cyrilzakka/clinical-trials huggingface dataset:
Non-Opioid Prescriptions After Arthroscopic Surgery in Canada (NO PAin)

This is a randomized controlled trial of 200 patients between the ages of 18 and 65 years undergoing outpatient knee or shoulder arthroscopy. Patients will be evaluated clinically at 2 and 6 weeks post-operatively. Patients will be recruited from experienced arthroscopic surgeons at 3 hospital sites in Hamilton, Ontario. All research will be conducted according to international standards of Good Clinical Practice and institutional research policies and procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing outpatient knee or shoulder arthroscopy for any of the following procedures: ACL reconstruction (with or without LET), MPFL reconstruction (not including TTO), Chondroplasty, Meniscectomy, Meniscal repair Meniscal transplant, Microfracture, ACI, Fixation of unstable osteochondral lesion, Subacromial decompression, Rotator cuff repair, Shoulder stabilization, Superior capsule reconstruction, Biceps tenotomy/tenodesis, Capsular release, SLAP repair, Diagnostic arthroscopy, Irrigation and/or debridement, Loose body removal, Synovectomy
2. Patients aged 18 years and older
3. Patients who have the ability to speak, understand, and read English
4. Provision of informed consent

Exclusion Criteria:

1. Patients who take or are on a home dose of an opioid medication (i.e. once daily or more)
2. Patients involved in ongoing litigation or compensation claims for any injury (e.g. Work Safety Insurance Board, WSIB)
3. Patients involved in another research study that requires a specific post-operative pain control medication regimen
4. Patients undergoing a knee or shoulder arthroscopy procedure that will likely have an operative time greater than 3 hours
5. Patients who will undergo concomitant open surgery
6. Patients who require overnight admission
7. Patients with a contraindication or allergy to NSAIDs, acetaminophen, or morphine and hydromorphone
8. Patients diagnosed with renal disease or cardiac disease
9. Patients who are scheduled for/plan to have an additional surgical procedure during the 6-week follow-up period
10. Patients who will likely have problems, in the judgement of the investigator, with maintaining follow-up
11. Any other reason(s) the investigator feels is relevant for excluding the patient
The Valid of GFR in Chronic Kidney Disease Patients

Study was cancel due to principle investigator had been resigned

Study was cancel due to principle investigator had been resigned

Eligibility Criteria:
Inclusion Criteria:

* Age more than 16

Exclusion Criteria:

* none
Compressive Stockings Therapy After TKA

Due to swelling after total knee arthroplasty, postoperative mobilization and training is impeded in addition to higher pain level in patients. With postoperative compressive stockings to prevent oedema, haematoma and postoperative pain we would like to investigate if compressive stockings reduce postoperative swelling and pain and furthermore improve mobilization and knee function.

In this randomized controlled trial, 88 patients are randomized in two groups. One group receives postoperatively compressive stockings for a period of 6 weeks. The control group is treated without compressive stockings. The patients compressive stockings wearing compliance is controlled with a temperature sensitive sensor. The patients will be informed about the implantation of the sensor.

Outcome measures are knee- calf- and ankle swelling in mm, pain, WOMAC and KSS score preoperatively and at 12 weeks, 12 months and 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving a total knee replacement
* Written consent of the study participant

Exclusion Criteria:

* Peripheral arterial disease II, III or IV
* Diabetes mellitus
* Systemic inflammatory diseases
* Benign or malignant neoplasms
* Revision interventions
* Right heart failure
* pulmonary edema
* Open / chronic skin lesions
The Effects of Oxytocin on Social Touch

The main aim of the study is to investigate whether intranasal oxytocin (24IU) can enhance hedonic experience and associated brain-reward reward responses to social touch.

