cyrilzakka/clinical-trials huggingface dataset:
European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms

INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of INCRAFT in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 150 subjects will be enrolled and followed through 5-years post procedure. Up to 25 sites in Europe may participate.

INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of INCRAFT in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 150 subjects will be enrolled and followed through 5-years postprocedure. Up to 25 sites in Europe may participate. Subjects will be enrolled and followed at 1 month and 6 month post-procedure and annually up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female age 18 years or older
2. Femoral access vessels should be adequate to fit the selected delivery system
3. Proximal neck length ≥ 10mm
4. Aortic neck diameters ≥ 17mm and ≤ 31mm
5. Aortic neck suitable for suprarenal fixation
6. Infrarenal and suprarenal neck angulation ≤ 60°
7. Iliac fixation length ≥ 15mm
8. Iliac diameters ≥ 7mm and ≤ 22mm
9. Minimum overall AAA treatment length (proximal landing location to distal landing location) ≥ 128mm
10. Morphology suitable for aneurysm repair
11. Provide written informed consent and as applicable written confidentiality authorization prior to initiation of study procedures
12. Subject is willing to comply with the specified follow-up evaluation schedule

Exclusion Criteria:

1. Subject has one of the following:

   1. Aneurysm sac rupture or leaking abdominal aortic aneurysm
   2. Mycotic, dissecting, or inflammatory abdominal aortic aneurysm
2. Known allergy or intolerance to nickel titanium (nitinol), Polyethylene terephthalate (PET), or polytetrafluoroethylene (PTFE)
3. Known contraindication to undergoing angiography or anticoagulation
4. Existing AAA surgical graft and/or a AAA stent-graft system
5. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial
Does Preventive Dexketoprofen Reduce Pain After Orthognathic Surgery

Background The purpose of this study was to evaluate the effect of a single-dose intravenous dexketoprofen administration for preventive analgesia on postoperative pain and reducing swelling in double jaw surgery.

Material and Methods The authors designed a prospective, randomized, and double-blind cohort study. Patients who have Class III malocclusion were randomly divided in two groups. 50 mg intravenous dexketoprofen trometamol were administrated 30 minutes before incision in treatment group, while intravenous sterile saline was administrated 30 minutes before incision in placebo group. The primary predictor variable was treatment group. Primary outcomes were pain, swelling and 24-hour opioid intake. Patient- controlled analgesia with tramadol was given for management of postoperative pain. Other variables were demographic and operation related parameters. Visual analogue scale was used to evaluate postoperative pain. 3dMD Face System (3dMD, USA) was used to measure postoperative swelling. Data were analysed using two independent samples t test and Mann Whitney U test.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for this study were as follows;
* patients,
* 18-45-year-olds,
* ASA I status,
* Class III malocclusion,
* elective double jaw surgery.

Exclusion Criteria:

* Exclusion criteria were ASA II and above,
* drug allergy,
* liver and kidney failure,
* pregnant or breastfeeding,
* long-term use of pain relievers such as NSAIDs and opioids,
* diabetes
CT Analysis of the Patellofemoral Joint in Patients Having Knee Surgery

The primary hypothesis is that measures of patellofemoral alignment obtained from the investigational cone beam CT scanner will be reduced, but still correlated to those obtained from the conventional CT scan.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed with acute or chronic patellar malalignment.
* At least 16 years old
* Be willing and able to provide informed consent

Exclusion Criteria:

* Open growth plates
* Previous knee surgery on the affected knee
* Pregnancy (females)
* Fracture of the patellofemoral joint
* Knee ligament injury (other than medial patellofemoral ligament)
* Have greater than Grade II degenerative changes of the patellofemoral joint
* Inability to bear weight on the extremity during the CT scan
Cardiovascular Responses in Congestive Heart Failure With Cheyne- Stokes Respiration

The purpose of the trial is to investigate the cardiovascular response to peripheral chemoreceptor stimulation in Congestive Heart Failure with Cheyne- Stokes Respiration


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe heart failure (NYHA Class II or above) on optimal medical therapy
* LVEF less than or equal to 45%
* Stable condition as defined as no hospital admission or changes to medical therapy within two weeks prior to enrolment

Exclusion Criteria:

* Patients taking known respiratory stimulants or depressants
* Clinically significant asthma requiring therapy
* Significant parenchymal lung disease
* Primary pulmonary hypertension
* Myocardial infarction within three months prior to enrolment
* Patients with cardiac resynchronisation devices and permanent pacemakers
* Anaemic (haemoglobin \< 12g/dL)
Hepatic De Novo Lipogenesis (DNL)in the Pathogenesis of Hepatic Steatosis in Obese Youth

Nonalcoholic Fatty Liver Disease (NAFLD) is becoming the most common cause of liver disease in pediatrics, but little is known about its pathophysiology in children. While studies in obese adults with hepatic steatosis have described an increased hepatic de novo lipogenesis (DNL) depending on the diet, there are no studies exploring the mechanisms by which excess hepatic triglycerides increases in obese youths, thus explaining the accompanying dyslipidemia and the metabolic syndrome. The central hypothesis of this study is that hepatic conversion of carbohydrates to lipid (DNL) is enhanced and associated with accumulation of excess liver fat, dyslipidemia and hepatic insulin resistance in obese youths with hepatic steatosis. The overall goal is to examine whether hepatic DNL is increased in obese youths with steatosis compared to matched controls without steatosis.

