cyrilzakka/clinical-trials huggingface dataset:
Antiglutamate Anticonvulsants in the Treatment of Alcohol Withdrawal Syndrome

The study is aimed to evaluate the efficacy of antiglutamate anticonvulsants (topiramate, lamotrigine, and memantine) in the treatment of alcohol withdrawal syndrome


Eligibility Criteria:
Inclusion Criteria:

Alcohol dependence Alcohol withdrawal syndrome

Exclusion Criteria:

Drug dependence Major psychiatric diagnoses Severe somatic illness
Inappropriate Sexual Behaviour of Patients Towards French General Practitioners

Occupational sexual harassment (HS) has come to the fore in recent years, particularly with the #MeToo social movement that has encouraged women victims of sexual violence to speak out around the world. The medical profession is not exempt from this phenomenon, whether during the training or professional life of practitioners. In France, very little data is available on this subject, particularly among general practitioners. However, the specific nature of the doctor-patient relationship in general practice makes it a potentially high-risk setting. Furthermore, practitioners' experiences of inappropriate sexual behaviour (ISB) can lead to changes in professional practice, and can thus directly influence the quality of care provided to patients. It is also described in the literature that sexual harassment in physicians is independently associated with a decrease in job satisfaction and sense of security at work, and may be associated with an altered mental health status. To date, the only French studies on ISB and HS in medicine have focused on the period of medical study, and none have looked at the particular problem of the patient as perpetrator of the violence. It is in this context that it has been decided to set up this cross-sectional study with the aim of evaluating the prevalence of ISB occurring during consultations with French general practitioners, to describe their characteristics and to evaluate the responses provided and the repercussions on professional practice.


Eligibility Criteria:
Inclusion Criteria:

* Any general practitioner
* Male or female
* Sole or mixed private practice
* Installed or substitute
* Having completed their internship in general medicine
* With or without a thesis
* Practising alone, in a group practice or in a health centre -

Exclusion Criteria:

* Specialty other than general medicine
* Exclusive hospital or salaried activity
* Refusal to participate
Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis

The MANUS Trial aims to examine the safety, feasibility and potential efficacy of intramuscularly injected allogeneic mesenchymal stromal cells as treatment for digital ulcers of systemic sclerosis.

The MANUS Trial is a randomized double-blind, placebo-controlled clinical trial. Patients with systemic sclerosis (SSc) and digital ischemia with intractable ischemic digital ulcers refractory to conventional treatments are eligible to participate.

20 participants will be randomised (1:1) to undergo intramuscular injection (8 sites) of allogeneic bone marrow derived mesenchymal stromal cells (BM-MSC) (45-50\*10\^6) or placebo in the most affected limb.

Main study parameters/endpoints: The primary outcome is the toxicity of the treatment at 12 weeks after MSC administration, defined as

1. Local toxicity, including signs of local inflammation (swelling, warmth, impairment of function), worsening of ulcers or new ulcers or hematomas after MSC administration
2. Other adverse events, graded according to the Common Terminology Criteria for Adverse Events version 4.0, expressed as maximum grade toxicity per organ system.

Secondary outcome measures are: number of serious adverse events, pain and disability parameters; healing, time to healing and reduction of new ischemic digital ulcers; modified Rodnan skin score; Scleroderma Health Assessment Questionnaire (S-HAQ) including visual analogue scales (VAS) for scleroderma-specific symptoms; Quality-of-life (SF-36, EuroQol (EQ-5D); Cochin hand function score. We will also evaluate changes in capillary morphology and architecture using capillaroscopy; biochemical parameters; markers for endothelial activation and injury, inflammation, oxidative stress, circulating cells including endothelial cells, hematopoietic and endothelial progenitor cells, cytokines and growth factors, immunological responses. Follow-up visits will be scheduled at 48 hours and 2, 4, 8, 12, 24 and 52 weeks post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of SSc according to the 2013 ACR/EULAR criteria
* At least one active digital ulcer (painful area, \>2 mm in diameter with visible depth and loss of dermis) refractory to intravenous prostacyclins

