cyrilzakka/clinical-trials huggingface dataset:
Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)

The study involves the planned use of a new microwave-based device during colonoscopy procedures in 50 patients to assess the performance and safety of its use for detection of colorectal polyps and lack of normal clinical practice modification. The device is a final design version, which has been previously tested in several preclinical studies (including phantom studies, an ex vivo study with human tissues, and an in vivo study with porcine model) and in a pilot study in humans (NCT05477836)

This study is designed as a single-center prospective, non-comparative study in 50 patients, whereby data will be subject to an analytical description, rather than to a statistical treatment (refer to Statistical design and analysis).

In this study the principal aims are to assess the performance and safety of the device for the detection of colorectal polyps when used as an accessory to colonoscopy. Relevant claims to verify in this study are that the device will detect in first instance polyps not detected initially with the endoscopic image and can be used without ADEs, without any change in the current clinical practice, as well as without any major difficulty by the endoscopist, neither in the preparation nor in the use of the device during exploration.

In addition, in the first phase of the study (n=15 patients), the study aims to gather real clinical data with the use of the device to optimise the processing software that will be key to demonstrate MiWEndo\&#39;s performance on the second part of the study (n=35 patients).

Consequently, principal and secondary objectives of this investigation, are:

Principal objectives:

* To assess the performance of MiWEndo-assisted colonoscopy in the detection of colorectal polyps.
* To assess the safety of MiWEndo-assisted colonoscopy.

Secondary objectives:

* To assess the perception of difficulty by the endoscopist when the device is used.
* To provide exploratory analysis of differences in MiWEndo-assisted colonoscopy in different groups of patients to guide future RCT.
* To assess the patient's comfort.

Eligibility Criteria:
Inclusion Criteria:

- Patients with a previously detected polyp in the rectum referred for resection.

These criteria will ensure the probability of finding polyps during the explorations.

All the patients will give written informed consent.

Exclusion Criteria:

* Patients at a high risk of having major complications as perforation or hemorrhage, suspected or proven lower gastrointestinal bleeding, non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure, inadequate bowel cleansing.
* ASA-IV patients.
* Urgent colonoscopy.
Post-Marketing Surveillance of the Safety and Efficacy of Orgalutran (Ganirelix)®

The purpose of this post-marketing surveillance is to identify problems and questions regarding the safety and efficacy of Orgalutran (Ganirelix)® when used for the prevention of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).


Eligibility Criteria:
Inclusion Criteria:

* Must be undergoing COH for ART

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients
* Hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH analogue
* Moderate or severe impairment of renal or hepatic function
* Pregnancy or lactation
Phase 1/2 Dose Confirmation Study of FLT180a in Hemophilia B

Study of FLT180a gene therapy in adults with Hemophilia B. Up to 9 patients will be enrolled to receive a single dose of FLT180a and be followed for 52 weeks. Results will confirm the dose for a future Phase 3 study.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of Hemophilia B with known severe or moderately severe FIX deficiency (≤2% normal circulating FIX activity) for which the subject is on continuous, stable and adequate FIX prophylaxis
* Have acceptable laboratory values of a) Hemoglobin ≥11g/dL; b) Platelets ≥100,000 cells/µL; c) AST, ALT and alkaline phosphatase (ALP) ≤ upper limit of normal (ULN); d) Serum albumin \> lower limit of normal (LLN); e) Total bilirubin ≤1.5 x ULN (except if caused by Gilbert's disease); f) Serum creatinine ≤2.0mg/dL.
* Level of neutralizing anti-AAV-S3 antibodies below the limit of the pre-established clinical cutoff using an in vitro transduction inhibition assay within the 4 weeks prior to FLT180a administration
* Has demonstrated ability to accurately, independently and in a timely manner enter bleed diary data during the lead-in study, as judged by the investigator
* At least 150 exposure days to FIX concentrates
* At least 6 months of satisfactory controlled prospective baseline data for bleeding events and FIX consumption data from the FLT-01 lead-in study (ECLIPSE)

Key Exclusion Criteria:

* Any history of alcohol or drug dependence
* Presence of neutralizing anti human FIX antibodies (inhibitor; determined by the Nijmegen modified Bethesda inhibitor assay) at the time of enrolment or a previous history of FIX inhibitor
* Subjects at high risk of thromboembolic events
* Evidence of advanced liver fibrosis
* Prior treatment with a gene transfer medicinal product
* Subjects with active hepatitis B or C
* Serological evidence of HIV-1, not controlled with anti-viral therapy and as evidenced by cluster of differentiation 4 (CD4)+ counts ≤200 μL
* Cytomegalovirus (CMV) immunoglobulin G positive subjects who are CMV polymerase chain reaction (PCR) positive at screening
* Known coagulation disorder other than hemophilia B
* High sensitivity (hs) troponin-T ≥14 pg/mL during screening
* History of uncontrolled cardiac failure, unstable angina, or myocardial infarction or other acute cardiac conditions requiring clinical management in the past 6 months
* Planned surgical procedure within the next 12 months requiring prophylactic FIX treatment
* Known active severe infection (including documented coronavirus (COVID)-19 infection), or any other significant concurrent, uncontrolled medical condition
Erectile Dysfunction Treatment Using Stem Cells

