cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Novel Diagnostic Tests for COVID-19

COVID-19 (also known as Coronavirus) originated in the Wuhan China and has since spread to at least 159 countries around the world. It was declared a pandemic by the World health organisation on the 11th of March 2020. The cases in the United Kingdom continue to increase exponentially with up to 5 683 people diagnosed as on the 22nd of March 2020. It is estimated that 1 in 5 people diagnosed will require hospital admission and 1 in 20 intensive care treatment. By developing and improving diagnostic testing, we can accurately diagnose infected cases to triage appropriate treatments, identify individuals for quarantine in order to prevent transmission and obtain information regarding patient's immune systems.

At present, the diagnostic test is a highly specific method of genetic amplification called 'Reverse Transcription - Polymerase Chain Reaction' or RT-PCR, which allows detection of very small amounts of genetic mutations caused by the COVID-19 virus. However, this method must be completed in highly specialised facilities, which are few and far between, increasing time to diagnosis (currently 48-72 hours), increasing exposure to non-infected individuals, and overburdening the analysing facilities. The ideal solution is a point of care (POC) test that can give results immediately. This study aims to harness the point of care technology of the SAMBA II device (Diagnostics for the Real World Ltd.), which is a CE-marked device that has been used with success in the identification of Human Immunodeficiency Virus (HIV), by amplifying genetic material without the need to increase and decrease temperatures during the amplification process.

In the COVIDx study, 200 patients meeting the Public Health England's (PHE) inpatient definition of having suspected COVID-19 will be approached, consented and a sample from throat and nasal swab (combined) or tracheal fluid taken and tested using the SAMBA II method. A combination of the standard PHE RT-PCR and an additional validated laboratory PCR technique will be used as a control in line with standard clinical practice. Patients will undergo an additional serum tests on existing samples as made available after routine clinical assessments to monitor antibody response. Patients will be followed for clinical outcomes at 28 days post-admission.


Eligibility Criteria:
Inclusion Criteria:

* 16 years or above
* Patient requiring hospital admission AND AT LEAST ONE OF
* Clinical or Radiological evidence of pneumonia
* Acute respiratory distress syndrome
* Influenza like illness (defined as fever \>37.8oC and at least one of the following respiratory symptoms, which much be of acute onset: persistent cough (with or without sputum), hoarseness, nasal discharge or congestion, shortness of breath, sore throat, wheezing, sneezing)

Exclusion Criteria:

* Patients who have not had the standard PHE COVID-19 test applied
* Unwilling or unable to comply with research swab of nose \& throat or tracheal fluid
Natural Killer Cells and Polycythemia Vera (Vaquez's Disease)

Natural Killer cells (NK) are pivotal cells of innate immunity, that sense defective expression of HLA class I molecules and are complementary to specific cytotoxic T lymphocytes. A defect in NK cell cytotoxicity has been described in some hematopoietic malignancies such as acute myeloid leukemia, multiple myeloma, myelodysplastic syndroms. This defect is at least partially linked to a decreased or absent expression of some activating NK cell molecules, more particularly the so-called Natural Cytotoxicity Receptors (NCRs) NKp30, NKp44 and NKp46. Some old publications have demonstrated defective NK cytotoxicity in myeloproliferative syndroms (chronic myeloid leukemia, primary thrombocytosis, polycythemia vera). The investigators more particularly focused their attention on polycythemia vera (Vaquez's disease), a myeloproliferative disease characterized by the recently describet mutation V617F of the JAK2 tyrosine kinase. The investigators will precise the mechanisms leading to this cytotoxicity defect, the investigators also will evaluate the implication of V617F mutation on NK physiology, and will study the interactions between NK cells and hematopoietic progenitors.


