cyrilzakka/clinical-trials huggingface dataset:
Role of Neoadjuvent Radiotherapy in Locally Advanced Cancer Rectum

This is a retrospective study comparing neoadjuvent short course radiotherapy to conventional chemoradiation in locally advanced cancer rectum and the effect of both regimens in overall survival and disease free survival

Colorectal cancer is the third most common cancer diagnosed in the western world. In 2019 there were approximately 44180 new cases of rectal cancer diagnosed in the United states.

Due to the close proximity of the rectum to pelvic structures and organs, the absence of a serious membrane surrounding the rectum and the restriction of the surgical view and access by the pelvic cavity, the locoregional recurrence rate in rectal cancer is relatively high after surgery alone.

Neoadjuvent therapy rather than surgery followed by adjuvent therap has been the preferred approach world wide in treatment of rectal cancer since the 2004 publication of the seminal German CAO/ARO/AIO-94 study ,which compared preoperative with postoperative chemoradiation in 823 patients The use of neoadjuvent therapy is recommended for all newly diagnosed rectal adenocarcinoma with a clinical stage T3 or T4 based on trans rectal endoscopic ultrasound or pelvic MRI .Neoadjuvent therapy may comprise of either radiotherapy alone or in combination with chemotherapy, commonly prescribed chemotherapy agents include 5-fluorouracil and Oxaloplatin.

Both short course radiotherapy (25 Gy in 5 fractions) and long course radiotherapy (50.4Gy in 28 fractions, conventionally fractionated therapy)can be applied as neoadjuvent radiotherapy.

Several phase lll RCTs,including three large well-designed international RCTs have reported that short course neoadjuvent radiation treatment improves local control compared with surgery alone in patients with respectable rectal cancer.

Also ,neoadjuvent chemoradiation with long course radiotherapy can be recommended for most patients with stage ll- lll rectal cancer with the aim of reducing the risk of local recurrence, for reducing rates of perioperative and post operative complications and in an attempt to avoid radical surgery with permanent colostomy.

Eligibility Criteria:
Inclusion Criteria:

* histologically proved adenocarcinoma of the rectum
* Age between 18 and 70 yrs
* T3 and T4 N1,N2 respectable tumor
* The WHO performance score 0-2
* have a free metastatic work up excluded by chest x-ray , abdominal ultrasonography or CT pelviabdomen

Exclusion Criteria:

* patients with locally advanced inoperable disease locally recurrent rectal cancer
* had a history of malignant tumor within 5 years except the skin cancer
* pregnant or lactating women
* previous irradiation in pelvis
* there was contraindication for neoadjuvent radiotherapy or surgery
* known metastatic disease
* mental disorder
Impact of Switching to NNRTI-based Therapy on the Quality of Life of HIV-infected Patients With Virological Suppression

Observational study to evaluate therapeutic switch to a NNRTI-based regimen on quality of life of HIV-positive patients


Eligibility Criteria:
Inclusion Criteria:

* NNRTI-naive patients with positive HIV serology, treated with at least triple combination therapy, with a viral load \< 500 copies/ml, in whom a new treatment comprising an NNRTI is initiated for a reason other than inefficacy of treatment will be included
* Patients must read and write French

Exclusion Criteria:

* Patients in whom a new treatment is initiated because of treatment failure
* new treatment does not comprise an NNRTI
A Gene Transfer Therapy Study to Evaluate the Safety of Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)

This study was an open-label single-dose gene transfer therapy study evaluating the safety of delandistrogene moxeparvovec intravenous (IV) administration in boys with DMD. This study was originally designed to consist of 12 patients across 2 Cohorts. Cohort A would have included participants ages 3 months to 3 years, and Cohort B included participants ages 4 to 7 years old. No participants were enrolled in Cohort A.


