cyrilzakka/clinical-trials huggingface dataset:
Ventilator Associated Pneumonia and Late Complications of Percutaneous Tracheostomy

The purpose of this study is to investigate the incidence of ventilator associated pneumonia and late complications by comparing two different cannulas and two different percutaneous tracheostomy techniques.

This study did not generate the expectations's we've expected, therefore, the analysis was prematurely stopped...

Eligibility Criteria:
Inclusion Criteria:

* all patients on the intensive care unit who receive a tracheostomy.

Exclusion Criteria:

* HIV/AIDS
* use of immunosuppressive
* with regard to the MRI-scan patients who have a pacemaker and/or who are claustrophobic
Correlation Between Circulating Tumor Cells and Brain Disease Control After Focal Radiotherapy for Metastases of Breast Cancer

This study assesses the number of CTCs before and 4-5 weeks after focal stereotactic radiotherapy, in single or fractionated dose, and correlate with the local and distant brain progression-free survival in patients with metastatic breast cancer.

Brain metastases (BM) are the most prevalent tumors of the central nervous system (CNS), with a ratio of 10: 1 relative to primary tumors. In breast cancer, BM are becoming more frequent due to longer life expectancy. Patients with HER2-positive metastatic disease are prone to develop BM more often and they occur in 20 - 40% of cases. Circulating tumor cells (CTC) originate from the primary tumor and can migrate to distant organs. The possible correlation between CTC and the incidence of brain metastases could help define radiotherapy in patients with oligometastatic or not so widespread disease in the brain. However, there are few studies that evaluate these scenarios. Purpose: To assess the number of CTC before and 4-5 weeks after focal stereotactic radiotherapy in single (SRS) or fractionated (SFRT) dose and correlate with the local and distant brain progression free survival in patients with metastatic breast cancer. Potential invasion markers in these cells will be evaluated and correlated with clinical outcome. Patients and Methods: Prospective, single-center research which will be developed at the Radiation Oncology Department of AC Camargo Cancer Center. Patients with diagnosis of metastatic breast cancer to the brain with an indication of focal radiotherapy, SRS or SFRT, will be recruited. The blood will be collected and processed for analysis of CTC by the ISET method (Rarecells, France). The invasion markers (HER-2, COX-2, EGFR, Notch 1 and ST6GALNAC5) will be analyzed on CTC by immunocytochemistry. Expected Results: If our hypothesis is proven, we may include the analysis and quantification of CTC in clinical practice as early indicator of local or distant recurrence in the brain.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of BM of breast cancer and indication of focal radiotherapy to the brain lesions.

Exclusion Criteria:

* Patients who received WBRT less than 30 days from the initial CTC dosage.
* Patients who received systemic treatment for less than 7 days of the initial CTC dosage.
* Pregnant patients.
Remineralization Effects of Hydroxyapatite Toothpaste

The objective of this in situ clinical study is to determine whether a toothpaste containing hydroxyapatite microclusters is as effective as a fluoridated kid's toothpaste in promoting remineralization of early caries lesions and inhibiting the development of caries lesions.

The investigators hypothesize that (1) both the hydroxyapatite and the fluoridated toothpaste promote caries remineralization that is significantly greater than zero, and (2) the two toothpaste formulations are equally effective with respect to post-treatment remineralization and inhibition of demineralization.

* Non-inferiority will be considered established if there is no statistically significant difference in percentage of remineralization between the hydroxyapatite-containing toothpaste and the fluoridated kid's toothpaste for any one measurement method.
* Superiority/inferiority will be considered established if at least 20% statistically significant difference is observed between the hydroxyapatite-containing toothpaste and the fluoridated kid's toothpaste for any one measurement method

Eligibility Criteria:
Inclusion Criteria:

1. Male and/or female subjects 18 to 50 years inclusive
2. Minimum of 20 natural uncrowned teeth (excluding third molars) must be present
3. Willing to wear retainer 24 hours per day
4. No active, unrestored cavities
5. Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥0.2 ml/min respectively) ascertained from a preliminary sialometry test
6. Available throughout entire study
7. Willing to use only assigned products for oral hygiene throughout the duration of the study
8. Must give written informed consent
9. Must be in good general health
10. No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

1. Advanced periodontal disease
2. Medical condition which requires premedication prior to dental visits/procedures
3. Not enough teeth to secure the oral retainer
4. Diseases of the soft or hard oral tissues
5. Wearing of an orthodontic retainer(s)
6. Impaired salivary function
7. Current use of drugs that can affect salivary flow
8. Use of antibiotics one (1) month prior to or during this study
9. Positive urine test for pregnancy or self-reported breastfeeding. A urine pregnancy test will be performed on female subjects of child-bearing potential.
10. Participation in another clinical study one (1) week prior to the start of the washout period or during this study period
11. Use of tobacco products
12. Allergic history to common toothpaste ingredients
13. Allergic history to amino acids
14. Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy) as determined by review of medical history
Evorpacept (ALX148) in Combination with Pembrolizumab in Patients with Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab and of pembrolizumab alone in patients with metastatic or unresectable, recurrent HNSCC that is PD-L1 positive (CPS ≥1 by an FDA-approved test) and who have not yet been treated for their advanced disease. The study comprises an initial safety lead-in cohort followed by a randomized portion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) that is PD-L1 positive (CPS \> 1) and who have not received prior systemic therapy for their advanced disease.
* Adequate bone marrow function.
* Adequate renal and liver function.
* Adequate ECOG performance status.

Exclusion Criteria:

* Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.
* History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
* Prior treatment with any anti-CD47 or anti-SIRPα agent.
* Prior treatment with anti-PD-1 or PD-L1.
Clinical Study of Multiple Dose Genakumab for Injection in Chinese Healthy Adults

To evaluate the safety and tolerability of multiple-dose subcutaneous injections of Genakumab for Injection in Chinese healthy adult volunteers.

There are 2 dose groups with 12 participants in each group, including 10 participants in the experimental group and 2 participants in the placebo control group. Each subject receives Genakumab or placebo once every four weeks for three times.

Eligibility Criteria:
Inclusion Criteria:

* 18 years ≤ age ≤45 years, and in good health;
* body mass index is within the range of 19 - 26 kg/m\^2 (including 19 kg/m\^2 and 26 kg/m\^2);
* No parental scheme from the screening period to 3 months after the study period.

Exclusion Criteria:

* Participants have abnormal physical and auxiliary examination results with clinical significance;
* History of cardiovascular, liver, kidney, digestive, blood, nervous system and allergic diseases, mental and metabolic disorders,
* Participants who use any prescription drugs within 2 weeks prior dosing.
* Participants who receive (attenuated) live vaccines within 3 months prior to dosing;
* Participation in any clinical investigation within 3 months prior to dosing;
* Donation or loss of 400 mL or more of blood within 3 months prior to dosing;
* Tuberculosis symptoms, contact with patients with suspected tuberculosis symptoms
* Positive results in Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, Syphilis antibody or HIV antibody;
* Current or previous drug or alcohol abuse;
* Other conditions in which the investigator preclude enrollment into the study
Evaluating Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using aSelf-Reported Questionnaire

The primary purpose of this study is to assess the ease-of-use of SimpleJectTM compared to pre-filled syringe(s) when using Kineret® in RA subjects. The secondary purpose of this study is to assess the level of fear and anxiety associated with the use of both injection methods, to assess safety when using SimpleJectTM and to evaluate the Ease-of-Administration Questionnaire (EAQ) in terms of the quality of items, item performance, and the instrument reliability.


