Record
stringlengths 1
197k
|
|---|
2. the effectiveness of an 8-week dietary energy restriction with exercise or dietary energy restriction alone on fitness and health outcomes.
|
Twenty-one participants will be randomly assigned in a 2:1 allocation ratio. The participants will be assigned to either the dietary energy restriction and exercise group (D+E) group, which combines dietary energy restriction and exercise intervention, or the dietary energy restriction group (D) group, which just undergoes dietary energy restriction using sealed envelopes. conditions: Spinal Cord Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: Dietary energy restriction group (D) name: Dietary energy restriction and exercise group (D+E) measure: Lipid profile measure: Fasting insulin concentration measure: Insulin sensitivity measure: Resting matabolic rate measure: Body mass measure: Waist and hip circumference measure: Height measure: Total body fat percentage measure: Total Fat-Free Mass measure: Visceral Adipose Tissue measure: Total Fat Mass measure: Muscle, adipose and bone cross-sectional areas around the tibia and femur measure: Bone geometry and tissue densities around the tibia and femur measure: adipose tissue measure: Upper extremity muscle strength measure: Balance measure: Health-related quality of life measure: Shoulder Pain measure: Energy intake and dietary macronutrient composition measure: Energy expended in different physical activity intensities (MET categories) (kJ or kcal) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bath city: Bath state: England zip: BA2 7AY country: United Kingdom name: James Bilzon, PhD role: CONTACT email: jb438@bath.ac.uk name: Jennifer Maher, PhD role: CONTACT email: jilm92@bath.ac.uk name: Chatwalai Sonthikul, Master degree role: PRINCIPAL_INVESTIGATOR lat: 51.3751 lon: -2.36172 hasResults: False
|
<|newrecord|> nctId: NCT06296758 id: SiFi_HIP FRACTURE briefTitle: SiFi vs FNB Local Anesthesia for Hip Fracture Surgeries overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-05-01 date: 2024-03-06 date: 2024-03-06 name: University of Alberta class: OTHER briefSummary: The goal of this clinical trial is to compare two commonly used local/regional anesthesia techniques in adults patients undergoing hip fracture surgery. The main question\[s\] it aims to answer are: • the impact of both interventions on patient level of pain. • impact on postoperative analgesics administered Participants will be randomly assigned to one of two local/regional anesthesia techniques, either femoral nerve block (FNB) or suprainguinal fascia iliaca block (SiFi). Both techniques are the usual practice at the hospital, and we are NOT aiming to experiment on new anesthesia technique in this study. conditions: Hip Fractures conditions: Surgery conditions: Anesthesia, Local studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A concealed-allocation parallel-group blinded randomized controlled clinical primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Randomization will be conducted through blocked randomization with blocks of 4 according to a schedule not known to the investigators using a computerized algorithm. The attending surgeon, anesthetist, and nursing team will be blinded to the randomization assignment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 106 type: ESTIMATED name: Regional anesthesia measure: Postoperative pain measure: Postoperative analgesics administered measure: Mobilization measure: Time to readiness for discharge measure: Complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alberta Hospital city: Edmonton state: Alberta zip: t6g2b7 country: Canada lat: 53.55014 lon: -113.46871 hasResults: False
|
<|newrecord|> nctId: NCT06296745 id: 2024-KY-008-01 briefTitle: Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib. overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2026-01-20 date: 2026-03-20 date: 2024-03-06 date: 2024-03-06 name: Guangzhou Medical University class: OTHER briefSummary: Pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer (NSCLC). Since 2017, intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from NSCLC. It has been recommended as the preferred drug for intrathecal chemotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines. Tyrosine kinase inhibitors (TKIs) play a promising role in treating non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations. An international multi-center clinical study published in 2019 confirmed that double dose of osimertinib showed significant improvement in leptomeningeal metastases from NSCLC with EGFR exon 19 deletion or exon 21 L858R/T790M mutation. It makes TKIs the mainstay of treatment for patients with EGFR-mutant NSCLC with leptomeningeal metastases. However, the choice of treatment after resistance to targeted therapy is a hot topic in clinical practice, with 78% of patients in the study above who responded to double-dose osimertinib still showing progression at the time of follow-up. The purpose of this study was to observe the safety and efficacy of intrathecal pemetrexed for leptomeningeal metastasis from lung adenocarcinoma that progressed after a double dose of a third-generation TKI such as osimertinib. conditions: Leptomeningeal Metastasis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Pemetrexed measure: Clinical response rate measure: Neurological progression-free survival (NPFS) measure: Overall survival measure: Incidence of treatment-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06296732 id: NCPHOI-2024-01 briefTitle: Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification acronym: ANLAP-R overallStatus: RECRUITING date: 2023-10-19 date: 2026-10-26 date: 2031-11-01 date: 2024-03-06 date: 2024-03-06 name: Federal Research Institute of Pediatric Hematology, Oncology and Immunology class: OTHER name: Corporate Fund University Medical Centre briefSummary: Surgery plays significant role in treatment of neurogenic tumors, both for benign ganglioneuroma and for high risk neuroblastoma. The world literature has accumulated large experience in laparoscopic surgery for abdominal neuroblastoma. The presence of IDRF (image-defined risk factors) and tumor size (\>4-7 cm) are considered as common contraindications for minimally invasive surgery in neuroblastoma. However, the recent studies have shown that presence of IDRF is not an absolute contraindication for laparoscopic surgery. This open-label, nonrandomized, observational, phase III evaluates role and weight of different surgical risk factors (including IDRF, tumor size, tumor localization, tumor volume/patient height ratio, previous open surgical procedures, previous chemotherapy etc.) in the laparoscopic neuroblastoma resections. The aim of this study is to create novel risk factors scoring system for laparoscopic surgery in abdominal neuroblastoma. conditions: Neuroblastoma conditions: Ganglioneuroma conditions: Ganglioneuroblastoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Duration of surgery intervention measure: Duration of surgery intervention measure: The influence of surgical risk factors measure: Cases of conversion from laparoscopic to cavity access measure: Comparison of surgeon's visual assessment of the tumor resection measure: 1-, 3-, 5-years local recurrence-free survival sex: ALL minimumAge: 1 Day maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Research Institute of Pediatric Hematology, Oncology and Immunology status: RECRUITING city: Moscow country: Russian Federation name: Dmitry m Akhaladze, MD, Doc role: CONTACT phone: +7 (905) 587-89-92, email: d.g.akhaladze@gmail.com lat: 55.75222 lon: 37.61556 hasResults: False
|
<|newrecord|> nctId: NCT06296719 id: ACP Community 2024 briefTitle: The Chit-Chat Educational Intervention to Promote Advance Care Planning in the Community overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-06 date: 2024-03-06 date: 2024-03-06 name: The Hong Kong Polytechnic University class: OTHER briefSummary: The purpose of this study is to estimate the effect size of the Chit-Chat intervention on ACP engagement among family members of older adults with multi-morbidity. conditions: Old Age conditions: Family Members studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Chit-Chat measure: ACP engagement measure: Knowledge of ACP sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06296706 id: HB1801-010 briefTitle: A Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-06-01 date: 2027-06-01 date: 2024-03-06 date: 2024-03-06 name: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. class: INDUSTRY briefSummary: This trial is a multicenter, randomized, controlled phase Ш clinical study of comparison of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma with previous first-line treatment failure. conditions: Gastric Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 630 type: ESTIMATED name: Docetaxel for injection (Albumin-bound) name: Taxotere (docetaxel) measure: OS measure: ORR by IRC measure: ORR by investigator measure: PFS measure: DCR measure: DoR measure: AE and SAE measure: Plasma concentration of docetaxel (free and total) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06296693 id: 2023.062(051-DEFI/053-CE) briefTitle: Diagnostic Accuracy of Pocket-size Lung Ultrasound in Pneumonia Etiology and Complications in Hospitalized Children acronym: POCUS-L overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-04-30 date: 2024-03-06 date: 2024-03-06 name: Centro Hospitalar Universitário de Santo António class: OTHER briefSummary: 1. Background and study aims Pneumonia is the leading infectious cause of death in children worldwide. Although the diagnosis is clinical, a chest radiograph (CXR) is often necessary to clarify it, exposing the patient to radiation. Ultrasound has been increasingly used in the evaluation of the lung parenchyma without exposing patients to radiation. The pocket-size Point-of-Care Ultrasound (POCUS) can be used at the patient's bedside proving comfort and saving time. Evidence suggests that ultrasound can detect CAP (community-acquired pneumonia) in children with similar accuracy and reliability as CXR. However, few studies evaluated the ability to distinguish the aetiology of pneumonia and none used a pocket-size POCUS device. This study aims to assess, for the first time, the diagnostic accuracy of a pocket-size POCUS device for the etiological diagnosis of CAP vs. CXR, in paediatric ages. Secondarily, the investigators intend to evaluate the correlation between CXR image vs. ultrasound, the correlation between clinical progression and ultrasound images, and the diagnostic accuracy to detect complications.