Eligibility Criteria:
Inclusion Criteria:

* Polycythemia vera
* Treatment by therapeutic bleedings
* No cytotoxic treatment during the previous six months

Exclusion Criteria:

* No Polycythemia vera
* No treatment by therapeutic bleedings
* Cytotoxic treatment during the previous six months
Add-on Dextromethorphan in Bipolar Disorders

Dextromethorphan has been reported affording neuroprotection on dopaminergic neurons and having protective effect against inflammation-related neuron damage. These anti-inflammatory and neuroprotective effects of dextromethorphan would suggest potential clinical benefits of dextromethorphan add-on therapy to valproate for bipolar disorder patients. This hypothesis was based on the findings that the mood stabilizers have been reported to be neuroprotective through the release of neurotrophic factors such as GDNF from astroglia. Thus, the combination treatment of mood stabilizers and dextromethorphan might improve the therapeutic efficacy for bipolar disorder patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient aged ≧18 and ≦65 years.
2. A diagnosis of bipolar I or II disorder according to DSM-IV criteria made by a specialist in psychiatry.
3. A total of HDRS score at least 18 or YMRS score at least 14 at screen.
4. Signed informed consent by patient or legal representative
5. Patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.

Exclusion Criteria:

1. Women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for duration of study.
2. Females who are pregnant or nursing.
3. Patient has received dextromethorphan, or other selective cyclo- oxygenase 2 (Cox-2) inhibitors, or other anti-inflammatory medication within 1 week prior to first dose of double-blind medication.
4. Axis-I DSM-IV diagnosis other than bipolar I or II disorder.
5. Current evidence of an uncontrolled and/or clinically significant medical condition (e.g., cardiac, hepatic and renal failure), which in the judgments of the investigator, would compromise patient safety or preclude study participation.
6. History of intolerance to valproate or dextromethorphan or other Cox-2 inhibitors.
7. History of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) precipitated by dextromethorphan.
8. Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to first dose of doubleblind medication.
9. Diagnosis of or treatment for esophageal, gastric, pyloric channel, or duodenal ulceration or related complications (bleeding and/or perforation) within 30 days prior to receiving first dose of double-blind medication.
10. Inclusion in another bipolar disorder study or study for another indication with psychotropic's within the last 30 days prior to start of study.
11. Increase in total SGOT, SGPT, BUN and creatinine by more than 3X ULN (upper limit of normal).
12. History of idiopathic or drug-induced agranulocytosis.
13. Substance-related disorders within 6 months prior to study start, borderline personality disorder, schizophrenia, or other major psychiatric disorders as defined by DSM-IV criteria.
Biologic Predictors of Leiomyoma Treatment Outcomes

The purpose of this study is to search for the hereditary (genetic) causes of uterine fibroids. Some women with uterine fibroids may have one or more genes that make them more likely to develop uterine fibroids. We are trying to identify these genes to better understand how and why uterine fibroids develop and to design better treatment options for women with uterine fibroids. This information may also help us to understand and treat other problems that may be caused by these genes.

There is little information to predict outcomes of leiomyoma therapies. It is clear that both environmental exposures and genetic predisposition influence disease manifestations. Our work has identified a new area of genetic linkage for leiomyomas from a genome wide scan. We therefore propose to prospectively collect biologic samples that will allow us to analyze gene/environment interactions of women enrolled in leiomyoma clinical trials or undergoing leiomyoma clinical treatments using the same methodology used previously. Specifically we will collect serum aliquots, genomic DNA and information using a genetic epidemiology questionnaire. In the short term we will also be able to use prospectively obtained information on epidemiologic and anthropomorphic data to characterize women undergoing treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to give consent
2. Age 18 or older
3. Presence of known uterine leiomyoma

Exclusion Criteria:

1. Suspected malignancy
Comparison of Culture Media for in Vitro Embryo Development

The purpose of this study is to collect development and outcome data on human embryos which are cultured in a 2nd generation continuous single culture medium (CSCM2) with the objective to demonstrate its performance efficacy in comparison to existing commercially available single culture or continuous embryo culture media.

A multi-center (3 sites and 2 investigators), prospective trial with up to 300 patients. Patients will be enrolled from participating sites from the United States. Study sites will conduct this study under the oversight of Sterling IRB. Each study site should enroll enough patients to achieve at least 50 evaluable patients that have undergone a treatment cycle using split case sibling embryos in which half of the embryos are cultured in CSCM2 and the other half in current CSCM (as control).

