rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota
Status: Not yet recruiting

Objectives: to assess the relevance of the "RiboTaxa" algorithm coupled with neural network learning based on analysis of vaginal microbiota metagenomic sequencing data for predicting prematurity in an identified at-risk population.

Study description: Longitudinal follow-up of a cohort of pregnant women, with collection of biological samples, and a posteriori case-control comparison based on the occurrence of an event (premature birth).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Pregnant women Admitted to the Clermont-Ferrand University Hospital maternity ward from 14 weeks' gestation onwards For threat of preterm birth (PTB) characterized by contractile activity and/or cervical changes, or for premature rupture of fetal membranes (PROM) And in need of vaginal swabbing Single or multiple pregnancy Able to understand and object to the study Covered by a French social security scheme. Give informed consent for the study  Exclusion Criteria:  Patient under guardianship, curatorship or safeguard of justice Patient having received antibiotic therapy in the 2 weeks prior to admission - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701
Status: Not yet recruiting

The goal of this clinical trial is to define a safe and effective dose of CRB-701 for participants with solid tumors that are expressing a protein called nectin-4.

The main questions it aims to answer are:

What is the the safe and effective dose of CRB-701 when used alone? What cancers can be treated effectively with CRB-701?

Participants will be asked to attend clinic and be given a intravenous infusion of CRB-701 on its own. They will have blood tests and other assessments to measure whether CRB-701 will have CT or MRI scans to measure the effect on tumors.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Confirmed diagnosis of select advanced or metastatic nectin-4 expressing solid tumors that have progressed following at least one line of therapy or have no other standard therapy with proven clinical benefit.  Exclusion Criteria:  Active of uncontrolled CNS metastases History of solid tumors other than the diseases under study History of and/or current cardiovascular events or conditions in the previous 6 months Pre-existing >/= Grade 2 neuropathy Hemoglobin A1C (HbA1C) >/= 8%, uncontrolled diabetes mellitus or know diabetic neuropathy Active ocular disease at baseline Chronic severe liver disease or live cirrhosis Interstitial lung disease or pneumonitis within 6 months on initiating treatment on study Other significant cormorbidities. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Does a Novel Intervention Targeting Derailment Decrease Depressive Symptoms?
Status: Not yet recruiting

The goal of this clinical trial is to understand if a reflective journaling intervention-"Me Through Time"- which is intended to decrease derailment (defined as the inability to meaningfully connect one's past self to their current self) may have downstream impacts on depressive symptoms.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants must be aged 18-29. Participants must be fluent in English. Participants must have attended at least one semester of college. Participants must live in the United States Participants must have a score on the Derailment Scale of at least 37 at pre-assessment. Participants must have a score on the Beck Depression Inventory II of at least 20 at pre- assessment. Participants must have a score on the GAD-7 of at least 10 at pre-assessment. Participants must be willing and able to engage in a 2-week reflective journaling experience.  Exclusion Criteria:  Those outside of the specified age range. Those who are not fluent in English. Those who have not attended at least one semester of college. Those who do not live in the United States. Those who have a score on the Derailment Scale of less than 37 at pre-assessment. Those have a score on the Beck Depression Inventory II of less than 20 at pre- assessment. Those who have a score on the GAD-7 of less than 10 at pre-assessment. Those who are neither willing nor able to engage in a 2-week reflective journaling experience. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 29 Years - StdAgeList: Adult
First In Human Study of CX-2051 in Advanced Solid Tumors
Status: Not yet recruiting

The purpose of this first-in-human study, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 in adult subjects with advanced solid tumors.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Measurable disease per RECIST v1.1 Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue Additional inclusion criteria may apply  Exclusion Criteria:  Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated Known active central nervous system (CNS) involvement by malignancy Systemic anticancer treatment, radiotherapy, or investigational agent(s) within 14 days prior to C1D1 Previous treatment with antibody-drug conjugates (ADCs) with Topo-I inhibitor payload Major surgery (requiring general anesthesia) within 4 weeks prior to C1D1 Elevated baseline laboratory values Serious concurrent illness Pregnant or breast feeding Additional exclusion criteria may apply - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Comparison of the Efficacy of Phenol Block and Corticosteroid-Local Anesthetic Block Applied to the Genicular Nerve
Status: Recruiting

