cyrilzakka/clinical-trials huggingface dataset:
Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques

The aim of this study is to develop techniques for non-invasive imaging of biology in participants with benign or malignant renal masses based on the novel scanning MRI techniques, including recently invented Hyperpolarised MRI, deuterium metabolic imaging and sodium MRI. This imaging study will: 1) acquire imaging data from human tissues following the injection of hyperpolarised 13C pyruvate and use 13C-MRI to monitor changes in the ratio of 13C-lactate to 13C-pyruvate; 2) acquire imaging data from human tissues using Sodium MRI or 3) acquire imaging data from human tissues following the oral consumable of deuterated glucose. Data acquired during this physiological study will be used to optimise future imaging protocols.In the UK and possibly in other countries, there are some patients with renal masses that are over treated or undergo unnecessary procedures such as surgery or biopsies, as they are thought to have a malignant tumour or a more aggressive tumour but after the procedure it is found that the mass was benign. The aim of this study is to determine whether one or all of these imaging techniques can differentiate between benign and malignant renal masses with the view to developing the techniques further and hopefully reducing the need for over treatment or unnecessary procedures in patients with benign masses.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Able to and provide written informed consent to participate
* If female, postmenopausal or if women of child bearing potential (WOCBP) using a suitable contraception
* If male, using a suitable contraceptive method for the duration of the study
* Radiologically suspected or pathologically confirmed benign or malignant renal masses, as determined by standard clinical practice
* Capable of undergoing a minimum of one study visit

Exclusion Criteria:

* Contraindication or inability to tolerate MRI
* Pregnant or actively breast-feeding woman
* If using an intrauterine contraceptive device (IUCD) as a method of contraception the device should be MRI safe at 3 T (researcher to confirm)
* Clinically significant cardiac, pulmonary or neurological diseases as determined by the investigators
* Laboratory abnormalities that may impact on the study results
* Any other significant medical or psychiatric history rendering the subject ineligible as deemed by the investigators
Endocrine, Metabolic and Inflammatory Characteristics of Offspring of Mothers With PCOS Hyperandrogenism

This study is a cross-sectional study to explore the endocrine metabolism and inflammatory characteristics of the offspring of mothers with PCOS hyperandrogenism, in order to provide a theoretical basis for finding the cause of PCOS.

This study randomly selected 20 women with PCOS and hyperandrogenism who gave birth to a singleton at term at Guangdong Maternal and Child Health Hospital from May 2023 to March 2024, and set them as the HA group. In addition, 22 healthy women were randomly selected as controls. group, the fasting blood glucose (FPG) level of the newborn\&#39;s peripheral blood and the androgen, fasting insulin and inflammatory factor levels of the newborn\&#39;s umbilical cord blood were collected respectively.

Among them, the detection indicators of newborn umbilical cord blood include testosterone (T), androstenedione (AND), dehydroepiandrosterone sulfate (DHEA-S), sex hormone binding globulin (SHBG), free androgen index (FAI), Fasting insulin (FINS), white blood cell count (WBC), neutrophil count (NEUT), high-sensitivity C-reactive protein (hs-CRP), and interleukin (IL)-6.

All collected data were statistically analyzed to compare the differences in levels of androgens, fasting insulin, and inflammatory factors in the umbilical cord blood of newborns in the HA group and the control group.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of polycystic ovary syndrome patients must meet the Rotterdam criteria.
* Aged between 18 and 45 years old.
* The gestational age of delivery is between 37 and 41 weeks of gestation.
* Hyperandrogenemia inclusion criteria: elevated peripheral blood androgens, including testosterone, androstenedione, and dehydroepiandrosterone sulfate.
* Singleton pregnancy.
* Signed informed consent form.