|
2. Who can participate:
|
The investigators will include, consecutively, all children aged \>12 months and \<18 years hospitalized to the Paediatric Department with the diagnosis of CAP on admission. The investigators will exclude children hospitalized with nosocomial pneumonia, with cystic fibrosis diagnosis or on long-term domiciliary ventilation.
|
3. What does the study involve:
|
The diagnostic accuracy between POCUS and CXR in differentiating the type of pneumonia will be assessed. All participants will perform a POCUS at admission, daily during hospitalization, 15 days and 1 month after discharge. All children will also undergo a CXR upon admission and whenever necessary.
|
4. What are the possible benefits and risks of participating:
|
Children will have a more frequent and serial assessment of CAP, which does not involve risks.
|
5. Where is the study run from:
|
The study if from Centro Materno Infantil do Norte - Centro Hospitalar Universitário de Santo António, a tertiary paediatric referral centre.
|
6. When is the study starting and how long is it expected to run for:
|
The recruitment period is expected to start in January/2024 and end in January 2025. conditions: Pneumonia conditions: Pneumonia, Viral conditions: Pneumonia, Bacterial studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 76 type: ESTIMATED name: Pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalized measure: POCUS vs. CXR for the etiological diagnosis of CAP measure: CXR image vs. ultrasound measure: Clinical progression and ultrasound images measure: Complications sex: ALL minimumAge: 12 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
|
<|newrecord|> nctId: NCT06296680 id: EGE_UNI_SEVCAN_OZ_KAHVECI_0001 briefTitle: Reiki for Cancer: Pain, Anxiety, and Stress overallStatus: COMPLETED date: 2022-09-02 date: 2022-11-30 date: 2023-06-30 date: 2024-03-06 date: 2024-03-06 name: Ege University class: OTHER briefSummary: The goal of this clinical trial is to investigate the effects of Reiki, Sham Reiki, and Progressive Relaxation Exercise on the levels of pain, anxiety, and stress in cancer patients.
|
The main questions it aims to answer are:
|
* Question 1: The effect of Reiki applied to cancer patients on the level of pain within the time series is higher in favor of the intervention group.
|
* Question 2: The effect of Reiki applied to cancer patients on the level of anxiety within the time series is higher in favor of the intervention group.
|
* Question 3: The effect of Reiki applied to cancer patients on cortisol levels within the time series is higher in favor of the intervention group.
|
* Question 4: The effect of Reiki applied to cancer patients on the level of stress within the time series is higher in favor of the intervention group.
|
* Participants have answered the questions in the Individual Identification Form, Visual Comparison Scale, State Anxiety Scale and Perceived Stress Scale and serum cortisol levels were evaluated in the pretest.
|
* Afterwards, the patients in the intervention group received Reiki for four consecutive days, the patients in the placebo group received Sham Reiki, and the patients in the control group received Progressive Relaxation Exercise.
|
* The patients in the experimental group received Reiki to the seven chakra regions and additional areas with pain for a total duration of 25-30 minutes for four days, with an average of three minutes.
|
* The patients in the placebo group received Sham Reiki to the seven chakra regions for a total duration of 25-30 minutes for four days, with an average of three minutes.
|
* Progressive Relaxation Exercise (PRE) group patients received PRE for four days.
|
* On the 4th day, pain and anxiety levels (0-10 Likert-type scale) of the patients were evaluated after the last applications.
|
* On the 21st day, the day of the next chemotherapy cycle, pain and anxiety levels were evaluated, state anxiety scale and perceived stress scale were administered, and serum cortisol level was evaluated in the morning before the start of chemotherapy.
|
* At the 3rd month follow-up, pain and anxiety levels (0-10 Likert-type scale), state anxiety scale and perceived stress scale were evaluated. conditions: Therapeutic Touch conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: This study is a three-arm intervention trial. Reiki was applied to the intervention group, Sham Reiki to the placebo group, and Progressive Relaxation Exercise to the control group. The effects of these three methods applied to cancer patients on their levels of pain, anxiety, and cortisol were examined. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: In order to prevent assessment bias, blinding was implemented throughout the collection of data from patients, evaluation of the effectiveness and reliability of the applied dependent variables, data processing, reporting, and statistical analysis. The researcher was provided with a randomization list by a statistical expert. The researcher was included in the study without knowing which group the patients would be assigned to, and the patients were also enrolled without knowledge of their group assignment. Therefore, this study was conducted as a three-arm, double-blind, randomized follow-up study in the experimental research model, with intervention, placebo, and control groups. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 58 type: ACTUAL name: Reiki name: Sham Reiki name: Progressive Relaxation Exercise measure: Stress levels measure: Anxiety levels measure: Pain levels sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ege University city: İzmir zip: 35100 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False
|
<|newrecord|> nctId: NCT06296667 id: P.T.REC/012/003644 briefTitle: Effect of Core Muscles Training On Patients With Chronic Mechanical Low Back Pain According To SALIBA'S Postural Classification System overallStatus: ACTIVE_NOT_RECRUITING date: 2023-05-01 date: 2024-03-15 date: 2024-04-01 date: 2024-03-06 date: 2024-03-06 name: Cairo University class: OTHER briefSummary: This study is designed as a pre and post experimental study. The purposes of this study are to evaluate the effect of core muscles training in patients with chronic mechanical low back pain according to SALIBA'S postural classification system (SPCS) in terms of pain intensity, function, and core muscles endurance. conditions: Chronic Low-back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ACTUAL name: core muscles training exercises measure: pain intensity. measure: function disability measure: core muscles endurance measure: participants gender will be male and females, their age in years,their height in meters,weight in kilograms. sex: ALL minimumAge: 20 Years maximumAge: 55 Years stdAges: ADULT facility: Cairo University,Faculty of Physical Therapy city: Giza zip: 11432 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False
|
<|newrecord|> nctId: NCT06296654 id: 25/2021-22 dt. Dec. 12,2021 briefTitle: Effect of Empowerment-Based Interventions on Self-Efficacy and Self-Care Capacity Among Adults With Sickle Cell Disease overallStatus: COMPLETED date: 2022-03-20 date: 2022-10-21 date: 2022-10-22 date: 2024-03-06 date: 2024-03-06 name: University of Bahrain class: OTHER briefSummary: This study aimed to To investigate the effect of empowerment-based interventions (EBI) on self-efficacy and self-care capacity among adults with Sickle Cell Disease (SCD).
|
The hypotheses of this study were: Adults with SCD who receive EBI exhibit higher self-efficacy, self- management capacity and HRQoL than those who do not. conditions: Self-Efficacy conditions: Self-Care studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 68 type: ACTUAL name: Empowerment-Based Interventions name: Standard Health Education measure: Sickle Cell Self-Efficacy measure: Self-Care Capacity sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: College of Health and Sport Sciences, University of Bahrain city: Manama zip: 11511 country: Bahrain lat: 26.22787 lon: 50.58565 hasResults: False
|
<|newrecord|> nctId: NCT06296641 id: AAAU9477 briefTitle: Needs Navigation for Caregivers of AYAs acronym: Cope-CAYAC overallStatus: RECRUITING date: 2024-02-16 date: 2025-02 date: 2025-05 date: 2024-03-06 date: 2024-03-06 name: Columbia University class: OTHER briefSummary: The overall aim of the study is to address unmet health-related social needs and reduce outcome disparities among AYA cancer survivors. Aim 1 aimed to refine a needs navigation model in partnership with expert consultants. Aim 2 and 3 will involve the deployment and pilot testing of the adapted needs navigation intervention among caregivers of younger AYAs with cancer. conditions: Cancer in Adolescence studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Participants who screen positive all move forward to receive the intervention primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 60 type: ESTIMATED name: Needs navigation intervention measure: Number of (OR percentage of) participants who completed the intervention measure: Percentage of eligible participants who consented to be in study measure: Personal Financial Wellness Scale (PFWS) / Comprehensive Score of Financial Toxicity (COST measure) sex: ALL minimumAge: 15 Years maximumAge: 26 Years stdAges: CHILD stdAges: ADULT facility: Columbia University Irving Medical Center status: RECRUITING city: New York state: New York zip: 10032 country: United States name: Melissa Beauchemin, PhD, MSN,CPNP-PC, CPO role: CONTACT lat: 40.71427 lon: -74.00597 hasResults: False
|
<|newrecord|> nctId: NCT06296628 id: 2000037049 id: 000 type: OTHER domain: CTGTY briefTitle: Rehabilitation Device for Hand Mirror Therapy overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-04 date: 2024-04 date: 2024-03-06 date: 2024-03-06 name: Yale University class: OTHER name: Management Center Innsbruck (MCI), Austria name: Yale School of Engineering Center for Engineering 26 Innovation and Design briefSummary: This study is a randomized and open comparative study that uses two parallel groups: a control group training with conventional therapy and another group that trains with the device "Miraπ". The participants are patients with stroke with motor weakness in one hand. Two measurement visits are required. During those visits, different hand function assessments will be carried out to analyze the motor function of the subjects hand. The measurements will be done during their inpatient rehabilitation stay, one at time of admission and the second at discharge, each taking 20 minutes. In the time between the measurement visits, the hand therapy takes place fivemtimes a week. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are patients admitted to the acute inpatient rehabilitation unit for rehabilitation of the hand and fingers who have one paralyzed hand without pronounced spasticity. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Miraπ name: Mirror Therapy measure: Change in Jebsen-Taylor Hand Function Test score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yale New Haven Health Inpatient Rehabilitation Unit, Bridgeport Hospital city: Bridgeport state: Connecticut zip: 06610 country: United States lat: 41.16704 lon: -73.20483 hasResults: False
|
<|newrecord|> nctId: NCT06296615 id: 2020-022 briefTitle: Whether Vaginal Microbiota Affects Pregnancy Outcomes After Embryo Transfer overallStatus: COMPLETED date: 2021-04-01 date: 2022-10-30 date: 2022-10-30 date: 2024-03-06 date: 2024-03-08 name: ShangHai Ji Ai Genetics & IVF Institute class: OTHER briefSummary: The goal of this observational study is to learn about vaginal microbial characteristics in the patients under in vitro fertilization treatment. The study aims to address the following questions: (1) Is there any difference in microbial composition between the pregnancy and non-pregnancy groups? (2) Is there any differences in specific bacterial species between the two groups? (3) What are the favorable or unfavorable profiles of vaginal microbiota associated with achieving pregnancy? Patients will be asked to complete a questionnaire regarding their basic characteristics, and vaginal secretions will be collected via vaginal swab during frozen-blastocyst transfer procedures. The study will compare vaginal microbiota between pregnant and non-pregnant patients to assess its potential influence on clinical outcomes. conditions: Infertility, Female conditions: Microbial Colonization studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 161 type: ACTUAL measure: Rate of clinical pregnancy sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Shanghai Ji Ai Genetics & IVF Institute city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False
|
<|newrecord|> nctId: NCT06296602 id: 2023/777 briefTitle: Screening Anal HPV Colonization in Men Sex Men Using Pre-exposure Prophylaxis for HIV (ANAPreP'HPV) acronym: ANAPreP'HPV overallStatus: RECRUITING date: 2024-03-04 date: 2024-11-04 date: 2024-11-04 date: 2024-03-06 date: 2024-03-08 name: Centre Hospitalier Universitaire de Besancon class: OTHER briefSummary: This is an interventional study investigating HPV carriage and liquid-based cytology at anal level. It will be offered to all patients undergoing PreP consultations at Besançon University Hospital. The anal swab will be taken by the doctor using a cyto-brush during the consultation. conditions: Pre-Exposure Prophylaxis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.
