pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Cognitive Assessment Tools for Huntington's Disease.
NCT Number: NCT06546488
Acronym: CAT-HD
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Huntington Disease
Interventions: BEHAVIORAL: Assessments
Sponsor: Ohio State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 76
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-12-01
Locations: The Ohio State University Wexner Medical Center, Columbus, Ohio, 43221, United States

Summary:
The purpose of the current proposal is to expand understanding of two currently available cognitive tools that are not typically used in Huntington Disease (HD) clinical trials that might be useful both for initial screening and for clinical trial application. One is the Digit Symbol Coding Test (DSC) and the other is the Self-Administered Gerocognitive Examination (SAGE). Both the DSC and the SAGE have been used for assessments of individuals with other neurodegenerative diseases, including Alzheimer's Disease, Parkinson's Disease and Lewy Body Disease, but data is lacking on their use in individuals with HD.

Primary Outcome Measures: Symbol Digit Modality Test (SDMT) compared to the Digit Symbol Coding Test (DSC), Comparison of scores on Symbol Digit Modality Test (SDMT) and Digit Symbol Coding Test (DSC). Associations will be investigated using Spearman correlations., One day visit|Self-Administered Gerocognitive Examination (SAGE) score compared to the Symbol Digit Modality Test (SDMT) and the Stroop Word reading scores, Comparison of SAGE score with the SDMT and the Stroop Word reading scores. (The two neuropsychological scores used in the UHDRS that have shown the best correlation with HD disease onset and progression). Associations will be investigated using Spearman correlations., One day visit
Secondary Outcome Measures: Comparison of Luria test scores and Symbol Digit Modality Test (SDMT) vs Digit Symbol-Coding (DSC) scores., Comparison of Luria test scores and SDMT vs DSC scores. The Luria test is a sub-score of the Unified Huntington's Disease Rating Scale (UHDRS) motor exam and is considered marker of cognitive motor skill. Associations will be investigated using Spearman correlations., One day visit|Comparison of Total Motor Chorea sub-score, a part of the Unified Huntington's Disease Rating Scale (UHDRS) total score and scores on the Symbol Digit Modality Test (SDMT), Digit Symbol-Coding (DSC) and Self-Administered Gerocognitive Examination (SAGE)., Comparison of Total Motor Chorea sub-score, a part of the UHDRS total score and scores on the SDMT, DSC and SAGE.Severity of chorea involuntary movements that are common in HD might affect ability to complete either test as both the DSC and the SAGE require fine motor and drawing skills. Associations will be investigated using Spearman correlations., One day visit|Correlation of age of HD symptom onset and SAGE scores, Assess correlation of age of HD symptom onset and SAGE scores, One day visit
A Pilot Trial of Tapering Antipsychotics for Patients in Remitted Psychosis Co-administering With N-Acetylcysteine
NCT Number: NCT06546475
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Psychosis
Interventions: DRUG: N-Acetylcysteine
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-07-31

Summary:
The investigators are going to observe if add-on of n-acetylcysteine (NAC) 1200 or 2400 mg/d during tapering of antipsychotics in patients with remitted psychosis can help to reduce the pre-requisite of stabilization to 3 months (compared to the 6 months prerequisite of a previous Guided Antipsychotic Reduction to Minimum Effective Dose (GARMED) trial,) smoothly, without increased risk of relapse or frequency of adverse events compared to the 2-year results of the GARMED trial

Primary Outcome Measures: Relapse rate (%), If a patient's recurrent psychotic symptoms cannot be controlled (any PANSS score \> 3 in P1, P2, P3, G5, or G9) within 2 weeks under an antipsychotic dose equal to their baseline dose, the patient will be designated as having a relapse, 1 year
Secondary Outcome Measures: Extent of dose reduction (%), The percentage of doses reduced at a designated time point will be calculated by the formula: \[1- (current dose)/(baseline dose)\]x100%, 1 year|Clinical severity: symptoms, Positive and Negative Syndrome Scale (PANSS) (1 to 7, 1: normal; 7: profound severity), 1 year|Clinical severity: global, Clinical Global Impression of Severity (CGI-S) (1 to 7, 1: no illness; 7: most severe), 1 year|Personal and Social Functioning, Personal and Social Performance scale (PSP) (0-100, worst to best), 1 year|Self-report of subjective wellbeing, EuroQoL-5D visual analogue scale (EQ-5D-VAS) (0-100, worst to best), 1 year|Self-report of Quality of Life, Mandarin Chinese version of the WHOQOL-BREF (1\~5, 1: very dissatisfied; 5: very satisfied), 1 year
Other Outcome Measures: Qualitative measurements by semi-structured interview, At each time point of shared decision-making regarding whether to taper down dose or not, we will conduct a semi-structure interview to explore patient's key considerations, such as psychosocial issues, soundness of supportive system, and self-assessed risk of relapse, which prompt the patient to feel comfortable about continuing tapering, or to halt at current dose for a longer term., 1 year|Self-report of Medication Adherence, 5-point Likert scale for medication adherence (1: \< 20%; 2: 20\~40%; 3: 40\~60%; 4: 60\~80%; 5: \> 80%), 1 year|Self-report of Medication Satisfaction, 7-point Likert scale for medication satisfaction (1: most dissatisfied; 7: most satisfied), 1 year|Adverse events, checklist of Udvalg for Kliniske Undersogelser (UKU) Side-effects Rating Scale, 1 year
A Phase 1 Trial of LH-001 vs Placebo in Healthy Participants
NCT Number: NCT06546449
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: LH-001|DRUG: Placebo
Sponsor: Chien-Liang Lin
Collaborators: National Institute on Aging (NIA)
Sex: ALL
Age: ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-12
Locations: The Ohio State University, Columbus, Ohio, 43221, United States

