cyrilzakka/clinical-trials huggingface dataset:
Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy

Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options.

Approximately 3 months after activation of HNS therapy, a fine-tuning sleep study is performed. To date, the standard of care involves an in-laboratory overnight titration PSG, which assesses the device settings and, if necessary, the stimulation strength will be adjusted based on observed respiratory events and/or snoring. Considering the growing patient population, the performance of these overnight titrations can become logistically challenging and labor-intensive. Recently, the feasibility of using a daytime PSG as an alternative to a conventional overnight PSG for titration of HNS therapy was demonstrated.

The aim of this study is to further investigate this technique by performing a non-inferiority analysis of daytime versus overnight PSG for titration of HNS therapy in patients with OSA.

This study is a prospective and retrospective, single-center non-inferiority study. The study population consists of two cohorts: (1) OSA patients treated with HNS that previously underwent an overnight titration PSG as part of the routine clinical care pathway and (2) OSA patients treated with HNS that recently underwent or will be undergoing a daytime titration PSG.

Data collection will include polysomnographic data, home sleep test data, therapy usage, device data and questionnaires (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire-30, Visual Analogue Scale (VAS) snoring. Data will be collected from different visits including: pre-implant, implant, activation, titration, follow-up (6 and 12 months post-implantation).

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with OSA and implanted with HNS therapy (Inspire system)
* Cohort 1: Patients that previously underwent an overnight titration PSG as part of their routine clinical care at the Antwerp University Hospital
* Cohort 2: Patients that recently underwent or will be undergoing a daytime titration PSG at the Antwerp University Hospital
* Able to give informed consent

Exclusion Criteria:

* Not able to understand the language of the questionnaires
Video Versus Face-to-face Preoperative Anaesthetic Assessment

Randomized clinical trial rewieving difference between anaesthetic preassessment in physical consultations vs. video consultations.

Preoperative anaesthetic assessment aims to reduce morbidity and mortality and are currently accepted as the gold standard of care for elective surgery. Technical advances in society have led to explora-tions within the telemedicine area which continues providing safe and effective services. The video versus face-to-face preoperative anaesthetic assessment (VIDFACE) trial aims to compare videobased preoperative anaesthetic assessment to standard face-to-face consultations with focus on patient safety and satisfaction including possible beneficial eco and economical effects compared to standard face-to-face consultations.

This is a randomised, single-centre, two-arm, assessor, and data analyst blinded clinical trial. We will enrol 2260 participants undergoing elective Ear-Nose-Throat or Tooth-Mouth-Jaw surgery. Participants will be randomised 1:1 stratified by malignant versus benign surgery to either video based preoperative anaesthetic assessment or face-to-face consultation. Data will be analysed by two blinded statisticians, and we will write abstracts covering all possible combinations of conclusions, before breaking the blind.

Results:

The primary outcome is the incidence of six predefined serious adverse events (SAE). Secondary outcomes are the proportion of participant with a change in anaesthesia plan as well as delays or cancellations on the day of surgery and patient satisfaction.

The VIDFACE trial will contribute valuable knowledge on the efficacy and safety on using video consultations in the an-aesthetic preoperative assessment.

Eligibility Criteria:
Inclusion Criteria:

* ENT and TMJ patients
* Adults \> 18 years
* Informed consent obtained after a consideration period of minimum 24 hours

Exclusion Criteria:

* If a patient is assessed unsuitable for the video technology in example, patients with severe mental challenges (dementia, retardation, etc.), they will not be included in the trial. If excluded, the patient receives standard care, face-to-face preoperative anaesthetic assessment.
* Local protocol screen patients
Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery

This study is designed to assess the tolerability and comfort of peri-operative 0.3% hypromellose eye drops in LASIK surgery patients and to assess whether pre-operative 0.3% hypromellose eye drops add to post-operative comfort in LASIK surgery patients compared to control (no pre-operative lubricant).


Eligibility Criteria:
Inclusion Criteria:

* Age 21 - 35
* Both sexes
* Seeking LASIK surgery at the Refractive Surgery Centre
* Meeting all established criteria for appropriateness for LASIK established by the treating center

Exclusion Criteria:

* Any corneal pathology including scars, prior herpes keratitis, prior corneal transplant
* Any immuno-compromised state including cancer, HIV infection, Hepatitis B or C, or diabetes mellitus
* Requirement for any eye-drops for any reason (eg, dry eye or conjunctivitis) within 3 months from time of enrollment
* Anticipated refusal or inability to undergo planned post-operative visits or assessment
* Failure to meet all established criteria for appropriateness for LASIK
A Prospective Randomised Multicenter Study Comparing the Sliding Hip Screw and the Intertan Nail in Trochanteric and Subtrochanteric Femoral Fractures

This is a study to compare the new nail "INTERTAN" with a Sliding Hip Screw in treating a specific group of hipfractures (trochanteric and subtrochanteric fractures).