|
A questionnaire will be completed by the doctor to record the data of interest. primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections. measure: prevalence HPV measure: typing HPV measure: High risk HPV risk factors measure: Cytologist abnormalies sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Besançon status: RECRUITING city: Besancon zip: 25000 country: France name: Cédric LEBRETON, Dr role: CONTACT lat: 47.24878 lon: 6.01815 hasResults: False
|
<|newrecord|> nctId: NCT06296589 id: HT94252310861 briefTitle: Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure acronym: PORT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-07 date: 2027-08 date: 2024-03-06 date: 2024-03-06 name: Veterans Medical Research Foundation class: OTHER name: University of Minnesota name: Center for Veterans Research and Education briefSummary: The goal of this clinical trial is to learn if receiving Trauma-Informed Guilt Reduction (TrIGR) Therapy is as effective as receiving Prolonged Exposure Therapy among veterans with PTSD and trauma related guilt. The main questions it aims to answer are:
|
Will TrIGR be comparable to PE in terms of PTSD symptom reduction? Will it TrIGR be comparable to PE in improving functioning and reducing depression symptoms? Will it be superior in improving trauma-related guilt and shame? conditions: Stress Disorders, Post-Traumatic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 158 type: ESTIMATED name: Trauma Informed Guilt Reduction Therapy name: Prolonged Exposure Therapy measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5) measure: Patient Health Questionnaire-9 (PHQ-9) measure: Brief Psychosocial Functioning Inventory (B-IPF) measure: Trauma Related Guilt Inventory Cognitions Scale (TRGI) measure: Trauma Related Shame Inventory (TRSI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Little Rock Veterans Health Care System (LRVHCS) city: Little Rock state: Arkansas zip: 72205 country: United States name: Brandon Griffin role: CONTACT phone: 501-257-1000 email: Brandon.Griffin2@va.gov lat: 34.74648 lon: -92.28959 facility: Southeast Louisiana Veterans Health Care System (SLVHCS) city: New Orleans state: Louisiana zip: 70119 country: United States name: Laurel Franklin, PhD role: CONTACT phone: 800-935-8387 email: Laurel.Franklin@va.gov lat: 29.95465 lon: -90.07507 facility: William S. Middleton Memorial Hospital city: Madison state: Wisconsin zip: 53705 country: United States name: Michael Messina, PhD role: CONTACT phone: 608-284-6302 email: Michael.Messina2@va.gov lat: 43.07305 lon: -89.40123 hasResults: False
|
<|newrecord|> nctId: NCT06296576 id: CHM-2023/S49/06 briefTitle: Acceleration Time Assessment for Prediction of Critical Limb Ischemia acronym: ATACLI overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-05-01 date: 2026-05-01 date: 2024-03-06 date: 2024-03-06 name: Centre Hospitalier le Mans class: OTHER briefSummary: Critical Limb Ischaemia (CLI), the final stage of arterial disease, is a therapeutic emergency whose prognosis depends largely on the time taken to diagnose it. The growing prevalence of this condition and the associated healthcare costs make it an important public health objective. Diagnostic criteria for Critical Limb Ischaemia differ between learned societies and countries.
|
Its diagnosis is most frequently based on the combination of a clinical criterion (ischaemic decubitus pain and/or necrotic wounds, with a time to onset \> 2 weeks) and a haemodynamic criterion (ankle systolic pressure (ASP) \< 50mmHg or toe systolic pressure (TSP) \< 30 mmHg or transcutaneous oxygen pressure (TCPO2) \< 30 mmHg).
|
Recent studies have highlighted the importance of pulsed Doppler flow analysis in quantifying arteriopathy of the lower limbs, both by systematically analysing flow modulation and by measuring the systolic rise time of distal arteries (dorsal artery of the foot and lateral plantar artery).
|
The main aim of our study is therefore to validate a reliable and accessible diagnostic tool for screening patients suffering from CLI so that they can be referred to a reference centre as early as possible. conditions: Critical Limb Ischemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 431 type: ESTIMATED name: arterial ultrasound scan measure: Evaluate the intrinsic diagnostic performance of the maximum systolic rise time (TASmax) in the distal arteries of the foot sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier de CHOLET city: Cholet zip: 49300 country: France name: Marie GAUME role: CONTACT email: marie.gaume@ch-cholet.fr name: Jean-Eudes TRIHAN, MD role: PRINCIPAL_INVESTIGATOR lat: 47.06667 lon: -0.88333 facility: Centre Hospitalier du Mans city: Le Mans zip: 72000 country: France name: Christelle JADEAU role: CONTACT phone: 02 44 71 07 81 email: cjadeau@ch-lemans.fr name: Claire NEVEUX-BRECHETEAU, MD role: PRINCIPAL_INVESTIGATOR lat: 48.0 lon: 0.2 hasResults: False
|
<|newrecord|> nctId: NCT06296563 id: SHR1316-ICC-SD-001 briefTitle: Perioperative Treatment of Resectable Intrahepatic Cholangiocarcinoma With the Combination of Adebrelimab and Apatinib and HAIC overallStatus: RECRUITING date: 2024-03-01 date: 2027-03-01 date: 2029-03-01 date: 2024-03-06 date: 2024-04-17 name: Lei ZHAO class: OTHER briefSummary: The goal of this clinical trial is to explore the efficacy and safety of combined infusion chemotherapy with Adebrelimab and Apatinib in the perioperative treatment of resectable intrahepatic cholangiocarcinoma patients. The main question it aims to answer are:
|
How to improve the survival of patients with intrahepatic cholangiocarcinoma and prolong the recurrence time after surgery.
