pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Clinical Trial Protocol for the Combined Use of VAG in the Treatment of ND-AML
NCT Number: NCT06536010
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Myeloid Leukemia
Interventions: DRUG: Venetoclax 100 mg d1，200 mg d2，400 mg d3-28；
Sponsor: Yang Xiaotian
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-11-03
Completion Date: 2028-07-31
Locations: Huai'an Second People's Hospital, Huai'an, Jiangsu, 210000, China

Summary:
This is a clinical efficacy study evaluating the VAG regimen in the treatment of newly diagnosed acute myeloid leukemia (AML).

The main objectives of the study are to assess the efficacy and safety of the VAG regimen and to explore the synergistic mechanisms of VAG in combating AML.

Primary Outcome Measures: Complete Remission (CR), A. No symptoms or signs of leukemia cell infiltration, normal or near-normal life; B. Blood counts: Hb ≥ 100g/L (males) or ≥ 90g/L (females and children), absolute neutrophil count ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L. No leukemia cells in peripheral blood leukocyte classification; C. Bone marrow morphology: Less than or equal to 5% of myeloblasts (type I + type II) (primitive monocytes + immature monocytes or primitive lymphocytes + immature lymphocytes), normal red blood cells and megakaryocytes; D. No extramedullary leukemia (no lymphadenopathy, splenomegaly, skin/gum infiltration, testicular masses, central nervous system involvement)., The period of 2 months from the start of treatment.
Secondary Outcome Measures: Partial Remission (PR), Myeloblasts (type I + type II) (primitive monocytes + immature monocytes or primitive lymphocytes + immature lymphocytes) \> 5% but ≤ 20%; or one of the following criteria is met in clinical, blood counts, and bone marrow morphology for complete remission., The period of 1 month from the start of treatment.|Complete Remission with incomplete blood count recovery (CRi), PLT \< 100 × 109/L or NE \< 1.5 × 109/L. Other criteria for CR should be met., The period of 1 month from the start of treatment.|Overall Response Rate (ORR), CR+CRi+MLFS+PR, The period of 4 months from the start of treatment.|Morphologic leukemia-free state (MLFS), \< 5% of primitive cells in bone marrow; no immature cells with Auer rods; no persistent extramedullary leukemia; no requirement for normal blood cell recovery., The period of 1 month from the start of treatment.|Overall survival, OS, The time from the start of treatment to death or the end of follow-up, evaluated at 2 years after treatment., The period of 2 years from the start of treatment.
The Effect of White Noise and Swaddling on Pain, Heart Rate, and Oxygen Saturation in Term İnfants Undergoing Eye Examinations
NCT Number: NCT06535984
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain
Interventions: OTHER: White Noise|OTHER: Swaddling|OTHER: White Noise+Swaddling
Sponsor: Tokat Gaziosmanpasa University
Collaborators: Ankara Bilkent City Hospital, University of Health Sciences
Sex: ALL
Age: CHILD
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-10-24
Completion Date: 2023-05-15
Locations: Sultan Güner Başara, Tokat, Erbaa, Turkey

Summary:
Eye examinations for vision screening in infants cause pain and stress. Aim: To evaluate the effect of white noise and swaddling on pain, heart rate, and oxygen saturation in term infants undergoing post-discharge eye examinations. This study was conducted with term infants born 30-36 days postpartum who visited the ophthalmologic outpatient clinic for eye screening. A total of 120 term infants were included in the sample, divided into three intervention groups: the white noise group (n=30), the swaddling group (n=30), and the white noise + swaddling group (n=30), along with a control group (n=30). Data were collected by the clinic nurse before the eye examination, 30 seconds into the examination, and at the end of the examination. The Premature Infant Pain Profile (PIPP) scale and pulse oximetry were used for data collection.There was no statistically significant difference in pain scores, heart rates, or oxygen saturation (SpO2) between the intervention and control groups (p\>0.05). In all groups, pain scores and heart rates were higher, and SpO2 values were lower after the ophthalmologic examination than before the examination (p\<0.001).Swaddling + white noise, white noise, and swaddling during the eye examination procedure did not affect reducing infants' pain or improving heart rate and oxygen saturation values.

Primary Outcome Measures: The Premature Infant Pain Profile total pain score, The Premature Infant Pain Profile (PIPP); The scale assesses seven items: gestational age, behavioral status, highest heart rate, lowest oxygen saturation value, forehead wrinkling, squinting, and widening of the wings of the nose. Each item is scored from 0 to 3 (from good to bad), with higher scores indicating greater pain. The total PIPP score ranges from 0 to 21, where 0-6 points indicate mild pain, 7-12 points indicate moderate pain, and 13-21 points indicate severe pain, Eye examination beginning and end (approximately 1-1.5 minutes)|heart rate value, Eye examination beginning and end (approximately 1-1.5 minutes)|oxygen saturation value, Eye examination beginning and end (approximately 1-1.5 minutes)
Individualized Exercise Combined With Manual Therapy in Severe Hemophilia Patients With Polyarthropathy
NCT Number: NCT06535971
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Severe Hemophilia
Interventions: OTHER: Manual therapy combined exercise
Sponsor: Far Eastern Memorial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-05
Completion Date: 2025-01-31
Locations: Far Eastern Memorial hospital, New Taipei City, 220, Taiwan

Summary:
The aim of this study is to investigate the effect of individualized physical therapy, combined manual therapy and exercise intervention, for pain perception, range of motion (ROM), muscle strength, joint health, cardiopulmonary endurance and quality of life (QoL) in patients with severe hemophilia A and multiple hemophilic arthropathy.

