cyrilzakka/clinical-trials huggingface dataset:
Physicians International CT Utilization Registry 2

To determine the total plaque burden, plaque severity and composition of patients undergoing Cardiac CT who do not have any previous history of CVD. There are two cohorts:

1. A retrospective follow-up for MACE endpoints of patients who underwent a CCTA \>1 year ago as part of the Big PICTURE Trial, who meet the inclusion criteria of Big PICTURE 2.
2. A prospective observational registry of patients referred to undergo CCTA with a 1 and 2 year follow-up.

In the original BIG PICTURE trial, the analysis of over 6000 subject's CCTA images found significant differences amongst patients of Arabic and south-east Asian descent, with regard to plaque burden, severity and composition. Due to the "all-comers" nature of that trial, the factors of diabetes, previous CVD, and other coronary risk factors were likely confounders in the results. In this trial, those subject selection is screened to eliminate those factors with the goal of working with a more homogenous population to perform the plaque analysis. This study is a multicenter, prospective, post marketing, observational registry study designed to describe frequency and patterns of various risk factors, indications and findings in patients who undergo CCTA.

BIG PICTURE 2 (abbreviated as "BP2") will collect data on patients from a wide variety of imaging sites (inpatient, outpatient, in-clinic CT machine). While the majority of the sites are within the US, the data collection will not be limited to US-only sites. A sub study of BP2 will perform a remote short follow-up questionnaire of subjects who were in the original Big PICTURE study.

Eligibility Criteria:
Subject Inclusion Criteria

* 18 years or older
* No prior CVD
* No hypertension
* No Diabetes
* Body mass index (BMI) \<35 kg/m2.

Subject Exclusion Criteria

* \<18 years or older
* Prior CVD
* Hypertension
* Body mass index (BMI) \>=30 kg/m2.
* Diabetes Mellitus Type 1 or 2
* Current or previous history of smoking
* Pregnancy
* Planned intervention or bypass surgery
* Known complex congenital heart disease
* Planned invasive angiography for reasons other than CAD
* Non-cardiac illness with life expectancy \< 2 years
* Inability to provide written informed consent
* Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
* Pregnant women
* Allergy to iodinated contrast agent
* Serum creatinine \>1.5 mg/dl or GFR \<30 ml/min
* Baseline irregular heart rhythm
* Heart rate ≥100 beats per minute
* Systolic blood pressure ≤90 mm Hg
* Contraindications to β blockers or nitroglycerin Strategies for Recruitment and Retention
Weight Reduction Surgery and Ovarian Function

This study will investigate the role of weight reduction surgery on the reproductive performance of obese women with ovulation problems. It is hypothesized that surgery offered when other methods of weight reduction have failed, may help restore ovulation.

We aim to recruit 30 patients suffering from chronic anovulation, with a body mass index of 35 or more, who failed to achieve weight reduction with other methods such as orlistat, metformin, diet and exercise.

Patients will be approached by one of the investigators in the infertility clinics and the assisted conception unit of the Royal Hallamshire hospital. Consent will be obtained by one of the designated investigators. The consent form has been designed in accordance with the guidelines of the central office for research and ethics committees (COREC). A patient information leaflet will be supplied and has been designed according to the COREC guidelines.

Patients will have a baseline history, clinical examination, hormonal profile (FSH/LH, fasting Insulin/glucose ratio, androgen profile, day 21 serum progesterone, serum leptin and ghrelin levels) ultrasound examination (ovarian volume and antral follicle count), including Doppler blood flow study (ovarian stromal velocity).

Patients will be offered laparoscopic gastric bypass surgery by Mr Roger Ackroyd, in line with the current recommendation for gastric surgery according to NICE guidelines i.e. patients with a BMI over 40 or a BMI over 35 with at least one co-morbidity. Patients will be reviewed monthly for six months. At each visit the following will be recorded:

1. Weight, menstrual diary.
2. Hormonal profile (FSH/LH, fasting Insulin/glucose ratio, androgen profile, day 21 serum progesterone, serum leptin and ghrelin levels).
3. Doppler of ovarian stroma (Pulsitility index, Peak velocity), ovarian volume and antral follicle count
4. Review of symptomatology especially androgenic symptoms.

