rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Plasma Beta-endorphin Levels and Suicidal Behavior
Status: Not yet recruiting

It is an interventional research, monocentric, which involves only minimal risks and constraints.

Psychological pain is closely associated with suicidal ideation (SI) and suicidal behavior, regardless of the severity of the depression. The psychological pain being regulated by the opioidergic system, it seems that a dysfunction of this system exists in suicidal attempters. The aim of this study is to explore the association between levels of β-endorphin and suicidal behavior.

The research team will measure plasma levels of β-endorphin in patients hospitalized for suicide attempt (SA) within 72 hours and compare them to those of patients hospitalized for current major depressive episode (EDC) without any lifetime history of SA. In order to follow the kinetics of β endorphin levels, The research team will carry out two measurements: at inclusion and on day 7 (+/- 2 days) of inclusion.

The main objective is to compare plasma β-endorphin levels in patients hospitalized following a recent SA (≤72 hours) and in patients hospitalized for an EDC without lifetime history of SA.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Common inclusion criteria: Aged between 18 and 65 years old, Subject with a psychiatric diagnosis of current major depressive episode according to DSM-5 criteria Able to understand the nature, purpose and methodology of the study  Specific inclusion criteria  Suicide attempters: Subject hospitalized for of proven suicide attempt (<72h) Affective controls: Subject hospitalized for a current major depressive episode according to DSM-5 criteria and without any lifetime history of suicidal behavior (proven, interrupted or aborted)  Non inclusion criteria  Diagnosis of bipolar disorder Lifetime diagnosis of schizoaffective disorder, schizophrenia or unspecified psychosis Current diagnostic of illicit substance / alcohol use disorder within the last 6 months Diabetes or obesity (BMI > 29) Inflammatory disease (e.g. Lupus, Rheumatoid Arthritis) Receiving opiate treatment or opiate substitution treatment Law protected ( guardianship or curatorship) Deprived of liberty (by judicial or administrative decision or forced hospitalization) Pregnant and breastfeeding women Inability to understand, speak and write French Refusal to participate in the study. Not be affiliated to a French National Social Security System - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Women Urinary Incontinence Prevalence Study (WUIPS)
Status: Not yet recruiting

The goal of this multicenter prospective and prevalence observational study is to punctually investigate and describe prevalence, predictors, quality of life and costs of Urinary Incontinence (UI) among female patients, female caregivers and female personnel in four hospitals in Northern Italy: San Raffaele hospital in Milan, San Raffaele Turro hospital in Milan, Zingonia Policlinico San Marco (BG) and Policlinico San Pietro in Ponte San Pietro (BG).

Eligibility:
- EligibilityCriteria: INCLUSION CRITERIA  Female sex Middle age (40-65 years old) Informed consent signed Comprehension of written and spoken Italian language Female outpatients intended for any hospital unit (outpatient clinic, day surgery and day hospital patients included) and every female caregiver respecting the previous inclusion criteria, recruited at the central admission and at the private admission of the four hospitals involved Female workers (healthcare professionals and administrative personnel) of the four hospitals  EXCLUSION CRITERIA  Male sex Young age (< 40 years) and older age (> 65 years) Pregnant women Puerperium women (up to 40 days post-partum) Women who had undergone urinary and gynecology surgery - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - MinimumAge: 40 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All female patients, female caregivers, female healthcare professionals and female administrative workers who meet the inclusion criteria will be included. Participants will be enrolled in four centers in Northern Italy which are the reference centers for UniSR: San Raffaele hospital in Milan, San Raffaele Turro hospital in Milan, Zingonia Policlinico San Marco (BG) and Policlinico San Pietro in Ponte San Pietro (BG). - SamplingMethod: Non-Probability Sample
Raman Spectroscopy Compared to Flow Cytometry
Status: Not yet recruiting

The detection of MRD is associated with an increased risk of relapse and adverse prognosis in all patient groups diagnosed with acute lymphoblastic leukemia (ALL). However, it has a sensitivity level that detects one leukemic cell in 10,000 normal cells, along with other disadvantages such as the need for a panel of fluorescent antibodies for MRD detection, and its measurement is not standardized in many centers. New determination techniques may be necessary for MRD evaluation. Raman spectroscopy is proposed as a potential technique for MRD measurement, which is based on the inelastic scattering of light that occurs when it interacts with matter, causing optical scattering, where a portion of the radiation changes its wavelength (by Raman effect).