Primary Outcome Measures: Hemophilia Joint Health Score (HJHS), To measure joint health, in the domain of body structure and function (i.e. impairment), of the joints most commonly affected by bleeding in hemophilia: the knees, ankles, and elbows. It provides a total score (higher score is worse; max=124), joint specific scores, and a global gait score., before intervention (baseline), after intervention 6th week and 12th week|Visual Analogue Scale (VAS), To assess the target joint pain in hemophilia. The minimum value is 0, and the maximum value is 10 (higher score is worse)., before intervention (baseline), after intervention 6th week and 12th week|6 minute walk test, To evaluate cardiopulmonary endurance. The predictive equation for males: 6MWD(m) = 867 - (5.71 age, yrs) + (1.03 height, cm). The predictive equation for females: 6MWD(m) = 525 - (2.86 age, yrs) + (2.71 height, cm) - (6.22BMI)., before intervention (baseline), after intervention 6th week and 12th week|Hemophilia Activity List (HAL), To measure the impact of hemophilia on self-perceived functional abilities in adults.Normalized scores for the domains, components, and the full questionnaire can also be obtained. Missing values are controlled for and the possible scores range from 0 to 100, where 0 represents the worst possible functional status and 100 the best possible functional status., before intervention (baseline), after intervention 6th week and 12th week|EQ-5D-5L, To measure the quality of life. Each dimension now has five response levels:

no problems (1), slight problems (2), moderate problems (3), severe problems (4), unable to/extreme problems (5). The minimum value is 55555 and the maximum value is 11111 (higher score is worse).

EQ VAS：the minimum score is 0, and the maximum score is 100 (higher score is better)., before intervention (baseline), after intervention 6th week and 12th week
Secondary Outcome Measures: Daily notes, record each intervention, such as manual therapy and exercise, once a week (each intervention) for 3 months
Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation
NCT Number: NCT06535945
Acronym: HALT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Liver Transplantation|Acute Kidney Injury
Interventions: DRUG: Albumin administration
Sponsor: Rennes University Hospital
Collaborators: Ministry of Health, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2028-06-30
Locations: 08_CHRU de Tours Hôpital Trousseau, Chambray-les-tours, 37170, France|03_APHP Hôpital Beaujon, Clichy, 92110, France|04_CHU de Lille Hôpital Huriez, Lille, 59000, France|05_HCL Hôpital de la Croix Rousse, Lyon, 69004, France|06_CHU de Montpellier Hôpital St Eloi, Montpellier, 34295, France|07_APHP Hôpital La Pitié Salpêtrière, Paris, 75651, France|02_CHU de Bordeaux - Hôpital Haut Leveque, Pessac, 33604, France|01_CHU de Rennes Hôpital Pontchaillou, Rennes, 35000, France|09_APHP Hôpital Paul Brousse, Villejuif, 94804, France

Summary:
To verify whether albumin administration to achieve serum concentration above 30g/L (treated group) and its maintenance within plasmatic physiologic range (=30 g/L) for five days diminishes rate of AKI at Day 7 after liver transplantation as compared to restrained albumin administration (when serum concentration is at 20 g/L or below (control)).

Primary Outcome Measures: Acute Kindey Injury at Day 7, To verify whether albumin administration to achieve serum concentration above 30g/L (treated group) and its maintenance within plasmatic physiologic range (=30 g/L) for five days diminishes rate of Acute Kindey Injury at Day 7 after liver transplantation as compared to restrained albumin administration (when serum concentration is at 20 g/L or below (control))., 7 days after liver transplantation
Secondary Outcome Measures: Occurrence and Severity of each Acute Kindey Injury during the first 7 days after liver transplantation, Occurrence and Severity of each Acute Kindey Injury during the first 7 days after liver transplantation, 7 days after liver transplantation|hospital length of stay, hospital length of stay, 28 days|occurrence of calcineurin inhibitor induced neurotoxicity, occurrence of calcineurin inhibitor induced neurotoxicity, 28 days|occurence of calcineurin inhibitor withdraw, occurence of calcineurin inhibitor withdraw, 28 days|occurrence of postoperative infections, occurrence of postoperative infections, 28 days|occurrence of acute graft rejection, occurrence of acute graft rejection, 28 days|occurrence of early graft dysfunction, occurrence of early graft dysfunction, 28 days|duration of mechanical ventilation, duration of mechanical ventilation, 28 days|reintubation rate, reintubation rate, 28 days|Intensive Care Unit length of stay, Intensive Care Unit length of stay, 28 days|Intensive Care Unit readmission rate, Intensive Care Unit readmission rate, 28 days|All cause mortality, All cause mortality, 28 days
Amara View Benchmarks Study
NCT Number: NCT06535932
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep Apnea Syndromes
Interventions: DEVICE: Amara View Minimal Contact Full Face Mask|DEVICE: F40 Minimal Contact Full Face Mask
Sponsor: Philips Clinical & Medical Affairs Global
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2024-09
Locations: Clayton Sleep Institute, Saint Louis, Missouri, 63123, United States