End point:

Completion of six months follow up.

Eligibility Criteria:
Inclusion Criteria:

1. Anovulation or irregular ovulation as determined by the following clinical or laboratory features:

   * Clinical:

     i. Irregular cycles (not 25-35 days) ii. Amenorrhoea (more than six months).
   * Biochemical: Day 21 or midleuteal serum progesterone of less than 30mmol/l.
2. BMI of 35 or more.
3. Age between 18 and 45.

Exclusion Criteria:

1. Contraindication for bypass surgery:

   i. Medically unfit ii. Psychologically unfit iii. Strong family history of gastric cancer
2. Insulin dependant diabetes or patients on oral hypoglycaemics. Insulin resistance and impaired glucose tolerance however, are not exclusion criteria.
3. Concomitant endocrine disorders including thyroid disease and Cushing syndrome.
4. Patients on steroid therapy.
5. Patients who have had one or both ovaries removed.
6. Biochemical evidence of ovarian failure i.e. FSH of 20 IU or more.
7. Patients who have had hysterectomy.
Fluorescence Image Guided Surgery in Cholangiocarcinoma

Cholangiocarcinoma is an epithelial cell malignancy arising from varying locations within the biliary tree and is difficult to diagnose due to the often-silent clinical nature. The best chance of long-term survival and potential cure is surgical resection with negative surgical margins, but many patients are unresectable due to locally advanced or metastatic disease at diagnosis. Because cholangiocarcinoma is difficult to diagnose at an early stage and extends diffusely, most patients have unresectable disease at clinical presentation, and prognosis is very poor (5-year survival is 0-40% even in resected cases)

There is a need for better visualization of tumor tissue, lymph nodes and resection margins during surgery for perihilar cholangiocarcinoma (PHCC). Optical molecular imaging of PHCC associated biomarkers is a promising technique to accommodate this need. The biomarkers Vascular Endothelial Growth Factor (VEGF-A), Epidermal Growth Factor Receptor (EGFR) and c-MET are all overexpressed in PHCC versus normal tissue and are proven to be valid targets for molecular imaging. Currently, tracers that target these biomarkers are available for use in clinical studies. In previous studies with other tumor types, the investigators tested the tracer bevacizumab-IRDye800CW for the biomarker VEGF-A with very promising results. Since all markers show roughly similar expression in ex vivo studies, the initial study will be performed with bevacizumab-IRDye800CW as the investigators have the most experience with this tracer. The investigators hypothesize that the tracer bevacizumab-IRDye 800CW accumulates in PHCC tissue, enabling visualization using a NIR intraoperative camera system and ex vivo NIR endoscopy. In this pilot study, the investigators will determine if it is possible to detect PHCC intraoperatively and by ex vivo NIR endoscopy using bevacizumab 800CW, and which tracer dose gives the best target-to-background ratio. The most optimal tracer dose will be selected for a future phase II trial.

See brief summary

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical suspicion of PHCC who are scheduled to undergo surgical intervention with curative intent
* WHO performance score 0-2.

Exclusion Criteria:

* Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
* Other invasive malignancy
* Pregnant or lactating women.
* History of infusion reactions to bevacizumab or other monoclonal antibody therapies.
* Inadequately controlled hypertension with or without current antihypertensive medications
* Within 6 months prior to inclusion: myocardial infarction, TIA, CVA pulmonary embolism, uncontrolled chronic hepatic failure, unstable angina pectoris.
Molecular Characterization of Penile Cancers in Developing Countries

This study explores penile squamous cell carcinoma (PSCC) in Brazil, a rare cancer associated with factors like poor hygiene and HPV infection, using next-generation sequencing to investigate its genomic profiles in 24 deceased patients with advanced PSCC.