Eligibility Criteria:
Inclusion Criteria: - Subjects must be diagnosed with RA as guided by ACR criteria - Subjects must have an inadequate response to methotrexate alone - Subjects must receive concomitant treatment with methotrexate during the study period - Before any study specific procedure, the subject must give informed consent for participation in the study Exclusion Criteria: - Subject has previous experience using SimpleJectTM - Prior treatment with Kineret® and/or etanercept - Less than 6 weeks wash-out period for patients receiving prior infliximab treatment - Subject is currently enrolled in other clinical trial, is receiving other investigational agent(s), or at least a 30 day period has not elapsed since completion of other investigational trials with device(s) or drug(s) - Subject currently has an infection requiring systemic anti-infective therapy - Baseline neutropenia (less than 1.5 x 10\^9/l) - Subjects with severe renal impairment (CLCR less than 30 ml/minute) - Subjects not willing to use adequate birth control methods - Women of childbearing potential who are pregnant, are breast-feeding or plan on becoming pregnant during the study - Planned administration of live vaccines during study period - Subject is not available for follow-up assessments - Subjects with a known sensitivity to Kineret® or any of the excipients of E. coli derived proteins - Pre-existing malignancies - Any other condition that in the investigators opinion would preclude the subject from participating
Inhaled Ciclesonide for Outpatients With COVID19

The CONTAIN (CiclesOnide cliNical TriAl covId-19 treatmeNt) is a randomized control study of ciclesonide vs placebo for mild covid-19 disease. The need for potential therapy for COVID-19 patients is urgent. Ciclesonide has shown encouraging in vitro results, is easy to be used and is readily available. It has a low rate of side effects and few interactions with other drugs. It is unusual to use an inhaled steroid drug for COVID-19 but there has been new data suggesting steroids may have an antiviral effect in addition to an anti-inflammatory effect. Investigators propose to use inhaled and nasal ciclesonide to stop viral replication in the nose and airways. Investigators hope this will accelerate recovery from COVID-19 illness in individuals who are not admitted to hospital at time of diagnosis of COVID-19.


Eligibility Criteria:
Inclusion Criteria:

Symptomatic adult patients positive by PCR for COVID-19 within 5 days of enrollment with fever, cough, or shortness of breath. Provision of Informed Consent

At day 0, patients should be at home

Exclusion Criteria:

* Already on inhaled corticosteroid medication
* Currently using systemic steroids (oral or intravenous or intramuscular such as Prednisone) or use of steroids 7 days prior to enrolment
* Severely ill patients at enrollment (i.e., admitted to ICU at admission)
* Unable to self-administer the inhaler
* Known or suspected pregnancy and breastfeeding
* Known allergy to study medication or its components (non-medicinal ingredients; including lactose allergy (type I))
* Patients with untreated fungal, bacterial, or tubercular infections of the respiratory tract
* Current hospitalization
* Current use of oxygen at home or in the hospital
Step by Step After Cancer

After treatment, women want to regain a 'normal' lifestyle while some factors interfere as chronic fatigue. In the absence of anemia, fatigue is often a consequence of physical deconditioning . The following protocol will focus at this problem.It will consist of a brisk walking program twice a week over a period of 6 weeks, at an intensity of 60% of HR pic during 20 minutes.

Pinto and colleagues, for a walking level from 55 to 65% HRmax, estimated a reduction of fatigue in post treatment. Supervised exercise show greater adherence to short-term practice at home. However, there are a growing number of studies suggesting a practice at home, the most activity being walking. The authors do not justify the choice of the type of supervision. But physical activity with a professional and / or group in a specific place definitely has different effects in relation to practice at home. Segal and his colleagues in 2001 for the first time wished to compare the two types of supervision. The results are in favor of supervised exercise. The training was identical. However, to answer the five weekly sessions requested, the patient group had to complete two supervised practice sessions at home. So, the investigators really can not quantify the difference in impact between home practice and supervised practice. In a meta-analysis, Velthuis and colleagues conclude a significant difference in fatigue during treatment for a supervised aerobic exercise against a home that does not show significant difference. If the training is the same in both situations, the investigators should not find any difference in physiologic responses. However, the psychological impact can vary from one situation to another.

