cyrilzakka/clinical-trials huggingface dataset:
Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty

The purpose of this study is to evaluate clinical performance and safety in total knee arthroplasty using HLS implants.

It is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in a French center where Total Knee Arthroplasty with HLS prosthesis is performed routinely.

All patients treated with HLS KneeTec (cemented, non-cemented or hybrid versions) implant will be included. All eligible patients seen in consultation and who agree to participate in the study should be included, systematically and consecutively, since the initiation of the study.

Data will be collected retrospectively for HLS I, II, Evolution and Noetos® implants, and when prospectively for cementless, cemented and hybrid HLS KneeTec prosthesis.

Post-surgery visit data will be collected at 1-y , 3-y , 5-y, 10-y FU visits per protocol then up to the latest FU visit available.

Eligibility Criteria:
Inclusion Criteria:

* For the HLS-1, HLS-2, HLS Evolution and HLS Noetos retrospective group:

  1. Adult patients older than 18 years old.
  2. Patients who have undergone routine preoperative clinical evaluations prior to their Total Knee Replacement surgery and implanted with one of the following prostheses from the HLS range: HLS-1, HLS-2, HLS Evolution and HLS Noetos between their first date of use in 1987 and their last date of use as normal practice at the participating site in accordance to indications and intended use as described in the Instruction for Use (IFU) of the study devices.
  3. Patients who have been informed about their participation into an observational study.

For the HLS KneeTec prospective group (with retrospective surgeries):

1. Adult patients older than 18 years old.
2. Patients who have undergone routine preoperative clinical evaluations and received a TKR or are suitable candidates for a TKR with a fixed or mobile postero-stabilized HLS KneeTec prosthesis (cementless, cemented or hybrid combination) for the treatment of a primary or secondary knee osteoarthritis and inflammatory disease such as rheumatoid arthritis in accordance to indications and intended use as described in the Instruction for Use (IFU) of the study devices.
3. Patients who are willing and able to complete the scheduled FU visits.
4. Patients who have been informed about their participation into an observational registry study

Exclusion Criteria:

* Patients mentally incompetent or unable to understand what participation in the study entails.
* Patients who present signs and symptoms of any of the known contraindications described in the Instruction for Use (IFU) of the study devices.
* Patients who deny their participation into the study.
Validation of DNA Methylation Biomarkers for Oral Cancer Detection

The purpose of this study is to investigate the correlation between DNA methylation and the treatment and recurrence of oral cancer.

In this study, investigators plan to recruit 40\~50 patients who had, or currently has oral cancer. The study procedures are as below:

* After the Informed Consent Form is signed, swab from the lesion site and normal site to obtain oral epithelial cells.
* Collect tissue from the tumor site and the non-cancerous matched site from the surgery or the tissue bank.
* Collect oral swab from the lesion site and the normal site when patients return to the clinic for a regular follow-up.

Specimens will be collected for DNA methylation testing, and the results will be compared with patient's clinical diagnosis. It is expected that the relationship between DNA methylation, oral cancer, and the recurrence of oral cancer will be found.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 75 years old
* Had or currently has cancer of the oral cavity
* Agree to sign the Informed Consent Form (ICF) and comply with follow-up procedures

Exclusion Criteria:

* Unwilling to sign the Informed Consent Form (ICF)
* Has an autoimmune disease of the oral cavity
A RCT on the Preventive Effect of HFNC on Postoperative Pulmonary Complications in Patients With Gynecologic Neoplasms

Patients at high risk of post-operative pulmonary complications (PPC) will be screened out from gynecological tumor patients undergoing surgical treatment, and randomly assigned into the HFNC group and control group, which uses conventional nasal cannula oxygen therapy. The primary outcome is the incidence of PPC, including postoperative hypoxemia, atelectasis, pneumonia, etc. Secondary outcomes are the improvement of postoperative oxygenation, antibiotic use, length of hospital stay, adverse events related to oxygen therapy, etc.

This randomized con aims to enroll patients at high risk of developing post-operative pulmonary complications after gynecological surgery, the eligible patients will be randomly assigned to receive oxygen therapy via high-flow nasal cannula or conventional nasal cannula. The study primary outcome is the incidence of post-operative pulmonary complications, including postoperative hypoxemia, atelectasis, pneumonia, etc. Secondary outcomes are the improvement of postoperative oxygenation, antibiotic use, length of hospital stay, adverse events related to oxygen therapy, etc.

