cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions

The objective of this study was to evaluate the efficacy of the Anti-Adhesion Product (AAP) in preventing or reducing post-operative adhesion formation and re-formation in a subject population having abdominal surgery and being left with a rectal stump and a temporary stoma from a first procedure and scheduled for a laparoscopy/ laparotomy as a second procedure in the normal treatment of the subjects' disease. In both study groups, surgical measures to prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. In the investigational product group, AAP was applied to the rectal stump and the incision line while no specific additional treatment was applied in the control group. The surgeon assessed preexisting adhesions during the first surgery. Newly developed and re-formed adhesions were evaluated during the second surgery by a surgeon or assistant who did not know the result of randomization. The safety of the study drug was also monitored.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from the subject or the subject's legally authorized representative prior to study entry
* Male or female subjects \> 18 years of age
* Subjects undergoing abdominal surgery with the possibility that a rectal stump would remain due to one or more of the following reasons: inflammatory bowel diseases, neoplasm, colon diverticulitis, colonic obstruction, colon polyposis, peritoneal trauma, fistula, incontinence, or other reasons
* Subjects for whom a second abdominal surgery is planned within approximately eight months of the first surgical procedure.

Exclusion Criteria:

Pre operative:

* Pregnancy and lactation period
* Subjects concurrently participating in another clinical trial with a drug or a device
* Subjects who have participated in a clinical trial with a drug or a device within 30 days prior to this study
* Subjects who have had abdominal/pelvic surgery within six months prior to this study
* Subjects who have received or will receive (approximately within the next eight months) abdominal/pelvic irradiation

Intra operative:

* Subjects with peritonitis
* Subjects with gastrointestinal metastatic cancer, or cancer growing per continuitatem into surrounding tissues
* Subjects treated with hemostatic agents (e.g. fibrin sealant, collagen, oxidized cellulose) during the first surgery
* Subjects treated with adhesion prevention agents other than the Anti-Adhesion Product (AAP) (e.g. Intergel® Adhesion Prevention Solution, Seprafilm® Membrane) during the first surgery
* Subjects with major fecal contamination needing an abdominal lavage during the first surgery
DYsphAgia In Mechanically Ventilated ICU patientS

Dysphagia significantly contributes to morbidity and mortality in non-critically ill patients (as e.g. in stroke). Long term consequences of dysphagia include, among others, malnutrition, prolonged enteral tube feeding and increased risk of aspiration. In the present observational analysis, the investigators aim to elucidate the incidence and the impact of dysphagia on the clinical course of a mixed population of ICU patients post invasive mechanical ventilation.

Dysphagia significantly contributes to morbidity and mortality in non-critically ill patients (as e.g. in stroke). Long term consequences of dysphagia include, among others, malnutrition, prolonged enteral tube feeding and increased risk of aspiration. In the present observational analysis, we aim to elucidate the incidence and the impact of dysphagia on the clinical course of a mixed population of ICU patients post invasive mechanical ventilation.

ICU patients are at increased risk for oropharyngeal dysphagia following endotracheal intubation. However, the incidence, respective underlying causes and clinical consequences of dysphagia in ICU patients are currently understudied. The impact on clinical outcomes of respective ICU patients thus remains currently unclear. A systematic review \[1\] reported highly variable dysphagia frequency rates depending on the time of mechanical ventilation/ intubation.

However, previous clinical trials were heterogeneous in design, methods of screening, and study outcome. The overall quality of evidence is considered low. The systematic review highlights the limited available evidence for dysphagia following intubation and hence the need for high-quality prospective trials. A recent retrospective single-centre trial \[2\] in a tertiary care ICU demonstrated a high presence of dysphagia in mechanical ventilated (MV) patients following extubation. Screening was performed using bedside swallowing evaluation (BSE).