Exclusion Criteria:

* Combined with reproductive organ malformations or chromosomal abnormalities.
* Combined with chronic diseases such as diabetes and hypertension.
* Combined with thyroid disease or other serious systemic diseases such as cardiovascular disease.
* Multiple pregnancy.
* Combined with congenital adrenal hyperplasia, Cushing\&amp;#39;s syndrome, hypertension Prolactinoma, and androgen-secreting tumor-related diseases.
Capecitabine and Bevacizumab ± Vinorelbine in Metastatic Breast Cancer

The aim of the trial is to detect the superiority of the triple combination of capecitabine, bevacizumab and vinorelbine versus the combination of capecitabine and bevacizumab in patients with metastatic breast cancer. 600 patients, 300 in each treatment group, are treated until progression of disease to determine PFS.


Eligibility Criteria:
Key Inclusion Criteria:

* Written informed consent.
* Able to comply with the protocol.
* ECOG Performance status 0 - 2.
* Life expectancy more than 12 weeks.
* Known ER / PR status.
* Confirmed HER2/neu-negative, adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy.
* Previous (neo)adjuvant chemotherapy is allowed provided that the last dose of chemotherapy was applied more than 6 months prior to randomization.
* Previous adjuvant radiotherapy is allowed as part of the treatment of early breast cancer provided that no more than 30% of marrow-bearing bone was irradiated.
* No signs and symptoms of CHF.
* Adequate hepatic and renal function values.
* Adequate hematologic function values.

Key Exclusion Criteria:

* Pregnant or lactating females.
* Previous chemotherapy for metastatic or locally recurrent breast cancer.
* Previous radiotherapy for the treatment of metastatic disease (unless given for the relief of metastatic bone pain)
* Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases.
* Major surgical procedure, open biopsy or significant traumatic in-jury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study treatment.
* History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
* Uncontrolled hypertension (systolic \> 150 mmHg and/or diastolic \> 100 mmHg). Clinically significant (i.e. active) cardiovascular disease, requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication.
* Non-healing wound, active peptic ulcer or bone fracture.
* History of abdominal fistula, or any grade 4 nongastrointestinal fistula, gastrointestinal perforation or intrabdominal abscess within 6 months of randomization.
* Active infection requiring i.v. antibiotics at randomization.
* Clinically significant malabsorption syndrome or inability to take oral medication.
* Known hypersensitivity to any of the study drugs or excipients.
* Concurrent treatment with any drug interfering with study medication. Concurrent participation in another clinical trial. Prior participation is allowed when the last study medication was applied more than 4 weeks prior to randomization.
Resuscitation Table Height for Face-mask Ventilation in Infants

Positive pressure ventilation (PPV) is the most important intervention in neonatal resuscitation. During PPV, it is important to hold the face-mask with care, as applying excessive pressure could cause injury to the infant, while insufficient pressure could be a contributor of mask leak and reduced effective ventilation. Application of positive pressure to face structures may trigger a vagally mediated reflex via the trigeminal nerve that innervates the skin of the face leading to apnoea and a decrease in heart rate (TCR, trigeminal-cardiac reflex).

The force exerted by providers during neonatal ventilation to improve mask seal might result in pressure lesions and the elicitation of the trigeminal-cardiac reflex. The height of the resuscitation could influence the forces applied to the face and the quality of the procedure. Information about the applied forces in relation to the height of the resuscitation table is unknown.


Eligibility Criteria:
Inclusion Criteria:

* Level III neonatal intensive neonatal care unit consultants and pediatric residents

Exclusion Criteria:

* None
Evaluation of the Abbott i-STAT TBI Biomarker Test

According to the Centers for Disease Control and Prevention, approximately 200,000 hospitalizations occurred in 2020 related to Traumatic Brain Injury (TBI), which does not include many TBIs treated only in emergency departments, urgent care, primary care, or that are not evaluated by a clinician. Head CT is a critical component of care for severe TBI, however in mild TBI there is practice variation with a wider risk to benefit estimation for obtaining head CT imaging. Potential disadvantages of head CT include longer Emergency Department (ED) length of stay (LOS), higher costs, and diagnostic radiation exposure. The i-STAT TBI test is a panel of in vitro diagnostic immunoassays for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in whole blood and a semi-quantitative interpretation of test results derived from these measurements, using the i-STAT Alinity instrument. This biomarker test is cleared for use in adults with mild TBI (Glasgow Coma Scale 13-15) within 24 hours of injury, to aid in determining the need for head CT imaging. Currently, CT head imaging for adults with suspected mild TBI is obtained based on clinicians' usual practice patterns and beliefs about patient expectations. Prior research has demonstrated the blood TBI test may reduce unnecessary CT scans by up to 40%, however the impact on head CT ordering has not yet been studied prospectively. It is important to understand the extent to which a negative TBI biomarker result empowers a clinician to cancel a previously ordered head CT. Given that adult patients with mild TBI often present to EDs, which have access to CT scanners, this is a key setting to assess real-world impact of the i-STAT TBI test on CT head utilization.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Head injury within 24 hours of research blood collection
* CT head ordered as part of routine care, not yet completed.
* Glasgow Coma Scale (GCS) 13 - 15

Exclusion Criteria:

* Unknown whether head injury occurred, and signs of head injury are absent
* Previously enrolled in this study in the past 30 days
* Prisoner or in police custody or known pregnancy
* Suspected current ischemic or hemorrhagic stroke
* Suspected open or depressed skull fracture, or signs of skull base fracture
* History of multiple sclerosis
* Venipuncture not feasible
Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer

The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).

This study was terminated on March 8, 2010 due to an analysis by an independent Data Safety Monitoring Committee (DSMC) indicating that the addition of CP-751,871 \[figitumumab\] to erlotinib \[Tarceva\] would be unlikely to meet the primary endpoint of improving overall survival when compared to erlotinib alone.

This Oncology study continues as terminated, however for ethical reasons some patients, noted with resultant benefit, continue receiving treatment.

Eligibility Criteria:
Inclusion Criteria:

* Non small cell lung cancer with a primary histology of squamous cell, large cell or adenosquamous carcinoma. At least 1 measurable lesion, as defined by RECIST.

Exclusion Criteria:

* Primary NSCLC adenocarcinoma and its subtypes or unknown/unspecified histology.
* Prior Erlotinib therapy.
* Prior anti IGF IR based investigational therapy.
Thoracoscopy in Patients With Stage IIIA Non-Small Cell Lung Cancer

RATIONALE: Diagnostic procedures such as thoracoscopy may help to measure a patient's response to previous treatment.

PURPOSE: Diagnostic trial to determine the accuracy of thoracoscopy in patients who have stage IIIA non-small cell lung cancer.

OUTLINE: The purpose of this study is to test the usefulness and safety of restaging the patient's cancer by a procedure called a thoracoscopy. Restaging is a process by which physicians measure the response of the patient to treatment. The primary and secondary objectives are described below.

OBJECTIVES:

Primary Objective:

1. Evaluate the feasibility of using videothoracoscopy to access and identify residual viable cancer in mediastinal lymph nodes and/or evaluate for other conditions which render patients unresectable (pleural carcinomatosis or T4 primary tumors) following prior mediastinoscopy and a period of neoadjuvant therapy for Stage IIIA N2 non-small cell lung cancer.

Secondary Objectives:

1. Evaluate the safety (morbidity and mortality) of pre-resectional, thoracoscopic restaging of patients who have undergone prior mediastinoscopy and induction therapy for Stage III (N2) NSCLC.
2. Assess the accuracy (false-negative rate) of thoracoscopic mediastinal node restaging after prior mediastinoscopy and induction therapy.

