cyrilzakka/clinical-trials huggingface dataset:
ePrime: Evaluation of Magnetic Resonance (MR) Imaging to Predict Neurodevelopmental Impairment in Preterm Infants

Preterm infants face an uncertain future because premature birth often leads to problems with brain development and can cause cerebral palsy.

A trial needs to be done to see if Magnetic Resonance Imaging (MRI) helps families and professionals by predicting long term problems more accurately, allowing better targeting of care to children with problems and reassuring the parents of normal babies.

This programme will provide the evidence-base for the National Health System (NHS) policy on the use of magnetic resonance imaging of the brain for preterm infants.

The trial will determine very accurately how well MRI predicts long-term problems, and it will assess whether it makes parents more or less anxious about their babies, and whether they seek more or less help in the first couple of years after birth,and see if the total cost to the NHS is increased by using MRI. It will also check up if there is a better way to do ultrasound examinations, and do a survey to see how much MRI is used in the United Kingdon (UK) and whether hospitals think they could provide it.

The core of the project is a study of preterm babies who will be referred to a specialist centre to have both ultrasound and MRI scans. Half the parents will be told the results of the MRI and half the parents the ultrasound. The programme will then ask them to fill in questionnaires or be interviewed about their stress levels and the amount of support they seek for their children until they are two years old, when the babies will be examined to see if MRI predicted their outcome accurately.

Eligibility Criteria:
Inclusion Criteria:

-Delivery at less than 33 completed weeks of gestation, estimated from early fetal ultrasonographic measurements as recommended in the National Institute of Clinical Excellence Guidelines: Antenatal Care for the Healthy Woman

Exclusion Criteria:

* Prior MR imaging
* Major Congenital Malformations
* Presence of Metallic Implants
Therapeutic Exercise and Vegan Diet on Pain and Quality of Life

45 sedentary volunteer female individuals whose age range is between 18-25 years and diagnosed with chronic idiopathic neck pain by a specialist physical therapy doctor will participate in the study. Participants will be randomly divided into three groups: vegan diet group (n=15), therapeutic exercise group (n=15) and control group (n=15). Participants with chronic neck pain who will be on a vegan diet will follow a diet program prepared by an expert dietitian under the supervision of an endocrinologist. In this diet program, a diet that includes grains, fruits, vegetables, legumes, as well as dairy products and eggs, known as lacto-ovo vegetarian, will be applied. Consumption of meat, poultry, fish, seafood and processed food and beverages will not be allowed. There will be no calorie restriction in the diet, and the diet will be arranged according to the amount of calories calculated by the expert dietitian according to BMI. The diet will last eight weeks. Individuals who follow a diet will be constantly checked by the workers with the mobile device application (My Fitness Pal®). Individuals in the therapeutic exercise group will perform therapeutic exercises for eight weeks, 3 days a week, accompanied by a specialist physiotherapist.The aim of this study is to compare the Effect of Therapeutic Exercise and Vegan Diet on Pain and Quality of Life in Young Women with Chronic Idiopathic Neck Pain.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18-25,
* neck pain for at least 3 months,
* VAS score greater than 5

Exclusion Criteria:

* using regular analgesic,
* having had neck surgery,
* the presence of neurological or specific problems in the neck (vertebral fracture, inflammation, infection, etc.),
* cortisone use,
* pregnancy,
* serious chronic diseases,
* those with serious psychiatric disorders
* Individuals who received physical therapy within 3 months
* Antidepressant use
Academic Performance and Refractive Error

Refractive errors constitute the leading cause of visual disability worldwide and that myopia progresses dramatically when students reach school age. Studies from different countries have reported inconsistent associations between educational outcomes and refractive errors. Therefore, our study aimed to assess the associations of high academic performance with ametropia prevalence and myopia progression in Chinese schoolchildren base on a multicohort observational design.