This study focuses on penile squamous cell carcinoma (PSCC), a rare cancer that is more prevalent in underdeveloped regions such as Africa, Asia, and South America, with Brazil having one of the highest incidence rates due to socioeconomic factors. PSCC is primarily associated with risk factors like poor local hygiene, smoking history, phimosis, and human papillomavirus (HPV) infection. The research aims to understand the genomic profiles of PSCC and their correlation with clinical characteristics, particularly in circumcised vs. non-circumcised populations in Brazil. The study will employ next-generation sequencing (NGS) on tumor specimens from 23 deceased patients with advanced PSCC who received treatment in Brazilian cancer sites.

Eligibility Criteria:
Inclusion Criteria:

* Men ≥ 18 years of age;
* Diagnosis of locally advanced or metastatic squamous-cell penile carcinoma;
* Have received at least one treatment for advanced disease (surgery, radiotherapy and/or chemotherapy);
* Available representative tumor block of formalin-fixed and paraffin-embedded (FFPE) archive, from primary or metastasis;
* Patients must be already deceased at time of data collection.

Exclusion Criteria:

* Patients without medical record available (lost, empty or irretrievable clinical information).
Evaluation of Pétale® (Small Hearing Test Equipment for Children) for the Screening of Hearing Disorders in Children From 9 Months to 3 Years Old by the General Practitioner or Pediatrician

The aim of this study is to confirm the value of this new version of Pétale® ((small equipment for testing the child's hearing) in the daily practice of general practitioners or pediatricians for the screening of hearing disorders in very young children.

The research procedure is auditory stimulation using Pétale® (small equipment for testing the child's hearing) based on the "orientation reflex" ("Ewing" test): the child is seated on the companion's knees between the two enclosures and the investigator observes whether or not he is attracted to a familiar calibrated noise coming from one side or the other.

Eligibility Criteria:
Inclusion Criteria:

* Chil, girl or boy between 9 months and 3 years-old
* Child seen in consultation by a general practitioner or a pediatrician whatever the reason for consultation
* Child attached to a beneficiary of a social security scheme
* Signature of informed consent by parents.

Exclusion Criteria:

* Age greater than 3 years and less than 9 months
* Refusal of one or more parents during the consultation
* State of the child which does not allow the screening test to be carried out
Multi-Modality Imaging for Head & Neck Cancer Free Flap Design Assessment

Surgical reconstruction of anatomical structures after head and neck cancer resection has made enormous strides in the past 20 years with advancing flap techniques and the usage of perforating vessels, but accurate and consistent identification of these perforators has remained a challenge due to the varying anatomy of vasculature in the donor region. Computed tomography angiography (CTA) has been used increasingly in preoperative free flap perforator mapping for breast reconstruction but has been limited in head and neck applications. In addition, indocyanine green (ICG) assisted NIR fluorescence angiography has been developed for intra-operative flap assessment. In this study, the investigators propose to assess a previously undocumented, multi-modal imaging technique with preoperative dual energy CTA to design and intraoperative ICG assisted NIR angiography to assess free flap in head and neck reconstruction.

CTA and NIR-assisted ICG angiography will be used in the mapping of the free flaps. CTA provides surgeons with preoperative information on the vascular anatomy and facilitates surgical planning for flap harvesting. The advantages of CTA are that it is noninvasive, rapid, and easy to read by the surgeon. Moreover, it provides information to help the surgeon decide which site to explore in the operation and reduces the rate of injuring or missing an optimal perforator.

This technique can help reduce the size of the incision needed for perforator exploration, which helps reduce the patient's postoperative discomfort. The operation time can be reduced by choosing suitable perforators in the preoperative stage, which can also help reduce the cost of hospitalization. NIR-assisted angiography gives live localization of the flap's dominant perforator perfusion zones while quantifying the relative tissue perfusion for immediate skin paddle design.

Eligibility Criteria:
Inclusion Criteria:

* The study will include patients planned for free anterolateral thigh/fibula or scapula flap for Head\&Neck cancer reconstruction.
* The patients should have a complete and detailed medical record.
* Subjects must be at least 18 years of age.
* Subjects must sign and be given a copy of the written Informed Consent Form.