  * 'Refractory to prostacyclins' is defined as
  * Worsening of ulcer(s) within 1 month after prostacyclins iv
  * No improvement of ulcer(s) after 2 months after prostacyclins iv, as judged by the referring physician
  * Recurrence of exactly the same ulcer(s) (same location) within 3 months after prostacyclins iv
* Written informed consent

Exclusion Criteria:

* Ulcer with underlying calcinosis (ruled out by X-ray prior to screening/inclusion)
* History of neoplasm or malignancy in the past 10 years
* Pregnancy or unwillingness to use adequate contraception during study
* Serious known concomitant disease with life expectancy \<1 year
* Uncontrolled hypertension
* Uncontrolled acute or chronic infection with systemic symptoms (e.g. fever)
* Follow-up impossible
The Effect of ESPB on Intraoperative Hemodynamics in VATS

Video-assisted thoracic surgery (VATS) is frequently applied in thoracic surgery operations. VATS has become the standard procedure in minor and major lung surgeries. In recent years, regional anesthesia techniques have also been frequently applied to patients for pain relief. Thoracic paravertebral block (TPVB), erector spinae plane block (ESPB), and serratus anterior plane block (SAPB) are also among the regional anesthesia techniques frequently used in thoracic surgery.

General anesthesia (GA) is the main method of anesthesia for thoracic surgery. However, GA can only inhibit the projection system of the cortical limbic system or hypothalamic cortex. GA cannot completely block the transmission of peripheral noxious stimulus to the central nervous system and cannot effectively inhibit the intraoperative stress response. With the addition of peripheral blocks such as TPVB, ESPB, and SAPB, more stable hemodynamics is expected by providing preemptive analgesia in patients. As a result of all these; In this study, we aimed to compare the intraoperative hemodynamic changes of patients who underwent preoperative ESPB in patients who will undergo VATS resection under GA with those who underwent postoperative ESPB.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years
* American Society of Anesthesiologists physical status I-II-III
* Body mass index between 18-40 kg/m2
* Patients undergoing elective video assisted thoracoscopic surgery

Exclusion Criteria:

* Advanced cancer
* History of chronic analgesic therapy
* History of local anesthetic allergy
* Infection in the intervention area
* Patients with bleeding disorders
DY002: Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery

The primary objective of this study is to test the hypothesis that DYME is safe and effective as a drug to facilitate continuous curvilinear capsulorhexis (CCC) by selectively staining the anterior capsule. Secondary objectives are to compare the safety and effectiveness of DYME to that of a smaller dose of the same API.


Eligibility Criteria:
Inclusion Criteria:

* Have a cataract sufficiently opaque/mature/brunescent that, in the surgeon's assessment,a dye could facilitate surgery;
* Be aged at least 18 years old at the time of enrollment;
* Be in a medical condition suitable for cataract surgery;
* Able and willing to participate in study examinations and visit schedule; and
* Understand and freely consent to participate in the study.

Exclusion Criteria:

* In either eye, ocular infection or inflammation within the past 3 months;
* Known allergy to BBG 250;
* Uncontrolled intercurrent diseases including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia;
* Active treatment for cancer or systemic infection within the past month;
* Active treatment with systemic corticosteroids within the past month;
* Previous participation in this Study for the contralateral eye;
* Participation in another clinical trial involving an investigational therapeutic during the past 30 days or 5.5 half-lives (if applicable), whichever is longer;
* Unwillingness to participate in the study or inability to give informed consent; or
* Any medical condition that in the opinion of the Investigator may compromise the research subject's safety or ability to participate in the study.
EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth

Primary objective: to assess the efficacy of Bacillus clausii versus metronidazole in the eradication of the small intestinal bacterial overgrowth, 30 days after the end of treatment.

