cyrilzakka/clinical-trials huggingface dataset:
Endometriosis Impact on Oocyte Quality

The aim of this study is to evaluate the impact of endometriosis on folliculogenesis and oocyte quality. To do so, a metabolomic approach will be conducted in order to analyze the follicular fluid. This evaluation will be completed by a transcriptomic analysis from the cumulus cells of the oocyte.

The normal and pathological oocyte cohort after controlled ovarian stimulation will be also characterized by identifying the oocyte leading to live birth.

Endometriosis pathophysiology remains under controversy. Among the various issues raised, that of his involvement in an implantation failure related to an alteration of the endometrium is advanced by some authors. For others, infertility would be linked to an alteration of the oocyte quality responsible for embryonic development impairment leading to a lack of implantation. Several research groups have also mentioned the association of the two mechanisms.

The oocyte quality evaluation is also subject to controversy. Indeed, its morphological approach remains the most commonly used in routine at the IVF laboratory. However, this tool remains limited and to date, no correlation between oocyte morphology and ART outcomes have been established. In this context, there is a real need to use functional approaches such as genomics, transcriptomics, proteomics and metabolomics. However, the clinical validation and application of these functional tools have to be evaluated from a human pathology model such as endometriosis.

Eligibility Criteria:
Inclusion Criteria:

Group 1: case

a. Womens with endometriosis i. Deep endometriosis without ovarian localisation ii. Deep endometriosis associated with ovarian localisation iii. Isolated ovarian localisation b. Male partner with normal sperm parameters Group 2 : control

1. Womens with isolated tubal factor
2. Male partner with normal sperm parameters

Exclusion Criteria:

* Other pathologies responsible for female infertility
* Altered sperm parameters
* Male or female viral risk
* Oocyte or sperm donation
Guiding Evidence Based Therapy Using Biomarker Intensified Treatment

The primary objective is to determine the efficacy of a strategy of biomarker-guided therapy compared with usual care in high risk patients with left ventricular systolic dysfunction.

Heart failure is a common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. Common symptoms of heart failure include shortness of breath, swelling, and fatigue. Standard treatment for heart failure include diuretics to control fluid, as well as drugs called "neurohormonal antagonists" (such as beta-blockers and ACE-inhibitors) that help the heart work more efficiently and prevent worsening of heart function. Typically, doctors adjust these medicines based on their clinical judgment about what doses and combination will work best for you. We are testing whether the use of a blood test called NT-proBNP (which measures a hormone released by the heart) can help doctors do a better job of adjusting these heart failure medicines over time than clinical judgment alone.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Most recent LVEF to be ≤ 40% by any method within 12 months of randomization.
* High risk heart failure as defined by the following criteria:

A Heart Failure Event in the prior 12 months, defined as any one of the following:

* HF Hospitalization
* Treatment in the Emergency Department (or equivalent) for Heart Failure
* Outpatient treatment for heart failure with intravenous diuretics

AND

* NT-proBNP greater than 2000 pg/mL or BNP greater than 400 pg/mL at any time during the 30 days prior to randomization
* Willing to provide informed consent

Exclusion Criteria:

* Acute coronary syndrome (clinical diagnosis) or cardiac revascularization procedure within 30 days
* Cardiac resynchronization therapy (CRT) within prior 3 months or current plan to implant CRT device
* Active myocarditis, Hypertrophic obstructive cardiomyopathy, pericarditis, or restrictive cardiomyopathy
* Severe stenotic valvular disease
* Anticipated heart transplantation or ventricular assist device within 12 months
* Chronic inotropic therapy
* Complex congenital heart disease
* End stage renal disease with renal replacement therapy
* Non cardiac terminal illness with expected survival less than 12 months
* Women who are pregnant or planning to become pregnant
* Inability to comply with planned study procedures
* Enrollment or planned enrollment in another clinical trial
Transesophageal Echocardiography (TEE) to Guide and Confirm Epidural Catheters in Pediatric Patients

The aim of this study is to assess whether transesophageal echocardiography (TEE) can be used to successfully guide an epidural catheter to a targeted thoracic level in pediatric patients. The catheter will be placed in the epidural space under real-time TEE imaging and assistance by a trained TEE operator (this could include an anesthesiologist or cardiologist).

