cyrilzakka/clinical-trials huggingface dataset:
Spectral Focused Imaging Versus White Light Imaging in Colorectal Adenoma Detection

Spectral Focused Imaging (SFI) is newly developed image-enhancing endoscopy technology that enhances the contrast of target tissue structures while improving color contrast because spectral signal energy is further concentrated on the absorption peak wavelength of microvessels by using digital spectral processing techniques. This technology, combined in the latest generation SonoScape\&#39;s endoscopes (SonoScape Co, Shenzhen, China) with new high-performance LED illumination system, enhances the visibility of colonic mucosal vessels and might increase the detection rate of colorectal polyps. Data available regarding colorectal polyp or adenoma detection with SFI are encouraging but are scanty and limited to back-to back studies.

This two parallel arms, randomized, multicenter trial is aimed at evaluating whether SFI is superior to WLI endoscopy in terms of adenoma detection

45-85 years-old subjects participating in their first colonoscopy and meeting all eligibility criteria are randomised 1:1 to SFI (SFI group) or WLI (WLI group) during insertion and withdrawal phase of colonoscopy. All procedures are performed with a high-definition HD-580 series videocolonscopes with or without magnification (SonoScape Co, Shenzhen, China).

The primary outcome measure is the ADR, defined as the proportion of participants with at least one adenoma (per-patient analysis).

Eligibility Criteria:
Inclusion Criteria:

* 1. Male or female aged 45 to 85
* 2. Patients undergoing colonoscopy for the first time due to colorectal cancer screening, having positive fecal immunochemical test (FIT) results, or experiencing gastrointestinal symptoms
* 3. Capable of providing informed consent and agreeing to participate
* 4. Able and willing to follow all research processes

Exclusion Criteria:

* 1. Participated in other clinical trials, signed informed consent form, and in the follow-up period of other clinical trials;
* 2. Participated in clinical trials of drugs and is in the discontinuation period of experimental or control drugs;
* 3. Pregnant or lactating patients;
* 4. Known to have polyposis syndrome;
* 5. Patients with gastrointestinal bleeding;
* 6. Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
* 7. Patients with contraindications to tissue biopsy;
* 8. History of allergies to the ingredients in intestinal cleansers;
* 9. Individuals with conditions such as intestinal obstruction or perforation, toxic megacolon, heart failure (grade III or IV), severe cardiovascular disease, severe liver failure, or renal insufficiency, among others.
* 10. Researchers believe that patients are not suitable to participate in the trial;
* 11. Have had drug or alcohol abuse or psychological disorders in the past five years.
Context Effects in Exercise Therapy for Knee and/or Hip Pain

The study is designed to investigate the effect of physical surroundings on the effect of exercise therapy for knee and hip pain.

Context effect have been shown to be influential in health-care settings, such as hospitals. This study investigates if context effects can be caused by the physical surroundings of exercise.

The study is designed as a double-blind randomized controlled clinical trial. Patients with knee and/or hip pain with a duration of a least 3 months are included in the trial and randomly assigned to 3 groups.

1. Exercise in pre-existing, standard room
2. Exercise in contextually enhanced room.
3. Waiting list.

The intervention consists markedly different between the two exercise rooms. The physical surroundings are described by factors such as acoustics, light source and intensity, decorations and air quality.

The exercise program applied is based on a previously investigated neuromuscular exercise program, NEMEX. The same program is performed in both exercise rooms. Consequently, only the physical surroundings differ between intervention groups.

Patients' "global perceived effect" is used as the primary outcome assessed at 8 weeks follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age: 35 years or older
* Self-report of knee and/or hip pain within the last 3 months.
* Willing and able to attend exercise therapy at the University of Southern Denmark, Odense M twice weekly.

Exclusion Criteria:

* Co-morbidities or contraindication prohibiting to participation in exercise therapy.
* Unable to fill-out questionnaires, or to speak, read or understand Danish.
* Already participating in exercise therapy\*, having had surgery to the hip/knee within the last 3 months or on waiting list for joint surgery within the coming 6 months. (\*defined as supervised exercise program by physiotherapist, systematic strength training etc. with duration of 6 weeks or more)
Prospective Athlete's Heart Study

The Pro@Heart (Prospective Athlete's Heart) study is an international multicentre long-term prospective trial. The primary objective of the Pro@Heart study is to investigate the impact of training load (i.e. accurately evaluated in term of type, frequency, duration and intensity) and genotype on the variability of structural, functional and electrical exercise induced cardiac remodeling (EICR) in young competitive endurance athletes. The second objective is to determine how EICR, training load and genotype are associated with physical performance, health benefits and cardiac pathology (e.g. exercise-related cardiomyopathies and arrhythmias) during follow-up over several decades.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females aged 14-23 years old
2. Athletes competing in endurance sports at national or international level for at least 2 years. Sports include:

   1. Triathlon
   2. Cycling
   3. Distance running (≥ 1500 meters)
   4. Rowing
   5. Swimming
3. Non athletes engaged in \< 3 hours per week of physical activity

Exclusion Criteria:

1. Medical history of cardiovascular disease
2. Current smoker of past history of smoking
3. Diabetes mellitus
A Prospective, Randomized, No-treatment Controlled, Evaluator-blinded Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Microspherical Injectable to Improve Forehead Contour

A Prospective, Multicenter, Randomized, No-treatment-controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Based Facial Injectable to Improve Forehead Contour


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age (whichever is the time of signing informed consent) of either sex;
2. Subjects who are seeking treatment for forehead contour improvement;
3. Subjects with moderate to severe forehead contour deficiency (i.e., ASFS score of 2-3) as evaluated by blinded investigator according to Asian Sloping Forehead Scale (ASFS);
4. Subjects who are in good health and suitable for receiving treatment for forehead contour improvement as assessed by the investigator;
5. Subjects who are willing to sign informed consent, understand and accept the duration of the study, and are able and willing to comply with all requirements, including scheduled treatment, follow-up, and other study procedures (including clinical photography).

Exclusion Criteria:

1. Those with a history of severe allergy or anaphylactic shock or those with a history of allergy which may result in a response to treatment;
2. Those with known allergy to polycaprolactone, carboxymethylcellulose, or any of the ingredients in this product, any local anesthetics such as lidocaine or other amide anesthetics;
3. Those with tattoos, scars, deformities, non-healing wounds, active skin disease or skin inflammation (e.g., herpes, acne, eczema, dermatitis, psoriasis, herpes zoster, etc.), abscess, cancer or pre-cancerous lesions and so forth on the forehead that may affect the evaluation of efficacy or increase the risk of treatment;
4. Those who have received, or plan to receive during the trial, any permanent filler (e.g., polymethyl methacrylate, organic silicon, expanded polytetrafluoroethylene, etc.), autologous fat or unspecified injectables in the frontal region;
5. Those who have received treatment on the forehead such as calcium hydroxyapatite (CaHA), poly-L-lactic acid (PLLA), and polycaprolactone (PCL) within 2 years prior to screening or during the planned trial;
Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk

4arms preference based Study to compare four therapy options in prostate cancer with low or early intermediate risk

The study will compare four possible therapy options for treatment of newly diagnosed prostate cancer with low or "early intermediate" risk according to the patients preferences.

The Following hypotheses will be tested:

* Radiation is not relevantly worse compared to prostatectomy with regard to time to prostate cancer-related deaths
* Permanent seed implantation therapy not inferior to prostatectomy with regard to time to prostate cancer-related deaths.
* Active Surveillance does not lead to a significant decrease of time to prostate cancer-related deaths compared to prostatectomy.

That for patients with newly diagnosed prostate cancer will be randomized into one of the four treatment arms. Randomization may be limited to at least two of the four treatment arms if a patient refuses one or two of the four treatment arms according to his own preference.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, biopsy proven adenocarcinoma of the prostate (ultrasound guided biopsy by standardized protocol)
* Men aged 18-75 years
* Recruitment within 3 months after histological confirmation
* Localized prostata cancer \<= cT2a, NX or N0 M0
* PSA \<= 10 ng / ml
* Gleason score \<= 7a (3 +4)
* ECOG performance status 0 or 1
* \<= 30% positive biopsy cores with largest contiguous tumor length \<= 5 mm
* IPSS score \< 18
* Urine flow (Qmax):\> 15 ml / s

Exclusion Criteria:

* Unifocal Gleason 6 cancer \<1mm
* History of treatment for BPH e.g. TURP, HIFU or cryotherapy
* History of radiation therapy to the pelvis
* Life expectancy \<10 years
* ASA \>= 4
* Post-void residual urine \> 50 ml
* Prostate volume on transrectal ultrasound \> 60 cm3
* large median prostate lobe visualized on transrectal ultrasound
* chronic intestinal inflammatory disease covering the rectum
* Other active malignancy within the past 5 years (except for superficial basal cell carcinoma or non muscle infiltrating bladder carcinoma)
* contraindications for prostatectomy, radiation therapy or Active Surveillance
* Patients refusing written informed consent
Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study

The pilot study will investigate whether combination treatment of Finacea 15% Gel and Brimonidine 0.33% Gel could be more effective than Brimonidine 0.33% Gel monotherapy in treating both the papules/pustules and erythema associated with rosacea.