There are different neurolysis methods. Aim of this study is to compare two different methods, phenol block and corticosteroid local anesthetic block.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with knee osteoarthritis must have pain at least 6 months NRS score of knee pain equal or more than 5 At least grade 3 in Kellgren-Lawrence grading scale Non responsive to life style change, weight control, exercises program, medical treatment and the other conservative treatments (physical therapy, intraarticular injections) Decreasing at NRS score more than %50 after diagnostic block Those who accept the consent form  Exclusion Criteria:  Patients who have acute knee injury Surgery history in knee Connective tissue disease that affect knee Sciatica Injection story in last 3 months Psychiatric or neurologic diseases that affect study Septic arthritis, active local or systemic infection Coagulopathy Pregnancy Allergic reaction - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand
Status: Not yet recruiting

The goal of this quasi-experimental study is to test the effectiveness of a digital health program designed to prevent non-communicable diseases (NCDs) in employees within a workplace setting in Thailand. The main questions it aims to answer are:

Can a digital health program help participants lose weight?
Does the digital health program improve other health outcomes such as Body Mass Index (BMI), blood lipid levels (triglycerides and LDL), blood sugar levels (HbA1c or fasting plasma glucose), and blood pressure? Is the digital health program feasible and acceptable in the Thai workplace setting, as measured by participation rates, usage, and participant satisfaction?

Participants will:

Attend four group health education sessions, each lasting one hour, scheduled over a six-month period.
Have unlimited access to individual chat consultations with a healthcare team, including doctors, dietitians, fitness coaches, and psychologists, available from 9:00 AM to 5:00 PM on workdays, excluding public holidays.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Must have a Body Mass Index (BMI) indicating overweight, specifically between 23.0 and 27.5 kg/m². Must have blood lipid levels indicating risk, such as triglyceride levels between 150 and 199 mg/dL or LDL levels between 160 and 189 mg/dL. Must have blood sugar levels indicating a pre-diabetic state, such as an HbA1c level between 5.7% and 6.4% or fasting plasma glucose levels between 100 and 125 mg/dL. Must have systolic blood pressure between 120 and 139 mmHg and/or diastolic blood pressure between 80 and 89 mmHg. Must be able to read and communicate in Thai to participate in project activities. Must have access to digital devices compatible with the digital health program, such as smartphones with operating systems equivalent to or higher than iOS 11 or Android 5.1, or computers capable of joining online seminars. Must consent to participate in the research study.  Exclusion Criteria:  Pregnancy, bedridden state, or disability that limits mobility or the ability to exercise. History of non-communicable diseases, such as heart disease, stroke, diabetes, or any acute illness. Participation in a health program or weight loss program currently or in the previous month. - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - StdAgeList: Adult, Older Adult
Comparison of NOM for ACLD Between Medical and Surgical Ward
Status: Recruiting

In Europe, patients with acute left colon diverticulitis (ALCD) are usually admitted to surgical wards even when only medical treatment is required. The study compares ALCD non-operative management (NOM) between surgical and non-surgical environments regarding clinical outcomes, hospitalization length(LOS), and follow-up.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  patients affected by ALCD using a contrast-enhanced CT scan at admission undergoing NOM  Exclusion Criteria:  immediate indication for surgery (i.e. patients with Hinchey III or IV ALCD or septic patients with Hinchey II) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients affected by ALCD - SamplingMethod: Non-Probability Sample
Electrical Stimulation of the Mandibular Nerve for Pain and Function Management in Temporomandibular Disorders
Status: Not yet recruiting

Temporomandibular disorders (TMD) encompass dysfunction and pain of the masticatory muscles and temporomandibular joint (TMJ). Pain in the TMJ, restricted jaw movement, and joint sounds are common conditions in this disorder. This can impact patients' ability to perform daily activities such as eating, speaking, laughing, or yawning, significantly affecting their quality of life.