Eligibility Criteria:
Inclusion Criteria:

* Patients with gynecologic Neoplasms, including benign gynecologic tumors and malignant gynecologic tumors, who are 18 to 90 years old and are scheduled for surgical treatment in our center shall receive plain chest CT scan within 1 week before surgery, and the estimated surgical time shall be ≥2 hours, and at least one of the following conditions shall be met:

  1. Assess respiratory risk in surgical patients in Catalonia (ARRSPC) ≥45 points;
  2. BMI≥30;
  3. Moderate to severe asthma;
  4. Moderate to severe chronic obstructive pulmonary disease (COPD);
  5. Smoking history ≥20 packs/year

Exclusion Criteria:

1. Patients with lung metastasis of malignant tumor or primary lung malignant tumor;
2. previous lung surgery or radiotherapy;
3. the surgery involved segmental bowel resection.
First-in-human Evaluation of [18F]CETO

Purpose of this clinical phase 1 trial was to determine if para-chloro-2-\[18F\]fluoroethyletomidate positron emission computed tomography (\[18F\]CETO-positron emission computed tomography(PET)/computed tomography(CT)) can be used in diagnostics of adrenal tumors and if the biochemical/pharmacological states conditions in humans with various illnesses, compared to healthy humans, such as the radio tracer is suitable?

After receiving oral and written information about the study and its potential risks, all participants provided written informed consent. All participants underwent a screening visit 1-28 days before their \[18F\]CETO PET/CT. At the screening visit their medical history was obtained, including besides information of previous disease(s) and medication, also a clinical examination, WHO performance status, height, weight, pulse rate and blood pressure, blood chemistry and haematology.

Right before the PET/CT investigation a baseline assessment was performed including:

* A physical examination according to Modified Early Warning Score (MEWS)
* 12-lead electrocardiogram (ECG)
* Any concomitant medications was recorded
* Medical history - occurrence of any new symptoms and events since the screening visit
* Hematology (International Normalized Ratio (INR) in patients with antiocoagulant treatment).
* Pregnancy test in women.
* Assessment of injection site monitored by visual inspection (rash and phlebitis)

Participants received on average 0,76 mikrograms (range 0,1-1.37 mikrograms) of administered mass of CETO in conjunction to the PET/CT investigation.

Potential adverse events were monitored closely during, and after the administration of \[18F\]CETO, with access to emergency medicine resources.

Each participant remained for observation at least 3 hours after administration of \[18F\]CETO and the following assessments were performed:

* Blood withdrawn for additional post-scan chemical analysis.
* Assessment of injection site monitored by visual inspection (rash and phlebitis).
* MEWS

The ten first participants were evaluated for serious adverse events/adverse events (SAE/AEs) the day after (approximately 24 hours after) performing the \[18F\]CETO PET due to the short half-life of the radionuclide used, fluorine- 18 (T1/2= 109.5 min). Safety reporting was assessed by use of clinical Adverse Events and Common Toxicity Criteria (CTC), laboratory and non-laboratory toxicities.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with adrenal incidentalomas with an concurrent overproduction of aldosterone or cortisol or no concurrent hormone production, or patients diagnosed with adrenocortical carcinoma
* For healthy volunteers inclusion criteria included no known diseases, no ongoing medication and no known adrenal anomalies.

Exclusion Criteria for patients and healthy volunteers:

* pregnancy, age below 18, claustrophobia
Effect of Aquatic Training on Motor Function in Children With Autism Spectrum Disorder

Clinically, infants with Autism Spectrum Disorder often display gross motor delays in supine, prone, and sitting skills in their first year of life . Studies reveal that motor abnormalities in Autism Spectrum Disorder can occur very early in developmental trajectory.

Hydrotherapy is an environment that may be conducive to encouraging physical activity in children with Autism Spectrum Disorder. The buoyancy of water can assist with movement, balance, and coordination .Water also provides an opportunity for social interaction through aquatic games and activities.Based on the literature, Aquatic therapy appears to be particularly beneficial for children with Autism Spectrum Disorder who need strong sensory stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Age ranges from 3 to 5 years.
* Mild to moderate autistic features according to GARS (scores from 60 to 110).

Exclusion Criteria:

* Significant visual or auditory defects.
* History of cerebral palsy or psychiatric disorder (e.g attention deficit hyperactivity disorder).
* Open wound.
* Dermatological diseases
Identifying Drug-related Problems at ED Triage (DRP-EDiT) V1

Up to a third of patients who visit emergency departments (EDs) do so because they have an issue with medicines prescribed by their doctor or purchased over the counter. For example, some patients might experience side effects (e.g., sickness), whereas others may feel their prescribed medicine is not working and want an alternative. While some patients who visit EDs know they have a problem with their medication, some are not aware. Furthermore, drug-related problems (DRPs) may not be identified by ED triage systems which are used to sort patients' priority for treatment. The currently used system in the UK (Manchester Triage System) mentions drugs infrequently and does not support the identification of the most common DRPs. For this project, DRPs include medication errors, adverse drug events, and adverse drug reactions. This project aims to revise the triage system to support the discovery of patients' medication problems when they are triaged by a nurse upon arrival to the ED.