Objectives:

MAIN OBJECTIVE:

To evaluate the presence of MRD in patients with ALL by comparing a standard evaluation method using flow cytometry with a new proposed method using Raman spectroscopy.

SPECIFIC OBJECTIVES:

To assess the presence of MRD using flow cytometry in patients with ALL.
To assess the presence of MRD using Raman spectroscopy in patients with ALL.
To perform a comparison between the MRD measurement techniques by determining sensitivity, specificity, positive predictive value, and negative predictive value.
To establish the validation of using Raman spectroscopy as a method for MRD evaluation.

Study Design:

An observational, cross-sectional, comparative, and diagnostic test study will be conducted on bone marrow aspirate samples from adult and pediatric ALL patients to evaluate the presence of MRD using Raman spectroscopy, comparing the results of this technique with those obtained using flow cytometry. As a diagnostic test study, sensitivity, specificity, positive predictive value, and negative predictive value will be evaluated. The study will be conducted on adult and pediatric patients diagnosed with acute lymphoblastic leukemia treated at the hemato-oncology department of the UMAE No. 1 National Medical Center Bajio and the UMAE Hospital Gynecology-Pediatrics No. 48.

Inclusion Criteria:

Patients diagnosed with ALL for whom MRD determination is clinically necessary will be included in the study. Their results will be evaluated using the gold standard, flow cytometry, and compared with results obtained through Raman spectroscopy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients diagnosed with ALL for whom MRD determination is clinically necessary will be included in the study.  Exclusion Criteria:  Patients without ALL - Gender: All - MinimumAge: 2 Years - MaximumAge: 70 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Acute lymphoblastic leukemia - SamplingMethod: Non-Probability Sample
The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)
Status: Not yet recruiting

This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjects may be enrolled in this study only if they satisfy all the following criteria:  Adult male or female subjects ≥18 years of age Diagnosis of ITP, with a duration of disease of at least 3 months prior to randomization or enrollment Intolerance or insufficient response or recurrence after at least 1 prior ITP treatment (excluding splenectomy) Response (defined as achieved a platelet count ≥50 × 109/L) to at least 1 prior ITP therapy (including splenectomy) Adequate hematologic, hepatic and renal function  Exclusion Criteria:  Subjects are not eligible for enrollment into this study if any one of the following criteria are met:  Evidence of the presence of secondary causes of ITP Clinically serious hemorrhage requiring immediate adjustment of platelets Known history of vital organ transplantation or hematopoietic stem-cell transplantation or chimeric antigen receptor T-cells (CAR-T) therapy Splenectomy within 12 weeks prior to enrollment Presence of active malignancy unless deemed cured by adequate treatment. History of serious cardiovascular disease corrected QT interval (QTcF) ≥450 ms Uncontrolled hypertension Being unsuitable to participate in this study as considered by investigators - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Nasal Packing Duration and Development of Pharyngitis After Septorhinoplasty Surgery
Status: Not yet recruiting

Septoplasty or septal reconstruction is a corrective surgical procedure performed to straighten the nasal septum. It may be associated with numerous complications. To minimize these complications, both nasal cavities are frequently packed with different types of nasal packing. In our study we will try to find relationship between duration of nasal packing and postrhinoplasty sore throat and pharyngitis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ASA I and II patients aged from 20 to 40 years old undergo septorhinoplasty  Exclusion Criteria:  Bleeding disorders Uncontrolled hypertension Cardiovascular diseases Uncontrolled diabetes mellitus Collagen disorders Pregnancy - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 40 Years - StdAgeList: Adult - StudyPopulation: 100 ASA I and II patients aged from 20 to 40 years old will undergo septorhinoplasty in Benha university hospitals - SamplingMethod: Probability Sample
Intraoperative Peak Airway Pressure Changes on Postoperative Pulmonary Function After Muscle Plication
Status: Not yet recruiting