|
Participants will receive receive neoadjuvant therapy with Adebrelimab combined with apatinib and FOLFOX-HAIC for 2 cycles (1 treatment cycle every 21 days, apatinib only used for the first cycle), and surgery was performed 14-28 days after the end of treatment. After 28 days of surgery, patients will continue to receive adjuvant treatment with Adebrelimab combined with apatinib for a maximum of one year. conditions: Intrahepatic Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: HAIC name: Adebrelimab name: Apatinib measure: Pathologic complete response (pCR) measure: Objective response rate (ORR) measure: Event free survival (EFS) measure: Overall Survival (OS) measure: Disease Control Rate (DCR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shandong Cancer Hospital and Institute status: RECRUITING city: Jinan state: Shandong zip: 250117 country: China name: Lei Zhao, MD role: CONTACT phone: +86 053167626368 email: drzhaolei@hotmail.com name: Peifei Sun, MD role: CONTACT phone: +86 053167626242 name: Lei Zhao, MD role: PRINCIPAL_INVESTIGATOR lat: 36.66833 lon: 116.99722 hasResults: False
|
<|newrecord|> nctId: NCT06296550 id: Dulce Digital CGM briefTitle: Enhancing Digitally Delivered Diabetes Education With Real-Time CGM overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-04-30 date: 2024-03-06 date: 2024-03-06 name: Scripps Whittier Diabetes Institute class: OTHER briefSummary: The current research study will add continuous glucose monitoring devices to the evidence-based text messaging diabetes education program for patients with type 2 diabetes for 6 months. Results on the effectiveness of this intervention will be compared for non-insulin using patients. conditions: Diabetes Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 140 type: ESTIMATED name: Dulce Digital Text Messaging Intervention name: CGM Device measure: HbA1c measure: CGM Metric Time in Range measure: CGM Metric Time above Range measure: CGM Metric Time Below Range measure: Summary of Diabetes Self Care Activitiers (SDSCA) Survey measure: Diabetes Distress Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scripps Whittier Diabetes Institute city: San Diego state: California zip: 92121-1520 country: United States name: Athena Philis-Tsimikas, MD role: CONTACT phone: 858-729-4830 email: tsimikas.athena@scrippshealth.org name: Kallie Brown, MA role: CONTACT phone: 858-678-6294 email: brown.kallie@scrippshealth.org lat: 32.71533 lon: -117.15726 hasResults: False
|
<|newrecord|> nctId: NCT06296537 id: E-10840098-202.3.02-1434 briefTitle: Effectiveness of Balance Training And Dynamic Neuromuscular Stabilization Training in Amateur Athletes With Chronic Ankle Instability overallStatus: RECRUITING date: 2024-03 date: 2024-07 date: 2024-07 date: 2024-03-06 date: 2024-03-06 name: Medipol University class: OTHER briefSummary: The goal of this clinical trial is to determine and compare the effects of balance and dynamic neuromuscular stabilization training on ankle function ability, functional instability severity, physical activity level, muscle strength, proprioception, stabilization, balance, reaction time and performance of amateur athletes with chronic ankle instability. The main questions it aims to answer are:
|
* Do balance and dynamic neuromuscular stabilization training positively affect functionality, balance, stabilization, proprioception and performance in amateur athletes with chronic ankle sprains?
|
* Does balance training or dynamic neuromuscular stabilization training have a more positive effect on functionality, balance, stabilization, proprioception and performance in amateur athletes with chronic ankle sprains?
|
Participants will apply:
|
* a dynamic neuromuscular stabilization training program consisting of a series of special exercises based on the developmental kinesiology steps of a healthy baby.
|
* balance training which consist of an effective postural stability program.
|
* conventional training program which consist of stretching, joint range of motion, strengthening and postural control exercises.
|
Researchers will compare balance and dynamic neuromuscular stabilization training to see if effectiveness of ankle function ability, functional instability severity, physical activity level, muscle strength, proprioception, stabilization, balance, reaction time and performance. conditions: Ankle Inversion Sprain conditions: Chronic Instability of Joint conditions: Chronic Pain conditions: Athlete Foot studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: It is designed as a prospective, randomized, controlled study. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Dynamic Neuromuscular Stabilization Training (DNS) name: Balance Training name: Conventional Training measure: Star Excursion Balance Test measure: Balance Error Scoring System (BESS) measure: Foot and Ankle Ability Measurement (FAAM) measure: Cumberland Ankle Instability Questionnaire measure: International Physical Activity Questionnaire - Short Form measure: Manual Muscle Strength Test with Hand Dynamometer measure: Single Heel Lift Test measure: Joint Position Sense Test measure: Foot Lift Test measure: Blazepod Reaction Time measure: Side Hop Test sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Sevval Yeşilkır status: RECRUITING city: Istanbul state: Beşiktaş zip: 34347 country: Turkey name: Sevval Yeşilkır role: CONTACT phone: +90 530 869 64 76 email: sevvalyslkr98@gmail.com name: Gizem Ergezen role: CONTACT phone: +90 216 681 24 70 email: gergezen@medipol.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False
|
<|newrecord|> nctId: NCT06296524 id: SPC-2022-09 briefTitle: Effect of Footcore Exercises on Navicular Drop and Plantar Pressure Distribution in Asymptomatic Individual With Flatfoot overallStatus: RECRUITING date: 2024-03-01 date: 2024-03-01 date: 2024-03-30 date: 2024-03-06 date: 2024-03-07 name: Maharishi Markendeswar University (Deemed to be University) class: OTHER briefSummary: Pes Planus is a medical condition in which arch of the foot is flattened, causing the entire sole of the foot to contact the floor. For those with flat feet, footcore exercises might be an effective non-invasive therapy. Footcore exercises aim to strengthen the intrinsic foot muscles that maintain the foot arch, enhance foot function and reduce the risk of injury in persons with flatfoot. conditions: Flatfoot studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Footcore exercises and conventional therapy name: conventional therapy measure: Navicular Drop Test measure: Harris Mat for Plantar Pressure Distribution sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: MMIPR status: RECRUITING city: Ambala state: Haryana zip: 133207 country: India name: Mousumi Saha, MPT role: CONTACT phone: +919366787310 email: msaha0029@gmail.com name: subhasish chatterjee, Phd(NEURO) role: CONTACT phone: +918950037407 email: subhasishphysio@gmail.com name: subhasish chatterjee, Phd role: PRINCIPAL_INVESTIGATOR lat: 30.36099 lon: 76.79782 hasResults: False
|
<|newrecord|> nctId: NCT06296511 id: Loughborough University briefTitle: The Influence of Acute Moderate-intensity Continuous Exercise on Appetite Regulation overallStatus: COMPLETED date: 2023-06-23 date: 2023-11-07 date: 2023-11-07 date: 2024-03-06 date: 2024-03-06 name: Loughborough University class: OTHER briefSummary: A key area of obesity research has focused on the link between appetite, energy balance and weight control. Within this area, several appetite-related hormones and cellular cytokines have been identified as key signals influencing appetite and food intake. This includes the appetite-suppressing hormone oxyntomodulin (OXM) and a cellular stress-induced cytokine growth differentiation factor 15 (GDF-15).
