cyrilzakka/clinical-trials huggingface dataset:
Radiofrequency Ablation vs Doppler-guided Haemorrhoidal Artery Ligation in the Treatment of Haemorrhoidal Disease

Surgical treatment of grade II/III internal haemorrhoidal disease is indicated in the case of medical and/or instrumental treatment failure. Minimal invasive alternatives to haemorrhoidectomy have been introduced in the last decades to treat grade II/III haemorrhoids. Doppler-Guided haemorrhoidal artery ligation (DGHAL) represents a good therapeutic option in this condition with good short and mid-term outcomes but postoperative recurrence rates up to 35% at 5 years.

Recently, a technique of radiofrequency ablation (RFA) has been introduced with promising outcomes. A recent systematic review reported a significant improvement of preoperative symptoms and a recurrence rate \< 5%.

To date, there is no study comparing DGHAL to RFA in the treatment of grade II/III haemorrhoids.

The aim of this study is to demonstrate the non-inferiority in terms of failure rate of haemorrhoidal radiofrequency ablation compared to Doppler-guided haemorrhoidal artery ligation, associated with mucopexy, in the treatment of grade II and III haemorrhoidal disease


Eligibility Criteria:
Inclusion Criteria:

* Major patient,
* With symptomatic Grade II or III haemorrhoidal disease,
* Requiring surgical management,
* Patient able to understand the protocol and having given written informed consent to participate in the study,
* Patient affiliated to the social security system or entitled to it.

Exclusion Criteria:

* Hemostasis disorders
* Associated external haemorrhoidal disease (thrombosis)
* History of surgical procedure for treatment of haemorrhoids (instrumental treatment is not a contra-indication)
* Associated proctological pathology (anal fissure, chronic suppuration, external rectal prolapse)
* History of colorectal cancer
* History of inflammatory bowel disease
* History of rectal resection
* Patient participating in another interventional clinical research protocol involving a drug or clinical investigation of a medical device
* Patient who is pregnant, breastfeeding or able to procreate without effective contraception\* at the time of inclusion
* Patient under guardianship, curators or deprived of liberty.
* Patient under court protection.

  * oral contraceptive (pill), monthly vaginal ring, weekly transdermal patch, subcutaneous implant, intrauterine devices (IUD), or sterilisation.
Pain in Oncolgy: Evaluation of a Non Invasive Monitoring Device (ANI). A Monocentric Prospective Study

l'ANI (Analgesia Nociception Index

The main objective of the research is to estimate the Analgesia Nociception Index (ANI) as a parameter giving the possibility of measuring the pain in painful metastatic cancer. The parameter ANI is compared with visual analogical scale (VAS) score.


Eligibility Criteria:
Inclusion Criteria:

* more than 18 years, -no legal protection, -
* life expectancy is considered over 3-months
* not receiving of béta-blocking,
* Having a rhythm sinusal without extrasystole
* benefiting from a coverage by a social security system

Exclusion Criteria:

* Pace-Maker
* Diabetes mellitus
Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer.

A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F) Positron Emission Tomography (PET) ligand in men with newly diagnosed prostate cancer.

Main objective is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central blinded image evaluation \[BIE\]) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during radical prostatectomy (RP) and pelvic lymph node dissection (PLND). At least one positive pelvic LN on PET (N1) and one positive lymph node (LN) as determined by histopathology (pN1) on the same side of the pelvis (left or right) will be deemed a True Positive (TP) at the patient level.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is male and aged \>18 years old.
2. Histologically confirmed adenocarcinoma of the prostate.
3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).

Exclusion Criteria:

1. Patients who are planned to have an x-ray contrast agent or other PET radiotracer \<24 hours prior to the PET scan.
2. Patients currently receiving, or with a prior history of, Androgen Deprivation Therapy (ADT).
AlmegaPL CV Health Open Label Study

The aim of this study is to assess the effectiveness of Almega PL, a Nannochloropsis algae-derived extract rich in eicosapentaenoic acid (EPA), on improving blood markers associated with heart health of iwi customers.

