cyrilzakka/clinical-trials huggingface dataset:
Intervention and Effect of Sleep Pattern on Cardio-cerebrovascular Disease

Because of the growing population of older people, cardio-cerebrovascular diseases has been the most important aging-related chronic disease, studying the pathogenesis and early warning mechanisms of cardio-cerebrovascular diseases in depth, exploring optimal strategies for early diagnosis and treatments of cardio-cerebrovascular diseases has becoming the urgent public health problem in China. Aging causes cellular changes that change the sleep status in older adults, leading to an increased risk of disease and death. Meanwhile, the rising prevalence of chronic diseases among older adults also increases the impact of sleep deprivation. Insufficient sleep has being a serious challenge to the health status of the elderly. However, there is no clinically significant treatment for sleep disorders caused by chronic diseases. Medication helps to sleep but will also lead to drug dependence and increasing the risk of recurrent sleep disorders, which is unfavorable for disease control.

Studies have shown that older adults who sleep 7-8 hours at night have better physical and mental health, cognition and quality of life. Shorter sleep durations (6 hours or less) and longer sleep durations (greater than 9 hours) had strong associations with adverse health outcomes such as cardiovascular, metabolic, immune, cognitive diseases, other psychiatric disorders, and mortality.

Therefore, on the basis of the established Pudong community cohort, the project applicant led the team to adopt an open-label, blind endpoint, and cluster-randomized two-phase trial method to randomly assign cohort members into intervention group and control group. According to the sleep health intervention plan formulated by the clinical team, family doctor provides health education materials according to the actual situation of the intervention group regularly. Family doctors in the control group used conventional management methods. The final assessment was that compared to control group, whether the intervention group improved members' sleep quality, reduced members' cardiovascular disease events, and individual cardiovascular disease morbidity and all-cause mortality during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged ≥ 60 years；
* Participate in the cohort of Shanghai Pudong community;
* There is a family doctor or regular family doctor in the neighborhood committee who is willing to participate in this project；
* Sign the informed consent;
* No immigrant intention in the next 3 years;
* Not pregnant or planning to become pregnant;
* No malignant tumor, life expectancy ≥ 3 years;
* Participating in the annual community-based elderly group examination project in the next three years

Exclusion Criteria:

* Those who are unwilling to participate in clinical research;
* Patients who participate in other clinical research;
* Patients with a history of severe mental illness or deafness;
* Patients who cannot complete follow-up
GREM1, HAS2 and PTGS2 Gene Expression Following the in Vitro Maturation (IVM)

Poor ovarian reserve (POR) is an adverse prognostic factor for In-Vitro Fertilization (IVF) success. Numerous established data showed low live birth rates per IVF cycle; 6 to 10%, including the usage of In-Vitro Maturation (IVM). In Malaysia, POR incidence increases mainly from cancer survival, endometriosis, and autoimmune diseases women; therefore, IVM implementation is paramount. In the molecular level, the low competence oocytes showed a low expression of GREM1, HAS2 and PTGS2 in human cumulus cells, thus leading to poor oocyte quality(OQ). Various IVM media had been formulated to enhance the competency and quality of the oocytes to date. Therefore, our study aims to elucidate the GREM1, HAS2 and PTGS2 gene expression as oocyte developmental competency markers among POR women following IVM and tailored to the IVF outcome.

In this study, we will follow up the normal and POR women. The discarded product - cumulus cell will be used in this study for evaluation following the standard IVF cumulus-oocyte-complex denudation. We will develop the In-Vitro Model to assess the expression of GREM1, HAS2, and PTGS2 in normal and POR women first. Subsequently, these gene expressions will be reassessed again via clinical model using IVF-IVM cumulus cell comparing the both groups to elucidate the modifying of oocytes quality following IVM. The cumulus cell RNA will be extracted,and the cDNA will be synthesized and quantitated. The RT-PCR standard curves will be produced, and the concentration range of these genes will be generated and quantified. The OQ, embryo morphology scoring, fertilization rates, and live birth rates will be recorded and compared. We anticipate a higher gene expression associated with good OQ thus better fertilization and live birth rate.

