cyrilzakka/clinical-trials huggingface dataset:
Pulmonary Rehabilitation Before Lung Cancer Resection

This is a study funded by the National Institute of Health. The rationale for the need of this research is the lack of any well proven risk-reducing intervention that may decrease the morbidity of lung cancer resection in patients with COPD or that may improve their quality of life trajectory, a meaningful outcome in the overall disease progression. The proposed intervention is unique as it combines exercise and behavioral interventions that were pilot tested in a randomized single-blinded controlled design in the proposed population and proved feasible and potentially effective. The aim is to test the effect of the proposed rehabilitation on length of stay, pulmonary complications and quality of life trajectory.

Prospectively, 194 patients will be randomized to either ten sessions of preoperative pulmonary rehabilitation (PR) vs. standard care at a number of healthcare centers throughout the United States. This study will be open for 36 months. Randomization will be stratified by three variables: very severe lung function (yes vs. no), prior neo-adjuvant chemotherapy for this operation (yes vs. no) and open thoracotomy vs. video assisted thoracoscopy. The primary and secondary objectives are provided below.

Primary Objective:

To prospectively determine the effect of 10 sessions of customized preoperative PR on the length of hospital stay in patients that undergo a lung cancer resection and have COPD compared to a matched control group. Hypothesis: Ten sessions of customized preoperative PR will significantly reduce the length of hospital stay.

Secondary Objectives:

1. To prospectively determine the effect of 10 sessions of customized preoperative PR on the number of postoperative complications in patients that undergo a lung cancer resection and have COPD compared to a matched control group.

   * Hypothesis: Ten sessions of customized preoperative PR will significantly reduce the number of postoperative pulmonary complications.
2. To prospectively determine the effect of a 10-session preoperative PR on the trajectory of quality of life at 3 and 6 months after the curative resection compared to a matched control group.

   * Hypothesis: Ten sessions of customized preoperative PR will significantly and meaningfully (more than the minimal clinically important difference) improve quality of life after surgery compared to a control group.

Patients will be followed at 3 and 6 months post-surgery.

Eligibility Criteria:
1. Patient is scheduled to undergo NSCLC resection: video assisted thoracoscopy (VATS) or open thoracotomy for: limited resection, lobectomy, or pneumonectomy. Surgery must not be scheduled to take place \< 3 weeks after registration.
2. Patient has a doctor diagnosis of COPD.
3. Patient is a current or ex-smoker with a smoking history of ≥ 10 pack years. (Calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked. For example, 1 pack-year is equal to smoking 20 cigarettes (1 pack) per day for 1 year, or 40 cigarettes per day for half a year, and so on).
4. Age ≥ 18 yrs
Care Pathways of Acute Heart Failure Patients: Impact on In-hospital Mortality.

The investigators conducted a prospective observational study to describe the different pre-hospital and in-hospital pathways of patients with acute heart failure (AHF) and their association with in-hospital mortality.

Prospective observational national multicentric study in 26 centres. Between june 2014 and october 2018 The investigators collected data about baseline characteristics, first recourse, in-hospital places of care and places of hospitalizations. Lengths of care and lengths of hospitalization.

Collected data of each patient were reported on a specific assessment tool. The investigators ran a univariate analysis and logistic regression between steps of the care pathway and in-hospital mortality. The main result was validated by an analysis with a propensity score: association between a hospitalization in cardiology and in-hospital mortality.

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting to hospital with Acute Heart Failure according to the physician in care

Exclusion Criteria:

-
Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer

The objective is to develop an organotypic model to assess the effects of obesity on the expression and methylation status of estrogen-responsive genes in endometrial cancer. Omental fat samples will be removed from participants during surgery and these fat samples will be used in laboratory analyses.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Any patient having abdominal surgery (Laparoscopic or open technique) for benign conditions
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Patients must have adequate:
* Hematologic function: Neutrophils ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L
* Renal function: serum creatinine ≤ ULN or estimated glomerular filtration rate (eGFR) \[CKD-EPI Formula\] ≥ 60 mL/min
* Hepatic function: serum bilirubin ≤ 1.5 x ULN and AST ≤ 2.5 x ULN and ALT≤ 2.5 x ULN
* Physically able to undergo surgery
* Written informed consent