The investigational product iwi/Cholesterol is a commercially available capsule-form herbal (algae) supplement containing Almega®PL, a Nannochloropsis algae-derived extract rich in eicosapentaenoic acid (EPA). EPA is a type of omega-3 essential fatty acid known to play a beneficial role in protection against cardiovascular disease.The aim of this study is to assess the effectiveness of AlmegaPL on improving blood markers associated with heart health of iwi customers.The study will involve over 200 male and female new consumers of this product and monitor their blood markers during 6 months of supplementation.

Eligibility Criteria:
Inclusion Criteria:

* New iwi/AlmegaPL subscribers.

Exclusion Criteria:

* Participants that are already taking AlmegaPL.
* Participants with serious conditions including but not limited to kidney, neurological, immunological, liver and gastrointestinal disease, any heart condition or diabetes).
* Any participant attempting conception, pregnant or breastfeeding
Effects of Bioflavanoids on Vascular Wall Remodeling in Patients With Varicose Veins

The study is aimed at assessing the dynamics of changes in biochemical markers of venous wall remodeling (type 1 plasminogen activation inhibitor (PAI-1), fibronectin (fibronectin, FN), vimentin (vimentin, VM), von Willebrand factor (vWF), PECAM-1 (CD31) ) in patients with C2s-C3s varicose veins compared with healthy volunteers while taking Venarus® (diosmin in combination with hesperidin).

The study will include 80 patients with varicose veins of the lower extremities, CEAP (CEAP classification stands for Clinical (C), Etiological (E), Anatomical (A), and Pathophysiological (P)) clinical class C2s-C3s and 20 healthy volunteers of similar age, gender, and ethnicity (100 patients altogether). The study participants will be divided into five groups: Group A: 20 patients with varicose veins who will be treated conservatively - receive the drug "Venarus®" (diosmin in combination with hesperidin) at a dosage of 1000 mg once daily for 6 months; Group B: 20 patients with varicose veins C2s-C3s who are not prescribed conservative therapy with venoactive drugs and will not undergo invasive treatment; Group C: 20 patients with varicose veins who will undergo invasive treatment (endovenous laser ablation with miniphlebectomy), followed by Venarus at a dosage of 1000 mg once daily for 6 months; Group D: 20 patients with varicose veins who will undergo invasive treatment (endovenous laser ablation with miniphlebectomy), after which no venoactive drugs will be prescribed. Group E: 20 healthy volunteers without clinical and ultrasound signs of varicose veins.

All subjects in groups A, B, C, and D will receive elastic compression.

Eligibility Criteria:
Inclusion Criteria:

* The study will include men or women over 18 years of age with varicose disease of the lower extremities C2-C3 according to the CEAP classification, confirmed by ultrasound duplex scanning of the veins of the lower extremities

Exclusion Criteria:

* the presence of neoplasms, previous operations on the vessels of the lower extremities, deep vein thrombosis, severe concomitant diseases, including infectious ones, pregnancy, lactation
An Observational Analysis of Voriconazole Therapeutic Drug Concentration Monitoring, Pharmacogenomics and Clinical Outcome Correlations in High-risk Hematology Patients

Hematology patients are at high risk for invasive fungal infection (IFI) and are being treated with voriconazole (VOR) at Princess Margaret Hospital (PMH). It is critical that patients' serum drug levels are within therapeutic ranges when undergoing treatment. The primary objective of this study is to determine whether clinical responses (complete/partial/failure) directly correlate with patients' blood VOR drug levels.

In patients whose disease progression is associated with inadequate voriconazole (VOR) drug levels, serum drug level determination can allow for dose adjustment, thereby preventing disease progression. Patients who are extensive metabolizers may have subtherapeutic VOR levels leading to treatment failure whereas, poor metabolizers may have high drug levels that cause toxicity. Isoenzyme such as CYP2C19 exhibits genetic polymorphism. Genotyping tests can also be helpful in determining patient risk subjecting to extreme spectrum of drug levels.


