pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
The Effect of Home Visit Supported Nursing Education Program on Some Parameters in Elderly People Living Alone at Home
NCT Number: NCT06517615
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Old Age; Debility|Loneliness|Healthy Lifestyle
Interventions: BEHAVIORAL: Home Visit Supported Nursing Training Program
Sponsor: Kastamonu University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-04-25
Completion Date: 2024-12-29
Locations: Kastamonu Üniversity, Kastamonu, 37300, Turkey|Zeynep ARABACI, Kastamonu, 37300, Turkey

Summary:
It is aimed to develop healthy lifestyle behaviors of elderly people living alone at home, reduce their loneliness levels and increase their social support capacity.The research was planned as a quasi-experimental research. The research population consists of elderly people living alone at home who are registered to the Elderly and Home Care Unit of a Municipality of a province.

Primary Outcome Measures: Healthy Lifestyle Behaviors Scale II score increase, Healthy Lifestyle Behaviors Scale II score, 8 week|UCLA Loneliness Scale Short Form-6 point decrease, UCLA Loneliness Scale Short Form-6 point, 8 week|Multidimensional Perceived Social Support Scale score increase, Multidimensional Perceived Social Support Scale score, 8 week
Effect of Moringa Oleifera Leaves on Glycemic Control of Women With Type 2 Diabetes
NCT Number: NCT06517602
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes
Interventions: DIETARY_SUPPLEMENT: Supplementation of Moringa oleifera leaf powder
Sponsor: University of Milan
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-11-07
Completion Date: 2020-02-23
Locations: Dispensaris of Edchedería, Bir Lehlu, Mahbes, and Farsia (Smara camp), Tindouf, Algeria

Summary:
The objective of this clinical trial was to understand whether supplementation of Moringa oleifera leaf powder improved glycemic management in Sahrawi women with type 2 diabetes living in refugee camps. The main question sought to be answered was:

- Does daily supplementation of Moringa oleifera leaf powder, in addition to oral hypoglycemic therapy, improve glycosylated hemoglobin and fasting blood glucose?

Researchers compared Moringa supplementation with no Moringa consumption to see if Moringa oleifera worked to improve glycemic control.

Participants had to:

* Take Moringa oleifera leaves daily or abstain from consuming Moringa for 3 months.
* Consistently take prescribed oral hypoglycemic agents
* Undergo clinical examinations and measurement of biochemical, metabolic and body composition parameters at the time of recruitment and at the end of the study.

Primary Outcome Measures: Glycosylated hemoglobin (HbA1c), Glycosylated hemoglobin was measured at recruitment and at the end of the study (three months)|Fasting glucose, Fasting glucose was measured at recruitment and at the end of the study (three months)
Secondary Outcome Measures: BMI, BMI were measured at recruitment and at the end of the study (3 months)|Waist circumference, Waist circumference were measured at recruitment and at the end of the study (3 months)|Hip circumference, Hip circumference were measured at recruitment and at the end of the study (3 months)|% body fat, % of body fat were measured at recruitment and at the end of the study (3 months)|Blood pressure, Systolic and diastolic blood pressure, Systolic and diastolic blood pressure were measured at recruitment and at the end of the study (3 months)
Effects of VMX-C001 on the Anticoagulant Effect of Different Forms of Heparin
NCT Number: NCT06517563
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Coagulation Disorder
Interventions: DRUG: VMX-C001|DRUG: Rivaroxaban|DRUG: UFH|DRUG: Enoxaparin
Sponsor: VarmX B.V.
Sex: ALL
Age: ADULT
Enrollment: 16
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-14
Completion Date: 2026-10
Locations: ICON, Groningen, 9728 NZ, Netherlands

Summary:
A single centre, open-label study to assess the effects of VMX-C001 in combination with an oral FXa DOAC on the efficacy of Unfractionated Heparin (UFH) and of VMX-C001 alone on the efficacy of Low Molecular Weight Heparin (LMWH) in healthy subjects conducted in two parts:

UFH cohort: Subjects will be administered 2 single doses of 5000 IU UFH i.v. on Day 1 and Day 5, oral doses of the DOAC Rivaroxaban once daily from Day 2 until the morning of Day 5, and one single dose of 170 mg VMX-C001 i.v. on Day 5.

LMWH cohort: Subjects will be administered 2 single doses of 40 mg Enoxaparin s.c. on Day 1 and Day 4, and one single dose of 170 mg VMX-C001 i.v. on Day 4.

Primary Outcome Measures: Change in thrombin time following dosing with VMX-C001(UFH cohort), Change from baseline in thrombin time, Up to Day 6|Change in prothrombin time (PT) following dosing with VMX-C001, Change from baseline in PT, Up to End of Study (Day 32/33)|Change in activated partial thromboplastin time (aPTT) following dosing with VMX-C001, Change from baseline in aPTT, Up to End of Study (Day 32/33)|Change in fibrinogen following dosing with VMX-C001, Change from baseline in fibrinogen, Up to End of Study (Day 32/33)|Change in dilute Russell viper venom time (dRVVT) following dosing with VMX-C001(UFH Cohort only), Change from baseline in dRVVT, Up to Day 6|Change in dilute prothrombin time (dPT) following dosing with VMX-C001 (UFH Cohort only), Change from baseline in dPT, Up to Day 6|Change in thrombin generation following dosing with VMX-C001, Change from baseline in thrombin generation measured by calibrated automated thrombography, Up to Day 6|Change in real time activated clotting time (ACT) following dosing with VMX-C001 (UFH cohort only), Change from baseline in ACT, Up to Day 6|Change in anti-factor 10a (FXa) activity following dosing with VMX-C001 (LMWH Cohort only), Change from baseline in anti-FXa activity, Up to Day 6
Pulmonary Complications in Elderly Patients
NCT Number: NCT06517550
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postoperative Complications
Interventions: OTHER: positive end-expiratory pressure while mechanical ventilation
Sponsor: China-Japan Friendship Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 136
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: PREVENTION
Start Date: 2024-07
Completion Date: 2025-07
Locations: China-Japan Friendship Hospital, Beijing, Beijing, 100029, China

Summary:
The incidence of postoperative pulmonary complications in elderly patients undergoing upper abdominal laparoscopic surgery remains high, and the lung protective mechanical ventilation strategy aims to reduce the incidence of lung injury caused by ventilators. PEEP, as an important protective ventilation strategy, maintains end expiratory alveolar volume to improve intraoperative oxygenation and pulmonary respiratory mechanics, and plays a protective role in the lungs; Personalized PEEP is the most beneficial, especially for elderly patients. However, there is currently no ideal way to achieve precise and personalized regulation of PEEP. This project aims to target and control intraoperative mechanical ventilation to drive pressure, personalize PEEP titration, and conduct a randomized controlled study on perioperative changes in pulmonary oxygenation function and pulmonary complications in elderly patients undergoing upper abdominal laparoscopy.

Primary Outcome Measures: the changes of oxygenation index, The patients' changes of Oxygenation index when leave-PACU, one-day after surgery and 7-day after surgery compared with pre-sugery oxygenation index, pre-surgery, leave-PACU, one-day after surgery and 7-day after surgery
Secondary Outcome Measures: Incidence of pulmonary complications, Incidence of pulmonary complications at 30 and 90 days after surgery, 30 and 90 days after surgery
Modified Aortic Root Enlargement Procedure
NCT Number: NCT06517537
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Small Aortic Annulus|Aortic Root Enlargement Procedure
Sponsor: China National Center for Cardiovascular Diseases
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2026-12-31
Locations: Fuwai Hospital, Beijing, Beijing, China

Summary:
This study is a prospective observational clinical trial, in which severe AS patients aged 50-70 years with SAA choose modified ARE or TAVR according to their wishes to investigate the safety and efficacy of modified ARE; Compare the incidence and clinical outcomes of moderate to severe PPM after modified ARE and TAVR surgery; Evaluate the feasibility of postoperative mid valve TAVR and explore the most ideal initial surgical plan for this type of patient from a full lifecycle perspective.

Primary Outcome Measures: Incidence of moderate PPM and severe PPM after surgery, Prospective collection of all echocardiographic data before surgery and upon discharge, measuring mean aortic valve area (EOA), mean transvalvular pressure gradient, and the degree and type of aortic regurgitation (AR). According to the patient's BSA calculation of iEOA, 0.65-0.85cm2/m2 is diagnosed as moderate PPM, and\<0.65cm2/m2 is diagnosed as severe PPM., Before discharge, 3 months after surgery, and 1 year after surgery
First-in-Human Dose Expansion Study of XMT-1536 in Cancers Likely to Express NaPi2b
NCT Number: NCT06517485
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Platinum Resistant Ovarian Cancer|Non-Small Cell Adenocarcinoma
Interventions: DRUG: upifitamab rilsodotin
Sponsor: Mersana Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 142
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-07-30
Completion Date: 2022-08-03
Locations: University of Oklahoma, Oklahoma City, Oklahoma, 73104, United States

Summary:
First-in-human, Phase 1b/2 safety study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion once every four weeks. Patients with platinum-resistant ovarian cancer and non-small cell lung cancer (adenocarcinoma subtype) were enrolled in the expansion segment of this study. In addition to safety assessments, the pharmacokinetics of the drug were assessed along with ADC activity.

Primary Outcome Measures: EXP: Safety and Tolerability, Evaluate incidence and severity of adverse events, First dose up until 30 days after study termination
Comparison of Pit Picking, Phenol and Combined Pit Picking and Phenol Applications in Pilonidal Sinus Treatment
NCT Number: NCT06517472
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pilonidal Sinus
Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 165
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-10-01
Locations: Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital, İstanbul, Other, 34785, Turkey

Summary:
Pilonidal sinus disease is a common condition, and treatment options and outcomes vary greatly. Chronic symptomatic pilonidal sinus disease (PSD) primarily affects young adults and causes work loss. In this study, three treatment methods will be performed: the minimally invasive pit-picking procedure, crystallized phenol application (CPT), and a combined method (minimally invasive pit-picking procedure and CPT). The aim of this study is to compare the effectiveness of these three methods, evaluate short- and long-term results, and determine treatment success, the incidence of postoperative complications, chronic pain levels, recurrence rates, and patient satisfaction. Additionally, the effects of these methods on hospital stay, wound healing time, and workforce loss will also be examined.

Primary Outcome Measures: Treatment Success, The primary outcome measure will evaluate the effectiveness of three different treatment methods for pilonidal sinus disease: Pit Picking, Crystallized Phenol (CPT) Application, and Combined Pit Picking and CPT Application. Effectiveness will be determined by the absence of disease recurrence and complete healing., Up to 12 months post-treatment|Postoperative Complications, This measure will assess the incidence of postoperative complications such as infection and pain., Up to 3 months post-treatment.
Secondary Outcome Measures: Recurrence Rate, Evaluation of the rate of disease recurrence after treatment., Up to 12 months post-treatment|Chronic Pain Level, Assessment of chronic pain levels in patients following treatment using the Visual Analog Scale (VAS). VAS is a scale from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. Higher scores indicate worse outcomes., Up to 3 months post-treatment|Patient Satisfaction, Measurement of patient satisfaction with the treatment process and outcomes using the Patient and Observer Scar Assessment Scale (POSAS). POSAS is a scale from 1 to 10, where 1 represents the best outcome and 10 represents the worst outcome. Higher scores indicate worse outcomes., Up to 12 months post-treatment
First-in-Human Dose Escalation Study of XMT-1536 in Cancers Likely to Express NaPi2b
NCT Number: NCT06517433
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Platinum Resistant Ovarian Cancer|Non Small Cell Lung Cancer Metastatic
Interventions: DRUG: upifitamab rilsodotin
Sponsor: Mersana Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 62
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-12-12
Completion Date: 2021-07-09
Locations: University of Oklahoma, Oklahoma City, Oklahoma, 73104, United States

Summary:
First-in-human, Phase 1b/2 safety study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion once every four weeks. Patients with tumor types likely to express NaPi2b were enrolled in dose escalation. Patients with platinum-resistant ovarian cancer and non-small cell lung cancer (adenocarcinoma subtype) were enrolled in the expansion segment of this study. In addition to safety assessments, the pharmacokinetics of the drug were assessed along with ADC activity.

Primary Outcome Measures: DES: Maximum tolerated dose or recommended Phase 2 dose, Evaluate adverse events and concomitant medication use after XMT-1536 (upifitamab rilsodotin) doses, Up to 36 weeks, from the date of first dose until unacceptable side effects or a dose-limiting toxicity is met|DES and EXP: Safety and Tolerability, Evaluate incidence and severity of adverse events, First dose up until 30 days after study termination
Secondary Outcome Measures: DES: Anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin), Monitor tumor size, Every 6 weeks for up to 36 weeks
Para Versus Trans Rectus Stoma Placement for Prevention of Stoma Related Complications
NCT Number: NCT06517407
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stoma Malfunction
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-01
Completion Date: 2026-12
Locations: Assiut university Hospital, Assiut, Egypt

Summary:
Fecal divertion is a surgical procedure by which stoma is constructed through exteriorization of small intestine or large intestine(loop or end stoma).There are many indications for enterostomies such as malignancy, bleeding per rectum, MVO, Volvulus, iatrogenic colon injury, adhesive bands....... etc.

Many factors concerning the operative technique are considered to influence the incidence of stoma related complications such as stoma prolapse, retraction, stenosis, para stomal herniation, para stomal soiling ,oedema and ileus. Site of stoma creation in relation to rectus abdominis muscle is believed to be one of them.

Primary Outcome Measures: para stomal herniation, * Stoma site was incised about 3-5cm from lateral edge of rectus abdominis muscle at para rectus position, or
* at he lateral edge of the rectus abdominis muscle in trans rectal position., 6 months
Secondary Outcome Measures: a_wound infection b_post operative ilieus c_oedema of the stoma d_soiling around the stoma e:prolapse f: stenosis g:retraction, Stoma related other complication, 6 months
Awareness About Warning Signs of Mental Illness Among Health Profession Students. A Quasi-Experimental Study
NCT Number: NCT06517381
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Health Wellness 1
Interventions: OTHER: Digital Online Warning Signs of Mental Illness Literacy Program
Sponsor: King Saud Bin Abdulaziz University for Health Sciences
Sex: ALL
Age: ADULT
Enrollment: 494
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-02-01
Completion Date: 2024-07-11
Locations: King Abdullah International Medical Research Center, Riyadh, 11481, Saudi Arabia|King Saud bin Abdulaziz University for health sciences, Riyadh, 11481, Saudi Arabia

Summary:
In Saudi Arabia, there are limited studies addressing mental health literacy, with no studies regarding warning signs of mental illness. Mental health literacy among healthcare professions students as future clinicians decreases stigma and promotes mental health through early detection and management of mental health problems.

The current study aimed to evaluate the effectiveness of a digital online educational session about the warning signs of mental illness called the Digital Base Warning Signs of Mental Illness Literacy Program.

This study hypothesized that the Digital Base Warning Signs of Mental Illness Literacy Program is effective and will enhance health profession students' literacy regarding warning signs of mental illness.

This is a non-randomized trial using a 30-minute digital educational session about the warning signs of mental illness. It involves a convenience sample of 493 undergraduate health profession students. The Mental Health Literacy Survey About Warning Signs of Mental Illness was developed and validated to measure the participants' mental health literacy before and after the intervention.

Primary Outcome Measures: Recognizing Warning Signs of Mental Illness, students will be able to identify warning signs of mental illness and understand the significance of early recognition measured byMental Health Literacy Survey About Warning Signs of Mental Illness scoring ranges from 15 to 75, Once the intervention is completed/immediately after the intervention
Ultrasound Elastography Combined With Conventional Mri in Differentiating Solid Renal Parenchyma Masses
NCT Number: NCT06517368
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Renal Masses
Interventions: DEVICE: MRI, Ultrasound
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-10
Completion Date: 2026-01
Locations: Assuit university, Assiut, Egypt

Summary:
Investigate the diagnostic accuracy of Ultrasound Elastography combined with conventional MRI in evaluation of solid renal masses using histopathology as a gold standard.

Primary Outcome Measures: Ultrasound Elastography combined with conventional mri in differentiating solid renal parenchyma masses, Investigate the diagnostic accuracy of Ultrasound Elastography combined with conventional MRI in evaluation of solid renal masses using histopathology as a gold stsndard., Baseline
Bullying Experiences Among Alexandria Faculty of Medicine Students
NCT Number: NCT06517329
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Bullying
Sponsor: Alexandria University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 565
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-11-01
Completion Date: 2024-05-01
Locations: Faculty of Medicine Alexandria University, Alexandria, Egypt

Summary:
A cross-sectional study was conducted at Faculty of Medicine, Alexandria to study the prevalence, types and consequences of bullying among medical students. An online survey was distributed among medical students. The data collection continued for two academic years: 2021-2022 and 2022-2023.

Primary Outcome Measures: Prevalence, Percentage of Students exposed to bullying, 2021-2023
Cosmetic Contact Lenses Post-Market Clinical Follow-up Study
NCT Number: NCT06517316
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cosmetic Appearance
Interventions: DEVICE: Nelfilcon A plano cosmetic contact lenses
Sponsor: Alcon Research
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 700
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-10
Completion Date: 2026-08
Locations: Contact Alcon Call Center for Trial Locations, Fort Worth, Texas, 76134, United States

Summary:
The purpose of this post-market study is to gather long term performance and safety data on FreshLook® One-day Colors cosmetic contact lenses and DAILIES FreshLook® ILLUMINATE cosmetic contact lenses in participants 12 years of age and older.

Primary Outcome Measures: Incidence of corneal infiltrative events, A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea., Up to Year 1|Incidence of microbial keratitis, Microbial keratitis is a sight-threatening infection of the cornea., Up to Year 1
Evaluation of the Implementation of Drug Prescription Recommendations Using Clinical Decision Support in Patients With Severe Obesity: Retrospective Study
NCT Number: NCT06517303
Acronym: RECOB-MED
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Obesity, Morbid|Drug Use
Sponsor: Assistance Publique - Hôpitaux de Paris
Collaborators: Rennes University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1050
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-09
Completion Date: 2026-06-09
Locations: HEGP, Paris, 75015, France|CHU de Rennes, Rennes, 35000, France

Summary:
No drug prescription guidelines for severe obesity (BMI\>35 kg/m2) are available, leading to non-standardized and / or potentially inappropriate drug management.

After validation of guidelines by the Delphi method, the main objective is to assess the agreement between the drug prescriptions and the guidelines after implementation in two health data warehouses.

The investigators will perform a retrospective, multicentric study in 2 hospitals. The investigators will check the relevance of rules (alerts) derived from the recommendations identified using the Delphi method.

Primary Outcome Measures: number of prescriptions concerned by rules, by type of recommendation, number of prescriptions concerned by rules, by type of recommendation, in patients with severe obesity., 8 months
Secondary Outcome Measures: Number of validated recommendations and their level of evidence, Number of validated recommendations and their level of evidence, validated by experts, 12 months|Rate of prescriptions concerned by a computerized rule with pharmaceutical advice on the drug concerned by the rule., Rate of prescriptions concerned by a computerized rule with pharmaceutical advice on the drug concerned by the rule. Sub-group analysis of this rate by type of recommendation., 8 months
Evaluation of the Risk of Infection During Fever in Labor
NCT Number: NCT06517290
Acronym: FEVERY
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Fever|Labor
Interventions: OTHER: Non applicable
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-08
Completion Date: 2025-05
Locations: APHP - Trousseau Hospital - Gynecology-Obstetrics-Maternity, Paris, IDF, 75012, France|AP-HP - Cochin Hospital - Maternity, Paris, IDF, 75014, France|APHP - Necker Hospital - Maternity, Paris, IDF, 75015, France

Summary:
* Fever during labor affects more than 8% of parturients. It is a heterogeneous entity and can be due to an infectious process, a side effect of a drug, or to labor itself (physiological hyperthermia).
* It has been the subject of several retrospective studies and a few prospective studies with varying methodologies, definitions, and inclusion criteria. None have proposed a combined obstetric, neonatal, infectious disease, and microbiological analysis.
* It raises concerns about the possibility of an emerging maternal (obstetric or otherwise) and/or fetal infection.
* Analysis of the available literature does not clarify the exact frequency of these infections or the predictive factors for their occurrence.
* It often justifies systemic antibiotic therapy, the modalities and benefits of which have never been evaluated.

The investigators aim to conduct a prospective multicenter study to analyze fever during labor with a combined obstetric, infectious disease, pediatric, and microbiological perspective.

Primary Outcome Measures: Percentage of maternal-fetal infections, intrauterine infection possibly responsible for early neonatal bacterial infection (proven or probable), endometritis, maternal sepsis, Up to 6 months|Percentage of proven maternal bacterial infections, (non-obstetric, intrauterine, endometritis), Up to 6 months|Percentage of proven and probable early neonatal infections, Up to 6 months
Secondary Outcome Measures: occurrence of proven or probable early neonatal infection, Maternal and neonatal prognosis, Up to 6 months|occurrence of endometritis, Maternal and neonatal prognosis, Up to 6 months|Occurrence of maternal sepsis, Maternal and neonatal prognosis, Up to 6 months|Occurrence of serious accident III or IV linked to the prescription of antibiotics, Maternal and neonatal prognosis, Up to 6 months|Percentage of antibiotic therapy, Type of care by category, Up to 6 months
Tirzepatide in Patients With Obesity or Overweight Who Have High Risk Early Breast Cancer and Are ctDNA+
NCT Number: NCT06517212
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Breast Cancer|Breast Neoplasms
Interventions: DRUG: Tirzepatide
Sponsor: Baylor Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-19
Completion Date: 2030-12-31
Locations: Baylor University Medical Center, Baylor Charles A Sammons Cancer Center, Dallas, Texas, 75246, United States

Summary:
This trial aims to asses if tirzepatide-induced weight loss of ≥10% body weight will lead to metabolic and hormonal changes in hormone receptor-positive (HR+), human epidermal growth factor receptor-negative (HER2-), node-positive (N+) high risk early breast cancer patients with obesity or overweight, inhibiting the growth and survival of micrometastatic disease and leading to clearance of tumor-informed circulating tumor DNA (ctDNA) and freedom from the development of metastatic disease.

Primary Outcome Measures: ctDNA efficacy, Clearance of the presence of plasma ctDNA within two years of documented ctDNA positivity at time of study entry., 2 years|distant disease-free survival efficacy, Percentage of patients alive and free of distant metastatic disease at 2 years following detection of ctDNA at the time of study entry., 2 years
Secondary Outcome Measures: ctDNA kinetic changes using Haystack MRD, Differences in ctDNA kinetics between patients who clear ctDNA versus patients who do not clear ctDNA while on tirzepatide using the Haystack MRD assay., 2 years|safety and efficacy, Number of patients with treatment related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0., 2 years|weight loss, Percentage of weight loss observed on tirzepatide associated with clearance or persistence of ctDNA in patients receiving standard adjuvant endocrine therapy., 2 years
Other Outcome Measures: time to recurrence, Breast cancer distant disease-free survival, defined as the time from beginning tirzepatide therapy to the time of distant disease recurrence or death, over five years in ctDNA-positive patients who clear ctDNA versus patients who do not clear ctDNA while on tirzepatide., 5 years|exploratory molecular changes via Next Generation Sequencing (NGS), Flow Cytometry, and Reverse Phase Protein Array (RPPA), Exploratory analysis of metabolic, hormonal and immune cell changes associated with weight loss on tirzepatide in early breast cancer patients. Exploratory analyses may include NGS, Flow Cytometry, and RPPA., 5 years
Olanzapine for Cancer Related Anorexia-cachexia Syndrome
NCT Number: NCT06517199
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Anorexia|Cachexia
Interventions: DRUG: Olanzapine 2.5 MG|DRUG: Olanzapine 5 MG|DRUG: Placebo
Sponsor: Mahidol University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 138
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-22
Completion Date: 2026-01-21
Locations: Faculty of Medicine Siriraj Hospital, Bangkok, 10260, Thailand|Division of medical oncology, department of medicine Siriraj Hospital, Bangkok, 10700, Thailand