Hypotheses: Hepatic conversion of carbohydrates to lipid (DNL) is enhanced and is associated with accumulation of excess liver fat, dyslipidemia and hepatic insulin resistance in obese youths with hepatic steatosis.

In this study obese youths, adolescents and young adults (12-30 years) will undergo MRI (magnetic resonance imaging) measurement of liver lipid content to determine hepatic fat content. They will undergo a sugary drink (75 grams of glucose and 25 grams of fructose) challenge and Hepatic de novo lipogenesis will be determined as the incorporation of deuterium, from deuterium labeled water (D2O), into plasma triglycerides. Subjects will undergo a 6 hours study assessing de novo lipogenesis, an oral glucose tolerance test, dual energy x-ray absorptiometry, magnetic resonance imaging, and Euglycemic-Hyperinsulinemic Clamp.

This study record has been re-opened in 2019 and updated to reflect any changes having remained open since its inception with the Yale University IRB and also having obtained additional funding though NIDDK.

Eligibility Criteria:
Inclusion Criteria:

* Cases will meet the following criteria:

  * BMI higher than 75th percentile
  * Hepatic fat fraction (the amount of fat into the liver) greater or equal than 5.5%
  * Absence of any endocrinopathy
  * Absence of any therapy with medication known to alter glucose metabolism

Controls will meet the following criteria:

* BMI higher than 75th percentile
* Hepatic fat fraction (the amount of fat into the liver) lower than 5.5%
* Absence of any endocrinopathy
* Absence of any therapy with medication known to alter glucose metabolism
* Absence of any therapy with medication known to alter glucose metabolism

Exclusion Criteria:

* BMI under the 75th percentile
* Hepatic fat fraction (the amount of fat into the liver) less than 5.5%
* Absence of any endocrinopathy
* Any therapy with medication known to alter glucose metabolism

Controls will meet the following criteria:

* BMI under the 75th percentile
* Hepatic fat fraction (the amount of fat into the liver) greater than or equal to 5.5%
* Any endocrinopathy
* Any therapy with medication known to alter glucose metabolism
Non-contact Boxing Training and Traditional Therapeutic Exercise for Persons With Parkinson's Disease

The primary purpose of this study is to compare the effects of a non-traditional boxing training program to a traditional therapeutic exercise program on activity and participation outcomes in persons with Parkinson's disease. Thirty participants will be randomly assigned to participate in either non-contact boxing training or traditional therapeutic exercise for 36 sessions over 12 weeks. Participants will be measured immediately before (pre-test) and after (post-test) the intervention.

Physical therapists commonly treat patients with Parkinson's disease. Typical clinical interventions used by physical therapists including strengthening, stretching and aerobic training have been shown to improve function and quality of life of persons with Parkinson's disease. Alternative exercise interventions that incorporate non-traditional concepts, such as tango dance, tai chi and taiji have also been found to lead to improvements in function in persons with Parkinson's disease. It is important that comparisons between different types of exercise programs for persons with Parkinson's disease be explored in order to determine effective options for care.

Here in Indianapolis, Indiana, individuals with Parkinson's disease have a unique opportunity for alternative exercise with the recent development of the popular non-contact boxing training program offered by the Rock Steady Boxing Foundation. Therefore, the purpose of this study is to compare the effects of the non-traditional boxing training program to a traditional therapeutic exercise program on activity and participation outcomes in persons with Parkinson's disease.

Thirty participants with Parkinson's disease will be recruited from Central Indiana. All potential participants will be screened to determine eligibility for the study. Participants who are eligible and give consent will be randomly assigned to participate in either the non-contact boxing training or the traditional therapeutic exercise program for 36 sessions lasting over 12 weeks with 60-90 minutes of exercise each session. Participants will be measured immediately before (pre-test) and after (post-test) the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Parkinson's disease
* currently not receiving physical therapy services
* medically stable with a physician release stating approval to enter an exercise program
* independently ambulatory in the home setting with or without the use of an assistive device
* able to follow at least three step verbal commands
* available for the entire period of the study
* have transportation to and from training and measurement sessions

Exclusion Criteria:

* preexisting neurological conditions other than Parkinson's disease
* current musculoskeletal conditions that would limit participation in either training program
* significant orthopedic surgery within the past six months
* past brain surgery or brain stimulator implant
* currently known pregnant
* pre-existing cardiovascular conditioner that would prohibit participation in an exercise program
Prediction of Recruitment Potential of Participating Centers in Clinical Trials by Standardized Translation of Selection Criteria and Queries From DRG Database

This retrospective study aims to assess, on a large number of clinical trials (CT), the usefulness of converting CT eligibility criteria into standardized queries performed on commonly available data, i.e. Diagnosis Related Groups (DRG) databases in order to estimate the potential recruitment of clinical trials centers.