Summary:
This randomized crossover, benchmark clinical trial aims to compare the Philips Amara View and ResMed AirFit F40 minimal contact full face masks on patient preference of mask attributes and usage parameters. At the first study visit participants will be fitted with either the Amara View or the AirFit F40. The order in which participants will use the masks will be randomized. After the fitting and completion of informed consent, eligibility, and baseline questionnaires, participants will take home the first mask and use it with their prescribed PAP device for 15-days. After the first 15-day time period participants will return for their second visit. At this visit participants will return the first mask to the study team and complete a survey on the mask attributes. They will then be fitted with the second study mask and will be given the mask to take home and use with their prescribed PAP device for 15-days. At the end of the second 15-day trial period, participants will return for the third study visit. At this visit they will return the second mask and complete a mask attributes survey on the second mask.

Primary Outcome Measures: Patient preference on Mask Attributes, Comparison in satisfaction ratings between the Amara View and the AirFit F40 on mask attributes including:

bed partner satisfaction, fit, comfort, ability to maintain a seal during use, stability of the mask, noise level, air venting, comfort of breathing, sleep quality, visual appeal, and overall satisfaction., up to 35 days|Difference in Ease of Use, Differences in ease of use and satisfaction ratings between the Amara View and the AirFit F40 on the following parameters: mask clips, mask overall, assembly, disassembly., up to 35 days|Difference in Net Promotor Score, Difference in the Net Promotor Score between the Amara View and AirFit F40., Up to 35 days|Patient Preference, Proportion of patients who prefer the Amara View compared to the AirFit F40 for the following: seal, comfort, stability, noise level, headgear, mask cushion ease of use, less disruptive air venting, and overall preference., Up to 35 days
Secondary Outcome Measures: Leak, Comparison of leak values between the Amara View and F40., up to 35 days|Residual AHI, Comparison of residual AHI between the Amara View and F40., up to 35 days|Air Pressure, Air pressure (cmH20) used during PAP therapy while using the Amara View and AirFit F40 masks., up to 35 days|Adherence to PAP Therapy, Daily hours of use of PAP therapy while using the Amara View and AirFit F40 masks., up to 35 days
Substance Use Treatment and Its Role in Supporting Social Cognition
NCT Number: NCT06535919
Acronym: SUE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Substance Use|Empathy
Interventions: BEHAVIORAL: Treatment as Usual
Sponsor: Nova Southeastern University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 108
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2026-01

Summary:
This study aims to assess changes in empathy levels before and after residential treatment among individuals with substance use disorders.

Primary Outcome Measures: empathy, gain in empathy, pre to post treatment and 2 month post treatment follow-up (6 months total)
Secondary Outcome Measures: differences in empathy gains by sex, male and female, pre and post treatment, 2 month post treatment follow-up (6 months total)
Other Outcome Measures: Substance Use, measure correlation of gains in empathy with substance use, 2 months post treatment follow-up|Social Support, measure perceived quality of social support, pre and post treatment as well as 2 month post treatment follow-up|Therapeutic Alliance, measure perceived quality of therapeutic relationship from client and therapist perspective, beginning of treatment, and at treatment pre-discharge
Sustainable and Efficient Platform Trial of New Therapeutic Development for Early Breast Cancer
NCT Number: NCT06535893
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Breast Cancer
Interventions: DRUG: TN|DRUG: TN-1
Sponsor: Nagoya City University
Collaborators: Japan Clinical Oncology Group
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-24
Completion Date: 2040-06-30
Locations: Nagoya City University, Nagoya, Aichi, 467-8601, Japan

Summary:
Randomized phase II trial targeting early-stage breast cancer (stage II-III) applicable to preoperative chemotherapy (NAC), comparing standard treatment with multiple experimental treatments.

Primary Outcome Measures: pathological complete response (pCR), pCR is defined as the absence of invasive cancer in the breast and sampled regional lymph nodes., Baseline to surgery|ctDNA clearance rate, ctDNA test was performed by Natera, Before Neoadjuvant chemotherapy to surgery
Trigeminal Brainstem Mapping 2: Higher Cortical Strucureas as Well as Subnuclei of the Spinal Trigeminal Nucleus
NCT Number: NCT06535880
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Trigeminal Pain, Headache Disorders, Migraine
Interventions: DEVICE: Electric Current Stimulation
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-01
Completion Date: 2027-12-31
Locations: University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany

Summary:
In previous studies we showed clustering of the three branches of the trigeminal nerve in brainstem, cerebellum and periaqueductal gray. To further evaluate higher cortical structures, which were not covered by our previous field of view (FOV) and to further investigate the identified 'subnuclei' of the spinal trigeminal nucleus, we aim to scan the whole brain as well as the brainstem and the upper spinal cord during trigeminal nociceptive as well as non-nociceptive electrical stimulation of all three branches of the trigeminal nerve (and the arm as a somatic control site) during acquisition of BOLD-fMRI in humans.