The following protocol will focus at this problem. It will consist of a brisk walking program twice a week over a period of 6 weeks, at an intensity of 60% of HR pic during 20 minutes.

Biweekly session from 60% of the heart rate pic during 20 minutes will be proposed.

Each patient of supervised walking group will meet the student each session. Each patient of home-based walking group will be called by phone every week by the student to inform the patient of the progress of the training, collect the work and answer any questions.

Eligibility Criteria:
Inclusion Criteria:

* Sex: female
* Age less than or equal to 75 years
* Breast cancer stage I to III
* Chemotherapy and / or radiotherapy adjuvant completed
* Hormone treatments ongoing

Exclusion Criteria:

* Age over 75 years
* Breast cancer stage IV and O
* Anemia, Cardiac arrhythmia, asthma, hypertension or uncontrolled diabetes, coronary artery disease or severe respiratory disease, psycho-cognitive may disturb walking program
Evaluation of One-stop Strategy of EVAR and PCI

The study is designed to evaluate the safety and effectiveness of the "one-stop" endovascular intervention strategy for patients with concomitant coronary artery disease and aortic atherosclerotic disease. It is a registration study, which will consecutively enroll at least 50 patients with at least 30 subjects receiving one-stop strategy.

It is a registration study, at least 50 patients will be consecutively enrolled and then be allocated into one-stop strategy group or staging strategy group with at least 30 subjects receiving one-stop strategy. In one stop strategy group, percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR). In staging strategy group, PCI will be performed several days after EVAR. The safety and effectiveness will be assessed between the two groups untill 1 year after the operation. The economic index will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 years to 75years, male or female;
* Aortic atherosclerotic disease with the indication of EVAR;
* Coronary heart disease with the indication of PCI;
* Provided informed consent.

Exclusion Criteria:

* Acute aortic dissection
* Acute coronary syndrome
* Dysfunction of coagulation system
* Patients with gastrointestinal hemorrhage
* Known allergy to contrasts or antiplatelet drugs
* Renal dysfunction (GFR≤60ml/min)
* Patient with multi-branch coronary preferred CABG
Minimal Stimulation Protocol Using Aromek(Letrozole) and Follitrope(recFSH) Combined With INVOCell-Low Cost IVF

The purpose of this study to evaluate a low cost minimal stimulation protocol combined with Intravaginal Culturing, to make IVF affordable and available across the large infertile/subfertile population

In routine ART procedures for IVF, ovarian stimulation is performed using down regulation with GNRH Agonist combined with high daily FSH doses followed with ovulation induction with HCG 10000 IU, ovum pick-up 34-36 hours after HCG injection and embryo transfer on day 2, 3 or 5.

In routine ART procedure for IVF, embryology is done in very high tech lab, contamination free environment, which also exclude VOC, high quality CO2 Incubators, laminar flow with heated table top, high magnification stereo microscope along with equipments for maintaining quality control, with a highly trained embryologist. The primary reason is we need to create a womb like environment in the embryology lab as eggs, and mainly fertilised embryos are going to spend minimum 2 or 3 and in case blastocyst 5 days in this lab.

In recent years, various studies have been published identifying various minimal stimulation protocols for IVF, and also another variation of IVF where rather than using CO2 Incubator for culturing, vaginal cavity of the female partner is used for incubation using a specially designed capsule which have walls permeable to vaginal pCO2 and O2. Oocytes are retrieved by the physician and handed over to basic embryologist to identify and grade oocytes and washed sperms are placed in a embryo toxic tested, sterile, individual single use capsule (INVOCell) and placed in vaginal cavity using diaphragm, patient goes back to home with some instructions for care, on day 2 patient comes back to the IVF Clinic and physician gets the capsule out and hands over to the basic embryologist trained on INVOCell to identify embryos and grade them, further loading of embryos on ET Catheter.