Efficacy of this Clinical Trial Recruitment Support Systems (CTRSS) will be checked against thorough examination of patient files.

Primary objective is to estimate the precision of the prediction system, i.e. ratio of numbers of eligible patient files / numbers of candidate patient files.

As secondary objectives, the study aims:

* to measure the recall rate or sensitivity of the system: ratio of number of candidates patient files / number of recruited patients;
* to measure the ability of coding: proportion of codable criteria (inclusion criteria or non inclusion criteria) into normalized language;
* to measure the time required for coding criteria and the time required to execute the queries on the national DRG database;
* to evaluate the reliability of coding process by an independent coding of a random sample of 30 protocols;
* to analyse influence of characteristics of the clinical study (design, disease, ...) and of the investigation site (volume, teaching status, ...) on the precision and sensitivity of the prediction system.

The study will be performed on a large sample (near 100) of multicenter terminated clinical studies with public funding covering therapeutic, diagnostic or prognostic studies. Selection (inclusion, non inclusion) criteria of each CT will be translated into a normalized description using ICD10 and french nomenclature of medical or surgical procedures (CCAM, Classification Commune des Actes Médicaux), these very nomenclatures being used in the french DRG system. Then a dedicated program will query the French DRG national database called PMSI (Programme de Médicalisation des Systèmes d'Information).

For each CT and for each center, the query will select "candidate" patients whose eligibility will be checked by thorough examination of the whole patient file by dedicated data extractors. In addition, already recruited patients will be compared to the prediction of the system.

Collected data span the period between 2010 and 2014, as well as with the medical files.

Eligibility Criteria:
Inclusion Criteria:

* Multicenter trials.
* Trials that have been completed between 2012 and 2014.
* Sponsors and principal investigators of trials belonging to the public hospital system of the region of Paris (Ile de France).

Exclusion Criteria:

* Trials in the domain of rare diseases.
* Trials involving children.
Neuroplastic Change in Myelin of the Brain

The main goal of this research is to advance understanding of how stroke changes both the structure and function of the brain. The investigators will determine which is the key driver of recovery of arm function after stroke: changes in the structure of the brain or changes in how brain regions interact with one another.

The main goal of this research is to advance understanding of how stroke changes both the structure and function of the brain. Further, the investigators will determine which is the key driver of recovery of arm function after stroke: changes in the structure of the brain or changes in how brain regions interact with one another. Together, these data will advance the investigators understanding of how neural systems support recovery from stroke. The investigators will use a MRI technique that allows us to assess the health of a brain structure called myelin. This structure is important as it allows information to travel down nerves faster; the more myelin the quicker the signal can be conducted. The investigators aim is to test whether or not movement training can restore myelin in the brain. If movement training does restore myelin in the brain, the investigators will have identified an important new target for rehabilitation interventions.

Eligibility Criteria:
Inclusion Criteria:

* individuals aged 40-75
* movement-related deficits associated with a middle cerebral artery stroke
* first time stroke affecting the corona radiata and/or internal capsule
* Fugl-Meyer upper extremity motor score of at least 15 but not greater than 55.

Exclusion Criteria:

* outside the age range of 40-75
* show signs of dementia (score \< 24 on the Montreal Cognitive Assessment)
* have aphasia (score \< 13 on the Frenchay Aphasia Screen)
* history of head trauma, a major psychiatric diagnosis, neurodegenerative disorder or substance abuse;
* taking any drugs (GABAergic, N-methyl-D-aspartate A-receptor (NMDA) antagonist) known to influence neuroplasticity;
* report contraindications to MRI (see supporting documents)
Trial of Steroid Avoidance and Low-dose CNI by ATG-induction in Renal Transplantation

Balancing immunosuppressive treatment in organ transplantation in order to achieve effective prevention of rejection on one side and avoidance of negative side effects on the other side is a major challenge, leading to developing different immunosuppressive protocols. Cornerstones of immunosuppressive treatment such as Corticosteroids (CS) and Calcineurin Inhibitors (CNI) are known to cause an increased incidence of diabetes, cardiovascular morbidity, nephrotoxicity and malignancies.

