cyrilzakka/clinical-trials huggingface dataset:
Clinico-biological Collection of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases

The aim of this project is to start a biological and clinical collection of patients presenting autoimmune, dysimmune or auto-inflammatory dermatological diseases. This collection will provide appropriate biological samples to identify new biomarkers and to be accessible to the medical, scientific and industrial communities for the identification of new therapeutic strategies.

Autoimmune diseases include around a hundred different clinical entities which are for the most part rare pathologies but which, in combination, concern 5-8% of the adult population with a strong female predominance (FAI²R: the disease chain rare autoimmune and auto-inflammatory drugs, fai2r.org). The common denominator of all these diseases is based on the breakdown of self-tolerance which is the origin of self-reactivity and whose physiopathological mechanisms are still not fully understood, which generates numerous cross-sectional or fundamental studies. In addition to this complexity, there are significant inter-individual variabilities which lead to the definition of subgroups of patients on the basis of the clinical-biological profile and / or the response to treatments. Consequently, and in view of the need to establish the diagnosis early and then to propose the best treatment in the perspective of an individualized medicine, the clinical, biological and genetic characteristics of these subgroups of patients must be explored in order to improve diagnostic and therapeutic capacities.

Eligibility Criteria:
Inclusion Criteria:

Skin damage of documented or probable autoimmune, dysimmune or autoinflammatory origin.

The patients included may be adults or children, and will be:

* Patients with autoimmune bullous dermatoses (pemphigus, pemphigoid and others),
* Patients with systemic autoimmune diseases associated with skin damage (lupus, scleroderma, dermatomyositis for example),
* Patients with cutaneous lupus
* Patients with dysimmune skin diseases (psoriasis, eczema)
* Patients with immuno-induced dermatological disorders or drug dermatitis
* Patients receiving, or likely to receive, new, innovative therapies (new molecule on the market, checkpoint inhibitors, gene therapy, cell therapy, etc.).

Patients with dermatological damage whose autoimmune, dysimmune or auto-inflammatory origin is suspected

Exclusion Criteria:

* Patients under protective supervision (guardianship, curators)
* Patients under 6 years old
* Pregnant or breastfeeding woman
Postmarketing Surveillance of Atrovent® in Chronic Obstructive Pulmonary Disease

To obtain further information on the tolerability and efficacy of Atrovent® inhalets in long term treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice


Eligibility Criteria:
Inclusion Criteria:

* Primarily patients of both gender, older than 40 years, who suffer from Chronic Obstructive Pulmonary Disease
* Only patients who had not been treated with Atrovent® within the last year were to be considered for inclusion

Exclusion Criteria:

• Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® Inhalets
Mitigating Cephalad Fluid Shifts: A NSBRI Study

This is a feasibility study to determine optimal thigh cuff design using a cephalad fluid shift protocol in patients who have an intraventricular catheter (such as Ommaya reservoir) placed for the delivery of central nervous system chemotherapy or for diagnosing potential elevation of ICP and monitoring its progression as part of standard medical care.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18-89 years old
* Willing and able to provide informed consent
* Patients who have an intraventricular catheter placed for the delivery of central nervous system chemotherapy or for diagnosing potential elevation of ICP and monitoring its progression as part of standard medical care
* KPS ≥ 70
* For patients on active anti-cancer (intra-thecal or IV) therapy, must be at least 2 weeks since last treatment; oral therapy is permitted

Exclusion Criteria:

* Less than 2 weeks since any prior surgery
* ICP \> 20 mmHg that cannot be clinically stabilized
* Pregnant (Note: women of child-bearing potential must have a negative urine pregnancy test; women who are not of child-bearing potential are defined as: post-menopausal, age \> 55 years with cessation of menses for 12 or more months; or less than 55 years with postmenopausal status confirmed by follicle-stimulating hormone in the post-menopausal range; or who have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)
* Existing cardiovascular disease, diabetes, syncope, ocular disease that, in the opinion of the investigator, may confound the study results
* Uncontrolled neurological symptoms such as headache, nausea or vomiting that, in the opinion of the investigator, will limit the patient's ability to participate in the study
* Injury, trauma, venous thromboembolism, peripheral arterial disease or any condition that, in the opinion of the investigator, will prevent the subject from tolerating the application of a thigh cuff; history of treated DVT is permitted
Repair by Rehabilitation of Pelvic Floor Lesions After Vaginal Delivery Identified by Transperineal Ultrasound 3/4 D