In a prospective observational analysis, we aim to further elucidate the impact of dysphagia on respective clinical outcomes in ICU patients after mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria: all adult ICU patients post mechanical ventilation (observational analysis)

Exclusion Criteria:

* patients prone to die / moribund patients/ or dying patients
* patients post oesophageal resection / with oesophageal rupture
Intestinal Microbiota and Visceral Pain in Chronic Intestinal Pseudo-Obstruction Syndrome (CIPO)

Chronic Intestinal Pseudo-Obstruction Syndrome (CIPO) is a rare gastrointestinal motility disorder. CIPO evolves through iterative flare-ups that can be triggered by viral or bacterial infections, psychological stress, or malnutrition. All of these factors are associated with dysbiosis of the intestinal microbiota (IM). Many studies have associated visceral pain with dysbiosis of the IM, particularly in the context of irritable bowel syndrome (IBS), a painful pathology associated with transit disorders. The team in Dr. Cénac's laboratory has demonstrated the analgesic effect of a bacterial lipid produced by an intestinal bacterium in the context of IBS. The study hypothesize that CIPO patients have a taxonomic and functional dysbiosis of the IM responsible for hyperactivation of sensory neurons inducing visceral pain.

The aim of the study is to identify metabolites differentially produced by the gut microbiota of CIPO patients with visceral pain to determine their effect on the host with a focus on intestinal homeostasis.

For that, 3 samples of digestive effluent will be collected in paediatric CIPO patients.

Then, the study will:

1. Characterize the intestinal microbiota of digestive effluents from painful and non-painful pediatric CIPO patients.
2. Quantify bacterial lipids in digestive effluents from painful and non-painful paediatric CIPO patients. In ileal effluents, we will perform absolute quantification of the bacterial lipidome. We will quantify short-chain fatty acids by gas chromatography coupled with mass spectrometry and, long-chain beta-hydroxylated fatty acids, GABA-lipopeptides, lipoamines and primary and secondary bile acids by liquid chromatography coupled with tandem mass spectrometry.
3. Test the function of these bacterial lipids on sensory neuronal activity in a primary culture of mouse dorsal root ganglia. The effects of bacterial lipids on sensory neurons will be evaluated in a primary culture of mouse dorsal root ganglia. We will quantify calcium mobilization in sensory neurons treated with the lipid compounds identified above. In a second step, in order to determine their inhibitory potential, the same experiments will be performed on neurons activated by a calcium channel receptor agonist, TRPV1 (capsaicin) or by a mix of agonists (histamine, serotonin and bradykinin) of G protein-coupled receptors involved in visceral hypersensitivity

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 1 to 21 years
* Patient diagnosed with CIPO for at least 12 months (= patients meeting at least 2 of the following 4 criteria: 1. Recurrent episodes of intestinal dilatation, 2. Inability to maintain nutrition, 3. Intestinal neuromuscular alteration and 4. Genetic variants.)
* Patient with an ileal or colonic digestive diversion
* Signature of informed consent by both holders of parental authority and agreement in principle given orally by the subject;
* Patients affiliated to a social security scheme

Exclusion Criteria:

-
The Correlation of Preoperative Measurement Parameter on the Predicting of Visual Outcomes Among Patients With Idiopathic Macular Holes

This study retrospectively analyzed the relationship between the preoperative optical coherence tomography(OCT) and optical coherence tomography angiography(OCTA) software related parameters of patients with idiopathic macular hole, the patient's own clinical data and the best corrected visual acuity (BCVA) for at least one month after surgery.

After Pars plana vitrectomy combined with removal of the internal limiting membrane (ILM) and air filling, it can not only promote the closure of the macular hole in patients with idiopathic macular hole, but also improve the visual acuity of the affected eye. There are various studies to predict the visual acuity of patients after surgery recovery, but due to many factors that affect the effect of macular hole surgery, the improvement of visual acuity after retinal surgery varies greatly in different eyes. As a new type of ophthalmology device, OCTA plays an important role in measuring the size of the hole and the changes of retinal capillaries. Therefore, this study intends to calculate patient parameters based on OCT and OCTA equipment. Statistical software was used to analyze the relationship between each parameter and the best corrected visual acuity (BCVA) for at least one month after surgery.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic MHs, the MH is closed ,and follow-up for at least 1 month after vitrectomy.