Primary Outcome Measures: Statistical Parametric Maps calculated from the fMRI data on brainstem level, At an small volume corrected threshold of p\<0.05 we will reproduce activation of all previously shown subnuclei of the spinal trigeminal nucleus for all three trigeminal branches using a sphere of 10 mm around previously published (Mehnert et al, 2023) MNI coordinates., only 1 visit|Statistical Parametric Maps calculated from the fMRI data of higher cortical brain structures, Anterior and posterior insula, the cingulate cortex and S1/S2 will show significant activation at an small-volume corrected threshold of p\<0.05, only 1 visit
Secondary Outcome Measures: Functional connectivty between insula and spinal trigeminal cortex, For each of the trigeminal subnuclei we will calculate the functional connectivity to higher cortical areas, such as the anterior and posterior insula, the cingulate cortex and S1/S2 with a psycho-physiological interaction analysis (PPI) for painful as well as non-painful stimulation to characterize the function of each subnucleus., only 1 visit
The Efficacy of Conventional Screening Versus mHealth Screening in Early Detection of Oral Potentially Malignant Disorders and Oral Cancer Amongst the Rural Population of Varanasi: A Prospective and Blinded Study
NCT Number: NCT06535867
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Smoking|Smoking, Cigarette|Smoking, Tobacco|Betel Chewer's Mucosa|Tobacco Use|Tobacco Smoking|Alcohol Drinking|Smokeless Tobacco Hyperkeratosis
Interventions: DIAGNOSTIC_TEST: mHealth
Sponsor: Memorial Sloan Kettering Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5122
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-30
Completion Date: 2031-07-30
Locations: Memorial Sloan Kettering Cancer Center (All protocol activites), New York, New York, 10065, United States

Summary:
Mobile health (mHealth) will be used for early detection of oral cancer and pre-cancer lesions, and to improve awareness of oral cancer among the population and knowledge of oral cancer diagnosis among frontline health providers. This program is inclusive of long term surveillance to downstage oral cancer in India

Primary Outcome Measures: Comparison of mHealth with conventional oral cancer screening, To compare the efficacy of conventional screening with mHealth in identification of oral potentially malignant disorders (OPMDs) / oral cancer., Up to 5 years
AIM4 AI and Mechanistic Modeling in Molecular Medicine
NCT Number: NCT06535828
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Molecular Medicine
Interventions: DEVICE: AI and mechanic modeling
Sponsor: M.D. Anderson Cancer Center
Collaborators: Phase One Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-30
Completion Date: 2027-11-30
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
To assess for potential pitfalls and to assess the feasibility of the approach of analysis of new tumor biopsies for selection of standard of care treatment selection in patients with metastatic hormone receptor positive breast cancer who have developed disease progression on 1st line endocrine therapy combined with a CDK4/6 inhibitor.

Primary Outcome Measures: Safety and adverse events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year.
KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting
NCT Number: NCT06535815
Acronym: KetoNiFast
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nutrition|Muscle Loss|Inflammatory Response
Interventions: OTHER: Cyclic enteral feeding with nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)
Sponsor: University Hospital of Cologne
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-09-01
Completion Date: 2026-03-01
Locations: Department of Anesthesiology and Intensive Care Medicine, Cologne, NRW, 50937, Germany

Summary:
A physiological human nutrition includes circadian feeding and nighttime fasting during sleep. There is increasing evidence, that this natural fasting episode over nighttime majorly contributes to repair processes of the human body. So far, intensive care patients are normally enterally fed continuously, so that there is no circadian nutrition and no nighttime fasting. An enteral nutrition for 12 hours followed by a fasting period of 12 hours supported by exogenous ketone salts potentially improves the reconstitution of ICU patients compared to ICU patients who are continuously enterally fed.

Primary Outcome Measures: Loss of muscle mass, Loss of muscle mass via Ultrasound of M. rectus femoris of a predefined leg, From date of randomization until the date of ICU discharge up to 1 month|Progress of urea / creatinine ratio, Urea / creatinine ratio in the patients´ blood, From date of randomization until the date of ICU discharge up to 1 month
Secondary Outcome Measures: Length of invasive and noninvasive ventilation, Length of invasive and noninvasive ventilation, From date of randomization until the date of ICU discharge up to 1 month|Length of ICU and hospital stay, Length of ICU and hospital stay, From date of randomization until the date of hospital discharge up to 6 months|30 day mortality on day 30, 30 day mortality on day 30, From date of randomization 30 days|ICU mobility scale on discharge, ICU mobility scale (lowest score 0, highest score 10), From date of randomization until the date of ICU discharge up to 1 month
iCCaRE Consortium Pilot Project 1: Feasibility of a Point of Prostate Cancer Diagnosis Intervention for Newly Diagnosed Black Men
NCT Number: NCT06535802
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Carcinoma
Interventions: OTHER: Non-Interventional Study
Sponsor: Mayo Clinic
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-20
Completion Date: 2026-12-01
Locations: Mayo Clinic in Florida, Jacksonville, Florida, 32224-9980, United States

Summary:
This study is being done to determine the acceptance and effectiveness of a virtual robot assistant model at a urology clinic.

Primary Outcome Measures: Point of Prostate Cancer Diagnosis (PPCD) iCCaRE Virtual Robot Assistant (ViRA) model, Will be assessed by the length of time needed to create the model. PPCD iCCaRE ViRA model development will be guided by the Translational Research \& Clinical Intervention Services (TRaCIS) and Digital Health \& Human Services (DHHS) core sections of the Inclusive Cancer Care Research Equity (iCCaRE) Consortium. This application (app) will be evaluated in Outcomes 2 and 3. The PPCD iCCaRE ViRA app will provide social determinants of health (SDOH) navigation services, psycho-oncology support and emotional support using qualitative formative research., Up to 4 months|Acceptance of the iCCaRE Virtual Robot Assistant (ViRA), Will be assessed by patient immediate reaction and patient delayed feedback., Baseline; follow-up interview 3-4 months post visit|Usability of the iCCaRE ViRA, Will be assessed by patient immediate reaction and patient delayed feedback., Baseline; follow-up interview 3-4 months post visit
Impact and Influence of the Use of Hypnosis Adapted to People With Severe Stage Neurocognitive Disorder (HAPNeSS) on the Professional Practices of EHPAD (Establishment for Dependent Elderly People) Caregivers With Elderly Residents
NCT Number: NCT06535763
Acronym: HAPNeSS-E
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Alzheimer Disease|Behavior Disorders
Interventions: OTHER: professional caregiver
Sponsor: University Hospital, Bordeaux
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-03
Locations: Chu de Bordeaux, Pessac, France

Summary:
The aim of this study is to propose a non-anxiety-inducing method of managing behavioral disorders for patients and healthcare professionals. The main objective of this study is to evaluate the implementation, use and effects of HAPNeSS (Hypnosis Adapted to People with Severe Neurocognitive Disorders) training on the management of residents aged over 75 with moderately severe to severe Alzheimer's disease or a related disorder, who may present behavioral disorders, with caregivers working in EHPAD.

Primary Outcome Measures: Impact of HAPNeSS on the management of work situations involving behavioral disorders., Number of work situations which the carer feels he/she has had difficulty managing, involving a resident with a neurocognitive disorder and behavioural problems., Month 2 and month 6
Secondary Outcome Measures: Effects of HAPNeSS method to professional practices, Scale QENA, minimum value 69 and maximum value 276. Analysis of feelings and impressions of professionals will be obtained from the analysis of the semi-directed interviews (qualitative analysis)., Month 2 and month 6
Comparison Of The Effects Of Conventional Physiotherapy And Strengthening Exercises With Rotator Cuff Syndrome
NCT Number: NCT06535750
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rotator Cuff Syndrome|Physiotherapy
Interventions: OTHER: Exercise
Sponsor: University of Beykent
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2024-06-22
Locations: Physical Therapy and Rehabilitation Clinic of Istanbul Health Sciences University Kanuni Sultan Süleyman Training and Research Hospital, Istanbul, Küçükçekmece, 34303, Turkey

Summary:
Various options are available for the treatment of rotator cuff syndrome, including conservative and surgical. Conservative treatment methods include activity modification, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections (CSIs), and physiotherapy. Physiotherapy methods include various interventions such as manual therapy, exercise, and electrotherapy. Although these treatments do not directly treat the specific pathology, they help correct rotator cuff and scapular muscle weakness and dysfunction, reduce the tightness of the posterior capsule and other soft tissues, and relieve pain and dysfunction. It focuses on correcting the postural abnormalities that contribute to the disease.

In our study, the investigators aimed to determine the effects of rehabilitation components in the conservative treatment of patients with rotator cuff syndrome and to determine the effects of strengthening exercises on the functional status of the patients.