The methods will consist of standard ovarian stimulation protocols at each facility to obtain a sufficient number of mature (MII) oocytes for fertilization by ICSI. Following fertilization, identified diploid (2PN) zygotes will be evenly divided and randomly allocated to the embryo culture treatment conditions of CSCM2 or CSCM and cultured according to standard laboratory procedure (incubated in 5-6% CO2 in air or low O2 concentrations of 5-6%) to the blastocyst stage (Day 5/6 or 7). Top quality blastocyst(s) will be transferred and monitored for implantation, pregnancy and ongoing birth. Embryo transfers will either occur in a fresh or frozen cycle.

The procedures in this study are designed to follow the standard medical care at each study site for women having IVF treatment (the participant will sign a separate consent at your clinic for your IVF procedures). The participants study doctor will explain in detail the procedures participants will undergo at the clinic; this form is only meant to explain the details of the research study. This study does not involve randomization of patient participation or any sham procedures.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age in good general physical and mental health.
* Women undergoing fresh in vitro fertilization treatment using their own eggs which will be fertilized by ICSI only
* Normal uterine cavity, as defined by the program.
* Normal BMI (\< 35).
* Normal endocrine workup (including PCOS patients).
* Fresh or Frozen Blastocyst transfer
* At least 4 diploid zygotes showing signs of normal (2PN) fertilisation
* Willing to have half of their 2PN embryos cultured in CSCM and the other half of their 2PN embryos cultured in CSCM 2nd generation
* Willing to comply with study protocol and procedures
* Willing to provide written informed consent

Exclusion Criteria:

* Use of donor egg / gestational carrier
* Couples for whom the male partner requires surgically extracted sperm (testicular or epididymal retrieval)
* History of complications related to tolerance to OCP's, Gonadotropins, Progesterone or estrogen.
* A medical condition that is contraindicated to pregnancy or gonadotropin therapy (eg. allergies, immune deficiency, etc.)
* History of cancer
Novosyn® Quick in Patients Undergoing Episiotomy Closure

Retrospective, monocentric clinical study on the clinical performance of Novosyn® Quick in patients undergoing episiotomy closure.

The study design is a retrospective, consecutive series of women with a spontaneous vaginal delivery who required an indicated episiotomy with Novosyn® Quick between the period January 2020 - December 2020 at Hospital General de Catalunya.

All women treated with Novosyn® Quick between January 2020 - December 2020 at the Hospital General de Catalunya will be analyzed. The investigator team will access medical records for the cohort of patients identified.

Eligibility Criteria:
Inclusion Criteria:

* Women who underwent an indicated episiotomy between January 2020 - December 2020 at the Hospital General de Catalunya (Sant Cugat del Vallès, Spain) and received Novosyn® Quick

Exclusion Criteria:

* No exclusion criteria have been set
Glycated Albumin Combined With Body Composition for Gestational Diabetes Mellitus Prediction

This study is going to investigate the predictive ability of glycated albumin combined with body composition, including body weight, BMI, fat free mass and fat mass for gestational diabetes mellitus (GDM) diagnosis.

The prevalence of GDM is increasing all over the world. It has bad influence for both pregnant women and fetus. Early treatment is useful for GDM prevention. Therefore early screening is important for healthcare doctors to detect the potential patients. Glycated albumin (GA) is an optimal index for blood glucose evaluation compared to HbA1c, however it may be influenced by body weight and composition. The investigators are going to investigate the predictive ability of glycated albumin combined with body composition, including body weight, BMI, fat free mass and fat mass for gestational diabetes mellitus (GDM) diagnosis. This study recruit pregnant women before 12 weeks of their pregnant age and test GA level and body composition via bioelectrical impedance analysis. During 24-28 weeks of pregnant age, all participants will do the glucose tolerant test for GDM diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-45
* Healthy, without heart disease, liver or kidney dysfunction, immune system or metabolic or infectious disease,

