cyrilzakka/clinical-trials huggingface dataset:
THE INFLUENCE OF GRAVITY

Although most ground studies showed that an egocentric reference frame better supports spatial orientation, it is not proven it will be the same during weightlessness.

Although it might justify that visuomotor performance will be better supported by egocentric target cueing under altered gravity conditions, the fact that exocentric target cueing induces less head movements and called for least attentional and physiological workload could be the key factors for a more efficient task localization process. Moreover, weightlessness can induce spatial disorientation, which can be additionally influenced by the intrinsic and extrinsic spatial reference frames (Gurfinkel et al., 1993; Glasauer \& Mittelstädt, 1997, 1998; Harm et al., 1998; Lipshits et al. 2005). We expect that during weightlessness the workload will be the key factor and thus we hypothesize that an exocentric target cueing will outperform egocentric target cueing.

To test this hypothesis, and find out which presentation scheme for target cueing (EGO, EXO, ED) contributes most to an efficient visual search, performance to a visuomotor task will be evaluated during parabolic flights in normogravity (1g), hypergravity (1.8g) and microgravity (0g). The visuomotor performance will be assessed by a multi-directional tapping task as defined by ISO9241-9, which requests for motor responses by aimed pointing movements. Besides analyzing the pointing performance, different workload indices will be additionally assessed to evaluate the effort spent on visuomotor coordination. The attentional workload will be evaluated by the performance of a secondary task (visual reaction-time task), which needs to be conducted in parallel to the visuomotor task. Furthermore, the workload will be also assessed subjectively by the NASA TLX rating scale and physiologically, by analyzing the heart rate variability (HRV).


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged from 18 to 67
* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
* Who accepted to take part in the study
* Who have given their written stated consent
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.

Exclusion Criteria:

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Pregnant women
Periimplant Bone Changes in Different Abutment Heights and Insertion Timing in Posterior Mandibular Areas

The aim of this study was to compare the influence of the abutment height and insertion timing on early marginal bone loss (MBL) in posterior mandibular partial implant-supported restorations.

Material and methods: The study was planned as a prospective, randomized, controlled parallel group including subjects in need of two implants for the restoration of an edentulous posterior mandibular area. Data were gathered on age, gender, attached gingiva height, bleeding on probing (BoP), smoking habits and previous periodontitis. The patients were allocated into three groups: Group A implants were immediately connected to 2 mm height abutments; Group B implants were immediately connected to 1 mm height abutments; Group C implants were left to heal in a sub-mucosal position and 2 mm abutments were inserted in a second stage surgery. Peri-apical radiographs were taken at the implant surgery (baseline), 4 weeks after surgery (T1), 16 weeks after implant placement at the final restoration delivery (T2) and 1-year after implant placement (T3).


Eligibility Criteria:
Inclusion Criteria:

* patients age \> 18 years;
* American Society of Anaesthesiologists (ASA) status I;
* no systemic medication or condition known to potentially alter bone metabolism; - absense of acute periodontal condition.

Exclusion Criteria:

* lack of primary stability at implant surgery;
* need for bone regeneration procedures during surgery;
* inability to correct place the implant in accordance with the prosthetic requirements.
Sentinel Lymph Node in Early Ovarian Cancer

This research study evaluates the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.

The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with early stage ovarian cancer.

With this research study it will be evaluated the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed previously to performing any procedure related to the clinical trial.
* Patients who are women 18 years of age or older at the moment of the randomization.
* Patients with anatomopathological diagnosis of malignant ovarian tumor in a deferred study proposals for staging surgery or patients with suspicious tumor of malignancy who are going to be subjected to exploratory lapaotomy or laparoscopy and operative biopsy, and in the case this is positive, surgery of staging will be performed .

Exclusion Criteria:

* Informed consent not obtained or withdraw.
* Benign result in extemporaneous study
* Previous history of vascular surgery in the aorta, cava or pelvic vessels
* Previous pelvic or para-aortic lymphadenectomy
* Previous lymphoma
* Previous abdomino-pelvic tumor
* Previous allergic reaction to indocyanine green
* Pregnancy / lactation
* Severe adherent syndrome
COVID19 Oral Vaccine Consisting of Bacillus Subtilis Spores

This is a study trial to assess the effectiveness of the immune response stimulated by the genetically engineered Bacillus subtilis which express and display Spike protein of the SARS-COV2 on the spore coat.