Exclusion Criteria:

* High myopia (≥6 diopters,AL≥26.5mm), increased intraocular pressure (IOP, \>21 mm Hg) or glaucoma, severe cataract, severe corneal disease，severe systemic conditions that prevent surgery, and history of ocular trauma, intraocular inflammation, retinal vascular disease, or previous ocular surgery
Azithromycin for Preterm Pre-labor Rupture of Membranes

The preterm prelabour rupture of membranes is defined as the spontaneous rupture of the fetal membranes before 37 completed weeks. Preterm prelabour rupture of membranes complicates up to 3% of pregnancies and is associated with 30-40% of preterm births. preterm prelabour rupture of membranes can result in significant neonatal morbidity and mortality, primarily from prematurity, sepsis, cord prolapse, and pulmonary hypoplasia. In addition, there are risks associated with chorioamnionitis and placental abruption The diagnosis of spontaneous rupture of the membranes is made by maternal history followed by a sterile speculum examination. If on speculum examination, no amniotic fluid is observed, clinicians should consider performing an insulin-like growth factor-binding protein-1 or placental alpha microglobulin-1 test of vaginal fluid to guide further management.

One of the risks associated with preterm prelabour rupture of membranes is ascending infection leading to chorioamnionitis, and subsequent fetal and neonatal infection.


Eligibility Criteria:
Inclusion Criteria:

1. Gestational age is between 28 wks and 37wks
2. Singleton living pregnancy.
3. Confirmed Premature Pre-labor rupture of membranes (PPROM).

Exclusion Criteria:

1. previable rupture of membranes (\<23+6wks)
2. Multiple gestations
3. Macrolide allergy
4. patient receiving combination macrolide therapy
5. lethal fetal anomalies
6. contraindications to expectant management of PPROM at time of diagnosis e.g. concurrent preterm labor, placental abruption, chorioamnionitis or non-reassuring fetal testing
Performance Evaluation of the Dreem 3 System for Sleep Assessment in Patients With Insomnia

The objective of the clinical investigation is to assess the performance of the Dreem 3 System for sleep assessment compared to a FDA-cleared PSG assessment and human sleep expert scoring in a population experiencing insomnia symptoms.

Subjects enrolled in the study will come to the sleep laboratory around 8 pm. Their involvement in the protocol will only require them to be equipped by the technician with Dreem 3 in addition to the PSG reference system. This involves the technician placing all the PSG electrodes on the subject's head as per normal practice, and then positioning the Dreem 3 headband so that both devices can operate simultaneously. The subject will be allowed to go to his/her room and do quiet activities (reading, film watching, chatting) prior to sleeping. At the end of the night, the technician will remove the Dreem 3 headband and the PSG.

A technical quality control will be performed on the collected data in accordance with the standard operating procedures, as defined in the study protocol. Recordings that do not meet the quality control criteria will be excluded from further analysis.

Subjects will receive the PSG report at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be ≥ 22 and ≤ 70 years old inclusive.
* Able to read, understand and sign an informed consent form.
* Subjects with stable disease or/and taking stable medications for at least 2 months can be included under Principal Investigator or Sub-Investigator discretion
* Self-reported insomnia symptoms (by means of a questionnaire completed by the participant before their visit to the sleep lab) as defined by International Classification of Sleep Disorders, third edition (ICSD-3), confirmed by a clinician.

