cyrilzakka/clinical-trials huggingface dataset:
Crosscultural Adaptation And Validation Of The Italian Version Of The New Knee Society Knee Scoring System

The present study aims to be a multicenter prospective analysis aimed at validating the Italian version of the new KSS introduced in 2011 15. To do this it is first necessary to create the translation of the questionnaire. Several steps will be performed to obtain an adequate Italian version of the new KSS:

1. The English version of the KSS will be translated into Italian by 3 bilingual translators
2. The 2 versions will be submitted to the study collaborators (one per centre), the final version (accepted by all the study collaborators) will be translated back into English by 2 bilingual translators (native English) not aware of the initial version. The back translation will then be sent to the original author (Prof. Scott) to ensure that the consistency of the questionnaire has been maintained throughout all processes despite the necessary cultural adaptations.
3. Once the definitive version has been obtained, it will be tested by 300 Italian patients (with an estimated dropout of 20%) suffering from gonarthrosis. The patients will be distributed as follows: approximately 50 patients in each of the 6 centers (total 300). The number of patients was chosen considering approximately 17-18 patients for each of the 17 items, this choice is consistent with previously published studies on translation into other languages


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of gonarthrosis and indication for primary TKA surgery
* Age between 18 and 85 years
* Ability to respond to the proposed questionnaires and provide informed consent
* Availability for follow-up for one year after surgery

Exclusion Criteria:

* Concomitant hip or spinal problems, understood as a cause of patient discomfort even if not yet undergoing medical or rehabilitation therapy
* History of ipsilateral or contralateral knee surgery
* Congenital knee deformities
* Previous septic arthritis
* Neuromuscular pathology (e.g. polio)
* Simultaneous bilateral prosthesis or within 12 months of both knee, hip and ankle
Does Double With Regular Monitoring Prevent Undesired Tooth Movement?

The goal of observational study is to learn about the stability of orthodontic treatment results in orthodontic patients during retention phase of treatment.

The aim of the present study was to three-dimensionally analyze tooth movement in retention phase of treatment and wherever double effectively retention prevents it.

Eligibility Criteria:
Inclusion Criteria:

* Non-extraction treatment
* No hypodontia
* Normal occlusion after treatment (Class I occlusion), perfect alignment
* Normal overjet and overbite
* Double retention including fixed retainer bonded from canine to canine in both dental arches and thermally formed removable splint

Exclusion Criteria:

* Fixed orthodontic treatment in one dental arch
* Extraction cases
* Patient treated with orthognathic surgery
* Imperfect treatment result due to treatment cessation on patients demand or health issues
* Craniofacial disorders
Autism & Anesthetic Exposure Study

As anesthesia is often needed for childhood surgery and procedures, researchers have examined the potential effects of anesthesia on neurodevelopment. There are few studies that have examined the effect of anesthesia on neurodevelopment in children with confirmed diagnoses of ASD, and the results of these studies are mixed. Children with neurodevelopmental disorders can have age-dependent variations in brain anatomy, function, and connectivity, which may alter their sensitivity to the potential neurotoxic effects of anesthetic and sedative drugs. Given the potential adverse neurodevelopmental effects of anesthesia on typically developing children, it is important to examine if anesthesia exposure can worsen the clinical course of ASD.

We hypothesize that children with a confirmed diagnosis of ASD will regress developmentally following general anesthesia for dental surgery in comparison to children without ASD (controls) undergoing dental surgery. In this pilot study, we will investigate this hypothesis through the following objectives:

1. to determine in a clinical study if anesthesia induces post-operative persistent adverse changes children with ASD as compared with typically developing controls;
2. to determine the potential mechanism for the adverse effects of anesthetics on patients with ASD compared to healthy controls, peripheral blood mononuclear cells will be isolated from blood samples (PBMCs), before genomic DNA isolation for mitochondrial content analysis.

Eligibility Criteria:
Inclusion Criteria For Autism Spectrum Disorder Group:

* child is undergoing dental surgery
* child is aged 4 to 12 years
* child has mild-to-moderate diagnosis of autism spectrum disorder
* child has an American Society of Anesthesiologists (ASA) Physical Status level I or II

Exclusion Criteria for Autism Spectrum Disorder Group:

- child does not use words or phrases to communicate

Inclusion Criteria for Typically Developed Controls Group:

* child is undergoing dental surgery
* child is matched to an autism spectrum disorder participant according to age, gender, and ASA level
Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease

This study investigates whether the specific carbohydrate diet (SCD) can maintain clinical remission in pediatric and adult patients with Crohn's disease.

