cyrilzakka/clinical-trials huggingface dataset:
A Study to Establish the Safety and Tolerability of Zimura™ (Anti-C5 Aptamer) in Combination With Anti-VEGF Therapy in Subjects With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)

The objectives of this study are to evaluate the safety and tolerability of Zimura™ intravitreous injection in combination with anti-vascular endothelial growth factor (VEGF) therapy in subjects with Idiopathic Polypoidal Choroidal Vasculopathy (IPCV).

Treatment experienced (Prior treatment with anti-VEGF monotherapy of ≥8 injections in the previous twelve (12) months) subjects of either gender aged 50 years or above with a diagnosis of IPCV, will receive 3 monthly (Q4W) intravitreal injections of Zimura™ (1 mg/eye) in combination with anti-VEGF therapy (Avastin® 1.25 mg/eye or Lucentis® 0.5 mg/eye or Eylea® 2 mg/eye).

Safety endpoints include visual acuity loss (proportion of subjects with \>15 letter loss at Month 3), ophthalmic adverse events (AEs), systemic adverse events (AEs), change in total retinal thickness (SD-OCT) at Month 3, regression and/or elimination of polyps at Month 3 compared to screening as measured by indocyanine green angiography (ICGA), and laboratory values.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of either gender aged ≥ 50 years
* Diagnosis of IPCV
* Treatment-experienced defined as prior treatment with anti-VEGF mono therapy of ≥ 8 injections in the previous twelve (12) months

Exclusion Criteria:

* Any intraocular surgery or thermal laser within three (3) months of trial entry
* Any prior thermal laser in the macular region, regardless of indication
* Any ocular or periocular infection in the twelve (12) weeks prior to entry
* History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant
* Previous therapeutic radiation in the region of the study eye
* A diagnosis of diabetic retinopathy (presence of microaneurysms or any vasculopathy and/or leakage from retinal vasculature in a subject with diabetes mellitus)
A Study to Compare QLS1128 With Placebo in Symptomatic Participants With Mild to Moderate COVID-19

A Phase 3 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects between ages of 18-80 years.
2. Confirmed SARS-CoV-2 infection as determined by RT-PCR or antigen test in any specimen collected within 120 hours prior to randomization.
3. Initial onset of the COVID-19-related symptoms/signs within 48 hours prior to the randomization,and any of the following conditions are met on the day of randomization.

   1. Score ≥2 for at least one symptom of body pain or muscle pain, headache,stuffy or runny nose,sore throat,cough,shortness of breath or difficulty breathing.
   2. Risk factors associated with progression to severe/critical COVID-19 with a score ≥1 for at least one symptom of fever,muscle or body pain, headache,stuffy or runny nose,sore throat,cough,shortness of breath or difficulty breathing.
   3. Score ≥1 for fever,with a score ≥1 for at least one symptom of muscle or body pain,headache,stuffy or runny nose,sore throat,cough,shortness of breath or difficulty breathing.

Exclusion Criteria:

1. Previous treatment with QLS1128 sustained-release tablets or other 3CL protease inhibitors failed.
2. has received vaccines within 28 days prior to screening or planned to receive vaccines during the study period (including but not limited to COVID-19 vaccine).
3. Those who have a history of SARS-CoV-2 infection and still have symptoms related to COVID-19 during the screening period.
4. A history of SARS-CoV-2 infection, and the time of diagnosis of the latest infection to the time of diagnosis of the current infection is not more than 28 days.
5. Has received local approved anti-SARS-CoV-2 drugs within 7 days before screening or plan to receive them during the study period.
6. Has received monoclonal antibody against SARS-CoV-2 virus within 1 year prior to screening.
7. Has received convalescent plasma therapy for COVID-19 patients or expect to receive convalescent plasma therapy for COVID-19 patients during the trial.
8. Has received any CYP3A4/2C8 strong inducer within 14 days prior to screening or plan to receive any CYP3A4/2C8 strong inducer during the study period.
9. A known history of active liver disease , including acute/chronic hepatitis B, hepatitis C, cirrhosis, or acute liver failure.
10. Allergic or have contraindications to test drugs or test drug excipients.
Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)