Exclusion Criteria:

* Female subjects who are pregnant, or breastfeeding.
* Subject under 22 and above 70 years old inclusive.
* Not able to read, understand and sign an informed consent form
* Subjects with BMI ≥ 40
* Taking medications that induce somnolence or wakefulness, or that can interfere with sleep recording:

  * If the subject is taking OTC medications that can induce somnolence or wakefulness, he/she must not take it the day of the measurement.
  * Prescription only drugs that induce somnolence or wakefulness must be stopped one week before, as PI or Sub-I discretion and/or review with subject's physician.
* Subjects previously diagnosed with Obstructive Sleep Apnea (OSA), REM Sleep Disorder, Narcolepsy, Hypersomnia, or significant difficulty breathing due to underlying condition(s), or subjects diagnosed with Central Nervous System (CNS) disease.
* Subjects that suffer from an unstable disease
* Any incidental finding on the Polysomnography reference system, happening during the study recording, that interferes with eligibility (probable moderate/severe undiagnosed OSA)
* Subjects who may experience fitting difficulties with the headband, including people with head circumference \< 53cm, or a hairstyle impeding the sensor placement (tight braids, hair extension, dreadlocks...) as determined by the investigator.
Perioperative Parameter and Treatment Outcomes of Surgical Treatment for Benign Prostate Hyperplasia in Hong Kong

This is a prospective data registry to assess the treatment outcomes and complications of different treatment approaches in our hospital clusters.

Benign prostatic hyperplasia (BPH) is a very common disease affecting men. Patients with BPH may present with voiding symptoms including hesitancy, intermittence, slow stream and sensation of incomplete emptying, and storage symptoms including urinary frequency, urgency and nocturia. Patients may also suffer from complications including urinary retention, recurrent urinary tract infection, bladder stone formation and obstructive uropathy. For patients who have lower urinary tract symptoms refractory to medications, or those who suffer from complications of BPH, transurethral prostatectomy should be considered.

Surgical intervention options have evolved from electrosurgical resection to the use of lasers for enucleation and ablation \[1\]. Aquablation and Rezum system are new minimally invasive surgical technology for BPH management. \[2,3,4\]. Different treatment approaches will result in different treatment successful rate and also potential adverse effects to patients.

However, large-scale studies investigating the different modalities of surgical treatment of BPH are lacking. Therefore, a prospective data registry is created to assess the perioperative surgical outcomes for different surgical treatment of BPH.

Eligibility Criteria:
Inclusion Criteria:

* Patient at the age of 18 or above

Exclusion Criteria:

* Patient is unable to give consent
Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients

The purpose of this study is to determine whether the use of a sonic toothbrush alone is more effective than two other toothbrushing protocols on dental plaque elimination in patients with fixed orthodontic appliances.


Eligibility Criteria:
Inclusion Criteria:

* no systemic diseases
* orthodontic appliance (min. 10 completely erupted permanent teeth with brackets/bands)
* informed consent

Exclusion Criteria:

* presence of caries lesion
* antibiotic therapy within the previous 6 months
* diagnosis of early onset periodontitis
Clinical and Anatomical Evaluation of Healing of Lesions of the Subscapular Tendon

This study is based on the hypothesis that fatty infiltration postoperative is not or only slightly modified after an atomic repair of lesions of the subscapularis tendon according to a new arthroscopic classification.

After repair of isolated lesions of the subscapularis, it is observed, in nearly half of the cases, a increased fatty infiltration of the subscapularis muscle indicating a probable persistence of the tendon rupture while the Healing failure rate is recognized as moderate (about 15%).

This study is based on the hypothesis that fatty infiltration postoperative is not or only slightly modified after an atomic repair of lesions of the subscapularis tendon according to a new arthroscopic classification.

Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, aged ≥ 18 years
* Patient who has undergone surgical repair for a rupture or rotator cuff injury involving the subscapularis tendon between April and September 2016 and between May 2018 and January 2019
* Patient with a lesion of the subscapularis tendon characterized with arthroscopic classification
* Patient who has previously participated in the classification study of subscapularis tendon injuries based on findings arthroscopy conducted only at the Jean Mermoz Hospital

Exclusion Criteria:

* Patient with a contraindication to MRI
Artificial Intelligence Models for Precision Prediction and Treatment of Prostate Cancer

The aim of this clinical trial is whether artificial intelligence models can be used for accurate clinical preoperative diagnosis and postoperative diagnosis of pathological findings, and will also measure the accuracy of the predictions made by the artificial intelligence models.The main target questions addressed by the model building are:

1. whether the AI model can learn from preoperative MRI and postoperative Whole Slide Images so as to accurately predict information such as benignness or malignancy, aggressiveness, grading, subtypes, genes, etc. for participants suspected of having prostate cancer preoperatively/puncturally.
2. whether the AI model is capable of learning postoperative macropathology slides to enable outcome diagnosis of surgical pathology slides in new participants.

Participants will:

1. complete an MRI examination and have their MRI images analysed by the established AI model to make an accurate diagnosis of them.
2. Based on the diagnosis, if prostate cancer is predicted, they will undergo radical prostate cancer surgery and refine their surgical pathology.

Based on artificial intelligence technology, the prediction model is built by outlining the quantitative mapping correlation between annotated prostate cancer Whole Slide Images and MRI, and clarifying the common features. Firstly, the model can accurately diagnose the radical pathology of prostate cancer, which can be exempted from immunohistochemistry to obtain detailed pathological information; secondly, the established AI prediction model can accurately diagnose the benign/malignant, invasiveness, grade and subtype of prostate cancer by predicting the participant's MRI images before surgery or puncture, so that a personalised treatment plan can be formulated for the patient before operation or puncture. Finally, based on AI technology, the model learns from the MRI images and performs 3D reconstruction of the prostate and lesions before surgery/puncture, thus clarifying the exact location of the lesions and guiding puncture or surgical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected PCa (elevated PSA or suspicious positive lesions on ultrasound or MRI results);

Exclusion Criteria:

* Previous treatment of the prostate in any form, including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy and immunotherapy;
* Patients with any item missing from the baseline clinical and pathological information;
* Patients with a history of other malignancies, serious comorbidities or other health problems;
* Unable to provide/sign an informed consent form;
* Patients who, in the judgement of the investigator, are deemed unfit to participate in this clinical trial;
MR-Guided Laser Ablation of Prostate Bed Recurrences

The purpose of this study is to see if MR-guided laser ablation can effectively treat prostate tumor recurrences.


Eligibility Criteria:
Inclusion Criteria:

* Patients with "biopsy proven" soft tissue tumor recurrences of prostate fossa referred to Urology and/or Interventional Radiology for treatment.
* Surgery is not a desirable alternative therapy at the time of enrollment
* Radiation therapy has failed or not indicated or can be safely postponed
* Tumor size ≤ 5 cm at its largest diameter
* Tumor does not encompass the rectal wall or external urethral sphincter
* Performance status is ECOG 2 or better in adults
* Patient is able to undergo MRI

Exclusion Criteria:

* Patients with pacemaker or defibrillator
Mitochondrial Video Assessment Source Material Study

Source material collection of videos to develop the Mitochondrial Video Assessment (MVA) for patients with mitochondrial myopathies.

This observational research is being conducted to facilitate the development of 2 related, disease-specific outcome measures assessing ease of movement in PMM and PolG clinical trials. The Mitochondrial Video Assessment (MVA) utilizes remote video capture to assess subtle shifts in compensatory movement patterns and measure change in function over time, and the Current State Questionnaire asks participants about external factors in their daily lives which may influence fluctuations in their symptoms. As part of the questionnaire, participants are asked to rate their own perception of their functional ability using a Patient Global Impression of Severity (PGI-S) scale.

Eligibility Criteria:
Inclusion Criteria:

* 16 years old and above
* Confirmed diagnosis of PMM or PolG
* Ability to understand and speak English
* Ability and willing to consent
* Able and willing to participate and perform tasks while being recorded
* Designating a recording partner to assist with video captures is strongly advised, but not required

Exclusion Criteria:

* N/A