cyrilzakka/clinical-trials huggingface dataset:
Study of the Intestinal Microbiota of Patients With Systemic Sclerosis

The term gut microbiota describes the entire intestinal microbial communities. Studies have established the important role played by the gut microbiome in modulating vital functions of the healthy host. The physiological effects of the microbiota for the host are, for the most part, beneficial. In several pathologies, an imbalance in the composition of the microbiota has been demonstrated.

Systemic sclerosis is an autoimmune, disorder of the connective tissue, characterized by vascular lesions, immunological abnormalities, and fibrosis of skin and internal organs As in many inflammatory diseases, there are painful digestive manifestations in systemic scleroderma that affect up to 90% of patients. The exact pathophysiology of the digestive involvement in systemic sclerosis is uncertain. The digestive manifestations of systemic sclerosis are frequent and can affect the entire digestive system.

However, there are few studies of the intestinal microbiota in this disease, which seems to be part of the same continuum of diseases with abnormalities of innate immunity. By analogy with chronic inflammatory bowel diseases, particularly Crohn's disease, we have raised the question of the existence of dysbiosis during scleroderma which could lead to episodes of acute, severe and recurrent inflammation of the peritoneum under the influence of triggering factors. The long-term prospects would be to look for ways to prevent attacks or to treat them more rapidly and effectively by using therapeutic targets in the intestinal microbiota.

The study population will be seen in the usual care setting, identically to all patients with systemic sclerosis treated in the department.

In case of an inflammatory disease outbreak, and depending on its severity, the patient will be seen again in consultation or hospitalized. Appropriate complementary examinations (biology, imaging, endoscopy) will be carried out and the treatment adapted.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Patient with a confirmed diagnosis of systemic sclerosis according to international criteria, before or after the start date of this study.
* Non-opposition of the patient

Exclusion Criteria:

* Subject under guardianship, curatorship or safeguard of justice
* Subject with state medical aid (AME)
* Subject does not speak French
* Subject unable to answer questions or express himself/herself
* Taking antibiotics or a colonic preparation within 6 weeks prior to stool collection will be a temporary contraindication to stool collection. The patient may be included, other usual care samples may be taken, but the stool sample will be deferred and taken at a later date.
Management of Pain in Persons With Multiple Sclerosis

The purpose of this study is to see if treatments that include components of self-hypnosis training and cognitive behavioral therapy (CBT) can help decrease pain in people with MS.

This study examined the benefits of two treatments, individually and together, for helping individuals with MS manage their pain. We conducted a time series design in which MS subjects received all four treatment conditions in two orders (randomly assigned): (1) Control (education intervention-CONT),Self-Hypnosis Training (HYP), Cognitive Behavioral Therapy (CBT), HYP-CBT(a combination of HYP and CBT) and (2) CONT, CBT, HYP, HYP-CBT. Subjects attended 16 60-minute treatment sessions conducted by one of the study's psychologists either at the UW,HMC or in the subject's home. Each subject received four treatment sessions of each treatment module listed above. Primary outcome measures were collected via the telephone and mail by research personnel blind to the treatment condition before treatment, immediately after treatment ends and one month after treatment ends. Secondary outcome measures were collected at the same assessment points via pencil and paper interviews completed by subjects.

Eligibility Criteria:
Inclusion Criteria:

* Chronic ongoing pain (i.e., pain at all times) with an average pain intensity of at least 4/10 on 0-10 numeric rating scale
* Pain is either worse or started since the onset of other MS symptoms.
* Pain of at least six months duration.
* Reads, speaks and understands English.
* Definitive diagnosis of multiple sclerosis (MS)
* At least 18 years of age
* Recruited from a recruitment source approved by the IRB

Exclusion Criteria:

* Severe cognitive impairment resulting in the inability to verbally comprehend, learn, and recall new auditory verbal information, as reflected by a TICS score of 20 or less.
* Currently participating in counseling and/or psychotherapy more than once a week.
* Currently taking anti-psychotic medications
* Has been hospitalized for psychiatric reasons in the past six months
* Experiencing current active suicidal ideation.
* Has received treatment or participated in a clinical trial that involved significant elements of either CBT or hypnosis within the past year.
Supramaximal Titrated Inhibition of RAAS in Dilated Cardiomyopathy

Dilated cardiomyopathy (DCM) is a poorly understood cause of systolic heart failure and is the most common indication for heart transplantation worldwide. Despite advances in medical and device therapy, the 5-year mortality of patients with DCM remains high.

Patients diagnosed of dilated cardiomyopathy with a NYHA functional class of II to IV and left ventricular ejection fraction(LVEF) \<35% were selected for randomized controlled study of the efficacy and safety of high dose Renin-angiotensin system (RAS) inhibitor (benazepril or valsartan), in comparison with low dose RAS inhibitor(benazepril or valsartan) and standard beta-adrenergic blocker therapy (metoprolol). The primary endpoint was all cause death or admission for heart failure. Additional prespecified outcomes included all-cause death, cardiovascular death, all-cause admission, heart failure admission. Secondary cardiovascular outcomes included the changes from baseline to the last available observation after treatment in NYHA functional class, quality-of-life scores, LVEF, LVEDD, mitral regurgitation and wall-motion score index assessed by ECG. Adverse events were reported during in-hospital observation and follow-ups.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dilated cardiomyopathy
* Left ventricular ejection fraction \< 35%
* NYHA Functional classes of II-IV
* Symptomatic but not rapidly deteriorating 1 month before enrollment
* Signed informed consent

Exclusion Criteria:

* Contradictions and intolerance of the studied drugs:

  * supine systolic arterial blood pressure \< 90 mmHg,
  * renal artery stenosis \>50%,
  * pregnancy or lactation,
  * impaired renal function (estimated glomerular filtration rate \< 60 ml/min/1.73m2,
  * impaired liver function (total bilirubin \>2 times upper limit of normal,
  * serum aspartate AST or alanine ALT \>3 times the upper limit of normal),
  * hemoglobin less than 8 mg/dl, hyperkalaemia (serum potassium \>5.5mmol/l),
  * obstructive lung disease,
  * advanced atrioventricular block,
  * any co-morbidity with impact on survival, and
  * known intolerance to benazepril, valsartan and metoprolol succinate;
* HF secondary to a known cause:

  * coronary artery disease based on coronary angiography (≥50% stenosis in ≥1 of the major coronary arteries) and/or a history of myocardial infarction or angina pectoris,
  * acute or subacute stage of myocarditis,
  * primary valve disease,
  * diabetes mellitus,
  * excessive use of alcohol or illicit drugs;
* Expected or performed cardiac resynchronization therapy and heart transplantation.
Effect of Dexmedetomidine on Heart-rate Corrected QT(QTc) Interval Prolongation During Robotic-assisted Laparoscopic Radical Prostatectomy -Randomized Blind Clinical Trial-

Sympathetic activity could be increased during robot-assisted laparoscopic radical prostatectomy, which is performed in a steep trendelenburg position under CO2 pneumoperitoneum.

Stimulation of the sympathetic nervous system prolongs the QT interval and can increases the susceptibility to life threatening cardiac arrhythmias.

Dexmedetomidine has sympatholytic effects and potential antiarrhythmic properties. Perioperative administration of dexmedetomidine is a potential preventive and treatment strategy for tachyarrhythmia. Thus the investigators decided to evaluate the effect of dexmedetomidine on heart-rate corrected QT interval during robot-assisted laparoscopic radical prostatectomy. Furthermore, the investigators evaluated the Tp-e, Tp-e/QT ratio and Tp-e/QTc ratio as well.