Patients will be seen in clinic at new diagnosis of Crohn's disease or a flare of existing disease. Potential subjects will be screened with for eligibility, followed by a baseline assessment by the clinic provider. Subjects who wish to participate will undergo further discussion with one of the study staff. At enrollment, a member of the study staff will explain the study to the prospective participant (for consent and/or assent, if applicable given patient's age).

The SCD will be started in addition to previous maintenance medication therapy or with short course of corticosteroids 1-2mg/kg/day (up to 60mg maximum). Steroid induction based on clinical need.

We anticipate improvement in clinical symptoms, laboratory values and/or a decline in PCDAI of 12.5 points (pediatric patients) or decline in CDAI of 70 points (adult patients) after 4 weeks. Patients who do not reach remission by 4 weeks will be excluded from the study. Patients who require additional medications for disease control will be excluded from the study.

Patients will be seen in clinic at diagnosis, 2 weeks (if required by clinical symptoms), 1 month, 3 months and 6 months.

Assessment at initial enrollment and at all follow-up visits includes:

1. History of symptoms
2. Physical exam including height, weight, BMI, Tanner staging
3. Calculation of Pediatric Crohn's Disease Activity Index (PCDAI) for pediatric patients or the Crohn's Disease Activity Index (CDAI) score for adult patients.
4. Dietary assessment and nutritional counseling
5. Completion of validated quality of life measurement (IMPACT III for pediatric patients and SIBDQ in adult patients)
6. Adverse event monitoring (record of symptoms and review of laboratory surveillance)
7. Laboratory assessment including: CBC with differential, basic metabolic panel, liver function tests, albumin, ESR, CRP, stool calprotectin and stool lactoferrin
8. Serum sample for cytokine studies
9. Stool studies for microbiota studies

Eligibility Criteria:
Inclusion Criteria:

* Adult or pediatric patients presenting with a new diagnosis or flare of existing Crohn's disease based on standard diagnostic criteria including: clinical symptoms, laboratory parameters, disease activity indices (Pediatric Crohn's Disease Activity Index (PCDAI) for patients \<19years and Crohn's Disease Activity Index (CDAI) for patients \>19years), pathology from upper endoscopy/colonoscopy and imaging studies.

Exclusion Criteria:)

* Pregnancy
* Other autoimmune conditions including celiac disease, rheumatoid arthritis, multiple sclerosis
* Otherwise immunosuppressed patients including HIV and prior organ transplant
* Patients diagnosed with ulcerative colitis or indeterminate colitis
* Active tuberculosis
Serum Vancomycin Levels in Patients Receiving Enteral Vancomycin

The study is based on the hypothesis that decreased creatinine clearance may be associated with detectable vancomycin levels in patients on enteral (oral / vancomycin enemas) vancomyicn for CDAD.

The objective of the study is to see whether enteral vancomycin is absorbed through the inflamed GI mucosa in CDAD, and if it is absorbed, does it achieve measurable serum concentration.

Vancomycin is a large glycopeptide compound with a molecular weight of about 1450 Da. It is not appreciably absorbed orally and is eliminated primarily via the renal route. Enteral vancomycin therapy (oral/intracolonic ) is used inpatients with severe Clostridium difficile associated colitis who are unable to take oral metronidazole or have failed treatment with metronidazole. Oral vancomycin is not detectable in serum of normal persons, but concentrations below therapeutic range may be found in patients with colitis. There are a few case reports of serum concentrations within the therapeutic range after oral/intracolonic administration of vancomycin, in association with renal failure. The use of enteral vancomycin in our geriatric population with variable creatinine clearance prompted us to measure the serum vancomycin levels in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients on enteral vancomycin therapy

Exclusion Criteria:

* Coadministration of intravenous vancomycin therapy,intravenousvancomycin administration in previous10 days.
Enhancing Medical Researchers' Self-learning With an Intelligent Language Model

Solving medical scientific problems is a crucial driving force behind the advancement of medical disciplines. As the complexity of scientific questions increases, an increasing number of problems require interdisciplinary collaboration to be resolved. However, most medical researchers lack interdisciplinary background knowledge and require substantial time to systematically learn relevant knowledge and skills. Furthermore, the continuous emergence of new knowledge and skills emphasizes the importance of researchers' ability for autonomous learning in the medical field. Therefore, to promote the development of medical disciplines, there is an urgent need for an effective method to enhance researchers' self-directed learning abilities for conducting interdisciplinary research.

