cyrilzakka/clinical-trials huggingface dataset:
Senicapoc in COVID-19 Patients With Severe Respiratory Insufficiency

SARS-CoV-2, one of a family of human coronaviruses, was initially identified in December 2019 in Wuhan city. This new coronavirus causes a disease that has now been named COVID-19. The virus has subsequently spread throughout the world and was declared a pandemic by the World Health Organisation on 11th March 2020. As of April 1, 2020, there are 874.081 numbers of confirmed cases with 43.290 fatalities. There is no approved therapy for COVID-19 and the current standard of care is supportive treatment.

Key markers implying a fatal outcome are acute respiratory distress syndrome (ARDS)-like disease with pronounced dyspnea, hypoxia and radiological changes in the lung. Senicapoc improves oxygenation and reduces fluid retention, inflammation, and bleeding in the lungs of mice with ARDS-like disease. In cells, there is an antiviral effect of senicapoc.

The investigators discovered that in an animal model with a knockout of a potassium channel with intermediate conductance (KCa3.1), the knockout protected against lung damage and accumulation of liquid in the lung. In subsequent studies, the investigators have developed a mouse model showing that genetic deletion of the KCa3.1 channels and senicapoc, a blocker of KCa3.1 channels, protects against the accumulation of liquid in the lung. Moreover, senicapoc treatment possesses anti-inflammatory effects illustrated as lower leukocyte accumulation inside the lungs after injury. Importantly, it also increases the FiO2/PaO2 ratio (ratio of inhaled to blood oxygen), hence preserving lung function in mice with an ARDS-like disease. In addition, there is evidence that senicapoc has antiviral properties. Aarhus University has patented senicapoc for use in the treatment of acute respiratory disease. In this case, respiratory disease is caused by an infection with a coronavirus. Senicapoc has been developed for the treatment of sickle cell disease and has been administered to 500 patients without observation of major treatment-related adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 positive
* Age ≥18 years
* Respiratory insufficiency
* ICU admission

Exclusion Criteria:

* Severe heart failure (ejection fraction \< 30%)
* Severe renal insufficiency (eGFR \< 30 mL/min/1.73m2)
* Severe hemodynamic instability (noradrenalin dose \> 0.3 μg/kg/min)
* Prior enrollment in the trial
* Pregnancy
* Allergy to senicapoc
* Inability to take enteral medication
* More than 24 hours since ICU admission
* Limitations of care
* Anticipated death within 24 hours
Analysis of Arterial Waveforms and Oxygen Pressure During Supervised Exercise for Peripheral Artery Disease

The goal of this observational study is to assess the evolution of oxygen pressure and arterial waveform during supervised exercise therapy in patients with peripheral arterial disease. The main questions it aims to answer are:

* can a significant increase in oxygen pressure be observed at 3 weeks?
* can a significant increase of oxygen pressure or arterial waveform be observed at 3, 6 or 9 weeks?

Peripheral arterial disease (PAD) is a frequent pathology that affects more than 200 million people worldwide, more than 800,000 in France, and is mainly of atheromatous origin. The prevalence of this disease in France is estimated at 11% in people over 40 years of age, with an annual additional cost of €11,000 per patient. Supervised exercise therapy (SET) is the first-line treatment for intermittent claudication PAD for at least 3 months, although 15-20% of patients will not benefit from this therapy. Ankle-Brachial Index, the main diagnostic and monitoring tool for PAD, is not altered during SET. Transcutaneous oximetry (TcPO2) has been used for many years in the diagnosis of chronic permanent ischaemia, in the choice of amputation level and more recently in the diagnosis of proximal PAD.

No studies have investigated the evolution and predictive value of exercise TcPO2 in this context of SET. The assessment of arterial Doppler waveform using an objective classification has also never been performed in the specific context of SET. .

The goal of this observational study is to assess the evolution of oxygen pressure and arterial waveform during supervised exercise therapy in patients with peripheral arterial disease. The main questions it aims to answer are:

* can a significant increase in oxygen pressure be observed at 3 weeks?
* can a significant increase of oxygen pressure or arterial waveform be observed at 3, 6 or 9 weeks.

The perspective is to predict the effectiveness of SET in terms of maximum walking distance.