Bacillus subtilis is regarded as safe organism by The Food and Drug Administration and it is presented in most food sources. Preliminary experiments have shown that the genetically engineered Bacillus subtilis can express and display receptor binding domain of spike protein of the SARS-COV2 on its spore coat, thus successfully inducing the secretion of cytokines of human cells in vitro. Previous experiments also successfully demonstrated that a increased detection of neutralizing IgG and IgM levels in mice and human after oral administrated with the Bacillus subtilis. This suggests that the transgenic spores of Bacillus subtilis have successfully activated the immune system, producing high-affinity neutralizing antibodies and memory B cells. Furthermore, no adverse effects were shown in all the mices. The engineered Bacillus subtilis will be further studied in a human trial through oral administration to test its safety and the immune effect resulted in human bodys.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* age over 12 years
* the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial);
* participant vaccinated with COVID-19 over 6 months
* anti-SARS CoV 2 neutralizing antibody is negative in serum.

Exclusion Criteria:

* pregnant women
* history of COVID-19 infection or showing COVID-19 infection symptoms
* having had contact to people with known COVID-19 infection in the last 14 days
* having fever (\> 37.4oC in the last 24 hours), dry cough or feeling tired and having aches and pains, nasal congestion, runny nose, sore throat and diarrhea.

positive real time RT-PCR COVID-19 test.

* persons with autoimmune diseases
* allergic diathesis or any clinically significant allergic disease (i.e. asthma)
* any condition that might impair the immune response
* recent or current immunosuppressive medication
* any other vaccine application 5 months before the first dose
Neural Pressure Support, Synchrony and Respiratory Muscle Unloading

In this study patients who are intubated and on ventilator for more than 24h will be ventilated at three different level of support in Pressure Support and Neural Pressure Support to study patient-ventilator synchrony and muscle unloading.

This study is an interventional randomized crossover study in intubated and mechanically ventilated patients for more than 24h. Eligible patients from whom informed consent is obtained and Pes and Edi catheter are successfully positioned are enrolled in the study. Patients will be ventilated in Pressure Support and Neural Pressure Support at three different level of assist (baseline, 50% and 150% of baseline respectively) in randomized order. Ventilator curves will be recorded and bloodgas obtained at the end of each study step, each lasting 20min.

Eligibility Criteria:
Inclusion Criteria:

-Patients intubated for more than 24 hours in the weaning phase from the ventilator.

Exclusion Criteria:

* bleeding disorders (PK INR\>1,5 or APTT\>50s or platelet count \<50000/µL)
* unstable circulation (requiring high vasopressor dose, for example Noradrenalin \>0,2µg/kg/min)
* severe lung disease (PFI ≤ 13,3 kPa)
* fever\> 38,5°C
* pregnancy.
Efficacy of a Combined ACT+ App Intervention to Improve Psychological Flexibility and Associated Symptoms in Cancer Patients

Introduction: emotional and physical alterations frequently appear in cancer patients. In this sense, interventions based on acceptance and commitment therapy (ACT) show their efficacy to improve these symptoms through increased psychological flexibility, however, there is little evidence of the efficacy of ACT using combined modality (face-to-face + app), despite the fact that this application modality may have beneficial effects in this group of patients, who may see their participation in the interventions limited as a consequence of the disease.

Method / design: Cancer patients will be randomly assigned to one of the following groups: (1) face-to-face ACT + app group, (2) face-to-face ACT group, and (3) group receiving usual treatment. The planned interventions last between 8 and 10 weeks and include experiential exercises, metaphors, discussions, and homework assignments to promote awareness and flexibility about thoughts and emotions associated with cancer. In the group that uses the app, exercises (mindfulness, breathing), reminder systems, recording, reinforcement and monitoring will also be provided. It is estimated that a total of 112 participants (38 per group) will be necessary, and four evaluations will be carried out: T0 (pre-treatment), T1 (post-treatment, T2 (follow-up at three months) and T3 (follow-up at six months). months).

Hypothesis : The primary results that are expected to be obtained are a significant increase in the psychological flexibility of patients receiving treatment, with greater flexibility in the group receiving the combined intervention, evaluated with the AAQ-II. Furthermore, as secondary outcomes, it is expected to obtain significant improvements in anxiety and depression (HADS), quality of life (EORTC QLQ C-30), Fatigue (BFI), Insomnia (ISI) and post-traumatic growth (PTGI-SF).

Hypothesis: the efficacy of the ACT-based intervention in cancer patients may be increased if the benefits of using a modality that combines face-to-face and not face-to-face are added to it.


Eligibility Criteria:
The inclusion criteria for participants are:

* Men and women, aged between 18 and 70 years.
* Cancer diagnosis, stages I-III.
* Cancer type: Breast / Lung / Colorectal.
* Eligible for or currently receiving cancer treatment.
* Ability to be fluent in Spanish.
* Have a smartphone with daily access and basic smartphone / application management skills.
* Access to email account and internet.
* Not currently participating in another clinical trial.
* Not currently receiving other psychological treatment.

Exclusion criteria for participants in the trial:

* Men and women aged\> 70 years.
* Diagnosis of cancer, stage IV or other types of cancer.
* Not eligible for treatment.
* Inability to handle himself fluently in Spanish.
* Not having a smartphone with daily access and basic smartphone / application skills.
* Not having access to an email account and the internet.
* Currently participating in another clinical trial.
* Currently receiving other psychological treatment.
A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants

The primary purpose of this study is to determine the effect of clarithromycin on the single-dose pharmacokinetics (PK) of brensocatib in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Females of nonchildbearing potential and males, of any race, between 18 and 65 years of age, inclusive, without current disease.
* Body mass index between 18.0 and 32.0 kilograms per square meter (kg/m\^2), inclusive, and a total body weight ≥50 kilograms (kg).

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed; cholecystectomy will not be allowed).
* Positive serology test results for hepatitis B panel or hepatitis C antibody and/or reactive human immunodeficiency virus 1/2 test.
* Participants whose results are compatible with prior immunization for hepatitis B or natural immunity may be included at the discretion of the investigator.
* Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test at screening or check-in.
* Poor peripheral venous access. Note: Other inclusion/exclusion criteria may apply.
Elderly Patients With Renal Insufficiency: Reasons for Using the Geriatrician, Modalities and Results of the Geriatric Evaluation, Becoming at One Year

The incidence and prevalence of kidney failure increases with age. Elderly people with chronic kidney disease may have factors of fragility (loss of independence, comorbidities, geriatric syndromes) that can complicate the choice and implementation of the nephrological therapeutic project. Joint and early assessment of these patients by a nephrologist and a geriatrician could help to optimize the definition of care objectives and patient pathway.

There is little data on how nephrologists and geriatricians cooperate and on the description of frailties in elderly patients with renal impairment.

In this context, the objective of this study is to describe in a French university hospital the reasons for the use of geriatricians by nephrologists, the modalities of geriatric evaluation and the socio-demographic and medical characteristics (including geriatric syndromes) of very elderly patients with renal insufficiency, and then to become so at one year.

Year of implementation of this research: 2019 based on data from 2017 and 2019. Approximate number of people likely to be included in the research: 100 patients

There is little data on how nephrologists and geriatricians cooperate and on the description of frailties in elderly patients with renal impairment.

In this context, the objective of this study is to describe in a French university hospital the reasons for the use of geriatricians by nephrologists, the modalities of geriatric evaluation and the socio-demographic and medical characteristics (including geriatric syndromes) of very elderly patients with renal insufficiency, and then to become so at one year.

Secondary objectives :

* describe the modalities of the geriatric evaluation
* describe the socio-demographic, medical characteristics (including fragilities and/or geriatric syndromes) of elderly patients with renal insufficiency
* describe how to become one year old.

Origin and nature of the data collected:

- Socio-demographic, medical and geriatric data (see attached document) based on geriatric assessment medical records (reports of external geriatric consultation and/or intervention by the mobile geriatric team).

The approximate duration of the study will be 9 months. This time includes the time required for statistical analysis and writing an article.

Eligibility Criteria:
Inclusion Criteria:

* 75-year-old patient and older
* Renal insufficiency
* Use in 2017 and 2018 of a geriatric evaluation at the Nîmes University Hospital at the request of nephrologists (mobile geriatric team or external geriatric consultation).

Exclusion Criteria:

* Patient under guardianship, curatorship or judicial protection
* Patient under 75-year-old
Mesenchymal Stem Cells for the Treatment of Pneumonia Post Haematopoietic Stem Cell Transplantation

The aim of this study is to determine whether mesenchymal stromal cell (MSC) treatment contribute to the good prognosis in patients with transplant-related complication, pneumonia post hematopoietic stem cell transplantation (HSCT).