Eligibility Criteria:
Inclusion Criteria:

* Cohort A participants: 3 months to 3 years of age, inclusive
* Cohort B participants: 4 to 7 years of age, inclusive
* Definitive diagnosis of DMD based on documented clinical findings and prior genetic testing.
* Ability to cooperate with motor assessment testing.
* Cohort A participants: No previous treatment with corticosteroids.
* Cohort B participants: Stable dose equivalent of oral corticosteroids for at least 12 weeks prior to screening and the dose is expected to remain constant (except for potential modifications to accommodate changes in weight) throughout the first year of the study.
* Cohorts A \& B: A frameshift mutation contained between exons 18 and 58 (inclusive).

Exclusion Criteria:

* Exposure to gene therapy, investigational medication, or any treatment designed to increase dystrophin expression within protocol specified time limits.
* Abnormality in protocol-specified diagnostic evaluations or laboratory tests.
* Presence of any other clinically significant illness, medical condition, or requirement for chronic drug treatment that in the opinion of the Investigator creates unnecessary risk for gene transfer.

Other inclusion or exclusion criteria could apply.
Safety and Feasibility Study of Mesenchymal Trophic Factor (MTF) for Treatment of Osteoarthritis

Allogeneic mesenchymal trophic factors (MTF) from human umbilical cord tissue-derived mesenchymal stem cells (UC-MSC) injected into the knee joints of 20 patients (group 1) or injected subcutaneously into 20 patients (group 2) is a safe and useful procedure for inducing joint function improvements in osteoarthritis (OA) patients with grade 2, 3, or 4 radiographic OA severity.

The proposed study will assess primary safety and secondary efficacy endpoints of allogeneic UC-MSC-derived MTF administered to two arms osteoarthritis patients with grade 2, 3, or 4 radiographic OA severity (20 per arm). The first arm will receive an intra-articular injection of MTF into the knee joint under fluoroscopy. The second arm will receive 12 subcutaneous MTF injections, once per week.

For both arms, the primary objective of safety will be defined as freedom from treatment associated adverse events for the period of one year. The secondary objective of efficacy will include evaluation at baseline and at months 3 and 12 of efficacy endpoints of joint function improvement as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years and ability to understand the planned treatment.
* Subjects 18 years of age or older with idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification

Exclusion Criteria:

* Pregnant women or cognitively impaired adults.
* Presence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging.
* Inflammatory or post infectious arthritis.
* More than 5 degrees of varus or valgus deformity.
* Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age.
* Intra-articular corticosteroid injection within the previous 3 months.
* A major neurologic deficit.
* Serious medical illness with a life expectancy of less than 1 year.
* Prior admission for substance abuse
* Body Mass Index (BMI) of 40 kg/m2 or greater
* Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent
* In the opinion of the investigator or the sponsor the patient is unsuitable for cellular therapy
Papaverine vs Heparin for Peripheral Arterial Catheter Patency in Pediatric Patients

The purpose of this study is to compare intraoperative papaverine plus heparin to heparin alone for prevention of arterial spasm and maintenance of patency of peripheral arterial catheters during surgery in pediatric patients. The hypothesis is that periodic, intraoperative small-volume boluses of diluted papaverine plus heparin in peripheral arterial catheters of pediatric patients will prevent arterial spasm and help maintain patency of arterial catheters during general anesthesia.

Peripheral arterial catheters measure blood pressure with every heartbeat and provide valuable information regarding the status of the heart and the overall well being. It is of utmost importance to maintain the utility and patency of these catheters throughout the procedure. As standard procedure, heparin, a blood thinner, is used routinely during the surgical procedure to keep these catheters from clotting, and papaverine, an arterial relaxation agent, is used after surgery to maintain patency of these catheters.

In this study, participants will be randomized to receive two boluses of papaverine with heparin during the procedure (experimental arm) or heparin alone during the procedure (control arm) \[in both arms, the first bolus will be administered as soon as the arterial catheter is placed and secured and again one hour after initial bolus\]. If the arterial catheter spasm/patency or waveform does not improve 10 minutes after the second bolus, then the anesthesiology care team will consider treating clinically with 0.3 mg of papaverine.

Eligibility Criteria:
Inclusion Criteria:

- All patients age 0-17 years who would require elective placements of arterial catheters based on patients clinical complexity (ex. congenital heart disease) or based on the type of surgery (ex. open heart surgery).