Polycystic ovary syndrome (PCOS) is a common endocrine disorder in reproductive age women, which causes disordered follicle growth and ovulation resulting in infertility. In addition women with PCOS have hyperandrogenemia and a dysregulated hormonal profile, resulting in altered feedback on the hypothalamic-pituitary-gonadal (HPG) axis. Obesity, insulin resistance, vitamin D (VD) deficiency and ageing worsen the symptoms. The gonadotrophins - follicle stimulating hormone (FSH) \& luteinising hormone (LH), along with the pregnancy hormone human chorionic gonadotrophin (hCG) have structural similarities. The altered levels of FSH and LH in women with PCOS cause production of hCG from the brain leading to false positive pregnancy tests. Part one of this project will involve the investigation of this over-production of hCG in urine and serum of women with PCOS to develop suitable ovulation and pregnancy test kits, in collaboration with Swiss Precision Diagnostics (SPD). In Part two of the project, we would like to see if intervention with VD supplementation and/or using myo-inositol supplement compared with metformin (insulin sensitiser), improves prediabetes, distribution of fat/water content, weight loss and menstrual cyclicity in women with PCOS. We aim to correlate these interventions with particular serum \& urine markers to develop better diagnostic tools.

Women are referred by the general practioner (GP)/primary care with a suspected diagnosis of PCOS to the Endocrine Clinic at St George's Hospital.

They have an initial routine clinical assessment involving history, BP, weight \& assessment of PCOS using the Rotterdam criteria.

The routine clinical investigations involve the following:

• one fasting blood sample to measure various hormones; fasting glucose:insulin ratio; pelvic ultrasound scan to determine ovarian morphology, follicular count and endometrial thickness

Part 1 of the research protocol will include obtaining the following:

* One urine \& serum sample to be taken at the same time as their routine clinical blood samples.
* These samples will be anonymised before despatch to SPD. Part 2 of the study will involve treating patients with Vitamin D (if they are deficient) and/or myo-inositol supplement or metformin depending on their clinical need. The outcomes measured will be as above (blood sample to measure hormones) and an assessment of body fat distribution.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women with PCOS (Rotterdam criteria) attending the endocrine clinic, aged between 18-45 years

Exclusion Criteria:

* There is a clear exclusion criteria under the Rotterdam criteria; age \<18 years or \>45 years; oral contraceptive use within 3 months prior to recruitment, diabetes mellitus \& pregnancy
Pilot Observational Study and Safety Analysis of FL Nourish Capsules in Cancer Patients in Remission

This is a single-centre, observational prospective study of cancer patients in remission administering FL Nourish capsules (FLNC), a proprietary Chinese Medicine herbal supplement, for the treatment of symptoms associated with qi deficiency and blood stasis syndrome.

Consultation data will be analysed from up to 24 cancer patients in remission receiving routine treatment at Singapore Thong Chai Medical Institution. Each participant will visit the institution in accordance with the protocol which includes up to 9 months of FL Nourish capsule (FLNC) use and up to 8 consultation visits. Participants will be evaluated based on consultation data, questionnaire data, routine blood test data and self-reporting of adverse events or severe adverse events. As this is a non-interventional observational study, all participants would have received FLNC prescriptions according to routine diagnostic and prescribing standards, and there were no additional visits required aside from routine follow up consultations.

Eligibility Criteria:
Inclusion Criteria:

* Aged 21-80;
* Cancer diagnosis ≤ 5 years;
* Received treatment with no current evidence of recurrence, with predicted life expectancy of 12 months and above;
* On regular follow-up with lab tests scheduled every 1-9 months;
* Recent (\<=3 months) blood test report(s) available on first study visit
* Diagnosed with the TCM syndrome of Qi deficiency and Blood stasis by the primary physician: experience 2 major symptoms coupled with typical tongue and pulse conditions; 2 major symptoms and 1 possible symptom coupled with tongue and pulse conditions; and 1 major symptom and at least 2 possible symptoms coupled with tongue and pulse conditions;

Exclusion Criteria:

* On active cancer treatment such as IV chemotherapy or radiotherapy or oral targeted therapy (excluding HRT and oral chemotherapy);
* Scheduled for IV chemotherapy, radiotherapy or surgery within the next 1 year from recruitment date;
* Diagnosed with active disease of the liver, kidney, brain, blood, blood vessels; with mental health conditions or are mentally incapacitated;
* Pregnant women.
Sonographic Signs of Gouty Arthritis in a Cohort of Egyptian Patients: a Cross Sectional Multicenter Study

The study is a cross sectional observational multicenter study. It is established in collaboration with the Egyptian college of rheumatology study group (ECRsg). It is conditioned that all the study participants had either mono- or oligo-arthritis with effusion of the knee or the first metatarsophalangeal (MTP) joint in patients with a known history of gout or at high risk. Patients with any known chronic arthritis, comprising rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus, scleroderma, neuropathic arthritis, seronegative spondyloarthropathy, will be excluded from the study. None of the participants had a history of intra-articular injection or aspiration in the scanned joints for 3 months prior to the inclusion in the study. The sonographers will be blinded for clinical data and the EULAR scanning protocol for the knee and 1st MTP will be considered \[2\]. Further, scanning of the double contour sign over the femur condyles anteriorly and posteriorly in sagittal planes will be assessed. All the sonographers in the study had an experience between 5 and 10 years in the field of musculoskeletal ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* mono- or oligo-arthritis with effusion of the knee or the first metatarsophalangeal
* patients with a known history of gout or at high risk

Exclusion Criteria:

* Patients with any known chronic arthritis, comprising rheumatoid arthritis, Sjoegren's syndrome, systemic lupus erythematosus, scleroderma, neuropathic arthritis, seronegative spondyloarthropathy
* History of intra-articular injection in the last 3 months.
Acute Medium Chain Triglycerides (MCT) Intake in Young and Older Participants

Compare plasma metabolites following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in young and older participants.


Eligibility Criteria:
Inclusion Criteria:

* 10 health young (20-40 y old) and 10 health older (\> 60 y old) participants
* Men and women

Exclusion Criteria:

* smoking
* diabetes (fasting glucose \>7.0 mmol/l and glycated hemoglobin \>6.9%)
* strenuous aerobic exercise more than three times a week
* untreated hypertension, dyslipidemia, and abnormal renal, liver, heart or thyroid function
* under medication known to affect triglycerides and carbohydrates metabolism (i.e. diuretics, beta-blockers, steroids, insulin sensitizing)
Analyses of Bone Marrow and Blood Samples From Healthy Volunteers: Focus on the redOx Metabolism

Oxidative stress is defined by an excess of reactive oxygen species (reactive oxygen species or ROS) in cells. ROS are essential to cell life (proliferation, differentiation), including kinase activity via inhibition of phosphatases. Very low levels of ROS are observed in quiescent cells, including hematopoietic stem cells. Conversely, an excess of ROS can induce DNA damage that may lead to the destruction of the cell.

The level of ROS in cells is the result of production (mainly the NADPHoxydase and the mitochondrial respiratory chain) and their disposal via antioxidant enzymes. The hematology team of the university hospital of Tours (France) found that certain antioxidant enzymes are essential for the self-renewal of normal and leukemic cells such as glutathione peroxidase-3 (Herault O et al, J Exp Med 2012, 209:895). Their expression is modified in hematological diseases (patent WO2012085188A1 / 2012-06-28 and FR1000267310 / 2014-11-27).

Age potentially affects the level of expression of antioxidant genes, since it was established a decrease in glutathione peroxidase activity in women over 65 years (Sara E, J Gerontol A Biol Sci Med Sci 2008 63: 505). The study HEALTHOX will determine the impact of age on the oxidative metabolism of normal hematopoietic cells, and in particular the expression of antioxidant genes. It will provide a reference for analyzing disturbances of oxidative metabolism in blood diseases. The main objective is the comparison of peripheral blood and bone marrow cells depending from 3 groups of healthy volunteers: 18-39 years, 40-59 years and 60-85 years. The level of ROS and the expression of genes encoding the major antioxidant enzymes involved in the regulation of oxidative stress will be studied. The secondary objectives are to create a cell bank (blood and marrow), a blood plasma bank and a cDNA library (blood and marrow) from healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age ≥ 18 years old and ≤ 85 ans
* Informed and written consent
* Affiliation to Social Security

