cyrilzakka/clinical-trials huggingface dataset:
Transgender Caregivers' and Patients' Representations of Parenthood as Part of a Fertility Preservation Pathway

This research aims to understand the impact of fertility preservation consultation on transgender patients' projection and how the possibility of preserving gametes influences transgender people's transition paths, parenthood projects and health and health of transgender people through qualitative interviews.

This research will also study the representations of members of medical and reproductive biology teams the possible use of stored gametes, and how these representations influence their clinical practice.

clinical practice. To answer the research question, we plan to include 30 patients who have consulted for fertility preservation at the at the CECOS of the Tenon hospital, located in the 20th arrondissement of Paris, and 20 members of the center's healthcare team.

care team.

Since the 2016 law, transgender people no longer need to provide "irreversible and medical proof of a physical transformation" in order to carry out a sex change at the Civil Registry, which puts an end to systematic sterilization and opens up the possibility of a hormonal-only transition. Yet hormonal treatments can have an impact on the fertility of transgender people, compromising a subsequent project for parenthood.

The Reproductive Biology department at Tenon, where the research will take place, now offers self-conservation of female and male gametes before hormone replacement treatments are introduced, or during a therapeutic window. Fertility preservation in transgender women relies primarily on sperm self-preservation. For transgender men, fertility preservation relies on cryopreservation of mature oocytes after ovarian stimulation.

In addition to assessing the psychic impact of care in order to prevent potential deleterious effects, psycho-sexological consultation offers an opportunity to express the desire for a child, a desire often inhibited for a long time, as well as information on the possibilities of reuse.

When it comes to research around the issue of fertility preservation for transgender people, there is often talk of problems concerning access to this care: the discriminatory practices of certain centers that refuse transgender people, the lack of training in transidentity issues for care teams, etc. The coercive weight of the law seems to be enough to evade the issue by moving it into the realm of legislation. And yet, in our clinical experience, the question of gamete reuse is a subject that merits research to determine the obstacles and levers for both caregivers and patients.

Eligibility Criteria:
Inclusion Criteria:

* Any transgender person undergoing fertility preservation in the department
* Any member of the reproductive biology and medicine services team
* Aged 18 and over, with or without children
* Informed and having signed consent to participate in the research project

Exclusion Criteria:

* No social security
* Persons under guardianship
DORAYA-HF OUS Assessment of the Doraya Catheter for the Treatment of ADHF Patients With Insufficient Response to Diuretics

The study objective is to evaluate the feasibility of the Doraya Catheter and measure clinical performance and safety endpoints, in ADHF patients deemed to have insufficient diuretic response.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is hospitalized with primary diagnosis of ADHF.
2. N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m orvBNP≥250 pg/mL.
3. Evidence of fluid overload.
4. Subject insufficiently responds to IV diuretic therapy

Exclusion Criteria:

Systolic blood pressure \< 80 mmHg at the time of screening. 2. Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleurocentesis within past 14 days or cardiovascular intervention within past 14 days. 3. Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).

4. Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade.

5. Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \\severe regurgitation) or Severe mitral disease with planned intervention.

6. Evidence of active systemic infection documented by either one of the following: fever \>38°C/100°F, or ongoing uncontrolled infection (i.e., inflammatory parameters not decreasing despite \> 48 hours of antibiotic treatment).

7. Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.
Effects of Genmont Probiotic on Improve the Level of Blood Glucose and Other Diabetic Associate Parameter in Type 2 Diabetes Patients

The purpose of this study is to evaluate the efficacy and safety of probiotics ADR-1/GMNL-263 capsules (Lactobacillus reuteri ADR-1/ Lactobacillus reuteri GMNL-263) for the treatment of adults with type2 DM.

Background：Based on animal studies, intake of probiotic bacteria was suggested to improve insulin sensitivity by reducing inflammation.