Eligibility Criteria:
Inclusion Criteria:

* schoolchildren in the 1st to 9th grades

Exclusion Criteria:

* schoolchildren unwilling to participate
* had a history of wearing rigid contact lenses, medical treatment or diseases that could cause poor vision or negatively affect the academic outcomes
* with unreliable auto-refraction values
Nobio Antimicrobial Particles Effect in a Split Mouth Model

The study purpose is to evaluate the antimicrobial effect of Nobio particles incorporated within Novidia Dental Bonding and Flowable Composite versus standard of care within a split mouth model.The study population will include 35 subjects considered to be at high risk for cervical caries and affected by uncontrolled plaque accumulation

An exploratory, comparative, self-controlled single blinded interventional study. Intended to evaluate the antimicrobial effect of Nobio particles incorporated within Novidia Dental Bonding and Flowable composite versus Filtek bond and flow composite within a split mouth model.The study population (N=35) will be high risk population for cervical caries (with at least 2 carious cavities in the mouth) affected by uncontrolled plaque accumulation.Each subject will serve in this model as his own control.On one side the Novidia intervention will be made and on the contralateral side the Filtek intervention.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years of age.
* Requires two cervical restorations or the exchange of existing ones
* Subject has poor oral hygiene and at high risk for plaque accumulation.
* Subject able and willing to comply with study visits and Follow up visits and signed the informed consent.

Exclusion Criteria:

* Allergic reaction to iodide.
* Pregnant or lactating women.
* Use of antiseptic mouth rinse or antibiotic up to 2 weeks before the beginning of study.

Exclusion criteria for the chosen teeth for the study:

* Tooth designated for extraction in the following 6 month.
* Tooth designated to have a root canal treatment.
* Tooth or several teeth designated for periodontal surgery.
The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy

The GUARD Trial is a multi-center, randomized, controlled, adaptive Phase 3 clinical trial of repeated intravitreal injections of ADX-2191 versus standard-of-care for the prevention of proliferative vitreoretinopathy.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years or older of any gender or race
2. Subject is undergoing pars plana vitrectomy due to recurrent retinal detachment due to proliferative vitreoretionapthy or open globe injury
3. Subject is willing and able to provide written informed consent, comply with clinical trial procedures, and return for all clinical trial visits
4. Subjects of childbearing potential must agree to use two forms of birth control for the duration of the clinical trial

Exclusion Criteria:

1. History of severe non-proliferative or proliferative diabetic retinopathy
2. Other planned eye surgery during the course of the trial
3. Participation in a clinical trial with an investigational medicinal product or investigational device within 90 days of subject enrollment
A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)

This study was designed to evaluate the safety and efficacy of neoadjuvant and adjuvant atezolizumab in participants with resectable Non-Small Cell Lung Cancer (NSCLC). Neoadjuvant therapy consisted of two 21-day cycles with atezolizumab. Following surgery, adjuvant therapy consisted of up to 12 months of atezolizumab in participants who demonstrate clinical benefit with neoadjuvant therapy. All participants who undergo surgery entered a surveillance period, which consisted of standardized blood sample collection and Chest CT Scans, for up to 2 years. All participants were monitored for disease recurrence and survival for up to 3 years after last dose of study drug.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically documented Stage IB, II, IIIA, or selected IIIB, including T3N2 or T4 (by size criteria, not by mediastinal invasion) NSCLC
* Adequate pulmonary and cardiac function
* Available biopsy of primary tumor with adequate samples
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* NSCLC that is clinically T4 by virtue of mediastinal organ invasion or Stage IIIB by virtue of N3 disease
* Any prior therapy for lung cancer within 3 years.
* Prior treatment with anti-PD-1 or PD-L1 therapies
* History or risk of autoimmune disease
Long Acting GnRH Antagonist in PCOS Women Undergoing IVF

PCOS is a common endocrinopathy affecting 5-10% of women in their reproductive age characterized by hyperandrogenism, chronic anovulation and polycystic ovaries. This syndrome is a serious problem in IVF since there is a high risk of developing ovarian hyperstimulation syndrome (OHSS) during ovarian stimulation with gonadotropins. The introduction of GnRH antagonist in IVF has reduced the incidence of severe OHSS, still maintaining a good ovarian response and pregnancy rate. Recently, a long acting GnRH antagonist, Degarelix, was introduced for prostatic cancer treatment. Furthermore a recent paper reported its use also for the induction of multiple follicular growth in a program of oocyte donation. The aim of this study is to evaluate the feasibility of GnRH antagonist depot use in a protocol of controlled ovarian hyperstimulation in PCOS women at risk of developing OHSS in IVF cycles.