The aim of this study is to assess whether transesophageal echocardiography (TEE) can be used to successfully guide an epidural catheter to a targeted thoracic level in pediatric patients. The catheter will be placed in the epidural space under real-time TEE imaging and assistance by a trained TEE operator.

The primary outcome is to determine the success rate achieved using TEE guidance to thread an epidural catheter to a targeted thoracic spinal level. Post-operative radiograph will be used to confirm catheter position.

The secondary outcomes include analysis of catheter tip position within the epidural space as anterior, lateral or inferior to the spinal cord. Further, efficacy of the catheter will be determined using the following criteria from previous studies: Hemodynamic response at skin incision analyzed by heart rate and systemic blood pressure changes using the no change in HR or BP or changes \< 20% from baseline were considered "sufficient block" to surgical stimulation, while HR or BP changes \> 20% from baseline were considered "not sufficient block" to surgical stimulation.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients scheduled to undergo cardiothoracic surgery or interventional cardiology diagnostic procedures under general anesthesia. All subjects will also be scheduled to undergo post-operative chest x-ray as a routine part of their clinical care, so no additional exposure to ionizing radiation will occur due to this study.

Exclusion Criteria:

* patients with known esophageal abnormalities, lesions or disease that would disqualify the patient for the use of TEE as standard procedure. We will further exclude any patients that are solely undergoing TEE diagnostic procedures and only include patients that are already scheduled to undergo procedures where TEE is used as part of routine surgical preparation.
Effectiveness of Peer Navigation and Contingency Management on Retention in HIV Care

Consistent treatment with anti-retroviral therapy (ART) suppresses viral load (VL), prolonging life and improving quality of life for HIV+ persons. Suppressing VL benefits communities by reducing transmission to others. Mere availability of ART and care, however, is insufficient; the benefits of ART depend upon HIV+ persons' continuous visits to the health care provider, regular monitoring and regular delivery of medications, - known as retention in HIV care. In spite of national efforts, up to a quarter of HIV+ persons, especially low-income minorities are out of care. Innovative interventions are therefore urgently needed to maximize engagement and retention in HIV care, self-reported adherence, as well as HIV-1 RNA viral load suppression. In pursuit of these aims, the proposed study will assess outcomes of the following interventions in comparison to usual care: 1) contingency management (CM) only; 2) peer navigation (PN) only; and 3) a combined approach that integrates both CM and PN (CA) which the investigators hypothesize to be most effective in improving HIV clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed HIV+
2. Age 18 years or older
3. English or Spanish speaking
4. Residence in Los Angeles County
5. prescribed ART in prior 24 months
6. \< 3 visits in prior 12 months or have detectable viral load, as identified in the Ryan White CaseWatch database

Exclusion Criteria:

Not meeting any of the criteria identified above
The Effectiveness of Saw Palmetto and Sanmiaoshan on Benign Prostatic Hyperplasia in Chinese Patients

The purpose of this study is to assess the effect of saw palmetto and sanmiaoshan, on top of alpha blocker, on urinary flow rate and BPH symptoms in patients with BPH.


Eligibility Criteria:
Inclusion Criteria:

* Age between 50 and 80 years old
* Clinically diagnosed to have BPH:

  * Suffered from lower urinary tract symptoms with IPSS\>=8
  * Detectable prostatic enlargement determined by DRE
  * Urinary flow between 5 and 15ml/second in a total void volume \>=150mL
  * Serum PSA level less than 4ng/ml or in between 4-10 ng/ml with percent free PSA \>25% or\>=4 with cancer excluded by biopsy

Exclusion Criteria:

* Acute retention of urine
* Congestive heart failure, unstable angina, arrhythmia, myocardial infraction
* Prostatic surgery
* Prostatic malignancy
* Gastrointestinal disease
* Renal impairment with serum creatinine \>140 umol/l
* Hepatic disorder
Psychological Wellbeing in Clients in Tier 3 Weight Management Service

This study aims to conduct an initial, single case investigation of changes in feelings of shame, overall psychological wellbeing, body image and disordered eating in patients in naturalistic setting, Tier 3 weight management service, following CFT based, online group intervention that runs for 12 weeks.