Summary:
The purpose of this clinical trial is to evaluate the safety and tolerability of LH-001 when administered as an oral, single or multiple dose(s) at ascending dose levels in healthy participants.

Primary Outcome Measures: Percentage of participants who experience at least one treatment-emergent AE, 8 days for SAD and 21 days for MAD|Percentage of participants who discontinue due to an AE, 8 days for SAD and 21 days for MAD|Percentage of participants who meet the markedly abnormal criteria for vital sign measurements at least once post-dose, 8 days for SAD and 21 days for MAD|Percentage of participants who meet the markedly abnormal criteria for safety ECG parameters at least once post-dose, 8 days for SAD and 21 days for MAD|Percentage of participants who meet the markedly abnormal criteria for safety laboratory tests at least once post-dose, 8 days for SAD and 21 days for MAD
Secondary Outcome Measures: Maximum concentration (Cmax), Day 1 for all cohorts and Day 14 for MAD cohorts|Time to reach maximum concentration (Tmax), Day 1 for all cohorts and Day 14 for MAD cohorts|Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration (AUC0-last), Day 1 for all cohorts and Day 14 for MAD cohorts|Time for LH-001 concentration to fall to half of its original value (T½), Day 1 for all cohorts and Day 14 for MAD cohorts
Study of the Infectivity, Safety and Immunogenicity of Two Recombinant, Live-Attenuated, B/HPIV3 Vectored Vaccines Expressing the Fusion Glycoprotein of HMPV Delivered by Nasal Spray to HPIV3-Seropositive Children 24 to <60 Months of Age
NCT Number: NCT06546423
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Human Metapneumovirus|Human Parainfluenza Virus Type 3
Interventions: BIOLOGICAL: B/HPIV3/HMPV-PreF-A vaccine|BIOLOGICAL: B/HPIV3/HMPV-F-B365 vaccine|DRUG: Placebo
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Johns Hopkins Bloomberg School of Public Health|Vanderbilt University Medical Center|University of Rochester
Sex: ALL
Age: CHILD
Enrollment: 25
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-12
Completion Date: 2025-06
Locations: CIR - Rangos, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, 21205, United States|CIR South, Columbia, Maryland, 21045, United States|University of Rochester Medical Center, Rochester, New York, 14642, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States

Summary:
HPIV3 and HMPV are viruses that can cause breathing problems in children. The goal of this clinical trial is to look at the safety of 2 experimental HPIV3/HMPV vaccines in HPIV3-seropositive children ≥ 24 months to \< 60 months of age. Children will receive B/HPIV3/HMPV-PreF-A vaccine, B/HPIV3/HMPV-F-B365 vaccine, or placebo, and participants will not know which study product they have received.

The main goals of the study are to find out whether these vaccines are well-tolerated and infectious in HPIV3-seropositive children.

The general procedures include daily temperature measurements and daily contact with the participant for the first 28 days, giving a single dose of one of the 2 study vaccines or placebo delivered by nasal sprayer, about 9 in-person visits, a physical examination, 7 clinical assessments, 2 blood samples, 9 nasal swabs and monthly contacts with the participant between Days 29-180.

Additional visits may occur if the child has a respiratory illness, fever, or ear infections. The illness visit will include a nasal swab and a clinical assessment.

Primary Outcome Measures: Number of Grade 1 or higher solicited AEs; any lower respiratory infections, Day 0 through Day 28|Percentages of vaccinees with a ≥4-fold rise in HPIV3 neutralizing serum antibody titers, Day 28|Percentages of vaccinees with a ≥4-fold rise in HMPV-neutralizing serum antibody titers, Day 28|Peak titers of vaccine virus shed, Study Days 0-28|Proportion of vaccinees shedding of vaccine virus, Detected by immunoplaque assay and/or RT-qPCR, and/or ≥4 fold rise in HPIV3 or HMPV-specific serum antibodies, detected by neutralizing antibody assay or ELISA, Day 28
Secondary Outcome Measures: Number of MAAEs and SAEs, MAAEs and SAEs from Day 0 through Day 180, Day 0 through Day 180
OASIS: RetrOspective Analysis on EEGs for Identifying Seizure Susceptibility in paediatrIcs Using biomarkerS
NCT Number: NCT06546410
Acronym: OASIS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Epilepsy|Epilepsy in Children
Interventions: DEVICE: BioEP
Sponsor: Neuronostics Ltd
Sex: ALL
Age: CHILD
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01-01
Completion Date: 2026-01-01

Summary:
The goal of this retrospective study is to validate a set of computational biomarkers (BioEP) for seizure susceptibility on retrospective routinely collected non-contributory EEGs in paediatric participants with epilepsy. The main objectives are:

Primary:

To validate a set of computational biomarkers (BioEP) for seizure susceptibility on retrospective routinely collected non-contributory EEGs in paediatric participants with epilepsy.

Secondary:

To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis (thus adding economic value), by reducing time to final diagnosis and/or the number of clinical appointments needed

Primary Outcome Measures: To validate a set of computational biomarkers (BioEP) for seizure susceptibility on retrospective routinely collected non-contributory EEGs in paediatric participants with epilepsy., We shall demonstrate biomarkers from those with epilepsy are distinct from controls by measuring levels of balanced accuracy (sensitivity, specificity, positive predictive ratio, negative predictive ratio, diagnostic odds ratio, and area under operator curve characteristics curve), 1 year
Secondary Outcome Measures: To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis (thus adding economic value), by reducing time to final diagnosis and/or the number of clinical appointments needed, Reduction in time and cost to patients with the use of BioEP, 1 year
Study on the Effect of Combined Estrogen and Progestogen Therapy on Endometrial Repair After Induced Abortion
NCT Number: NCT06546397
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pregnancy Complications
Interventions: DRUG: 17β-estradiol/dydrogesterone tablets
Sponsor: Women's Hospital School Of Medicine Zhejiang University
Sex: FEMALE
Age: ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-05-09
Completion Date: 2025-12-31
Locations: Women's Hospital School Of Medicine Zhejiang University, Hangzhou, Zhejiang, 310006, China

Summary:
Induced abortion is a common method to terminate pregnancy, but during the operation, it is necessary to dilate the cervix and aspirate the uterine cavity. Repeated induced abortions may increase the risk of uterine damage, leading to cervical stenosis or intrauterine adhesions, thinning of the endometrium, which may affect the implantation of fertilized eggs and the development of embryos, and ultimately may lead to infertility or miscarriage. This study aims to explore the effects of combined estrogen and progesterone on endometrial repair and ovarian function recovery after induced abortion.

Primary Outcome Measures: The thickness of the endometrium, Measurement of endometrial thickness by B-ultrasound on the 21st day after induced abortion surgery, The 21st day after induced abortion surgery|Cycle normalization rate, proportion of ovarian function recovery; blood sampling for estradiol and progesterone level check on the 21st day of the first post-operative menstrual cycle, 21st day of the first post-operative menstrual cycle
Secondary Outcome Measures: Duration of vaginal bleeding after surgery, number of days of vaginal bleeding after induced abortion surgery, The 21st day after induced abortion surgery|menstrual flow volume, Amount of menstrual flow during the first menstrual cycle after surgery, 21st day of the first post-operative menstrual cycle
Spinal Cord Stimulation for Intractable Mononeuropathy
NCT Number: NCT06546371
Acronym: SCIMONO
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mononeuropathies|Spinal Cord Stimulation
Interventions: DEVICE: Spinal cord stimulator
Sponsor: Erasmus Medical Center
Collaborators: Boston Scientific Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-13
Completion Date: 2025-05
Locations: Erasmus Medical Centre, Rotterdam, Zuid-Holland, 3015GD, Netherlands

Summary:
Rationale: For patients with mononeuropathy, literature has shown that spinal cord stimulation (SCS) is an effective therapy for patients who are therapy-resistant to more conventional treatments. However, there is a strong need for higher quality evidence to determine the place of this therapy in this target group. Before conducting a large RCT we propose to conduct an explorative pilot study based on which an effect size estimation and power calculation for a larger study can be done. We will assess the effects of SCS in patients with mononeuropathy measured according to the IMMPACT guidelines, and assess the stimulation paradigm preferences in these patients.

Objective: To perform an explorative pilot study based on which an effect size estimation and power calculation for an efficacy trial can be done. Study design: Mono-center explorative pilot study in 12 patients with intractable peripheral mononeuropathic pain who receive a spinal cord stimulator at the Erasmus MC. Study population: 12 patients suffering from intractable peripheral mononeuropathic pain Intervention (if applicable): Participants who receive a spinal cord stimulator must fill in IMMPACT guideline questionnaires and undergo several measurement procedures after receiving SCS implantation. The effect of various SCS paradigms on the chronic mononeuropathic pain is assessed at 3 and 6 months. Main study parameters/endpoints: Effect of 6 months of individually optimized SCS in patients with mononeuropathy according to the IMMPACT guidelines.

Primary Outcome Measures: Effect of SCS in patients with mononeuropathy as assessed by the perceived pain intensity., Perceived pain intensity as assessed by the brief pain inventory (BPI), with pain scores where 0 is no pain and 10 is worst pain imaginable., 6 months
Secondary Outcome Measures: Effect of SCS in patients with mononeuropathy as assessed by quantitative sensory testing (QST)., Quantitative sensory testing (QST) measures sensory thresholds for pain, touch, vibration, and temperature sensations, with the main goal to assess sensory functioning., 6 months|Effect of SCS in patients with mononeuropathy on quality of life., Quality of life as assessed by the EQ-5D-5L questionnaire., 6 months|Patient preferences for SCS paradigms as assessed by the perceived pain intensity., Perceived pain intensity as assessed by the brief pain inventory (BPI), with pain scores where 0 is no pain and 10 is worst pain imaginable., 3 months
Quetiapine Versus Trazadone in Women With Postpartum Depression
NCT Number: NCT06546358
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Postpartum Depression
Interventions: DRUG: Trazodone|DRUG: Quetiapine
Sponsor: Lawson Health Research Institute
Sex: FEMALE
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-12
Locations: Parkwood Institute, London, Ontario, N6V 0A7, Canada

Summary:
Postpartum depression is a serious disorder that affects approximately 17% of women who have recently given birth. Untreated postpartum depression can negatively affect the mother, the infant, and the family. Lack of sleep is common after delivery and can trigger or worsen depression in some women. Trazodone is used for sleeplessness and depression, but it has not been studied for postpartum depression. There is preliminary evidence that quetiapine, another drug used for depression and sleeplessness, may be effective for postpartum depression. We are planning a study to compare the effectiveness and side effects of quetiapine and trazodone in women with postpartum depression. The results of this study will help us carry out larger studies comparing these drugs with a placebo (a sugar pill) in postpartum depression. We expect the results of our study will improve the mental health of mothers and the well-being of their babies and make it easier for healthcare staff to select the right drug for women with postpartum depression.

Primary Outcome Measures: Hamilton Depression Rating Scale, The primary outcome will be the mean change from baseline to week 8 in the HDRS total score, the proportion of participants achieving response (≥50% reduction in HDRS score at baseline), and the proportion of participants achieving remission (HDRS ≤12)., 8 weeks
Post Market Clinical Follow-Up KeriFlex®
NCT Number: NCT06546345
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Rheumatoid Arthritis|Degenerative Arthritis|Traumatic Arthritis
Interventions: DEVICE: KeriFlex®
Sponsor: Keri Medical SA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 86
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-14
Completion Date: 2035-01
Locations: CHU Jean Minjoz, Besançon Cedex, 25030, France|Clinic Lille Sud, Lesquin Cedex, 59813, France|Institut aquitain de la main et du membre supérieur, Pessac, 33600, France

Summary:
The general objective of this study is to assess the performance and safety of the KeriFlex® silicone joint implant and its associated instruments, used in accordance with the labeling and instructions in force.

The performance and safety of the KeriFlex® joint implant will be established in the short and long term with regard to the life cycle of the implant.

Primary Outcome Measures: Assessment of the effectiveness of the KeriFlex® implant in improving the functional results of the hand, Proportion of patients with a bMHQ score greater than the preoperative value at 6 months (postoperative)., 6 months
Post Market Clinical Follow-Up KeriFuse®
NCT Number: NCT06546332
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Arthritis
Interventions: DEVICE: KeriFuse®
Sponsor: Keri Medical SA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 97
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-07-05
Completion Date: 2027-03
Locations: Centre de la main du Pays d'Aix, Aix-en-Provence, 13090, France|Clinique de la Chataigneraie, Beaumont, 63110, France|Centre Ostéo Articulaire Fleming, Bourgoin-Jallieu, 38300, France|Clinique de la main, Caen, 14000, France|Clinique Saint François, Nice, 06000, France|Clinique Mutualiste Catalane, Perpignan, 66000, France|Clinique du Parc, Périgueux, 24000, France

Summary:
The general objective of this study is to evaluate the performances and the safety related to the KeriFuse® intramedullary arthrodesis implant and associated instrumentation used in accordance with their approved labelling and instruction for use. Performance and safety of KeriFuse® intramedullary arthrodesis implant will be established on short and middle-terms in regards to the implant life-cycle.

Primary Outcome Measures: Pain and radiological assessment, At 3 months postoperatively, the proportion of patients with a pain level ≤ 3 on VAS (ranking from 0 to 10 cm) and with a fused DIP or IP joint (radiological assessment), 3 months
Post Market Clinical Follow-Up TOUCH® CMC 1
NCT Number: NCT06546306
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Osteoarthritis Thumb
Interventions: DEVICE: TOUCH® CMC 1
Sponsor: Keri Medical SA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 216
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-11-22
Completion Date: 2031-12
Locations: Centre de la main du Pays d'Aix, Aix-en-Provence, 13090, France|Clinic of Chataigneraie, Beaumont, 63110, France|Orthopaedics and Trauma Surgery Practice, Bezannes, 51430, France|Médipôle De Savoie, Challes-les-Eaux, 73190, France|Medical Office of Dr TCHURUKDICHIAN, Dijon, 21000, France|Medical Office Archimed, Lesquin, 59810, France

Summary:
Because severe pain, weakened pinch and grip strength produce functional disabilities, the basal joint of the thumb is the most common site of surgical reconstruction in the upper limb due to OA.

The cement-free dual mobility Touch® prosthesis consists of a metacarpal implant (stem), a trapezium implant (cup), and a connection implant (neck).

The main objective of this study is to describe the performance and safety of the Touch® prosthesis used with its instruments set in accordance with its intention and CE marking in force.

Performance and safety will be assessed over the short and long term in accordance with the life cycle of the Touch® prosthesis.

Primary Outcome Measures: Mobility and pain, At 3 months post-surgery, the proportion of patients with a Kapandji score \> 8 and a pain score ≤ 3 on a VAS scale., 3 months
A Study of Camrelizumab Plus Apatinib as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Radical Resection or Ablation
NCT Number: NCT06546280
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hepatocellular Carcinoma
Interventions: DRUG: Camrelizumab|DRUG: Apatinib
Sponsor: Zhujiang Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 38
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-26
Completion Date: 2026-09-01
Locations: Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, 510220, China

Summary:
The goal of this clinical trial is to evaluate the efficacy and safety of camrelizumab plus apatinib as adjuvant therapy for patients with hepatocellular carcinoma at high risk of recurrence after radical resection or ablation.

Primary Outcome Measures: 1-year recurrence free survival rate, Proportion of patients who did not experience recurrence of hepatocellular carcinoma within 1 year of enrollment, Assessed up to 12 months
Secondary Outcome Measures: Recurrence free survival, Time from enrollment to first occurrence of intrahepatic or extrahepatic hepatocellular carcinoma or death from any cause, Assessed up to 24 months|Time to recurrence, Time from enrollment to first occurrence of intrahepatic or extrahepatic hepatocellular carcinoma, Assessed up to 24 months|Overall survival, Time from enrollment to death of any cause, Assessed up to 24 months|2-year recurrence free survival rate, Proportion of patients with no recurrence of hepatocellular carcinoma within 2 years of enrollment, Assessed up to 24 months|Adverse events, Includes type, incidence, severity, onset and end time, correlation with treatment/drugs, and regression; severity was graded according to NCI CTCAE v5.0., Assessed up to 12 months
1% Lidocaine Paracervical Block for Endometrial Biopsy
NCT Number: NCT06546254
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endometrial Biopsy
Interventions: DRUG: Lidocaine 1% Injectable Solution|DRUG: Saline|OTHER: Capped needle
Sponsor: Mount Sinai Hospital, Canada
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 174
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-08-05
Completion Date: 2025-12-31

Summary:
The objective of this study is to determine whether 1% lidocaine paracervical block reduces pain during endometrial biopsy in comparison to sham paracervical injection with normal saline or no intervention.

The proposed study is a double-blind, triple arm, placebo-controlled randomized controlled trial (RCT). Each participant will be randomly assigned to one of three arms:

1. intervention (paracervical block - 10 cc 1% lidocaine with epinephrine)
2. placebo (10 cc paracervical injection of normal saline)
3. control (gently tapping the cervicovaginal junction with a capped needle)

The primary outcome will be a global pain score, which will be patient-reported by the 100 mm Visual Analogue Scale (VAS) following the procedure.

Primary Outcome Measures: Global pain score, 100 mm Visual Analogue Scale (VAS), minimum value 0 (no pain at all) and maximum value 100 (worst pain imaginable), Immediately after the completion of the procedure
Secondary Outcome Measures: Pain scores during procedure, Pain rating on scale of 0 - 10 at the following time points: baseline, after injection/control, placement of tenaculum, endometrial biopsy completion, 1-minute post-biopsy, During the procedure|Immediate complications of endometrial biopsy and/or intervention/control, Provider reported, Immediately after the completion of the procedure|Difficulty for provider to complete the biopsy, Provider reported on Likert scale, minimum 1 (least difficult) and maximum 5 (most difficult), Immediately after the completion of the procedure|Length of time for analgesia, Stopwatch, During procedure|Length of time for endometrial biopsy completion, Stopwatch, During procedure|Number of passes with biopsy pipelle to collect sufficient tissue, Provider reported, Immediately after the completion of the procedure|Amount of tissue obtained: scant, minimal, adequate, Provider reported, Immediately after the completion of the procedure|Patient satisfaction, Survey, Immediately after the completion of the procedure
Long Term Predictors of Acute Myocardial Infarction in Patients With Coronary Revascularization
NCT Number: NCT06546228
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Acute Myocardial Infarction|Revascularization
Interventions: OTHER: No intervention. Only observational.
Sponsor: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 652
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-01-13
Completion Date: 2022-12-31
Locations: Azienda Ospedaliera Universitaria G. Martino, Messina, Italy

Summary:
Worldwide, Ischemic heart disease is the single most common fatal disease. One of the most common causes of acute myocardial infarction is represented by obesity. Numerous cardio metabolic variables play a key role in incidence of adverse cardiovascular outcomes. The purpose of this research was to investigate the factors allowing to acute coronary syndrome, related to the metabolic status, to help guide each patient toward early preventing behaviors.

Primary Outcome Measures: Incidence of Acute Myocardial Infarction (AMI), Occurrence of AMI. Unit of measure: Medical records, electrocardiogram (ECG), cardiac biomarkers, 7 years
Secondary Outcome Measures: Change in Left Ventricular Ejection Fraction (LVEF), LVEF before and after revascularization Measurement Tool: Echocardiogram Unit of Measure: Percentage (%) change in LVEF, 7 years|Incidence of Cardiovascular Death, Occurrence of cardiovascular death Measurement Tool: Medical records Unit of Measure: Number of cardiovascular deaths per patient-year, 7 years
Bioequivalence Study of Digoxin Tablet in Healthy Subjects
NCT Number: NCT06546215
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Heart Failure
Interventions: DRUG: Digoxin
Sponsor: Xiangya Hospital of Central South University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2020-07-05
Completion Date: 2021-01-23
Locations: Xiangya Hospital Central South University, Changsha, Hunan, 410008, China

Summary:
The study followed an open-label, randomized, single-dose (0.25mg), four-period full-replicate design encompassing both fasted and fed conditions. Subjects were randomized into two sequences, labeled as group A (TRTR) and group B (RTRT), for the four sessions. By the use of a random table produced by SAS statistical software, the individuals were assigned at random to administer a single-dose (0.25mg) of either the reference or the test formulation of digoxin tablets. During the fasted study phase, participants were randomly administered digoxin tablets after an overnight fast of a minimum of 10 hours, and fasting continued for 4 hours post dose. During the fed trial, subjects consumed a high-fat breakfast 30 minutes before administering digoxin tablets, which consisted of approximately 500 to 600 kcal of fat, 150 kcal of protein, and 250 kcal of carbohydrates, totaling around 800 to 1000 kcal calories. The breakfast must be finished within 30 minutes. Digoxin tablets were administered to each subject in a single dosage with 240 mL of water. Each subject was assigned equitably and at random to one of the two groups. A 14-day washout period was implemented between each period. In the fasted study, blood samples were collected at various time points: predose, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours after dosing. Similarly, in the fed study, blood samples were collected at predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours after dosing. Following collection, the samples underwent centrifugation at 1700g for 10 minutes at 4℃. The resulting supernatant was then divided into two aliquots and stored at -80℃ until further analysis was conducted. A validated high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS) method was employed to assess the level of digoxin in plasma samples. The PK analysis of the plasma concentration-time curve was performed using a non-compartmental modeling method with Phoenix WinNonlin software version 8.2.

Primary Outcome Measures: plasma concentration in fasted study., plasma concentration-time curve, predose, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours|plasma concentration in fed study., plasma concentration in fasted study., predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours
Oral Lactobacillus Supplementation as Treatment for Overactive Bladder Syndrome: A Randomised Controlled Trial
NCT Number: NCT06546189
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Overactive Bladder Syndrome
Interventions: DIETARY_SUPPLEMENT: OMNi BiOTiC® 41167|OTHER: Placebo
Sponsor: Medical University of Vienna
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-10

Summary:
Background: Overactive bladder describes a syndrome characterized by frequent urges to urinate and increased urination with or without nocturia and with or without urinary incontinence. Overactive bladder affects approximately 13% of older women and thus represents a condition with high prevalence. Affected women report significant limitations in daily life, as well as social isolation. Despite the high occurrence of this condition, therapeutic options are limited, partly because the etiology of this condition is not fully understood. Increasingly, studies suggest an imbalance in the urogenital microbiome as a possible cause of the development of the condition. Therefore, the aim of this study is to test, whether the oral administration of a lactobacillus preparation can lead to a reduction in symptoms.

Design: Randomized controlled study

Methods: Intake of OMNi BiOTiC® 41167 or placebo twice daily for 6 months; swabs (vaginal and urethral) and urine samples from a single-use catheter for microbiome determination at 0, 3, and 7 months.

Outcome: Reduction of subjective symptoms (yes/no) after 3 and 7 months; reduction of Overactive Bladder Symptom Score after 3 and 7 months; change in the urogenital microbiome after 3 and 7 months (comparison of intervention vs. placebo).

Primary Outcome Measures: symptom reduction, yes/no, 6 months|ICIQ-OAB symptom score reduction, 6 months
Secondary Outcome Measures: change in vaginal/urethral/bladder microbiom, between groups and within one participant, 3 months and 6 months
End to End Anastomosis With Omega Suture Versus End to Anterior Rectal Wall In Colorectal Anastomosis in Sigmoid and Upper Rectal Cancer
NCT Number: NCT06546176
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: End to End Anastomosis|Colorectal Anastomosis|End to Anterior Rectal Wall|Sigmoid Cancer|Upper Rectal Cancer
Interventions: OTHER: End to end with Omega suture|OTHER: End to anterior rectal wall
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-09-01
Completion Date: 2024-09-01
Locations: Ain Shams University, Cairo, Egypt

Summary:
The aim of this study is to compare end to end anastomosis with omega suture versus end to anterior rectal wall in colorectal anastomosis as regard post operative anastomotic leakage, bowel function, operative time and intra operative blood loss.

Primary Outcome Measures: Anastomotic leakage, Anastomotic leakage will be measured for 5 days after surgery, 5 days after surgery
Secondary Outcome Measures: Operative time, Operative time will be measured from the start of surgery till the end of surgery., Until the procedure is completed|Hospital stay, Hospital stay will be assessed from admission till discharge from hospital, 28 days postoperative|Time of bowel function, Time of bowel function will be assessed, 7 days postoperative|Wound complications, Wound complications will be recorded as bleeding and infection., 7 days postoperative
RE002 T Cell Injection for the Treatment of KRAS G12D Mutated Solid Tumors
NCT Number: NCT06546150
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: KRAS G12D|T Cell Therapy
Interventions: BIOLOGICAL: RE002 T cell
Sponsor: Henan Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-04-01
Locations: Henan Cancer Hospital, Zhengzhou, Henan, 450008, China

Summary:
At present, there is an urgent need for new drugs for KRAS mutant tumors in clinic. Preclinical studies support the specificity, safety and anti-tumor activity of RE002. Previous similar studies suggest the feasibility of TCR-T treatment, and measures have been taken to ensure the safe administration of RE002 and the close monitoring and management of adverse events. To sum up, RE002 has controllable safety and anti-tumor activity on KRAS mutant solid tumor, which can be preliminarily studied to provide support for clinical research of patients with advanced solid tumor.

Primary Outcome Measures: Overall response rate (ORR)., Defined as the proportion of subjects with confirmed CR and PR., 24-36 months
Secondary Outcome Measures: Duration of response (DOR)., Defined as the time from cell infusion to disease progression or death in subjects achieving CR or PR., 24-36 months
Other Outcome Measures: Disease control rate (DCR)., Defined as the proportion of subjects who achieved CR, PR, and SD after treatment., 24-36 months|Stable disease (DOSD)., The definition refers to the period from the start of treatment to the time of evaluation for PD., 24-36 months|Progression-free survival (PFS)., Definition refers to the time from the subject's enrollment date (starting treatment date) to the occurrence of PD or death for any reason, whichever occurs first., 24-36 months|Overall survival (OS)., Definition refers to the time from the beginning of treatment to death from any cause., 24-36 months|Self-evaluation results of patients., EORTC QLQ-C30 scale was adopted and evaluated according to the scoring manual provided by EORTC., 24-36 months
National Network for Cardiovascular Genomics: Advancing Cardiovascular Healthcare for Hereditary Diseases in Brazil's Unified Health System Through a Multicenter Registry
NCT Number: NCT06546137
Acronym: RENOMICA-Hcor
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiomyopathy, Hypertrophic|Cardiomyopathy, Dilated|Cardiomyopathy Restrictive|Arrhythmogenic Right Ventricular Dysplasia|Non-Compaction Cardiomyopathy|Familial Hypercholesterolemia|Marfan Syndrome|Ehlers-Danlos Syndrome, Vascular Type|Loeys-Dietz Syndrome|Long QT Syndrome|Short Qt Syndrome|Brugada Syndrome|Catecholaminergic Polymorphic Ventricular Tachycardia
Interventions: DIAGNOSTIC_TEST: whole genome sequencing
Sponsor: Hospital do Coracao
Collaborators: Instituto Nacional de Cardiologia de Laranjeiras|Universidade Federal do Rio de Janeiro
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2026-12
Locations: Hospital do Coracao, São Paulo, 04004-030, Brazil

Summary:
The goal of this observational study is to develop a registry of Brazilian patients with hereditary cardiovascular diseases, combining clinical and genomic data. The main questions it aims to answer are:

Which genes are most commonly affected? What is the frequency of these genetic alterations in our population? Participants will be interviewed in routine medical care visits and their DNA will be sequenced.

Primary Outcome Measures: Diagnostic yield, Percentage of participants with pathogenic or likely pathogenic variants, 30 months after study start date|Genetic diversity, Determine genes that cause hereditary cardiovascular diseases in Brazil, 30 months after study start date|Variant frequency, Determine the frequency of disease-causing and benign variants in the Brazilian population, 30 months after study start date
Clinical Study to Evaluate the Possible Efficacy and Safety of Diosmin and Hesperidin Combined Therapy in Patients With Helicobacter Pylori Infection
NCT Number: NCT06546111
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Helicobacter Pylori Infection
Interventions: DRUG: Placebo|DRUG: Daflon
Sponsor: Sadat City University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-10-01
Locations: National Liver Institute, Shibīn Al Kawm, Egypt

Summary:
This study intends to assess the possible effectiveness and safety of Diosmin and Hesperidin combination in patients with Helicobacter pylori Infection through evaluating its effect on stool antigen test and serum levels of inflammatory biomarkers as(TNF-A and MDA).

