cyrilzakka/clinical-trials huggingface dataset:
Evaluation of an Alternative Method of Obtaining Viral RNA for the Detection of SARS-CoV-2 Virus Using PCR

The current coronavirus disease pandemic has posed a problem and a challenge for health systems globally. In the framework of a pandemic, a diagnosis is a key tool in containing and monitoring disease outbreaks.

In this pandemic, the qPCR technique has become vitally important in virus detection, due to its wide detection and quantification range, and the high levels of sensitivity and specificity it presents. The methodology for diagnosing coronavirus by qPCR requires the prior extraction of viral genetic material, which is carried out using commercial kits created for this purpose. Currently, the high demand for supplies to carry out this technique has generated reagent shortage problems, including commercial kits for the extraction of viral genetic material.

This research aims to evaluate a solution called AAA-Safe and its method, developed to optimize the diagnostic process, eliminating and replacing the viral RNA extraction stage. We hope that this alternative can be implemented in any molecular diagnostic laboratory, in order to speed up the delivery of a fast and safe diagnosis.

This analytical and non-interventional study will evaluate the performance of a new workflow for the detection of SARS-CoV-2 viral RNA from samples of nasopharyngeal, oropharyngeal, buccal, nasal and saliva mucosa using as transport medium the propietary AAA-Safe solution, in 150 volunteers in two different locations. The first sampling location will be held in a private clinic, where healthcare professionals will be enrolled. The second sampling location will be held at an essential services company, where samples will be taken by employees who voluntarily want to participate in the study.

All volunteers will be informed of all aspects of this protocol and must sign an informed consent before there participation. All the information associated with the samples requested will be duly anonymized in order to protect the identity of the volunteers.

The extracted samples will be processed and analyzed to obtain the detection limit of the diagnostic flow by implementing the developed solution and to establish the clinical performance in terms of sensitivity and specificity of the technique.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Volunteer able to understand and sign the informed consent
* Healthcare professionals
* Essential services company workers

Exclusion Criteria:

* Older than 75 years
Influence of Preoperative Support on Anxiety, Pain and Satisfaction With Postoperative Analgesia

The aim of this study was to analyze a relationship between information support provided by an interdisciplinary team and the levels of anxiety, pain and satisfaction with postoperative analgesia in children and adolescents subjected to thoracic surgeries.

The study included 112 consecutive pediatric patients qualified for lateral thoracotomy or Ravitch procedure. The subjects were randomized to the control group (n=56) provided with a routine preoperative information from a nurse, and the experimental group (n=56) offered additional psychological consultation.

Eligibility Criteria:
Inclusion Criteria:

* thoracic surgery (lateral thoracotomy or Ravitch procedure),
* the American Society of Anesthesiologists score 1 or 2.

Exclusion Criteria:

* presence of a mental disorder,
* anticancer treatment,
* preoperative pain,
* problems with verbal communication ,
* lack of postoperative drainage of the chest.
Observational Study in Patients With Nail Psoriasis Treated With Enstilar® to Assess the Severity Change and the Quality of Life

Observational, prospective and multicentre study to evaluate the effectiveness of calcipotriene and betamethasone dipropionate aerosol foam (Cal / BD), prescribed according to clinical practice and following the Product Data Sheet instructions, in the topical treatment of nail psoriasis according to the change in the score of the Nail Psoriasis Severity Index (NAPSI) at 12 weeks of treatment with respect to the initial score.


Eligibility Criteria:
Inclusion Criteria:

* Patients with nail psoriasis who start, according to clinical practice, topical treatment with calcipotriene and betamethasone dipropionate aerosol foam
* Patients who authorize their participation in the study by signing written informed consent.