Primary Outcome Measures: Disability Questionnaire for Arm, Shoulder and Hand (Quick DASH):, Quick DASH was used as the primary outcome measure because it is a questionnaire that assesses upper extremity injuries and symptoms and measures their impact on patients' activities of daily living. Each section of the Quick-DASH questionnaire yields a score between 0 and 100 (0= no disability, 100= maximum disability).10,11, 3 months
Secondary Outcome Measures: Western Ontario Rotator Cuff Index (WORC), WORC was used to assess the impact of rotator cuff problems on quality of life.(Kirkley Alvarez) Each question is answered with a 100mm VAS. The total is between 0 and 2100, with lower scores indicating higher quality of life., 1 months|Nothingam Health Profile (NSP):, The NSP was used to measure the general health status and quality of life of the patients. The scoring of the sections ranges from 0-100, with higher scores indicating health problems., 1 months
A Phase 2, Single Arm Study of Cabozantinib in Patients With Hepatocellular Carcinoma Who Have Received Prior Atezolizumab and Bevacizumab
NCT Number: NCT06535737
Acronym: CPAB
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hepatocellular Carcinoma Non-resectable
Interventions: DRUG: Cabozantinib
Sponsor: Chulalongkorn University
Collaborators: Mahidol University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-12

Summary:
Hepatocellular carcinoma (HCC) is the most common liver cancer and a leading cancer death worldwide. Currently, atezolizumab and bevacizumab combination is the standard of care for patients with advanced HCC. There have not been proven therapy for patients with advanced HCC previously treated with atezolizumab and bevacizumab. Cabozantinib is a proven therapy for patients with advanced HCC previously treated with sorafenib. The study aims to demonstrate the efficacy and safety of cabozantinib in patients with advanced previously treated with atezolziumab and bevacizumab. It is a multi-center single-arm study which all participants will receive cabozantinib. Participants will continue cabozantinib until. disease progression or unacceptable toxicities.

Primary Outcome Measures: Disease control rate (DCR) per RECIST 1.1 at 4th month, Proportion of participants with stable disease, partial response and complete response at 4th month of cabozantinib treatment based on RECIST 1.1, 4th month of treatment
Secondary Outcome Measures: Objective response rate (ORR) per RECIST 1.1 at 4th month, Proportion of participants with partial response or complete response at 4th month of treatment based on RECIST 1.1, 4th month of treatment|Progression-free survival (PFS) per RECIST 1.1, Time from treatment initiation to documented disease progression per RECIST 1.1 or death, Time from treatment initiation to documented disease progression per RECIST 1.1 or death, whichever came first, assessed up to 24 months|Overall survival (OS), Time from treatment initiation to patient death, Time from treatment initiation to patient death, assessed up to 36 months
Endoscopic Debridement of Chronic Plantar Fasciitis
NCT Number: NCT06535724
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fasciitis, Plantar|Fasciitis, Plantar, Chronic|Heel Spur
Interventions: PROCEDURE: Chronic plantar fasciitis endoscopic debridement coupled with heel spur resection
Sponsor: Rehasport Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-01-01
Completion Date: 2023-12-31

Summary:
The aim of the study was to prospectively evaluate the results of endoscopic treatment of chronic plantar fasciitis with resection of the heel spur. Treatment was assessed based on the results of clinical examinations and functional assessment as well as X-ray examination.

Primary Outcome Measures: American Orthopedic Foot and Ankle Society (AOFAS) AnkleHindfoot Scale, This comprehensive scale evaluates various aspects of foot health, including pain levels, functionality, and alignment, and is widely recognized for its reliability in orthopedic studies, 3 months - 60 months after the treatment
Impact of Acute Computed Tomography on Treatment Decisions and Time to Intervention in Renal Colic
NCT Number: NCT06535711
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Kidney Stone
Interventions: RADIATION: Acute CT|RADIATION: Deferred CT
Sponsor: Region Skane
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 612
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-07-01
Completion Date: 2024-09-01
Locations: Department of Urology, Helsingborg, Sweden

Summary:
This study intend to evaluate the use of acute computed tomography (CT) when acute renal colic, regarding treatment decisions, time to intervention and additional visits to the Emergency Department

Primary Outcome Measures: Rate of interventions, Rate of ESWL (extracorporal shockwave lithotripsy), URS (ureteroscopy) and PCNL (percutanous nephrolithotripsy), 1 year|Time to intervention, Time to intervention, measured in number of days, 1 year|Number of additional visits to the Emergency Department, Number of additional visits to the Emergency Department, 1 year
Evaluating the Effect of a Supplement on Symptoms of Hormonal Imbalance.
NCT Number: NCT06535698
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Women's Health
Interventions: DIETARY_SUPPLEMENT: Perelel Health Hormonal Balance Support
Sponsor: Perelel Inc.
Collaborators: Citruslabs
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-19
Completion Date: 2024-06-10
Locations: Citruslabs, Santa Monica, California, 90404, United States

Summary:
This is a virtual single-group trial lasting 12 weeks to evaluate the effects of Perelel Health's hormonal balance support on symptoms of hormonal imbalance and overall menstrual health.

Primary Outcome Measures: Changes in Symptoms of Hormonal Imbalance, Evaluation of the effect of Perelel Health hormonal balance support on symptoms of hormonal imbalance using a self-reported questionnaire., Baseline, Week 4, Week 8, Week 12
Secondary Outcome Measures: Changes in Overall Menstrual Health, Assessment of the impact of Perelel Health hormonal balance support on menstrual health using a self-reported questionnaire., Baseline, Week 4, Week 8, Week 12
A Study of Romiplostim for the Treatment of Refractory Transfusion-dependent NSAA
NCT Number: NCT06535685
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Aplastic Anemia
Interventions: DRUG: Romiplostim
Sponsor: Peking Union Medical College Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-02
Completion Date: 2025-12-31
Locations: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China

Summary:
Efficacy and safety of Romiplostim in the treatment of refractory transfusion-dependent NSAA.