Exclusion Criteria:

* Confirmed gynaecological malignancy
* Contraindications and/or unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
* Patients who are pregnant or lactating
* Serious illness or medical condition but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (patients with stable AF are eligible), or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients with disseminated intra-peritoneal malignancy or suspected ovarian cancer
* HIV positive
* Previous bariatric surgery
Evaluation of Newborns Presenting With Suspected COVID 19

This study evaluates the newborns who had respiratory symptoms at the neonatal intensive care admission


Eligibility Criteria:
Inclusion Criteria:

* All newborns who had respiratory symptoms at the NICU admission

Exclusion Criteria:

* Congenital abnormalities
Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Children Using Transthoracic Echocardiography

Initial fluid resuscitation remains the first treatment step for most children experiencing circulatory failure and/or systemic hypotension. Only one-half of these patients respond to fluid administration by a significant increase in cardiac output. A positive fluid balance is a poor prognostic factor that increases mortality. There are few markers validated in children to assess volume reactivity by dynamic ultrasound parameters mainly based on heart-lung interaction.

In this work, the investigators propose to investigate whether dynamic parameters validated in adults, such as the superior vena caval collapsibility and the variability of cardiac output during an end-expiratory and end-inspiratory occlusion, are also reliable indicators of volume responsiveness in sedated children under controlled-mode ventilation.

After standardized volume expansion, patients who present an increase of cardiac index measured by transthoracic echocardiography greater than or equal to 15% of baseline measurement will be considered responders .

A previous similar study using respiratory variations in aortic blood flow to predict fluid responsiveness in ventilated children reported a ROC curve area 0.85, while the prevalence rate of circulatory failure was 50%. Given these assumptions, a sample size of 38 subjects per group (Responders / No responders) was estimated to provide a AUC equivalent. A total of 76 subjects should be included.

Eligibility Criteria:
Inclusion Criteria :

* Patient \< 18 years (child and neonate)
* Sedated and mechanically ventilated under controlled-mode ventilation
* In whom fluid administration was planned by the attending physicians

Exclusion Criteria :

* High-frequency oscillatory ventilation
* Cardiac arrhythmia
* Congenital heart defect
Web-based Intervention for Lung Cancer Patients and Their Informal Caregivers

The purpose of this study is to find out if patients with lung cancer and their main informal caregiver (person providing physical, emotional, or financial support) are helped by getting information, support, and decision making tools through a computer system called CHESS(the Comprehensive Health Enhancement Support System)

Many patients and their family/friends use the internet for obtaining information regarding the cancer diagnosis and treatment. In this study, the main caregiver of patients with advance (stage III or IV) non-small cell lung cancer is provided with a computer and internet access. Approximately one-half of the participants will also receive CHESS.

Eligibility Criteria:
Inclusion Criteria:

* Advanced Non-Small Cell Lung Cancer (Stage III or Stage IV)
* Needs to have a "caregiver" - a spouse, partner, family member, or friend providing emotional, physical, and/or financial support - to participate with the patient.
Detection of Muscle Loss in Acute Stroke Patients Who Need Enteral Nutrition (MASS)

The degree of muscle loss over the course of inpatient stay will be evaluated in patients with a diagnosis of acute ischemic stroke admitted to Neurocritical Care Units and necessitating enteral nutrition.

This study is a multicenter, prospective observational study. The study period is 12 months. There are no investigational products to be followed or used in the study.

Demographic data, stroke subtype, lesion localization, anthropometric measures will be recorded. Muscle in three different anatomical sites will be measured by CT following admission in patients included in the study.

For anthropometric measurements, height, body weight, body mass index, waist circumference, triceps skin thickness and calf circumference values will be used.

The muscle mass will be measured from the paraspinal muscles at the L3 vertebra level and from the muscles around the humerus and femur on the non-paralytic side of the extremities by CT.