Are there differences in terms of pain, early and late functional mobility and complications between the to implants (and methods of operation)?


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 60 years with a trochanteric or subtrochanteric hip fracture.

Exclusion Criteria:

* Patients with pathologic fractures, patients already included with a fracture on the opposite side.
The Use Of FFR Guided PCI Versus Complete Revascularization and Treatment Of Infarct Related Artery Only In Patients With STEMI

In patients with ST elevation myocardial infarction (STEMI) the treatment goal is revascularization of the occluded artery with the use of primary percutaneous coronary intervention (PCI). There is a large subset of patients with STEMI who also have significant disease in arteries other than the site of occlusion, and away from the culprit artery. It is estimated that up to 50% have disease of more than 50% in the non-culprit arteries.

The evidence on how to treat those patients with multi vessel disease is conflicting. Earlier large-scale studies and registries have suggested early and complete revascularization is of no benefit or even harmful. More recent studies have showed the opposite of that. The CVLPRIT study showed that early complete revascularization or preventive PCI reduced primary endpoint of a composite of all cause mortality, myocardial infarction and need for repeat revascularization. The benefit was mainly due to reduced repeat revascularization in the more intensive intervention group. The PRAMI study showed very similar results as well.

The use of Fractional flow Reserve (FFR) in deciding complete revascularization has also showed conflicting results so far. A previous trial showed that FFR guided intervention post STEMI increased MACE. This was conflicted with more recent study, which showed FFR guided complete revascularization improved outcome when compared with more conservative treatment of ischaemia driven intervention.

In this study, the investigators are going to assess the issue of staged revascularization guided by FFR or by angiogram, compared to the standard treatment of ischaemia driven revascularization

To compare the clinical outcomes measured by composite of mortality, myocardial infarction and repeat revascularization by using FFR guided and angiographically guided revascularization to the standard strategy of ischaemia driven revascularization.

Participants will be allocated to three arms, first conservative group of ischaemia guided PCI, second FFR guided PCI and third angiogram guided PCI where patients where patients with more than 50% lesion will undergo revascularization.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with STEMI and multi-vessel disease on initial angiogram.
2. Above 18 years of age
3. Able to give consent

Exclusion Criteria:

1. Patients with indication for CABG
2. Left main stem lesion of \>50%
3. Cardiogenic shock
4. Intractable angina during hospital admission
5. Patients with limited life expectancy
6. Patients with severe chronic kidney disease
7. Patients with contraindication to dual antiplatelet therapy
8. Patients with very complex lesions that deemed not favourable for PCI
9. Pregnancy or childbearing age
A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years

RATIONALE: Drugs used in chemotherapy, such as vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating older patients with previously untreated Hodgkin's lymphoma.

OBJECTIVES:

Primary

* Determine the efficacy and toxicity of vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin in older patients with Hodgkin's lymphoma.
* Determine whether the application of the Hasenclever prognostic index is valid in these patients at diagnosis.

OUTLINE: This is an open-label, multicenter study.

* Chemotherapy: Patients receive vinblastine IV and cyclophosphamide IV on day 1; oral procarbazine and oral prednisolone on days 1-5; oral etoposide on days 15-19; and mitoxantrone IV and bleomycin IV on day 15. Treatment repeats every 28 days, in the absence of disease progression or unacceptable toxicity, for a total of 3 courses in patients with early (stage IA or IIA) disease or 6 courses in patients with advanced (stage IB or IIB-IV) disease.
* Radiotherapy: Patients with early stage disease receive involved-field radiotherapy. Patients with advanced stage disease receive radiotherapy limited to sites of initial bulky disease or residual disease. Radiotherapy begins 4 weeks after the completion of chemotherapy.

Patients are followed monthly for 3 months, every 3 months for 6 months, and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 36 months.

Eligibility Criteria:
Inclusion criteria:

Histologically confirmed classical Hodgkin Lymphoma (HL). No previous treatment for HL. Age ≥ 60. "Non fragile" patient (see Appendix 1) i.e. patient's mental and physical status must be sufficient to withstand the treatment described.

No concomitant neoplasia requiring treatment or known HIV infection. Written informed consent.