After identification, problems with a patient's medication should be dealt with by the healthcare professional who is most appropriate to manage that particular issue. For example, a patient who has been prescribed a new medicine but already takes 20 medicines will likely benefit from a review by a pharmacist in the ED. This project will aim to support the management of patients who might benefit from care provided by pharmacists by providing them with this care.

As well as ensuring medication problems are identified at triage, and that pharmacists are involved in helping to deal with those problems, this project will also try to understand how we can investigate how pharmacists actually make a difference to the care of ED patients.

A multi-step approach (Stages A-F) is proposed to answer the question "How can patient DRPs be identified, triaged and managed in the ED?" In summary, the steps include: STAGE A, a systematic review and scoping survey; STAGE B, researcher visits to ED sites to shadow ED staff; STAGE C, Interviews with healthcare professionals (including those shadowed in STAGE B) to validate findings of site visits and explore topics in more depth; STAGE D, developing additional drug-related content for the Manchester Triage System; STAGE E, involving a panel of experts in a RAND appropriateness method to rate the content developed in STAGE D; STAGE F, testing the revised triage system for a future pilot study involving interviews with staff visited in STAGE B.


Eligibility Criteria:
Inclusion Criteria: The following groups will be included in various stages of the project

* STAGE A: ED clinicians at UK-wide NHS trusts
* STAGE B: ED staff from 8 NHS sites across the UK
* STAGE C: ED staff from 8 NHS sites across the UK
* STAGE E: Clinicians and academics with expertise in Emergency Care and/or ED Triage
* STAGE F: ED staff from 8 NHS sites across the UK

Exclusion Criteria:

* Those who do not consent or who are unable to consent
A Multi-Dose Study With a Treatment for Open-Angle Glaucoma

The purpose of this study is to determine whether Anecortave Acetate is effective for lowering intraocular pressure caused by open-angle glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years old with a clinical diagnosis of Open-Angle Glaucoma for at least 6 months and currently treated with a monotherapy hypotensive medication

Exclusion Criteria:

* Prior angle surgery in the study eye, severe visual field loss in either eye, and any other form of glaucoma besides open-angle glaucoma
N-GAL Allows Intensive Treatment of Contrast Induced Nephropathy

Patients who undergo urgent/emergency coronary angiography can not receive any preventive treatment of contrast induced nephropathy. We tested the hypothesis that Neutrophil gelatinase-associated lipocalin (NGAL), a new biomarker predictive for AKI, allows early and effective treatment of contrast induced nephropathy in patients with urgent/emergency coronary angiography

Background Patients who undergo urgent/emergency coronary angiography can not receive any preventive treatment of contrast induced nephropathy.

An acute kidney injury is generally detected too late to allow effective intervention in patients who undergo urgent/emergency coronary angiography.

Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI already shown to be useful for earlier diagnosis of contrast induced nephropathy.

Purpose The primary objective of this study is to to test the hypothesis that a NGAL-driven early intensive strategy can reduce the occurrence of contrast induced nephropathy in patients with urgent/emergency coronary angiography

Eligibility Criteria:
Inclusion Criteria:

* Indication to urgent/emergency coronary angiography
* Normal renal function (eGFR\> 60 ml/min/1.73 m2)
* Moderate or high Mehran's risk score for CIN (\>11).
* Able to understand and willing to sign the informed consent form

Exclusion Criteria:

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before
Methylphenidate on Intracortical Inhibition in Methamphetamine Abusers Attention Deficit Hyperactivity Disorder (ADHD)

Previous studies using transcranial magnetic stimulation (TMS) with paired pulse protocols have shown that a conditioning TMS pulse applied to the human motor cortex changes the excitability of motor pathways from the motor cortex to spinal motorneurons. These effects depended on the stimulus intensity of both conditioning and test pulse and also the ISI). A characteristical sequence of inhibition (short interval cortical inhibition \[SICI\], GABA-Aerg), facilitation (intracortical facilitation \[ICF\]), and inhibition again (long interval cortical inhibition \[LICI\], GABA-Berg) is thought to be physiologically involved in motor control. Previous studies have also shown that neuronal inhibitory motor circuits are also disturbed in ADHD which will be restored by using methylphenidate. In this study the investigators sought to investigate if methamphetamine abuse (from the same chemical class of medications) will alter such effects of methylphenidate.

Design:

Prospective, randomized, -controlled (1:1 randomization), duration-2 single sessions one week apart

Setting:

University psychiatric hospitals in Tehran including Roozbeh Hospital, Rasool Hospital and Imam Hossein General Hospital will refer clients to Iranian National Center for Addiction Studies, Tehran University of Medical Sciences.

