cyrilzakka/clinical-trials huggingface dataset:
Rectal Surgery Evaluation Trial (RESET)

Total mesorectal excision (TME) is the standard of care for rectal cancer, which can be combined with low anterior resection (LAR) in patients with mid-to-low rectal cancer. The narrow pelvic space and difficulties in obtaining adequate exposure make surgeries technically challenging. Four techniques are used to perform the surgery: open laparotomy, laparoscopy, robot-assisted surgery, and transanal surgery. Comparative data for these techniques is required to provide clinical data on the surgical management of rectal cancers by surgery.

The Rectal Surgery Evaluation Trial will be a prospective, observational, case-matched, four-cohort, multicenter trial designed to study TME with LAR using open laparotomy, laparoscopy, robot-assisted surgery, or transanal surgery in high-surgical-risk patients with mid-to-low, non-metastatic rectal cancer. All surgeries will be performed by surgeons experienced in a technique. Oncologic, morbidity and functional outcomes will be assessed in a composite primary outcome, with success defined as circumferential resection margin ≥1 mm, TME grade III, and minimal postoperative morbidity (absence of Clavien-Dindo grade III-IV complications within 30 days after surgery). Secondary endpoints will include the co-primary endpoints over the long-term (2 years), quality of surgery, quality of life, length of hospital stay, operative time, and rate of unplanned conversions.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Rectal adenocarcinoma from middle and lower third (less than 10 cm from the anal verge) with a sphincter saving procedure
3. High risk operative patients (two of these factors as assessed on MRI):

   1. Obese patient with a BMI \> 30 (male or female)
   2. Narrow pelvis: inter-tuberous distance \< 10 cm
   3. Large tumoral volume with suspicion of close predictive margin (CRM ≤ 1 mm) at diagnosis
   4. Expected coloanal or ultra-low colorectal anastomosis
4. Patients with adequate performance status (Eastern Cooperative Oncology Group Scale score of ≤2)
5. Patient has signed and dated the informed consent before inclusion in the study.

Exclusion Criteria:

1. Patient with a comorbid illness or condition that would preclude the use of surgery.
2. Patients with T4b tumors which impose a pelvectomy
3. Patient requires an abdominal perineal resection (APR)
4. Patients with concurrent or previous invasive pelvic malignant tumors (cervical, uterine, or rectal; excluding the prostate) within 5 years before study enrollment
5. Patient undergoing emergency procedures
6. Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections)
7. Metastatic disease
8. Pregnant or suspected pregnancy
9. Patients unwilling to comply with all follow-up study requirements
10. Patient included in another study which impact on the surgical technique or its choice.
Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice

The purpose of the study is to determine if neonates (who already have an increased risk of hyperbilirubinemia due to mother's history of having previous neonate who received phototherapy for hyperbilirubinemia) have higher bilirubin levels 24 hours after birth with delayed cord clamping.


Eligibility Criteria:
Inclusion Criteria:

* mothers delivering at 35 weeks or greater
* mothers who have had at least 1 previous child that received phototherapy for hyperbilirubinemia
* multiple gestations can be included unless the neonate does not meet criteria for delayed cord clamping as described below or due to concerns about safety of delayed cord clamping for timing of delivery of the 2nd twin (ie: 2nd twin requires immediate delivery intervention)

Exclusion Criteria:

- Neonates who do not meet criteria for delayed cord clamping (any infant that any provider in the room felt needed evaluation by the neonatal transport team immediately so that the infant would be handed off for resuscitation. If the patient required delivery by cesarean section the delayed cord clamping protocol would be abandoned).
Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling

The main purpose of this study is to see whether heavy drinking will interfere with a specific pathway, called FXR signaling in the liver. The abnormality of this pathway may lead to liver injury in some patients who drink heavily.


