cyrilzakka/clinical-trials huggingface dataset:
COVID-19 Infection at Samusocial in Paris: Descriptive and Serological Survey

Study of COVID-19 seroprevalence in precarious population living in shelters of Samusocial de Paris and in staff working in these centers during COVID-19 epidemic.

After emergence of a new coronavirus (Severe Acute Respiratory Syndrome Coronavirus 2, SARS-CoV2) responsible for a cluster of respiratory infection at Wuhan, China, on January, 7th 2020, first cases were diagnosed in France in January 24th 2020.

Health care components of Samusocial de Paris (Lits Haltes Soins Santé (LHSS)) were created in 2006. They provide medical care for homeless people and people in social distress not needing an hospitalization. Sometimes there are 3 persons in a bedroom.

In december 2018, a special shelter for isolated women or women in precarious situations opened.

Because of the living conditions in these centers and the difficulty for these populations to respect social distancing and hygiene recommendations.

A first case of COVID-19 was identified on March 8th 2020 in one of these healthcare centers. Other cases were detected in the same center, then in another center on March 16th, then in the dormitory of the women shelter on March 30th.

A recent study showed an important prevalence of SARS-COV2 in residents of a homeless shelter in Boston (36%), most of them were asymptomatic.

Seroprevalence studies are done in general population or in health care workers, but don't include vulnerable people.

It seemed important to us to describe the epidemic in these centers and to study COVID-19 seroprevalence in these particular populations.

Eligibility Criteria:
Inclusion Criteria:

* to have been hosted or working in one the three centers (LHSS Ridder-Plaisance or Saint Michel or Halte femmes) between march and may 2020
* to be aged 18 y or more
* to be able to give an informed consent

Exclusion Criteria:

* people who refuse to participate
* not being able to give an informed consent
* Person subject to a legal protection measure (safeguard of justice, curatorship or guardianship)
* Person who does not understand the information provided on how to carry out the research
* Obstacle to venous sampling
Polymyalgia Rheumatica Associated to Primary Sjogren Syndrome

To determine the phenotype of patients having PMR symptoms and primary Sjogren syndrome (pSS), we used a French national call to identify patients combining both diseases and collected retrospective clinical and biological data.

A national call to identify patients combining pSS and PMR was disseminated in France. Patients with Sjögren's syndrome associated with rheumatoid arthritis were excluded. We described the global population having both diseases and compared them to two historic prospective cohorts of isolated pSS (the prospective cohort of primary Sjögren DiapSS), or isolated PMR (TENOR, a cohort of recent PMR), regarding clinical, imaging and treatments characteristics.

Eligibility Criteria:
Inclusion Criteria:

* fulfilling the ACR/EULAR 2012 criteria for PMR and the ACR/EULAR 2016 criteria for pSS

Exclusion Criteria:

-
Pain Relief by Intra-Peritoneal Ropivacaine During Gynecological Laparoscopy

In our prospective, randomized, placebo controlled and double-blinded study we will study the efficacy of intraperitoneal ropivacaine nebulization on pain relief during gynecological laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Elective gynecologic laparoscopic surgery including unilateral or bilateral salpingo-oopherectomy or ovarian cystectomy.
* The patient is not participating in other medical study at present or in the last 30 days.
* The patient signed on an informed consent.
* Age 18 years and above.
* ASA (American Society of Anesthesiologists) physical status grade 1- 2.

Exclusion Criteria:

* Allergy to Ropivacaine, other local anesthetics or other medications listed in the protocol.
* The patient is participating in other medical experiment at present or in the last 30 days.
* Acute Pelvic Inflammatory Disease.
* Coumadin or Aspirin treatment.
* ASA physical status grade 3-4.
* Age \< 18 years.
* Significant arrythmias
* Analgesic treatment for chronic pain
Dose of Corticosteroids in COPD

COPD (chronic obstructive pulmonary disease) is a long-lasting lung disease usually caused by long-term smoking. COPD can get worse, making people sick enough to need hospitalization. Corticosteroids are very effective and are almost always used, but nobody knows the right dose. High doses may work better but could cause more side effects than low doses. Typical treatment lengths last at least one week. This study will be comparing two common regimens: either 40mg of corticosteroids daily (low dose), or 80mg of corticosteroids daily (high dose). It is unknown which regimen works better..

The goal of the study is to determine whether a high-dose corticosteroid regimen in patients admitted to the hospital with COPD exacerbations is associated with better clinical outcomes and at acceptable risk of adverse effects compared to a low-dose corticosteroid regimen. Our hypothesis is that high-dose corticosteroids is associated with a decreased rate of treatment failure, shorter length of hospital stay, and improved quality of life with similar risk of adverse effects. The study population includes patients ≥ 40 years-old with a ≥ 10 pack-years smoking history and a diagnosis of COPD, emphysema, or chronic bronchitis who present to the emergency room with increased dyspnea, increased sputum, or increased cough that requires admission to the hospital. We will perform a prospective, randomized, double-blinded study to determine if a high-dose corticosteroid regimen, which is already in use in clinical practice, decreases treatment failure compared to a low-dose corticosteroid regimen that is based on national consensus guidelines.

Eligibility Criteria:
Inclusion Criteria:

i. Patients with a diagnosis of COPD, emphysema, or chronic bronchitis ii. Age ≥ 40 years-old iii. Smoking history ≥ 10 pack-years iv. Presentation to the emergency room with increased dyspnea, increased sputum, or increased cough v. Admission to the hospital

Exclusion Criteria:

i. Alternative diagnosis for cause of dyspnea, increased sputum or cough ii. Patients who requires intubation at time of recruitment iii. Patients who are unable to give consent iv. Patients who are pregnant or could be pregnant or are currently breast-feeding v. Women of child-bearing age who cannot use methods of contraception as described in the consent, including condoms, female condoms, cervical caps, diaphragms, and intra uterine devices.

vi. Patients who were previously entered into the trial and are re-admitted to the hospital with a new COPD exacerbation.
Eye Soft Surgery for Facial Sinkynesis

Facial synkinesis (FS) is a distressing sequela of facial palsy (FP) characterized by involuntary, simultaneous movements of facial muscles occurring during voluntary facial expressions. Treatment of synkinesis is challenging, and preventive methods are needed.

This study evaluates the efficacy of physical facial nerve rehabilitation (PFNR) therapy alone versus PNFR with eyelid surgery to correct lagophthalmos and prevent the onset of synkinesis.

25 outpatients are randomized to receive either PFNR alone (neuromuscular retraining and Kabat proprioceptive neuromuscular facilitation) or PNFR and early (90 days after FP onset) eyelid surgery (involving a conservative oculoplastic correction for lagophthalmos with epiphora or ectropion). Comprehensive otolaryngological assessments and Magnetic Resonance Imaging (MRI) will be conducted. Synkinesis progression was measured using Another Disease Scale (ADS) at baseline, 3 months 6 months, 12 months, and 24-months post-treatment. The data were analyzed with ANOVA, t-test, Chi-Square analyses.


Eligibility Criteria:
Inclusion Criteria:

* people over 18 years old
* willingness to participate
* acute/new onset of FP (less than 15 days)

Exclusion Criteria:

* neuro-inflammatory diseases (e.g., Multiple Sclerosis)
* FP from systemic disorders (e.g., Guillain-Barré syndrome, Lyme disease, encephalitis)
* FP from middle ear infections or untreated cholesteatoma
* severe cognitive or psychological disorders
* non-consent to participate in the study
Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.

Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists.

The aim of this study was to evaluate the efficacy and safety of tegaserod on bowel habits in male patients with chronic constipation.


Eligibility Criteria:
Inclusion Criteria:

* A 6-month history of constipation defined as \<3 complete spontaneous bowel movements per week and \>1 of the following symptoms \>25% of the time: hard stools, sensation of incomplete evacuation and straining

Exclusion Criteria:

* Patients with cancer, inflammatory bowel disease or other structural bowel disease
* Past or current diagnosis of irritable bowel syndrome were excluded.

Other protocol-defined inclusion/exclusion criteria may apply.
The Effect of Prognostic Factors on the Success of Full Pulpotomy in Permanent Mature Molars With Irreversible Pulpitis

This study aims to evaluate the effect of prognostic factors, such as the degree of pulpal inflammation and the radiographic caries depth, on the success of full pulpotomy in mature permanent molars with irreversible pulpitis.

* Patients with mature permanent molars diagnosed with irreversible pulpitis will be enrolled in the study.
* The pre-operative pulpal status will be assessed using the American Association of Endodontists (AAE) classification and Wolters classification.
* Pre-operative radiographs will be taken, and radiographic caries depth will be assessed.
* An Artificial Intelligence software will process the pre-operative X-rays to assess the presence of carious pulp exposure. The diagnostic accuracy of the software will be evaluated by comparing its readings with clinical findings of pulp exposure after caries removal.
* The patients will be randomized to receive either full pulpotomy or conventional root canal treatment.
* The patients will be followed up for 1, 3 and 6 months to assess clinical and radiographic success.

Eligibility Criteria:
Inclusion Criteria:

* Mature permanent molars with irreversible pulpitis.
* Presence of bleeding pulp tissues from all canals.
* The tooth is not periodontally compromised.

Exclusion Criteria:

* Non-vital teeth.
* Uncontrolled bleeding from any of the canals after ten minutes of application of hemostatic agent.
* Molars with immature roots.
Gait Retraining for Runners with Knee Osteoarthritis

Tibiofemoral osteoarthritis (TFOA) is highly prevalent in older adults, and often causes symptoms and functional limitations. Physical activity is widely advocated in people with TFOA, and running is an easy and accessible activity that provides many benefits on general health. However, running induces high knee loads, which could potentially contribute to symptoms of runners with TFOA. Previous studies have suggested that running gait modifications can help in decreasing symptoms and knee loading in runners with knee conditions. Yet, no study has been conducted in runners with TFOA. This intervention study will investigate the effects of a 4-week running gait retraining program on symptoms and running biomechanics in runners with TFOA. We hypothesize that running modifications will decrease symptoms, improve function and reduce knee loading.


Eligibility Criteria:
Inclusion Criteria:

* TFOA of Grade 2 (mild) or 3 (moderate) on the Kellgren and Lawrence scale
* report knee pain greater than or equal to 3/10 on a numerical pain rating scale (0-10) during most days of the previous month
* run at least 10 km per week for a minimum of 6 months
* declare being comfortable running on a treadmill for at least 30 minutes

Exclusion Criteria:

* history of traumatic knee injury
* neurological or inflammatory arthritic condition
* cardiovascular or cardiopulmonary disease preventing from safely performing moderate intensity running
* presence of any lower limb condition affecting running (other than TFOA)
* use of any oral or injected corticosteroids or viscosupplementation in the previous six months
* regular use of non-steroidal anti-inflammatory drugs, analgesics or knee unloading bracing devices before, during or after running
* non-English speaking
Nerve Sparing Versus Non Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male

To compare the perioperative, functional, and oncologic outcomes between non nerve sparing and nerve sparing robot-assisted radical cystectomy with orthotopic ileal neobladder in male patients with bladder cancer.

This study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy with orthotopic ileal neobladder. The patients will be distributed into two comparable groups according to surgical procedures: non nerve sparing group and nerve sparing group. Patient demographic and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Male patients aged 18 or older.
2. Patients those who are diagnosed with urothelial carcinoma.
3. Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder.
4. Patients those who are able to cooperate and complete the follow-up.
5. Patients those who volunteer to participate in this study and sign the informed consens.

Exclusion Criteria:

1. Patients thsoe who are diagnosed distant metastasis before surgery.
2. Patients those who are diagnosed with other malignancies.
3. Patients those who had received pelvic radiotherapy or major pelvic operation.
Steriwave ICU Pilot Study

This is a single-center, non-blinded, prospective, pilot study enrolling patients admitted to the critical care unit at Royal Columbian Hospital. This study investigates the effects of universal nasal decolonization using antimicrobial photodynamic therapy (aPDT) on the prevention of hospital-acquired pneumonia (HAP), ventilator-acquired pneumonia (VAP), and hospital-acquired bloodstream infection (BSI) in this patient population.

Main Objectives include:

* To determine whether a large, multi-center RCT of this protocol is feasible
* To determine baseline rates of VAP, HAP, and ICU-acquired BSI
* To gather preliminary efficacy data regarding VAP, HAP, and ICU-acquired BSI prevention using universal aPDT nasal decolonization
* To gather preliminary microbiological data on the effect of universal aPDT procedures on nasal carriage of various microoganisms in ICU patients.


Eligibility Criteria:
Inclusion Criteria:

* All ICU patients 19 years and above
* Expected length of ICU stay \>48 hrs

Exclusion Criteria:

* Pregnant/breastfeeding individuals
* Allergy to methylene blue and/or chlorhexidine gluconate, or unknown allergy status
* Nasal or facial trauma that limits access to the nose
* Inability for the patients to tolerate or comply with treatment, as determined by their treating physician
* Patient, TSDM or MRP declines participation
* Co-enrolment with other research studies will be considered in an individual basis.
Multiparametric Magnetic Resonance Imaging (MRI) in Medullary Sponge Kidney

Background :

Medullary sponge kidney disease is a congenital disorder caracterised by tubular ectasia and cystic dilatation of the collecting ducts in the pericalyceal region of the renal pyramids, which can lead to nephrolithiasis and frequently associated with impaired tubular function such as distal renal tubular acidosis.

The disease knowledge is limited, especially about origin, diagnosis, and physiopathology of the disease.

The disease is associated with impaired tubular function such as distal renal tubular acidosis, hypocitraturia, hypercalciuria, which suggest altered kidney medulla function.

Multiparametric MRI may provide further informations about the physiopathology and help in earlier diagnosis of the medullary sponge kidney.

Objective :

The aim of this study is to test the hypothesis that early kidney medulla function alteration in medullary sponge kidney can be detected and characterised with multiparametric MRI. We are expecting to see in medullary sponge kidney a decreased oxygenation content in BOLD MRI (Blood oxygenation level dependent magnetic resonance imaging), and decreased ADC (Apparent diffusion coefficient) value in the medulla.

Design :

A monocentric prospective case/control study will be conducted in adults with medullary sponge kidney. Controls are adults patients with glomerular filtration rate \> 60 mL/min/1.73m2 without kidney stone attending a renal exploration.

After a screening visit, patients included will be evaluated on one day with lithiasis assessment and measurement of glomerular filtration (Urinary collection of the last 24 hours, Urine sample, Blood sample) and they will perform multiparametric magnetic resonance imaging of the kidneys.


Eligibility Criteria:
Inclusion Criteria:

* medullary sponge kidney attending medical consultation
* Patients with glomerular filtration rate \> 60 mL/min/1.73m2 without kidney stone
* consent signed
* effective contraceptive method for women
* affiliated to social insurance scheme

Exclusion Criteria:

* kidney transplant
* polycystic kidney diseases
* Chronic kidney disease (GFR \< 60 mL/min/1,73m² )
* MRI contraindications (claustrophobia, pacemaker, cardioverter defibrillators implantable, mechanical heart valve non MRI-compatible)
* Weight\> 130 kg
* pregnancy
* legal protection measure (guardianship, curatorship)
* Deprived of liberty by a judicial or administrative decision
* subject participating in another research that may interfere with the research and including an exclusion period still in progress at inclusion
Exercise Training on Health and Medical Costs of Metabolic Syndrome Individuals.