Eligibility Criteria:
Inclusion Criteria:

* Tubal factor without Hydrosalpinx
* Unexplained infertility with unsuccessful attempts in achieving pregnancy through timed intercourse or IUI
* Boarder line male factor infertility
* Sperm DNA Fragmentation \< 30%
* Normal Uterine Cavity
* Normal baseline ultrasound with adequate number of primary follicles present
* Normal FSH and E2 on Day 3
* Age of the female is \< 35 years old

Exclusion Criteria:

* If previous IVF or INVO attempts resulted in failed fertilisation
* Male partner who has difficulty in producing semen sample
* Very low sperm count, very low percentage of sperm motility and morphology
* Sperm DNA Fragmentation \> 30%
* Age of female patient \> 37 years
* Borderline or elevated E2 or FSH on day 3 or failed CCCT or low blood inhibin levels
* Poor ovarian response
* Hydrosalpinx
* Anatomic difficulties in reaching ovaries for oocyte retrieval
* Cervical stenosis, making embryo transfer difficult
* Uterine abnormalities or deformities
* Obesity
The Impact of Abdominal Wall Reconstruction on Abdominal Wall Tension and Intra-Abdominal Pressure

This is a prospective cohort study. Patients have an incisional or parastomal hernia with \>20 cm fascial defect on pre-operative imaging who will undergo an anticipated open bilateral transversus abdominis release with retromuscular synthetic mesh will have their abdominal wall tension measured using a tension scale and their intra-abdominal pressure measured using a urinary catheter containing pressure sensors. The investigators aim to quantify the changes, as well as explore and describe the physiologic shifts that may be associated with these changes.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* Incisional or parastomal hernia with \>20 cm fascial defect on pre-operative imaging
* Anticipated open bilateral transversus abdominis release with retro-muscular synthetic mesh placement

Exclusion Criteria:

* Pregnant patients
* Require a Legally Authorized Representative (LAR) to sign the informed consent form
EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE)

Spasticity is a common and debilitating complication in neurological conditions such as multiple sclerosis, cerebral palsy, and stroke. Stroke, a leading cause of global disability and death, occurs when blood flow to the brain is disrupted, causing neuronal damage. Approximately 80% of strokes are ischemic, with 20% being hemorrhagic. Several factors, including age, sex, vascular conditions, and lifestyle choices, increase the risk of stroke. Spasticity affects 19-28% of stroke survivors in the short term and up to 46% in the long term, severely impacting mobility and quality of life. Management typically involves pharmacological and nonpharmacological interventions, though these often have limited effectiveness and side effects. In this context, non-invasive techniques like transcutaneous stimulation with the EXOPULSE Mollii suit may offer a valuable alternative for managing spasticity and its associated symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years.
* Having a clinical diagnosis of stroke for at least three months
* Being able to walk freely or with the need of support (modified Rankin score

  * 4)
* Being a French speaker, able to understand verbal instructions, and affiliated with the national health insurance (sécurité social).
* Having spasticity with a score of at least 1+ on the MAS

Exclusion Criteria:

* Being included in another research protocol during the study period.
* Inability to undergo medical monitor for the study purposes due to geographical or social reasons.
* Having contraindications for using EXOPULSE Mollii suit (having implanted electronic medical devices or equipment which can be disrupted by magnets or an electronic life support equipment or high-frequency operation equipment; e.g., cardiac stimulator, ventriculoperitoneal shunt, intrathecal baclofen pump).
* Being pregnant (confirmed by a blood beta-HCG test).
* Having a change in their pharmacological therapy in the last three months.
* Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).
* Having a body mass index above 35 Kg/m2.
* In case of introducing a medical device other than EXOPULSE Mollii suit during the study period.
* Patients under juridical protection (" mesure de protection) judiciare : tutelle, curatelle, sauvegarde de justice ")
* Patients deprived of freedom (" personnes privées de liberté ".)