Exclusion criteria:

Nodular lymphocyte predominance Hodgkin Lymphoma (NLPHL) Age \<60. Patient previously treated for HL. Known HIV infection or concomitant neoplasia. "Fragile patient" (see Appendix 1) or significant abnormality of another system (pulmonary, cardiac, renal, and hepatic) which is a contraindication to full dose chemotherapy.

Unable to give informed consent.
Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines

The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults.

This multi-center study evaluates the safety and efficacy of four different doses of RT001 compared to vehicle applied as a single, bilateral topical application in at least 60 subjects with moderate to severe lateral canthal lines. Subjects will be randomized to one of the five treatment groups in a 1:1:1:1:1 ratio. Follow-up visits are scheduled through 28 days post-treatment. The safety and efficacy of Cohort 1 (through the Day 14 visit) will be assessed prior to the decision to enroll subjects into Cohort 2 if additional doses or treatment regimens need to be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Female or male; 30 to 55 years of age
* Bilateral lateral canthal lines rated as moderate or advanced
* Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening through End of Study
* Women of childbearing potential must be practicing and willing to continue to use an effective method of birth control during the course of the study

Exclusion Criteria:

* Muscle weakness or paralysis in the area receiving study treatment
* Active skin disease or irritation at the treatment areas
* Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to Screening
* Previous treatment with botulinum toxin (any serotype) in the head or neck area within 9 months prior to Baseline (Day 0)
* Use of a topical steroid on either of the treatment areas or use of medications that suppress the immune system 30 days prior to Screening and continuing through End of Study (Day 28)
* Any abnormality on the electrocardiogram (ECG) at Screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive heart failure
The Effect of Natural Food Flavourings on Gastrointestinal and Cardiovascular Physiological Responses.

The purpose of this study is to determine whether 3 g cinnamon was sufficient to delay the gastric emptying rate of a high-fat solid meal and subsequently reduce postprandial blood glucose and lipid responses, oxidative stress, arterial stiffness and satiety responses in a healthy adult population.

Cinnamon has been shown to delay gastric emptying (GE) of a high-carbohydrate meal and reduce postprandial glycaemia in healthy adults. However, it is dietary fat which is implicated in the etiology and is associated with obesity, type 2 diabetes (T2D) and cardiovascular disease (CVD). We aimed to determine the effect of 3 g cinnamon on GE, postprandial lipemic and glycemic responses, oxidative stress, arterial stiffness, as well as appetite sensations and subsequent food intake following a high-fat (HF) meal.

The effect of acute oral administration of 3 g cinnamon on gastric emptying of a high-fat pancake test meal and subjective appetite sensations by visual analogue scale will be measured for six hours postprandially. During this time course, measurements of postprandial lipemic, glycemic, oxidative stress and arterial stiffness responses will be collected. Subsequently, food intake will be measured using an ad libitum buffet meal. The study will be conducted in a randomized, placebo-controlled, single-blinded manner in 9 healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 18-35 years
* Recreationally trained individuals (participate in at least 2hrs/wk of individual/team sport)
* Not currently taking antioxidant or lipid-lowering medication
* Fasting blood lipid, glucose and blood pressure (BP) levels were all within the normal limits.

Exclusion Criteria:

* History of gastrointestinal-related conditions, diabetes mellitus or cardiovascular disease.
* Allergies to foods in study.
* Blood disorder
* Pregnancy.
The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis

Patients will be assigned to receive either Depo Medrol or Acthar treatment. A synovial biopsy, blood draws, synovial fluid aspiration, and physician assessments will be performed before and after initiating treatment.

Patients will be assigned to receive either Depo Medrol or Acthar treatment. A synovial biopsy, blood draws, synovial fluid aspiration, and physician assessments will be performed before and after initiating treatment. At screening visit, inclusion and exclusion criteria will be assessed. If assessments have not been completed to verify these criteria, they will be performed at this visit. After patients are confirmed to meet criteria, patient disease activity will be assessed and blood draw, synovial aspiration, and biopsy will be performed before first treatment injection. About 5 days after this first treatment injection, these assessment and samples will be performed again. About 5-6 weeks after first treatment injection, a final physician assessment will be performed. Patients will have the option of consenting to allow storage of samples for future research.

Eligibility Criteria:
Inclusion Criteria:

* Anti-Cyclic Citrullinated Peptide positive rheumatoid arthritis
* on a stable regimen of medications
* moderate to severe disease activity as measured by the Clinical Disease activity index (CDAI), or DAS28 (Disease Activity Score) within 30 days of starting the study
* Patients must have at least one joint with the following features within 30 days of starting the study:

  1. Joint must be tender
  2. Joint must be swollen
  3. Joint must have +2 or +3 doppler signal by ultrasound exam
  4. Joint must have +2 or +3 gray scale synovitis by ultrasound exam e. Joint must be amenable to synovial biopsy.

  f. Clinician assessing the joint must conclude, with a reasonable degree of certainty, that the swelling and tenderness observed in the joint is caused by rheumatoid arthritis, and not by another arthritic condition such as osteoarthritis, crystal arthritis, or infection.