Objective ： The objective of this study was to determine the effects of supplementation with the probiotic strain Lactobacillus reuteri ADR-1(ADR-1) and Lactobacillus reuteri GMNL-263 (GMNL-263) over six months on metabolic profiles, intestinal microbiota profiles and biomarkers of inflammation in type 2 diabetes patents. Methods ： This randomized double-blind placebo-controlled clinical trial was performed on 120 diabetic patients. Subjects were divided into 3 groups: 40 subjects in the group A received placebo, 40 subjects in the group B received ADR-1 (4 x 109 colony-forming units/d), and 40 subjects in the group C received GMNL-263. (2 x 1010 cells/d) for 6 months. Fasting blood samples were taken at baseline and after intervention to measure metabolic profiles and biomarkers of inflammation including C reactive protein (CRP), Interleukin 6 (IL-6) and Tumor necrosis factor-alpha( TNF-α). The intestinal microbiota profiles were detected in stool samples by real-time polymerase chain reaction (RT-PCR).

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes with a duration\> 6 months
2. 7 % \< HbA1c ≦ 10 %
3. Adults 25- 70 years of age
4. BMI\>18.5

Exclusion Criteria:

1. Pregnancy
2. Subjects with any other serious diseases such as cancer (patient with benign tumor under medical control should not be ruled out), kidney failure / dialysis, heart disease, stroke.
3. Autoimmune Disease
4. Administration of other healthy food for diabetes 4 weeks before inclusion
5. Administration of probiotic 4 weeks before inclusion
6. Administration of antibiotics 4 weeks before inclusion
7. Participation in other clinical trials
8. ALT/SGPT or AST/SGOT \> 3x upper limit of normal (ULN)
9. eGFR\<30mL/min/1.73m2
10. Subjects who is lack of physical integrity of gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication.
Evaluation of the Home Visiting Pilot Program on Early Childhood Outcomes in Fortaleza Brazil

This is a cluster-randomized study of a home visiting program targeting mothers of children 0 to 2.5 years of age with the objective of improving global child development. The program, Programa Cresça com Seu Filho (PCCSF), will be randomized across 220 microareas in the poorest Region (V) of the state of Fortaleza, Brazil.

This is an evaluation of pilot program, Programa Cresça com Seu Filho (PCCSF) which is publically funded and, developed in a partnership between the Ministry of Health (MoH) of Brazil and the municipal government of Fortaleza. The program targets low-income mothers of children 0 to 2.5 years old, living in low-income neighborhoods in Fortaleza Brazil. The home visits are carried out by community health workers (CHW), who currently work for the Ministry of Health as part of the program Programa Saúde da Família. The CHWs will be trained on the PCCSF curriculum in order to provide 1-hour visits with the early stimulation package during two years. The PCCSF home visiting program is planned to begin implementation the week of March 15, 2016 for half of the community health workers and April 15, 2016 for the other half.

Eligibility Criteria:
Inclusion Criteria:

* Mothers of children ages 0-2.5 years of age
* Included in the poverty registry CadastroUnico
* Residents of specific 440 poor microareas of Region V of Fortaleza

Exclusion Criteria:

* Data will not be collected if parental consent not given.
SMN Circular RNAs as Potential New Targets and Biomarkers for SMA

Spinal Muscular Atrophy (SMA) is a life-threatening disease in infancy that is caused by inactivating mutations in the Survival Motor Neuron 1 (SMN1) gene1,2. SMN1 mutations lead to deficiency in SMN protein, which results in degeneration of motor neurons in the spinal cord, progressive muscle weakness and atrophy. The almost identical SMN2 gene does not suffice SMN function, because skipping of exon 7 in its mRNA yields an unstable protein. Nevertheless, SMN2 represents a disease modifier gene and increasing its expression or rescuing its splicing defect have long been considered elective strategies for SMA1,2. After substantial translational research efforts, the first therapies eliciting clinical benefits for SMA patients have recently become available3. Nusinersen, an antisense oligonucleotide (ASO), and Risdiplasm, a small molecule, bind the SMN2 RNA and promote splicing of exon 7. On the other hand, Zolgesma, an adeno-associated virus delivering the SMN1 gene (scAAV9-SMN), bypasses the need to correct the splicing defect. Nevertheless, none of these therapies currently represents a complete cure for patients, because not all of them respond equally and in a significant portion of patients the symptoms are attenuated but not corrected3. It is believed that early treatment, possibly at a pre-symptomatic stage, would positively affect the clinical response and may significantly improve patient's management. However, another critical point is the current lack of information on the long-term efficacy and safety of the current treatments4. In this scenario, it is likely that further elucidation of the biological functions of the SMN genes and the identification of robust biomarkers for stratification of patients will set the ground for more "personalized" therapies, which may account for the clinical variability observed in patients and help improving the therapies in use.

This project aims at investigating the potential value of SMN circRNAs as biomarkers of SMA, in terms of prediction of disease severity and response to therapeutic treatments.

In particular, we aim to:

1. Evaluate the potential of SMN circRNAs as biomarkers of SMA clinical outcome. We will evaluate which SMN circRNAs are released in body fluids of SMA patients undergoing treatments and whether they display prognostic power as predictors of disease progression and clinical response to therapies.
2. Perform a prospective analysis of SMN circRNAs expression in pre-symptomatic SMA patients. We will analyze the expression levels of SMN circRNAs in body fluids of SMA patients identified by neonatal genetic screening.

The results of our project may identify new tools to better stratify SMA patients and to improve the efficacy of the currently available treatments for this disease.

Eligibility Criteria:
Inclusion Criteria:

* Genetic diagnosis of SMA, without any restrictions for phenotype (i.e. presymptomatic patients, SMA 0, SMA I, SMA II, SMA III, SMA IV patients), number of SMN2, age or gender.
* Treatment with Nusinersen or Risdiplam or Zolgensma.

Exclusion Criteria:

unable to provide consent
Lung Irradiation for COVID-19 Pneumonia

In this research study the investigators want to learn more about the potential benefit of radiation to the lung to improve the health of patients who are hospitalized with Coronavirus-19 (COVID-19) due to infection with a virus called SARS-CoV-2. This infection causes inflammation of the lung, which can make it difficult to breathe. As a result, patients may need supplemental oxygen or be placed on a ventilator. The investigators believe that low dose radiation therapy to the lung may reduce this inflammation and increase the likelihood that patients will need less oxygen support such as ventilation or supplemental oxygen, or be discharged from the hospital in fewer days, compared to without radiation therapy. The amount of radiation is much lower than what is typically used to treat other conditions such as cancer, although it is higher than the dose used for routine medical imaging.


Eligibility Criteria:
Inclusion criteria

* Diagnosis of SARS-CoV-2 infection by RT-PCR or another approved laboratory test ≤ 3 days before enrollment or ≤ 14 days before enrollment with progressive disease suggestive of ongoing SARS-CoV-2 infection; retesting allowed
* Current hospitalization for ≤ 14 days with SARS-CoV-2 infection at the time of enrollment
* Use of supplemental oxygen or oxygen saturation ≤ 94% on room air
* Age ≥ 40
* May receive antiviral medication (e.g., remdesivir, lopinavir/ritonavir, oseltamivir, favipiravir), antibiotics (e.g., azithromycin), chloroquine, hydroxychloroquine, corticosteroids, statins, anticoagulation, antiplatelet agents (e.g., aspirin) and/or convalescent plasma from recovered individuals off study and/or on study if permitted by the other protocol