Secondary objective: to assess the efficacy of Bacillus clausii versus metronidazole in avoiding recurrence of the small intestinal bacterial overgrowth, 90 days after the end of the treatment; to assess the efficacy of Bacillus clausiiversus metronidazole in improving irritable bowel syndrome -related symptoms; to assess the efficacy of Bacillus clausii versus metronidazole in the satisfactory relief of overall irritable bowel syndrome symptoms and of abdominal discomfort or pain; to assess the efficacy of Bacillus clausii versus metronidazole in improving irritable bowel syndrome quality of life.


Eligibility Criteria:
Inclusion criteria:

* Irritable bowel syndrome patients with small intestinal bacterial overgrowth (based on positive lactulose or glucose hydrogen breath test)
* Patients able to maintain their usual diet and lifestyle during the course of the study.

Exclusion criteria:

* Pregnancy or breast-feeding
* Major concomitant diseases (including tumours and hepatic and/or renal insufficiency)
* Inflammatory bowel diseases
* History of intestinal surgery (except cholecystectomy and appendectomy)
* Use of antibiotic, laxative, antidiarrheic drugs or probiotics (medications or dietetic supplements) in the last month prior to study entry
* Hypersensibility to the investigational product and reference drug
* Clinical evidence of relevant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, neurologic or of any disease that may interfere with the patient successfully completing the trial or the objectives of the trial
* Eating disorders such as anorexia or bulimia, and/or psychosis, schizophrenia, mania or major psychiatric illness needing pharmacological treatment. Well-compensated depression does not exclude a potential patient
* Participation to a trial in the previous three months
* Drug or alcohol abuse
* Subjects with unstable personality or not able to be compliant with the study procedures

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Intravascular Volume Expansion to Neuroendocrine-Renal Function Profiles in Chronic Heart Failure

Researchers are trying learn more about how the heart and blood volume interact in subjects with heart failure and how measuring blood volume may help them develop better ways of treating and managing heart failure patients.


Eligibility Criteria:
Inclusion Criteria:

* Acute Decompensated Chronic Heart Failure, diagnosed clinically with volume overload by the primary Heart Failure provider or Emergency Department physician and admitted to hospital.
* New York Hear Association functional class III-IVa with stage C or D Heart Failure with Left Ventricular Ejection Fraction \<50%
* Intended treatment plan with intravenous loop diuretic therapy during hospitalization
* Meeting none of the Exclusion Criteria

Exclusion Criteria:

* Age \< 18 years
* Having received any investigational drug or device within 30 days prior to entry into the study.
* Clinically unstable patients (e.g. systolic blood pressure \< 90 mmHg, ongoing requirement for vasopressors or mechanical circulatory support, or mechanical ventilation).
* Hospitalization within three months prior to study for hemodialysis or an ongoing requirement for hemodialysis or ultrafiltration.
* Prior organ transplantation or being on a waiting list for organ transplantation
* Presence of cardiac conditions such as clinically significant cardiac valve stenosis, hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or primary arterial pulmonary hypertension (Group 1 PAH).
* History of blood pressure \> 190/115 mmHg or unexplained syncope within the past 3 months.
* Symptomatic carotid artery disease, known critical carotid stenosis, or stroke within the past 3 months
* Clinically significant intrinsic renal disease (eGFR \<15 ml/min/1.72m2), renal artery stenosis, or history of fibromuscular dysplasia of the renal arteries
* Baseline hemoglobin \< 8.5 g/dl, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) that is five times or more the upper limit of normal or bilirubin three times or more the upper limit of normal
* History of alcohol abuse within the past 6 months.
To Demonstrate the Effect of Food on the Bioavailability of Glipizide

To demonstrate the effect of food on the bioavailability of Glipizide.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis (RA) and Crohn's Disease (CD)

This is an observational trial in Rheumatoid Arthritis and Crohn's Disease patients treated with Cimzia aiming to evaluate the risk and incidence of Tuberculosis.