Eligibility Criteria:
Inclusion Criteria:

1. ASA class I-II
2. Otaining written informed consent from the patients who were undergoing robot- assisted laparoscopic radical prostatectomy

Exclusion Criteria:

1. Emergency operation
2. Cardiac disease (unstable angina, congestive heart failure, valvular heart disease)
3. Ventricular conduction abnormality
4. Prior pacemaker insertion
5. Abnormal electrolyte values
6. Patients who take antiarrythmic agent
7. Hepatic or renal failure
8. Drug hyperactivity
9. Neurological or psychiatric illnesses
Molecular, Pathologic and MRI Investigation of the Prognostic and Redictive Importance of Extramural Venous Invasion in Rectal Cancer (MARVEL) Trial

Extramural venous invasion (EMVI) is the spread of microscopic tumour cells into the veins around the tumour. Rectal cancer treatment has improved greatly over recent years. However, it is important for us to learn as much about the tumours as possible in order to develop newer therapies. Current treatments may benefit from new genetic information relating to the cancer. We hope to identify genetic differences in certain types of rectal cancer which will allow future treatments.

Neoadjuvant chemoradiotherapy (CRT) is widely accepted as beneficial to selected patients in terms of decreased risk of local recurrence and overall survival. Current management of rectal cancer involves risk stratification through pre-operative staging leading to formulation of treatment strategy. Very little is known about the long-term outcomes and response to CRT on MRI detected extramural venous invasion (mrEMVI). Although mrEMVI is accepted as a marker of poor prognosis, whether it has a predictive value and should be specifically treated is not known.

Molecular and genetic profiling provides us with an opportunity to understand the underlying mechanisms which govern clinical behaviour in rectal cancer. Using high-throughput technology such as tissue microarray analysis allows large-scale analysis of specimens in a relatively short amount of time. It offers the ability to compare the molecular profiles of different subtypes of rectal cancer such as mrEMVI-positive and -negative tumours and whether any changes are observed following CRT. This can then be correlated with clinical behaviour over the medium and long-term with regards to local recurrence, distant metastases and overall survival.

This study will identify important differences between key rectal cancer tumour subtypes. Identification of reliable pathological markers of EMVI pathways (from both the primary tumour sample, but more importantly from the pre-operative biopsies) has real potential for taking us a step closer to more personalised management of rectal cancer by establishing prognostic biomarkers reflective of disease type, but also through the underlying biology that may be highlighted (with its promise of therapeutic translation).

Eligibility Criteria:
Inclusion Criteria:

1. Locally advanced primary rectal cancer (requiring pre-operative treatment); diagnosed on tissue biopsy
2. Adult patients - over 18 years
3. Able to undergo curative (TME) surgery
4. Able to undergo MRI and CT with relevant contrast agent
5. Able to undergo LCRT

Exclusion Criteria

1. Metastatic disease at presentation
2. Emergency diagnosis/treatment
3. Unable to undergo staging (MRI and CT) or treatment procedures (LCRT/surgery)
Asthma Patient Education in the Emergency Room

The objective of this randomized trial is to assess the effectiveness of an intervention involving education, self-efficacy, and social support in improving quality of life outcomes among 296 adult asthma patients treated in the emergency room. The main outcome will be a comparison of within-patient change in quality of life between enrollment and 8 weeks. Secondary objectives will be to assess the effectiveness of the intervention in decreasing the need for rescue inhaled beta agonists, in improving peak flow meter rates, and in decreasing the number of days lost from work or school due to asthma. These outcomes will be measured again at 16 weeks to determine if benefits are sustained. Additional outcomes at 16 weeks and 1 year will be to assess the effectiveness of the intervention in decreasing urgent resource utilization for asthma and cost effectiveness.

BACKGROUND:

Many urban asthma emergency room patients lack effective self-management. Most current training programs are administered in outpatient settings and have low attendance rates for emergency room patients. There is a great need to develop effective programs that can be easily administered in the emergency room for patients who, in many cases, are not present in other settings to receive education. This proposal builds on preliminary studies and is tailored to provide emergency room patients with basic education during "a teachable moment" when they may be most receptive to asthma information.