Exclusion Criteria:

* Patients with a history of significant liver dysfunction.
* Patients undergoing liver transplants.
* Patients with Grade 2 or more of intraventricular hemorrhage.
* All preterm patients with a gestational age less than 37 weeks at the time of surgery.
Cohort of Patients With Inflammatory Bowel Disease During COVID-19 Pandemic

Multicenter cohort of patients followed for 6 months during the pandemic in France with biocollection of sera and peripheral blood mononuclear cells

Multicenter cohort of patients followed for 6 months during the pandemic in France with biocollection of sera and peripheral blood mononuclear cellsNo data has been published concerning the incidence and prevalence of SARS-CoV-2 infection in patients with IBD and treated by IV infusion of infliximab or vedolizumab. It seems that biotherapies have a minimal impact on the severity of the viral infection but data are scarce. The objectives of the cohort are to quantify the incidence and the prevalence of SARS-CoV-2 in this population of patients, to determine clinical, demographic and biological factors associated with the risk of infection and the severity of the disease with a Multicenter cohort of patients followed for 6 months during the pandemic in France with biocollection of sera and peripheral blood mononuclear cells.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (\>18 years), know Crohn's disease or ulcerative colitis, treated by infliximab or vedolizumab

Exclusion Criteria:

* not affiliated to a sanitary social insurance
Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers

The primary objective of this study is to evaluate the safety and tolerability of a single intravenous (IV) and oral (PO) ascending dose of NRX-1074 as evidenced by the incidence and severity of adverse events (AEs), changes in serum chemistry, hematology, and urinalysis, changes in physical examination findings and subject-reported symptoms.

The secondary objectives of this study are to assess the plasma and cerebrospinal fluid (CSF) pharmacokinetics (PK), the oral bioavailability of experimental formulations and the renal elimination through urine concentration of NRX-1074 through 24 hours following dosing.

Randomized, double-blind, placebo-controlled, single ascending dose level study. On Day 1, eligibility of each subject will be confirmed, physical examination will be performed, and blood and urine for laboratories will be obtained. Each subject will be randomized, then will receive either a single IV, SC or IN dose of GLYX-13 or placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects
2. Aged 18 to 55 years
3. For female subjects, surgically sterile or at least 2 years menopausal, or using an acceptable method of birth control from date of screening to at least 30 days after the last dose of study drugIf of childbearing potential, have a documented negative blood or urine pregnancy test within 24 hours prior to dosing.
4. Clinical laboratory values less than or equal to 2 times the upper limit of normal (ULN) or deemed not clinically significant by the Investigator.
5. Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.

Exclusion Criteria:
Emla-Cream as Pain Relief During Pneumococcal Vaccination

The aim of this intervention study is to compare the efficacy of Emla cream as a pain relief or no pain relief in connection to the first pneumococcal vaccination at the age of three months in Child health care.

Primary objective

1.Leads Emla cream as pain relief to children in connection with pneumococcal vaccination at the age of three months to lower pain scores in the use of FLACC as a pain measurement instrument?

The aim of this intervention study is to compare the efficacy of Emla cream as a pain relief or no pain relief in connection to the first pneumococcal vaccination at the age of three months in Child health care.

Primary objective

1. Leads Emla cream as pain relief to children in connection with pneumococcal vaccination at the age of three months to lower pain scores in the use of FLACC as a pain measurement instrument?

   Secondary objectives
2. Leads Emla cream as pain relief in connection with pneumococcal vaccination to any difference in the child's heart rate response and saturation?
3. Leads Emla cream as pain relief that it takes longer before the baby starts crying and does the child cry for a shorter time in connection with vaccination?

Method: The study is randomised and singleblind. The study involves 72 children who are 3 months old. 36 children will receive Emla-cream and 36 children will receive placebo-cream.

This study will lead to new knowledge about Emla cream and pneumococcal vaccination. The study will give new knowledge how painful pneumococcal vaccination is for the children. If the study shows that Emla cream don´t give enough pain relief during pneumococcal vaccination more studies should be done with other pain relief.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children, born vaginally or by cesarean section after 37 weeks of gestation, who were not admitted to the neonatal unit. Children should only have been with the PKU testing performed routinely at the hospital.