SUMMARY: (Objective, design, scope of the study, subjects of study, instrumentation, results, conclusions)

Objectives: To evaluate if the physiotherapy treatment in pelvic floor dysfunctions, identified by transperineal ultrasound 3 / 4D, in postpartum improve the tone and functionality of pelvic floor.

Design: Post-authorization, prospective, longitudinal randomized intervention study

Scope: Full-term deliveries at the University Hospital. Subjects of study: Full-term primiparous and full-term pregnancies with pelvic floor lesion, identified by transperineal ultrasound 3 / 4D, which are randomized between the physiotherapy treatment of pelvic floor and the non-work.

Variables: Primary variable: Assess the improvement in contractility / tone, evaluation by manometry and assess the anatomical improvement of the area of ?? the genital hiatus, stay by transperineal ultrasound 3 / 4D. Secondary variables: Identify the levator ani muscle injury rate, estimate the sonographic changes in the levator ani muscle through rehabilitation. Analyze the improvement of the symptoms associated with the public organic prolapse and evaluate the improvement of the quality of life.

Data analysis: To detect a difference of 10% in the reduction of the size of the index between the study groups (not intervened / intervened) after 6 months of intervention, standard deviation 10%, Error-alpha 5%, Error- beta 10% (P90%) we need 23 women in each group. Assuming a loss of 10% in the follow-up, the final size would be 52 women, 26 per group.


Eligibility Criteria:
Inclusion Criteria:

* Vaginal delivery
* Cephalic presentation
* Primiparity
* At term gestation (37-42 weeks)
* No prior pelvic floor corrective surgery
* Written informed consent

Exclusion Criteria:

* Pregnancies with severe maternal or fetal pathology
Preoperative Application of Chlorhexidine to Reduce Infection With Cesarean Section After Labor

Surgical site infections (SSI) are the second most common cause of nosocomial infections accounting for 15% of all nosocomial infections among hospitalized patients and 38% of nosocomial infections in surgical patients. In obstetric patients, infectious morbidity (i.e. SSI, endometritis) occurs in 5-10% of cesarean sections, which is 5-fold higher than vaginal deliveries. Additionally, infectious morbidity is thought to be highest in those patients who have cesarean sections after undergoing labor.

Chlorhexidine, a chemical antiseptic effective on gram positive and gram negative bacteria, reduces skin microflora/colonization but it is not clear if it decreases the risk of SSI.

Historically, chlorhexidine has been studied and used in orthopedic and cardiac implant surgeries. Research on the use of chlorhexidine for SSI prevention in cesarean sections is limited. This study intends to evaluate the effectiveness of use of both chlorhexidine gluconate (CHG) wipe and vaginal scrub in reducing SSI in patients undergoing cesarean section that have previously been laboring. Patients will be randomized to one of two groups: wash with both a pre-operative CHG cloth prior to surgery and chlorhexidine gluconate vaginal scrub in addition to standard preoperative scrub as compared to standard preoperative scrub alone.

The study will be offered to women who are admitted to undergo labor at Mount Sinai Medical Center. The eligible women will be randomized to use of a 2% chlorhexidine gluconate (CHG) cloth with 4% chlorhexidine gluconate vaginal scrub (including standard preoperative care prior to cesarean section) or standard preoperative care. Participants will not be blinded to the arm in which they have been assigned.

Researchers will have access to all patients scheduled for delivery at Mount Sinai Medical Center. About 1800 deliveries by cesarean section occur each year at Mount Sinai. Of these, approximately 800 are cesarean sections after failed labor. Assuming a primary outcome rate of 20% in the control arm, a sample size of 329 in each group would give 80% power to detect a 40% reduction in surgical site infection between the active group and control. The aim is to recruit 400 patients per group (for a total of 800 patients) to account for patient drop out or non-compliance.