Eligibility Criteria:
1. Histologic Documentation: All patients must have histologic documentation of Stage IIIA non-small cell lung cancer on the basis of involved N2 nodes from a documented mediastinoscopy performed prior to induction therapy. Previously treated relapsed patients are not eligible.
2. Prior Treatment: greater than or equal to 2 cycles of chemotherapy with or without radiotherapy (greater than or equal to 40 Gy) or radiotherapy alone (greater than or equal to 40 Gy) must be completed within 60 days of registration.
3. No distant metastatic disease or local disease progression. Patients with responding or stable local disease are eligible. Those with local disease progression defined as a 25% increase in local tumor size or the appearance of new areas of malignant disease are ineligible.
4. No previous intrapleural surgery on the ipsilateral side.
5. ECOG Performance Status: 0-2
Fast Spectral Imaging Device for Tumor Margin Mapping

The objective of the proposed research is to develop a clinical-trial-ready device and to evaluate its practical utility as a routinely used intra-operative tool. Our multidisciplinary group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. The proposed technology will be a multi-channel optical assay device for intra-operative imaging of margins in specimens excised from patients undergoing breast conserving surgery (partial mastectomy) or mastectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a partial mastectomy or mastectomy for the treatment of an invasive or non-invasive breast malignancy
* Age \> 18
* Clinically detectable disease either by physical examination or radiographic studies
* Patients of all ethnic and gender groups will be included. Protocol accrual will be reviewed annually to include a determination of minority and gender representation. If accrual demonstrates under representation of any group with comparison to disease incidence in that group, appropriate measures will be undertaken to increase participation of patients of that minority or gender group.
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients considered in "vulnerable" populations
Non-anesthesiologist Administered Propofol Sedation for Colonoscopy - a Randomized Clinical Trial

Propofol is the preferred sedation for colonoscopy. There is debate on the safety of the administration of propofol by non-anesthesiologists, despite moderate quality evidence that support its' use.

There is only one small trial of a direct comparison of propofol sedation by anesthesiologists versus non-anesthesiologists.

Our aim is to compare the incidence of sedation related adverse events, the procedural quality indicators, times (onset, recovery, discharge) and patient satisfaction between non-anesthesiologist administered propofol sedation (NAAP) sedation and anesthesiologist propofol sedation.

A randomized clinical trial with the incidence of sedation related minor adverse events as primary endpoint will be conducted. Secondary endpoints include procedure quality indicators, propofol dosage and patient satisfaction.

A sample size of 330 subjects (2 arms of 165 patients) will be needed in order to obtain 90% power and a 5% significance level to exclude a 15% difference (15 - 30%) in adverse events incidence, estimated from our pilot experience. The sample size was adjusted for a 2% cross-over rate.

Informed and consenting patients undergoing colonoscopy examinations will be randomly assigned to one of two arms. One group will be sedated by an anesthesiologist according to a protocol of propofol mono-sedation. The other group will be sedated with propofol boluses, according to the European Society of Gastrointestinal Endoscopy (ESGE) NAAP guideline, with a 3-man team consisting of one endoscopist, one endoscopy nurse and a sedation nurse, trained in NAAP and exclusively dedicated to sedation and patient monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Referred for elective colonoscopy as outpatients
* Must be able to provide the informed consent

Exclusion Criteria:

* American Society of Anaesthesiologists (ASA) class \>2
* Pregnant women
* Difficult airway predictors (more than 2 ou Mallampati \>3)
* Allergy to propofol or its' components
* IV drugs abuse
99mTc-ADAPT6 SPECT-based Non-invasive Quantification of HER2-expression in Breast Cancer With Metastatic Lymph Nodes

An open-label, single center study with 99mTc-ADAPT6 SPECT and biopsies of primary tumour and metastatic lymph nodes in breast cancer patients, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 99mTc-ADAPT6 SPECT and standard histopathology from relevant tumor and lymph node biopsies.