Exclusion Criteria:

* Patients receiving treatment with systemic drugs or their prescription is scheduled for the next 3 months. However, may be included patients who receive the same systemic treatment regimen from at least 6 months before their inclusion in the study and up to 14 weeks later.
* Patients with any situation or state that in the opinion of the investigator discourages their participation in the study.
Analysis of Oculo-motor Deficiencies Associated With FMR1 Gene Expression (Genetic Abnormality Predisposing to a Neurodegenerative Disease)

The specific aim of this study is to compare ocular movements abnormalities between males with pre-mutation on FRM1 gene (symptomatic or asymptomatic on the motor plan and/or on the cognitive plan), males without the pre-mutation and males with multi-systematized atrophy, in order to identify the neuronal structures implicated in this pathology.

Patient will be followed at the Nantes hospital during half a day for :

* examination of ocular movements
* performing Neuro-psychological test (MATTIS)
* performing tests with scales of motricity (UPDRS, CRST, ICARS).

Eligibility Criteria:
FOR PATIENTS WITH PREMUTATION ON FMR1 GENE (30 patients expected):

Inclusion criteria:

* Male
* \> or equal to 50 years old
* Ally second or third degree with a child affected of "fragile X"
* Not living far from Nantes so that visits to the Nantes hospital can be easy
* Pre-mutation on FMR1 gene
* Signed informed consent

Exclusion criteria:

* Female
* \<50 years old
* visual acuteness \< 1/10
* MATTIS dementia scale \<100 (normal:144)
* Occurrence, shown by MRI (Magnetic Resonance Imaging), of a pathology either ischemic vascular or hemorrhagic or tumoral

FOR PATIENTS WITHOUT PRE-MUTATION ON FMR1 GENE (10 patients expected):

Inclusion criteria:

* Male
* \> or equal to 50 years old
* Ally second or third degree with a child affected of "fragile X"
* Not living far from Nantes so that visits to the Nantes hospital can be easy - Signed informed consent

Exclusion criteria:

* Female
* \<50 years old
* visual acuteness \< 1/10
* MATTIS dementia scale \<100 (normal:144)
* Pre-mutation on FMR1 gene
* Occurrence, shown by MRI, of a pathology either ischemic vascular or hemorrhagic or tumoral

FOR PATIENTS WITH MULTI-SYSTEMATIZED ATROPHY (10 patients expected):

Inclusion criteria:

* Male
* \> or equal to 50 years old
* Not living far from Nantes so that visits to the Nantes hospital can be easy
* "probable" diagnosis of multi-systematized atrophy
* Signed informed consent

Exclusion Criteria:

* Female
* \<50 years old
* visual acuteness \< 1/10
* MATTIS dementia scale \<100 (normal:144)
* Occurrence, shown by MRI, of a pathology either ischemic vascular or hemorrhagic or tumoral
The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy

Evaluation of the histologically proven adenoma and carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets.


Eligibility Criteria:
Inclusion Criteria:

* Males or females, aged between 50 and 75.
* Outpatients scheduled for screening or surveillance colonoscopy for polyps or colorectal cancer )
* Able to comprehend the full nature and purpose of the study, including possible risks and side effects.
* Able to co-operate with the investigator and to comply with the requirements of the entire study.
* Signed written informed consent prior to inclusion in the study.

Exclusion Criteria:

* Patients at high risk of colorectal cancer e.g. ulcerative colitis
* Previous medical history of, or suspected hypersensitivity to, the Methylene Blue and/or formulations' ingredients.
* Previous medical history of, or suspected hypersensitivity to, the PEG based bowel cleansing preparation and/or bowel cleansing formulations' ingredients.
* Previous medical history of gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, severe diverticulitis, heart failure (Class III or IV), serious cardiovascular disease, ulcerative colitis or Crohn's disease.
Vascular Malformations and Abnormalities of Growth

To take part in this study you/your child have a vascular malformation, a type of blood vessel disorder whose cause is unknown.

The investigators will do this by looking at changes in the genes and proteins in the cells of the malformation as well as normal cells.

The investigators are doing this research because currently there is no known cause of vascular malformations and no way to know whether or not other health problems will occur in addition to the malformation. Through this research we hope to create standard methods for doctors to examine and treat people with vascular anomalies.