Exclusion Criteria:

* Patients who are not able to consent by themselves or grasp the implication of the study.
* Subjects participating in any other clinical trial during the time of this clinical investigation and that may have an impact on this evaluation.
* Pregnant or potentially pregnant woman
* Lactation.
* Iodine, shellfish, cough mixture, betadine or ICG allergy
* The exclusion criteria for the IV contrast detailed in appendix 2.
B-vitamin Levels and Adverse Pregnancy Outcomes

This prospective nested case-control study aims to examine the effects of blood vitamin B levels in first-trimester pregnant women on the pregnancy outcomes

Folate deficiency can cause severe adverse pregnancy outcomes, such as neural tube defects. Effective folate functioning requires essential metabolic interactions with other B vitamins including vitamin B2, vitamin B3, vitamin B6, and vitamin B12, which can also influence pregnancy outcomes independently. For example, animal and family studies have identified that niacin (B3) deficiency can lead to congenital malformations. However, how folate and related B-vitamin levels interact with each other while affecting various pregnancy outcomes including abortion, birth defects, pregnancy complications, etc. is unclear. Besides, folate levels in previous studies were mostly measured in plasma which are easily influenced by dietary factors, instead of red blood cell folate which can reflect the long-term status. Moreover, the difference in the risk of neural tube defects across a range of maternal red blood cell folate concentrations has been largely ignored. Using data of pregnant women recruited at Beijing Obstetrics and Gynecology Hospital from December 2020 to December 2021, this case-control study aims to examine the association of folate and related B-vitamin levels in first-trimester blood samples (plasma and red blood cell) with pregnancy outcomes, particularly the association between niacin deficiency and birth defects.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with 6-13(+6 days) gestational weeks
* Resided in Beijing in the past year
* Pregnant women who intend to have antenatal examinations and delivery at Beijing Obstetrics and Gynecology Hospital
* Pregnant women who are willing to participate in this study with informed consent

Exclusion Criteria:

* Women with Hepatitis B, syphilis, HIV/AIDS and other infectious diseases.
Clinical Study of 18F-FAPI-RGD in Interstitial Lung Disease Associated With Connective Tissue Disease

The goal of this observational study is to examine clinical utility of 18F-FAPI-RGD PET/CT imaging in evaluating connective tissue disease-associated interstitial lung disease. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT examination.

Interstitial lung disease is an overarching term for a wide range of disorders characterized by inflammation and/ or fibrosis in the lungs. Interstitial lung disease associated connective tissue diseases(CTD-ILD) is one of the most common types.The goal of this study is to explore the feasibility of using 18F-FAPI-RGD, a dual-targeting heterodimeric PET tracer that recognizes both fibroblast activation protein (FAP) and integrin αvβ3 for detecting connective tissue disease associated interstitial lung disease (CTD-ILD), and analyze the relationship between 18F- FAPI-RGD PET/CT images and related parameters of lung function, clinical laboratory indicators and HRCT scores.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* Patients who have been diagnosed with, or are clinically highly suspected of ILD
* Patients who have been diagnosed with, or are clinically highly suspected of CTD-ILD

Exclusion Criteria:

* Pregnant or breastfeeding
* Patients with tumor, other respiratory diseases, and lung surgery
* Abnormal cardiopulmonary function or mental state, unable tolerate PET/CT
Pain During Pars Plana Vitrectomy With Sub-tenon Anesthesia

Vitreoretinal surgery has evolved to less invasive procedures, and it is used to treat a wide range of diseases. So anesthesia for vitreoretinal procedures has evolved, promoting adequate analgesia while reducing risks to the patient. In the present study two types of procedures for anesthesia during vitreoretinal surgery are evaluated regarding the pain referred by the patient during the whole procedure: peribulbar anesthesia versus sub-tenon injection plus topical jelly anesthesia. Through the comparative analysis of the pain scale of the two groups it is expected that the two modalities present the same anesthetic efficacy, showing that the methods used may be equivalent.


Eligibility Criteria:
Inclusion Criteria:

* Patients that have the diagnosis of epiretinal membrane, macular hole, complication of diabetic retinopathy such as vitreous hemorrhage or traction retinal detachment or other vitreomacular diseases that require treatment by pars plana vitrectomy.