Patients:

Fifteen patients with Methamphetamine abuse for at least 2 years plus ADHD are compared with a control group of 15 ADHD patients matched for age and gender

INTERVENTION:

We administer 2 single doses of methylphenidate tablets (10mg) separated by a week interval. A paired pulse protocols will be performed with ten single (unconditioned test pulse) and ten paired TMS pulses (conditioning and test pulse) in an intermixed randomized order.

Short interval cortical inhibition is measured with an Inter-stimulus Intervals (ISI) of 3 msec and a stimulator output of 80% RMT for the conditioning stimulus and 1mVT stimulation intensity for the test stimulus. ICF investigation is measured with an ISI of 13 msec), with the condition of an ISI of 50 msec (ISI 50) and both stimuli applied with 1mVT intensity). Long Interval Cortical Inhibition (LICI) is measured with ISIs of 100 msec (ISI 100), 200 msec (ISI 200), and 300 msec (ISI 300); both stimuli with 1mVT intensity.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of Methamphetamine abuse co morbid with ADHD
* Right handedness

Exclusion Criteria:

* Other current Axis I disorders (except simple phobia and nicotine addiction)
* Personal or close family history of seizure disorder
* Ferromagnetic material in body or close to head
* Neurologic disorder
* Pregnancy
* Taking medications known to lower seizure threshold (eg, theophylline)
A Study to Determine the Flow Changes And/or AHI Reduction When Stimulating Two Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea in Adult Subjects

This Proof-of-Concept study will collect acute and sub-acute flow and/or AHI data following the placement of lead arrays under direct vision. The acute placement and data collection will be collected following the completion of the pre-scheduled neck dissection surgery. The sub-acute data will be collected in a sleep lab during a polysomnography (PSG). Both data collections will be done when stimulating (using an external pulse generator) the hypoglossal nerve or Genioglossus muscle (GG) and a second neural target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid) with a set of Off-the-Shelf (OTS) electrode arrays.


Eligibility Criteria:
Inclusion Criteria:

A patient must meet all of the following inclusion criteria to be eligible for inclusion in this study:

* Age above 18 years not under guardianship, under curatorship or under judicial protection.
* Body Mass Index (BMI) \< 38 kg/m2.
* Subject must be eligible for neck dissection surgery.
* Written informed consent obtained from the patient prior to performing any study specific procedure.
* Willing and capable to comply with all study requirements, including specific lifestyle considerations, evaluation procedures and questionnaires for the whole duration of the trial.

Exclusion Criteria:

Patients meeting any of the following criteria will be excluded from participation in this study:

* Major anatomical or functional abnormalities that would impair the ability of the electrode arrays to be positioned.
* Significant comorbidities that contraindicate surgery or general anesthesia.
* Significant tongue weakness.
* Aerodigestive tract tumor or reconstructive surgery performed at the same time as neck dissection.
* Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia in the judgment of the investigator.
* Prior surgery or treatments that could compromise the placement and effectiveness of the electrode array systems:

  * Airway cancer surgery or radiation, or
  * Mandible or maxilla surgery in the previous 3 years (not counting dental treatments).
* Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery).
* Prior hypoglossal nerve stimulation device implantation.
* Currently pregnant or breastfeeding during the study period.
* Concomitant oral or pharyngeal surgery.
The Avoiding Diabetes Thru Action Plan Targeting Pilot Randomized Control Trial

The goal of this randomized control trial is to study the impact of an electronic health record embedded tool's ability to facilitate shared provider-patient goal setting to promote lifestyle behavior change and prevent diabetes in primary care.

The ADAPT (Avoiding Diabetes Thru Action Plan Targeting) trial is an innovative study that leverages persuasive technology to enhance the lifestyle behavior change counseling efficacy of primary care providers. Using principles of behavior change theory and persuasion technology, the multidisciplinary design team utilized in-depth interviews and in-vivo usability testing to produce a prototype diabetes prevention counseling system embedded in the electronic health record. The core element of the tool is a streamlined shared goal setting module within the electronic health record system. The system also utilizes a pre-encounter patient behavior change goals elicitation survey to help tailor the goal setting session to patient preferences and encourage shared decision making. The patients also interact with a website that collects their longitudinal behavior change data and visualizes their progress over time and in comparison to other study members. The ADAPT system utilizes the influential powers of goal setting, tailoring, reminders, social comparisons, testimonials and other methods to integrate evidence based behavior change principles and persuasion techniques into routine primary care clinical encounters. If successful, the ADAPT system may represent an adaptable and scalable technology-enabled behavior change tool for all primary care providers.

Eligibility Criteria:
Inclusion Criteria:

* prediabetes

Exclusion Criteria:

* age\<18
* diabetes