Exclusion criteria

* Prior or planned treatment with interleukin inhibitors (e.g., tocilizumab, canakinumab, sarilumab) or TNF-α inhibitors within 14 days of enrollment
* Prior lobectomy or pneumonectomy
* Prior thoracic radiotherapy with cumulative lung V20 \> 15% to either lung within 1 year of enrollment, or any radiotherapy resulting in a maximum lung dose of 100 cGy or higher within 14 days of enrollment
* Prior chemotherapy or other systemic therapy with potential for pulmonary toxicity or radiosensitization within 14 days or 5 half-lives, whichever is greater, of enrollment, e.g., bleomycin or gemcitabine
* Prior cancer immunotherapy with an immune checkpoint inhibitor within 60 days of enrollment
* Severe pre-existing heart disease, e.g., New York Heart Association (NYHA) functional class ≥ 3 congestive heart failure
* History of bone marrow or solid organ transplantation
* Known history of autoimmune collagen vascular disease, e.g., scleroderma
* Known hereditary syndrome with increased sensitivity to ionizing radiation, e.g., ataxia-telangiectasia or Fanconi anemia
* Pregnancy
* Inability to be positioned supine and flat for radiation planning and delivery
* Inability to provide informed consent or lack of an authorized representative who can provide informed consent
Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel

The purpose of this study is to evaluate the safety and effectiveness of AdvaCoat® sinus gel, a nasal/sinus dressing, for adhesion prevention following endoscopic ethmoid sinus surgery. Subjects were randomized to receive AdvaCoat applied to the right or left middle meatus tissues and Merogel applied to the middle meatus tissues on the opposite side.

Chronic rhinosinusitis is a very common condition, affecting 35 million Americans each year. All paranasal sinuses need ventilation to prevent infection and inflammation. Sinus ventilation occurs through the ostia into the nose. When rhinosinusitis occurs, the mucous membranes of the sinuses become swollen, resulting in ostia closure. Functional endoscopic sinus surgery (FESS) is a minimally invasive surgical procedure that opens the sinus ostia.

The most common unwanted side effect of the FESS procedure is the formation of adhesions (fibrous bands) in the area of surgery. These bands (adhesions) can prevent proper ventilation and drainage from the paranasal sinuses.

Various hyaluronan based biomaterials are now available and in common use to provide a post-surgical nasal dressing which is absorbable, can prevent adhesion formation, and eliminate the pain and tissue abrasion caused by removal of non-absorbable nasal packing.

AdvaCoat is a bioresorbable hyaluronan gel that conforms to mucosal surfaces and provides a post-surgical nasal dressing to prevent adhesion formation as tissues heal.

Eligibility Criteria:
Inclusion Criteria:

Patients who:

1. Have bilateral chronic rhinosinusitis confirmed by physical exam, clinical history, and prior radiography
2. Have bilateral ethmoid sinus disease
3. Are scheduled for bilateral anterior or total ethmoidectomy

Exclusion Criteria:

1. Unilateral ethmoid sinus disease
2. Partial resection of middle turbinates, unilateral or bilateral
Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis

This is a proof of concept, randomized, open label, 2-arm study of OPRX-106 in subjects with active mild to moderate ulcerative colitis. Eligible subjects will be enrolled and randomized to receive 2 mg or 8 mg of OPRX-106 administered orally, once daily for 8 weeks.


Eligibility Criteria:
Main Inclusion Criteria:

1. Have had a diagnosis of ulcerative colitis for a minimum of 3 months
2. Have active mild to moderate ulcerative colitis, as defined by a full Mayo score at screening
3. Have adequate cardiac, renal and hepatic functions as determined by the investigator and demonstrated by screening clinical and laboratory evaluations, and physical examination results
4. High level of calprotectin (\>100 mg/kg of stool)

Main Exclusion Criteria:

1. Have a history of colonic or rectal surgery other than hemorrhoidal surgery or appendectomy
2. .Positive for active/ latent mycobacterium tuberculosis (TB) infection
3. .Have a history of infection requiring administration of any IV antibiotic, antiviral or antifungal medication or any oral anti-infective agent
4. Severe ulcerative colitis
5. Ulcerative proctitis, defined as disease limited to less than 15 cm from the anal verge
6. Use \>4.8 g 5-ASA or equivalent
7. Use of corticosteroid or 5-ASA enemas, foams, or suppositories
8. Use of anti-inflammatory medications or natural remedies
9. Use oral or parenteral antibiotics
10. Use of chronic non-steroidal anti-inflammatory (NSAID) therapy
11. Use of immune suppressive agents including anti-TNF agents, Azathioprine, 6MP, Methotrexate
12. Use of steroids
13. Have a diagnosis of: Crohn's disease; Indeterminate colitis; Microscopic colitis; Ischemic or infectious colitis; Clostridium difficile colitis, Parasitic disease
The Effect of Percutaneous Radiofrequency Ablation of Feeding Arterial for Hepatocellular Carcinoma

To evaluate a novel technique-ultrasound guided percutaneous abaltion of tumor feeding artery before RFA for liver malignancy.