An abdominal panniculus excision procedure is known as an abdominoplasty (panniculectomy). Musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. This study aimed to evaluate the effect of intraoperative changes in peak airway pressure (PAP) after muscle plication on postoperative pulmonary function.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  age ranged between 20 and 50 years old, American Society of Anesthesiologists (ASA) physical status classification I came for abdominoplasty operation  Exclusion Criteria:  anemia or hemoglobin levels below 11g/dl bleeding problems cardiovascular disorders restrictive and obstructive respiratory disease abdominoplasty without plication. - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 50 Years - StdAgeList: Adult - StudyPopulation: age ranged between 20 and 50 years old,- American Society of Anesthesiologists (ASA) physical status classification I and came for abdominoplasty operation - SamplingMethod: Probability Sample
Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)
Status: Not yet recruiting

The primary objective of this study to evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria and slow the rate of eGFR decline in adult participants with IgAN who are at risk of disease progression.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior to or during the Screening Period. UPCR ≥ 0.75 g/g or UP ≥1 g/day from the mean of two 24-hour urine collections during Screening. Estimated GFR ≥ 30 mL/min/1.73 m2 at Screening. Exploratory Cohort: eGFR 20-29 mL/min/1.73 m2 at Screening. A kidney biopsy is required within 6 months prior to Screening or during the Screening Period. Presence of hematuria as defined by a positive result on urine dipstick for blood or ≥ 5 red blood cells (RBCs)/high power field microscopy on urine sediment during or within 3 months of Screening. Stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for ≥ 3 months prior to Screening with no planned change during Screening through Week 106. Participants who are on an SGLT2I, ERA, or MRA must be on a stable and maximum allowed or tolerated dose for ≥ 3 months prior to Screening with no planned change through Week 106.  Exclusion Criteria:  Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 50% over a period of 3 months prior to Screening. Secondary IgAN (eg, due to systemic lupus erythematosus (SLE), cirrhosis, or celiac disease). Concomitant clinically significant renal disease other than IgAN. Prior use of immunosuppressive treatment for IgAN within 6 months of screening. Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%. Clinically active Henoch-Schonlein purpura (IgA vasculitis) requiring ongoing systemic immunosuppressive therapy at Screening. History of kidney transplant or planned kidney transplant during the Treatment Period. Splenectomy or functional asplenia. History of Neisseria meningitidis infection. Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 130 Years - StdAgeList: Adult, Older Adult
Impact of Administration of Esmolol on Nociception Level-guided Control of Nociception.
Status: Not yet recruiting

This study aims to evaluate esmolol's perfusion impact during induction and maintenance of general anesthesia, using Nociception-Level-guided control of nociception, in adult patients undergoing laparoscopic and lower abdominal surgery, on intraoperative remifentanil consumption and postoperative pain in the Post-Anesthesia Care Unit.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Fully consented, American Society of Anesthesiologists Classification Score 1-3 patients from 18yo to 65yo Undergoing laparoscopic surgery associated with sub umbilical mini-laparotomy. Eligible surgeries will be hysterectomy (excluding vaginal approach) and left hemicolectomy, of duration time expected under 180 minutes, under general anesthesia No allergy to one of the medications used in this study  Exclusion Criteria:  Contraindication to the use of the study drug (esmolol) is an exclusion criterion :  Hypotension Sinus bradycardia Sick sinus syndrome Second and third degree A-V block Pulmonary hypertension Right ventricular failure secondary to pulmonary hypertension Decompensated heart failure Cardiogenic shock Nontreated pheochromocytoma Known hypersensitivity to esmolol or any of the inactive ingredients of the product Allergy to esmolol or other beta blockers (cross-sensitivity is possible) Renal dysfunction Airway disease such as asthma or chronic obstructive pulmonary disease Thyrotoxicosis Myasthenia gravis Raynaud's disease or peripheral circulatory disorder  Other situations leading to exclusion :  Severe mental impairment Chronic use of opioids, β-adrenergic receptors antagonists High risk of conversion to laparotomy according to the surgical team (>25%)  Patients will automatically be excluded after recruitment if they withdraw their consent, or if laparoscopy is converted to laparotomy. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
PERIODONTAL AND INTESTINAL MICROBIOTA IN PATIENTS WITH GINGIVAL SCARRING PEMPHIGOID
Status: Not yet recruiting

Patients suffering from Mucous Membrane Pemphigoid with desquamative gingivitis (MMPg) generally present a more degraded periodontal condition compared with controls. Bullous disease could represent a risk factor for plaque-induced periodontal disease, and vice versa.