Eligibility Criteria:
Inclusion Criteria:

* PAD with intermittent claudication
* SET prescribed
* ABI \< 0.9
* Beneficiary of French health care insurance

Exclusion Criteria:

* PAD with rest ischemia
* Chronic respiratory failure
* Acute decompensated disease
* Lower limb prosthesis
* Pregnant women and breastfeeding mothers
* Place of residence more than 100 km from Caen University Hospital
CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase3)

The purpose of this study is to evaluate the efficacy and safety of CORETOX® in the treatment of post-stroke upper limb spasticity


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 19 years
* ≥ 6 months since the last stroke
* ≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of elbow flexor and finger flexor as measured on MAS(0 to 4)
* Informed consent has been obtained

Exclusion Criteria:

* Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis
* History(within 4 months of screening visit) or planned(during study period) treatment with phenol or alcohol injection or surgery in the target limb
* History(within 4 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb
* Fixed joint/muscle contracture
* Severe atrophy
* Concurrent treatment with an intrathecal baclofen
* Patients who have bleeding tendency or taking anti-coagulant
* Dysphagia and Breathing Difficulties
* History(within 4 months of screening visit) Planned(during study period) treatment with Botulinum Toxin
* Known allergy or sensitivity to study medication or its components
* Concurrent or planed Muscle relaxants and/or benzodiazepine medication If patient has taken these medication stable from one month before screening and no treatment changes are not planned during the study, participation is allowed.
* Current Physical, occupational, Splinting therapy These therapy regimens will be permitted if they have been stable in the one month before screening; no treatment and no changes are planned during the study.
* Patient who are participating in other clinical trials at the screening
* Females who are pregnant, breastfeeding, or planning a pregnancy during the study period, or female of childbearing potential, not using a reliable means of contraception.
* Patients who are not eligible for this study at the discretion of the investigator.
Creativity Group for Borderline Personality Disorder

The investigators hypothesize that a creativity skills group for Borderline Personality Disorder can reduce symptoms of BPD, depression, and anxiety.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* participant self-reports clinical diagnosis of Borderline Personality Disorder
* currently seeing an individual therapist on a regular basis
A Study to Evaluate Sleep Quality in Patients With Mild to Moderate Alzheimer's Disease

The purpose of this study is to evaluate sleep quality in patients with mild to moderate Alzheimer's disease treated with anticholinesterase drugs in clinical practice.

This is an epidemiological (the study of health-related states or events in specific populations) study of patients with mild to moderate Alzheimer's who have been treated previously with anticholinesterase drugs (class of drugs that act in the central nervous system) up to a maximum of fifteen days. The data for each patient will be recorded on two occasions; first at a baseline visit and then at a follow-up visit at 3 months. At the baseline visit, after the patient or his/her legal representative has given written informed consent, each participating neurologist will use the study questionnaire to collect patient sociodemographic characteristics (characteristics such as age, years of education, race, sex, religion, birthplace, income, occupation, geographic location, among others), medical history and diagnosis of Alzheimer's disease. The neurologist will also record treatment for Alzheimer's disease and concomitant hypnotic medications (simultaneous use of medications that induce sleep) and evaluate the patient using two scales: the Pittsburgh Sleep Quality Index (PSQI) to record sleep disturbances and the Epworth Sleepiness Scale to determine the level of daytime sleepiness. Alzheimer treatment and concomitant hypnotic medications will be recorded again at the follow-up visit. Patient sleep quality using the PSQI and daytime sleepiness using the Epworth scale will also be evaluated again at this visit.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a recent diagnosis of possible or probable Alzheimer's disease (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA criteria) within a maximum of 60 days before the baseline visit.
* Patients with mild or moderate Alzheimer's disease, defined by a Mini-Mental State Exam (MMSE) score between 11 and 25.
* Patients whose caregivers are sufficiently informed of the patients' state and if possible live with the patient.
* Patients who are capable of attending a second clinic visit with their accompanying person 3 months later, based on the clinical practice of the investigator.
* Patients and/or legal representatives who have given and signed written informed consent.

Exclusion Criteria:

* Patients who have psychotic manifestations.
* Patients who have clinically significant sleep disorder (sleep apnea syndrome, restless leg syndrome).
* Patients treated with memantine.
* Patients and/or legal representatives who refuse to give written informed consent to participate in the study.
Intimacy of Women With Cystic Fibrosis

The intimate life of patients with cystic fibrosis has not been the subject of specific research, it is even left behind in favor of respiratory, digestive or endocrinological dysfunctions endangering these patients. After 16 years of practice, it is significant that this subject is problematic, painful but difficult to tackle; No doubt just as much on the side of caregivers: this question has never found its way into team exchanges, it seems to be evaded doubtless difficult or too intimate to welcome. These disorders arise from the effects of the disease on the health of the mucous epithelial tissues also located in the genital area. These difficulties are more closely approached by the difficulties of procreation; PMA allows them to get around them, nevertheless making it possible to be a parent, with the residual frustration of a satisfactory sex life: a deaf "addition", adding to many care constraints.

It is therefore in terms of sexual health and quality of sexual life that it is desirable to shed light on this aspect of cystic fibrosis in women.

Bibliographic research confirms this approach: this subject is not explored, the rare publications concern the vulnerability of the cervix or the difficulty on both sides of tackling this subject.