Sage Products, Inc will be providing the CHG cloths.

This study intends to show that simultaneous use of 2% CHG cloths and 4% CHG vaginal scrub prior to cesarean section will reduce the rate of SSI in women who have previously been laboring.

Eligibility Criteria:
Inclusion Criteria:

* Women at \> 24 weeks gestation who are admitted in labor or admitted for induction of labor at Mount Sinai Hospital

Exclusion Criteria:

* Allergy to chlorhexidine
* Unplanned or emergency cesarean section
* Women at \<24 weeks gestation
* Estimated fetal weight \<500 grams
* Fetal face presentation regardless of gestational age.
The Effects of CPAP Withdrawal on Cerebral Vascular Reactivity and Brain Oxygenation in OSA

Obstructive sleep apnoea (OSA) is a highly prevalent sleep-related breathing disorder associated with adverse cardiovascular outcome. Underlying mechanisms are subject of debate. A causal relationship between OSA and systemic hypertension as well as peripheral endothelial dysfunction was shown, and there is accumulating evidence from physiologic and observational studies that cerebral autoregulation is insufficient to protect the brain from the nocturnal consequences of OSA. However, there are no data from randomised controlled trials proving a causal relationship between OSA and impaired cerebral vascular reactivity (CVR). The aim of this randomised controlled trial is to study the effects of a short-term CPAP withdrawal, and thus returning OSA, on daytime CVR and brain oxygenation to establish whether there is a causal relationship between OSA and cerebral vascular damage.


Eligibility Criteria:
Inclusion Criteria:

* Objectively confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI) and apnoea-hypopnoea-index (AHI) of ≥20/h.
* Currently an oxygen desaturation index (≥4% dips) of ≥15/h during an ambulatory nocturnal pulse oximetry performed on the last night of a four-night period off CPAP.
* Treated with CPAP for more than 12 months
* Device usage \>4h per night, \>80% of the last 365 days, and AHI\<10 with treatment (according to CPAP machine download data).
* Age between 20 and 75 years.
* Written informed consent as documented by signature.

Exclusion Criteria:

* Previous ischemic or haemorrhagic stroke; known cerebral aneurysm or arterio-venous malformation.
* Carotid artery stenosis \> 70%
* Use of alpha- and beta-adrenergic blocking medication, antianginal medications, triptans, selective COX-inhibitors
* Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (\>180/110 or \<90/60mmHg)
* Implanted pacemaker or internal cardiac defibrillator
* Changes in medication during the trial
* Previous ventilatory failure (awake SpO2 \<93% andPaCO2\>6kPa).
* Obesity hypoventilation syndrome, COPD
* Previously diagnosed with Cheyne-Stokes breathing.
* Current professional driver or any previous sleep related driving accidents.
* Caffeine or nicotine abuse 12 hours before measurements
Thoracal Radiotherapy and Tarceva

The purpose of this study is to determine if erlotinib given orally along with concurrent palliative irradiation to lung cancer improves local control compared to those treated with radiotherapy alone.

Endpoints:

Primary:

* To determine if erlotinib given orally along with concurrent external beam radiation therapy, prolongs local tumour control as determined by CT evaluation compared to treatment with external beam radiation therapy alone

Secondary:

* To confirm the safety profile of erlotinib along with concurrent external beam radiation therapy.
* To evaluate if erlotinib along with concurrent external beam radiation therapy, improve quality of life as assessed with the EORTC QLQ-C30 and the EORTC QLQ-LC13.
* To evaluate if PET-CT examination can be used to predict response to treatment.
* To evaluate overall survival in the different groups

Trial Design: Open multicenter two-armed randomized phase II trial.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Histological or cytological verified NSCLC
* Palliative radiotherapy to thorax indicated
* ECOG Performance status 0-2
* Fertile patients must use contraception
* Signed informed consent
* Ability to understand and fill in QoL questionnaires
* Capability to take per os medication
* Serum bilirubin \< 2 times upper limit of normal (ULN)
* AST and ALT \< 2 times ULN (\< 5 times ULN if liver metastases are present)
* Creatinine \< 5 times ULN