A prospective clinical study to investigate the safety and efficacy of intracavernosal injections of umbilical cord stem cells (UCSCs) combined with platelet-rich plasma (PRP) for erectile dysfunction

Umbilical cord mesenchymal stem cells (UC-MSCs) combined with platelet-rich plasma (PRP) will be injected into the corpora cavernosa of the penis of male patients with erectile dysfunction. The injection will be done at four points along the shaft on both sides of the penis. Penile Doppler ultrasonography will be performed on all patients before the initiation of the treatment. This assessment will be conducted to establish a baseline measurement of penile blood flow in both left and right sides of the penis. Subsequently, after four months of treatment, penile duplex Doppler ultrasonography will be repeated to compare the penile doppler before and after treatment. Statistical analyses will be performed using IBM SPSS Statistics for Windows, version 26.

Eligibility Criteria:
Inclusion Criteria:

* male patient with erectile dysfunction

Exclusion Criteria:

* undergo other treatments for erectile dysfunction
Correlation Between Reticulated Platelets and Major Adverse Cardiac and Cerebrovascular Events After Noncardiac Surgery

This is an observational study designed to monitor the course of the fraction of reticulated platelets and the correlation thereof to major adverse cardiac and cerebrovascular events after noncardiac surgery.

Reticulated platelets (RP) are newly formed, immature platelets which in contrast to mature platelets have high granule content and a residual amount of mRNA. An increased mean platelet volume (MPV) and the fraction of RP have been shown to be correlated to cardiovascular events like myocardial infarction or cardiovascular death. However, there are no trials so far investigating how surgery impacts the fraction of RP and how this fraction correlates with the outcome after noncardiac surgery.

Patients with an age above 18 years undergoing high-risk or intermediate-risk noncardiac surgery are to be included. The fraction of RP is to be investigated in routinely acquired blood samples preoperatively, postoperatively in the recovery room, as well as 24-72 hours after anaesthesia and surgery.

A primary common endpoint are major adverse cardiac and cerebrovascular events (MACCEs), as well as deep vein thrombosis and pulmonary embolism. MACCEs are defined according to Sabaté et al. as: cardiac death, cerebrovascular death, nonfatal cardiac arrest, acute myocardial infarction, congestive heart failure, new cardiac arrhythmia, angina or stroke. Secondary endpoints are lengths of hospital stay and intensive care stay as well as mortality after 3 months. All participants are to be contacted by phone three months after discharge and their health situation is to be determined.

1000 patients will be enrolled in a defined time frame of six months

Eligibility Criteria:
Inclusion Criteria:

* high-risk or intermediate-risk surgical patients undergoing noncardiac surgery
* age ≥ 18 years
* written informed consent

Exclusion Criteria:

* low-risk surgery
* age \< 18 years
AI-based Social Software to Manage wARfarin Therapy

The investigators have demonstrated that social software could improve warfarin therapy quality by Human management. however,the efficiency of management will decline if patients' number expands huge. So it is needed that a human-like and automatic management tool could replace the human work. The aim of this study is to evaluate whether an AI-based social software management model could replace human to guide warfarin therapy.

1. The investigators have developed an AI-based miniprogram, and embedded in the Wechat social application.
2. The investigators invited patients receiving warfarin therapy to participant this randomized controlled trial .
3. Participants were randomized to the experimental group and control group in a ratio of 1:1.
4. Participants' warfarin therapy were managed by an AI-based social miniprogram and a Human-based social miniprogram respectively.
5. International normalized ratio(INR) was monitored once a month at least, and the time in therapeutic range was calculated to evaluate the warfarin anticoagulation quality.
6. Participants were followed-up for 24 months, and clinical events, including major bleedings and thrombotic events were recorded during follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Atrial fibrillation
* Patients with Mechanical valve replacement
* Patients receiving warfarin therapy

Exclusion Criteria:

* Plan to stop warfarin therapy within 1 years
* Bleeding within 3 months
* Refuse to participate in this study
* Other conditions that the physician considers inappropriate for participation
Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry

Patient Registry aiming to provide regional evidence documenting the clinical merit of EUS (Endoscopic_ Ultrasound) guided liver biopsy, per local standard of practice, in patients with suspected liver disease indicated for an endoscopic intervention and a liver biopsy.