Hematopoietic stem cell transplantation (HSCT) is a standard therapy strategy for most hematologic disorders and malignancies. Despite the improved survival attributed to advances in HSCT including transplantation techniques and supportive care, transplant-related pneumonia (severe pneumonia in particular) remains the leading cause of death for most HSCT patients and a major challenge for clinicians.

Mesenchymal stromal cells (MSCs), a form of multipotent cells, have been applied in therapy for various intractable disorders. MSC exerts its therapeutic effect through various biological functions including immunoregulation, tissue repairing, self-renew and differentiating into various cell lines. The American Thoracic Society has also suggested MSCs as a cell therapy agent for lung diseases. However, MSC therapy for pneumonia following HSCT has not been well investigated.

By investigating the efficacy of MSC treatment for HSCT-related pneumonia via comparing the outcomes in patients with and without MSC treatment, this study will provide a promising therapy for HSCT-related pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* patients with pneumonia after HSCT;
* patients under the age of 18 years;
* patients with normal pulmonary function before HSCT.

Exclusion Criteria:

* patients with other severe complications in progress when pneumonia occurred.
Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg

The purpose of the study is to determine the long term safety of Enbrel in adults with active rheumatoid arthritis in Luxemburg. This is a post-marketing surveillance study in rheumatology practice patients. All patients initiated with Enbrel will be observed from the start of the study in Feb 2003 for a period of at least 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Have moderate to severe active rheumatoid arthritis
* Be aged of 17 years or more
* Have inadequate response to DMards
* Give written informed consent
* Physician decides to prescribe Enbrel

Exclusion Criteria:

n/a
Technology-based Symptom Monitoring Intervention for Locally Advanced Head and Neck Cancer Patients

The goal of this observational study is to assess the satisfaction and usability of an interactive and patient-centered mobile application (app), Oleena™, designed to assist head and neck cancer patients undergoing chemoradiation in managing common and distressing symptoms in real-time, as well as to assess the satisfaction and usability of the related HCP web portal. Additional secondary usage and clinical endpoints that would be used to assess intervention efficacy in future trials will be collected.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Planned to initiate chemoradiation for locally advanced head and neck cancer at Moffitt Cancer Center
* ECOG performance status ≤2
* Able to speak and read US English or Spanish
* Able to provide informed consent
* Owns a smartphone with an iOS or Android operating systemcompatible with Oleena
* Able to access the internet
* Willing to use a mobile app for symptom management

Exclusion Criteria:

* Documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., psychosis, active substance abuse).
* A prior cancer diagnosis except for non-melanoma skin cancer.
* Currently enrolled in an industry-sponsored clinical trial.
* Pregnant women.
* Patients undergoing RE-irradiation
* Patients who meet the inclusion criteria may be excluded at Investigator's discretion
Sexual Health After Endometriosis Surgery

Endometriosis is a disease affecting between 5 and 15% of women and more than 40% of infertile women.

The main stakes of this disease are that it is benign but difficult to diagnose, often very painful, difficult to predict, potentially recurrent, while being resolvable at menopause. It affects women of childbearing age and can cause infertility and pain during intercourse. Also, by its characteristics, it can significantly deteriorate the quality of life.

The management of endometriosis, from diagnosis to treatment, is not consensual. There are medical or surgical treatments depending on the severity of the lesions, their location and the severity of the symptoms. Deep endometriosis, that is to say when there is digestive, urinary, utero sacral or peritoneal ligament more than 5mm deep, poses, in particular, a therapeutic problem because surgery is often the only option but it can be decadent.

Due to genital involvement, this disease has a real impact on the sexuality of patients. Surgery allows in a number of cases to reduce pain, including those occurring during intercourse. But the impact on sexuality in a more global way remains to be studied. The latter can be improved by the reduction of pain, but impacted by the surgery which is not insignificant on the representation of the woman of her own body.


Eligibility Criteria:
Inclusion Criteria:

* Major women operated for deep endometriosis at the Lyon Sud Hospital Center (CHLS) of the Hospices Civils de Lyon (HCL).

Exclusion Criteria:

* Minor patient
* No indication for operation or indication of hysterectomy
* Isolated uterine adenomyosis
* Patient opposing her participation in the study