A double-blind, within-subject, placebo controlled design is employed in this study. In total 50 healthy male subjects will be recruited and they will come twice, once with the administration of oxytocin nasal spray and the other placebo (interval time is more than 2 weeks). 45 minutes after treatment subjects will be applied two different types of pleasant touch: social touch from a masseur (professional therapist) and non-social touch from a massage device. After each condition the subjects will be asked to rate pleasantness, likability, and arousal. Simultaneously functional brain activity will be acquired via fMRI. Blood samples will be taken before and after the intervention to assess oxytocin levels. All subjects were asked to complete a range of questionnaires measuring trait personality and mood: Beck Depression Inventory (BDI), Cheek and Buss Shyness Scale (CBSS),Autism Spectrum Quotient (ASQ), Empathy Quotient (EQ), NEO Five Factor Inventory (NEO-FFI), Liebowitz Social Anxiety Scale (LSAS),Behavioral Inhibition System and Behavioral Activation System Scale (BISBAS),Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ),State-Trait Anxiety Inventory (STAI), Social Touch Questionnaire (STQ), Sensory over Responsivity Scale (SOR) and Under Responsivity Scale (URS) one day before the first scanning. On the first and second scanning day, the subjects were asked to complete Positive and Negative Affect Schedule (PANAS) before and after treatment administration.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without any past or present psychiatric or neurological disorders

Exclusion Criteria:

* History of brain injury
* Medical or mental illness
A Study to Compare the Use of Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency

The purpose of this study is to determine, relative to placebo, the effect of iron repletion therapy using intravenous (IV) ferric carboxymaltose on exercise capacity in patients with chronic heart failure and iron deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF
* Reduced left ventricular ejection fraction
* Capable of completing 6 minute walk test
* At least 18 years of age and with written informed consent prior to any study specific procedures

Exclusion Criteria:

* Erythropoietin stimulating agent (ESA) use, IV iron therapy and/or blood transfusion in previous 6 weeks prior to randomisation
* Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months
* Chronic liver disease and/or elevated liver enzymes
* Vitamin B12 and/or serum folate deficiency
* Subject is not using adequate contraceptive precautions during the study
* Body weight ≤ 35 kg
* No other significant cardiac or general disorders that would compromise the ability to give informed consent and/or comply with study procedures
OSA (oRisk of Obstructive Sleep Apnea and Traffic Accidents Among Bus Drivers in Ecuador: is There a Significant Association

Our study aims to determine the frequency of individuals at high risk of obstructive sleep apnea, and excessive daytime sleepiness, as well as any potential association between these conditions and traffic accidents among a sample of Ecuadorian bus drivers.

We conducted a cross-sectional study from September 2019 to January 2020 among 340 male professional bus drivers in the city of Guayaquil, Ecuador. To be included in the study, participants were required to be male, have an unexpired professional driver's license, as well as being currently enrolled at any local transformational company. Individuals who did not met the inclusion criteria, or who declined voluntary participation were excluded from the study. We screened 340 male professional bus drivers whose mean age was 44.3. We analyzed demographic and clinical variables including age, educational level, associated comorbidities (hypertension and diabetes), years as a professional driver, and number of accidents and near-accidents while working. Accidents were defined as a collision involving the vehicle in which the participant was the driver and another vehicle or stationary obstruction. Near-accidents were defined as unplanned events involving the driver that did not result in injury but had the potential to do so. We used STOP questionnaire to assess four questions related to snoring, tiredness during daytime, observed apnea, and high blood pressure (STOP), and the Bang aspect for screening BMI ≥ 35, age ≥ 50, neck circumference \> 40 cm and male gender. Also, we used Epworth Sleepiness Scale (ESS) to assess excessive daytime sleepiness (EDS).

Eligibility Criteria:
Inclusion Criteria:

* Male
* Have an unexpired professional driver's license
* Being currently enrolled at any local transformational company

Exclusion Criteria:

* Not meeting inclusion criteria
* Declined voluntary participation
Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase)in Patients With Pancreatic Cancer

The interest in using L-asparaginase in pancreatic cancer arose from in vitro and in vivo studies data showing an anti-neoplastic effect on pancreatic tumor cell lines. Interestingly, these studies suggest an additional effect of L-asparaginase associated to gemcitabine.GRASPA is a suspension of red blood cells encapsulating L-asparaginase. The aim of this phase I clinical trial is to evaluate the Maximum Tolerated Dose (MTD) of GRASPA on locally advanced or metastatic pancreatic tumors, after therapy failure of first or second line chemotherapy using gemcitabine.