Summary:
Cancer anorexia-cachexia syndrome is one of the common conditions in cancer patients. Olanzapine has been demonstrated to reduce chemotherapy-induced anorexia. However, there is scarce information regarding olanzapine as a treatment of cancer anorexia among patients who does not receive chemotherapy. Therefore, this randomized controlled trial aims to evaluate the efficacy of olanzapine to lessen cancer cachexia-anorexia syndrome.

Primary Outcome Measures: no greater than 5% weight loss in olanzapine 2.5 mg versus placebo, proportion of patients with olanzapine 2.5 mg without greater or equal to 5% weight loss compared to placebo, 4 weeks
Secondary Outcome Measures: no greater than 5% weight loss in olanzapine 5 mg versus placebo, proportion of patients with olanzapine 5 mg without greater or equal to 5% weight loss compared to placebo, 4 weeks|numerical scale of anorexia, proportion of patients with decreased numerical scale of anorexia, 4 weeks|body weight, body weight change from baseline, week 2 and 4|adverse effects, adverse effects, week 1, 2, 3, 4
Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction
NCT Number: NCT06517186
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Failure|Heart Failure With Preserved Ejection Fraction
Sponsor: Northwestern University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)|Massachusetts General Hospital|Brigham and Women's Hospital|Mayo Clinic|Wake Forest University Health Sciences|University of Pennsylvania
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-06
Locations: Northwestern University, Chicago, Illinois, 60611, United States|Johns Hopkins University, Baltimore, Maryland, 21287, United States|Mass General Brigham, Boston, Massachusetts, 02114, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|Wake Forest University, Winston-Salem, North Carolina, 27157, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

Summary:
The purpose of this study is to identify changes in heart tissue structure and biological function in patients with heart failure by performing an endomyocardial biopsy (EMB or heart biopsy) during a right heart catheterization (RHC). The ultimate goal is to use this information to develop new treatments for heart failure.

Primary Outcome Measures: Number of participants with Heart Failure with Preserved Ejection Fraction (HFpEF), Up to 5 years
Cooling Via Cryogenx Body Cooling Device
NCT Number: NCT06517147
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Body Temperature Changes
Interventions: DEVICE: Cryogenx cooling|DEVICE: Regular cooling
Sponsor: Brunel University
Sex: ALL
Age: ADULT
Enrollment: 12
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-01
Completion Date: 2025-07-31

Summary:
The aim of this project is to test the rate of cooling following exercise in the heat utilising the CRYOGENX Cryosuit device i) against passive cooling, and ii) to quantify the rate of cooling and compare this rate with established cooling intervention thresholds i.e. -0.11 to 0.15°C.min-1. As this project is to determine the efficacy of the intervention in populations equivalent to sporting and military personnel, these aims will be tested in young (18-40 year old) healthy male and female participants whom participate in regular physical activity. As a commercially funded project, the experimental design implemented will closely replicate that of the independent investigation into the efficacy of the CAERvest® device.

Primary Outcome Measures: Core (rectal) temperature, The rate of change of core temperature during cooling will be calculated from realtime data, 12 months
Prescribing Patterns of Antihypertensive Drugs in Uncomplicated Hypertension
NCT Number: NCT06517134
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Hypertension,Essential|Cardiovascular Diseases
Interventions: DRUG: Antihypertensive Agents
Sponsor: University Hospital, Caen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3325032
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-01-01
Completion Date: 2024-06-05
Locations: Xavier Humbert, Caen, 14200, France

Summary:
Hypertension incurs substantial cardiovascular morbidity and mortality, particularly in primary prevention settings. General practitioners (GPs) play a pivotal role in the management of hypertension in primary care, yet variations exist among GPs. The determinants shaping GPs' antihypertensive medication (AD) prescription patterns in the setting of hypertension remain ambiguous. This investigation sought to elucidate how GPs' characteristics and professional activities influence AD prescriptions. A cross-sectional study utilizing a sample of 2,165 GPs was conducted in Normandy, France, in 2019. The ratio of AD prescriptions to overall prescription volume was computed for each practitioner. GPs were classified as 'low' or 'high' AD prescribers based on the median of this ratio. The ratio was examined in relation to GPs' demographic and professional variables such as age, gender, practice setting, years of experience, consultation frequency, the demographics and socioeconomic status of their patient panels, and prevalence of chronic conditions in patients. These associations were explored using both univariate and multivariate analyses.

Primary Outcome Measures: GP demographics, age and gender of GPs, the urban or rural classification of the practice location (based on the GP's clinic postal code and DATASANTE tables from the French National Institute for Statistics and Economic Studies, INSEE), and the number of years in practice., 1 year|medical practice activities, frequency of home visits and consultations, the total number of registered patients, the average number of visits or consultations per patient, the average patient age, the number of very low-income patients, and the prevalence of registered chronic diseases (notably diabetes mellitus and cardiovascular diseases)., 1 year
tDCS in People With Subthreshold Depression
NCT Number: NCT06517121
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Subthreshold Depression
Interventions: DEVICE: Personalized Experimental Transcranial Direct Current Stimulation (tDCS)|DEVICE: Sham Transcranial Direct Current Stimulation (tDCS)|DEVICE: Conventional Experimental Transcranial Direct Current Stimulation (tDCS)
Sponsor: Education University of Hong Kong
Collaborators: The University of Hong Kong|Chinese University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 204
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-01

Summary:
This study evaluates the effects of multi-session transcranial direct current stimulation on loneliness, mood and depressiveness in people with subthreshold depression.

Primary Outcome Measures: Changes in self-reported loneliness, Loneliness is assessed based on the University of California, Los Angeles (UCLA) loneliness scale (Version 3), a 20-item 4-point Likert scale (score range 20 - 80) in which higher scores indicate greater degrees of loneliness., From baseline to after the 10th tDCS session (2 weeks); from baseline to 3 months after the last tDCS session|Changes in self-reported mood, Mood is assessed based on the Chinese Affect Scale, a 20-item 5-point Likert scale where participants rate the degree to which they currently feel the listed affects (scoring for each item: 0 = no at all; 4 = very)., From baseline to after the 10th tDCS session (2 weeks); from baseline to 3 months after the last tDCS session|Changes in depressive symptoms, Depressive symptoms are assessed based on the Hospital Anxiety and Depression Scale, a 14-item scale assessing severity of depressive and anxiety symptom (score range 0 - 21 for both subscale), with a higher scores indicating higher severity, From baseline to after the 10th tDCS session (2 weeks); from baseline to 3 months after the last tDCS session|Changes in brain activation and connectivity related to socio-affective processing, Neural activities and connectivity in Ventral Attention Network, Frontoparietal Network, and Default Mode Network are assessed by functional MRI during socio-affective task, From baseline to after the 10th tDCS session (2 weeks); from baseline to 3 months after the last tDCS session
Ambient AI for Provider Well-Being
NCT Number: NCT06517082
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthcare Provider Well-being
Sponsor: University of Wisconsin, Madison
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08
Completion Date: 2025-08

Summary:
The goal of this clinical trial is to learn whether using Ambient Artificial Intelligence for provider documentation will enhance provider well-being and improve documentation quality.

Participants will complete their documentation using the Ambient AI software.

Primary Outcome Measures: Change in provider fulfillment index, Using the Professional Well-Being Academic Consortium Survey Measures, the fulfillment index is a 6-item questionnaire. Each question is scored on a 0-4 Likert scale, with total possible scores of 0-24. Higher scores indicate greater fulfillment, Baseline to weeks 6, 12, 18, and 24|Change in provider burnout, Using the Professional Well-Being Academic Consortium Survey Measures, the burnout index includes two subcomponents of work exhaustion and interpersonal disengagement. It is a 10-item questionnaire, scored together as a composite. Each question is scored on a 0-4 Likert scale, with a total possible range of 0-40. Higher scores indicate greater burnout, indicating lower well-being, Baseline to weeks 6, 12, 18, and 24
Secondary Outcome Measures: Change in time spent on documentation outside work hours, Providers will track amount of time spent on EHR (electronic health records) outside of scheduled patient hours per 8 hours of patient scheduled time, Baseline to 24 weeks|Change in task load, Hours spent on documentation per 8 hours of scheduled patient time, Baseline to 24 weeks|Change in meaningfulness of work, Meaningfulness of work is a 4-item questionnaire, where each question is scored on a 0-4 Likert scale. Total possible scores range from 0-16, with higher scores indicating lower sense of meaningfulness of work., Baseline to 24 weeks|Change in meaningful relationships, Using the Professional Well-Being Academic Consortium Survey Measures, the negative impact of work on relationships index is a 4-item questionnaire. Each question is scored on a 0-4 Likert scale, with total possible scores ranging from 0-16. Higher scores indicate less meaningful relationships., Baseline to 24 weeks
Effect of TEAS Combined With Oxycodone on Postoperative Visceral Pain in Gynecologic Laparoscopic Patients
NCT Number: NCT06517069
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Visceral Pain
Interventions: OTHER: TEAS|DRUG: Oxycodone
Sponsor: Yangzhou University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-01
Completion Date: 2025-07-01
Locations: Affiliated Hospital of Yangzhou University, Yangzhou, Jiangsu, 225000, China

Summary:
To investigate the effect and feasibility of percutaneous acupoint stimulation combined with oxycodone on postoperative visceral pain in laparoscopic patients, and provided a clinical basis for optimizing perioperative pain management in laparoscopic patients.