Eligibility Criteria:
Inclusion Criteria:

* Acute leukemia (including myelogenous and lymphocytic) patients for remission induction chemotherapy, reinduction chemotherapy and consolidation chemotherapy whose antifungal treatment include voriconazole.
* Patients have been subscribed voriconazole for probable or proven fungal infections by microbiological/cytohistological evidence from fine needle aspirate or bronchoalveolarlavage means.
* Patients will also have imaging positive from lose dose CT results depicting halo signs or crescent signs suggestive of invasive fungal infections.
* Patients must be able to tolerate oral intake of medications.

Exclusion Criteria:

* Patients unable to tolerate oral administration with any combinations of severe mucositis (\> or = grade 3), nausea/vomiting (\> or = grade 3), diarrhea (\> or =grade 2), neutropenic enterocolitis (\> or = grade3).
NAC in Preventing CIN in CRF Patients Who Need Enhanced CT Scan in ED

The purpose of this study is to evaluate the effect of NAC or sodium bicarbonate in preventing the aggravation of renal function in chronic renal failure when enhanced computed tomography scan is checked in emergency room.

CIN is frequent in CRF patients. However most studies about CIN has been focusing on elective PCI patients. There is no study that the NAC nor sodium bicarbonate would help in preventing CIN in CRF patients who need enhanced CT scan in ED.

Our intention was to investigate the effect of NAC or sodium bicarbonate in preventing the aggravation of renal function in chronic renal failure when enhanced computed tomography scan is checked in emergency room.

Eligibility Criteria:
Inclusion Criteria:

* CRF patients who need enhanced CT scan

Exclusion Criteria:

* less than 15 years old
* hypersensitivity to NAC
* on dialysis
* no consent from patient or next of kin
Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 9 Months Postpartum.

This study evaluates if the application of resistive capacitive monopolar radiofrequency therapy associated with Thiele massage is effective when treating de novo dyspareunia at 4 to 9 months postpartum.

Dyspareunia is a type of genito-pelvic pain (GPP) that takes place during vaginal penetration at some point in sexual intercourse. It greatly affects quality of life as well as psychological and sexual wellbeing. A delivery with episiotomy, perineal tearing or labor dystocia using forceps or vacuum, are risk factors that contribute to the appearance of de novo dyspareunia with a prevalence of 17-45% at 6 months postpartum.

There is no evidence in the scientific literature of the effect of radiofrequency is this group of patients, however there is a clinical trial that describes the effect in scar tissue although not in the perineum. It is for all of the above that the following project is proposed, to evaluate the effect of RF in perineal healing and vaginal trigger points caused as a consequence of GPP.

The main objective of this study is to evaluate the role that radiofrequency (RF) plays in reducing the level of pain in de novo dyspareunia in postpartum women that persists from 4 to 9 months.

Eligibility Criteria:
Inclusion Criteria:

* 4-9 postpartum
* de novo dyspareunia after delivery
* obstetric injury
* Grant informed consent

Exclusion Criteria:

* radiofrequency contraindications (pacemaker, active infection or pregnancy)
* cesarean section
* dyspareunia previous to labour
* previous vulvo-vaginal pathology
* patients with postpartum depression
* patients with a pelvic region oncological history
Use of Alternative Medicine Among Outpatients in Dermatology and Primary Care Clinics

This study is to assess the practice of complementary and alternative medicine (CAM) for skin related conditions among patients in the Primary Care and Dermatology clinics.

This study aims to determine the prevalence and characteristics complementary and alternative medicine (CAM) usage among Primary Care and Dermatology clinic patients through the use of an anonymous, self-completed written survey. This survey will assess the prevalence and regularity of CAM usage (with and without concurrent use of allopathic therapies), the reasons for CAM usage, perceived success with CAM usage, and socioeconomic status, in both Dermatology and Primary Care patients. We will then compare these elements of CAM usage between the two clinic patient populations.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Presents for a clinic appointment with a dermatologist or primary care physician
* English-speaking

Exclusion Criteria:

* Less than 18 years or older
* Non-English speaking
A Journey Into Participation Patterns Among Patients With Hidradenitis Suppurativa

This study aims to uncover the factors driving patient decisions regarding enrollment, withdrawal, or re-engagement in hidradenitis suppurativa clinical trials. Understanding these factors will significantly improve the relevance and effectiveness of future research endeavors.

Ultimately, this trial endeavors to deepen our understanding of the factors impacting hidradenitis suppurativa clinical trial participation. Enhancing participation rates could accelerate the development of innovative treatments for this debilitating condition.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old
* Diagnosis of hidradenitis suppurativa
* Able to comprehend the investigational nature of the protocol and provide informed consent

Exclusion Criteria:

* Female patients who are currently pregnant or nursing
* Inability to perform regular electronic reporting
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Safety to Evaluate the Efficacy and Safety of HIP1601 in Patients With Non Erosive Reflux Disease

The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with Non-erosive gastroesphageal reflux disease.

A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase Ⅲ Study to Compare Efficacy and Safety of HIP1601 in Patients with Non-Erosive Gastroesophageal Reflux Disease(NERD)

Eligibility Criteria:
Inclusion Criteria:

* 19≤ age ≤ 75
* Patients who were not observed mucosal break('not present') according to the LA classification(LA grade) on the EGDEsophago-Gastro-Duodenoscopy
* Patients who had experienced major symptom within 3 months Patients experienced heartburn or acid regurgitation within 7 days of screening day
* Patients who had experienced major symptom within 7 days before randomization. Entry into study also required that patients had experienced at least mild symptoms on at least 2 days/week or at least moderate symptoms on at least 1 day/week based on RDQ
* Patients understood the consents and purpose of this trial and signed consent form

Exclusion Criteria:

* Patients who have erosive GERD, Barrett's esophagus(other significant dysplasia of esophagus), gastroesophageal varicose veins, active peptic ulcer, gastrointestinal bleeding or malignant GI tumor confirmed by endoscopy
* Patients who have a history of gastric or gastroesophageal surgery
* Patients who have Zollinger-Ellison syndrome, eosinophilic esophagitis, primary esophageal motility disorder, acute upper gastrointestinal bleeding, Functional dyspepsia, IBS, IBD within 3 months before Visit 1
* Patients with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease.
* Patients Has a severe liver disorder(AST or ALT level exceeds 3 times more than normal upper range at Visit 1)
* Has a clinically significant renal failure(MDRD eGFR ≤ 59 mL/min/1.73m2 or Serum creatinine \>2.0mg/dL at Visit 1)
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery

The main objective is to evaluate the FreeO2 device combined with noninvasive respiratory support technique for COPD patients and postoperative bariatric surgery patients.

The main hypothesis is that FreeO2 device for oxygen therapy associated with NIV or nasal high flow oxygen therapy (NHFOT) allows to reach better oxygenation and avoid hypoxemia and hyperoxia.

Bariatric surgery patients:

The main objective of this study is to evaluate the time spent in the SpO2 target (+/- 2% SpO2 target) and partial pressure of carbon dioxide (PCO2) values on patients with morbid obesity after bariatric surgery.

COPD patients:

The main objective of this study is to evaluate the time spent in the SpO2 target (+/- 2% SpO2 target) and PCO2 values on patients with exacerbation of COPD (hypercapnic patients) with different ventilatory supports (NIV and NHFOT) associated with FreeO2.

Eligibility Criteria:
Inclusion Criteria (AECOPD):

* Respiratory acidosis (pH \<= 7.35 and PaCO2 \> 45 mmHg), with or without NIV (last blood gas available during hospitalization)
* Oxygen therapy and/or SpO2 \<90% room air (FiO2 \<= 50% or nasal cannula \<= 7 L/min to maintain SpO2 90%)
* High flow nasal cannula with flow \<= 30 L/min

Inclusion Criteria (Bariatric surgery post-op):

* Patients using CPAP before the surgery (obstructive sleep apnea documented).
* Patients with obesity hypoventilation syndrome in addition to obstructive sleep apnea can be included.

Exclusion Criteria:

* Age \< 18
* Pregnancy
* Respiratory distress or other clinical situation requiring continuous NIV or CPAP
* Glasgow \< 12 or agitation/delirium/dementia (limiting NIV)
* Any contraindication to NIV (state requiring immediate endotracheal intubation, pneumothorax, recent esophagus surgery)
* Hemodynamic instability (at the beginning of the study) (increasing doses of vasopressors or inotropes)
* Refusal to consent to the study

  5 patient with AECOPD and 5 patient with bariatric surgery will be included.
A Safety Study Assessing the Effects of Receiving Genome Sequencing Results

This study uses new methods called "genome sequencing" that allow the investigators to study part or all of a person's genome. The genome is the collection of all of a person's genes. Genes carry the instructions that our bodies need to develop and function. Genes are passed on from one generation to the next. Genome sequencing can study all of a person's genome (whole genome sequencing) or just parts of their genome (whole exome sequencing). In the study, the investigators refer to all these research methods as 'genome sequencing'. Genome sequencing typically shows a large number of gene changes, known as "variants." Some (but not all) of these genetic variants may be linked to increased risks of diseases other than cancer.

The purpose of this study is to learn what kinds of genetic variants the patient wants to learn about from their genome.


Eligibility Criteria:
Inclusion Criteria:

Cancer survivors (sample #1):

* Consented individuals with a personal history of cancer enrolled on protocols 09-068 or 96-051 who have indicated their interest in participating in future research or learning their results, defined as either:
* For samples #1-2: checking "yes" to the re-contact question in their consent form; or,
* checking "I wish to know these results" in their consent form.

Unaffected Relatives (sample #2):

* Consented individuals with no personal history of cancer enrolled on protocols 09-068 and 96-051 (parents or siblings of probands) who have indicated their interest in participating in future research or learning their results, defined as either:
* checking "yes" to the re-contact question in their consent form or,
* checking "I wish to know these results" in their consent form

Focus group participants (sample #3- hypothetical group):

* Individuals with or without a personal history of cancer

Exclusion Criteria:

* Non-English speakers; or,
* Individuals \< 18 years of age; or
* Individuals unable to complete the follow-up assessments (e.g., unavailable to complete questionnaires over the 12-month study period).
* For samples #1-2: Individuals who indicate in their consent form that they do not want to
* checking "no" to the re-contact question in their consent form; or,
* checking "I prefer not to know these results" in their consent form
* Cases where it is unclear whether individuals' are interested in participating in future research or learning their results, defined as:
* Not answering the re-contact question in their consent form (i.e., left blank); or,
* Not answering the re-contact question because it did not exist in the version of the consent form that was originally signed (i.e., re-contact question missing).
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic Bronchitis

This study was performed to confirm that a single 2.0-g dose of azithromycin SR is at least as effective as 7 days of levofloxacin 500 mg/day in adults with acute exacerbation of chronic bronchitis Secondary objectives: To assess safety and the bacteriologic efficacy of both treatment regimens


Eligibility Criteria:
Inclusion Criteria:

Adult patients with a history of chronic bronchitis (i.e., chronic cough and sputum production on most days for 3 consecutive months for more than 2 years) and current evidence of an acute bacterial exacerbation of their disease, as demonstrated by production of purulent sputum and the presence of at lest 2 of the following signs and symptoms, were included: increased sputum production, increased dypsnea, increased cough, or increased sputum purulence.

Exclusion Criteria:

Key exclusion criteria were treatment with any systemic antibiotic within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; a chest radiograph consistent with pneumonia; and previously diagnosed conditions which tend to mimic or complicate the course and evaluation of the infectious process (e.g., bronchiectasis, lung abscess or empyema, active TB, pulmonary malignancy, cystic fibrosis).