Eligibility Criteria:
Inclusion Criteria:

* Major women with cystic fibrosis
* Tracked in the various CRCMs in France,
* Having or having had sexual intercourse,
* Having previously been informed of the aims and confidentiality of this research and not having opposed their participation.

Exclusion Criteria:

* Major women with cystic fibrosis whose state of health (acute episode of their disease or worsening phase) does not lend itself to such a collection
* Adult women with cystic fibrosis who are unable to receive the information and make a non-objection
T-SPOT.CMV and T-SPOT.PRT Diagnostic Assays

The T-SPOT assay quantifies the number of peripheral blood interferon-γ producing effector T cells \[spot forming cells/million peripheral blood mononuclear cells - PBMC)\]. The T-SPOT platform technology can be applied to diagnose and monitor any major disease process driven by a T cell response, including a viral disease such as cytomegalovirus (CMV) infection (the T-SPOT.CMV assay) or an allograft rejection (the T-SPOT.PRT assay).

Approximately 600 subjects who meet inclusion/exclusion criteria will be enrolled in the prospective, non-randomized, observational study. Sample size is based on having an adequate overall number of subjects to assess the T-SPOT.PRT endpoint (350) and the T-SPOT.CMV endpoint (250) in the defined populations. Subjects may be enrolled from pre-transplantation to post-transplantation up to completion of antiviral prophylaxis.

Study duration: 37 months; 25 months to enroll all subjects with 12 months (365 days) of patient participation.

Study population:

All subjects enrolled in this study will be men or women, aged 18 years or older and recipients of a first or subsequent renal transplant.

Eligibility Criteria:
Inclusion criteria:

1. Active candidate or recipient of a kidney transplant. Patients enrolled post-transplant must be within 6 months of transplantation and on active CMV anti-viral prophylaxis.
2. Age ≥ 18 years.
3. CMV serology of donor and recipient confirmed prior to enrollment. For seronegative subjects (R-), CMV serostatus should be confirmed within eight weeks prior to transplant by the site local laboratory.
4. Able to provide T-SPOT pre-transplant samples up to a maximum of one month prior to transplant (in the interval between Day -30 and Day 0), or at the time of enrollment if this occurs following transplantation.
5. IRB approved written Informed Consent and privacy language per national regulation (e.g., Health Insurance Portability and Accountability Act for US sites) must be obtained from the subject or legally authorized representative prior to any study related procedures, including screening evaluations and tests.

Exclusion criteria:

1. Anemia prior to transplant that indicates not a candidate for blood draw.
2. On active immunosuppression within two months prior to transplant.
3. Multi-organ transplant (dual-kidney allocation is allowed).
4. Subject has received prior exposure to a CMV vaccine.
5. Subject has undergone or is planning to undergo plasmapheresis.
6. Subject requires desensitization for ABO blood type incompatibility or a positive T or B-cell crossmatch.
7. Subject is known to be HIV positive.
8. Subject is known to have a clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study.
First-Sight Refractive Error Correction in the Developing World

The aim of this study is to test the efficacy of the First-Sight refractive kit designed to provide refractive correction of simple hyperopia, myopia and astigmatism with autorefraction.

In remote and underserved areas, a patient may have limited or no access to eye specialists or healthcare facilities that offer equipment to provide standard refraction and purchase corrective lenses. First Sight Refracting system (FSR) is designed specifically to be used in remote and underserved areas. FSR is not considered the standard of care in the US. FSR is a portable refraction and lens-frame dispensing system with low cost of production. As a kit, it contains +/- 6.00 diopters of corrective lenses, color coordinated flipper, - 1.25 diopter astigmatism lens, visual acuity chart, astigmatic eye chart, measuring tape to measure the distance of the subject to the eye charts, pupillary distance ruler to measure for the frame size of the glasses to be dispensed, and lint free gloves. The kit comes with two standard frames. The corrective lenses are designed to be placed in the frames that can be readily dispensed to the patient after the refraction is done. The refraction technique is simple and straightforward and any healthcare worker in remote and underserved areas can provide the test and dispense glasses at no cost.

This is the third phase of First Sight refractive study to be done in Haiti. Adult and children subjects will be recruited during their routine examinations and/or visual acuity screenings at the Justinien Hospital. The proposed study will compare the visual acuity measurements obtained from the First Sight refraction system (test procedure) with the visual acuity measurements obtained from the autorefraction (standard care). The international study will recruit 150 subjects which will test FSR's effectiveness as a refracting tool of choice to be used in remote and underserved areas. Data from this study will be compared with the US studies.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 7 years of age and older
* Healthy subjects with no known ocular trauma, no surgery, ocular disease or pathology that would prevent obtainment of best correctable visual acuity to 20/30.