Exclusion Criteria:

* Baby delivered by vacuum extraction or forceps. Children born before gestational week 37. Children in neonatal care and subjected to other testing than PKU. Shoulder dystocia. Children susceptible to methaemoglobinaemia in glucose 6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia. Children with atopic dermatitis.
Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation

The aim of this randomized double-blinded study is to determine whether transition to propofol for 3 min at the end of sevoﬂurane anaesthesia reduces the incidence of EA in children undergoing genito-urinary paediatric surgeries.


Eligibility Criteria:
Inclusion Criteria:

1. Children Aged 3 - 8 years
2. ASA (I - II)
3. Genito-urinary Surgeries: hernia, varicocele, etc.

Exclusion Criteria:

1. Patients or parental refusal
2. Allergy to Propofol or egg products; or a family history of malignant hyperthermia
3. Operating time more than 60 minutes
4. Performance of any other procedure under the same anaesthetic
5. Presence of co-morbidities or congenital anomalies
6. mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.
Improving Emergency Department Testing for Deep Vein Thrombosis

This observational study will use a new way to test for deep vein thrombosis (DVT) of the leg. A DVT is a blood clot in the leg and is a medical problem that can cause swelling, pain, and redness. If the blood clot is not treated, it can cause more serious, long-term effects, and occasionally lead to death.

The main questions the study aims to answer are:

1. How safe is our new blood clot testing method?
2. How efficient is our new blood clot testing method?

The study will be run in the emergency department and urgent care centre in Kingston, Ontario. Patients who are tested for a DVT in the leg can be included in the study. Researchers follow the patient through chart review to make sure the new system is safe and efficient.


Eligibility Criteria:
Inclusion Criteria:

- emergency physician decides to test for DVT of the lower limb.

Exclusion Criteria:

* \<18 years of age;
* tested for DVT without using the DAYS algorithm at the index visit;
* D-dimer level is known before DAYS item assessment;
* a new indication for anticoagulation at the emergency department assessment (other than DVT) in a patient not previously prescribed an anticoagulant;
* a history of prior lower limb DVT, where there is no access to baseline ultrasound imaging;
* suspected of having a pulmonary embolism;
* has previously participated in this study;
* has previously opted out of all research at hospital site;
* left the emergency department or urgent care centre against medical advice;
* D-dimer was ordered prior to initial physician assessment;
* imaging for DVT or pulmonary embolism within the previous 30 days;
* transferred from another hospital organization.
KONVERT-AF - Relevance of Point in Time for Conversion of Acute Atrial Fibrillation

To investigate if in acute symptomatic atrial fibrillation (AF) the early (\>2 hrs but within 12 hrs of the beginning of the arrhythmia) electrical cardioversion leads to a longer recurrence-free interval than the delayed cardioversion (\> 36 hrs but \< 48 hrs after the beginning of the arrhythmia) within the first 3 months after cardioversion.

So far it is unknown if early or delayed cardioversion is most beneficial for patient outcome and which strategy is best to prevent recurrence of AF. The KONVERT-AF trial investigates if in acute symptomatic AF the early (\>2 hrs but within 12 hrs of the beginning of the arrhythmia) electrical cardioversion leads to a longer recurrence-free interval than the delayed cardioversion (\> 36 hrs but \< 48 hrs after the beginning of the arrhythmia) within the first 3 months after cardioversion. Primary endpoint is the time to the first recurrence of AF. The KONVERT-AF trial will be conducted as prospective, randomized, non-blinded multicentre study. It is planned to include 380 patients in 10-20 recruitment centres.