|
The aims of this study are: (1) to investigate the effect of acute moderate-intensity continuous exercise on oxyntomodulin and GDF-15 concentrations; (2) to investigate whether exercise-induced changes in circulating OXM and GDF-15 concentrations are correlated with subjective appetite perceptions and subsequent energy intake. conditions: Obesity conditions: Overweight studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ACTUAL name: Exercise measure: Oxyntomodulin measure: Growth Differentiation Factor 15 measure: Visual analogue score (VAS) for subjective appetite measure: Energy intake sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Loughborough University city: Loughborough zip: LE11 3TU country: United Kingdom lat: 52.76667 lon: -1.2 hasResults: False
|
<|newrecord|> nctId: NCT06296498 id: 20230505HU briefTitle: Application of L-PRF in Periodontal Surgery overallStatus: RECRUITING date: 2023-08-19 date: 2025-12 date: 2026-03 date: 2024-03-06 date: 2024-03-06 name: The University of Texas Health Science Center at San Antonio class: OTHER briefSummary: The study will compare the clinical outcomes of the two procedures, open flap debridement (OFD) compared to open flap debridement with leukocyte and platelet-rich fibrin (L-PFR) as well as differences in patient postoperative pain perception. conditions: Periodontal Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The proposed study is a split-mouth design, randomized, prospective clinical trial in which we will use either OFD alone or OFD + L-PRF for periodontal surgery. Both procedures are standard of care primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants will be blinded to the intervention which they are randomized to. whoMasked: PARTICIPANT count: 32 type: ESTIMATED name: Leukocyte Platelet-rich fibrin name: Standard of care OFD measure: Probing depth measure: Postoperative Pain (PROM) sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Texas Health Science Center at San Antonio status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States name: Charles Powell, DDS, MS role: CONTACT phone: 210-567-3593 email: powellc2@uthscsa.edu lat: 29.42412 lon: -98.49363 hasResults: False
|
<|newrecord|> nctId: NCT06296485 id: IRB-1996616 id: R01DK134446 type: NIH link: https://reporter.nih.gov/quickSearch/R01DK134446 briefTitle: Safer Aging With Diabetes Monitoring acronym: SAGE overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2027-03-30 date: 2028-01-31 date: 2024-03-06 date: 2024-03-06 name: Kaiser Permanente class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: Older adults with type 2 diabetes are at higher risk for severe hypoglycemia and its related complications (including hospitalization and death) when taking insulin. This study proposes to evaluate, in a randomized clinical trial, a strategy of safe insulin prescribing based on an educational program that leverages continuous glucose monitoring to support older adults at high risk for hypoglycemia. If the aims of this project are achieved, this novel care strategy could be widely applied to reduce severe hypoglycemia episodes in older, high-risk adults with type 2 diabetes. conditions: Diabetes Mellitus, Type 2 conditions: Hypoglycemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 3-arm pragmatic randomized clinical trial primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Participant randomization status will be masked during data collection (baseline and follow-up surveys) by research assistants whoMasked: OUTCOMES_ASSESSOR count: 360 type: ESTIMATED name: SAGE Group Sessions name: SAGE Group Sessions + Diabetes Pharmacist name: Usual Care measure: Hypoglycemia aggregate outcome measure: Self-reported hypoglycemia measure: Hypoglycemia-related utilization measure: Diabetes Distress measure: Hypoglycemia Confidence measure: Hypoglycemia Distress measure: Technology Proficiency measure: Confidence in Adjusting Insulin measure: Insulin Adjustment measure: Caregiver Action sex: ALL minimumAge: 75 Years stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06296472 id: MDQ23 briefTitle: De Quervain's Disease in the Acute Phase:a Study Aimed at Evaluating the Effectiveness of Standard Physiotherapy Treatment (HANDGUIDE), Compared to Experimental Treatment After Performing Ultrasound-guided Infiltrative Therapy. overallStatus: RECRUITING date: 2024-02-27 date: 2025-02-01 date: 2025-12-30 date: 2024-03-06 date: 2024-03-06 name: Istituto Ortopedico Rizzoli class: OTHER briefSummary: The objective of the study is to compare pain reduction and disability reduction in two groups of patients diagnosed with de Quervain syndrome who will undergo ultrasound-guided infiltrative treatment with corticosteroid as per normal clinical practice:
|
* the control group will subsequently be subjected to a standard treatment based on the European guidelines of the HANDGUIDE group,
|
* the experimental group will subsequently carry out a program of eccentric exercises. conditions: De Quervain Disease conditions: Hand Tenosynovitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 134 type: ESTIMATED name: Rehabilitation name: Standard measure: Numeric Pain Rating Scale measure: Numeric Pain Rating Scale measure: Numeric Pain Rating Scale measure: Numeric Pain Rating Scale measure: Disabilities of Arm, Shoulder and Hand measure: Disabilities of Arm, Shoulder and Hand measure: Disabilities of Arm, Shoulder and Hand measure: Disabilities of Arm, Shoulder and Hand measure: Patient-Rated Wrist Evaluation measure: Patient-Rated Wrist Evaluation measure: Patient-Rated Wrist Evaluation measure: Patient-Rated Wrist Evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Ortopedico Rizzoli status: RECRUITING city: Bologna zip: 40136 country: Italy name: Fabio Vita, MD role: CONTACT email: fabio..vita@ior.it lat: 44.49381 lon: 11.33875 hasResults: False
|
<|newrecord|> nctId: NCT06296459 id: 20220556HU briefTitle: Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation overallStatus: RECRUITING date: 2022-09-21 date: 2024-12 date: 2025-03 date: 2024-03-06 date: 2024-03-06 name: The University of Texas Health Science Center at San Antonio class: OTHER briefSummary: A closed sinus augmentation is performed for dental implant placement. conditions: Dental Implant studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A 2 arm study using two methods of imaging in a participant primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: 3D R100 scanner name: Conventional Radiograph measure: Dimensional Change in augmentation at 8mm measure: Dimensional Change in augmentation at 10mm measure: Dimensional Change in augmentation at 12mm sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Texas Health Science Center at San Antonio status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States name: Charles Powell, DDS, MS role: CONTACT phone: 210-567-3593 email: powellc2@uthscsa.edu lat: 29.42412 lon: -98.49363 hasResults: False
|
<|newrecord|> nctId: NCT06296446 id: disability fibromyalgia briefTitle: Disability of People With Fibromyalgia in Poland overallStatus: RECRUITING date: 2024-04-15 date: 2024-05-01 date: 2024-11-01 date: 2024-03-06 date: 2024-04-16 name: University of Rzeszow class: OTHER briefSummary: Fibromyalgia is a syndrome characterized by chronic, generalized pain in muscles and joints with the presence of characteristic, symmetrically occurring so-called "tender points" - areas of the body that are excessively sensitive to pressure. The condition is associated with a feeling of chronic fatigue, mood and sleep disturbances and a sensation of body stiffness. These complaints are bothersome and significantly impair patients' functioning in every aspect of their lives. There are few studies evaluating the functioning and disability of people with fibromyalgia. No such study has been conducted in Poland to date. Therefore, the purpose of this study is to evaluate the functioning and disability of fibromyalgia patients and the relationship of the level of disability with selected factors, such as pain intensity, emotional state, sleep quality, etc. conditions: Fibromyalgia conditions: Disabilities Multiple studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 700 type: ESTIMATED measure: disability measure: functioning measure: depression measure: Sociodemographic data sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Rzeszow status: RECRUITING city: Rzeszów state: Podkarpacie zip: 35-310 country: Poland name: Agnieszka Sozańska, professor role: CONTACT phone: +48 530172857 email: asozanska@ur.edu.pl lat: 50.04132 lon: 21.99901 hasResults: False
|
<|newrecord|> nctId: NCT06296433 id: HCB_2023_1196 briefTitle: Extended Reality-Assisted Therapy for Chronic Pain Management acronym: XR-PAIN overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-11-30 date: 2024-12-31 date: 2024-03-06 date: 2024-03-18 name: Institut d'Investigacions Biomèdiques August Pi i Sunyer class: OTHER briefSummary: The goal of this clinical trial is to test a home-based virtual reality rehabilitation application in patients with chronic low back pain. The main question it aims to answer are:
|
Is a prototype of a novel VR software application effective at reducing pain, improving daily function, improving range of motion, and reducing fear of movement in adult patients with chronic low back pain compared with a passive VR intervention? Participants in the treatment group will use the application daily for 20 minutes for a period of 3 weeks at home and unsupervised. Researchers will compare use of the VR application with a control group that watches 2D video to see if the treatment group have improved pain, disability, range of motion, and fear of movement. conditions: Chronic Pain conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: VR rehabilitation name: VR video application measure: Brief Pain Inventory measure: Roland-Morris Disability Questionnaire measure: Short-Form 12 measure: Patient Global Impression of Change measure: Pain Catastrophization Scale measure: Spinal Range of motion measure: Adherence to treatment measure: Embodiment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IDIBAPS city: Barcelona zip: 08036 country: Spain lat: 41.38879 lon: 2.15899 hasResults: False
|
<|newrecord|> nctId: NCT06296420 id: 24C304 briefTitle: Dysphagia After Thyroidectomy acronym: DYSPHATHYR overallStatus: RECRUITING date: 2024-01-31 date: 2025-11-30 date: 2026-11-30 date: 2024-03-06 date: 2024-03-12 name: Istituto Auxologico Italiano class: OTHER briefSummary: The goal of this observational study is to develop a questionnaire for measuring swallowing and throat discomfort symptoms in patients with goiter or thyroidectomy, which complies with the model of Rasch and which satisfies the fundamental measurement axioms (e.g., unidimensionality, linearity, generalizability). Developing a scale with such characteristics would provide clinicians and researchers with a reliable tool for assessing the impact of goiter and for measuring the outcomes after surgery.
|
Also, the study will assess the psychological impact of goiter and thyroidectomy, as well as the characteristics of the surgical scar after thyroidectomy.
|
The questionnaire will be developed in the first phase of the study. Items and response categories will be identified through interviews performed with patients affected by goiter or after thyroidectomy.
|
In the following phases of the study, the questionnaire will be administered to patients before and after thyroidectomy. conditions: Goiter conditions: Thyroid Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 420 type: ESTIMATED measure: The primary outcome measure will be the questionnaire which will be developed in the first phase of the study itself. measure: Patient and Observer Scar Assessment Scale (POSAS) 2.0. measure: Depression Anxiety Stress Scales-21 (DASS-21). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Auxologico Italiano status: RECRUITING city: Milan state: MI zip: 20122 country: Italy name: Stefano Scarano, MD role: CONTACT phone: +3902619116717 email: s.scarano@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False
|
<|newrecord|> nctId: NCT06296407 id: 01C319 briefTitle: Psychophysical Analysis of Adolescent Patients With Obesity and Efficacy of the Respiratory Approach (PSICOFISADOLOB). acronym: PSICOFISADOL overallStatus: RECRUITING date: 2023-08-08 date: 2024-12-31 date: 2024-12-31 date: 2024-03-06 date: 2024-03-06 name: Istituto Auxologico Italiano class: OTHER briefSummary: Specifically, the project aims to pursue the following objectives:
|
1. To evaluate in male and female adolescents with obesity the interaction between different psycho-body aspects such as respiration - posture - self-perception and affectivity and tolerance to physical exercise;
|
2. To evaluate in a subgroup of male and female adolescents the effectiveness of exercises aimed at respiratory muscles and of respiratory consciousness on the parameters above indicated and on their interaction.
|
The final objective of this project is to define and propose "take home" specific respiratory exercises to promote greater body awareness and a condition of psychophysical well-being stable over time, creating a condition that can favor further interventions on obesity. Finally, the project aims to build solid scientific bases to insert respiratory exercise among the intervention guidelines to prevent and reduce obesity, particularly youth obesity. conditions: Obesity, Childhood studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 24 type: ESTIMATED name: Standard metabolic integrated rehabilitation protocol - duration 3 weeks name: Standard metabolic integrated rehabilitation protocol + respiratory exercises - duration 3 weeks measure: Fat mass measure: Fat-free mass measure: Maximal Inspiratory Pressure measure: Maximal Expiratory Pressure measure: Interoceptive awareness sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Istituto Auxologico Italiano, Site Piancavallo status: RECRUITING city: Oggebbio state: Verbania zip: 28824 country: Italy name: Alessandro Sartorio, MD role: CONTACT phone: +390261911 phoneExt: 2426 email: sartorio@auxologico.it lat: 45.99088 lon: 8.64663 hasResults: False
|
<|newrecord|> nctId: NCT06296394 id: STUDY23080161 id: 1R01HL161164-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R01HL161164-01A1 id: KAZMER22A0 type: OTHER_GRANT domain: Cystic Fibrosis Foundation briefTitle: Health Outcomes of Parents With Cystic Fibrosis-Aim 2 acronym: HOPeCF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2030-02-01 date: 2031-02-01 date: 2024-03-06 date: 2024-04-19 name: University of Pittsburgh class: OTHER name: Cystic Fibrosis Foundation name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The goal of this observational prospective study is to determine the health impact of parenthood on United States (US) people with CF in the era of CF transmembrane regulator protein (CFTR) modulators. The investigators will collect physical and mental health data to comprehensively evaluate the impact of parenthood in CF with widespread highly effective CFTR modulator use. The main hypotheses this study aims to examine are:
|
H1: Parents with CF and moderate-to-severe depression have more rapid change in ppFEV1 (percent predicted forced expiratory volume in one second) versus those with mild or no depression.
|
H2: Parents with CF who have more parental responsibility and/or stress have more rapid ppFEV1 (percent predicted forced expiratory volume in one second) change than those with less responsibility/stress
|
H3: Parents using CFTR modulators have decreased ppFEV1 (percent predicted forced expiratory volume in one second) change versus those not using CFTR modulators
|
Participants will complete quarterly surveys during the first year of parenthood and biannual surveys, thereafter, using the computer-based survey system on an iPad protected for infection control or via personal device or computer via emailed survey link. conditions: Cystic Fibrosis conditions: Parenthood Status studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 146 type: ESTIMATED name: Parenthood measure: Forced Expiratory Volume (FEV1) measure: Pulmonary Function Tests (PFTs) - Forced Vital Capacity (FVC) measure: Pulmonary Function Tests (PFTs) - Forced Expiratory Volume (FEV1) measure: Pulmonary Function Tests (PFTs) - Forced Expiratory Flow at 25 and 75 percent (FEF25-75) measure: History of CF Diagnosis measure: History of CF Genotype Information measure: History of CF Mutation measure: Number of Hospitalizations measure: Length of Hospitalizations measure: Number of Pulmonary Exacerbations measure: Severity of Pulmonary Exacerbations measure: Treatment of Pulmonary Exacerbations measure: Rate of Hospitalizations Due to Pulmonary Exacerbations measure: Clinic Visit Attendance measure: Microbiologic Profile measure: Medication use measure: History of CF-Related Diabetes Status measure: CF-Related Diabetes Control - Hemoglobin A1C measure: CF-Related Diabetes Control - Glucose Tolerance measure: CF-Related Diabetes Control - Insulin Prescription Usage measure: Liver Disease Status measure: Transplantation Status measure: Transplantation Type measure: BMI measure: Sleep Quality measure: Parental Stress measure: Life Stressors measure: Cystic Fibrosis Questionnaire to evaluate quality of life domains measure: Parental Responsibility measure: Daily Care Check-In measure: Social Support measure: Anxiety measure: Depression measure: Self-Reported Adherence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama-Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: George M Solomon, MD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 facility: National Jewish Health city: Denver state: Colorado zip: 80206 country: United States lat: 39.73915 lon: -104.9847 facility: Northwestern University city: Evanston state: Illinois zip: 60208 country: United States name: Manu Jain, MD role: PRINCIPAL_INVESTIGATOR lat: 42.04114 lon: -87.69006 facility: Indiana University city: Indianapolis state: Indiana zip: 46202 country: United States name: Cynthia Brown, MD role: PRINCIPAL_INVESTIGATOR lat: 39.76838 lon: -86.15804 facility: University of Kansas Medical Center city: Kansas City state: Kansas zip: 66160 country: United States name: Megan Behrman role: CONTACT email: mbehrman@kumc.edu name: Amanda Bruce, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.11417 lon: -94.62746 facility: Johns Hopkins University city: Baltimore state: Maryland zip: 21218 country: United States lat: 39.29038 lon: -76.61219 facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States lat: 42.35843 lon: -71.05977 facility: Boston Children's Hospital/Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States name: Jonathan Greenberg role: CONTACT email: jonathan.greenberg@childrens.harvard.edu name: Manuela Cernadas, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Shijing Jia, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: University of Minnesota city: Minneapolis state: Minnesota zip: 55455 country: United States lat: 44.97997 lon: -93.26384 facility: Washington University School of Medicine city: Saint Louis state: Missouri zip: 63110 country: United States name: Daniel Rosenbluth, MD role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: University of North Carolina city: Chapel Hill state: North Carolina zip: 27599 country: United States lat: 35.9132 lon: -79.05584 facility: Oregon Health and Science University city: Portland state: Oregon zip: 97239 country: United States name: Aaron Trimble, MD role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Denis Hadjiliadis, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: University of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15213 country: United States lat: 40.44062 lon: -79.99589 facility: Medical University of South Carolina city: Charleston state: South Carolina zip: 29425 country: United States name: Patrick Flume, MD role: PRINCIPAL_INVESTIGATOR lat: 32.77657 lon: -79.93092 facility: University of Texas-Southwestern city: Dallas state: Texas zip: 75390 country: United States lat: 32.78306 lon: -96.80667 facility: University of Washington city: Seattle state: Washington zip: 98195 country: United States lat: 47.60621 lon: -122.33207 hasResults: False
|
<|newrecord|> nctId: NCT06296381 id: 6.131.540 briefTitle: Normative Values for Peripheral Muscle Strenght in Critical Patients and Healthy Individuals acronym: HHD-ICU overallStatus: RECRUITING date: 2024-03-01 date: 2024-10-31 date: 2027-12-30 date: 2024-03-06 date: 2024-03-15 name: University of Pernambuco class: OTHER name: Universidade Federal de Pernambuco name: Conselho Nacional de Desenvolvimento Científico e Tecnológico briefSummary: Muscle strength is an important indicator of overall health and is a factor that has been associated with increased mortality in critical patients. Its measurement must be reliable and reproducible to ensure a quality outcome for clinical applicability. Recently, the use of digital handheld dynamometers in intensive care has gained support; however, analysis becomes challenging due to the absence of standardized reference equations for the Brazilian population. The aim of this study is to develop reference equations for the Brazilian population and define specific cutoff points for men, women, healthy individuals, and critical patients. conditions: Intensive Care Unit conditions: Muscle Strength studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 180 type: ESTIMATED measure: Peripheral muscle strength measured by hand held dynamometer measure: Peripheral muscle strength measured by Medical Research Council score measure: Peripheral muscle strength measured by hand grip dynamometer measure: Mobility in ICU measured by Perme Intensive Care Unit Mobility Score measure: Level of frailty in older adults by the Multidimensional Assessment of Older People (AMPI-AB) measure: Level of physical activity in young adults by the International Physical Activity Questionnaire - Short Form sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Federal University of Pernambuco (UFPE) status: RECRUITING city: Recife state: PE zip: 50740-600 country: Brazil name: Shirley Campos role: CONTACT phone: +5581999413087 email: shirley.campos@ufpe.br name: Pedro Vinicius Porfirio role: CONTACT phone: +5581993954400 email: pedro.porfirio@ufpe.br name: Lucas Rafael da Silva Fraga role: SUB_INVESTIGATOR lat: -8.05389 lon: -34.88111 facility: Hospital Otávio de Freitas status: NOT_YET_RECRUITING city: Recife state: PE zip: 50920-460 country: Brazil name: Shirley L Campos role: CONTACT phone: +5581999413087 email: shirley.campos@ufpe.br lat: -8.05389 lon: -34.88111 facility: Hospital Nossa Senhora das Graças status: RECRUITING city: Recife state: PE zip: 51030-020 country: Brazil name: Lidier Roberta Moraes Nogueira role: CONTACT phone: +5581995479644 email: lidierroberta@outlook.com name: Shirley L Campos role: CONTACT phone: +5581999413087 email: shirley.campos@ufpe.br name: Jose Douglas de Souza Cordeiro role: SUB_INVESTIGATOR lat: -8.05389 lon: -34.88111 hasResults: False
|
<|newrecord|> nctId: NCT06296368 id: LCCC2305 briefTitle: DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics acronym: DISCOVERY overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2029-04 date: 2024-03-06 date: 2024-03-06 name: UNC Lineberger Comprehensive Cancer Center class: OTHER briefSummary: The purpose of this study is to evaluate whether a novel decision support tool called PRIME (Preference Reporting to Improve Management and Experience), which combines values-elicitation with tailored feedback to patients and providers, improves patient-reported values-concordance of initial treatment decisions compared to usual care. conditions: Hematologic Malignancies conditions: Lymphoma conditions: Multiple Myeloma conditions: Leukemia conditions: Blood Cancers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 500 type: ESTIMATED name: Preference Reporting to Improve Management and Experience (PRIME) measure: Difference in COLLABORATE scores between arms measure: Difference in COLLABORATE scores between arms in a subgroup of patients sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lineberger Comphrehensive Cancer Center at University of North Carolina city: Chapel Hill state: North Carolina zip: 27516 country: United States name: Mireille L Leone role: CONTACT phone: 919-445-0768 email: mireille_leone@med.unc.edu name: Daniel R Richardson,, MD, MA, MSc role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False
|
<|newrecord|> nctId: NCT06296355 id: 24-0300d briefTitle: Impacts of Warning Labels on Ultra-Processed Foods overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2024-06-20 date: 2024-06-20 date: 2024-03-06 date: 2024-04-18 name: University of North Carolina, Chapel Hill class: OTHER name: Robert Wood Johnson Foundation briefSummary: Purpose: The overall purpose of this study is to identify the impacts of an ultra-processed (UPF) health warning label and UPF identify warning label compared to a control label (i.e., a barcode).