Exclusion Criteria:

* Refractive error greater than (+)/(-) 6.00 diopter, or astigmatism greater than 1.50 diopters.
* Known ocular (corneal, lenticular, vitreal, or retinal) pathology that may limit best correctable visual acuity.
Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?

This study evaluates whether patients with Clostridium difficile infection (CDI) who are treated with fidaxomicin have less contamination of their skin and surrounding environment with spores of C. difficile than patients treated with other drugs (metronidazole or vancomycin)

Fidaxomicin is a newly licensed drug for the treatment of CDI. Patients treated with fidaxomicin have a significantly lower C. difficile spore count in their faeces than patients who receive alternative drugs (metronidazole or vancomycin). In vitro evidence has shown that the drug persists in the gut for several weeks after treatment has finished and also prevents the outgrowth of spores. These findings suggest that fidaxomicin therapy could be associated with less contamination of CDI patient's skin and their surrounding environment than metronidazole or vancomycin therapy.

This prospective, case control study aims to investigate this hypothesis by measuring C. difficile spore counts in patient's stool samples, on their skin and in the surrounding environment. Results for patients receiving fidaxomicin will be compared with those on either metronidazole or vancomycin.

If fidaxomicin therapy does reduce contamination levels, it might be a useful adjunct to existing measures used to control CDI in healthcare settings, particularly in outbreak situations.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CDI (see above)
* Prescribed fidaxomicin, vancomycin or metronidazole by attending physician

Exclusion Criteria:

* Patients whose clinical care team indicates it would be inappropriate to include him/her in the study (e.g. due to terminal illness)
* In a patient receiving metronidazole or vancomycin, receipt of fidaxomicin within the previous 3 months
* patients unable to give informed consent for whom no consultee is available to give approval
* non-English speakers
Study for Validation of Target Therapy in Multiple Myeloma Cells From Patients With miRNAs Released From B Cells, and Study of the Bone Marrow Tumor Microenvironment (Microenvironment of MM)

Multiple Myeloma (MM) is a hematologic cancer caused by the selective clonal expansion of plasma cells. By acting on the microenvironment of the bone marrow, MM shifts the niche balance and becomes chemoresistant due to its interaction with stromal cells. Despite new therapeutic strategies, MM still remains incurable and new strategies are urgently needed. In order to successfully act on MM, we must use a strategy that reflects its plasticity and blocks it on several targets: proliferation, interaction with the microenvironment, and metastasis.

The main interest of the project is to evaluate the effect of gene therapy identified in vitro, directly on patient-derived samples, in particular to translate the knowledge gained on myeloma cell lines in vitro to primary tumor cells taken from patients.

Multiple Myeloma (MM) is a hematologic cancer caused by the selective clonal expansion of plasma cells. By acting on the microenvironment of the bone marrow, MM shifts the niche balance and becomes chemoresistant due to its interaction with stromal cells. Despite new therapeutic strategies, MM still remains incurable and new strategies are urgently needed. In order to successfully act on MM, we must use a strategy that reflects its plasticity and blocks it on several targets: proliferation, interaction with the microenvironment, and metastasis.

The main interest of the project is to evaluate the effect of gene therapy identified in vitro, directly on patient-derived samples, in particular to translate the knowledge gained on myeloma cell lines in vitro to primary tumor cells taken from patients.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years;
* Diagnosis of multiple myeloma for which a bone marrow biopsy is scheduled for practice
* Patients able to express appropriate consent to participation in the study (e.g., able to understand Italian, patient with intact cognitive abilities).

Exclusion Criteria:

* Absence of signed informed consent form
* Inadequate or insufficient bone marrow biopsy material
Improving Sleep Among Cancer Patients: Comparison Between Physical Activity and Self-administered Cognitive-behavioral Therapy (CBT)

It has been suggested that the practice of physical exercise can improve sleep, but few studies have investigated this issue in the context of cancer, despite the proven benefits of exercise in this population. This randomized-controlled trial (RCT) aimed to compare the efficacy of an aerobic intervention program to that of a self-administered cognitive-behavioral therapy (CBT) to improve sleep of cancer patients. Forty-one men and women with insomnia symptoms and treated within 6 months for a non-metastatic cancer participated in the study.


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of non-metastatic cancer
* adjuvant treatments completed within the past 6 months
* insomnia symptoms as defined by a score ≥ 8 on the Insomnia Severity Index
* practicing less than 90 minutes of physical exercise per week
* able to readily read and understand French
* available during a consecutive 6-week period to complete the intervention
* written permission from physician to engage in a physical exercise program

Exclusion Criteria:

* severe cognitive impairments (e.g., diagnosis of Parkinson disease)
* severe psychiatric disorder (e.g., severe major depression)
* diagnosis of a sleep disorder other than insomnia (e.g., obstructive sleep apnea)
* any contraindication for the practice of physical exercise