Exclusion Criteria:

* Subject with an history of hematologic disease
* Subject with an history of tumoral disease with chemotherapy or radiotherapy
* Subject with an history of infectious or inflammatory disease
* Subject taking a treatment in prevention of blood clots
* Subject under guardianship or protection measure
* Subject with in the last 30 days food supplement rich in antioxidant : ascorbic acid, trace elements, etc...
* Subject with in the last 30 days treatment with known effect on oxydative metabolism : N-Acetyl-Cysteine, etc...
* Participant to a drug study
* Pregnant woman
Effect of Nordic Walking on Gait-asymmetry Patterns in Children With Hemiparesis

Nordic walking is a physical activity consisting of walking with poles similar to ski poles. The poles are designed for the purpose of activating the upper body during walking. The poles are equipped with rubber or spike tips and the walking itself resembles.

Compared to normal walking in Nordic walking there is a stronger involvement of the upper body. Furthermore, by using the poles, the muscles in the upper body can be activated, and the length of each step taken is supposedly increased, resulting in a faster gait .

Eligibility Criteria:
Inclusion Criteria:

* Their age will range from 6-10 years, from both sexes.
* Level I, II and III of gross motor functional classification system (GMFCS) (Jooyeon et al., 2011)
* Grade 1 and 1+ spasticity according to the Modified Ashworth Scale (MAS). (Cloptonetal et al., 2005).

Exclusion Criteria:

* Uncontrolled epilepsy.
* Mental retardation or autistic features.
* Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination),
* Structural or fixed soft tissue deformities of the lower and/or upper extremities.
* Neurological or orthopedic surgery in the past 12 months in the lower and/or upper extremities.
* Botox injection in the lower and/or upper extremities in the past 6 months.
Effect of Thoracic Epidural Analgesia on Intravenous Closed-Loop Anesthesia

The association of general anesthesia and of thoracic epidural anesthesia is used in thoracic surgery with a demonstrated benefit on the risk of postoperative respiratory complications.

The objective of the study is to analyze the influence of thoracic epidural administration of chirocaine (5 mg/ml) on the administration of anesthetic agents (propofol and remifentanil), these drugs being administrated using a closed-loop system with the Bispectral Index as the controller.

Two groups of patients are compared:

* one group will receive general anesthesia and thoracic epidural administration of saline. Chirocaine will be administered before patient's awakening,
* one group will receive general anesthesia and thoracic epidural administration of chirocaine (5 mg/ml).

In both groups, the closed-loop system ensures that le depth of anesthesia is similar in both groups.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing a thoracotomy under general anesthesia and epidural anesthesia

Exclusion Criteria:

* age lower than 18 years,
* pregnant woman,
* psychotropic treatment,
* central neurological disorder or lesion cerebral,
* allergy to propofol or to a muscle relaxant,
* refusal or contra-indication of epidural anesthesia,
* severe emphysema,
* coronary disease,
* treatment with a beta-blocker or a vasoactive drug.
Propofol Versus Midazolam for Lower Gastrointestinal Endoscopy

propofol versus use of midazolam as sedative agent in patients with liver cirrhosis presented for lower gastrointestinal endoscopy

Effect of use of propofol versus use of midazolam as sedative agent in patients with liver cirrhosis presented for lower gastrointestinal endoscopy, Randomised controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis
* presented to colonoscopy

Exclusion Criteria:

* Encephalopathy
* Hypersensitivity
* Coagulopathy
Study on Prediction of Left Ventricular Remodeling Using ST2

Patients who underwent percutaneous coronary intervention after diagnosis of acute coronary syndrome should be enrolled in the study and follow - up.

Obtain written consent for patients who meet all of the selection criteria and who do not meet the exclusion criteria.

ACS(Acute Coronary Syndrome) patients with LV systolic dysfunction(LVEF\<50%) on TTE test who underwent successful PCI. At that time, patient proceed with the Baseline blood test(ST2) in hospital.