Exclusion Criteria:

* Pregnancy or nursing
* Other prior or concurrent malignant disease likely to interfere with study treatment or comparisons
* No evidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications
* No prior radiotherapy to the same organ / place
* No concurrent treatment with other experimental drugs
* Known brain metastases in need of radiotherapy
* Known hypersensitivity to erlotinib or other substances in the erlotinib tablets.
Transarterial Ethanol Ablation (TEA) Versus Transcatheter Arterial Chemoembolisation (TACE) for Hepatocellular Carcinoma

The current randomized controlled trial comparing LEM and TACE aims to evaluate the safety and efficacy of LEM as compared to TACE for treating patients with unresectable HCC.

The standard loco-regional treatment for unresectable hepatocellular carcinoma is transarterial chemoembolization (TACE). However, The drawback of conventional chemoembolization (TACE) for liver cancer is that it cannot effectively embolize portal venules supplying the tumors, therefore chemoembolization is difficult to completely eradicate the tumor. Usually multiple treatments are required and tumor recurrences are common.

Transarterial Ethanol Ablation (LEM) can potentially provide a better treatment outcome with fewer treatment sessions. Preliminary results from a clinical study showed that the complication rate is reduced while survival rate may be improved. This study aims to compare survival duration and response rate between the treatments TACE and LEM.

Eligibility Criteria:
Inclusion Criteria:

Patient factor

* Age \> 18
* Child-Pugh A or B cirrhosis
* ECOG performance status Grade 2 or below
* No serious concurrent medical illness
* No prior treatment (including surgery) for HCC

Tumor factor

* Histologically or cytologically proven HCC (an alphafetoprotein level \> 500 ug/ml in the presence of radiological findings suggestive of HCC in a patient with chronic HBV or HCV infection can be considered eligible at investigator's discretion)
* Unresectable and locally advanced disease without extra-hepatic disease
* Massive expansive or nodular tumor morphology with measurable lesion on CT
* Size of largest tumor \<= 15cm in largest dimension
* Number of main tumor \<= 5, excluding associated small satellite lesions.

Exclusion Criteria:

Patient factor

* History of prior malignancy except skin cancer
* History of significant concurrent medical illness such as ischemic heart disease or heart failure
* History of acute tumor rupture
* Serum creatinine level \> 180 umol/L
* Presence of biliary obstruction not amenable to percutaneous drainage
* Child-Pugh C cirrhosis

Evidence of poor liver function

* History of hepatic encephalopathy, or
* Intractable ascites not controllable by medical therapy, or
* History of variceal bleeding within last 3 months, or
* Serum total bilirubin level \> 50 umol/L, or
* Serum albumin level \< 28g/L, or
* INR \> 1.3

Tumor factor

* Presence of extrahepatic metastasis
* Predominantly infiltrative lesion
* Diffuse tumor morphology with extensive lesions involving both lobes.

Vascular complications

* Hepatic artery thrombosis, or
* Partial or complete thrombosis of the main portal vein, or
* Tumor invasion of portal branch of contralateral lobe, or
* Hepatic vein tumor thrombus, or
* Significant arterioportal shunt not amenable to shunt blockage, or
* Significant arteriovenous shunt not amenable to shunt blockage
Thalidomide in Treating Patients With Extensive-Stage Small Cell Lung Cancer

RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have extensive-stage small cell lung cancer that has responded to previous chemotherapy.

OBJECTIVES:

* Determine the effect of thalidomide on time to disease progression and survival in patients with extensive-stage small cell lung cancer who achieve a complete or partial response to induction chemotherapy.
* Determine the toxicity of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive oral thalidomide daily beginning 3-4 weeks after completion of induction chemotherapy. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within approximately 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of extensive-stage small cell lung cancer
* Complete or partial response after 4-6 courses of induction chemotherapy

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2

Life expectancy

* At least 2 months

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 effective methods of contraception for at least 4 weeks before, during, and for at least 4 weeks after study
* No greater than grade 1 peripheral neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* See Disease Characteristics

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Buprenorphine/Naloxone Micro-Dosing for Postoperative Pain Management in Opioid-Tolerant Patients

A randomized clinical study evaluating the effect of buprenorphine/naloxone (bup/nx) sublingual film on postoperative pain management in opioid-tolerant patients.


