the abolition of nasal ventilation could affect brain activity and respiratory control, consequently altering regional pulmonary ventilation.

The hypothesis of the study is that nasal ventilation through the passage of humidified nasal airflow in patients intubated via the orotracheal route would be associated with modulation of cerebral electrical activity and tissue oxygenation and a modification of regional pulmonary ventilation.

The effects of nasal ventilation on cerebral activity will be studied on orally intubated and sedated patients in six experimental conditions. The first condition consists of nociceptive stimulation of the left upper limb as a negative control. In three conditions, the inspired fraction of oxygen (FiO2) will remain at 21% while applying three different rates of humidified nasal air at 0L/min, 30L/min and 60L/min respectively. The last two conditions consist of applying humidified nasal air at 30L/min and 60L/min with a FiO2 of 100%. The primary objective of this study is to evaluate the effects of high-flow humidified nasal air on electroencephalogram activity (root mean square gamma frequency) in sedated, orally intubated patients. The secondary objectives of the study are to evaluate the effects of high-flow humidified nasal air on cerebral perfusion and oxygenation, gas exchange and regional pulmonary ventilation in the same patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Hypoxemic acute respiratory failure
3. Intubation and mechanical ventilation since less than 4 days
4. PaO2/FiO2 ratio less than 200
5. RASS\<-4
6. Consent obtained from next of kin
7. Patient with health insurance

Exclusion Criteria:

1. Central nervous system diseases (stroke, MS, epilepsy)
2. Psychiatric illnesses (psychosis, depression) (indicated on patient's medical record)
3. Hemodynamic instability (noradrenalin\>2mg/h)
4. Patient on AME
5. Patients under legal protection (guardianship/curators)
6. Pregnant or breast-feeding women
Kinesiotaping in Treatment of Pes Anserinus Tendino-bursitis

The aim of this study was to determine the effects of kinesiotaping in comparison to NSAIDs and physical therapy in treatment of pes anserinus tendino-bursitis.

The treatment of pes anserinus tendino-bursitis includes refraining from aggravating activities, local modalities such as heat, ice, ultrasound (US), iontophoresis, phonophoresis, electrical stimulation (ES), nonsteroidal anti-inflammatory drugs (NSAIDs) and injections with either corticosteroids or local anesthetics. Another treatment that seems to have a significant effect on the improvement of the disease is kinesiotaping. Kinesiotaping is a cotton strip with an acrylic adhesive that is used for treating athletic injuries and a variety of physical conditions. The therapeutic effects of the tape is to relax the overused muscles and in rehabilitation to facilitate the underused muscles. Advocates claim that the wave pattern found on the kinesiotaping has a lifting effect on the skin which can diminish swelling and inflammation via improving circulation and reduce pain by removing pressure from pain receptors.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical diagnosis of pes anserinus tendino-bursitis.

Exclusion Criteria:

* Previous history of trauma or surgery on the knee joint,
* History of NSAIDs induced acid-peptic disease
* Systemic and rheumatic diseases
The s100β Levels in Patients With Mild Brain Injury.

Mild traumatic brain injury (TBI) accounts for the majority of TBI. At present, whether TBI has traumatic intracranial lession is mainly diagnosed by computed tomography (CT), while only 5% of mild TBI has positive CT results. The risk stratification method for patients with mild TBI is needed to reduce unnecessary CT use and reduce medical costs.

S100β is a protein in glial cells and can be used as a biomarker of brain injury. S100β is showed to have the clinical and economic value in ruling out traumatic intracranial lesions in mild TBI patients in Europe and the United States. However, it was showed to have difference between races, and there lacks systematic research data from Chinese population. In addition, if it is used for emergency departments, it is necessary to evaluate new rapid detection methods.

This study is based on a novel fast S100β test. The reference intervals of S100β in Chinese adults will be established. Further, evaluation of S100β in diagnosis of traumatic intracranial lesions in acute mild TBI will be conducted from the perspective of clinical and economic value in China, which will provide data for screening of low-risk TBI patients and avoiding unnecessary CT use in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Study on healthy people: Apparently healthy people \>18 years old who came to our hospital for physical examination.
2. Study of emergency trauma patients: 1) Emergency trauma patients at least 18 years old with suspected brain injury; 2) Glasgow Coma Score 13-15 (patients with mild traumatic brain injury); 3) Closed head trauma; 4) Clinical judgment of patients requiring craniocerebral CT examination.