Eligibility Criteria:
Inclusion Criteria:

* documented AF that began between 2 and 8 hrs before randomization
* indication for electrical cardioversion.
* age above 18 yrs
* written informed consent

Exclusion Criteria:

* AF caused by not adequately treated reversible conditions(e.g. myocardial infarction, thyrotoxicosis, ethanol intoxication, infection, pericarditis, surgery)
* newly initiated (i.e. within 7 days before randomization) antiarrhythmic agents of class I, II and/or III
* catheter ablation of AF within 3 months before randomization
* pacemaker or icd
* myocardial infarction within 3 months before randomization
* urgent need to cardioversion of AF because of associated potentially dangerous symptoms such as chest pain, syncope, dyspnea
* contraindications for therapy with vitamin k-antagonists
* intracardial thrombus
* primary indication for pharmacological cardioversion
* in females: pregnancy, lactation period or no sufficient contraception within last 3 months
In-hospital Initiation of PCSK9 Inhibitor in Patients With Acute Myocardial Infarction

Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been shown to improve cardiovascular outcomes when added to conventional statin therapy. This study aims to investigate the efficacy and safety of in-hospital initiation of PCSK9 inhibitor among patients with acute myocardial infarction(AMI) based on real-world experience.

A total of 7556 AMI patients from the biobank database between January 2016 and December 2020 were screened for eligibility. After excluding those without revascularization or Statin based therapy, the remaining 5802 Statin users, 801 Statin plus Ezetimibe users and 170 Statin plus Evolocumab users (including 95 users without and 75 users with Ezetimibe), were selected for this study. Then, 1st and 3rd-month follow-up data were collected and analysed, including in-hospital mortality, readmission rate and lipid profiles


Eligibility Criteria:
Inclusion Criteria:

* confirmed admission diagnosis of AMI and were defined based on the universal definition criteria by the American Cardiology College

Exclusion Criteria:

* (1) severe noncardiac disease with an expected survival of less than 1 year and unwillingness to participate; (2) patients over the age of 80 years or living far away from the hospital's catchment area.
Measurement of in Vivo Mitochondrial Capacity in Infants

The overarching aim of this project is to determine the test re-test reliability of 31P-magnetic resonance spectroscopy measurements in infants. Primary endpoints include two separate measures of in vivo mitochondrial capacity (ATPmax) over a 1-10 day period to assess feasibility and reliability.


Eligibility Criteria:
Inclusion Criteria:

* healthy, full-term infant
* aged 14-28 days at Visit 1
* willingness of parents to be notified of incidental findings from study procedures

Exclusion Criteria:

* born preterm
* implanted metal or electronic objects that render MRI unsafe
* unable to complete 2 clinic visits 1-10 days apart at Pennington Biomedical Research Center
A Study of the Effects of Fish Protein Intake on Glucose Regulation in Overweight and Obese Adults.

The purpose of this study is to compare the possible health benefits of intake of proteins from salmon, herring, cod and milk on glucose tolerance in overweight and obese adults. Overweight and obese subjects often have reduced glucose tolerance, and previous findings from a study on cod proteins suggested that glucose tolerance was improved.

Participants receive 2.5g protein per day for 8 weeks as tablets.

Eligibility Criteria:
Inclusion Criteria:

* BMI above 27 kg/m2
* healthy

Exclusion Criteria:

* fasting blood glucose above 7 mM
* medication that affects blood glucose, lipids and inflammatory status
* pregnancy or breastfeeding
* allergies to fish or milk
* intentional weight loss and large fluctuation in body weight
* a high consumption of fish
* an extreme diet
* use of fish oil, n-3 or multivitamin supplements
Comparison of New Suture Anchor Technique for Bony Mallet Injury Versus Conservative Treatment

This study aims to compare conservative treatment versus a new suture anchor technique for bony mallet finger in 29 patients.

This study aims to compare conservative treatment versus a new suture anchor technique for bony mallet finger in 29 patients who presented to investigators' clinic between 2013 and 2015. Patients were randomly assigned to conservative or surgical treatment groups. Patients in the conservative group were followed with immobilization with aluminum splint and physical therapy. Patients in the surgical group were treated with investigators' new surgical suture anchor technique and then received physical therapy. The patients were followed for 12 months. Primary study outcomes were extension deficit, days to return to work and DIP flexion.

Eligibility Criteria:
Inclusion Criteria:

* Wehbe Schneider type 1 - 2 and type A - B fractures
* ability to provide closed reduction
* patients' voluntariness

Exclusion Criteria:

* Wehbe Schneider type C and type 3 fractures