This is a prospective non interventional study. Patients enrolled in this study will receive Cimzia on prescription according to the instructions for use approved in Russia and within the frame of current standard clinical practices. The patient is evaluated at the Screening Visit for enrollment. A Baseline Visit is to be scheduled no more than 28 days after the Screening Visit. Subsequent evaluations are done routinely every 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been prescribed Cimzia

Exclusion Criteria:

* Any contra-indication according to the Russian Summary of Product Characteristic
Biomarkers in Obstructive Sleep Apnea Surgery

Recent years have witnessed major advances in the understanding of the hormonal, metabolic, and biochemical changes that occur in obstructive sleep apnea (OSA). This project evaluates the biomarkers that measure the most significant health impacts of this disorder and creates a specimen bank that will facilitate evaluations of additional biomarkers in the future.

This is a case-control study to examine the relationship between obstructive sleep apnea (OSA) and elevated levels of leptin, homocysteine, and C-reactive protein (CRP) in moderate or severe OSA and control patients. This is followed by a prospective cohort study to examine the relationship between surgical treatment of moderate or severe OSA and serum levels of these biomarkers.

The short-term goals of this study consider the abnormalities in biomarker levels associated with OSA and specific aspects of the disorder as well as whether the changes seen after surgical treatment of OSA mirror those demonstrated after efficacious non-surgical treatment. The long term goals are in two areas: 1) the development of measures to determine which patients require treatment for sleep-disordered breathing and to monitor the effectiveness of therapy, and 2) a deeper understanding of the connection between OSA and its adverse health consequences.

Eligibility Criteria:
Inclusion Criteria:

* OSA group is adults with moderate or severe OSA (apnea \>= 15 based on preoperative sleep study) undergoing surgical treatment. Assessment is done prior to surgery.
* Control group is overweight (body mass \>25) adults without OSA (apnea-hypopnea index \<5 based on sleep study) or other sleep disorders. Assessment is prior to treatment.
Reference Values for Gastric Emptying Scintigraphy After Bariatric Surgery

Oesophageal and gastric scintigraphy evaluates the function of the gastrointestinal system including variables such as oesophageal transit and gastric emptying (GE). Some variables are known to change after bariatric surgery. In patients that have symptoms of pain or nausea after bariatric surgery, oesophageal and gastric scintigraphy plays an important role in determining the nature of symptoms and is necessary for adequate treatment. However, literature on reference values in the bariatric population are scarce. At this moment, quantitative evaluation of the scintigraphy cannot be performed and conclusions are based on visual interpretation. There is a need for a standardised scintigraphy protocol for the population that underwent bariatric surgery taking into account the changed anatomy and physiology. Then, reference values that describe the oesophageal transit and GE assessed using scintigraphy have to be determined.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years;
* RYGB or SG as primary bariatric surgery;
* A 2 year post-operative period without significant peri-operative or postoperative complications that could affect oesophageal transit, GE, or weight loss;
* "Normal" weight loss, according to our expectations (25% \< TWL \< 35%);
* Participants must be able to adhere to the study visit schedule and protocol requirements;
* Participants must be able to give informed consent (IC) prior to any study procedures;
* Willing to be informed about incidental findings of pathology and approving of reporting this to their general physician.

Exclusion Criteria:

* Pre-existent oesophageal or gastric motility disorders, dysphagia, reflux, dumping syndrome, (postprandial) abdominal pain, neurological or metabolic conditions that significantly affect oesophageal or gastric motility;
* When using proton pump inhibitors (PPI) or H2-antagonists, the inability to stop using them for 3 days;
* Using opioids;
* Previous oesophago-gastric surgery, other than bariatric surgery;
* Unable to stop smoking for 24h;
* Pregnancy or breast-feeding;
* Patients with a drug or alcohol addiction;
* Gluten intolerance;
* Intolerance to tracer ingredients;
* Participating in another scientific study at the same time, if this study interferes with the current study in any way.
Psoriasis and Non Alcoholic Steatohepatitis: Is There a Shared Inflammatory Network ?

