cyrilzakka/clinical-trials huggingface dataset:
The Effects of Position on the Oxygenation Instability of Premature Infants as Documented by SpO2 Histograms

SpO2 instability is in the nature of premature infants. Hypoxic episodes occur spontaneously in many of these infants, especially after the first week of life. Different interventions have been shown to influence the incidence of hypoxemic episodes in premature infants. A few studies point towards potential clinical benefits of better oxygenation and less hypoxic events by positioning very low birth weight infants prone, though a recent meta-analysis didn't find a clear benefit of prone position.

The aim of this study is to evaluate the changes in oxygenation among preterm infants receiving respiratory support when positioned prone versus supine, as documented by SpO2 histograms.


Eligibility Criteria:
Inclusion Criteria:

Premature infants with a weight \< 1500 g who are receiving respiratory support

Exclusion Criteria:

Congenital anomalies, acute lung pathology for example x-ray confirmed pneumonia, air leak, active culture proven sepsis or on inotropic support for low blood pressure.
Study of Immune Response and Liver Damage Induced by Chemotherapy for Liver Metastases of Colorectal Cancer

The immune response at primary tumor has a major role in the prognosis of colorectal cancer (CRC). Some studies suggest a prognosis value of cytotoxic T cell and memory T cells at primary tumor greater than tumoral stage. There is no work in the literature that has examined the prognosis value of the immune response in liver metastases. To study immune cells (histology) and inflammatory response (cytokines) in liver metastases is a challenge to understand the effectiveness of chemotherapy used in this situation.

The chemotherapy used in liver metastases of colorectal cancer also have effects on non-tumoral liver tumor and therefore can interfere with postoperative complications of hepatic resection. Sinusoidal dilatation is present in 20% to 80% of patients who received oxaliplatin before hepatectomy. Steatosis is frequently observed after administration of 5-FU alone or in combination with irinotecan. This steatosis may also be accompanied by inflammatory lesions (steatohepatitis), especially after administration of oxaliplatin or irinotecan and is associated with increased postoperative mortality. The hepatic toxicity of new biological agents is not well known (cetuximab and bevacizumab). The mechanisms of chemotherapy-induced toxicities are currently unknown. The main objective is to analyze the profile of the immune response in liver metastases of CRC and find the link with the radiological response. Measurements will be made by quantitative RT-PCR on frozen liver biopsies. Secondary objective is to seek a correlation between the histological lesions induced by chemotherapy and non-invasive tests for liver fibrosis. The secondary endpoints are rate of immune cells, histologic response (percentage of tumor necrosis), disease-free survival, the non-invasive test of fibrosis, the chemotherapy-induced liver injury, cytokines and circulating angiogenic factors.


Eligibility Criteria:
Inclusion Criteria:

Patient older than 18 years.

* Patients with histologically proven colorectal cancer with resectable or potentially resectable liver metastases.
* First line chemotherapy alone or combination with intravenous 5FU, oral 5FU (capecitabine), oxaliplatin, irinotecan, cetuximab, panitumumab or bevacizumab (LV5FU2, XELODA, FOLFIRI, FOLFOX, XELOX, XELIRI alone or in combination with either cetuximab or panitumumab or bevacizumab).
* Signature of informed consent.
* Patient affiliated to French Social Security.

Exclusion Criteria:

Patients taking immunosuppressive therapy.

* Lack of measurable tumoral target.
* Patients with a contre-indication of all chemotherapy used: oxaliplatin, irinotecan, fluorouracil, capecitabine, cetuximab, panitumumab, bevacizumab.
* Patients hospitalized without consent.
* Patients in emergency situations.
* Patients under guardianship.
* Patients deprived of their liberty by judicial or administrative procedure.
* Pregnant or nursing women, women without effective contraception.
Effects of Transcutaneous Vagal Nerve Stimulation on Hemodynamics Parameters

The vagal stimulation is a promising therapy for a lot of disorders as well as hemodynamic regulatory way. In order to minimize the harm of a surgery chip implantation, actually it was developing a non-invasive device that is able to stimulate the auricular branch of vagal nerve. It has been shown that trans-auricular vagal stimulation (tVNS) causes direct stimulation of the vagal nerve. However, there are still no strong evidences about it actions regarding the autonomic modulation. The aim of this study is to evaluate effects of tVNS on heart rate, blood pressure and the autonomic control in healthy and hypertensive subjects, at rest and after orthostatic position


Eligibility Criteria:
Normotensive group Inclusion Criteria:

* healthy volunteers
* sign the consent term

Normotensive group Exclusion Criteria:

* smokers
* alcoholism
* drug treatment
* skin lesion in the ear region
* chronic or acute diseases
* pregnancy
* be participating in another research protocol
* high performance athletes
* recent surgery
* vaso-vagal syndrome

Hypertensive group Inclusion Criteria:

* hypertensive diagnosis (with or without anti-hypertensive drugs treatment) or
* ambulatory blood pressure monitoring (ABPM) \>130/85
* sign the consent term

Hypertensive group Exclusion Criteria:

* smokers
* alcoholism
* beta-blockers treatment
* skin lesion in the ear region
* associated diseases
* pregnancy
* be participating in another research protocol
* high performance athletes
* recent surgery
* vaso-vagal syndrome
The Nocebo Effect: a Prospective Study of Informed Consent as a Factor in the Prevalence of SSRI's Side Effects

In this study we invetigate the influence of the nocebo effect (as part of obtaining informed consent) on the prevalence of side-effects. The study is prospective, focusing on the connection between what the physicians says to the patient about side-effects to the frequency of these side effects during treatment period. We also inquire whether informing the patient about the existence of the nocebo effect influences the extent of phenomena.

In this study the investigators wish to inquire whether the nature of the explenation given to the patient as part of informed consent has an effect on the prevalence of side-effects. The study will take place in the out-patient clinic at the Shalvata Mental health Center. Three arms are included:

1. 50 patients started on SSRI's will be updated about its common side effects
2. 50 patients started on SSRI's will be updated about its common side effects and will receive an explenation on the nocebo effect
3. 50 patients started on SSRI's will receive an explenation on the nocebo effect, but will not be updated about common side-effects. Nonetheless, they will be informed of severe side-effects.

Following the prescription of an SSRI the subjects will we enter the follow-up phase of the study. They will attend two follow-up meetings: 3 days after the initiation point and one month after the starting point. During each meeting they will be asked to fill the Antidepressant Side-Effect Checklist (ASEC)and the General Health Questionnaire (GHQ).

Eligibility Criteria:
Inclusion Criteria:

1. age 18-60
2. started on an SSRI

Exclusion Criteria:

* Psychotic spectrum disorder
* Suicidality
* Sensitivity to SSRI
* Has taken the prescribed SSRI in the past
Mindfulness Based Smoking Cessation Program

This is a study designed to mindfulness based stress reduction (MBSR) training program to assess feasibility and acceptability of the intervention. Participants will participate in a 9-week training program and complete pre-and post-questionnaires. Participants will have the option of participating in a follow-up focus group.

The investigators will introduce a mindfulness based stress reduction (MBSR) training program at Boston Medical Center's oncology clinic to promote engagement of low-income and minority smokers with cancer in smoking cessation. This training will follow an adapted MBSR curriculum designed by and for Boston Medical Center patients with chronic pain in the Integrated Medical Group Visit research program in Family Medicine. The investigators will tailor this adapted MBSR curriculum to address smoking cessation. To test the feasibility and acceptability of our intervention, the investigators will pilot test it with 30 patients over the course of three MBSR training programs (each cohort is 9 weeks). The investigators will acquire feasibility data (number of inquiries, number of sessions attended, and satisfaction with MBSR). Additionally, pre and post questionnaires will assess readiness to quit, stress level, and satisfaction with and acceptability of MBSR after every cohort). The primary outcome is engagement in smoking cessation treatment which includes counseling and/or pharmacotherapy. Additionally, the investigators will hold a focus group after each of the 3 cohorts have completed the program to discuss acceptability of study materials as well as facilitators and barriers to participation in the training. Data collected from this study will generate preliminary data to successfully justify and secure future funding for a larger controlled study.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* smoked cigarettes in the past week
* cancer diagnosis more than 6 months
* have a scheduled visit in the oncology clinic with an oncologist or mid-level provider
* telephone access
* English speaking for screening/consenting purposes
* able and willing to participate in the study protocol and provide informed consent

Exclusion Criteria:

* cancer prognosis less than 6 months
* planning to move out of the area within 6 months
* actively using evidence-based smoking cessation treatment during screening
* pregnant women and women planning on becoming pregnant
cDC1 Prognostic and Predictive Role in Non-Small-Cell Lung Cancer Patients Receiving Immune Checkpoint Inhibitors

The response rate of immune checkpoint inhibitors remains relatively low and the identification of the new predictive biomarkers is necessary. The rare population of cDC1 is very interesting, as its mouse counterparts is essential for the cross presentation of tumor-associated antigens, tumor immunity and response to immunotherapies. Their role in humans has not been studied. This proposal aims to study the prognostic role of cDC1 in a cohort of patients with advanced NSCLC, possibly demonstrating their positive predictive value of immune checkpoint inhibitors response.

Multicenter study aiming to collect patient's clinical data retrospectively and their histological samples prospectively.

The cohort will include:

* 30 patients PD-L1 \> 50% treated with pembrolizumab in first line and having a progression free survival ≥ 3 months
* 30 patients PD-L1 \> 50% treated with pembrolizumab in first line and having a progression free survival \< 3 months
* 30 patients PD-L1 \< 50% treated with cisplatin-based chemotherapy in first line

Eligibility Criteria:
Inclusion Criteria:

* NSCLC diagnosis
* Advanced disease (Stage III-IV) according to the TNM 7th/8th classification
* Patients have to have performed pembrolizumab in first line if PD-L1 ≥ 50% or cisplastin-based chemotherapy if PD-L1 \< 50%
* FFPE material available from diagnostic sample

Exclusion Criteria:

-
Evaluation of Academic and Professional Trajectories of Narcoleptic Patients

Narcolepsy is a chronic, disabling condition characterized by excessive daytime sleepiness and, in some patients, falls in muscle tone related to emotions (cataplexies). It often begins in childhood or in young adults. Symptoms of narcolepsy are responsible for an important handicap in everyday life, and are often misunderstood by the family and professional environment. In addition, many comorbidities are associated with narcolepsy, such as depression, anxiety, or obesity.

Few studies have examined the impact of narcolepsy on patients' educational background, socio-professional integration, and quality of life. In particular, the factors of professional handicap related to the characteristics of the disease and the determinants of the insertion of the patients remain poorly known.

As a better understanding of these determinants could help to inform patients and guide them in their choices, NARCOWORK study aims at evaluating the academic and professional trajectories of a wide population of narcoleptic patients.


Eligibility Criteria:
Inclusion Criteria:

Group "Narcoleptic Patients":

* Type 1 or Type 2 narcolepsy
* \> 18 years
* Usually followed at the Lyon Sleep Medicine Center

Group "Control":

* At least one member of each family of cases (siblings, cousins ...)
* \> 18 years and of the same age as the case if possible (+/- 5 years)
* No narcolepsy

Exclusion Criteria:

* uncertain diagnosis (for the "Narcoleptic Patients" Group)
* poor knowledge of the French language
* Refusal to participate
Ruxolitinib Plus LVP in Patients With R/R ETP-ALL

To determine the maximum tolerated dose (MTD), if present, and dose schedule of ruxolitinib in combination with L-ASP, vincristine, and prednisone (LVP) in patients with relapsed-and-refractory (R/R) early T precursor acute lymphocytic leukemia (ETP-ALL). Once determined, the purpose of this study will be to determine the efficacy of ruxolitinib in combination with LVP in patients with R/R ETP-ALL.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with early T-precursor ALL, with any of the following:

   * refractory to primary induction therapy or refractory to salvage therapy,
   * in untreated first relapse with first remission duration \<12 months
   * in untreated second or greater relapse
   * relapse at any time after allogeneic HSCT
2. Subject has received intensive combination chemotherapy for the treatment of ALL for initial treatment or subsequent salvage therapy.
3. Greater than 5% blasts in the bone marrow
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

1. Malignancy other than ALL within 5 years before recruitment, except for adequately treated selected cancers without evidence of disease
2. Current relevant central nervous system (CNS) pathology or known or suspected CNS involvement
3. Isolated extramedullary disease
4. Current autoimmune disease or history of autoimmune disease with potential CNS involvement
5. Autologous HSCT within 6 weeks or allogeneic HSCT within 12 weeks before blinatumomab treatment, or eligibility for allogeneic HSCT at the time of enrollment
6. Active acute grade 2 to 4 graft versus host disease (GvHD) according to Glucksberg et al (1974) criteria that required systemic treatment to prevent or treat GvHD 2 weeks before blinatumomab treatment
7. Known exclusion criteria to investigator choice of SOC chemotherapy (per package insert)
8. Cancer chemotherapy or radiotherapy with 2 weeks, or immunotherapy (included CD19 therapy) within 4 weeks of protocol-specified therapy
9. Abnormal laboratory values (alanine or aspartate transaminase \[ALT or AST\] or alkaline phosphatase \[ALP\] ≥ 5 × upper limit of normal \[ULN\]; total bilirubin or creatinine ≥ 1.5 × ULN), or calculated creatinine clearance \< 60 mL/min.
Use of Laparoscopy in the Treatment of Pelvic Ring Ruptures

Case series to describe the use of laparoscopy for the treatment of pelvic ring disruption.


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent laparoscopy for the treatment of pelvic ring disruption

Exclusion Criteria:

* patient \< 18 years old
Incidence of Residual Neuromuscular Blockade in Fraility in OncoGynae Surgery

Frailty among patients undergoing surgery is strongly associated with an elevated risk of adverse perioperative outcomes, heightened incidence of postoperative complications, increased mortality rates, and prolonged hospital length of stay. Our focus centers on investigating the frailty index in the context of complications experienced by patients undergoing oncologic gynecology surgery. The principal objective of this research is to elucidate the extent to which residual neuromuscular blocking agents are linked to frailty.

Among patients undergoing oncologic gynecological procedures, such as those for vulvar cancer, endometrial cancer, and ovarian cancer, the incidence of frailty has been observed to range from 14% to 45%. Frailty directly influences the metabolism of anesthetic agents and intraoperative management. Furthermore, the prevalence of residual neuromuscular blocking agents following surgery can be as high as 26% to 53%. No prior research has investigated the correlation between residual muscle relaxants and frailty in gynecologic oncology patients. This study is designed to assess the prevalence of residual muscle relaxants in these patients with frailty. Additionally, data on the incidence of frailty and its impact on postoperative outcomes and prognosis in patients undergoing gynecologic oncology surgery will be collected and reported.

Eligibility Criteria:
Inclusion Criteria:

* Age \>,= 18 years
* Patients undergoing elective gynecologic-oncology surgery

Exclusion Criteria:

* Unable to communicate Thai
* Unable to understand the questionnaire
* Preexisting neuromuscular disease
* Preexisting disease involved wrist that may affect the nerve stimulator examination
Quantitative Diaphragmatic Ultrasound Evaluation in Pleural Effusions : A Feasability Study

Malignant pleural effusions cause breathlessness and impairs quality of life. Thoracocentesis is frequently used to relieve breathlessness.

The severity of breathlessness correlates poorly with the size of the effusion. Symptom reduction from fluid drainage varies between patients. No predictors exist to identify which patients benefits more of pleural effusion. One study suggests that a inverted hemidiaphramatic (inverted shape) is associated with a greater dyspnea improvement. Others parameters of diaphragmatic motion have not been studied till now.

This study aims to evaluate the feasability of diaphragmatic ultrasound evaluation (shape by B-mode, quiet, deep inspiratory motion and sniff diaphragm motion by TM-mode) before and after pleural drainage.

Primary end point aims to evaluate the feasability of deep breath inspiratory excursion in ipsilateral side of thoracocentesis by anterior subcostal approach in the mid-clavicular line in the right in patients with malignant pleural effusions. The liver or spleen was identified as a window for each hemidiaphragm.

Secondary end points aim to evaluate

* the feasability of quiet breath inspiratory motion ,
* the feasability of sniff diaphragm motion
* the feasability of deep breath inspiratory motion by posterior method
* the comparaison of feasibility with different types of breathing and or anterior or posterior approach for ultrasound
* the feasability of the shape by B-mode.
* the correlation between the change of the shape of ipsilateral diaphragm and the evolution of dyspnea, before and after thoracocentesis.
* the correlation between the volume of pleural effusion evacuated and the evolution of dyspnea, before and after thoracocentesis.
* the comparaison of the changing of dyspnea in patients with noticed paradoxal movement of diaphragm before thoracocentesis and patients with persistent paradoxal/or non persistant paradoxal movement of ipsilateral hémidiaphragm.
* the correlation between the feasability of diaphragmatic ultrasound motion measurments evaluation and the body mass index.
* the comparaison between the different diaphragmatic ultrsound times for anterior or posterior approach.


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years old
* Male or female patient
* Patient with known lung cancer, regardless of histology or suspected of having unknown lung cancer or relapse / progression of lung cancer
* Presenting a pleural effusion with clinical necessity of evacuating pleural puncture
* Subject who expressed his non opposition to the research

Exclusion Criteria:

* Patient's refusal to participate in the study
* History of pleurodesis whatever the indication (pneumothorax or recurrent pleural effusion) or the technique used
* Permanent chest drain
* inability to provide informed information to the subject (subject in an emergency, difficulty understanding the subject, etc.)
* Subject under judicial protection
* Subject under guardianship or curatorship
* Pregnant or lactating woman
BI 671800 ED in Steroid-naive Asthmatic Patients

This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids.


Eligibility Criteria:
Inclusion criteria:

1. Signed informed consent consistent with ICH-GCP
2. Three month history of reversible (12% with 200 mL) asthma (according to GINA) with following spirometry at randomization: FEV1 60%-85%.
3. No ICS previous 3 months prior to screening.
4. Diagnosis of asthma prior to 40 years.
5. ACQ at least 1.5 at randomization.
6. Male or female, 18 to 65 years.
7. Non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine screen.
8. Able to perform PFT

Exclusion criteria:

1. Significant diseases other than asthma or allergic rhinitis.
2. Hepatic transaminases or total bilirubin greater than 1.5 ULN.
3. Hospitalizations for asthma or asthma related intubation within 3 months.
4. Uncontrolled asthma.
5. Respiratory tract infection or exacerbation within 4 weeks.
6. FEV1 less than 40%, more than 12 puffs of SABA on more than two consecutive days or asthma exacerbation during the run-in period.
7. Participation in another interventional study.
8. Pregnant or nursing women.
9. Women of child bearing potential nor using appropriate methods of birth control as defined by protocol
Evolution of a Novel Optical Coherence Tomography Based Index in Diagnosing Keratoconus

Comparison of corneal topography based on oct OCT principle (CASIA2) with Pentacam and Scheimpflug-based biomechanical devices (Corvis ST) in screening and diagnosing keratoconus; and evaluation of the consistency with Pentacam in measuring corneal parameters (such as curvature and thickness).


Eligibility Criteria:
Inclusion Criteria:

1. Best corrected visual acuity (BCVA) ≥ 20/20;
2. No other eye diseases except myopia and astigmatism;
3. The cornea was transparent, and there was no cloud or pannus;

Exclusion Criteria:

1. The presence of ocular diseases other than myopia and keratoconus;
2. Ocular trauma;
3. Previous ocular surgery; 4 Patients were required to stop wearing soft contact lenses for at least 2 weeks and rigid contact lenses for at least 4 weeks before examination; 6. Pregnant and lactating women;