Tier 3 weight management services are led by multidisciplinary teams (MDTS) what usually include physicians, dieticians, nurses, physiotherapist, psychiatrists, and psychologists. In the service where the study is conducted referrals to psychology are often made by a dietician. The psychologist in the service also accepts self referrals from patients either during initial assessment with dieticians or at any point of their journey in the service. The psychology pathway is "opt-in", in other words, only patient who actively express interest, motivation and wish to make use of the additional psych resource and accepted.

The participants will be offered the intervention by the group facilitating clinician (who is a part of care team). Initially the principal supervisor was meant to facilitate group intervention, but because the principal supervisor is going on maternity leave the group will be facilitated by a qualified substitute clinician. This clinician will offer an assessment of needs to all patients referred for psychological support. The clinician will act as a gatekeeper and will offer CFT based group intervention when clinically and ethically appropriate (see the exclusion and inclusion criteria below). Taking part in the intervention and signing up for the research will not affect the care patients receive from MDT in the service.

Eligibility Criteria:
Inclusion Criteria:

* adults with BMI over 30 who have been referred to Tier 3 weight management service.
* Adults with BMI over 25 with Diabetes who have been referred to Tier 3 weight management service.

Exclusion Criteria:

* group intervention not considered clinically appropriate, following specialist assessment of needs
* not being able to commit to 12-week intervention
* severe interpersonal difficulties that would be disruptive to other group's participants
* moderate to severe learning difficulties
* current alcohol or drug abuse.
Effect of Cervical Block on Recurrent Laryngeal Nerve Monitoring During Thyroid Surgery

Non-inferiority study aimed to assess the impact of cervical block on recurrent laryngeal nerve monitoring during thyroid surgery Secondary outcomes will assess post-operative recovery, post-operative pain and post-operative dysphonia


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18, able to give consent after clear and fair information
* Affiliated to social security
* Total thyroidectomy performed in the context of Graves' disease in biological euthyroidism with the need for surgical treatment (pregnancy project, fluctuating TSH, etc.), or multiheteronodular goiter with suspect or compressive nodules, or lobo-isthmectomy
* No previous homolateral cervical surgery
* Professional activity
* Telephone line (at home or cellular)

Exclusion Criteria:

* Patients over 18 under legal protection
* Allergy to local anesthetics
* Existence of preoperative laryngeal dysphonia or paralysis
* Patient with a submerging goiter (lower edge of the thyroid not seen on the preoperative cervical ultrasound)
* Presence of uncontrolled infectious pathology
* Pregnant or breastfeeding woman or no contraception
* Lymph node dissection planned or patient at high risk of lymph node dissection (BETHESDA 5 and 6)
Prognostic Performance of a Chemogram in Patients With Bladder Cancer.

The aim of the study is to evaluate chemogram in patients with intermediate-grade superficial bladder cancer and patients with infiltrating bladder cancer, who are likely to be treated according to the standard procedure. This project is based on the premise that treatments - notably chemotherapy - are standard, but that each cancer is unique. It is therefore necessary to personalize the treatment for each patient, while at the same time proposing an approach that is economically bearable for the healthcare system. For both types of bladder tumor, chemotherapy is used either as an alternative to immunotherapy, or as an adjuvant to surgery. Its use is therefore based on its effectiveness in reducing post-treatment recurrence.

The project is based on the premise that treatments - particularly chemotherapy - are standard, but that each cancer is unique. It is therefore necessary to personalize treatment for each patient, while proposing an approach that is economically viable for our healthcare system. The chemogram is inspired by the principle of antibiograms, since it tests, for a given patient and in conjunction with oncologists, different chemotherapeutic or targeted treatment options based on clinical and anatomopathological data. These tests are carried out in vitro in academic research laboratories.