Primary Outcome Measures: Overall response rate (ORR), Overall response rate (ORR) was defined as the ratio of complete response (CR) + partial response (PR).CR was defined as a haemoglobin level ≥120 g/L, neutrophil count \>1.5 × 10\^9/L and platelet count \>150 × 10\^9/L in patients who did not receive a transfusion.PR was defined as not being transfusion-dependent (if previously transfusion-dependent), or doubling or normalisation of at least one cell line or baseline increase, or initial ANC \<0.5 × 10\^9/L increased by at least 0.5 × 10\^9/L after treatment, or initial PLT \<20 × 10\^9/L increased by at least 20 × 10\^9/L after treatment., 3 months|Overall response rate (ORR), Overall response rate (ORR) was defined as the ratio of complete response (CR) + partial response (PR).CR was defined as a haemoglobin level ≥120 g/L, neutrophil count \>1.5 × 10\^9/L and platelet count \>150 × 10\^9/L in patients who did not receive a transfusion.PR was defined as not being transfusion-dependent (if previously transfusion-dependent), or doubling or normalisation of at least one cell line or baseline increase, or initial ANC \<0.5 × 10\^9/L increased by at least 0.5 × 10\^9/L after treatment, or initial PLT \<20 × 10\^9/L increased by at least 20 × 10\^9/L after treatment., 6 months|CRR, CR was defined as a haemoglobin level ≥120 g/L, neutrophil count \>1.5 × 10\^9/L and platelet count \>150 × 10\^9/L in patients who did not receive a transfusion., 3 months|CRR, CR was defined as a haemoglobin level ≥120 g/L, neutrophil count \>1.5 × 10\^9/L and platelet count \>150 × 10\^9/L in patients who did not receive a transfusion., 6 months
Secondary Outcome Measures: safety events, Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, 3 months|safety events, Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, 6months
Comparison of the Effect of Red Wine With Alcohol on Flow-mediated Dilation Versus Red Wine Without Alcohol
NCT Number: NCT06535620
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Healthy|Healthy Diet
Interventions: OTHER: red wine with alcohol|OTHER: red wine without alcohol
Sponsor: Instituto de Cardiologia de Santa Catarina
Collaborators: Universidade do Sul de Santa Catarina
Sex: ALL
Age: ADULT
Enrollment: 15
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-08-13
Completion Date: 2024-11-15

Summary:
Introduction: Cardiovascular diseases (CVDs) are the leading cause of global mortality, despite being preventable. Moderate wine consumption has been associated with one of the preventative approaches due to its benefits on cardiovascular health, including endothelial protection and antioxidant effects, attributed to its chemical composition, such as flavonoids.

Objective: To assess endothelial function through flow-mediated dilation after the consumption of red wine compared to non-alcoholic wine.

Methodology: A parallel, randomized, placebo-controlled clinical trial with a blinded evaluator will be conducted with 20 healthy participants, evaluated at two distinct time points. Participants will be selected to receive either red wine or non-alcoholic wine and will be crossed over after 7 days to receive the opposite beverage from the initial one. The primary outcome will be the change in flow-mediated dilation of the brachial artery pre- and post-intervention in both groups. The secondary outcomes will include the flow-mediated dilation values, brachial artery diameter after the intervention, and measurements of systolic blood pressure (SBP) and diastolic blood pressure (DBP).

Primary Outcome Measures: Flow-mediated dilation, Evaluate flow-mediated dilation after the consumption of red wine compared to placebo, 40 minutes after the substance intake
Secondary Outcome Measures: Heart rate, Analyze the difference in heart rate (in bpm) after the consumption of red wine compared to the consumption of non-alcoholic wine., 40 minutes after the substance intake|Blood pressure, Analyze the difference in blood pressure (in mmHg) after the consumption of red wine compared to the consumption of non-alcoholic wine., 40 minutes after the substance intake|Brachial artery diameter at rest, Evaluate the difference in the diameter (at rest) of the brachial artery (measured in millimeters) before and after consuming red wine., 40 minutes after the substance intake|Brachial artery diameter after endothelial stress, Evaluate the difference in the diameter (after endothelial stress) of the brachial artery (measured in millimeters) before and after consuming red wine., 40 minutes after the substance intake
Perfusion Index in the Follow-up of Postoperative Pain
NCT Number: NCT06535581
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Perfusion; Complications
Interventions: PROCEDURE: surgery patient
Sponsor: Amasya University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-04-05
Completion Date: 2024-06-01
Locations: Amasya University Training and Research Hospital, Amasya, 05100, Turkey

Summary:
Background: The effect of the perfusion index (PI) as an indicator of postoperative pain was investigated. To this end, the presence of the perfusion index in predicting the need for analgesia and its effect in hypertensive patients were investigated. Researher aimed to investigate the change in perfusion index in the prediction of postoperative pain after laparotomic abdominal surgery. As a secondary aim, the results of the relative change in perfusion index in the presence of hypertensive disease were analysed. Methods: A total of 100 patients with ASA 1-3 with or without hypertension who were scheduled to undergo open abdominal surgery between 1 April 2023 and 30 November 2023 were included in the study. The relative variability of visual analogue scale (VAS) and PI in patients receiving postoperative analgesia was examined. The degree of prediction of postoperative pain by these variables after rescue analgesia was investigated. Hypertensive patients were analysed along with other patient groups.