|
Participants: \~4,000 US Latino adults of parental age (18-55 years), approximately 50% of whom will have limited English proficiency, recruited from a Latino-focused panel company.
|
Procedures: Participants will be randomly assigned to view food products with one of three label types: health warning labels, identity labels, or barcode control labels. Participants will be asked a series of questions about the products and the label they were assigned. conditions: Health Behavior conditions: Diet, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 4000 type: ESTIMATED name: Health Warning Label name: Identity Warning Label name: Barcode Label measure: Identification of a product as ultra-processed measure: Perceived product healthfulness of ultra-processed products measure: Intentions to purchase ultra-processed products measure: Perceived message effectiveness sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: UNC Carolina Population Center city: Chapel Hill state: North Carolina zip: 27516 country: United States name: Violet Noe role: CONTACT email: violetn@email.unc.edu lat: 35.9132 lon: -79.05584 hasResults: False
|
<|newrecord|> nctId: NCT06296342 id: 24-0300c briefTitle: Message Framing and Policy Support for Front-of-package Labeling overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-03-31 date: 2024-03-31 date: 2024-03-06 date: 2024-03-06 name: University of North Carolina, Chapel Hill class: OTHER name: Duke University name: Stanford University briefSummary: This study aims to assess whether different message framing about front-of-package labeling policies elicits more policy support than the control (no framing) among Latino and limited English proficiency populations. The study also seeks to identify which message framing elicits the most policy support. conditions: Diet, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 4000 type: ESTIMATED name: Exposure to information framing message name: Exposure to healthier choices framing message name: Exposure to industry framing message measure: Support for the front-of-package labeling policy, proportion sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: The University of North Carolina at Chapel Hill's Gillings School of Global Public Health city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Marissa G Hall role: CONTACT phone: 919-445-1310 email: mghall@unc.edu lat: 35.9132 lon: -79.05584 hasResults: False
|
<|newrecord|> nctId: NCT06296329 id: 21C309 briefTitle: Rubber Hand Illusion in Anorexia Nervosa acronym: RHI_size_AN overallStatus: RECRUITING date: 2023-04-01 date: 2024-02-27 date: 2024-04-30 date: 2024-03-06 date: 2024-03-08 name: Istituto Auxologico Italiano class: OTHER name: University of Turin, Italy briefSummary: The present research project aims to verify a possible difference in the recalibration of the real hand position (i.e. proprioceptive drift) in relation to the dimensions of the plastic hand in the Rubber Hand Illusion, among a group of female participants with anorexia nervosa compared with a normal weight control group. conditions: Anorexia Nervosa studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 28 type: ESTIMATED name: Rubber Hand Illusion measure: Proprioceptive drift in centimeters measure: Score at the Embodiment questionnaires sex: FEMALE minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe status: RECRUITING city: Piancavallo state: VCO zip: 28824 country: Italy name: Federica Scarpina, PhD role: CONTACT phone: +39032351 phoneExt: 4003 email: f.scarpina@auxologico.it hasResults: False
|
<|newrecord|> nctId: NCT06296316 id: IU022 briefTitle: Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair acronym: REPAIR overallStatus: RECRUITING date: 2023-11-21 date: 2031-12 date: 2031-12 date: 2024-03-06 date: 2024-03-06 name: Coloplast A/S class: INDUSTRY name: International Clinical Trials Association briefSummary: The purpose of this study is to prospectively follow patients after a sacrocolpopexy with Restorelle® mesh for apical prolapse repair as part of routine care. It will help to describe the safety profile and to confirm the clinical benefits of Restorelle mesh for at least 5 to 8 years post-surgery. conditions: Genital Prolapse studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 428 type: ESTIMATED name: Restorelle Polypropylene Mesh measure: The incidence rate of a surgical reintervention related to Restorelle mesh use over at least the 5 first years of post-index procedure follow-up measure: Incidence rate of surgical reintervention related to Restorelle mesh use in patients measure: Number of patients who have only had surgical reintervention not related to Restorelle mesh use measure: Percentage of patients who have only had surgical reintervention not related to Restorelle mesh use measure: Number of patients who have had more than 1 surgical reintervention (unrelated to mesh use) measure: Percentage of patients who have had more than 1 surgical reintervention (unrelated to mesh use) measure: Description of patients who have had more than 1 surgical reintervention (unrelated to mesh use) measure: Patient impression of improvement of surgical reintervention assessed by the PGI-I-Reintervention measure: Number of Adverse Device Effect measure: Percentage of Adverse Device Effect measure: Number of Restorelle mesh Device Deficiencies measure: Percentage of Restorelle mesh Device Deficiencies measure: Description of Restorelle mesh Device Deficiencies measure: Monitoring of postoperative pain related to Restorelle mesh use using the modified TOMUS/PREM questionnaire measure: Changes of prolapse symptoms measure: Prolapse symptoms - number measure: Prolapse symptoms - percentage measure: Assessment of health related quality of life using the EQ-5D-5L questionnaire measure: Assessment of health related quality of life using the PFIQ-7 questionnaire measure: Assessment of the sexual functioning by the PISQ-IR questionnaire measure: Assessment of the sexual functioning by the changes in dyspareunia status of patients who are sexually active. measure: Number of patients defining success via patient global impression of improvement (PGI-I) scale measure: Percentage of patients defining success via patient global impression of improvement (PGI-I) scale measure: Number of patients satisfied after the index procedure as assessed by the Surgical Satisfaction Questionnaire (SSQ-8). measure: Percentage of patients satisfied after the index procedure as assessed by the Surgical Satisfaction Questionnaire (SSQ-8) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Polyclinique de la Baie status: NOT_YET_RECRUITING city: Avranches state: Choisir Une Région zip: 50300 country: France name: Frédéric Dubois, Dr role: CONTACT name: Frédéric Dubois, Dr role: PRINCIPAL_INVESTIGATOR lat: 48.68333 lon: -1.36667 facility: Centre Aliénor d'Aquitaine status: NOT_YET_RECRUITING city: Bordeaux zip: 33076 country: France name: Claude Hocké, Pr role: CONTACT name: Claude Hocké, Pr role: PRINCIPAL_INVESTIGATOR lat: 44.84044 lon: -0.5805 facility: CHU Pellegrin status: NOT_YET_RECRUITING city: Bordeaux zip: 33076 country: France name: Grégoire Capon, Dr role: CONTACT name: Grégoire Capon, Dr role: PRINCIPAL_INVESTIGATOR lat: 44.84044 lon: -0.5805 facility: CH Paul Ardier d'Issoire status: NOT_YET_RECRUITING city: Issoire zip: 63500 country: France name: Clément Bruhat, Dr role: CONTACT name: Clément Bruhat, Dr role: PRINCIPAL_INVESTIGATOR name: Aslam Mansoor, Dr role: PRINCIPAL_INVESTIGATOR lat: 45.55 lon: 3.25 facility: CH La Rochelle status: RECRUITING city: La Rochelle zip: 17019 country: France name: Philippe Ferry, Dr role: CONTACT name: Philippe Ferry, Dr role: PRINCIPAL_INVESTIGATOR name: Yannick Thirouard, Dr role: PRINCIPAL_INVESTIGATOR lat: 46.16667 lon: -1.15 facility: Clinique Bon Secours status: RECRUITING city: Le Puy-en-Velay zip: 43000 country: France name: Jacques Philippe Largeron, Dr role: CONTACT name: Jacques Philippe Largeron, Dr role: PRINCIPAL_INVESTIGATOR name: Marlène Guandalino, Dr role: PRINCIPAL_INVESTIGATOR lat: 45.04366 lon: 3.88523 facility: CH Général Robert Boulin status: NOT_YET_RECRUITING city: Libourne zip: 33505 country: France name: Michel Briex, Dr role: CONTACT name: Michel Briex, Dr role: PRINCIPAL_INVESTIGATOR lat: 44.91667 lon: -0.23333 facility: Institut Mutualiste Montsouris status: NOT_YET_RECRUITING city: Paris zip: 75014 country: France name: Isabelle Sauret role: CONTACT name: Christine Louis Sylvestre, Dr role: PRINCIPAL_INVESTIGATOR name: Yael Levy Zauberman, Dr role: PRINCIPAL_INVESTIGATOR name: Camille Baraud, Dr role: PRINCIPAL_INVESTIGATOR name: Mathilde Allanche, Dr role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: CH privé Saint Grégoire status: NOT_YET_RECRUITING city: Saint-Grégoire zip: 35760 country: France name: Frédéric Dubois, Dr role: CONTACT name: Frédéric Dubois, Dr role: PRINCIPAL_INVESTIGATOR lat: 48.15085 lon: -1.68706 facility: CH de Saintonge status: NOT_YET_RECRUITING city: Saintes zip: 17108 country: France name: Damien Emeriau, Dr role: CONTACT name: Damien Emeriau, Dr role: PRINCIPAL_INVESTIGATOR lat: 45.75 lon: -0.63333 hasResults: False