Exclusion Criteria:

1. Healthy population study: stroke history, trauma, surgery, mental illness, senile dementia, cognitive impairment, and tumor patients within 3 months.
2. Study of emergency trauma patients: 1) neurological or psychiatric history, 2) intellectual disabilities, 3) alcohol or drug addiction (trauma after drinking was eligible for inclusion, but alcohol consumption was recorded), 4) brain tumor patients, 5) time of trauma was not available, and 6) patients whose clinical conditions were deemed unsuitable for participation in the trial.
An Epidemiological Investigation on Correct Wearing of Mask by Direct Spray Test

The purpose of this study was to explore the relationship between the transmission of respiratory diseases and the correct wearing of masks, as well as the factors affecting the correct wearing of masks. The research is beneficial to the prevention of respiratory diseases and moves the barrier of prevention and control forward. It is of great significance to COVID-19 's practical prevention and control.

1. Overall design：This study uses the methods of cross-sectional survey and chance sampling.
2. Sign the Informed Consent Form.
3. Investigation on the basic situation of personnel: The gender, age and education level of the subjects were analyzed as the factors influencing whether the mask was worn correctly or not.
4. Investigation on the types of wearing masks： 1) The types of masks worn by the subjects were recorded as the basis of stratified statistics.

2) Mask suitability testing：

1. Visual inspection whether the mask is close to the face with obvious gaps.
2. Breathing test Are there any obvious gaps or whether the cotton around the mask is blown when the subject taking a deep breath.
3. Spray test The FT-30 qualitative fitness test system of 3M company was used to test the suitability and correctness of wearing mask.

In the spray test, all subjects underwent a sensitivity test to prove their ability to smell the bitterness of the reagent, sensitive subjects can participate in the direct spray test.

In order to objectively reflect the overall situation of the subjects, it is necessary to cover many ages and educational levels of men and women.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy people with autonomous behavior ability and language expression ability who are older than or equal to 7 years old, Persons under the age of 18 need to obtain the consent of their legal guardians；
2. The subjects and / or their legal guardians have the ability to understand the contents of the study and to participate in all the research processes with the subjects；
3. People who volunteered to take part in the study；
4. There was no respiratory infection in nearly one month.

Exclusion Criteria:

1. People with a history of allergies, including those who are allergic to pollen, dust mites, etc；
2. People with any history of drug allergy；
3. People who have participated in the experiment are not allowed to participate in this study for the second time;
4. Pregnant women；
5. The healer after COVID-19 's infection；
6. After questioning, it was found that the subjects were the factors that affected the study, such as dysosmia, or those who had decreased olfactory ability due to disease, or facial paralysis, which affected the judgment of the test；
7. Those who are participating in clinical trials of other drugs / devices；
8. Subjects with poor compliance or unwilling to cooperate with the operation as required；
9. The researchers believe that any other situation that may affect the evaluation of the study.
Phase 1/2 Study Evaluating Safety and Potential Efficacy of Allocetra-OTS Via Pressurized Intra-Peritoneal Aerosol Chemotherapy as Add-on to Standard of Care Chemotherapy for Treatment of Peritoneal Metastasis

This is an open-label study to evaluate safety and potential efficacy of Allocetra-OTS in the treatment of patients with peritoneal metastasis as an add-on to the standard of care (SoC) chemotherapy.

Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) is utilized in patients with malignant dissemination to the peritoneal cavity, for the treatment of peritoneal metastasis that have a high tumor burden or are unresectable, and are unresponsive to systemic therapy.

Allocetra-OTS is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.

The study will evaluate the safety and potential efficacy of Allocetra-OTS in the treatment of peritoneal metastasis as an add-on to the standard of care (SoC) chemotherapy. Patients will be treated with escalating doses of Allocetra-OTS as an add-on to the chemotherapy administered via PIPAC, and in addition to systemic chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Diagnosis of peritoneal metastasis due to any primary tumor by histopathology or cytology
* Possession of unresectable tumors (not eligible for Cytoreductive Surgery / Hyperthermic Intra-Peritoneal Chemoperfusion CRS/HIPEC).
* Adequate performance status and surgical risk
* Adequate hematopoietic, hepatic and renal function

Exclusion Criteria:

* Extraperitoneal disease.
* Bowel obstruction
* History of Liver cirrhosis with CHILD PUGH classification of B or C or signs of portal hypertension, portal vein thrombosis.
* Patient with known New York Heart Association (NYHA) class 3 or 4 symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias.
* Previous history of organ allograft or stem cell transplantation.
Lifestyle Online Intervention On EB and BMI On Obese Hypertensive Adults

This study aims to analyze the effects of a online program focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on obese or overweight adults with hypertension. Participants will be recruited from a hypertension unit of a public hospital. These patients will be randomized allocated into two interventional groups: experimental group will receive audiovisual instructions from their hypertension specialist doctor, and the control group from a doctor outside the patient. Assessment will include: body composition (BMI), blood pressure, and eating behaviour.

Hypertension incidence and overweight or obesity related, constitute a worrying public health problem nowadays. Evidence indicates that, despite the existence of several factors involved in their etiology, diet and physical activity play a particularly important role in the treatment and prevention of obesity and associated disorders. However, interventions for the treatment of obesity encounter some environmental and personal barriers, specifically problems or deficits in motivation. These barriers sometimes make it difficult to implement intervention strategies. In this sense, there is an important agreement about the need to generate alternatives and strategies which promote intrinsic motivation, self-regulation and self-efficacy as fundamental variables which have a direct relationship with the adherence and success of obesity treatments. To achieve this, Information and Communication Technologies (ICTs) are a very promising alternative, as they can provide personalised feedback and can be flexibly adapted to each user. In addition, ICTs also present other important advantages, especially their excellent cost-benefit ratio, and the possibility of increasing the efficiency of the interventions, since they allow to reach a greater number of users at a lower cost.

Therefore, this study aims to analyze the effects of a 3 months duration self-applied online program, composed of 9 modules focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on obese or overweight adults with hypertension. Participants will be recruited from a hypertension unit of a public hospital. These patients will be randomized allocated into two interventional groups: experimental group will receive audiovisual instructions from their hypertension specialist doctor, and the control group from a doctor outside the patient. Assessment will include: body composition (BMI), blood pressure, and eating behaviour.

Eligibility Criteria:
Inclusion Criteria:

* Hypertension
* Overweight or obesity (25 ≤ BMI ≤ 35 kg/m2)
* Aged between 18-75 years
* Being a participant of the program 5 years ago

Exclusion Criteria:

* Not having access to the Internet or lack of information about it.
* Treatment with more than 3 antihypertensive drugs.
* Meet the criteria of the DSM-IV-TR of a Food Disorder.
* Presenting some type of severe psychiatric disorder.
* Disability that prevents or hinders physical exercise.
* Receiving some treatment for weight loss.
Inositols and FSH in IVF

Ovarian hyperstimulation syndrome (OHSS), although quite uncommon, represents the most serious complication of ovulation induction during in-vitro fertilization (IVF) protocols. The syndrome is triggered by exaggerated ovarian response to gonadotropins, which eventually leads to pathological manifestations that range from mild symptoms, such as abdominal discomfort, to life-threatening complications in the most severe cases. Prevention is paramount during fertilization programs and requires assessment of risk factors and close monitoring of risk markers. Clinicians quite generally consider unusually elevated estrogen levels as both indicator for OHSS and one possible etiological factor. In this scenario, myo-inositol (MYO) treatment proved to reduce the amount of FSH units and the duration of the stimulation protocol, decreasing the risk of OHSS onset. On the other hand, inconclusive evidence is available about the effect of D-chiro-inositol (DCI) supplementation within assisted reproductive treatments. The aim of the proposed pilot study is to assess the effect of DCI supplementation on the doses of FSH used in IVF-ET protocols, also with respect to MYO treatment.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing IVF-ET procedure
* HOMA-IR index \< 2.0
* AMH in the range 1.0 - 2.0 ng/ml

Exclusion Criteria:

* History of cancelled IVF cycles
* BMI \< 20 kg/m2 or ≥ 30 kg/m2
* Diagnosis of PCOS
* Thyroid diseases
* Presence of co-morbidities
Epidemiologic Registry PETHEMA LMA 2015

Epidemiologic and retrospective multicenter registry of all patients diagnosed with de novo or secondary acute myeloid leukemia (AML) in the PETHEMA Group institutions. This study is a non-interventional research regarding diagnosis and therapeutic approach

To perform this registry, every patient diagnosed with AML in the participant institutions, regardless type of AML and treatment administered, must be reported. It will be required to registry the main characteristics of the patients and AML at diagnosis, as cytomorphologic, immunophenotypic, and cytogenetic results, according to the habitual practice of the centers. The treatment which has been administered by every center of the PETHEMA Group, even when it is considered as supportive care, and evolution of the disease will also be reported (relapse o death). PETHEMA Group will input all the reported information in data bases

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with acute myeloid leukemia

Exclusion Criteria:

* No exclusion criteria
Focused Spinal Stenosis Rehabilitation Program for Lumbar Spinal Stenosis

Lumbar spinal stenosis with neurogenic claudication is a common condition in the elderly population and is characterized by bilateral buttock, thigh, or calf discomfort and/or pain, as well as by weakness precipitated by walking and prolonged standing. Self-management options include physical therapy, which includes exercise as a core component for improving the flexibility and mobility of the spine and hips. A Williams flexion protocol has historically been used to treat low-back pain following degenerative changes to the posterior elements of the lumbar spine. However, few studies have been done to validate the efficacy of this protocol. A more focused treatment protocol may be more efficacious. Patients in this study will be randomized to receive either the generic physical therapy protocol (15 sessions) or the focused rehabilitation program (5 sessions). The sessions will take place over the course of 6 months. Outcomes will be assessed using validated questionnaires and physical function tests.