Therefore, this research will understand the impact of IVM in oocytes competency, aiming to improve the fertility rate among POR women in Malaysia.

Eligibility Criteria:
Inclusion Criteria:

* women underwent IVF with normal and Poor ovarian reserve based on the Bologna criteria( anti-Müllerian hormone (AMH) below 0.5-1.1 ng/ml\]).

Exclusion Criteria:

* Male factor infertility (to reduce bias for embryo quality factor)
* Not agree to participate.
Amygdala Memory Enhancement

The objective is to understand how amygdala activation affects other medial temporal lobe structures to prioritize long-term memories. The project is relevant to disorders of memory and to disorders involving affect and memory, including traumatic brain injury and post-traumatic stress disorder.

Direct electrical stimulation (DES) of the basolateral complex of the amygdala (BLA) can improve declarative memory, reflecting the role of the BLA in modulating memory processes in medial temporal lobe (MTL) regions as a function of emotional arousal. Thus, DES can reveal mechanisms of BLA-mediated memory enhancement relevant to human mental health and disease. DES of the BLA can be used to interrogate the function of memory circuits, especially how neuronal oscillations in the MTL support declarative memory. First, BLA is hypothesized to wield the capacity to prioritize long-term retention of information initially encountered adjacent in time over days and weeks after encoding. Second, the BLA preferentially projects to anterior MTL regions and thus is hypothesized to preferentially modulate memory processes in those anatomic regions, processes thought to support memory for non-spatial items more so than memory for spatial locations. Third, although emotional arousal, amygdala activity, MTL activity, and memory performance are typically correlated, the investigators hypothesize that DES will reveal that BLA outputs to other MTL regions cause improved memory performance by directly eliciting pro-memory oscillatory states in those networks. The expected outcomes represent a significant advancement for the basic science of normal memory function and significant movement towards novel therapeutics designed to emulate endogenous mechanisms of memory enhancement.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to understand and speak English.
* Able to provide informed consent.
* Diagnosed with epilepsy.
* Scheduled to undergo long-term intra-cranial video monitoring for seizure onset localization.
* Must be implanted with intracranial depth electrodes to the left or right amygdala, hippocampus, and parahippocampal/perirhinal cortices.

Exclusion Criteria:

* Unable to understand and speak English.
* Unable to provide informed consent.
* Not diagnosed with epilepsy.
ThoHSpEkt Thoracoscopic Ectomy of Radioactively Marked Pulmonary Nodules With Free-hand SPECT

Title ThoHSpEkt

Study Design Pilot Study concerning the technical operative methods and a phase II study concerning the radiopharmaceutical (therapeutic-explorative study with an approved drug in a new indication)

Location Kantonsspital St.Gallen

Aim Proof of feasibility of thoracoscopic ectomy of radioactively marked pulmonary nodules with the help of free-hand SPECT.

Background In the Cantonal Hospital of St.Gallen an average of 30 - 40 patients will be operated with thoracoscopic ectomy for a pulmonary nodule. When localisation of the nodule is not possible a switch to minithoracotomy is performed.

Study intervention Marking of pulmonary nodules with radioactivity. Free-hand SPECT guided surgery

Risks Risks of bronchoscopic or CT-intervention Radiation risk (minimal)

Rational for patient number 10 patients for each group are enough to prove the feasibility, to manage difficulties and to record complications

Duration approximately 24 months.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* Planed thoracoscopic surgery of a pulmonary nodule
* Informed consent

Exclusion Criteria:

* mental incapacity
* contraindications for this treatment
* pregnancy
Transcutaneous Breast Cancer Diagnosis by Canine Odorology

Patient with an indication of interventional percutaneous procedure for characterization of a breast lesion, palpable or not, classified as category 4 or 5, according to the Breast Imaging (BI) Report and Data System of the American College of Radiology (RADS) classification detected at mammography and/or breast ultrasound examination.