The next-generation artificial intelligence language models, exemplified by ChatGPT, hold great potential in assisting researchers to access knowledge and information from various domains. Whether researchers can leverage such AI tools to enhance their self-directed learning abilities for conducting interdisciplinary research remains to be further explored. Additionally, concerns have been raised regarding the potential degradation of cognitive abilities through their use, although valid evidence is currently lacking.

To investigate whether AI tools, represented by ChatGPT, can effectively assist medical researchers in conducting interdisciplinary research and whether their usage may negatively impact researchers' cognitive abilities, a randomized controlled trial is warranted. This trial aims to ascertain the potential benefits and risks associated with utilizing AI tools in the medical research domain.


Eligibility Criteria:
Inclusion Criteria:

* Junior ophthalmologist with 1-3 years of clinical experience
* 20-28 years old, regardless of gender
* No prior experience in interdisciplinary research involving digital medicine
* Self-reported a minimum of 20 hours of participation in this study during the trial period
* Agree to participate in this study and sign informed consent

Exclusion Criteria:

* Individuals with reading difficulties or reading disabilities
* Reluctance to participate in this study
Spiriva® in Patients With Chronic Obstructive Pulmonary Disease (COPD)

As part of the post-marketing surveillance, information is to be gathered regarding the tolerance and efficacy of Spiriva® 18 micrograms in patients with COPD under conditions of daily practice


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged at least 40 years presenting with the symptoms of COPD

Exclusion Criteria:

* Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information
Active Surveillance Reporting to Identify Adverse Events Following Chiropractic Care in Older Adults

In Canada, almost 19% of chiropractic patients are aged over 65 years. Although most of patients ≥65 years seek care for musculoskeletal conditions (such as back, neck and lower limb pain), there is inadequate prospective data on the safety of chiropractic care for these patients and the frequency of potential associated adverse events remains unknown. Our study will investigate changes in symptoms reported by older adults receiving chiropractic care, with a focus on safety.

Rationale: Musculoskeletal conditions are more common and more severe in older adults than in younger adults and have a negative effect on their overall health-related quality-of-life by decreasing mobility, reducing social participation and causing substantial difficulties with activities of daily living. Canada's population is rapidly aging and the socioeconomic burden associated with these conditions will continue to escalate. Indeed, older patients (≥65 years) account for 18.8% of a chiropractor's case load. Given the high proportion of older adults as chiropractic patients, research on the safety of chiropractic care for this population is critical. Previous studies have reported adverse events (AEs) following specific chiropractic techniques or as secondary outcome measures in older adults; however, there has been no attempt to prospectively capture changes in symptoms (and specifically AEs).

Purpose: To: 1) calculate the frequency of AEs reported by older adults following chiropractic care with an active surveillance reporting system; and 2) explore patient and provider factors related to changes in symptom (e.g., new, worsening, improving) following chiropractic care.

More specifically, this study will use active surveillance reporting system to track the change in symptoms experienced by older adult patients after a chiropractic visit, in comparison to before. These symptoms can be pain, stiffness, fatigue, weakness, dizziness, nausea, etc. As active surveillances track the change in all symptoms experienced by all patients in a participating clinic, no specific condition/disease is being studied, but how the symptoms experienced by older adults seeking chiropractic care for a musculoskeletal condition (such as low back, neck, hip, should pain) change.

Eligibility Criteria:
Inclusion Criteria:

* older adults (≥65 years) seeking chiropractic care

Exclusion Criteria:

* diagnosed with cognitive decline (e.g. Alzheimer's Disease, dementia), acute infections, unable to read English and no access to email.
The Effects of Renal Denervation on Insulin Sensitivity

Renal sympathetic nerves contribute to development of hypertension. Sympathetic overactivity also induces insulin resistance and it could therefore be assumed that a renal denervation might improve insulin sensitivity. Studies have shown that glucose metabolism is improved in patients with treatment resistant essential hypertension both 1 and 3 months after renal denervation compared to a control group with treatment resistant essential hypertension. Fasting glucose, insulin and C-peptide decreased significantly as did insulin resistance assessed by HOMA-IR. The investigators wish to investigate the effect of renal denervation on insulin sensitivity using the gold standard - the hyperinsulinemic euglycemic clamp and to investigate the degree of insulin resistance in muscle, liver and adipose tissue.