Overall goal of the project: To determine HER2 expression level in primary breast cancer and axillary lymph node metastases before neoadjuvant targeted (trastuzumab or trastuzumab+pertuzumab) therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is \> 18 years of age
2. Diagnosis of primary breast cancer with lymph node metastases
3. Availability of results from HER2 status previously determined on material from the primary tumor and metastatic LN, either a. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or b. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative
4. Hematological, liver and renal function test results within the following limits:

   * White blood cell count: \> 2.0 x 109/L
   * Hemoglobin: \> 80 g/L
   * Platelets: \> 50.0 x 109/L
   * ALT, ALP, AST: =\< 5.0 times Upper Limit of Normal
   * Bilirubin =\< 2.0 times Upper Limit of Normal
   * Serum creatinine: Within Normal Limits
5. A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination

7. Subject is capable to undergo the diagnostic investigations to be performed in the study 8. Informed consent

Exclusion Criteria:

1. Any system therapy (chemo-/targeted therapy)
2. Second, non-breast malignancy
3. Active current autoimmune disease or history of autoimmune disease
4. Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or C
5. Administration of other investigational medicinal product within 30 days of screening
6. Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions

The purpose of this study was to determine whether the new crosslinked hyaluronan hydrogel was safe to use, and was effective for the prevention/reduction of adhesion formation following gynecological surgery

Postsurgical adhesions are a common medical complication of gynecologic and pelvic surgeries, and are frequently associated with chronic or recurrent pelvic pain, intestinal obstruction and infertility. This randomized, controlled, multicenter, clinical study was designed to evaluate the safety and performance of the new crosslinked hyaluronan hydrogel versus the standard of care for the reduction of postoperative adhesions in subjects undergoing laparoscopic surgeries. Subjects were scheduled to return at 9 weeks after the initial surgical procedure. At that time, a second-look laparoscopy was performed for postsurgical adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS) scoring system.

Eligibility Criteria:
Inclusion Criteria:

* Female.
* Aged 18-45 years.
* Been scheduled for removal of myomas, ovary cysts, endometriotic cysts or adhesions.
* Been willing to comply with all aspects of the treatment and evaluation schedule.
* Agreed to a second-look laparoscopic procedure to assess and lyse any adhesions formed at 9 weeks following the primary surgery.
* Provided voluntary written informed consent.

Exclusion Criteria:

* Acute or severe infection.
* Autoimmune diseases such as diabetes etc.
* Abnormal liver/renal and cardiovascular function
* Abnormal blood coagulation
* Medical histories of peripheral vascular disease, alcohol or drug abuse, and mental illness.
* Known or suspected intolerance or hypersensitivity to hyaluronan or its derivatives.
* Concurrent use of systemic antiinflammatory drugs.
* Clinical evidence of cancer.
* Use of anticoagulant, fibrin glue, other thrombogenic agents, or any other anti-adhesion agent during the procedure.
* Concurrent peritoneal grafting or tubal implantation.
Nutritional Status and Prognosis in Heart Failure.

The purpose of this study is to determine whether nutritional status or body composition influences the prognosis of heart failure patients.

Despite obesity is a cardiovascular risk factor, numerous studies have identified a better prognosis in overweight and obese heart failure (HF) patients. This paradox has been named "the obesity paradox". However, this paradox has been criticized because the parameter used to classify obesity, the body mass index (BMI), has several limitations. Obesity is defined as an abnormal or excessive fat accumulation, and BMI does not always reflect real body fat.

What is more, patients with HF can have their body composition altered with hyperhydration or undernourishment. A pilot study proved that BMI does not indicate true nutritional status in HF. Thus, a further assessment of body composition of HF patients, analyzing the nutritional status rather BMI, could shed light on the obesity paradox. The aim of this study was to assess the nutritional status of a cohort of HF patients, its correspondence with BMI, and its significance in terms of survival.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of heart failure according to the European Guidelines of Heart Failure.
* Depressed LVEF (\< 45%) or ≥ 1 hospital admission due to HF decompensation
* Outpatients \> 18 years of age, male or female, capable of giving an informed consent.

Exclusion Criteria:

* Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
* Myopathy or other diseases that could cause significant sarcopenia beyond HF.
* Non-controlled hyperthyroidism