The study is to assess frequency of NASH in Psoriatic patient and to measure the level of proinflammatory cytokines including TNFα, interleukin (IL)-6 and IL-17 and anti-inflammatory cytokines including IL10, IL35 by ELISA.

• Psoriasis is a chronic proliferative and inflammatory condition of the skin. It is characterized by erythematous plaques covered with silvery scales, particularly over the extensor surfaces, scalp, and lumbosacral region.

The disorder can also affect the joints and eyes. Psoriasis has no cure and the disease waxes and wanes with flareups. There are several subtypes of psoriasis but the plaque type is the most common and presents on the trunk, extremities, and scalp.

Psoriasis has a prevalence ranging from 0.2% to 4.8%.

In parallel, nonalcoholic fatty liver disease (NAFLD) is the most frequent liver disease worldwide, affecting an estimated 30% of the adult population in developed countries.

NAFLD and the metabolic syndrome are mutually and bi-directionally associated, as these two pathologic condition share insulin resistance as a common pathophysiological mechanism.

NAFLD encompasses a spectrum of pathologic conditions ranging from simple steatosis to nonalcoholic steatohepatitis((NASH) featuring steatosis associated with inflammatory changes, hepatocellular ballooning and pericellular fibrosis), to advanced fibrosis and cirrhosis. NAFLD is projected to become the most common indication for liver transplantation in the United States by 2030 .

Over the last few years, multiple studies have demonstrated that psoriasis is associated with NAFLD. The majority reported a prevalence of around 50 % (range 14.4 % to 65.5 %) for NAFLD in psoriatic patients.

The contribution of IL-17 to the pathogenesis of both psoriasis and NAFLD is intriguing. Th17 cells can be detected in fat tissue and IL-17 itself regulates glucose metabolism and adipogenesis. Likewise, IL-17(A)-secreting Th17 cells may promote the progression from simple steatosis to steatohepatitis \[10\] Therefore, both psoriasis and NAFLD pathogenesis seem to be linked to the joint proinflammatory Th17 axis (and other cytokines such as TNFα and IL-6).

Eligibility Criteria:
Inclusion Criteria:

* Any naive psoriatic patient above 18 years old.

Exclusion Criteria:

* Any psoriatic patient who received treatment for psoriasis.
* Diabetic patients.
* Patients under 18 years old.
* Patient's refusal.
COVID-19 and Rhino-orbital Mucormycosis

Detect the clinical presentation and outcome of post covid-19 fungal mucormycosis in patients referred to Minia university Hospital.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who had positive PCR test for Covid-19.
2. Fungal rhino-orbital infection was confirmed.

Exclusion Criteria:

1. Suspected patient with COVID-19 not confirmed with PCR
2. Incomplete data
the Value of Transanal Endoscopic ISR

The Intersphincteric resection (ISR) technique is an alternative for anal preservation in ultra-low rectal cancer. The transanal total mesorectal excision (TaTME) technique might compensate for the deficiencies of ISR in terms of tumor spillage and poor surgical field exposure. Thus, the investigators perform ISR through a transanal endoscopic approach (taE-ISR), seeking to evaluate the value of this innovative technique in anal preservation in ultra-low rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* American Society of Anesthesiologists (ASA) score I to III
* A biopsy proven histological diagnosis of rectal carcinoma
* preoperative stage as (y) cT1-3N0-2M0
* lower margin of the tumor less than 5cm from the anus
* tumor diameter ≤5cm

Exclusion Criteria:

* Pregnant or lactating women
* Synchronous rectal carcinoma
* History of colorectal cancer or other malignant tumors
* Clinical evidence of metastasis
* Emergency procedure