The TMJ and masticatory muscles are innervated by the auriculotemporal branch and the mandibular nerve (V3), a branch of the trigeminal nerve. An estimated 60% to 70% of the population shows signs of TMD, of which up to 12% report intense symptoms requiring treatment.

Percutaneous electrical nerve stimulation (PENS) could be a clinically relevant therapy in TMD patients applied through minimally invasive physiotherapy. To our knowledge, there are no trials evaluating the non-surgical clinical efficacy of PENS on the mandibular nerve.

The project's objective is to assess the effectiveness of PENS on the mandibular nerve in this type of condition.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with local myofascial pain and/or increased tension in the masticatory muscles. Patients with myofascial pain from temporomandibular disorder (TMD) at the time, diagnosed according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Absence of temporomandibular disc displacement with or without reduction. Pain in the masticatory muscles associated with limited mouth opening (<40mm). Good general health (absence of chronic diseases that may affect the temporomandibular joint or masticatory muscles). Written consent to participate in the study.  Exclusion Criteria:  Injury to the face or head during the research participation. Undergone surgical procedures performed in the craniocervical region and degenerative neurological diseases. Sudden illness of the patient that prevented participation in the study. Will to end participation in the study. Less than 2 weeks of evolution. Inability to understand instructions or sign the informed consent. Minor patients. Regular medication, such as muscle relaxants, anticonvulsants, antidepressants, or anxiolytics Facial paralysis. Presenting a disease or infectious/inflammatory process of dental origin. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Intermittent Hypoxemia, Lung Function Decline, Morbidity, and Mortality in COPD (PROSA Study).
Status: Not yet recruiting

This study aims to analyze if patients with chronic obstructive lung disease who experience a decline of blood oxygen saturation during physical exercise have a disease course different from that of COPD patients who do not experience a decline in blood oxygen saturation during exercise. Patients will be followed for a total of 3 years.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients of both sexes with a diagnosis of chronic obstructive lung disease (COPD) stages 2-3, groups B and E according to GOLD 38 as assessed by their primary family doctor or pneumology specialist who are treated with long-acting bronchodilators on a stable dose for at least four months prior to inclusion into the study; Age at inclusion 18 - 80 years; Physical ability and willingness to perform 6-minute walk testing and bicycle ergometry testing; Signed written informed consent form  Exclusion Criteria:  Participation in another clinical study within the last 3 months before inclusion into the present study; Any somatic or psychic disease that may hamper participation in the study or compliance with the study protocol (at the investigator's discretion); Any somatic disease that puts the patient at increased risk when performing the exercise tests or impairs the patient's ability to properly perform the exercise tests, like advanced coronary artery disease, advanced chronic heart failure, uncontrolled hypertension, orthopaedic, or neurological diseases (non-exclusive list of examples); Any disease or health condition that reduces the patient's life expectancy to less than the expected time frame of this study, other than chronic obstructive lung disease (at the investigator's discretion); Pregnancy or nursing. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: This study will be conducted a patients with chronic obstructive pulmonary disease of all sexes aged 18 - 80 years. They must be graded as stage 2 - 3 according to GOLD criteria (FEV1 between 30 and 79% of the age-adjusted predicted value) and belong to groups B or E according to symptom scores (mMRC or CAT questionnaires) and exacerbation history. - SamplingMethod: Probability Sample
Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery
Status: Not yet recruiting

There is little scientific data concerning the use of negative pressure therapy after immediate breast reconstruction.

That strategy of treatment-reconstruction has expanded increasingly since the last years.

The current literature reports only 3 studies on the use of preventive negative pressure therapy in oncologic breast surgery.

Moreover, all three are retrospective, case-control studies with serious limitations.