Eligibility Criteria:
Inclusion Criteria:

1. Women 18 years and older, with one or more ipsilateral mammary lesion(s), palpable or not, detected at mammography and/or ultrasound and with at least one lesion classified as BI-RADS® category 4 or 5 with an indication of percutaneous sampling (cytology, microbiopsies, macro-biopsies) ;
2. Benefit from the national social security ;
3. Signature of the informed consent of the study ;
4. There is no contraindication for the person to simultaneously participate to another research program and there is no exclusion period planned after the study.

Exclusion Criteria:

1. Patient with bilateral breast lesions classified as BI-RADS® category 4 or 5;
2. Patient with breast implant(s);
3. Patient with a personal history of breast surgery for benign lesion(s) of the concerned breast operated less than 4 weeks before the date of inclusion in this study;
4. Patient with a personal history of cancer (in situ or invasive) less than 5 years before inclusion whatever the anatomical site including cutaneous basal cell carcinoma;
5. Patient with a personal history of punctures and/or percutaneous breast biopsies of the concerned breast less than 4 weeks before inclusion;
6. Patient with a breast skin ulceration;
7. Patient under insulin (risk of sudation that may impair compress sample);
8. Concomitant antibiotics or corticoids taken one week before inclusion in the study;
9. Patient with a current viral infection (fever);
10. Persons under guardianship or deprived of liberty;
11. Impossibility to submit to the medical monitoring expected by the study for geographical or severe psychological reasons.
Characterisation of the Immune Infiltrate and Molecular Features of Thymic Epithelial Tumors Tumors (TETs)

The IMMUNO-TET trial aims to assess the feasibility of characterising the immune environment of TETs and the constitutional and somatic molecular profiles of patients with localised thymic epithelial tumour (TET).

In this prospective study, patients undergoing thymectomy and thymomectomy as part of routine care undergo the following care pathway:

1. During the pre-surgical visit (for n = 50 patients): as part of routine care, a blood sample is collected for analysis of CBC, leukocytes, lymphocytes, CRP, ferritinemia, TSH, T3L, T4L, anti-acetycholine receptor antibodies, ...CMV, EBV, HSV, HIV serologies, ...and HLA class I and class II typing.
2. During thymectomy and thymomectomy surgery, the following samples are taken (for n = 50 patients):

   * 6 blood samples on EDTA tubes are collected at the time of surgery for analyses.
   * 3 fresh samples of the surgical specimen are taken by the pathologist: tumour T, juxta-tumour J and distant D locations for analyses by flow cytometry and RNA sequencing. Anatomopathology blocks/slides are also cut in the same way (tumour T, juxta-tumour J and distant D locations) for additional exploratory analyses.
   * The feasibility of developing patient-derived xenografts (PDX) from TETs will be tested for n = 20 tumor samples. These models will allow to test potential therapeutic agents for this pathology.
3. During the 1st month (+/- 7 days) post-surgery check-up, a blood sample is taken again (for n = 50 patients) for routine care: CBC, leukocytes, lymphocytes, CRP, ferritinemia, anti-acetycholine receptor antibodies and for peripheral immune system analysis at a distance from surgery and for constitutional molecular analysis.

Informed consent is given to participate in this prospective study.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with suspicion of localised thymic epithelial tumour.
2. Age ≥ 18 years.
3. Treatment-naïve patient for this disease.
4. Patient with an indication for thymectomy and thymomectomy in one of the partner centers.
5. Signed informed consent form of the patient.

Exclusion Criteria:

1. Neoadjuvant chemotherapy.
2. No social security affiliation.
3. Person under legal protection.
4. Other neoplasia in progress or cured within the last 3 years (except for operated carcinoma in situ).
Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy

Subject/Participant Groups:

Study Group: Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment Control Group: Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment

Hypothesis:

Subjects undergoing ILM peeling during vitrectomy will have lower central macular thickness on OCT, fewer postoperative epiretinal membranes, and thereby better final visual acuity to control subjects Randomization: Subjects will be randomized according to a coin toss during PPV, once Grade 2 or Grade 3 vitreoretinal adhesion has been determined: heads undergo ILM peeling, while tails do not.