Exclusion Criteria:

* Diabetes that appeared before pregnancy
* Pregnant with medical disease, such as asthma, hypertension, cardiovascular diseases, kidney diseases or liver disease.
* Hormone use in the recent 1 year
* Assisted reproduction pregnancy
* Multiple births
* Cannot complete the blood test or body composition examination
Evaluation of Beauty Care Before Chemotherapy in Women With Breast Cancer

Evaluation of beauty care in women receiving adjuvant chemotherapy for breast cancer


Eligibility Criteria:
Inclusion Criteria:

* breast cancer with no metastasis receiving adjuvant chemotherapy

Exclusion Criteria:
Ultrasonic vs. Fluoroscopic Guided PNL in Pediatric Renal Stones

Percutaneous Nephrolithotomy (PNL) was accepted as a treatment modality for large renal stones since 1980. Although radiation exposure during PNL is within the safe limits for expert endourologist, the mutagenic hazard is still present especially in pediatric population. Therefore, employing an alternative imaging technique during PNL would be of added advantage. So, the investigators want to compare the efficacy of ultrasound guided PNL with the conventional (fluoroscopy guided) PNL in pediatric population. If ultrasound guided PNL was as effective as conventional one, this means that many children could be protected from the variable hazards of radiation exposure.

The incidence of pediatric urolithiasis varies by geographic area. Most cases of pediatric urolithiasis are associated with anatomic or metabolic abnormalities or urinary tract infection . PNL can be performed safely and effectively in children by experienced surgeons, resulting in a high stone-free rate and lower requirement for ancillary treatment. In adults, PNL is performed under fluoroscopic or ultrasound guidance. In pediatric age group, fluoroscopic guidance was preferred in most of the reported studies. However, fluoroscopy exposes the patient to radiation. The International Commission on Radiological Protection recommends that whole body exposure in adults should be limited to an effective dose of 20 mSv per year over 5 years. In young children, it is particularly important to protect the developing gonads and thyroid gland, as the long-term effects of exposing these organs to radiation are still unclear. In contrast to fluoroscopic guidance, ultrasound guidance does not expose the patient to radiation, it also can provide real-time monitoring during the puncturing procedure. The path and depth of the needle, and the anatomy in and around the kidney, are clearly visible on ultrasound examination

Eligibility Criteria:
Inclusion Criteria:

* All kidney stones in pediatric age group and indicated for PNL.

Exclusion Criteria:

* Children unfit for the procedure or non indicated for it.
* Parental refusal.
Change in the Lower Leg Muscle Stiffness Following Peroneal Artery-based Flap

In the field of reconstructive microsurgery, donor site morbidity after free flap harvest is one of the key factors to consider when choosing among different options of free flap. Peroneal artery-based free flap, such as fibula flap or peroneal flap, is one of the popular options of free flap. There are a plenty of literature using a variety of modalities to evaluate the donor site morbidity after free fibula harvest, such as gait analysis. Elastography has been used to evaluate the stiffness change of soft tissue, such as skeletal muscle, or liver. The purpose of this study is to use elastography to evaluate the stiffness of lower leg muscle after peroneal artery-based free flap harvest.

A total of twenty-three patients will be recruited at National Taiwan University Hospital Yunlin Branch. All of them will receive fibula flap or peroneal flap harvest operations. At the time points of pre-operation, 1-month post-operation, 3-month post-operation, and 6-month post-operation, the muscles of both legs of each patient will be evaluated by elastography, and the function of both legs will be evaluated by American Orthopedic Foot and Ankle Score (AOFAS). Paired t-test will be used to compare the results of each evaluations.

Eligibility Criteria:
Inclusion Criteria:

* No previous major operations over both legs
* Able to walk freely during daily life
* Going to receive peroneal artery-based free flap harvested from one leg

Exclusion Criteria:

* Previous major operations over either leg
* Unable to walk freely during daily life
Surgical vs Percutaneous LAAO

Atrial fibrillation is the most common cardiac arrythmia globally. Its prevalence ranges between 2-4% worldwide. It is associated with significant morbidity and mortality. One of the main concerns of AF is the risk of thromboembolism, which can result in debilitating or detrimental stroke. The gold standard for preventing AF stroke is long term oral anticoagulation in the form of warfarin or NOAC1,2.