Exclusion Criteria:

* Previous pars plana vitrectomy in the studied eye.
* Previous scleral buckle surgery
* Uncontrolled arterial hypertension
* Any ocular surgery performed in the studied eye in the previous three months
* Medical or psychological condition that preclude study adherence
Myofascial Techniques and Proprioceptive Neuromuscular Facilitation in Patients With Systemic Lupus Erythematosus.

Introduction. Systemic lupus erythematosus is an autoimmune disease. The musculoskeletal system is affected in 90% of patients. The most common manifestations are myalgias, arthralgias and arthritis.

Objective. To analyse the efficacy of an intervention using myofascial techniques and proprioceptive neuromuscular facilitation in patients with systemic lupus erythematosus.

Methods. Randomised clinical study with 20 patients with systemic lupus erythematosus, randomised to an experimental and control group. The intervention will last 4 weeks, with a periodicity of 2 weekly sessions of 50 minutes each. The intervention of the experimental group will consist of a protocol using myofascial and proprioceptive neuromuscular facilitation techniques.

Expected results. Improvement of knee and ankle pain intensity, functional capacity, basic mobility skills, strength, balance, agility and fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Subjects over 18 years of age
* With a medical diagnosis of systemic lupus erythematosus
* Who sign the informed consent form.

Exclusion Criteria:

* Patients with fever or acute phlebitis.
* Patients with recent lower limb fractures
* Amputees and people with neurological or cognitive impairments that prevent them from correctly understanding the questionnaires and performing the guided techniques.
Stress-MRI Assessment After Right Coronary Artery CTO Recanalization

The hypothesis of this study is that Stress-MRI is a clinically significant method of myocardial perfusion assessment after coronary angioplasty with stenting of right coronary artery (RCA) chronic total occlusion (CTO) is performed.


Eligibility Criteria:
Inclusion Criteria:

* Stable angina, CCS FC II-IV
* "Right-dominance" coronary circulation according to coronary angiography
* Absence of other significant atherosclerotic coronary lesions (more than 65%)
* High risk of myocardium ischemia according to stress-MRI data (perfusion defect in 2 or more segments in the area of interest)
* Signed, documented informed consent prior to admission to the study

Exclusion Criteria:

* Acute coronary syndrome
* Contraindications for adenosine stress test
* Low and moderate risk of myocardium ischemia according to stress-MRI data (perfusion defect in less than 2 segments in the area of interest)
Hysteroscopic Tubal Occlusion With the Use of Iso Amyl-2-cyanoacrylate

Is to assess the effectiveness of hysteroscopic tubal application of Iso Amyl-2-cyanoacrylate in occluding uterine tubes of women, which would make it an easy approach for occluding tubes with hydrosalpinx prior to IVF and in tubal sterilization.

The study will be conducted according to the guidelines on human experimentation of the 1975 Declaration of Helsinki. For all patients after taking signed informed consent , transcervical hysteroscopic cannulation of the proximal one centimeter of both fallopian tubes, will be done using a 5 Fr, 42cm long, polyethylene ureteric catheter, where 0.5 ml of Iso Amyl-2-cyanoacrylate (AMCRYLATE®) will be injected in each side.

All the surgical procedures will be performed without anesthesia, only premedication with an NSAID (e.g. NaproxenR) is given orally one hour before the procedure.

Each patient will be under close observation for the first 24 hours postprocedure for any signs of inflammation as abdominal pain, tenderness or fever and for the vital data.

Total abdominal hysterectomy and bilateral salpingoophorectomy will be done, second day, a week, two weeks and three weeks and four weeks after injection,. Hysterectomy samples will be sent to histopathologist to assess the degree of tubal occlusion and the extent and the severity of inflammation in the tubal wall.

Eligibility Criteria:
Inclusion Criteria:

* patients planned for abdominal hysterectomy with well seen tubal ostia through hysteroscope

Exclusion Criteria:

* Any patient with Upper or lower genital tract infection as evidenced by fever, lower abdominal pain or tenderness and abnormal vaginal discharge will be excluded from the study