Eligibility Criteria:
Inclusion Criteria:

* Systolic daytime ambulatory BP at least 145 mmHg and compliance to a minimum of 3 antihypertensive drugs, including a diuretic

Exclusion Criteria:

* Diabetes
* Pregnancy
* Non compliance
* Heart Failure (NYHA 3-4)
* LV ejection fraction \< 50 %
* Renal insufficiency (eGFR\<30)
* Unstable coronary heart disease
* Coronary intervention within 6 months
* Myocardial infarction within 6 months
* Claudication
* Orthostatic syncope within 6 months
* Secondary Hypertension
* Permanent atrial fibrillation
* Significant Heart Valve Disease
* Clinically Significant abnormal electrolytes, haemoglobin, Liver enzymes, TSH
* Second and third degree heart block
* Macroscopic haematuria
* Proximal significant coronary stenosis
* Renal artery anatomy not suitable for renal artery ablation (Stenosis, small diameter \< 4 mm, length \< 2 cm, multiple renal arteries, severe calcifications)
Targeted Intensification With ZBEAM and Autologous Stem Cell Transplantation in Patients With High-grade B-Cell Lymphoma

The purpose of this study is to evaluate the efficacy and the safety of a preparative regimen utilizing standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy combined with high-dose BEAM followed by ASCT after first line treatment in patients aged from 18 to 65 years with poor prognosis CD 20 Diffuse Large B-Cell lymphoma


Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 65 years.
* Patient with pathologically proven, high grade B-cell Lymphoma CD 20 positive (WHO classification) :
* Diffuse large B cell lymphoma.
* Adverse prognostic factors IPI\>1
* In Complete Remission, or partial response to first line treatment.
* Previously treated with chemotherapy regimen containing rituximab: R CHOP or R ACVBP
* Chemo-sensitive disease
* PET Scan prior transplant
* Eligible for autologous stem cell transplantation
* With a minimum life expectancy of 3 months.
* Negative HIV, HBV and HCV serologies (in the last 4 weeks except after vaccination).
* Having previously signed a written informed consent.

Exclusion Criteria:

* Histological transformation in diffuse large B cell lymphoma, any type of low grade lymphoma
* More than one line of treatment. Prior transplantation. Prior exposure to Zevalin
* Central nervous system or meningeal involvement by lymphoma.
* Contraindication to any drug contained in the chemotherapy regimen.
* Any serious active disease or co-morbid medical condition (according to the investigator's decision and information provided in the IDB).
* Poor renal function (creatinin level up to 2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
* Poor hepatic function (total bilirubin level up to 30 micro mol/l, transaminases up to 2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
* Poor bone marrow reserve as defined by neutrophils less than 1.5 G/l or platelets less than 100 G/l
* Large bone marrow irradiation more than 40percent.
* Bone marrow infiltration
* Lack of sufficient autologous hematopoietic stem cells for transplantation.
* Prior treatment with murine antibodies
* Known hypersensibility to murine antibodies or proteins
* Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
* Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
* Adult patient unable to give informed consent because of intellectual impairment.
* Pregnant or lactating women.
Autism Registry for French Guiana

The objective of the autism registry is to estimate the prevalence of autism in French Guiana in the cohort of children aged 8 years. Secondary objectives are to determine the prevalence of comorbidities, and to determine the theoretical and actual orientation of these children regarding care and education in a territory with significant structural deficits relative to mainland France. The outcomes of this registry will be to guide decision makers in their funding priorities to improve, screening, diagnosis, care and education for children on the autistic spectrum


Eligibility Criteria:
Inclusion Criteria:

* children aged 8 years with a diagnosis of autism spectrum disorder

Exclusion Criteria:

* refusal to participate
Clinical Outcomes With Omni Apex Ultracongruent Knee System

A prospective, matched case comparison of total knee arthroplasty with the OMNI Apex Ultracongruent vs. Triathlon® CS tibial insert vs. the Triathlon® PS tibial insert.


Eligibility Criteria:
Inclusion Criteria:

* Patients willing to sign the informed consent.
* Patients able to comply with follow-up requirements including postoperative weight bearing restrictions and self-evaluations.
* Male and non-pregnant female patients ages 21-80 years of age at time of surgery.
* Patients requiring a primary total knee replacement.
* Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
* Patients with intact collateral ligaments.

Exclusion Criteria:

* Patients with inflammatory arthritis.
* Patients that are morbidly obese, body mass index (BMI) \> 40.
* Patients with a history of total or unicompartmental reconstruction of the affected joint.
* Patients that have had a high tibial osteotomy or femoral osteotomy.
* Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
* Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
* Patients that are immunologically compromised, or receiving chronic steroids (\>30 days).
* Patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
* Patients with knee fusion to the affected joint.
* Patients with an active or suspected latent infection in or about the knee joint.
* Patients that computer-assisted surgical navigation (CAOS) techniques will be used.
* Patients that minimally invasive surgical technique will be used.
* Patients that are prisoners.