Number of Subjects: With study power of 80%, a significance level of 0.05, a sample size of 60 patients for each group was calculated.

Eligibility Criteria:
Inclusion:

1. Subject age is 18-85 years.
2. Subject consents to study participation and is capable of 6 months of follow-up.
3. The subject has type I or II Diabetes Mellitus with active PDR in the study eye.
4. Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from 20/40 to hand motions in the study eye.
5. The subject is determined to need a PPV for the indication of TRD (Grades 2 and 3).

Exclusion:

1. Subject is known to have a significant retinal/optic nerve disease otherwise unrelated to Diabetes Mellitus, which in the opinion of the examiner is responsible for two or more lines of reduced BCSVA (macular degeneration, optic neuritis, glaucoma, amblyopia, etc.) in the study eye.
2. Subject is known to have macular ischemia, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA in the study eye.
3. Subject has a significant corneal or cataract opacity, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA (corneal scar, ectasia, etc.) in the study eye.
4. Subject has had a previous vitrectomy (anterior or PPV) in the study eye.
5. Subject has uncontrolled neovascular glaucoma (intraocular pressure \> 30 mmHg despite medical/surgical treatment) in the study eye.
6. Subject has uncontrolled hypertension (systolic \> 200 mmHg or diastolic \> 120 mmHg) despite adherence to a multiple anti-hypertensive medication regimen.
A Study of GFS101A in Combination With Toripalimab in Patients With Advanced Solid Tumors

The purpose of this study is to evaluate the safety/tolerability, pharmacokinetics, and efficacy of GFS101A in combination with Toripalimab in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily participate in this clinical trial, and are willing to sign informed consent forms.
2. Male or female aged from 18-75 years old (inclusive).
3. Diagnosed with histologically or cytologically confirmed advanced solid tumors.
4. Evaluable lesions defined by RECIST v1.1.
5. Eastern Cooperative Oncology Group performance status of 0 to 1.
6. Subjects or their legal representatives are able to communicate well with Investigators and are willing to comply with the protocol and complete the study.

Exclusion Criteria:

1. With clinically significant cardiac diseases
2. With clinically significant digestive disorders.
3. Other severe disease.
4. Pregnant or lactating women.
5. Other unfavorable situations for subjects to participate in the study judged by Investigators.
Efficacy of Ultrasound Contrast Agent to Assess Renal Masses

Patients with an incidentally discovered small renal masses (SRM) \< 4 cm in diameter are included. All patients will undergo biopsy for tissue diagnosis. Most patients will be followed by imaging. Study intervention includes low MI US to be performed following both bolus and infusion injection of Definity contrast. Presence and absence of vascularity, pattern of vascularity, and TIC values will be correlated with the final pathology to find features differentiating benign from malignant masses.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed Renal mass \< 4 cmm, who are going to undergo diagnostic CT, MRI or biopsy.
Lung Ultrasound Score As Post Operative Predictive Value of Pulmonary Complications in Living Liver Transplant Recipient

The aim of this study is to determine if lung ultrasound score has a strong predictive value for post operative pulmonary complications in living liver transplant recipient

Back ground :Traditional diagnostic tools such as auscultation or chest x-ray have inferior diagnostic accuracy compared to the gold standard (chest computed tomography), Lung ultrasound is becoming popular in intensive and perioperative care and there is a growing interest to evaluate its role in the detection of postoperative pulmonary pathologies.