Eligibility Criteria:
Inclusion Criteria:

* Exocrine pancreatic adenocarcinoma cytologically or histologically confirmed
* Locally advanced and non-resectable with invasion of the superior mesenteric artery (stage III) or metastatic (stage IV) as defined by TNM (primary tumor, regional nodes, metastasis) 2002 classification (UICC 2002)
* resistant to a first or second line chemotherapy with gemcitabine
* Patient aged between 18 to 70 years
* Signed Informed Consent Form
* Life expectancy ≥ 12 weeks
* Accurate measurement of tumor volume by imagery (in at least one dimension)
* Presence of one or several tumor markers (carcinoembryonic antigen \[CEA\] and cancer antigen \[CA\] 19.9)
* Eastern Cooperative Oncology Group \[ECOG\] Prognostic Score : 0, 1 or 2
* Patient beneficiary of a Social Security Insurance

Exclusion Criteria:

* Patient with an endocrine or acinar pancreatic tumor
* Patient with known or suspected cerebro-meningeal metastases
* Haemoglobin level greater than 13 g/L
* Patient hypersensitive to L-asparaginase or have had prior exposure to any form of L-asparaginase
* Splenic vein thrombosis \< 3 months or under active treatment
* Anti-vitamin K treatment
* Hepatic Insufficiency unrelated to pancreatic cancer
* Renal insufficiency unrelated to pancreatic cancer
* Pancreatitis or pancreatitis history unrelated to pancreatic cancer
* Insulin-dependant diabetes mellitus unrelated to pancreatic cancer
* Current or prior coagulopathy disorders unrelated to pancreatic cancer
* ECOG Prognostic Score 3 or 4
* History of grade 3 blood transfusion reaction (life threatening situation)
* Presence of rare and dangerous anti-erythrocyte antibodies preventing from getting a compatible packed Red Blood Cells for the patient
* Patient already included in another clinical trial
* Pregnancy, breast-feeding or absence of secured contraception
* Unwillingness to sign the informed consent form
Chromosome Abnormalities in Chronic Myeloid Leukemia (CML) on Imatinib. GIST Patients on Imatinib

In order to distinguish between clonal instability driven by imatinib in CML and actual changes with secondary clones induced by imatinib we would like to investigate the karyotype of non-CML patients treated with imatinib such as GIST patients.

Chronic myeloid leukemia (CML) is a myeloproliferative disorder characterized by the presence of the Philadelphia (Ph) chromosome - a t(9:22) translocation that results in the production of a BCR/ABL fusion protein with Abl kinase activity.

Imatinib mesylate (Gleevec) specifically targets a limited set of protein tyrosine kinases - ABL, Arg (Abl-related gene), c-Kit, platelet-derived growth factor receptor (PDGF-R) - and their oncogenic forms, most notably BCR/ABL Imatinib is also a potent inhibitor of a receptor-type c-Kit tyrosine kinase. Therefore imatinib was examined for therapeutic efficacy against malignant gastro-intestinal stromal tumors (GIST) Recent articles have drawn attention to the development of new Ph-negative, cytogenetically unrelated clones after therapy of Ph-positive CML with imatinib. Trisomy 8 and monosomy 7 are the most frequent defects, but other aberrations have also been reported. Some of these cytogenetic abnormalities are associated with acute myeloid leukemia and MDS.

Eligibility Criteria:
Inclusion Criteria:

* GIST patient on Imatinib for more than 12 months

Exclusion Criteria:

* nil
Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)

This is a prospective, non-randomized, observational, multicentre (5 sites) study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a TVT SECUR operative procedure.

The study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires, Intraoperative procedural data will be collected.

Postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals up to 24 months. The anatomic position of the device will be characterize by transvaginal ultrasound testing.

To determine the rate and/or improvement rate of patients who have received the Gynecare Secur device after 12 months and after 24 months.