All patients will receive standard enteral nutritional support with a standardized calorie and protein-based protocol recommended by international guidelines. The choice of the commercial enteral product will be left to the investigator, without any encouragement or restriction for use of any commercial product.

The enteral nutrition protocol will be implemented as follows;

* Nasogastric or nasojejunal access
* Continuous infusion
* Targeted daily calories - 25-30 kcal / kg
* Targeted daily protein - 1.2-1.5 gr / kg
* 20 ml / h initial infusion rate
* Increase infusion rate by 10-20 ml / h in 8-12 hours
* Targeted calorie-protein requirement will be reached at the end of 72 hours.

Patients will continue their routine follow-up in the neurology intensive care unit / stroke unit / neurology department. Daily enteral nutrition dose, complications attributed to enteral nutrition and systemic comorbidities will be recorded. Anthropometric measurements and muscle mass measurements with CT at three different locations will be repeated at the end of the second week (14 days ± 3 days) .

The study will evaluate whether or not muscle mass develops 14 days after acute ischemic stroke. The end points of the study is deterioration of anthropometric measurements and loss of muscle mass demonstrated by CT at follow up. The differences between patients with and without muscle loss will be assessed from the the aspects of demographic characteristics, ischemic stroke subtype, comorbidities and the success attained in reaching enteral nutritional goals.

Eligibility Criteria:
Inclusion Criteria:

Patients to be included in this study are required to meet all of the following inclusion criteria:

* Acute ischemic stroke
* Admission within first 24 hours after symptom onset
* Admission NIHSS score \> 8
* Being unable to walk
* Need for enteral tube feeding due to problems with consciousness or dysphagia

Exclusion Criteria:

Patients with any of the following exclusion criteria can not be included in the study:

* Retained ability for oral feeding
* Known muscle disease, neuropathy, neuromuscular junction disease
Cathelicidin LL-37 Levels in the GCF and the Saliva of Smokers and Non-smokers With Stage III,IV Periodontitis

Periodontitis is considered an inflammatory disease that results in the disruption of oral hemeostasis and is associated with the presence of dental plaque influenced by genetic and environmental factors. It is well-establised that smokers have an increased severity of periodontal disease,a higher prevalance of tooth loss and total edentulism.

Antimicrobial peptides (AMPs) are soluble molecules participating in the innate immunity of mucosal surfaces against pathogens. Dysregulated expression of AMPs has been considered a possible causal mechanistic link in the microbial dysbiosis associated with periodontal disease and some risk factors, including tobacco smoking, diabetes mellitus, and obesity.Antimicrobial peptides as a part of innate immunity are important molecules that provide a balance between disease and health. Moreover, they are considered to be an important intermediate step in initiating an initial immune response against the microbial side of the gingival epithelium and in the transition to acquired immunity. Cathelicidins, in particular - which play an important role in regulating the immunological response of oral tissues, are a group of peptides released from neutrophil granules and they are present only in humans in the form of LL-37.

Eligibility Criteria:
Inclusion Criteria:

1. Presence of a minimum of 15 natural teeth.
2. At least four non-adjacent teeth sites in each jaw having CAL ≥ 5 mm and PD \> 5 mm in one or more sites.
3. Bleeding on probing (BOP) ≥ 30%.
4. Tooth loss due to periodontitis ≤ 4 teeth.
5. For smoker's patients; study will include patients who regularly smoked at least 10 cigarettes/day for a minimum of 5 years.
6. For non-smokers patients; study will include patients who had never smoked.

Exclusion Criteria:

1. Individuals with a history of systemic diseases or immunological disorders.
2. Individuals using hormone replacement therapy.
3. Pregnant and lactating women.
4. Individuals that received periodontal treatment within the last 6 months.
5. Individuals with a history of systemic antibiotics and anti-inflammatory drugs within the last 3 months.
Is Clonal Hematopoiesis of Indeterminate Potential Associated With Unprovoked Pulmonary Embolism?

The clonal hematopoiesis of indetermined prognosis (CHIP) has been described as risk factor for juvenile atherosclerosis. Moreover, some of CHIP genes are responsible of myeloproliferative disorders. Venous thrombosis are frequent in these disorders. The purpose of this project is to determine if CHIP is frequent in unprovoked pulmonary embolism and could be part of the pathophysiology.


Eligibility Criteria:
Inclusion Criteria:

* For cases : Previous proximal unprovoked pulmonary embolism, negative thrombophilia screening.
* For control : Previous proximal provoked pulmonary embolism, negative thrombophilia screening.

Exclusion Criteria:

* Age superior to 65 years old,
* Active cancer
Super: a Joint System in a Rehabilitation Educational Digital Platform

Due to its complexity and variability, Autism Spectrum Disorder (ASD) requires multidisciplinary and multidimensional interventions. SUPER (in Italian: Sistema Unitario in una Piattaforma Riabilitativa ed Educativa) is an Italian digital platform, implemented to facilitate collaboration between families, health services, and schools and to promote personalized intervention for children with ASD. The research protocol, aimed to test SUPER's feasibility and usability, foresees the enrollment of 12 ASD children in the Experimental Group (EG) and 12 ASD children for the Control Group. All families, teachers, and clinicians will perform usual rehabilitative and educative interventions, but the EG will use SUPER, in addition to ordinary programs. The feasibility and acceptability of SUPER will be assessed through usability scales and questionnaires realized ad hoc for the purpose. At baseline and established endpoints, ASD patients will be evaluated with different assessment tools.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Autism Spectrum Disorder
* Access to Child Neuropsychiatry or Pediatric Rehabilitation services participating in the study
* Age of patients from 3 to 7,11 years
* Informed consent freely acquired before the start of the study by the patient's parents

Exclusion Criteria:

* Patients with severe genetic degenerative diseases
* Patients with severe sensory disabilities
* Patients with severe medical complications
Monitoring of Immune and Microbial Reconstitution in (HCT) and Novel Immunotherapies

This protocol serves as a mechanism to collect, store, and distribute bodily fluid and tissue samples obtained from Hematopoietic Cell Transplant (HCT) or novel immunotherapy patients and their donors at the Masonic Cancer Center in order to conduct correlative studies of the immune system, microbiota, and their interactions. Fluid (including but not limited to, blood, urine, saliva, cerebrospinal fluid, bronchoalveolar lavage fluid) sample log-in, processing, relabeling, and storage is performed by the Masonic Cancer Center (MCC) Translational Therapy Lab (TTL).


Eligibility Criteria:
Inclusion Criteria:

* Patients planning to undergo HCT or other cellular therapy/immunotherapy
* Allogeneic related donors
* Aged 0-80
* Willing and able to sign voluntary written consent

Exclusion Criteria:

* Patients whose medical record indicates that they have opted out of research
Investigation of the Relationship Between Internet Gaming Disorder and Sensorimotor Functions in Adolescents

Using computer for long have been shown to cause vision problems, musculoskeletal pain particularly in neck, postural deviations, obesity and physical inactivity in several studies. The relation between obesity and physical activity, neck pain and postural deviations with altered sensorimotor function has been also shown with many studies. However, there were not enough study that assess sensorimotor congruence such as proprioception and reaction time in adolescents diagnosed with Internet Gaming Disorder (IGD). This study aimed to evaluate the proprioception and reaction time and investigate its relation with the relationship with neck pain, proprioception and reaction time in adolescents with IGD.

The aim of this study is to evaluate reaction time, motor dexterity, cervical posture and proprioception and its relationship with Internet Gaming Disorder (IGD) in adolescents. It's anticipated that 60 adolescents aged between 10-18 years will be included to this study (30 healthy adolescent; 30 adolescent with IGD. After recording sociodemografic data of participants, age of starting to use the internet, the age of starting to play games on the internet, the time spent on the internet, the name and type of the game played will be questioned. The presence of musculoskeletal pain and its localization, if any, will be recorded. The severity of internet addiction will be assessed with Internet Addiction Scale, motor dexterity will be assessed with The 9 Hole Peg Test, reaction time of upper extremity will be assessed with Ruler Drop Method, the severity of forward head posture will be assessed with Cervical Range of Motion (CROM) device, and lastly, proprioception of cervical region will be assessed with Joint Position Error which will be evaluated CROM device. All parameters will be compared between healthy adolescents and adolescents with IGD.

Eligibility Criteria:
Inclusion Criteria:

For healthy group as follows:

* being male in age between 10-18 years old
* having accepted the research on a voluntary basis and signed the informed consent.

For the experimental group, being diagnosed with IGD according to DSM-5 is an additional criterion.

Exclusion Criteria:

* being diagnosed with psychotic, bipolar, or autism spectrum disorder
* the presence of mental retardation in the child or family that prevents answering the questions and following the instructions properly in clinical assessment
* Use of psychotropic drugs.
Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®

Vulvovaginal candidiasis (VVC) is a common infection among women that is associated with considerable morbidity and health-care cost. 75% of women will suffer of Candida infection for at least one time in their life. 20% of women who suffer from VVC will have ≥ 4 episodes of VVC during the one year prior to the survey. 80% of these VVC are caused by Candida albicans. Current treatments, based on imidazoles, face many failures or recurrences. The type of probiotic Lactobacillus may participate in the prevention of recurrent vulvo-vaginitis in reducing the proliferation of intestinal Candida albicans, its adherence to the vaginal walls, the potentiation of its propagation. The primary objective of this study was to investigate if our supplementary treatment could improve the initial cure rate after vaginal econazole therapy.


Eligibility Criteria:
Inclusion Criteria:

* women
* 18-65 years
* suffering from 4 or more episodes of VVC during the 1 year prior to the survey
* all participants must be symptomatic with a microbiological proof of infection with candida albicans

Exclusion Criteria:

* Pregnancy, lactation being
* HIV infection, chemotherapy or illness serious enough to induce an immune deficiency. A diabetic patient will not be systematically excluded;
* Vulvo-vaginitis and / or cervicitis specific, defined in a bacteriological examination by the presence of herpes virus, gonorrhea or chlamydia;
* Bacterial Vaginosis or Trichomonas;
* Use of vaginal probiotics in the months before inclusion;
* Cure of probiotics in the months preceding the inclusion;
* Contraindication to Gynopévaryl LP
Oral Teleconsultation

In this study we want to compare a dental diagnose during face to face consultation vs remote consultation with telemedicine device.

Using Soprocare® camera, videos of patients' oral cavity are recorded and analysed remotely. 200 patients have been included: 100 in Montpellier (France) and 100 in Kitakyushu (Japan).

A classical face-to-face oral consultation is realized using ICDAS II classification. Then a student recorded 6 videos of patients' mouth: one video by sector, showing each face of molars and premolars in cario fluorescence mode of Soprocare® and one video of the maxillary and mandibular incisor-canine block in perio mode.

In a third step, a remote dentist analysed videos and made a telediagnosis using the same classification. Dental hygiene and missing teeth are also noted in classical and tele diagnostic.

The direct and the tele diagnostic are compared.

Eligibility Criteria:
Inclusion Criteria:

* The subject is aged at least 18 years
* The subject must be given free and informed consent
* Topics scheduled consultation from the dental center of Montpellier University Hospital and the Center Kyushu University (Japan).

Exclusion Criteria:

* NA
Effect of GLP-1 and GIP on Insulin Secretion in Type-1 Diabetes Mellitus

study hypothesis: treatment with GLP-1 and/or GIP is able to potentiate the maximal stimulated insulin secretion even in c-peptide negative type-1 diabetic patients classified as having no residual beta cell function left.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years
* Type-1 diabetes diagnosed between 5-40 years of age
* Normal weight(BMI 18-27),
* Insulin treatment from time of diagnosis.

Exclusion Criteria:

* Severe complications to diabetes
* Abnormal liver or kidney function
* Haemoglobin below the lower limit
* Macroalbuminuria
* Systemic disease
* Pregnancy.