If you/your child agree to participate

1. Informed consent and permission to use or disclose you/your child's health information for reserve purposes will be obtained by the research team. You will receive a copy of the consent form.
2. You/your child will be examined by a physician from the research team and interviewed about your medical background and condition every year for five years.
3. You/your child will have photographs taken of the affected area at each visit.
4. You/your child will have two, one time biopsies or skin samples taken by a dermatologist. Skin areas will be numbed with lidocaine and a 4 or 5 millimeter (or approximately 0.15 to 0.19 inch) sample will be taken in two different locations. The dermatologist taking the skin sample will use every effort to choose an area that can be covered by clothing or kept out of sight to others. The doctor will either use gelfoam or one stitch/suture per biopsy to seal off the area, which helps with healing and preventing bleeding. If a stitch is placed in the biopsy site, another visit about 7-10 days following the procedure will be necessary to remove the stitch.

5. You may still participate in the study if you consent to having only one biopsy taken of your affected (lesion) skin and not one of your unaffected (normal) skin.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 1 year of age
* Diagnosis of vascular malformation
* Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation given they have the cognitive capacity to do so.

Exclusion Criteria:

* Patients less than 1 year of age
* Vascular malformations likely to result in poor wound healing or located in areas of the body prone to significant scarring
* Individuals with vascular malformations and previous diagnosis of disseminated intravascular coagulopathy
Retrospective Analysis of Response Markers and Adverse Events in Melanoma Patients Treated With Pembrolizumab

This study is a retrospective cohort study. A database will be created from the data available of all patients that have participate in the named patient program for pembrolizumab in the Netherlands. This database will be used for analysis of response markers and for an evaluation of adverse events.

This study is a retrospective cohort study. A database will be created from the data available of all patients that have participate in the named patient program for pembrolizumab in the Netherlands. This database will be used for analysis of response markers and for an evaluation of adverse events.

Eligibility Criteria:
All patients that were eligible for treatment with pembrolizumab in the Named Patient Program in the Netherlands.
Early Diagnosis of GDM by Multiomics

Gestational diabetes mellitus (GDM) is prone to cause a variety of adverse pregnancy outcomes, and has potential harm to the short-term and long-term health of both mothers and infants. However, its diagnosis mainly relies on oral glucose tolerance test (OGTT) at 24-28 weeks of gestation, so it is often diagnosed in the second and third trimester, and may be too late to intervene. Therefore, advancing the diagnostic window period of GDM is the key to the prevention and treatment of GDM and its complications. It is urgent to establish a new technology for the early diagnosis and screening of GDM with high detection rate and accuracy. Based on literature survey and previous studies, this study found that the combined analysis of metabolomics and lipidomics may have broad clinical application prospects in the early diagnosis and screening of GDM. It is hoped that a set of new techniques based on multi-omics for early diagnosis and screening of GDM can be constructed, providing a feasible and effective tool for early detection and treatment of GDM in clinical.


Eligibility Criteria:
Inclusion Criteria:

* Plan to have routine prenatal examinations and give birth in the research center
* First trimester
* Singleton pregnancy
* Without pregnancy complications
* Willing to cooperate with the hospital to follow up

Exclusion Criteria:

* Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, heart disease, liver and kidney diseases, thyroid diseases with drug, autoimmune diseases, malignant tumors, AIDS, etc.
* Fetus has a known deformity or genetic defects
* Incomplete clinical data
Assessing Sedentary Behaviour in Adults With Type 2 Diabetes - A Randomized Controlled Trial

The purpose of this health behaviour change research study is to assist adults with T2D in achieving the Canadian 24-hour sedentary behaviour movement guidelines.