Hepatocellular carcinoma is one of the most common tumor in clinical practice. In recent years, various local therapies, especially radiofrequency ablation (RFA) has been proved safe and effective.The main limitation of RFA is that its therapeutic impact is significant compromised by blood flow cooling effect, especially in hypervascular HCC. Recent studies showed combined therapy of TACE and RFA can decrease the blood supply of tumor, increase ablated volume and therefore improve the outcome. However, TACE application is limited in patients who cannot tolerate this therapy due to the side effects of repeated TACE, poor liver function or previously legated hepatic artery. The present study is focus on "difficult-to-treat" HCC patients who are neither surgical candidates, nor TACE candidates. The investigators introduce the novel treatment mode that RFA followed ultrasound guided percutaneous ablation of tumur feeding arterial to treat these difficult cases and evaluate the clinical effect.

Eligibility Criteria:
Inclusion Criteria:

1. tumor number ≤3， maximum tumor size ≤5cm;
2. accessibility of tumors via a percutaneous approach;
3. tumor feeding artery can be detected by 3D contrast enhance ultrasound;
4. platelet count ≥ 50,000/ml and INR \<1.6;
5. life expectancy more than 6 months
6. Child grade A or B

Exclusion Criteria:

1. patients who scheduled liver transplantation
2. with extrahepatic metastasis
3. women during menstruation, pregnancy, child birth and baby nursing period
4. patients with severe mental disorder
5. cardiopulmonary failure
Kharituwe TB Contact Tracing Study

The purpose of this study is to characterize the role of human mobility in fueling TB epidemics and estimate the potential impact of innovative case finding interventions tailored to mobile populations

The investigators propose a randomized trial of two novel TB case-finding interventions among household members of patients diagnosed with active TB: holiday-based screening in a rural South African province (Limpopo) and off-peak (weekend/evening) screening in an urban settlement into which many residents of Limpopo migrate for work. The investigators will enroll index cases of TB plus their household contacts in each setting and randomize them to novel versus standard contact investigation. In Specific Aim 1, investigators will use whole genome sequencing of all cases, overlaying transmission trees with data on human movement, to evaluate associations between mobility and TB transmission in this population. In Specific Aim 2, investigators will employ a multidisciplinary approach to compare novel versus standard contact investigation in each setting along the following dimensions: (a) effectiveness (number of secondary TB cases diagnosed and starting treatment); (b) implementation (reach, fidelity, and maintenance of contact investigation outside of business hours); (c) cost-effectiveness (cost per disability-adjusted life year) and budget impact; and (d) projected population-level impact on TB incidence. Successful completion of these aims will have long-term impact by characterizing the role of mobility in fueling TB epidemics and testing two tailored approaches to improve TB control in highly mobile populations - an underserved group that is increasingly recognized as playing a major role in global TB transmission.

Eligibility Criteria:
TB index cases:

Inclusion criteria:

* Age 0-99 years (Including those recently deceased)
* Diagnosed with pulmonary TB at a study hospital or clinic (microbiological and/or chest x-ray diagnosis)

Exclusion criteria:

* Unwilling/unable to provide informed consent (including next of kin, for those recently deceased)
* Plan not to pursue TB treatment within the study district
* Unwilling/unable to comply with study procedures

Contacts:

Inclusion criteria:

* Age 0-99 years
* Currently resides with or visiting eligible TB index case

Exclusion Criteria:

* Unwilling/unable to provide informed consent
* Unwilling/unable to comply with study procedures