Eligibility Criteria:
Inclusion Criteria:

* regular menstrual cycle (26-39 days)
* primary infertility
* BMI \< 30

Exclusion Criteria:

* women with diabetes and other metabolic disease
* women with heart disease
* women with inflammatory or autoimmune disease
Comparison of Whole-body MRI, Circulating DNA and PET-CT in Staging, Prognosis, and Treatment Response in Patients with Diffuse Large Cell B Lymphoma

The aim of the study is to compare the diagnostic performance of whole-body MRI scan, positron emission tomography + CT, and circulating tumor DNA in patients with hematologic malignancy called diffuse large cell B lymphoma (DLBCL) in staging and restaging, and prognosis.

Patients newly diagnosed with DLBCL or patients with relapsed DLBCL who consent to participate in this study will apart from standard staging and restaging examination with PET/CT undergo whole-body MRI (wbMRI). From blood samples, the level of circulating tumor DNA (ctDNA) fragments will be estimated. These procedures will be repeated during restaging after primary treatment. The diagnostic accuracy of wbMRI in initial staging and restaging will be compared with PET/CT as the gold standard. Circulating tumor DNA levels will be compared at baseline with staging from PET/CT. The change in levels of ctDNA will be compared with the treatement response assessed by PET/CT. All three methods will be used as prognostic indicators.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* performance status according to the Eastern Cooperative Oncology Group between 0 and 3
* satisfactory clinical condition to participate in this study
* adequate hematologic and renal functions
* no contraindications to MRI
* recent or planned PET/CT at the institution
* informed consent to participate.

Exclusion Criteria:

* history of indolent lymphoma
* anti-lymphoma treatment initiated before PET/CT or wbMRI
* central nervous system lymphoma
Effect of Sitagliptin on Progression of Coronary Intermediate Lesion

This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor, on Progression of Coronary Intermediate Lesion.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18, \< 80 years old, with type 2 diabetes mellitus and angiographically proven Coronary Intermediate Lesion.

Exclusion Criteria:

* Allergy or hypersensitivity to any of the drug's components.
* Severe liver failure, moderate or severe kidney failure
* Malignant disease.
* Active infectious disease.
* Pregnancy or breastfeeding.
Quality Of Life in Patients With Malignant Biliary Obstruction

You may have symptoms like itching, abdominal pain, loss of appetite, fatigue, fevers and chills. The treatment you will receive to relieve the blockage is also intended to relieve symptoms and improve your quality of life. The purpose of this study is to find out if relieving the blockage in your bile duct improves your quality of life.

Malignant biliary obstruction (MBO) may arise in patients with cholangiocarcinoma, pancreatic carcinoma, primary gallbladder carcinoma, hepatocellular carcinoma, or metastatic disease to the liver or portal lymph nodes. MBO is often accompanied by significant symptoms that may result in impairment of health-related quality of life (HRQL), including pruritus, fever, nutritional deficits, abdominal pain, nausea and vomiting, and fatigue. Approaches to the relief of MBO include surgical bypass and/or resection, percutaneous drainage with or without biliary stenting, or endoscopic stenting. The non surgical procedures may be done prior to attempted curative resection or for palliation in individuals with unresectable or recurrent disease.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of malignant biliary obstruction
* Radiologic or histologic evidence of MBO
* Percutaneous biliary drainage procedure planned or
* Surgical biliary enteric bypass, or hepatic resection with biliary reconstruction (high bile duct tumors) planned
* KPS \>50%
* Age 18 years or greater
* Able to speak and read English
* Able to comprehend and execute informed consent
* Prior intervention for MBO not exclusionary

Exclusion Criteria:

* Unable to complete questionnaire due to performance status
* Proxy completion is not accepted
* Medical or psychiatric condition that, in the judgment of the investigator, prevents appropriate comprehension and execution of either the informed consent or the study instrument
Preoperative Ascites Drainage Versus Standard Care for Patients With Advanced Ovarian Cancer

Patients with significant ascites and advanced ovarian cancer (AOC), undergoing complex, cytoreductive surgery are at risk of malnutrition, poor quality of life and the risk of hypo- or hypervolemia in a perioperative period. All these factors may cause hemodynamic consequences during anesthesia and surgery, and elevate the risk of morbidity and mortality.