And then, Medical therapy for 3 months later patient proceed with the Follow-up blood test(ST2) and TTE in OPD.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 19 or older
* Patients with acute coronary syndrome who underwent successful percutaneous coronary intervention
* Patients with left ventricular ejection fraction less than 50% on transthoracic echocardiography
* Patients who voluntarily agreed to participate in the study

Exclusion Criteria:

* Failure to obtain TIMI 3 flow after procedure
* If the remaining life span is less than one year
* Women who are breastfeeding or plan to become pregnant or are planning to become pregnant during the study period
Attachment Bonding and Neonatal Hospitalization: the Impact of Hospitalization in a Kangaroo Unit

The Kangaroo Unit (UK) takes care of newborns requiring special care or monitoring for a pathology whose clinical situation is stable and whose prognosis is favorable. In order to avoid separating mother and child, these units were created with a care pathway somewhere between that requiring hospitalization in a neonatal unit and that of pathology-free newborns in post-natal care. Theoretically, the mother-child bond created in the UK is as good as that created in conventional post-natal care. However, studies show that there are limits to the quality of the bond in the UK. This study aims to assess whether the mother-child bond is degraded in the UK, in comparison with that of mothers in post-natal care.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age, hospitalized in a Kangaroo Unit or in a post-natal unit,
* Affiliated to a social security scheme,
* fluent in French
* no objection of participation

Exclusion Criteria:

* Patient who :

  * given birth to a child who was stillborn or died at birth
  * difficulty understanding written French
  * psychological incapacity (psychiatric disorder, too great a vulnerability) or physical incapacity (physical/motor disability) to answer questionnaires,
* Patient under court protection, guardianship or curatorship.
Alzheimer's Disease and Aging: Therapeutic Potential of Estrogen

This study is designed to evaluate the potential beneficial effects of estrogen on cognitive function of women with Alzheimer's Disease.


Eligibility Criteria:
* Post menopausal women with alzheimer's disease
* free of any major medical or neurological disease,
* medically safe to be treated with estrogen.
Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults

The 13-valent pneumococcal conjugate vaccine (13vPnC) is being developed for adults to prevent pneumococcal diseases such as meningitis (inflammation of the brain lining), septicemia (blood poisoning), and pneumonia (inflammation of the lungs). As trivalent influenza vaccine (TIV) is frequently given to adults, it is important to show that both vaccines can safely be given together without affecting the immune response (body's ability to protect against disease).


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy male or female adults 65 years of age or older.
* Available for the duration of the trial - approximately 2 months.
* No previous vaccination with any pneumococcal vaccine.
* No history of severe adverse reaction associated with a vaccine.
* No allergy to egg proteins (eggs or egg products) and chicken proteins.
Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas

This study evaluates the use of specialized magnetic resonance imaging (MRI) techniques including magnetic resonance (MR) perfusion and 2-hydroxyglutarate (2HG) spectroscopy in the surgical treatment of gliomas.

Cohort 1 participants will undergo an MR perfusion scan or 2-HG spectroscopy prior to surgery and intra-operatively.

Cohort 2 participants will only undergo standard of care imaging and tumor acquisition. Participant participation will end at the completion of surgery and will be transitioned to standard of care follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Suspected glioma (grade II, III, or IV)
* Preoperative MR perfusion (enhancing tumors)
* Preoperative MR 2-HG spectroscopy (nonenhancing tumors)Patient indicated for surgical resection, standard radiation, and standard chemotherapy as a standard of care
* Karnofsky performance status ≥ 60
* Life expectancy \> 12 weeks
* Cohort 1: Ability to comply with study and follow-up procedures
* Cohort 2: Ability to comply with study procedures

Exclusion Criteria:

* Prior diagnosis of intracranial glioma
* Other malignancy with expected need for systemic therapy within 3 years
* Inability to have 6000 grays of radiation to the brain
* Need for urgent palliative intervention for primary disease (e.g., impending herniation)
* Evidence of bleeding diathesis or coagulopathy
* History of intracerebral abscess within 6 months prior to Day 0
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
* Pregnant females
* Subjects unable to undergo an MRI with contrast