Primary Outcome Measures: the VAS score of postoperative visceral pain, the visual analogue scale of postoperative visceral pain,The basic method is to use a swimming scale about 10cm long, marked with 10 scales on one side, and "0" and "10" at each end, with 0 being painless and 10 being the most unbearable pain., 30 minutes after surgery、6 hours after surgery、24 hours after surgery、48 hours after surgery
Emovi 3D Knee Assessment Device Intervention for Operational Readiness
NCT Number: NCT06517056
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Patellofemoral Pain|Patellofemoral Pain Syndrome
Interventions: DEVICE: Emovi Knee Kinesiography
Sponsor: Womack Army Medical Center
Collaborators: Medical Technology Enterprise Consortium|The Geneva Foundation
Sex: ALL
Age: ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07
Completion Date: 2025-10
Locations: Tripler Army Medical Center, Honolulu, Hawaii, 96859, United States|Womack Army Medical Center, Fort Liberty, North Carolina, 28310, United States

Summary:
This is a randomized clinical trial investigating the use of the Emovi Knee Kinesiography information in the treatment of anterior knee pain in physical therapy.

Primary Outcome Measures: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function, PROMIS asks patients about their functional ability, and symptoms. This tool is designed as a health-focused rather than a disease-focused measurement system. The primary outcome measure will focus on the the Physical Function domains since PFPS is known to limit function during daily and sports \& recreation activities. This is an adaptive questionnaire that is taken in RedCap and contains up to 166 questions that will not all be asked, scored 1-5 on a Likert scale based on limits of function.

The primary outcome is the between-group difference in PROMIS Physical Function T-score at 3 months. A linear mixed effects model will be used to analyze the between-group differences across the various time points (repeated measures)., 12 weeks
Secondary Outcome Measures: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference, This PROMIS tool focuses on pain interference in daily life. This questionnaire is adaptive taken in RedCap and contains up to 41 questions that will not all be asked. It is scored on a 5 point Likert scale based on limitation due to pain., 12 weeks|Anterior Knee Pain Scale (AKPS), The Anterior Knee Pain Scale is a 13-item more specific questionnaire related to PF pain which will allow to assess pain and symptoms during specific loading-activities. The 13 items on the scale are used to assess subjective symptoms and functional restrictions. A score can have a minimum of 0 points or a maximum of 100 points. Athletes would receive a score of 100 if they showed no signs of anterior knee pain., 12 weeks|Self-Reported Readiness to Return to Duty, The Self-Reported Readiness to Return to Duty questionnaire consists of three questions to assess perceived readiness to return to duty, 12 weeks|Total Lost Duty Days, Tracking the amount of duty days a soldier missed while enrolled in protocol., 12 weeks|Provider Satisfaction, A provider satisfaction survey will be used to measure patient satisfaction with quality of physical therapy care., 12 weeks
An Open-label, Single-arm Study of JWCAR201 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
NCT Number: NCT06517004
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Diffuse Large B Cell Lymphoma
Interventions: BIOLOGICAL: JWCAR201
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-18
Completion Date: 2027-08
Locations: Fudan University Shanghai Cancer Center, Shanghai, 200032, China

Summary:
This is an open-label, single-arm study to investigate the efficacy and safety signals of JWCAR201 amongst subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Primary Outcome Measures: Rate of dose-limiting toxicities (DLTs), Dose limiting toxicities for each subject, 28 days|AE/SAE, Incidence and severity of adverse events (AE), and serious adverse event (SAE), 24 months
Secondary Outcome Measures: Copy number of the vector transgene of JWCAR201 in peripheral blood, The pharmacokinetic parameters of JWCAR201 will be evaluated by quantitative polymerase chain reaction (qPCR) for the copy number of the vector transgene of JWCAR201 in peripheral blood to evaluate T-cell expansion and persistence., 24 months|CD19-positive cells and CD20-positive cells in peripheral blood, CD19-positive cells and CD20-positive cells in peripheral blood will be tested by flow cytometry (FCM)., 24 months|Objective response rate (ORR), Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients., 24 months|Complete response rate (CRR), The percentage of patients with advanced or metastatic cancer who have achieved complete response to a therapeutic intervention in clinical trials of anticancer agents., 24 months|Duration of response (DOR), The time from the date of first response (PR or better) to the date of disease progression or death after JWCAR201 infusion., 24 months|Progression-free survival (PFS), The time from JWCAR201 infusion to the date of progression as assessed by Lugano criteria or death., 24 months|Overall survival (OS), Defined as the time from the date of first infusion of JWCAR201 to death due to any cause., 24 months