Acne rosacea is a chronic inflammatory disease with different components including inflammatory lesions (papules/pustules), erythema and telangiectasia. Brimonidine 0.33% Gel primarily affects the erythematous components of rosacea. As such, combination treatment with a standard rosacea treatment, such as Finacea 15% Gel, may provide additional relief for the inflammatory component of rosacea.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* 18 years of age and older
* Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline
* Female subjects of childbearing potential must practice a reliable method of contraception throughout the study
* Moderate or severe rosacea with an Investigator Global Assessment (IGA) score of 3 or 4
* Able to understand and comply with the requirements of the study and sign Informed Consent/Health Insurance Portability and Accountability Authorization forms

Exclusion Criteria:

* Female subjects who are pregnant, breast feeding or who are of childbearing potential and not practicing a reliable method of birthcontrol
* History of hypersensitivity or idiosyncratic reaction to any component of the test medications
* Subjects who have not completed the proper wash-out periods for prohibited medications and/or procedures
* Medical condition that contraindicates the subject's participation in the study
* Alcohol or drug abuse is evident within the past 5 years
* History of poor cooperation, non-compliance with medical treatment, unreliability
* Participation in an investigational drug study within 30 days of the Baseline visit
Evaluation of the Stroke Caregiver Education and Support Program

The study will be evaluating to a 4 week education and support program for stroke caregivers. The 4 week program will provide education, information, and strategies for dealing with areas that caregivers may find challenging in their caregiving role. The study will evaluate the effectiveness of the program to decrease the caregiver's stress, strain and burden, increase the caregiver's knowledge of strategies and community services and increase their role satisfaction as a stroke caregiver and quality of life two weeks after the program and 6 months after the program.

The modules in the program are: 1) Program Introduction, sharing Caregiving Stories and an introduction to Self Management; 2) Community Connections; Session 3 and 4 are chosen by the participants during session 1 from 6 possible options: Communication in your relationship; Cognition, Memory and Personhood; Dealing with your Emotions; Managing your Stress; Changing roles in your relationships and How to be Caregiver Smart? The programs provides education, information and strategies to deal with the areas that caregivers struggle with as caregivers in order to help them feel better able to prepared to manage as caregivers. Also, the investigators also hope to develop some beginning understanding of when is the best time to provide the program to stroke caregivers to be most helpful to them in their caregiving role.

Eligibility Criteria:
Informal unpaid family stroke caregivers

Inclusion Criteria:

Informal unpaid family stroke caregivers

* 18 years of age or older;
* Have provided care to stroke survivor within the home for at least 2 months;
* Have the ability to communicate in English;
* Live within Central South Ontario Stroke Region or the West GTA Stroke Region.

Exclusion Criteria:

Caregivers who:

* Paid to provide care;
* Are friends who provide care to stroke survivor;
* Are providing palliative care to stroke survivor within the home.
Evaluation of Myocardial Reperfusion After Primary PCI in Patients With High Platelet Reactivity Treated by Cangrelor or Not

This study aims to evaluate the impact on myocardial reperfusion and residual thrombotic burden of adding Cangrelor -a potent and immediate P2Y12 inhibitor- to ticagrelor in primary PCI patients with high on ticagrelor platelet reactivity compared to standard of care with ticagrelor alone.

Despite the use of potent P2Y12 inhibitor such as ticagrelor, half of the patients presented high platelet reactivity (HPR) at the time of primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). HPR has been associated with impaired myocardial reperfusion. Myocardial reperfusion, assessed using myocardial blush grade, is a strong prognostic factor associated with infarct size and mortality. Antiplatelet therapy intensification using a potent and immediate P2Y12 inhibitor such as Cangrelor according a point-of-care platelet function test has not been studied in the acute phase of STEMI.

This study aims to evaluate the impact on myocardial reperfusion and residual thrombotic burden of adding Cangrelor to ticagrelor in primary PCI patients with high on ticagrelor platelet reactivity compared to standard of care with ticagrelor alone.

Eligibility Criteria:
Inclusion Criteria:

* patient admitted for STEMI within 24 hours from symptom onset
* pretreated with ticagrelor, aspirin and enoxaparin (according local protocol)
* successfully treated by primary PCI of a native coronary culprit lesion
* anatomy accessible to optical coherence tomography (OCT or OFDI)

Exclusion Criteria:

* cardiogenic shock
* stent restenosis or thrombosis
* use of glycoprotein IIb/IIIa inhibitors before or during PCI
* known coagulation disease
* high bleeding risk (thrombocytopenia \<100,000/dL, surgery \<30 days, active bleeding)
* uncontrolled arterial hypertension (\>180/110 mmHg)
* history of stroke (ischemic or hemorrhagic) or transient ischemic attack
* known severe renal insufficiency (eGFR \<30 ml/min)
* oral anticoagulation
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy

This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or within 6 months preceding conception. Pregnancy-related data, potential confounding factors and information related to pregnancy outcome will be collected. The schedule of office visits and all treatment regimens will be determined by the treating healthcare provider. Duration of the study is 10 years, at minimum.

Acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent
* Are a female of reproductive potential with a confirmed or suspected diagnosis of NMOSD
* Have been exposed to UPLIZNA during pregnancy as defined by receipt of any dose during pregnancy or within 6 months preceding conception

Note: Other Protocol Defined Inclusion/Exclusion Criteria Apply
Inspire Home Study: Utilization of Home Monitoring During Therapy Optimization in Patients With an Inspire Upper Airway Stimulation System (Comparison of Home Sleep Testing vs. In-lab Polysomnography Testing)

Inspire intends to conduct this study to compare Apnea-Hypopnea Index (AHI), between the two randomization arms, at 6 months post-activation

This study is a prospective, randomized, non-blinded, multi-center study of therapy optimization related to the Inspire UAS System (implanted in a commercial setting under current labeling).

Comparison of outcomes between two (2) groups of patients (both implanted with the Inspire UAS system) who undergo different post-implant care algorithms throughout follow-up, in order to determine whether home sleep monitoring may be used as a surrogate for an in-lab PSG titration in a sub-set of patients.

Subjects who have been identified as candidates for Inspire therapy (implant of the Inspire UAS system), according to commercial labeling, will be recruited to participate in the study.

A maximum of 100 subjects will be enrolled at up to 5 clinical centers. A total of 60 subjects will be randomized (1:1) to one of two study arms.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is ≥ 22 years of age;
2. Patient has been diagnosed with moderate to severe OSA, with a baseline (pre-implant) AHI ≥ 15 based on a qualified sleep study;
3. Patient has been implanted with the Inspire UAS System but not yet activated, or has been scheduled for implant of the Inspire UAS System;
4. Patient currently owns a SmartPhone and is willing and able to install and use SmartPhone apps (at no cost to patient);
5. Patient is willing to utilize study equipment at home including Home Sleep Test (HST) equipment, pulse oximetry equipment, and sleep tracking equipment in accordance with the study protocol;
6. Patient is willing and able to return for all follow-up study visits;
7. Patient is willing to be randomized and adhere to randomization allocation;
8. Patient is willing to and capable of providing informed consent.

Exclusion Criteria:

1. Patient has central + mixed apneas more than \> 25% of the total AHI;
2. Patient currently uses adjunctive sleep therapy (eg. CPAP, oral appliance, positional therapy) and will not discontinue use of adjunctive therapy upon implant of the Inspire UAS System;
3. Patient is pregnant or plans to become pregnant;
4. Patient has a terminal illness with life expectancy \< 12 months;
5. Any other reason the investigator deems that the patient is unfit for participation in the study.
Immune Response After Pancreatic Cancer Treatment

The aim of this project is to describe the differential immunologic responses of patients who undergo in situ IRE, margin accentuation IRE with surgical resection of the primary tumor, and surgical resection of the primary tumor only. The primary hypothesis is that IRE induces a long and sustained activation of the cell-mediated immune system, which is distinct from the immune response after surgical resection only. The primary endpoint of this study is the comparison of the CD4+/CD8+ ratio as an indicator of antitumor immunity both longitudinally within a group after the intervention and over time between the three groups. CD4+/CD8+ ratio will be measured preoperatively and at postoperative days 1, 7, 42, and 180. As a secondary outcome, additional measurements will be taken to more specifically characterize the immune response based on peripheral blood samples. Flow cytometry will be used to quantify cell subsets, and ELISA will be used to measure cytokine levels , at the same time-points as for the primary outcome. Each group of patients as described above will consist of 10 consecutive pancreatic cancer patients. Patients aged 18 or older with resectable, borderline resectable, or locally advanced pancreatic cancer will be included. Patients with locally advanced disease will undergo 3 months of preoperative chemotherapy with monitoring to exclude metastatic disease. Main exclusion criteria are cardiac conduction abnormalities and signs of distant metastasis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Able to undergo general anesthesia (ASA ≤ 4)
* Performance status ECOG \<=2 (Eastern Cooperative Oncology Group)
* Life expectancy of at least 6 months
* Resectable, borderline resectable, or locally advanced pancreatic cancer
* Patients who have locally advanced disease have to show no tumor progression after 3 month of neo-adjuvant chemotherapy+/-XRT before undergoing in situ IRE

Exclusion Criteria:

* Cardiac AV conduction abnormalities, ventricular fibrillation
* History of epilepsy
* Recent history of myocardial infarction (2 months)
* Evidence of distant metastasis (e.g. liver, lung, peritoneum)
* Informed consent cannot be given by the patient
* Known hypersensitivity to the IRE electrodes (stainless steel 304L)
* Women of childbearing potential who are pregnant, breast feeding, or not taking an adequate method of contraception at the time of procedure