Eligibility Criteria:
Inclusion Criteria:

To be considered eligible to participate in this study, subjects must meet the following requirements:

1. Subject has agreed to undergo surgical implantation of the TVT SECUR System
2. Subject has the complaint of SUI for at least 6 months prior to the Preoperative Evaluation Visit.
3. Subject has confirmed SUI resulting from urethral hypermobility on cough stress testing.
4. Subject has at least 4 gm of urine leakage on 1-hour pad testing during the Preoperative Screening Visit.
5. Subject is at least 18 years of age to maximum of 85 years of age
6. Subject is willing and able to give written informed consent prior to any study related procedures.
7. Subject is willing to return for follow-up evaluation and questionnaire completion at 4-6 weeks, and at 3, 6, 12 and 24 month follow-ups.
8. Subject is willing to undergo transvaginal ultrasound evaluation at the 4 weeks and 12 month follow-up visit.

Exclusion Criteria:

Subjects will not be eligible for entry into the study if they meet one of the following criteria:

1. Subject is pregnant.
2. Subject has had any previous synthetic sub-urethral sling procedure.
3. Subject has current urinary tract or vaginal infections.
4. Subject has blood coagulation disorders.
5. Subject has a compromised immune system or any other conditions that would compromise healing.
6. Subject has upper urinary tract obstruction.
7. Subject is unwilling to provide written informed consent.
8. Subject is unwilling or unable to return for evaluation at 4-6 weeks, and at 3, 6, 12, and 24 months.
9. Subject has uncontrolled detrusor overactivity.
10. Subject has PVR greater than 100 cc.
11. Subject has Peak Flow Rate less than 10 ml/sec.
12. Subject has urethral diverticulum.
13. Subject has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.
14. Subject has had radiation therapy to the pelvic area at any time.
15. Subject has current or active history of pelvic cancer.
16. Subject who in the opinion of the investigator is unable and/or unlikely to comprehend the nature, scope and possible consequences of the study and to follow the study procedures and instructions and complete all study related measurements.
DISCO - Influence of a Simple Information Booklet on the Evolution of Acute Low Back Pain (LBP)

To assess the impact of standardized written information on outcome in acute LBP.

A 3-month prospective, controlled study with a quasi-experimental design (i.e., a nonrandomized controlled sample with geographic stratification \[30 areas\]). Control and intervention areas ARE selected for their similarities in rural-to-urban distribution of the population and patients' access to GPs and to minimize risk of overlap between areas.

Eligibility Criteria:
Inclusion Criteria:

* Each GP have to enroll up to 4 patients with acute LBP.

Exclusion Criteria:

Patients are excluded if they

1. are less than 18 years old;
2. have pain for more than 4 weeks;
3. have pain intensity for the previous 24 hours less than 3 on a 11-point numeric scale (0= no pain, 10=maximal pain);
4. have sciatica;
5. have had a previous episode of acute LBP during the last 12 months;
6. have no occupational activities;
7. have consulted another practitioner for the same episode of back pain;
8. are pregnant;
9. have back pain related to infection, tumor, or inflammatory disease; or (j) have previously undergone back surgery.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Diffusion MRI and Growth Plate Injuries: Pilot Study

Children who suffer fractures to the growth plates (physes) of their bones are at risk for premature growth arrest which can lead to long term complications. There is currently no technique to predict who is at risk of growth arrest following a physeal injury. The investigators aim to determine if diffusion MRI (an imaging method to analyze tissue properties) can effectively pick up differences between a healthy growth plate and an injured one. This would allow orthopaedics surgeons to predict which injuries are at a higher risk of growth arrest, so earlier interventions can be done in the orthopaedic clinic.

The purpose of this study is to determine if diffusion MRI can be used for tissue characterization in childhood and adolescent growth plate injuries, and to get a better understanding of the physiologic disturbance of an injured physis

Eligibility Criteria:
Inclusion Criteria:

* Salter-Harris Type II, III, or IV fracture through the distal radius
* Growth plates are open
* Ages 8-12
* Able to consent in English

Exclusion Criteria:

* All fractures not sustained to distal radius
* SH Type I or V fracture
* Injury to contralateral limb
* Previous injury to distal radius
* Diseases known to alter bone healing or growth\]
* Contraindications to undergoing an MRI scan
Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)

A clinical study to determine the safety, efficacy and the way sitagliptin works in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.


Eligibility Criteria:
Inclusion Criteria:

* Participant has type 2 diabetes mellitus
* Males
* Females who are highly unlikely to become pregnant
* Participants poorly controlled without taking any, or taking one or two oral antidiabetic medications

Exclusion Criteria:

* Participant has a history of type 1 diabetes mellitus or history of ketoacidosis
* Participant required insulin therapy within the prior 8 weeks
* Participant is on or has been taking TZDs such as Actos® (pioglitazone) or Avandia® (rosiglitazone) within the prior 12 weeks of the screening visit
A Single-center Study on the Effect of Systemic/Selective Lymph Node Dissection on the Prognosis of Ground Glass Nodules Smaller Than 3cm and With Components With Consolidation/Tumor Ratio Between 0.5-1

A single-center study on the effect of systemic/selective lymph node dissection on the prognosis of ground glass nodules smaller than 3cm and with components with consolidation/tumor ratio between 0.5-1

A single-center study on the effect of systemic/selective lymph node dissection on the prognosis of ground glass nodules smaller than 3cm and with components with consolidation/tumor ratio between 0.5-1

Eligibility Criteria:
Inclusion Criteria:

Patients enrolled in the study must meet all of the following conditions:

* 1.Aged between 25 and 75 years;
* 2. GGO is diagnosed by thin-section lung CT (thickness \<1.5mm) within one month before surgery;
* 3. The maximum diameter of the GGO is smaller than 3cm;
* 4. The solid component in GGO between 50%-100%;
* 5. Preoperative examination showed that the patient could tolerate lobectomy;
* 6. The patient is able to understand and comply with the study and has provided written informed consent.

Exclusion Criteria:

Patients meeting any of the following criteria are not eligible for this trial:

* 1. Patients with a history of lung surgery;
* 2. Postoperative pathology showed non-primary lung cancer;
* 3. The scope of surgical resection is larger than one lung lobe;
* 4. Patients with a history of other tumors;
* 5. Patients with severe complications (coronary heart disease, valvular heart disease, end-stage renal disease, severe liver cirrhosis);
* 6. Unable to cooperate with the researchers because of dementia or cognitive decline
* 7. Other situations that are not in conformity with the standards and requirements of this trial.
Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery

The purpose of this six site multi-center study is to determine if BTX-A can alleviate the post-operative pain and improve the functional and quality of life outcomes of children with limb length discrepancy or angular deformity undergoing limb lengthening or deformity correction.

The specific aims are to determine if BTX-A will:

* 1a. Reduce pain post operatively and during the distraction and consolidation process,
* 1b. Reduce the amount, frequency and duration of narcotics taken in the postoperative period.
* 2. Improve the quality of life during the distraction and consolidation process.
* 3 Decrease muscular spasm and subsequent muscle contracture during the distraction and consolidation process and accelerate earlier return to pre-operative mobility function including earlier weight bearing.
* 4. To develop clinical practice guidelines for the interdisciplinary care of children undergoing limb lengthening or deformity correction.

Methodology: A randomization process for this one time injection will be used to determine who will receive the BTX-A or the placebo. 150 subjects will be recruited; 75 to the BTX-A group and 75 to the placebo group. There will be an equal number of subjects in each group at each site. The medication will be injected intraoperatively into specific major muscles in the lower limb adjacent to the bone or soft tissue being lengthened or corrected at a dose of 10 U/kg with a maximum of 50 U per site, not to exceed a total maximum dose of 400 units. Pain scores, medication dosages, range of motion and an ambulation scale will be measured post-operatively and during the distraction and consolidation phases.

In addition families will be asked to complete six different questionnaires related to pain, quality of life and psycho-social issues at various times during the process. The children will receive standard nursing care and physical therapy and will be followed for three months after the external fixator is removed, for a total time of approximately one year.

Eligibility Criteria:
Inclusion Criteria:

* Age: 5 to 21 years.
* Aetiology of the deformity: congenital or acquired.
* Amount of lengthening or deformity correction: any amount.
* Site of lengthening or deformity correction: lower extremity.
* Type of fixator: circular or uniplanar.

Exclusion Criteria:

* Children younger than 5 years of age.
* Associated neuromuscular conditions that may hinder weight bearing.
* Individuals on aminoglycosides, as aminoglycosides can potentiate the effect of Botulinum toxin A.