|
<|newrecord|> nctId: NCT06296303 id: MBH24 briefTitle: Effect of Pulsed Magnetic Therapy Versus Phonophoresis in Discogenic Lumbar Radiculopathy Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-03 date: 2024-06-30 date: 2024-06-30 date: 2024-03-06 date: 2024-03-06 name: Cairo University class: OTHER briefSummary: Purposes of the study
|
To investigate the effect of pulsed magnetic therapy versus phonophoresis in discogenic lumbar radiculopathy patients conditions: Lumbar Radiculopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Pulsed electromagnetic therapy name: Ultrasound phonophoresis name: Conventional physical therapy measure: Pain measure: Disability measure: Sciatic nerve cross sectional area measure: H-reflex amplitude measure: H-reflex side-to-side amplitude (H/H) ratio sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
|
<|newrecord|> nctId: NCT06296290 id: CARDIOCOLD briefTitle: Impact of Prolonged Cold-water Swimming on Heart Rate and Cardiac Function acronym: CARDIOCOLD overallStatus: COMPLETED date: 2022-06-04 date: 2022-06-06 date: 2022-08-15 date: 2024-03-06 date: 2024-03-06 name: University Hospital, Caen class: OTHER name: INSERM UMR U1075 Comète GIP Cyceron, unicaen, Caen Normandie briefSummary: A significant medical risk associated with hypothermia during exercise in a cold environment cardiac arrhythmia due to a possible autonomic conflict. However, little is known about the changes in heart rate and cardiac function after prolonged cold water swimming.
|
The investigators propose to measure the changes in core temperarure during and after a cold water swim at at a water temperature below 15.5°C qualifying for English Channel swim and to test the association with changes in heart rate variability, resting electrocardiogram and left ventricle function. conditions: Hypothermia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ACTUAL measure: Heart rate from a resting ECG recording measure: Heart rate from a 5-minute ECG recording measure: Transthoracic echocardiography (TTE) analysis measure: Change in Body Core Temperature measure: Body composition, body fat mass measure: Body composition, fat-free mass measure: Duration measure: Individual characteristics, gender measure: Individual characteristics, age measure: Individual characteristics, training in cold environment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Caen Normandie city: Caen zip: 14000 country: France lat: 49.18585 lon: -0.35912 hasResults: False
|
<|newrecord|> nctId: NCT06296277 id: UPO#1! briefTitle: Mechanical Ventilation in Surgical Patients acronym: MEET VENUS overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-10-31 date: 2025-03-31 date: 2024-03-06 date: 2024-03-18 name: Azienda Ospedaliero Universitaria Maggiore della Carita class: OTHER name: University Of Perugia name: University of Chieti name: Medical University of Vienna name: The Netherlands Cancer Institute name: Monash University briefSummary: This is an investigator-initiated, international, multicenter, prospective, cross-sectional study that aims to 1) describe the incidence and types of postoperative pulmonary complications (PPCs), 2) describe patient demographics, baseline characteristics, and intraoperative ventilation management, 3) describe the occurrence of intraoperative adverse events (IAEs), and 4) their associations with PPCs, 5) assess the practice of intraoperative mechanical ventilation.
|
Patients will be eligible for participation if: 1) adult and 2) receiving intraoperative ventilation during general anesthesia for surgery. Patients receiving ventilation outside of an operating room as well as patients receiving intraoperative ventilation during extracorporeal life support will be excluded conditions: Surgery conditions: Ventilator Lung conditions: Postoperative Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10000 type: ESTIMATED name: Intraoperative mechanical ventilation for surgery measure: Postoperative pulmonary complications (PPCs) measure: Intraoperative adverse events (IAEs) measure: Intraoperative mechanical ventilation practice measure: Postoperative clinical outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06296264 id: ULTRACATHLON briefTitle: Ultra-portable Ultrasound vs. Standard Ultrasound to Help Place a Peripheral Catheter in Patients at Risk of Difficult Puncture overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-09 date: 2024-03-06 date: 2024-03-06 name: Centre Hospitalier Saint Joseph Saint Luc de Lyon class: OTHER briefSummary: The placement of an intravenous (IV) line is a common procedure when treating adult patients in critical care, in the emergency room or in the operating room. This simple and minimally invasive procedure can sometimes be made difficult depending on the patient's morphology or their clinical condition. The procedure then becomes time-consuming, anxiety-provoking, painful and its success is uncertain.
|
The placement of intravenous (IV) lines under ultrasound by nurses is a rapidly developing alternative in intensive care, emergencies and the operating room. conditions: IV Line Placement With Ultrasound studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 250 type: ESTIMATED name: Standard ultrasound name: Ultra-portable ultrasound measure: Intravenous (IV) line placement time measure: Placement of the IV line successfully obtained from the first puncture measure: Number of skin perforations measure: Overall success rate after 3 punctures measure: Use an alternative solution (central catheter) measure: Patient satisfaction with IV line placement measure: Nurse satisfaction with IV line placement measure: Immediate complications related to intravenous access measure: Delayed complications related to intravenous access measure: Date of IV line placement and removal sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Saint Joseph Saint Luc Hospital city: Lyon state: Rhone-alpes zip: 69007 country: France name: Emmanuel VIVIER, MD role: CONTACT phone: 0033478618209 email: evivier@saintjosephsaintluc.fr name: Fanny DOROSZEWSKI, Mrs role: CONTACT phone: 0033478618398 email: fdoroszewski@saintjosephsaintluc.fr name: Emmanuel VIVIER, MD role: PRINCIPAL_INVESTIGATOR name: Raphaël STREIFF, MD role: SUB_INVESTIGATOR name: Guillaume MARCOTTE, MD role: SUB_INVESTIGATOR lat: 45.74848 lon: 4.84669 hasResults: False
|
<|newrecord|> nctId: NCT06296251 id: BIO-2313 briefTitle: Dietary Supplementation on Body Fat Composition overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-12-27 date: 2025-02-27 date: 2024-03-06 date: 2024-04-01 name: Brightseed class: INDUSTRY briefSummary: The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels in otherwise generally healthy adults with risk factors (high BMI at dyslipidemia and/or pre-diabetes) for body fat composition. The primary hypothesis is that supplementation with plant derived phenolics will decrease body fat composition compared to placebo. conditions: Dyslipidemias conditions: Pre-diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 150 type: ESTIMATED name: Placebo treatment name: Plant derived phenolics measure: Body fat mass measure: Body composition measure: Android fat mass measure: Gynoid fat mass measure: Abdominal visceral fat mass measure: Abdominal circumference measure: Hip circumference measure: Chest circumference measure: Upper thigh circumference measure: Upper arm circumference measure: Waist to hip ratio measure: Fasting glucose measure: Fasting insulin measure: HbA1c measure: FGF21 measure: Systolic blood pressure measure: Diastolic blood pressure measure: Total-Cholesterol measure: HDL-C measure: LDL-C measure: VLDL-C measure: non-HDL-C measure: Triglycerides measure: Body Weight measure: Physical functioning measure: Bodily pain measure: Role limitations due to physical health measure: Role limitation due to personal or emotional problems measure: Emotional well-being measure: Social functioning measure: Energy/Fatigue measure: General health perceptions measure: Total kcals measure: Total fat measure: Total protein measure: Total carbohydrates measure: Fiber measure: Healthy Eating Index (HEI) score measure: ALT measure: AST sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.