With this study, its proposed a "proof of concept" for the clinical use of chemograms in patients with superficial or infiltrating bladder cancer. The use of chemograms will have no impact whatsoever on the patient's treatment, which will be administered according to standard practice. Nevertheless, this study may help determine whether chemograms can detect tumor sensitivity to certain anti-cancer treatments.

In the years to come, the aim of this research work is to be able to guide the therapeutic management of patients whose tumours are resistant to the treatment envisaged (tumours with intrinsic resistance to treatment). This will avoid unnecessary treatments for the patient, often with very serious side effects.

For these two types of bladder tumour, the use of a chemogram to detect the tumour's chemosensitivity would make treatment more effective and rapid.

Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Patient with suspected bladder cancer likely to be treated with chemotherapy
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Insufficient tumor volume
* Patient under guardianship
* Pregnant or breast-feeding women
* Patient opposed to participation in the study
Difference Strain Ratio Ultrasound Elastography Between Benign and Malignant Peripheral Lung Lesions

Diagnostic accuracy study to investigate the sensitivity and specificity of sonographic elastography using strain ratio to differentiate between benign and malignant peripheral lesions in comparison to biopsy, clinically, or radiologically.

This is a diagnostic accuracy study with comparison to gold standard tests e.g., chest computed tomography, transthoracic biopsy, or microbiological analysis. All patients included in this study will give informed consent according to the guidelines of ethics committee, Alexandria Faculty of Medicine. (http://www.med.alexu.edu.eg/wp-content/uploads/2012/04/Checklist-FINAL- 20141.pdf-)

Eligibility Criteria:
Inclusion Criteria:

* 1) Adult patients above age of 18 years old. 2) Patients with peripheral lung lesion.

Exclusion Criteria:

1. Pure pleural lesions.
2. Clinical instability to reach the final diagnosis.
3. Inaccessibility by ultrasound.
Comparison of Free-breathing 3D Quantitative Perfusion in Patients With MINOCA and MINOCA-mimics

This clinical study examines patients presenting with acute myocardial infarction and no significant coronary artery disease on coronary angiography (MINOCA) and patients with MINOCA-mimics with advanced CMR.

The present study aims to:

* assess the microvascular function with a novel quantitative 3D myocardial perfusion imaging approach in the acute phase and post-convalescence
* refine the role and diagnostic potential of advanced quantitative CMR imaging
* assess the potential prognostic significance of microvascular dysfunction and epicardial adipose tissue on cardiovascular outcomes

Participants will undergo advanced CMR imaging in the acute setting (within 10 days after event) and post convalescence (after 3 months).

Advanced CMR includes a novel free-breathing motion-informed locally low-rank quantitative 3D myocardial perfusion imaging. Perfusion imaging will be compared with 3D late gadolinium enhancement (LGE) imaging. A cine Dixon sequence is performed for the assessment of epicardial adipose tissue (EAT).

Eligibility Criteria:
Inclusion Criteria:

* acute presentation with signs/symptoms of acute coronary syndrome or myocarditis
* elevated cardiac biomarkers
* no signficant coronary artery disease on coronary angiogram or coronary CT

Exclusion Criteria:

* pacemaker/other devices or claustrophobia
* severe asthma, chronic obstructive lung or kidney disease
* acute pulmonary embolism
* arrhythmia on ECG
* moderate to severe valvular disease
Spirometry Interpretation Performance of Primary Care Clinicians With/Without AI Software

To evaluate whether an artificial intelligence decision support software (ArtiQ.Spiro) improves the diagnostic accuracy of spirometry interpreted by primary care clinicians, as measured by Clinician Diagnostic Accuracy (vs Reference Standard).

This is a randomised controlled study to evaluate the effects of AI support software on the performance of primary care clinicians in the interpretation of spirometry. Clinicians will be provided with a clinical dataset of 50 entirely anonymous, previously recorded real-world spirometry records to interpret and will be asked to complete specific questions about diagnosis and quality assessment. The records will be randomly selected from a database comprising spirometry records from 1122 patients undergoing spirometry in primary care and community -based respiratory clinics in Hillingdon borough between 2015-2018.