DESIGN NARRATIVE:

Patients will be recruited from two New York City urban emergency rooms or inpatient settings and randomized to the intervention or control groups. Intervention patients will receive a protocol focusing on asthma self-management, education, self-efficacy, and social support, with telephone reinforcement for 8 weeks. Control patients will receive standard emergency room education about asthma.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible if they are 18 years of age or older
* Fluent in English
* Have a known diagnosis of asthma
* Will receive treatment for asthma during the current hospitalization or emergency room visit.

Exclusion Criteria:

* Cognitive deficits
* Other pulmonary diseases or severe comorbidity
* Do not have out-patient access to a telephone
Validity and Reliability of the Polar M200 Activity Monitor

The aim of this study will be to investigate the validity of a consumer available activity tracker (Polar M200) in free-living conditions to measure sedentary time.

The aim of the present study is to evaluate the validity from a commercially available wearable Polar device. Consumer-based activity trackers are generally cheaper, designed for long-term wear and are less intrusive. Potentially, consumer-based activity trackers can be used for research purposes, but high-quality validation studies are needed. The aims of this study will be to assess validity of sedentary outcome measures of a Polar device during free-living conditions in comparison with the ActivPAL3TM activity monitor (AP; PAL Technologies Ltd, Glasgow, UK), which is considered the gold standard to measure sedentary time in free-living conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* /
The Relationship Between Patients' Head Position and ETT Intracuff Pressure

This study is designed to investigate the relationship between patients' position and endotracheal tube intracuff pressure in the pediatric population.

There are currently no data in the literature as to the effect of changes in head position on CP. As the cuff is located in the patients' trachea, the shape of the patents' trachea may be change depending on the position of the patient's head and therefore, the CP may also change. If the intracuff pressure will increase as the patient's head is moved into a flexed or extended position, these patients may be at risk for tracheal damage. The investigators will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age less than 18 years
* Undergoing otolaryngological surgery with endotracheal intubation

Exclusion Criteria:

* Patient who is intubated with an uncuffed endotracheal tube
* Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine
Exploration of Ejaculation Changing Mechanism After Surgery for Benign Prostatic Hyperplasia

Every year in France, more than 60 000 people are operated for benign prostatic hyperplasia (BPH). This surgery is accompanied by a change or even a loss of ejaculations externalized what constitutes the main constraint for patients. Empirically, the investigators talk to the patient "retrograde ejaculation" to explain a possible loss of ejaculation. Yet the underlying mechanism of this modification or loss of ejaculation remains completely unknown. Yet the underlying mechanism of this modification or loss of ejaculation remains completely unknown. No study could not determine whether the predominant mechanism was a real retrograde ejaculation or aspermia. Moreover, technical changes are sometimes tempted to preserve antegrade ejaculation but no scientific rationale can not validate.

Every year in France, more than 60 000 people are operated for benign prostatic hyperplasia (BPH). This surgery is accompanied by a change or even a loss of ejaculations externalized what constitutes the main constraint for patients. Empirically, the investigators talk to the patient "retrograde ejaculation" to explain a possible loss of ejaculation. Yet the underlying mechanism of this modification or loss of ejaculation remains completely unknown. No study could not determine whether the predominant mechanism was a real retrograde ejaculation or aspermia. Moreover, technical changes are sometimes tempted to preserve antegrade ejaculation but no scientific rationale can not validate.

Eligibility Criteria:
Inclusion Criteria:

* Man, at least 18 years, which is scheduled for a BPH surgery
* Sexually active
* Measurement of Residual postvoid less than 6 months
* Patients accepting the constraints of the study
* Signed Consent
* Affiliate or beneficiary of social security system.