Indeed, the dysbiotic periodontal microbiota could aggravate the gingival damage specific to MMP, either directly by activating inflammatory pathways, or indirectly by degrading cellular and matrix components. On the other hand, areas of erosive gingiva generated by the autoimmune process could increase the virulent power of periodontal pathobionts, by representing accessible, nutrient-rich connective surfaces. Moreover, in recent years, bacterial studies based on a high-throughput metagenomic approach have suggested the existence of a relationship between the oral and intestinal microbiota in patients with degraded periodontal conditions and suffering from autoimmune inflammatory diseases (inflammatory bowel disease, acute graft-versus-host disease). This relationship can also be envisaged in MMPg patients who meet the conditions that allow this type of pathological process to occur: autoimmune disease; disruption of the gingival epithelial barrier in erosive gingival areas (increasing the risk of antigen exposure); large amounts of thick plaque; degraded periodontal condition with the presence of numerous periodontal pockets from which periodontopathogenic bacteria can translocate intra-tissularly and cause distant adverse consequences.

The main aim of this observational, multicentre, case-control, matched study is to compare the composition of the periodontal microbiota between MMPg patients and control patients (arm 2 and arm 3). The secondary objectives are to compare the composition of periodontal and intestinal microbiota in cases and control patients (arm 2 and arm 3), to compare periodontal microbiota composition in cases and control patients (arm 2) according to periodontitis severity, and to compare gut microbiota composition between cases and control patients (arm 2 and arm3). To date, no such study exists.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults (over 18), non-smokers Arm 1  MMPg (initial, persistent despite medical treatment, recurrent), periodontitis Arm 2 non-MMPg, periodontitis, matched to cases on age, gender and severity of periodontitis  Arm 3:  - non-MMPg, healthy periodontal conditions, matched to cases on age and gender  Exclusion Criteria:  Antibiotic therapy and mechanical periodontal treatment within 3 months prior to study, other chronic general illness of immune or digestive origin - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
WATD and Cancer-Related Fatigue: A Study For Patients Undergoing Anti-Cancer Treatment
Status: Not yet recruiting

The purpose of this study is to evaluate the feasibility of using a commercial WATD (Wearable Activity Tracker Device) to collect HRV (Heart Rate Variability) data from pancreatic and breast cancer patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Written informed consent and HIPAA authorization for release of personal health information Patients pancreatic or invasive breast cancer per enrolling investigator who is planning on or has started anti-cancer treatment. Note: Patients with cancer who are not planning to receive anti-cancer treatment are not eligible for study participation Patients with any severity of self-reported fatigue per enrolling investigator Age ≥ 18 years at the time of consent Ability to read and understand the English language As determined by the enrolling investigator, the ability of the participant to understand and comply with study procedures (i.e., completing questionnaires and device return) for the entire length of the study  Exclusion Criteria:  Any documented, clinically significant cardiac-related abnormality per enrolling investigator that could compromise the outcome of the study. NOTE: The heart rate data collected using the WATD will not be used for patient care. Other factors or conditions, per investigator discretion, for which participation in the study would not be in the patient's best interest or could interfere with study assessment results or preclude study completion No internet, Wi-Fi access or email account No access to a smartphone or mobile device - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients ≥ 18 years of age who have any stage pancreatic or breast cancer per enrolling investigator and have self-reported fatigue - SamplingMethod: Non-Probability Sample
Non-Invasive Plasma Treatment for Cervical Infections: Targeting High- and Low-Risk HPV Variants
Status: Recruiting

This is a prospective, single-center, observational proof-of-principle clinical trial at the Department of Women's Health of the University Hospital Tübingen.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Inclusion criteria for NIPP treatment  Age ≥ 18 years mRNA or DNA-based virus detection by smear (also external findings) Clearly visible transformation zone of the cervix and margins of the lesions corresponding to T1/T2 Written informed consent to participate in the study  Inclusion criteria for control group  Age ≥ 18 years Swab-based mRNA or DNA-based virus detection (also external findings) Clearly visible transformation zone of the cervix corresponding to T1/T2 Written informed consent to participate in the study  Exclusion criteria:  The following exclusion criteria apply to both groups of patients (NIPP treatment and control group).  Transformation zone not fully visible Evidence of invasive disease Serious cardiovascular diseases - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study includes patients aged 18 and over from the dysplasia clinic of the University Women's Hospital Tübingen who have been diagnosed with an infection of the cervix uteri involving both high- and low-risk HPV viruses. - SamplingMethod: Probability Sample