Primary Outcome Measures: PI value, The correlation between the relative change in PI value and the relative change in VAS value after anesthesia induction and postoperative pain management was investigated., minutes 90|hypertension patient, The relative change in PI value and the relative change in VAS value were compared in hypertensive patients and non-hypertensive patients., minutes 90
Secondary Outcome Measures: complication, Complications developing in all patients, minutes 90
Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB
NCT Number: NCT06535568
Acronym: PICCOLETO IV
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coronary Disease|Heart Diseases|Cardiovascular Diseases|Myocardial Ischemia|Atherosclerosis|Arterial Occlusive Diseases|Vascular Diseases|Coronary Artery Disease|Acute Coronary Syndrome|Coronary Stenosis|Molecular Mechanisms of Pharmacological Action|Enzyme Inhibitors|MTOR Inhibitors|Protein Kinase Inhibitors|Physiological Effects of Drugs|Immunosuppressive Agents|Antineoplastic Agents|High Bleeding Risk|Single Antiplatelet Therapy|Dual Antiplatelet Therapy|Cyclooxygenase Inhibitors|P2Y12 Inhibitor|Platelet Aggregation Inhibitors|Aspirin|Clopidogrel
Interventions: DEVICE: Drug-coated balloon|DRUG: Single antiplatelet therapy (SAPT)|DRUG: Dual antiplatelet therapy (DAPT)
Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS
Collaborators: Fundación EPIC
Sex: ALL
Age: OLDER_ADULT
Enrollment: 416
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-10
Completion Date: 2026-12-20

Summary:
International multicenter, investigator-driven, open-label, randomized (1:1) clinical trial to observe and evaluate the rate of ischemic and bleeding adverse events of a single antiplatelet regimen (SAPT) since the time of PCI with latest generation DCB in elderly or HBR population with stable or unstable coronary syndromes.

Primary Outcome Measures: Rate of major adverse cardiovascular events (MACE) at 12 months, Non-inferiority of SAPT vs. DAPT in terms of MACE, a composite of all-cause mortality, target vessel revascularization-TVR, target vessel spontaneous MI at 12 months, after successful DCB angioplasty., 12 months|Rate of clinically relevant bleeding events (Bleeding Academic Research Consortium 2, 3, or 5), Superiority of SAPT vs. DAPT in terms of clinically relevant bleeding events (BARC 2, 3, or 5) at 12 months., 12 months
Safety and Feasibility of ActivSight(tm) in the Identification of The Ureter Via Riboflavin Fluorescence
NCT Number: NCT06535555
Status: WITHDRAWN
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgical Procedure, Unspecified
Interventions: DEVICE: Investigational Safety and Feasibility
Sponsor: Activ Surgical
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 0
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2023-03
Completion Date: 2023-12
Locations: Center for Special Surgery, Roswell, Georgia, 30076, United States

Summary:
The main Objective of this study is to determine the safety and feasibility of a prototype ActivSightTM in identifying the ureter in real-time during elective laparoscopic abdominopelvic surgery after pre-surgical administration of riboflavin. This study seeks to identify the ureter only; ActivSight™ will not be used to Safety and Feasibility of ActivSightTM in the Identification of the Ureter via Riboflavin Fluorescence guide treatment or the surgical procedure. As such, this is a non-significant risk study. Riboflavin is a common dietary supplement and will be administered at dosages shown previously to be well-tolerated for migraine prophylaxis \[6\]. ActivSight™ is an imaging system connected to the standard laparoscopic system already existing in the OR at the site. Changes made to the commercial ActivSight™ hardware for this study introduce no significant risk

Primary Outcome Measures: Ureteral visibility, 1-5 point scale, surgeon assessment of how visible the ureter was on imaging, Immediately post-operative|Ease of use, 1-5 point scale, surgeon assessment of how easy the technology was to use intraoperatively, Immediately post-operative|Time required to identify ureter, 1-5 point scale, surgeon assessment of how much time it took to identify the ureter, Immediately post-operative
Other Outcome Measures: Adverse events, Adverse events will be summarized descriptively and tabulations on the type, severity, and relationship to the prototype ActivSight™ or administration of riboflavin will be performed and any changes of outcomes from baseline on follow up will be examined using the nonparametric Wilcoxon rank test., 28 days post-op