Exclusion Criteria:

* Patients unable to understand the study or to give consent
* Patients with known infertility
* Patients previously operated prostate
* Patients previously treated with a natural prostate treatment (radiotherapy, microwave, radio frequency, ultrasound)
* Patients with known urethral stenosis before surgery
* Patient with impaired preoperative in ejaculation
* Patient under guardianship or under judicial protection
* Patient subject to psychiatric care
Analysis of Histopathological Factors Predictive of Lymph Node Involvement and Management Practices in pT1 Colorectal Cancers Treated by Primary Endoscopic Resection

Colorectal cancers (CRC) extending beyond the muscularis mucosae and invading the submucosa without extending beyond it are classified as pT1.

Among these, a number of lesions presenting pejorative criteria, notably histopathological, have a significant risk of lymph node invasion, and are therefore candidates for partial colectomy with lymph node dissection. Tumors deemed to be at low risk of lymph node involvement can be treated by endoscopy alone.

It should be noted that further surgical intervention is not without comorbid consequences, and that a significant proportion of post-surgical surgical specimens are free of cancerous lesions.

The aim of this study is therefore to analyze the current histopathological criteria predictive of lymph node invasion, in order to more accurately select candidates for surgical management.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with pT1 colorectal cancer (of adenocarcinoma subtype only) diagnosed from January the 1st, 2009 to December the 31st, 2020, with first endoscopic resection, in the area of Finistère (France)

Exclusion Criteria:

* other than adenocarcinoma
* other than T1
* primary surgical management
* neoadjuvant treatment
* refusal to data collection
Evaluate the Response to 2 Induction Courses (12 Intravesical Instillations) of Bacillus Calmette-Guérin (BCG) for High Risk Superficial Bladder Cancer

This is a phase II study. This means that BCG therapy has already been found to be safe in humans. The investigators just want to see if using more treatments works better.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have high risk non-muscle invasive urothelial bladder carcinoma (Tis, TaHG, or T1) that is pathologically confirmed by the Memorial Sloan Kettering Department of Pathology or a documented history of TaHG or T1 non-muscle invasive urothelial bladder tumors.
* 18 years and older
* All visible papillary lesions must be macroscopically resected within 60 days of treatment initiation.
* Absence of urothelial carcinoma involving the upper urinary tract (documented by radiological imaging or biopsy) preferably within 12 months from the start of treatment. Should the imaging or biopsy be performed outside this window it will be up to the physicians discretion to re-scan/biopsy.
* Patients who have received a single dose of mitomycin C following staging TUR.

Exclusion Criteria:

* Currently being treated or scheduled to have radiation treatment for bladder cancer during the study.
* Treatment with intravesical BCG or chemotherapy for a patient's current \<T2 tumor during the 12 months prior to the current diagnosis.
* Currently being treated or scheduled to have treatment with any systemic or intravesical chemotherapeutic agent during the study.
* Currently being treated with or having been treated in the last 12 months with any investigational drug for high risk superficial bladder cancer.
* Previous muscle-invasive (i.e., stage T2 or higher) transitional cell carcinoma of the bladder.
* Currently being treated for metastatic transitional cell carcinoma.
* Scheduled to have surgery for bladder cancer during the study.
* Presence of clinically significant infections or congenital or acquired immunodeficiency.
Study of Patient Preferences in Relation to the Fitting of a Personalized and Connected Joint Prosthesis.

The goal of this observational study is to learn about patients' preference toward the use of customized and connected prosthesis. The main questions it aims to answer are:

* What is the acceptability of new customization and connectivity technologies by patients?
* Are they all at the same level of acceptability?

Participants will have to answer to a questionnaire of choice.


Eligibility Criteria:
Inclusion Criteria:

* More than 18
* Non opposition expressed
* Should have a hip, knee or shoulder joint replacement

Exclusion Criteria:

* Opposition expressed
* Having already a hip, knee or shoulder joint prosthesis