The finding of this patient Registry may lead to recommendations towards optimizing liver biopsy procedures. If the study demonstrates the optimization of the number of interventions needed to reach diagnostic and therapeutic goals in the setting of suspected liver disease thanks to the utilization of Acquire compared to other liver biopsy procedures, this data can be used as part of economic messaging of the BSC Acquire Fine Needle Biopsy.

This Registry will document all relevant diagnostic and therapeutic radiologic - trans jugular or percutaneous - and endoscopic/endosonographic interventions which enrolled patients undergo when they are suspected to have liver disease and are indicated for an endoscopic procedure and liver biopsy. The study will help illustrate that an EUS guided approach for liver biopsy in patients with suspected liver disease that is indicated for:

Upper endoscopy and Liver biopsy will benefit both the patients and the hospitals from completing both procedures in one setting.

Where possible, the proposed Registry will also allow for the dynamic assessment of the severity of liver disease and for monitoring of changes to therapy for liver fibrosis and/ or portal hypertension. It is anticipated that the ability to monitor changes in liver status over time will become increasingly important as new therapies emerge in the field.

Eligibility Criteria:
Inclusion Criteria:

* Adult (per local age threshold)
* Suspected liver disease based on abnormal liver function tests, standard ultrasound, transient elastography (Fibro Scan) or CT or MRI of the liver
* Planned upper endoscopy to evaluate for varices
* Planned liver biopsy based on suspected hepatitis or cirrhosis

Exclusion Criteria:

* Severe Coagulation/bleeding disorder as defined by INR \> 2 IU which cannot be corrected with FFP or Platelets \< 50,000 per microliter which cannot be corrected with platelet transfusion.
* Severe organ failure considered unsafe to undergo sedation (ASA class 4 or 5)
* Inability to provide informed consent
Point of Care Ultrasound Lung Artificial Intelligence (AI) Validation Data Collection Study

This study is being conducted to collect image data and relevant clinical data from medical records of patients with suspicion of lung consolidation or pleural effusion. The information will be used to test the performance of Artificial Intelligence (AI) in identification of features associated with the above lung conditions.

This is a prospective, observational, multi-center, post-market clinical study. Enrollment will continue (up to a maximum of 500 adult subjects and up to 300 pediatric subjects) until diagnostic LUS exams are acquired for each of the following groups:

Approximately 500 Adult subjects targeting:

* Approximately 175 exams from patients positive for lung consolidation
* Approximately 175 exams from patients positive for pleural effusion
* Approximately 150 exams from patients negative for both conditions

Approximately 300 pediatric subjects targeting:

* Approximately 150 exams from patients positive for lung consolidation
* Approximately 150 exams from patients negative for lung consolidation

Eligibility Criteria:
Inclusion Criteria:

1. Subjects presenting to the Emergency Department, admitted to the hospital, or seen in the outpatient setting with suspicion of pleural effusion or lung consolidation who received chest imaging to include chest X-ray or CT, or for whom chest X-ray or CT are planned.

   Suspicion of pleural effusion or lung consolidation may be based upon imaging findings or presentation of symptoms including (but not limited to) dyspnea, hypoxia, tachypnea, rales, or dullness.
2. All attempts should be made for subjects to undergo scanning of 14 lung zones (adults) and 12 lung zones (pediatrics). Attempts should also be made to capture all required lung zones in adults and pediatrics. Instances where all zones cannot be captured need to be documented and reason for inability to scan them provided in EDC. See Section 8.1.3 Lung Ultrasound Exams.
3. Subject is willing to provide informed consent (or assent where age appropriate) to participate in the study. Subjects under 18 years of age require informed consent of a parent or guardian and assent as required by institutional IRB.
4. Weight of subject is greater than or equal to 10 kg.

Exclusion Criteria:

1. Subject has pathology precluding safe and pain-free ultrasound probe placement such as burn, significant soft tissue injury or surgical incisions.
2. Current imprisonment.
3. Pregnancy (self-reported)
4. Subjects with breast implants
5. Prior pleurodesis procedure.
6. History of severe lung disease and home oxygen use
7. Presence of subcutaneous air that precludes imaging
8. Body Mass Index (BMI) \> 40
9. Significant scoliosis (Cobb angle ≥ 20 degrees).
10. Pediatric subjects with chronic lung diseases other than asthma.
11. Pediatric subjects on chronic respiratory support (i.e., nasal canula, CPAP, BiPAP, or tracheostomy).
Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)

The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of tiotropium. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.


Eligibility Criteria:
Main Inclusion Criteria:

* History of COPD for at least 12 months prior to baseline visit and chronic productive cough for 3 months in each of the 2 years prior to baseline visit
* FEV1/FVC ratio (post-bronchodilator) ≤ 70%
* FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted
* Treated with tiotropium for at least 3 months before enrollment
* At least 28 puffs of rescue medication during last week prior to randomization

Main Exclusion Criteria:

* COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit
An Open-Label Study of the Safety and Efficacy of Cidofovir for the Treatment of Relapsing Cytomegalovirus Retinitis in Patients With AIDS

To evaluate the safety and tolerance of cidofovir (HPMPC) infusions in AIDS patients with relapsing cytomegalovirus (CMV) retinitis. To determine the time to retinitis progression in this patient population. To evaluate the impact of cidofovir therapy on visual acuity.

Patients are randomized to receive intravenous HPMPC either at one dose for both induction and maintenance or at a higher dose for induction than for maintenance. Induction consists of two consecutive weekly doses followed by maintenance every other week. All patients receive concomitant probenecid and saline hydration. Treatment continues until retinitis progression, as assessed by retinal photographs, or treatment-limiting toxicity occurs.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiretroviral agents.
* Oral trimethoprim/sulfamethoxazole.
* Aerosolized pentamidine.
* Dapsone.
* Fluconazole.
* Rifabutin.
* Filgrastim (G-CSF).
* Itraconazole.
* HIV vaccines.

Patients must have:

* AIDS.
* CMV retinitis, with severity as specified in the Disease Status field.
* Life expectancy of at least 3 months.
* Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Known clinically significant allergy to probenecid.
* Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
* Other active medical problems sufficient to hinder study compliance.

Concurrent Medication:

Excluded:

* Amphotericin B.
* Aminoglycoside antibiotics.
* Vidarabine.
* Intravenous pentamidine.
* CMV hyperimmune immunoglobulin.
* Other nephrotoxic or potentially nephrotoxic agents.
* Other investigational agents with anti-CMV activity.
* Ganciclovir.
* Intravenous or oral acyclovir (except following development of herpetic lesion).
* Foscarnet.
* Diuretics.

Prior Medication:

Excluded within 2 days prior to study entry:

* Ganciclovir or foscarnet.

Excluded within one week prior to study entry:

* Amphotericin B.
* Aminoglycoside antibiotics.
* Vidarabine.
* Intravenous pentamidine.
* CMV hyperimmune immunoglobulin.
* Other nephrotoxic agents.
* Other investigational agents with anti-CMV activity.

Excluded at any time:

Prior systemic or intravitreal HPMPC.

Drug or alcohol abuse that is considered sufficient to hinder study compliance.
Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)

The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.

Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged more than 18 years,
* Strongly suspected of having renal arterial disease,
* Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography examination,

Exclusion Criteria:

* Known grade IV or V chronic kidney disease (GFR\<30 mL/min/1.73m²),
* Contraindication to MRI,
* Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination,
Evaluation of the Beneficial Effects of a Nasal Spray of Resveratrol in Children With Seasonal Allergic Rhinitis

The aim of this study is to evaluate whether treatment with a nasal spray based on resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or severe.

The aim of this study is to evaluate whether treatment with a nasal spray based on resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or severe. The primary objective is to assess whether the treatment with nasal spray based resveratrol is able to improve the allergic rhinitis symptoms during the two months of treatment. The secondary aim is to evaluate if the resveratrol nasal spray is able to reduce respiratory infections and wheezing episodes.

Eligibility Criteria:
Inclusion Criteria:

* Children of both sexes, ranging in age from 4 to 17 years
* History of seasonal allergic rhinitis, mild, moderate or severe, defined according to the ARIA guidelines in 2010, documented by recurrent episodes in the previous year and confirmed by a positive skin test results
* Written informed consent from at least one parent or a legal representative

Exclusion Criteria:

* Lack of informed consent in writing by at least one parent or a legal representative
* Concomitant disorders, such as infection of the upper (sinusitis, etc..) or lower respiratory tract, nasal surgery in the last year, abnormalities of the respiratory tract, immune diseases
* Use of antihistamines, nasal or systemic corticosteroids, leukotriene modifiers, cromolyn sodium, in the last six weeks
Carrageenan for the Prevention of Oral HPV Infection

This is a placebo-controlled, triple-blind randomized clinical trial (RCT) designed to evaluate the feasibility of conducting a larger multicentric RCT investigating the effect of a Carrageenan mouthwash on oral HPV infection. Eligible participants will complete a single in-person visit at baseline, filling out a questionnaire on their electronic device and giving an oral rinse sample for HPV testing. They will receive an adequate supply of mouthwash and instructions on its use. They will subsequently be followed up for up to six months. Every two weeks, participants will fill out a follow-up questionnaire on mouthwash use and sexual activities and self-collect oral rinse sample to be returned by mail.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 45 years old
* Sexually active and have had oral sex in the past month
* Will be residing in Montreal for the next six (6) months after study enrolment

Exclusion Criteria:

* Previous vaccination against HPV
* Previous cancer of the mouth or throat