Eligibility Criteria:
Inclusion Criteria:

* Individuals ≥ 21 to 65 years old
* Able to provide informed consent \& negative urine pregnancy test where appropriate
* Healthy controls must have not consumed any alcohol within 3 months prior to the screening visit
* Heavy alcohol drinking is defined as \> 40 grams per day on average in women and \> 60 grams per day on average in men for a minimum of 6 months
* Women of child bearing potential should be willing to practice contraception throughout the treatment period

Exclusion Criteria:

* Active infection as evidenced by positive urine culture, blood culture, or pneumonia
* Serum creatinine \> 1.5 mg/dL
* Known co-existing infection with hepatitis C, hepatitis B, or HIV
* Significant systemic or major illness including COPD, CHF and renal failure that in the opinion of the Investigator would preclude the patient from participating in and completing the study.
* Participation in another investigational drug, biologic, or medical device trial within 30 days prior to Screening
* Previous history of jaundice or signs of liver diseases such as spider angiomata, ascites, or history of esophageal varices or hepatic encephalopathy
* Total bilirubin \> 2 mg/dl and INR \> 1.5 Page 20 of 37
* Women who are pregnant or nursing
* Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the intestine. Patients who have undergone gastric bypass procedures will be excluded (gastric lap band is acceptable).
* Subjects who are taking warfarin
Computer-assisted Detection of Colonic Polyps

Screening colonoscopy is considered the gold standard for adenoma detection in the colon. However, it has been shown that a considerable number of polyps can be missed during screening colonoscopy. Until now the endoscopist himself is responsible for the detection of adenomatous polyps. No automatic tools are available supporting the colonoscopist to detect lesions. Recently, a computer program was developed that can be used to recognize and extract suspicious structure from colonoscopy video sequences. The program was built to automatically detected colonic polyps and to highlight the polyps by colour marking. The program was now refined so that the respective structures can be highlighted during real time colonoscopy. The aim of this feasibility study is to test whether the software is applicable during real time colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Indication for colonoscopy
* age ≥ 40 years

Exclusion Criteria:

* American Society of Anesthesiologists class IV or higher
* pregnant women
* indication for colonoscopy: inflammatory bowel disease
* indication for colonoscopy: polyposis syndrome
* indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
Comparison Between Haparin and Herodin in HD

The goal of this study is to compare the efficacy and drawbacks of Heparin and Hirudin in Haemodialysis patients. The main question it aims to answer is:

which drug is more safe in Haemodialysis?

Extracorporeal thrombogenesis is a major problem associated with haemodialysis. The composition of the artificial membrane in the extracorporial system and large surface area to which the blood is exposed, contribute significantly to activation of the coagulation cascade and platelets. The use of anticoagulant is to prevent thrombotic occlusion of the dializer to ensure effective dialysis.

The most common anticoagulant options for Hemodialysis include unfractionated heparin (UFH), low-molecular weight heparin (LMWH), thrombin antagonists, and platelet inhibiting agents. The choice of anticoagulant for Haemodialysis should be determined by patient characteristics, local expertise, and ease of monitoring.

Heparins are currently the anticoagulants of choice in long-term haemodialysis (HD), but because of their shortcomings, including the increasing incidence of heparin-induced thrombocytopenia (HIT II), alternative anticoagulation is necessary, as there are several complication associated with its long term use, They include thrombocytopenia, increase bleeding tendency, osteoporosis, increase lipolytic activity and change of lipid pattern, activation of of lipolysis also leads to immunosuppressive effect.

Hirudin the most potent natural inhibitor of thrombin, it is a direct thrombin inhibitor and does not require endogenous cofactors. Hirudin inhibits all actions of thrombin and so effectively inhibit coagulation and prevent heparin resistant arterial type thrombosis when given in large enough doses. Hirudin has no adverse effect when it is used into human, because it is pharmacologically inert. Hirudin is also a weak immunogen.

Few researches evaluate the efficacy and drawbacks of Hirudin in HD patients.

Eligibility Criteria:
Inclusion Criteria:

1. patient age between 18:70
2. Haemodialysis duration less than 6 months
3. Agree to participate in the study

Exclusion Criteria:

1. AKI
2. patients with impaired coagulation profile
3. Decompensated liver disease
Efficacy of a Prebiotic Galactooligosaccharide to Reduce Metabolic Syndrome Risk Factors in Overweight Adults

The traditional risk factors for obesity are inappropriate diet, lack of exercise and genetic factors. However, recent observations have involved gut microbiota profiles as having an additional influence. In this case, there exists the possibility to modulate this through diet. Research has shown that the gut microbiota of both obese humans and mouse models of obesity is altered towards less beneficial one compared to lean counterparts. This raises the possibility of modulating the gut microbiota as a novel strategy in tackling the epidemic of obesity and diabetes sweeping the developed world. In addition, a more direct effect of high-fat induced disruption of the intestinal microbiota has also been seen with a murine model. Elevated circulating levels of lipopolysaccharide (LPS) a major building block and antigen of Gram-negative bacteria, was shown to generate a low grade chronic inflammation, termed metabolic endotoxemia, which then onsets insulin resistance. High-fat diets were shown to disrupt the Gram-negative intestinal populations of these animals, liberating LPS. The effects of prebiotics on the microbiota or metabolic syndrome (combination of disorders that increase the risk of developing cardiovascular disease and diabetes) in overweight adults have not been investigated thus far. The investigators therefore propose to investigate the effect of galactooligosaccharide (GOS) on the faecal microbiota and metabolic syndrome risk factors in overweight adults in a double-blind, randomised, placebo controlled, cross-over trial.


Eligibility Criteria:
Inclusion Criteria:

* 18-65y
* BMI \>25 kg/m2

Exclusion Criteria:

* Suffered from a myocardial infarction/stroke or cancer in the past 12 months
* Diabetic or suffering from endocrine disorders
* Suffer from renal or bowel disease/gut disorder or have a history of cholestatic jaundice or pancreatitis
* Requirements to take long-term medication for hyperlipidaemia, hypertension, inflammation or hypercoagulation
* History of alcohol or drug abuse
* Planning or on a weight reducing regime
* Taking antioxidant (or phytochemical), probiotic or prebiotics supplements
* Pregnant or lactating women or those planning pregnancy in the next 6 months or of child-bearing age who are not using contraception
* Use of antibiotics within the previous 1 month
* Anemic
* Smoker
Effect of Pezzi Ball on Balance in Pregnant Women

The effect of kinaesthetic training on performance and postural stability during pregnancy and 2 weeks postpartum

The effect of kinaesthetic training using pezzi ball for 12 sessions with rate of 3 session per week on postural stability and performance during pregnancy and at the 2-week postpartum follow-up. Postural stability was measured using a balance check board 636-1

Eligibility Criteria:
Inclusion Criteria:

* age between 25 and 30 years a body mass index (BMI) not exceeding 32 kg/m2, low-risk gestation primiparous pregnancy intact sensory motor integration in the lower extremities.

Exclusion Criteria:

* more than 28 weeks gestation
* had chronic disease
* multiparous
Observational, Prospective, Single-center Study: Should Body Mass Index (BMI) be Added to the Scoring Criteria of Hepatic Critically Ill Patients in Intensive Care Unit??

The purpose of the study is to evaluate the hypothesis of poor clinical outcomes in critically ill patients that are having abnormal BMI.

All demographic data will be obtained including the patients' age, sex, body mass index (BMI) \& categorized into; BMI \< 18.5Kg/m2 = underweight, BMI between 18.5-24.9Kg/m2 = normal weight, while BMI between 25-29.9Kg/m2 = overweight \& obese = BMI ≥ 30Kg/m2, associated co-morbidities (diabetes mellitus, hypertension, chronic renal failure, cancer\& chronic liver disease), the cause of admission to ICU, Sequential Organ Failure Assessment (SOFA), nutritional risk screening (NRS) on admission \& discharge, prior cardiac arrest, previous ICU admission within 6months, nosocomial infection, organ failure e.g. cardiovascular, respiratory, renal \& organic support requirement e.g. hemodynamic support, mechanical ventilation, renal replacement therapy (RRT).

Eligibility Criteria:
Inclusion Criteria:

* Patients who are admitted to the intensive care unit of National Hepatology \& Tropical Medicine Research Institute (NHTMRI) for medical \& surgical indications during the period from February 2018 to December 2020.

Exclusion Criteria:

* Patients will be excluded if they have stayed in ICU ≤24 hours and underweight (BMI\<18.5).
e-BioMatrix PostMarket Surveillance Registry

The purpose of the e-BioMatrix PMS registry is to capture clinical data of the BioMatrix (Biolimus A9-Eluting) stent system in relation to safety and effectiveness.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Patients that need a treatment with a BioMatrix™ drug-eluting stent
3. Presence of one or more coronary artery stenoses in a native coronary artery or a saphenous bypass graft from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents
4. No limitation on the number of treated lesions, and vessels, and lesion length

Exclusion Criteria:

1. Inability to provide informed consent
2. Patients needing additional stent NOT of the BioMatrix™ type
3. Patients receiving next to the BioMatrix™ stent also other coronary vascular interventions, for example dilation.
Acceptance-Based Treatment for Generalized Anxiety Disorder

This study will develop and implement an awareness- and acceptance-based for treatment of individuals with generalized anxiety disorder.

Participants in this study are recruited from intakes at the Center for Anxiety and Related Disorders at Boston University. Participants will be randomly assigned to receive either acceptance and mindfulness-based strategies plus cognitive behavioral therapy or no treatment for 16 weeks. The treatment will involve daily practice of mindfulness techniques to help draw attention to and accept various emotional states. Interviews, questionnaires, and depression and anxiety scales will be used to assess participants. Assessments will be conducted post-treatment and at 3- and 9-month follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Generalized Anxiety Disorder (GAD)
* Willing to maintain medication levels and refrain from any additional psychosocial treatment during the course of the study

Exclusion Criteria:

* Bipolar disorder, psychotic disorder, or substance dependence
Restorations and Furcation Involvement on Molars

The aim of this study will be to analyze the relationship between the presence of second class restorations (interproximal fillings) or prostheses (crowns, bridges) on molar teeth and the presence of bone resorption between the roots of the latter. Patients with this type of restorations will be identified and a non-interventional clinical and radiographic analysis will be conducted.

Patients who have a molar tooth reconstructed with a second class filling according to Black, or a with crown or that is abutment of a prosthetic bridge will be included in the study provided they have at least one other intact molar.

The molars included in the study do not have to be wisdom teeth. In these patients, in addition to the presence of furcations (bone resorption in the space between the roots), the probing depth (PD), the loss of clinical attachment (CAL), bleeding on probing ( BOP), mobility, width of the keratinized tissue, the length of the root trunk (measured radiographically), the presence or absence of endodontic treatments (evaluated on the radiography), the anatomy of the roots (widely separated, fused, separated but fused) and the presence of enamel projections will be recorded.

Data will be analyzed with utilizing Pearson chi-square and the pair-wise t test.

The analysis of these data will provide us with evidence on the influence that interproximal restorations and fixed prostheses, in the presence of other co-factors, have on the presence of furcations in molars.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have molars both with and without restorations
* Restorations presents for at least 5 years

Exclusion Criteria:

* Patients who do not want to undergo evaluation
* Patients who cannot undergo radiation (pregnant women)
* Patients who do not have at least one other unrestored molar
Chest Lymph Node Sampling in Patients with Advanced Lung Cancer to Be Treated with Curative-intent Radiation Treatment

This study will investigate the role of sampling suspicious chest lymph nodes with a procedure called endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA) or transesophageal ultrasound-guided fine needle aspiration (EUS-FNA) in patients planned to receive radical dose radiation.

This study will use Stereotactic Ablative Radiotherapy (SABR) for treatment methods. SABR is a newer radiation treatment that delivers high-dose, precise radiation to small tumors and can be delivered more accurately than with older radiation treatment methods. It is considered a standard treatment for small lung cancers, and select cancers that have spread to the brain.

The purpose of this study is to compare if the lymph node sampling procedure is valuable for determining the extend of nodal disease in metastatic Non-Small Cell Lung Cancer (NSCLC) compared to imaging alone.


Eligibility Criteria:
Inclusion Criteria:

* Patients with oligometastatic non-small cell lung cancer (NSCLC), including a primary lung tumour (± hilar/mediastinal adenopathy) with up to 5 synchronous metastases
* Radical treatment intent to all sites is recommended at multi-disciplinary tumour board or by discussion by medical oncologist and radiation oncologist and/or surgeon.
* Age 18 years or older
* Good performance status (Eastern Cooperative Oncology Group \[ECOG 0-1) with life-expectancy of at least 6 months as determined by enrolling physician
* Patient has undergone staging investigations less than 3 months prior to registration.

  1. Positron Emission Tomography (PET) / Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) brain (CT brain with contrast if contraindication to MRI) OR
  2. CT chest/abdomen, radionucleotide bone scan and MRI of brain (CT brain with contrast if contraindication to MRI)
* Pathologic confirmation of NSCLC

Exclusion Criteria:

* Contraindication to Endobronchial Ultrasound (EBUS) / Endoscopic Ultrasound (EUS)
* Unable to provide consent for EBUS/EUS
* Contraindication to chest radiotherapy
* Pregnant or lactating women
Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter Registry

The overall objective of CONFIRM2 is to perform the largest cardiovascular phenotype outcomes study ever.

CONFIRM2 is a retrospective and prospective, open-label, international, multicenter observational registry designed to evaluate associations between CCTA imaging findings and clinical presentation (cross-sectional) and their ability to predict mortality and major adverse cardiac events (longitudinal) in patients with chronic CAD.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Undergoing clinically indicated CCTA with \>64-detector row CT
* Signed informed consent, including of release of medical information, long term follow-up and Health Insurance Portability and Accountability Act (HIPAA) documentation

Exclusion Criteria:

* Individuals unable to provide informed consent
* Non-cardiac illness with life expectancy \< 2 years
* Pregnancy
Clinical Trial for 'Shen Qu Xiao Shi' Oral Liquid in the Treatments of Children's Functional Dyspepsia

With domperidone suspension as the control, the effect of shenqu xiaoshi oral liquid on functional dyspepsia in children was evaluated objectively through multi-center, randomized, double-blind and double-simulation experiment, which alleviated the clinical symptoms, restored and promoted the normal growth and development of children.


Eligibility Criteria:
Inclusion Criteria:

1. Children aged 3-14 years, regardless of gender;
2. Meet 1 or more conditions: (1) full after dinner; (2) early full; (3) abdominal pain, and defecation has nothing to do; After appropriate evaluation, symptoms cannot be fully explained by other diseases; Or have other symptoms of dyspepsia, but not caused by other diseases;
3. Have symptoms at least 2 months before diagnosis and at least 4 days per month;
4. During the 2-week leading-in period, no drugs were used to treat infantile anorexia and functional dyspepsia, and good eating habits were established. The patients were fed on time and still had the above-mentioned symptoms of anorexia and functional dyspepsia; The symptom score was 3.
5. The legal guardian of the child should sign the informed consent form. If the child is 10 years old or older, they should sign the informed consent form and agree to participate in the study.

Exclusion Criteria:

1. Anorexia and dyspepsia caused by anorexia or dyspepsia caused by the influence of certain drugs or other confirmed diseases, such as erosive gastritis and gastric ulcer;
2. Children with severe malnutrition;
3. Children with abnormal ecg, liver and kidney functions, nervous system, respiratory system and endocrine system considered by the investigator;
4. Children with mental disorders, dementia and unclear speech;
5. Lactose intolerance or allergy to drug ingredients, or allergy to traditional Chinese medicine;
6. Children who have participated in other clinical trials or are participating in clinical trials of other drugs within 12 weeks; According to the judgment of the researchers, there are other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as unstable living environment and inconvenient transportation, which are easy to cause loss and follow-up.