The purpose of this study is to determine if an exercise training intervention together with conventional medical treatment can decrease the annual healthcare cost in patients with metabolic syndrome.

It is proposed a multicentral clinical trial with cluster randomization among research nodes located in towns of Castilla-La Mancha and Toledo neighborhoods (Spain). The aim is to compare the annual healthcare cost of patients receiving conventional medical treatment against patients receiving the same intervention plus exercise training for 16 weeks. Exercise training will be based on high-intensity interval training conducted on stationary bikes, and strength training using weight-bearing exercises. Each research node will be composed of the clinical center and the sports facilities available in the town/neighborhood. Research nodes will be randomized into two experimental interventions: i.) conventional medical treatment, and ii.) conventional medical treatment + exercise training. After verbal and written information about the study and related potential risks, all patients fulfilling inclusion criteria will be included after giving written informed consent. At baseline, and after 12 and 24 months, annual healthcare costs will be obtained from the volunteers' clinical records. In addition, at baseline, and after 4, 12, and 24 months, metabolic syndrome components prevalence, metabolic syndrome z-score, body composition, and cardiorespiratory fitness will be tested.

Eligibility Criteria:
Inclusion Criteria:

* Fulfilling criteria for metabolic syndrome diagnosis.

Exclusion Criteria:

* At baseline, engagement to an exercise training program for the last 6 months.
Subcutaneous vs. Intramuscular Testosterone

In this randomized, cross-over study 20 subjects who are undergoing testosterone (T) therapy for the treatment of T deficiency will receive both subcutaneous testosterone therapy and intramuscular testosterone therapy. One group will receive a SQ injection followed by an IM injection and one group will receive an IM injection followed by a SQ injection. The primary objective of this study is to measure testosterone concentration in men after these two treatment routes and determine if there are any significant differences due to modes of administration. Endpoints will include total serum testosterone and calculated free testosterone. A questionnaire will also be administered to assess overall patient experience with each route of administration.

Subjects planning to initiate testosterone treatment via injection at MHB will be consented into the study. Upon enrollment in the study, the randomization will be completed for each subject.

Blood collection will occur before each injection. Subjects will rate pain on the Likert scale following each injection. After treatment with the first mode of T administration (SQ or IM depending on randomization), subjects will come in for blood draws 3 days and 7 days following the injection. Two weeks after the initial injection, subjects will come in for treatment with the second mode of T administration (SQ or IM depending on randomization). Subjects will come in for blood draws 3 days and 7 days following the second injection. Two weeks after the second injection, subjects will complete an end of study assessment with an Investigator and will complete a survey assessing their satisfaction with treatment. Subjects will likely continue testosterone therapy at Men's Health Boston after completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Ability to read, write, and understand English
* Age greater than or equal to 18
* Diagnosed with testosterone deficiency
* Pre-enrollment testosterone concentration of less than 350 ng/dL
* Planning to initiate testosterone treatment at MHB
* Willing to be followed at MHB for at least one month
* Willing to provide informed consent for this study

Exclusion Criteria:

* Previous exposure to exogenous T, clomiphene citrate, or other Selective Estrogen Receptor Modulators, unless off therapy for at least 12 weeks
* American Urological Association Prostate Symptom score of 15 or greater or significant prostatic symptoms
* History of carcinoma, tumors or induration of the prostate or the male mammary gland, including suspicion thereof
* Pre-enrollment serum PSA more than 4 ng/ml
* Serious psychiatric disease or uncontrolled medical illness, as suspected from the history or clinical examination
* Used any sex hormones or steroidal anabolic drug supplements within 28 days before pre-enrollment testosterone collection or at any time throughout the study
* Incapable of giving informed consent or complying with the protocol