Primary Outcome Measures: Eradication rate of helicobacter pylori infection, The primary outcome is the improvement of eradication rate of H. pylori infection which is measured by stool antigen test (Negative result)., At baseline and after 6 weeks of initiation of therapy
Secondary Outcome Measures: Inflammatory biomarkers suppression, The secondary outcome is the change in the measured specific biomarkers (TNF-α which is measured by pg /mL unit), (MDA which is measured by µmol/L), At baseline and after 6 weeks of initiation of therapy
Molgramostim Nebulizer Solution Expanded Access Program Protocol
NCT Number: NCT06546098
Status: TEMPORARILY_NOT_AVAILABLE
Study Type: EXPANDED_ACCESS
Conditions: Autoimmune Pulmonary Alveolar Proteinosis
Interventions: DRUG: Molgramostim nebulizer solution
Sponsor: Savara Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT

Summary:
Autoimmune pulmonary alveolar proteinosis (aPAP) is a rare disorder in which a material called surfactant builds up in the lungs and makes it hard to breathe. In addition to shortness of breath, people with aPAP can experience persistent cough, overwhelming fatigue, unintentional changes in weight, chest or back pain, suddenly feeling out of shape, and general discomfort.

Currently, there are no approved medications for aPAP in the United States, but the symptoms of aPAP can be treated with whole lung lavage (WLL). WLL is an invasive procedure that temporarily removes surfactant, and it can result in serious consequences like trauma to the lung, a collapsed lung, and prolonged requirement for artificial ventilation.

Savara is studying an investigational drug called molgramostim nebulizer solution to see if it activates the cells that help clear surfactant from the lungs, which improves oxygen transfer from the lungs to the bloodstream. Molgramostim nebulizer solution is administered by inhalation using a hand-held nebulizer. In clinical trials, molgramostim nebulizer solution has shown improvements in gas exchange and patient reported outcomes.

This expanded access program will make molgramostim nebulizer solution available to adult patients with diagnosed aPAP. Access must be obtained through the treating physician. Patients will dose molgramostim nebulizer solution 300 micrograms (mcg) once daily and be followed by their physician every 3 months to assess their clinical status and report any adverse events.
Extracellular Vesicles, Insulin Action, and Exercise
NCT Number: NCT06546085
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes|Obesity
Interventions: BEHAVIORAL: Exercise
Sponsor: Rutgers, The State University of New Jersey
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|University of Virginia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08
Completion Date: 2029-04
Locations: Institute for Food, Nutrition, and Health, New Brunswick, New Jersey, 08901, United States|Robert Wood Johnson University Hospital Clinical Research Center, New Brunswick, New Jersey, 08901, United States|Rutgers University Loree Gymnasium, New Brunswick, New Jersey, 08901, United States

Summary:
Extracellular vesicles (EVs) play a role in obesity-induced insulin resistance and likely impact the development of cardiovascular disease. However, little is known on how EVs affect vascular insulin action in people. The purpose of this study is to understand how EVs play a role in type 2 diabetes related cardiovascular disease. This research will also study if exercise can change how EVs impact blood flow and metabolic health. This study will contribute to designing precision medicine to treat/prevent cardiovascular disease in type 2 diabetes.

Primary Outcome Measures: Change in Extracellular Vesicles during insulin infusion, Extracellular vesicles (CD41 -CD31+, CD45, Tx, CD31, CD105) will be isolated from plasma before and during insulin stimulation., From enrollment to the end of treatment at 16 weeks.
Secondary Outcome Measures: Change in Metabolic Insulin Sensitivity by the Isoglycemic Clamp, Measure of glucose metabolism determined by the glucose infusion during the last 30 minutes of the 150 clamp procedure., From enrollment to the end of treatment at 16 weeks.|Change in Contrast Enhanced Ultrasound, Measure of microvascular blood flow before and during insulin stimulation., From enrollment to the end of treatment at 16 weeks.|Change in Flow Mediated Dilation of the brachial artery, Measure of blood flow using ultrasound before and during insulin stimulation., From enrollment to the end of treatment at 16 weeks.|Change in Pulse Wave Velocity, Measure of arterial stiffness using pulse waves at the carotid and femoral arteries before and during insulin stimulation., From enrollment to the end of treatment at 16 weeks.|Change in Augmentation Index, Measure of aortic pressure waveforms before and during insulin stimulation., From enrollment to the end of treatment at 16 weeks.|Change in Post Ischemic Flow Velocity in the brachial artery, Measure of blood flow using ultrasound before and during insulin stimulation., From enrollment to the end of treatment at 16 weeks.