Participating clinicians will be allocated at random to receive either spirometry records alone or spirometry records with the addition of an AI spirometry interpretation eport. The clinical spirometry records will be de-identified (name, date of birth, address, postcode, occupation, GP, medications data removed), by a member of the clinical care team.

Study participants (participating clinicians) will independently examine the same 50 spirometry records through an online platform. For each spirometry record, the primary care clinician participant will answer questions about technical quality, pattern interpretation, preferred diagnosis, differential diagnosis and self-rated confidence with these answers.

The study statistician will be blinded to treatment allocation up to completion of analysis and interpretation.

The reference standards for spirometry technical quality and pattern interpretation will be made by a senior experienced respiratory physiologist but without access to AI report.

The reference standard for diagnosis will be made by a panel of three respiratory specialists from the clinical care team with access to medical notes and results of relevant investigations but without access to AI report.

Eligibility Criteria:
Inclusion Criteria:

1. Clinicians working in primary care (for at least 50% of their job plan) in the UK, who refer for or perform spirometry (typically GP, practice nurse)
2. Able to access spirometry traces on study platform
3. Provide written informed consent via study platform

Exclusion Criteria:

1. Clinicians who have completed specialist training in respiratory medicine and recognised by the General Medical Council with a right to practise as a NHS consultant in respiratory medicine
Diet Quality and Cognitive Control Function in Early Childhood: A Pilot Study

This study aims to study the relationship between diet and cognitive function among 4-5-year-olds.

Children's ability for optimal cognitive function is critical for their long-term capacity to learn and achieve scholastic success. However, there is a gap in the knowledge pertaining to the selection of appropriate cognitive tasks for studying relationships between diet and cognitive control, particularly among young children. Accordingly, this study aims to study the relationship between diet and cognitive function using a standardized neuropsychological assessment and a modified cognitive task battery.

Eligibility Criteria:
Inclusion Criteria:

* Parental consent
* Child Assent
* 4 and 5 years of age
* Absence of neurological disorders
* Normal or corrected-to-normal vision

Exclusion Criteria:

* Younger than 4 and older than 5 years of age
* Presence of neurological disorders
* Uncorrected vision
DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma

The purpose of this study is to determine the feasibility of administering DFMO to patients with relapsed Ewing sarcoma and osteosarcoma who have completed all planned therapy and have no evidence of disease.

Approximately 30-35% of patients diagnosed with osteosarcoma or Ewing sarcoma will develop relapsed/refractory disease and carry a very poor prognosis. DL-alpha-difluoromethylornithine, commonly known as DFMO or eflornithine, is a synthetic analog of the amino acid ornithine. DFMO has been studied in a number of different cancers as either a therapeutic or a chemopreventative agent and is now FDA approved to reduce the risk of relapse in patients with newly diagnosed high-risk neuroblastoma. As DFMO has now been given to over 100 children with metastatic cancer, dosing and safety in this population is well established. Given the stagnant survival rates for children, adolescents, and young adults with relapsed Ewing sarcoma and osteosarcoma over the past few decades, this study will explore the feasibility of using DFMO in patients with relapsed osteosarcoma and relapsed Ewing sarcoma who are without any evidence of disease at the end of therapy in order to prevent disease recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Patients \< 40 years of age at the time of enrollment
* Diagnosis of relapsed osteosarcoma or relapsed Ewing sarcoma who have completed all planned therapy for their relapse, as described in the protocol, and have no evidence of disease
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2
* Adequate bone marrow function defined as:
* Peripheral absolute neutrophil count (ANC) greater or equal to 750/microliters
* Platelet count greater or equal to 75,000/microliters (transfusion independent)
* Adequate renal function defined by serum creatinine based on age and gender
* Adequate liver function defined as:
* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) for age AND
* SGPT (ALT) ≤ 5.0 x ULN for age. For this study the ULN is 45 U/L

Exclusion Criteria:

* Pregnant or breastfeeding females
* Patients must not have an uncontrolled infection
* Patients must not have any significant intercurrent illness