Exclusion Criteria:

* Patients on anti-coagulation therapy
* Patients with an active infection
* Patients receiving oral corticosteroids within 5 days of enrollment, or parenteral corticosteroids within 3 weeks of enrollment (unless deemed able to taper off medication under investigator oversight and supervision)
* Patients with any history of joint infection
* Patients with a history of tuberculosis or coccidioidomycosis
Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening

The purpose of this study is to evaluate how well women may adopt a Contrast-enhanced Spectral Mammography (CESM) as their yearly breast screening test compared to the standard 2-D or 3-D mammogram.

Contrast-enhanced spectral mammography (CESM) is an FDA approved tool for breast cancer detection. However, adoption into clinical practice has been slow. In this study, we will explore patient issues related to the use of CESM for breast cancer screening. For this study, 210 women with heterogeneous or dense breast tissue reported on a previous mammogram, will be recruited to undergo a screening Contrast-enhanced Spectral Mammography (CESM). The CESM will serve as the subject's annual screening breast exam for clinical care. A survey will be administered before and after the examination that evaluates the patient experience. Women will not be at high risk for breast cancer (\<20% lifetime risk). All abnormal findings will be acted upon independently. Results of the general screening population survey will be compared with those of women who choose to undergo the CESM examination in order to evaluate the influence of age, education, and lifetime risk on decision making about advanced screening.

Eligibility Criteria:
Inclusion Criteria:

* • Female

  * 40 to 69 years
  * Previous normal mammogram (BI-RADS 1 or 2) showing heterogeneous or extremely dense breast tissue within last 24 months
  * Scheduled for screening mammogram as part of the patient's clinical care

Exclusion Criteria:

* • No mammogram within last 24 months

  * Fatty or scattered fibroglandular tissue on last mammogram
  * History of allergy to iodinated contrast
  * History of renal disease or renal function abnormalities
  * Pregnant women
  * History of diabetes
  * History of paraproteinemia syndromes such as multiple myeloma
  * History of collagen vascular disease
  * History of vascular disease (coronary artery disease, myocardial infarction, carotid disease, peripheral vascular disease, or known visceral artery disease)
  * Previously identified as high risk for breast cancer (\>20% lifetime risk)
  * Asthma
  * Sickle Cell Anemia
  * Currently on Dialysis
Evaluation of Positioning Protocols on a Wheelchair in Hemiplegic Patients

The main purpose of this study is to assess the interest of using wheelchair positioning equipment on the decrease of postural disorders, compared to the standard use of a wheelchair

The stroke is the main cause of hemiplegia in developed countries. Fifteen percent of people who say they have a stroke need, at home, a wheelchair to get from one room to another. The use of a wheelchair can cause postural disorders which can lead to pain, orthopedic deformity and pressure ulcers.

This study aims to assess the interest of using wheelchair positioning equipment (Seat back, Positioning cushion and Belt) on the decrease of postural disorders.

This decrease will be assessed after a standardized course, performed under three different conditions: with the positioning equipment (Positioning cushion and Seat back), with the positioning equipment and the belt and with the wheelchair alone.

Clinical tool used to assess the decrease is the Seated Postural Control Measure for Adults 2.0 (SPCMA 2.0).

This study, which will be the first prospective, interventional, multicenter, controlled and randomized study, could pave the way for guidelines of good practice, for wheelchair positioning of hemiplegic patients in France

Eligibility Criteria:
Inclusion Criteria:

* Hemiplegic patient following a stroke
* Hospitalized in a follow-up and rehabilitative care service, after hospital stays in a MCO service (neurology, neurosurgery or reanimation)
* With a planned exit from hospital (homecoming, residential care facilities, nursing home, Long Term Care Unit ...)
* Patient whose wheelchair choice should be already done
* Patient who propels the wheelchair with the valid hand and/or valid foot
* Written informed consent (IC) obtained
* Patients with affiliation to the social security system

Exclusion Criteria:

* Good walk recovery (FAC scale \>3)
* Wheelchair with a double hand rim
* Patient who cannot use his2 wheelchair independently
* Cognitive disorders which prevent the ability to well understanding the instructions
* Other pathology which can interfere with this protocol (Spinal disorder, morbid overweight (BMI\>40...)