The investigators believe that both avoidance of CS and minimization of CNI, while using Anti-ThymocyteGlobuline(ATG) induction (instead of interleucin-2 receptor blockers) and mycofenolate mofetil(MMF) therapeutic drug monitoring is going to reduce negative side effects, without increased rejection frequency in renal transplanted patients.


Eligibility Criteria:
Inclusion Criteria:

* First or second single kidney (cadaveric or living donors) transplant recipients.
* Considered for a standard immunosuppressive protocol.
* Must be capable of giving written informed connect for participation in the study for 24 months.

Exclusion Criteria:

* Diabetes mellitus or plasma glucose \>11,1 at admission.
* Receiving steroids at the time of transplantation or likely to need steroids after transplantation.
* Multiorgan transplants and/or previously transplanted with any other organ than kidney.
* Panel reacting antibodies(PRA) \>25% in most recent test or considered to be of high risk for rejection which requires an enhanced immunosuppression.
* Renal transplants from HLA-identical sibling.
* Hypersensitivity to, or disability to take immunosuppressive drugs.
* Blood group(ABO)-incompatible transplants.
* Unlikely to comply with the study requirements.
* Transplant from donor positive for HIV, HBsAg, Hepatitis C.
* Female of childbearing potential planing/being pregnant or unwilling to use contraception.
Early Administration of Aspirin in Patients With Acute Ischemic Stroke Treated With Systemic Thrombolysis

The aim of this study is to determine whether early administration of aspirin in acute ischemic stroke patients treated with systemic thrombolysis is safe and can improve outcomes due to decreasing the number of early rethromboses.

According to the current guidelines (European Stroke Organisation, 2009; American Heart Association-American Stroke Association, 2013) on the systemic thrombolysis in ischemic stroke patients it is recommended (class C) to start antithrombotic therapy (including antiplatelets and anticoagulants) when 24 hours go after alteplase (rtPA, recombinant tissue plasminogen activator) administration. Meanwhile rtPA has wery short lifetime in blood (T1/2 4-6 minutes). Some retrospective studies have found that early administration of antithrombotics (8-16 hours) after systemic thrombolysis can improve functional outcome and does not increase the risk of haemorrhage.

The investigators suggest a controlled prospective trial to recognise risks and benefits of early administration of aspirin (in 12 hours) after rtPA therapy in patients with acute ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* acute ischemic stroke patients treated with rtPA
* mRS score before current stroke \<4
* NIHSS score after rtPA treatment \<25

Exclusion Criteria:

* contraindications for treatment with aspirin
* contraindications fot iodinated radiocontrast agents administration
* intracranial haemorrhage after rtPA treatment
MiniLap Vs Standard Laparoscopy in Prophylactic Bilateral Salpingo-oophorectomy in BRCA-Mutated Patients

The study hypothesis is that surgical treatment performed with MiniLap results in reduced postoperative pain in a population of patients undergoing prophylactic laparoscopic adnexal surgery. The primary objectives are to assess differences in operative duration, intraoperative blood loss, and postoperative complications in patients undergoing bilateral laparoscopic adnexectomy performed with standard laparoscopy versus MiniLap. The secondary objectives of this study are to compare postoperative pain and patient satisfaction with aesthetic outcomes.

Patients with BRCA 1/2 mutations undergoing prophylactic surgery will be assigned to either MiniLap or standard laparoscopic treatment based on randomization. Subsequently, the necessary study data will be collected using the hospital's electronic management system and medical records.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing prophylactic bilateral adnexectomy via laparoscopic surgery.
* Patients with a germline mutation in the BRCA1/2 gene.

Exclusion Criteria:

* Patients who underwent additional surgery during the adnexectomy procedure.
* Patients in whom an intraoperative frozen section is required.
Population Burden of STI and Implication for Intervention in Hong Kong

This is a 5-year cross-disciplinary sexually transmitted infection (STI) project involving a) territory-wide and community-based studies (survey and specimen collection); b) simulation of STI transmission dynamics and comparison of STI intervention strategies through mathematical modelling and cost-effectiveness analysis. The aim of this project is to assess the burden and the transmission dynamics of STIs in the general population and men who have sex with men (MSM) in Hong Kong. Around 1300 sexually experienced adults and 900 MSM would be recruited, 100 participants would be invited for individual in-depth interviews. Main outcome measures include STI history and service preference, effectiveness as measured by the proportion of new STI infections (chlamydia, gonorrhoea and human papillomavirus infections) averted above base-case scenario, and incremental cost-effectiveness ratio.

After completion of baseline questionnaire, the participants are invitied for STI self-sampling. If agree, a package of self-sampling kits, instructions, and packaging materials for return post would be delivered to their selected collection points. The second round of self-sampling would be offered at least one year from the first round of self-sampled specimens collected.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 or above
* ever having sex
* normally living in Hong Kong
* can communicate in English or Chinese

Exclusion Criteria:

* failed to provide consent