METHODOLOGY Type of Study: observational prospective study

* Study Setting: After obtaining approval from the Research Ethical Committee of Ain Shams University, this study will be conducted in specialized Ain Shams University Hospitals.
* Study Population : living liver transplant recipient patients post operative in intensive care unit ( 25 patients ), all patients included in this study will be subjected to lung ultrasound score at the pre mentioned times (0,12,24) by most senior expert staff then follow up of patients in Intensive care unit,will reveal that patients will be divided into two groups according to occurance of lung complications to Pulmonary complications positive ( group that developed pulmonary complications ) and pulmonary complications negative (group that didn't develop pulmonary complications ) then sensitivity, specificity and predictive value of lung ultrasound score will be determined .

Eligibility Criteria:
Inclusion Criteria:

* living liver transplant recipient patients post operative in intensive care unit in first day
* Age ( Adults 21-60 )
* Sex ( both genders will be included )
* ASA 4 liver failure patients .

Exclusion Criteria:

* Presence of preoperative chronic lung diseases
The Efficacy of Prednisone and Combination Therapy With Methylprednisolone and Cyclophosphamide on IMN in Stage I.

Multi-center, prospective, randomized, controlled study to verify the efficacy of prednisone alone and combination therapy with methylprednisolone and cyclophosphamide in the treatment of stage I membranous nephropathy.

Idiopathic membranous nephropathy (IMN) is one of the most common cause of adult nephrotic syndrome. Prednisolone and methylprednisolone are essential drugs for IMN. However, there are no recommendations for the treatment of IMN in China. KDIGO guidelines recommend combination therapy with methylprednisolone and cyclophosphamide as first-line therapy of IMN, but there is a large side effect of cyclophosphamide.There were retrospective study showed that the use of glucocorticoid hormones (including prednisone and methylprednisolone) alone may be effective in patients with membranous nephropathy in Asia, but there is no high quality evidence of evidence-based medicine.The study is a randomized prospective controlled multi-centered trial,to compare the efficacy of prednisone alone and combination therapy with methylprednisolone and cyclophosphamide in the treatment of membranous nephropathy in stage I.

Eligibility Criteria:
Inclusion Criteria:

1. The pathological examination of renal biopsy was consistent with the early idiopathic membranous nephropathy
2. Meeting one of the following three condition：

   * Urine protein quantitation \>4g/d,or 50% higher than baseline,RASS blocker treat for 6 months without trend of decrease ②Serious or disabling complications related to nephrotic syndrome ③In the 6-12 months after diagnosis of idiopathic membranous nephropathy, serum creatinine increased by more than 30%, while eGFR eGFR≥25ml/min/1.73m2.And excludeing other causes of renal dysfunction

Exclusion Criteria:

1. Secondary membranous nephropathy
2. Serious complications
3. Considering the effect of cyclophosphamide on the of function of sex gland，all patients with childbearing age or fertility requirement cannot participate in this study
Safety Study of SPC3649 in Healthy Men

A placebo-controlled, double-blind, randomized, single dose, dose escalating trial in healthy men to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPC3649.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* BMI: 19-28 kg/m2
* No clinically significant disease/disorder
* Screening laboratory tests without clinically significant abnormalities, must agree to use condoms during intercourse for one week after study drug infusion
* Following receipt of verbal and written information about the study, the subject must provide signed informed consent before any study related activity is carried out.

Exclusion Criteria:

* Heavy exercise within the past 7 days
* Alcohol intake\> 21 units weekly
* Regular smoker
* Received experimental drug within 30 days of study entry
* Planned participation in any experimental study during the study period
* HIV-Ab, HBsAg and/or HCV Ab positive
* History of specific allergy
* Current use of any drug or narcotics.
Primary Care in AURA for COVID-19

As few data are available on the epidemiology of the COVID-19 in primary care, the project aims to implement a practice-based surveillance network based on multiprofessional health homes in the French region Auvergne-Rhône-Alpes (Aura), able to monitor the evolution of the current epidemic.


Eligibility Criteria:
Inclusion Criteria:

* Suspect or confirmed COVID-19 case consulting in primary care in the Aura region

Exclusion Criteria:

* Patient with a COVID-19 diagnosis excluded after clinical examination or investigation.
* Patient refusing to participate to the study