Eligibility Criteria:
Inclusion Criteria:

1. Opioid tolerance, defined as the daily use of greater than or equal to 60mg of oral morphine or an equianalgesic dose of any other opioid for more than 7 days immediately prior to the surgery
2. Undergoing orthopedic or general surgery
3. 18 years of age or older
4. Willing and able to adhere to the study protocol and follow-up schedule
5. Able to provide written informed consent to participate in the clinical trial
6. If female and of childbearing potential, agree to use an effective method of birth control approved by the study investigators throughout the study

Exclusion Criteria:

1. Buprenorphine or buprenorphine/naloxone use in the last two weeks
2. Patients receiving pre-, intra-, or post-operative regional blocks or neuraxial anesthesia
3. Patients receiving postoperative ketamine or lidocaine boluses or infusions
4. Patients receiving postoperative nonsteroidal anti-inflammatory drugs (NSAIDs) for pain control
5. Diagnosis of severe medical or psychiatric conditions contraindicated for bup/nx treatment
6. Liver disease, including clinically significant transaminitis, active hepatitis infection, cirrhosis with evidence of impaired synthetic function
7. Anticipated deterioration of health due to discontinuation of medications that are contraindicated with bup/nx
8. Positive pregnancy test for women of childbearing potential
9. Known allergy or sensitivity to bup/nx
10. Anticipation that the subject may need to initiate pharmacological treatment during the trial that is deemed unsafe by the study physician or could prevent study completion
11. Current participation in additional pharmacologic research study
12. Active suicidal ideation as determined by PI or study clinician
Sidestream Dark-Field (SDF) Imaging of the Intestinal Microcirculation

Sepsis is the most frequent cause of death in critically ill patients in non-coronary care Intensive Care Units in the developed world. Microcirculatory disturbances are central to the development of the disorder, leading to organ dysfunction, multi-organ failure and fatal outcome.

In particular the intestinal microcirculation is impaired early in the course of the disease. This may result in a breakdown of the gut barrier function with translocation of bacteria and their toxins into the systemic circulation, thus sustaining a "gut derived" septic state. Therefore, the impaired intestinal microcirculation has been suggested to act as the "motor of multiple organ failure" in sepsis.

The aim of the project is to evaluate a new diagnostic tool and the impact of Activated Protein C administration on the intestinal microcirculation in patients with severe sepsis and compare the findings with septic patients who are not candidates for APC therapy and healthy patients post bowel surgery using an innovative diagnostic tool (side stream dark-field imaging, SDF).


Eligibility Criteria:
Inclusion Criteria:

* ileostomy, no infection at the site of stoma, informed consent.
* diagnosed sepsis according to American College of Chest Physicians/Society of Critical Care Medicine criteria13.
* indication for treatment according to hospital guidelines

Exclusion Criteria:

* infection at the site of stoma,
* moribund patients
Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities

This is an observational study comparing a novel ultrasound-based imaging system (MAUI K3900) to standard-of-care (SoC) imaging systems used to guide and/or manage interventional radiologic procedures such as solid organ biopsies or lesion ablations.

The purpose of this study is to obtain images using the MAUI Imaging Inc.'s K3900 Ultrasound System and compare them to images captured with FDA cleared imaging devices including traditional ultrasound, CT, MRI and Xray, and to study device safety. The information obtained in this study will inform MAUI Imaging as to what specific follow-on studies will be done in support of appropriate FDA clearances and/or claims. No diagnostic or patient management decisions will be made using the MAUI K3900 Ultrasound System in this study.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing standard / routine interventional radiologic procedure

Exclusion Criteria:

* Unwilling or unable to provide informed consent