The objective of the study is to evaluate, whether slow ascites evacuation for a few days before the surgery for AOC, could 1) influence the hemodynamic consequences of ascites on systemic circulation in patients undergoing surgery, 2) improve patient's quality of life and 3) ability to feed correctly before treatment starts, and thus lower the risk of perioperative morbidity.

Eligible patients are those with significant ascites, diagnosed or suspected for AOC, who are scheduled for primary surgery (both upfront cytoreduction or laparoscopic evaluation before neoadjuvant chemotherapy), that cannot be performed within next 7 or more days, for any reason. Patients will be asked to fill in quality of life questionnaire (QLQ). Clinical data, a Subjective Global Assessment (SGA) will be recorded. Patients will be randomized to either intervention arm A - insertion of vascular catheter into abdominal cavity and slow, systematic, daily ascites evacuation, or to observation arm B - standard of care with just observation (acute large volume (\>5000ml) paracentesis allowed if needed). Patients in both groups will be encouraged to use oral nutritional support. Randomization will be open, 1:1, for every eligible, consecutive patient. After 7 days patients will be interviewed, asked to fill in QLQ, patient's experience on the treatment survey, a SGA will be recorded. During the first hour of the surgery hemodynamic data from anethetic charts will be recorded along with other clinical data concerning patient's characteristics, surgery details and 30-day postoperative follow-up. A template is provided.

The hypothesis of the study is that slow, systematic ascites evacuation few days before surgery for advanced ovarian cancer can facilitate hemodynamic control of systemic circulation of patients undergoing surgery, and improve patients' quality of life, feeding ability before treatment starts. Secondary we would expect lower risk of perioperative morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

* patients with significant ascites and suspected ovarian cancer scheduled for upfront cytoreductive surgery, or diagnostic laparoscopy and neoadjuvant chemotherapy, and the surgery is planned to be performed in at least 7 days,
* signed informed consent of the patient.

Exclusion Criteria:

* ascites not of malignant origin,
* low volume ascites,
* other then primary ovarian malignancy suspected,
* suspected or clinically apparent infection especially at the site of planned drainage placement,
* no patient's consent.
A Study to Evaluate the Efficacy and Safety of Add-on Therapy of Wuling Capsule in Epilepsy Patients With Depression

The main purpose of this study is to determine the effects of add-on therapy of wuling capsule on depressive symptoms in patients with comorbidity of epilepsy and depression, to evaluate its influences on the frequency and severity of seizures, and to observe its effects on patients' sleeping condition, quality of life.

The phenomenon of epileptic patients who have psychiatric disorders is very common, of which the prevalence of depression is the highest and depression is also an independent risk factor affecting epileptic patients' quality of life. Due to some social factors, non-typical clinical symptoms and limited therapeutic methods(tricyclic antidepressants, lithium chloride and 5-serotonin uptake inhibitors may all have risks of lowing threshold of seizures), epileptic patients with depression are usually not be recognized and treated properly. Wuling capsule has been used in therapy of insomnia, nervous breakdowns and a previous small sample clinical trial revealed that it could improve mood disorders of epileptic patients and hadn't affected severity of seizures (not published). Therefore a multi-center, randomized, double-blinded and placebo-controlled superiority clinical trial will be carried out to determine the effects of add-on therapy of wuling capsule on depressive symptoms in patients with epilepsy, to evaluate its influences on the frequency and severity of seizures, and to observe its effects on patients' sleeping condition, quality of life.

Eligibility Criteria:
Inclusion Criteria:

Subjects for this study will meet the following criteria:

1. Age greater than or equal to 18 years.
2. Must be in accordance with the diagnostic criteria of epilepsy and have taken antiepileptic drugs regularly at least for 6 months, which will not be changed recently. The duration to the latest seizure must be longer than 24 hours.
3. Score of a 17 item Hamilton Depression is greater than or equal to 17 and depressive symptoms have lasted for at least 2 weeks.
4. Haven't taken any anti-anxiety, anti-depressant and anti-psychotic drugs in recent 2 weeks.
5. Must sign the informed consent form.

Exclusion Criteria:

1. Now accepting or have accepted other drugs clinical trial in the last month.
2. History of serious psychiatric illness other than depression.
3. Having suicide ideas or suicide behaviors.
4. Progressive illness of central nervous system, such as degenerative disease or tumor.
5. History of serious cardiac or pulmonary disease, hepatic and renal dysfunction, and malignant tumors.
6. The value of ALT or AST is higher than 1.5 times normal range, or the number of white blood cells is less than 2500/ul, or the number of neutrophil granulocyte is less than 1000/ul.
7. During pregnant or lactation period.
8. The person who is disabled or mentally disabled.
Surviving a Decade or More After Coronary Revascularization in a Middle Eastern Population

The study will look at the cardiovascular risk factors as they arise, as well at the need for further revascularization after at least 10 years of coronary revascularization in Middle Eastern patients.

The PI will overlook the whole process. Dr Ahmad Tamari, the assistant to the PI will asses this whole process of data collection, management and manuscript drafting.

Middle Eastern patients aged 18 years or above presenting to cardiology service at one tertiary care center who had coronary revascularization (stent or coronary bypass surgery, i.e., index procedure) at least 10 years back, will interviewed to determine:

1. Evolution of cardiovascular risk factors in the period from index procedure to time of interview. These risk factors include; hypertension, diabetes, smoking, dyslipidemia and obesity.
2. Need for further arterial revascularization from the index procedure to time of interview.

   These arterial revascularization procedures include A. Coronary: stent and/or bypass surgery B. Carotid endarterectomy. C. peripheral arterial revascularization D. Renal artery stent.
3. Medications used at the time if interview with special emphases on the guideline-recommended medications including antiplatelet agents, beta blockers, statins and renin angiotensin blockers.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Coronary stent or bypass 10 years ago or more.
3. Dependable mental status to recall events.

Exclusion Criteria:

1. Non coronary operations
2. Inability to recall evnets
Assessment of Acute Renal Injury During Partial Nephrectomy Using Neutrophil Gelatinase-associated Lipocalin (NGAL): Prospective Comparative Study Between Open, Video-assisted Minilaparotomy, Laparoscopic, and Robotic-assisted Laparoscopic Surgery

Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be related with the degree of acute kidney injury. We are trying to analyze whether it is related with the grade of acute kiney injury after partial nephrectomy and there is any difference between the kinds of surgery.


Eligibility Criteria:
Inclusion Criteria:

1. adults patient more than 20 years old with ASA score 1-3
2. the patients who undergoing partial nephrectomy for the renal mass less than 7 cm

Exclusion Criteria:

1. the patient with previous history with renal surgery
2. the patient with bilateral partial nephrectomy
3. the patient with synchronous operation for other intraperitoneal surgery
4. the renal mass more than 7 cm
5. previous kinds of surgery is changed into other kinds due to bleeding, etc
6. the patient with serum Cr level more than 1.4 mg/dl
7. the patient who does not understand the consent form
Incidence and Patterns of Nausea/Vomiting With Combined Chemotherapy and Radiation

Questionnaire study to observe the incidence and pattern or nausea and vomiting in patients receiving combined chemotherapy and radiation. 83% of patients experience radiation therapy-induced vomiting; significant nausea and vomiting could develop with concurrent chemotherapy despite standard anti-nauseous medication prophylaxis.

Questionnaires will be answered daily on a weekly basis during period of radiation and chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Concurrent radiation and chemotherapy treatment
* Aerodigestive malignancy

Exclusion Criteria:

* Other causes of vomiting (i.e.gastrointestinal obstruction...)