Eligibility Criteria:
Inclusion Criteria:

* Lumbar spinal stenosis with neurogenic claudication
* Symptoms present for at least 3 months
* Moderate to severe acquired or congenital LSS based on radiological evaluation
* Lumbar MRI obtained within the past 12 months prior to initial physical therapy visit
* 40 years of age or older
* Body mass index less than or equal to 35
* Can tolerate a 6-min treadmill test
* Willing to comply with home exercises as prescribed

Exclusion Criteria:

* Acute disc herniation
* Grade 3 or greater spondylolisthesis
* Rheumatoid or autoimmune conditions (e.g., ankylosing spondylitis)
* Active spinal compression fractures
* Knee surgery in the previous 6 months (e.g., total knee arthroplasty)
* Previous spinal fusion
* Absence of pedal pulses
* Inflammation/infectious process
* Myelopathy
* Psychiatric disorder preventing informed consent or participation in assigned physical therapy sessions
* Patients with pending litigation or workers compensation
PROSABI: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Abiraterone Acetate.

PROSABI is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with abiraterone

This study is a prospective biomarker study of patients with mCRPC undergoing treatment with abiraterone as standard of care treatment. The participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Male age ≥ 18 years
2. Histologically confirmed adenocarcinome of the prostate
3. ECOG Performance Status ≤ 2
4. Castration resistance must be documented with surgical or medical castration with serum testosterone \< 50 ng/mL (\< 2.0 nM).
5. Men diagnosed with at least one metastatic lesion on CT or bone scan.
6. Documented biochemical and/or radiographic progression to previous treatment according to PCWG2 criteria.
7. Patients who are candidates for standard of care treatment with abiraterone acetate: 1000 mg every 24 hours plus prednisone 5 mg every 12 hours.
8. Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy.
9. Acceptable hematological, hepatic and renal functions.9. Acceptable haematological, hepatic and renal functions.

Exclusion Criteria:

1. Previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ carcinomas.
2. Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data
Anti PD-L1 Antibody + Anti CTLA-4 Antibody in Combination With Hormone Therapy in Patients With Hormone Receptor Positive HER2-negative Recurrent or Metastatic Breast Cancer

The aim of this study is to evaluate the safety and efficacy of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged \>= 20 years at informed consent.
2. Patients who have provided written informed consent themselves.
3. Patients who have metastatic and/or advanced lesion
4. Documentation of ER-positive and/or PR-positive tumor (\>=1% positive stained cells).
5. Patients with cancer confirmed to be HER2-negative.
6. Patients with confirmed menopause
7. Patients who have plans of 2nd hormone therapy.
8. Patients with a measurable lesion based on RECIST 1.1
9. Patients with ECOG PS of 0 to 1.
10. Patients without any severe disorder in the major organs.

Exclusion Criteria:

-

Exclusion Criteria:

1. Active or prior documented autoimmune disease within the past 2 years.
2. Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab
3. Patients with central nervous system metastasis
4. Patients with life-threatening disease.
5. Patients with a history of treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibody drug.
6. Patients who have received live vaccination within 30 days before start of the investigational products.
7. Patients with a past medical history of pneumonia requiring steroid treatment or with a past medical history of interstitial pneumonia.
8. Patients considered ineligible for participation in this study by their attending physicians.
Orange Juice Consumption and Glucose Metabolism and Antioxidative Status

Aim of the study is to investigate the impact of orange juice consumption (with meals or between meals) as well as sugar sweetened beverage (SSB) consumption (between meals) on glucose homeostasis and antioxidative status.

Duration of the study is 3x three weeks including one wash-out week each followed by two weeks of juice/SSB consumption under free living conditions.

During wash-out weeks consumption of orange juice or citrus fruits is restricted.

During intervention weeks, participants are asked to eat three regular meals per day without snacking. Intervention weeks are (i) orange juice consumption with meals (ii) orange juice consumption between meals and (iii) SSB consumption between meals. Daily energy intake with orange juice/SSB is 20% of individual energy requirement. Additional caloric beverages (SSB, juice, coffee with sugar/milk, alcohol) are not allowed. At the beginning and the end of each intervention phase insulin sensitivity and antioxidative status are assessed.

Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* regular use of medication,
* smoking,
* chronic disease,
* vegan/vegetarian diet,
* fructose intolerance,
* irregular eating behaviour (less then 3 meals/day)