Around 50% of patients who need anticoagulation are not on any form tablets and about 5% of patients who are not anticoagulated developed stroke. Some patients could not take anticoagulation because of high risk of bleeding, and this result in challenges within this cohort of patients. The left atrial appendage (LAA) is believed to be the main source of embolic in atrial fibrillation. The LAA is an anterolateral structure which is the smallest part of the left atrium. It originates anterior from the left pulmonary vein ostium. More than 90% of thromboembolic events happened in the LAA of non-rheumatic patients whereas only 57% of thrombi in rheumatic mitral valve disease3. This suggests that occluding the LAA is more beneficial in the non-valvular AF patients. Incomplete LAA closure is associated with a higher occurrence of thromboembolism. The growing evidence of LAA occlusion has been emerged. Percutaneous LAA Occlusion (LAAO) has been suggested that it may be considered for stroke prevention in patients with atrial fibrillation and contraindication for long term anticoagulation (class IIB, level B)1,2. This recommendation is based on the randomized controlled trials to show that percutaneous devices are non-inferior to oral anticoagulation in terms of preventing stroke in AF patients.

Surgical LAA clip occlusion (LAAC) has emerged as a potential method to isolate LAA to prevent thromboembolism. The recent LAAOS III trial shows that the risk of ischemic stroke or systemic embolism was lower with concomitant left atrial appendage occlusion performed during the surgery than without it, most of whom continued to receive ongoing anticoagulant therapy4. This reinforced the mechanistic value of occluding the LAA in prevention of stroke. However, the efficacy of isolated LAAC without anticoagulation is uncertain. Besides, as this surgical clip occlusion is frequently performed together with other concomitant cardiac surgery, post evaluation in the form of imaging is lacking. Our study aims to study the imaging follow-up result and clinical efficacy of surgical and percutaneous left atrial appendage closure.


Eligibility Criteria:
Inclusion Criteria:

* Atrial fibrillation diagnosis
* Underwent LAA clip (Atriclip) or left atrial appendage occlusion with CHADVASC \>=2

Exclusion Criteria:

* Subject not required anticoagulation due to low CHADVASC
* Mechanical valve replacement
* Tissue mitral valve replacement or tissue aortic valve replacement with underlying chronic rheumatic heart disease
In Vitro Model of the Cystic Fibrosis Bronchial Epithelium Via iPS Technology

In order to further enable physiopathology studies, the aim of this project is to validate an in vitro model of cystic fibrosis created using induced pluripotent stemcell (iPS) differentiated bronchial epithelium from cystic fibrosis (CF) patients homozygous for the p.Phe508del mutation of the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

The investigator's primary objective is to generate iPS lines from 3 CF patients and from 3 healthy subjects.

Secondary objectives include verification that cell lines express the CFTR gene according to their genotype, verification or relative production of the CFTR protein for each iPS line, and amplification of obtain iPS lines for aliquot creation to facilitate sharing.

Eligibility Criteria:
Inclusion Criteria for subjects with Cystic Fibrosis:

* Homozygote for the p.Phe508del mutation
* Signed informed consent given by the subject

Inclusion Criteria for subjects without Cystic Fibrosis:

* Signed informed consent given by the subject

Exclusion Criteria:

* Pregnancy, breastfeeding
* Participant in an exclusion period determined by a previous study
* Participant under any kind of guardianship
* Unaffiliated with or not a beneficiary of a social security program (health insurance)
* Subject deprived of liberty (e.g. prisoners)
* Subject with positive infectious markers for HIV1, HIV2, HBC or HBV

Exclusion Criteria for subjects with Cystic Fibrosis:

* Any pathology requiring a treatment or a pathology not requiring treatment but with clinical significance according to the investigator