Adults with type 2 diabetes (T2D) are less active and accumulate more sedentary behaviour (SB) than those without. Among adults with T2D, increased SB is associated with increased mortality after adjusting for physical activity. Canadian 24-hour SB movement guidelines recommend limiting SB to ≤8 hours, no more than 3 hours of recreational screen time, and breaking up long periods of SB as often as possible. Therefore, the purpose of this research study is for adults with T2D to achieve these SB Canadian 24-hour SB movement guidelines. To address this purpose, we will be conducting a six-week two-arm repeated measures randomized control trial. The intervention group will receive a theory-based behaviour change counselling session through zoom at week 0, mobile phone application at weeks 2 and 4 that encourage participants to create their own personal and specific action plans and coping strategies, and daily text messages that motivate participants to reduce and break up their SB. The control group will receive no intervention. The primary objective of the study is to reduce SB, while the secondary objectives are to break up SB, reduce screen time, improve quality of life, determine the perceptions towards the intervention, and validate the SB questionnaires. SB will be collected in the form of total daily SB, frequency of SB breaks, and duration of SB breaks. These variables will be measured through a SB and quality of life questionnaires that will be delivered through a downloadable mobile phone application. Outcome measures will be compared within and between groups to detect differences.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* diagnosed with type 2 diabetes
* access to a smart phone with internet connection
* be able to read, write, and speak in english

Exclusion Criteria:

* any medical or physical limitation that would prevent standing, stretching, and/or light physical activity
Puncture Breast Abscess

Several breast diseases can complicate breastfeeding : 4% of women develop a mastitis and 1% develop an abscess.

The study deals with cases of breast abscess that have been treated according to a defined protocol (Parisian Perinatal Health Network), by a multidisciplinary team (center of Medical Imaging Duroc) trained in breastfeeding and ultrasound-guided punctures.

The aim of the study is to define the risk factors for the onset of a breast abscess, to evaluate the indications and methods of management of abscess by ultrasound puncture, and to provide arguments motivating the continuation of breastfeeding.


Eligibility Criteria:
Inclusion Criteria:

* Nursing mothers
* Patients referred for breast abscesses during lactation
* Having an abscess confirmed ultrasoundly and indicating a puncture
* Women punctured of an abscess of the breast abscess in the center of Medical Imaging Duroc
* Not opposing the use of them given and to answer the questionnaire on the immediate and medium-term future by telephone
* Women aged \> 18 years old
* Women understanding French
* Affiliated to Social Security

Exclusion Criteria:

No
Partnerships to Improve Lifestyle Interventions (PILI) 'Ohana Dissemination Project Partners in Care

The 3-month face-to-face Partners in Care intervention will be community-based and community-led by trained community peer educators from these four partnering community organizations. The intervention involves 12 weekly, group lessons with each lesson lasting about 1 and 1/2 hours. Individuals with a hemoglobin A1c (HbA1c; average blood sugar levels) greater than or equal to 7% will be recruited for the study because they represent the most at-risk for diabetes-related complications. Over a 3-year accrual period, the community partners will recruit and enroll 150 eligible NHs and PPs, as well as deliver and evaluate the intervention in their respective community settings. The primary outcomes of our study are hemoglobin A1c and self-reported diabetes specific quality of life. Secondary outcomes are cholesterol levels (including HDL, LDL, total cholesterol, and triglycerides), blood pressure, body mass index, and psychosocial adaptation.


Eligibility Criteria:
Inclusion Criteria:

1. Adults age \>18 years of age,
2. English-speaking,
3. Physician-diagnosed type 2 diabetes, and
4. Baseline hemoglobin A1c \>7%.

Exclusion Criteria:

1. Survival less than 6 months,
2. Planning to move out of the community during the intervention study period,
3. Pregnancy,
4. Any co-morbid condition (physical and mental disabilities) that would prevent the individual from participating in the intervention protocol (i.e., major psychiatric illness).
Assessment of Post-operative Sore Throat After Scheduled General Anesthesia

Precise description of the technique for intubation or laryngeal mask placement during general anesthesia Research on factors that can influence sore throat due to the placement of an endobuccal or endotracheal device during general anesthesia


Eligibility Criteria:
Inclusion Criteria:

- General Anesthesia required Endotracheal or endobuccal device

Exclusion Criteria:

* Tracheotomy per or post surgery
* Patient with pre-operative pharyngeal irritation.
* Patient with a prior respiratory tract infection.
* Surgery of the laryngeal or tracheal vein, old or new
* Surgery scheduled less than 24 hours ago.
Umbilical Cord-derived Mesenchymal Stem Cell Infusion in the Management of Adult Liver Cirrhosis

This is a phase I, open label, single arm trial using UC-MSCs to treat patients with liver cirrhosis that includes 20 patients. The primary outcome measure will be change in MELD score at 3, 6, and 12 months after UC-MSC transplantation from baseline. The safety is assessed by frequency and severity of the adverse event or serious adverse event associated with stem cell injection. This study could reconfirm the efficacy of stem cell transplantation for liver cirrhosis and would open a novel cell therapy for the treatment of adult liver cirrhosis.

Liver cirrhosis is defined as the histological development of regenerative nodules surrounded by fibrous bands and causes by many forms of liver diseases and conditions such as hepatitis and chronic alcoholism. Liver cirrhosis has become one of the major causes of morbidity and mortality with over one million people died due to cirrhosis in 2010 worldwide. Currently, the only curative treatment for end-stage liver disease is liver transplantation. However, the shortage in donor organ availability and the side-effect associated with long-term immunosuppression after transplant requires the development of new alternative therapies for liver cirrhosis. Recent clinical trials demonstrate that bone marrow-derived stem cells (BMDSCs) as well as umbilical cord-derive mesenchymal stem cells (UC-MSCs) improve liver function in patients with liver cirrhosis. In Vietnam, however, there are no clinical trials to date that investigate the potential of UC-MSCs for liver cirrhosis management. This is a phase I, open label, single arm trial using UC-MSCs to treat patients with liver cirrhosis that includes 20 patients. The primary outcome measure will be change in MELD score at 3, 6, and 12 months after UC-MSC transplantation from baseline. The safety is assessed by frequency and severity of the adverse event or serious adverse event associated with stem cell injection. This study could reconfirm the efficacy of stem cell transplantation for liver cirrhosis and would open a novel cell therapy for the treatment of adult liver cirrhosis

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 70 years old.
* Patients diagnosed of liver cirrhosis: splenomegaly, elevated hepatic enzymes and/or esophageal varices detected by endoscopy, or liver biopsy demonstrated liver cirrhosis
* Be willing to complete the study and sign the consent form.

Exclusion Criteria:

* Younger than 18 or older than 70 years old
* Recent infection
* Patients with history of chronic diseases such as cancer, chronic hepatitis, chronic kidney disease.
* Any clinically significant blood coagulation disorder(s)
Preservation of Blood in Extremely Preterm Infants

Current clinical protocols for blood sampling and analyses in extremely preterm infants rely on an infrastructure adapted to and developed for adult medicine. Excessive blood sampling volumes and the resulting loss of fetal blood components are related to neonatal morbidity. This randomised trial aims to provide evidence that preservation of blood using micro-methods results in decreased morbidity and increased quality of life in extremely preterm infants.

Extremely preterm (EPT) infants are subjected to a sample-related withdrawal of whole blood of 50 % of total blood volume during the first 2 postnatal weeks and a transfused volume of 100 % of total blood volume with donor blood during the corresponding time period. The resulting decrease in the proportion of fetal hemoglobin is strongly associated with morbidity outcome, especially broncho-pulmonary dysplasia (BPD), in the EPT infant.

This randomized trial evaluates if a reduction in sample-related blood volume loss by 50% during the first two postnatal weeks leads to a reduced rate of BPD in EPT infants. Half of the included infants will be subjected to clinical blood sampling using micromethods during the first two postnatal weeks whereas blood sampling in the other half of infants will be performed using standard clinical methods.

Eligibility Criteria:
Inclusion Criteria:

* gestational age \< 27 weeks at birth

Exclusion Criteria:

* major malformation