The largest published series reports a reduction in the overall complication rate from 15.9% to 8.5%, and a significant reduction in several criteria: infection, scar dehiscence and necrosis. However, the study presents significant biases, with non-comparable populations in terms of comorbidities, surgical procedure performed, inclusion periods (and therefore experience in performing oncological surgery).

There was also a high probability of under-assessment or postponement of post-operative complications, which is typical of published retrospective surgical studies.

The published results therefore strongly encourage further investigation of negative pressure therapy in oncological breast surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Female ≥ 18 years Patient with unilateral invasive or in situ breast carcinoma Patient with or without neoadjuvant treatment Patient presenting an indication for complex breast surgery by mastectomy with immediate breast reconstruction by implant or oncoplasty by T-shaped mammoplasty.  Patient presenting at least one of the following risk factors for scarring disorders:  Obesity with Body Mass Index BMI ≥ 30 Cup size ≥ E Active smoking or smoking cessation for less than one month Diabetes History of homolateral breast radiotherapy Long-term corticosteroid therapy Patient to have signed informed consent prior to study entry Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. Patient affiliated with a health insurance plan.  Exclusion Criteria:  Legal incapacity or limited legal capacity. Medical or psychological conditions preventing the patient from completing the study or signing the consent form. Pregnant or breast-feeding patient Patient under guardianship or safeguard of justice - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia
Status: Not yet recruiting

To study the optimal therapeutic strategies for salvage treatment of refractory/relapsed AML, and to clarify the effectiveness and safety of various salvage treatment options. A prospective, multicenter, platform-type study was conducted to explore the overall response rate, tolerability, and survival of patients with R/R AML with different treatment regimens.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  1. Patients with acute myeloid leukemia (except for acute promyelocytic leukemia) diagnosed by bone marrow cell morphology, immunology and genetics above are classified according to the French-British-American Collaboration diagnostic criteria (FAB criteria) and the World Health Organization diagnostic criteria (WHO2016 criteria).  2. Meet criteria for refractory/recurrent AML (except APL). The recurrence was morphological recurrence, excluding molecular recurrence. Except for simple extramedullary leukemia.  3. Age and gender are not limited. 4. Informed consent must be signed before the start of the study procedure, and the informed consent must be signed by the patient himself or his immediate family if he is 18 years old and above; For young patients under the age of 18, the legal guardian shall sign the informed consent. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family.  Exclusion Criteria:  Concurrent malignant tumors of other organs (patients requiring treatment). Participants considered unsuitable for inclusion by the researchers. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult
Collagen-targeted Positron Emission Tomography (PET) Imaging for Assessment of EGCG Effect
Status: Recruiting

The primary purpose of this substudy is to determine if collagen-targeted PET using the type 1 collagen-targeted PET probe, Gallium-68 (68Ga)-labeled collagen binding probe 8 (CBP8) can inform as to drug effect of EGCG and assist in dose selection.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Enrolled in and eligible (based on screening procedures - Visit 1) for the main EGCG Phase 1 study, "Dose ranging study of oral epigallocatechin-3-gallate (EGCG) given daily for 12 weeks to patients with Idiopathic Pulmonary Fibrosis (IPF) evaluating safety, PK interactions with standard of care drugs, and biomarkers of drug effect Signed informed consent  Exclusion Criteria:  Pregnant or breastfeeding (a negative quantitative serum human chorionic gonadotropin (hCG) pregnancy test is required for females having child-bearing potential before the participant can participate)* Research-related radiation exposure exceeds 50 millisievert (mSv) in the prior 12 months Determined by the investigator to be clinically unsuitable for the study  Additional exclusion criteria for participants undergoing PET-MRI:  Electrical implants such as cardiac pacemaker, defibrillator, or perfusion pump Metallic or electric implants contraindicated for magnetic resonance-PET (MR-PET) scanning Claustrophobic reactions Estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m2 within the prior 30 days  Known allergy to gadolinium  Women of childbearing potential (WCBP) are defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if < 55 years or 12 months if ≥ 55 years. - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult