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To determine the maximum tolerated dose (MTD) and recommended dose for further investigation of lurbinectedin and dostarlimab in combination therapy for advanced or recurrent endometrial cancer. |
To assess the antitumor activity of lurbinectedin and dostarlimab combination therapy, measured by objective response rate (ORR), in patients with advanced or recurrent endometrial cancer. |
Secondary Objectives: |
To evaluate the safety and tolerability of lurbinectedin and dostarlimab combination therapy in patients with advanced or recurrent endometrial cancer. |
To characterize the pharmacokinetic profile of lurbinectedin and dostarlimab when administered in combination therapy. |
To explore pharmacogenomic biomarkers predictive of response and/or resistance to lurbinectedin and dostarlimab combination therapy in patients with advanced or recurrent endometrial cancer. |
To assess progression-free survival (PFS), duration of response (DOR), clinical benefit rate (CBR), and overall survival (OS) in patients receiving lurbinectedin and dostarlimab combination therapy for advanced or recurrent endometrial cancer. |
To investigate the impact of lurbinectedin and dostarlimab combination therapy on quality of life and symptom control in patients with advanced or recurrent endometrial cancer. conditions: Endometrial Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Lurbinectedin name: Dostarlimab measure: Maximum Tolerated Dose (MTD) and Recommended Dose (RD) Determination measure: Evaluation of Lurbinectedin and Dostarlimab Combination Therapy in Advanced/Recurrent Cervical Cancer Patients measure: Safety Evaluation of Lurbinectedin in combination with Dostarlimab measure: Evaluate the progression-free survival (PFS) measure: Pharmacokinetic (PK) and Pharmacogenomic Evaluation measure: Overall Response Rate (ORR) measure: Evaluate the Duration of Response (DOR) measure: Evaluate the Clinical Benefit Rate (CBR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06385535 id: IRB_00171031 briefTitle: Clinical Characteristics and Temporal Properties of Individual Tics in Persistent Tic Disorder acronym: PTD overallStatus: RECRUITING date: 2024-04-04 date: 2024-12 date: 2024-12 date: 2024-04-26 date: 2024-04-26 name: University of Utah class: OTHER briefSummary: The goal of this clinical study is to learn more about the timing of tics (sudden, fast movements and sounds that people do and make without meaning to) in people who have multiple tics that have been going on for more than one year. The main questions it aims to answer are: |
1. See whether a tic's timing is related to other characteristics of the tic, like how long it has been happening and how well the person can control/stop that tic |
2. See whether the timing of a tic can tell us how well the person can control/stop that tic |
3. See whether tic treatment changes the timing of tics, and if the timing of a tic has anything to do with how well treatment will work to stop it |
Participants will meet with a study researcher to learn more about the study, ask questions, and decide whether or not they would like to be involved. If they decide to do the study, they will meet with the researcher 6 times: |
1. During the first visit, the study researcher will ask questions about the participant's life, tics, and other psychological symptoms. The researcher will watch the participant's tics for 10 minutes. The participant will do a computer task where they follow instructions to tic or not tic. |
2. During the second visit, the study researcher will treat one of the participant's tics. |
3. During the third visit, the study researcher will treat another one of the participant's tics. |
4. During the fourth visit, the study researcher will treat another one of the participant's tics. |
5. During the fifth visit, the study researcher will treat another one of the participant's tics. |
6. During the sixth visit, the study researcher will ask questions about the participant's tics and other psychological symptoms. The participant will do a computer task where they follow instructions to tic or not tic. conditions: Tics conditions: Tic Disorders conditions: Vocal Tic conditions: Motor Tic conditions: Tourette Syndrome conditions: Tourette Syndrome in Children conditions: Tourette Syndrome in Adolescence conditions: Tics/Tremor studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Clinical trial with a single arm (i.e., participants are not assigned to groups). primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: The Principal Investigator and Outcomes Assessors will be blinded to the fractal properties of participants' tics until all study procedures have been completed. count: 12 type: ESTIMATED name: Habit Reversal Training (HRT) measure: Estimates of baseline individual and total tic fractality within free-to-tic (FTT) and differential reinforcement of other behavior (DRO) environmental contingencies measure: Voluntary tic suppression success at baseline measure: Total tic severity at baseline as measured by the Yale Global Tic Severity Scale (YGTSS) measure: Total and individual tic severity at baseline as measured by the Parent Tic Questionnaire (PTQ) measure: Changes in voluntary individual and total tic suppression success pre- and post-intervention measure: Changes in individual and total tic fractality within free-to-tic (FTT) and differential reinforcement of other behavior (DRO) environmental contingencies pre- and post-intervention measure: Changes in individual and total tic severity pre- and post-intervention as measured by the Yale Global Tic Severity Scale (YGTSS) and Parent Tic Questionnaire (PTQ) measure: Individual and total premonitory urge severity at baseline as measured by the Individualized Premonitory Urge for Tics Scale (I-PUTS) measure: Individual and total premonitory urge severity post-intervention as measured by the Individualized Premonitory Urge for Tics Scale (I-PUTS) measure: Changes in individual and total premonitory urge severity pre- and post-intervention as measured by the Individualized Premonitory Urge for Tics Scale (I-PUTS) measure: Total tic severity post-intervention as measured by the Yale Global Tic Severity Scale (YGTSS) measure: Individual and total tic severity post-intervention as measured by the Parent Tic Questionnaire (PTQ) measure: Voluntary tic suppression success post-intervention measure: Estimates of individual and total tic fractality within free-to-tic (FTT) and differential reinforcement of other behavior (DRO) environmental contingencies post-intervention sex: ALL minimumAge: 8 Years maximumAge: 12 Years stdAges: CHILD facility: University of Utah status: RECRUITING city: Salt Lake City state: Utah zip: 84112 country: United States name: Kirsten Bootes, MS role: CONTACT phone: 801-585-7114 email: [email protected] name: Kirsten Bootes, MS role: CONTACT email: [email protected] lat: 40.76078 lon: -111.89105 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-11 uploadDate: 2024-01-30T18:49 filename: ICF_000.pdf size: 244576 hasResults: False |
<|newrecord|> nctId: NCT06385522 id: BITR2101-C-01 briefTitle: A Clinical Trial in Adults With Non-Hodgkin Lymphoma (NHL), With a Particular Emphasis on Cutaneous T Cell Lymphoma (CTCL), Testing the Safety and Activity of a Novel Drug to Inhibit a Protein Called Tumor Necrosis Factor Receptor 2 That Drives Both Lymphoma Growth and Escape of the Immune System overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2027-02 date: 2027-02 date: 2024-04-26 date: 2024-04-26 name: Boston Immune Technologies and Therapeutics class: INDUSTRY briefSummary: The goal of this trial is to learn if a new drug, BITR2101, works to treat non-Hodgkin lymphoma (NHL) in adults, with CTCL patients being sought in particular. The trial also seeks to learn about the safety of this drug. This drug is a protein called an antibody. The drug prevents a molecule called a receptor, named TNFR2, from being made. TNFR2 regulates the immune system and provides important signals to lymphoma cells to grow, make more of themselves and survive. When the drug prevents TNFR2 from being produced in lymphoma cells from CTCL patients, those cells died in the laboratory. Therefore, the trial seeks to enroll CTCL patients in particular, in addition to other subtypes of NHL. When the drug prevents the receptor from being made in certain immune cells, there is increased immune activity. Thus, the trial will test if this drug is a new immune therapy that helps the immune system to keep lymphoma under control. In particular, we want to find out if the amount of lymphoma in the body decreases while taking the drug. Patients with autoimmune diseases are not permitted because of this potential increase in immunity brought on by this drug. Patients should have NHL that has been previously treated, that is getting worse on their current therapy, and their doctors think a new treatment is needed. All patients will receive BITR2101 by a 3 hour infusion into a vein, periodically, initially every 3 weeks. There is no placebo in this trial. Visits to the clinic facility will be required, initially at least every week and later less frequently. Patients will be expected to report changes in their health to the clinic staff including new findings and any change in the status of their lymphoma they may be aware of. Patients can continue to receive BITR2101 for up to a year or until their lymphoma worsens. For patients who are clearly benefiting, they may be able to receive BITR2101 for another year. conditions: NHL conditions: Cutaneous T Cell Lymphoma conditions: Peripheral T-cell Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: BITR2101 measure: to assess the safety and tolerability of BITR2101 administered intravenously every 3 weeks in order to determine the MTD, if any, and to inform the RDE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06385509 id: TOL-CLAR-20024 briefTitle: A Phase 4 Study to Evaluate Adrenal Function in Hypogonadal Men Treated With JATENZO® for 12 Months overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-10 date: 2026-02 date: 2024-04-26 date: 2024-04-26 name: Tolmar Inc. class: INDUSTRY name: ICON plc briefSummary: TOL-CLAR-20024 is a Phase 4, multi-center, open-label safety study evaluating the potential effect of JATENZO on adrenal function in hypogonadal men treated with JATENZO for 12 months. conditions: Hypogonadism studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 110 type: ESTIMATED name: Jatenzo measure: CST Test measure: Adrenal Insufficiency measure: Estrogen changes measure: Follicle Stimulating Hormone (FSH) changes. measure: Luteinizing hormone (LH) changes measure: Sperm analysis measure: Sperm analysis measure: Sperm analysis measure: Testis volume analysis sex: MALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06385496 id: NCI-2024-01145 id: NCI-2024-01145 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAY131-L id: EAY131-L type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAY131-L type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Testing MLN0128 (TAK-228) as Potentially Targeted Treatment in Cancers With mTOR Genetic Changes (MATCH - Subprotocol L) overallStatus: ACTIVE_NOT_RECRUITING date: 2017-03-12 date: 2024-12-31 date: 2024-12-31 date: 2024-04-26 date: 2024-04-26 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II MATCH treatment trial tests how well MLN0128 (TAK-228) works in treating patients with cancer that has certain genetic changes called mTOR mutations. MLN0128 (TAK-228) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. conditions: Advanced Lymphoma conditions: Advanced Malignant Solid Neoplasm conditions: Refractory Lymphoma conditions: Refractory Malignant Solid Neoplasm conditions: Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Magnetic Resonance Imaging name: Sapanisertib measure: Objective response rate (ORR) measure: Overall survival (OS) measure: 6-month progression free survival (PFS) measure: Progression free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ECOG-ACRIN Cancer Research Group city: Philadelphia state: Pennsylvania zip: 19103 country: United States lat: 39.95233 lon: -75.16379 hasResults: False |
<|newrecord|> nctId: NCT06385483 id: NCI-2024-01125 id: NCI-2024-01125 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAY131-A type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAY131-A type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Testing Afatinib as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH - Subprotocol A) overallStatus: ACTIVE_NOT_RECRUITING date: 2015-08-11 date: 2024-12-06 date: 2024-12-06 date: 2024-04-26 date: 2024-04-26 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II MATCH treatment trial tests how well afatinib works in treating patients with cancer that has certain genetic changes. Afatinib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the EGFR gene. It works by blocking the action of mutated EGFR that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. conditions: Advanced Lymphoma conditions: Advanced Malignant Solid Neoplasm conditions: Refractory Lymphoma conditions: Refractory Malignant Solid Neoplasm conditions: Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Afatinib name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Echocardiography name: Magnetic Resonance Imaging name: Radionuclide Imaging measure: Objective response rate (ORR) measure: Overall survival (OS) measure: 6-month progression free survival (PFS) measure: Progression free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ECOG-ACRIN Cancer Research Group city: Philadelphia state: Pennsylvania zip: 19103 country: United States lat: 39.95233 lon: -75.16379 hasResults: False |
<|newrecord|> nctId: NCT06385470 id: HSEARS20231112001 briefTitle: Treatment of Cantonese Speakers With Childhood Apraxia of Speech overallStatus: RECRUITING date: 2024-04-15 date: 2024-08-01 date: 2025-02-01 date: 2024-04-26 date: 2024-04-26 name: The Hong Kong Polytechnic University class: OTHER name: University of Vermont name: The University of Hong Kong briefSummary: The proposed study aims to investigate the efficacy of the Dynamic Temporal and Tactile Cueing treatment in Cantonese-English bilingual speakers with childhood apraxia of speech. conditions: Childhood Apraxia of Speech studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 4 type: ESTIMATED name: Dynamic Temporal and Tactile Cueing treatment measure: Phonemes accuracy measure: Stress accuracy measure: Tone accuracy sex: ALL minimumAge: 3 Years maximumAge: 11 Years stdAges: CHILD facility: The Hong Kong Polytechnic University status: RECRUITING city: Kowloon country: Hong Kong name: Min Ney Wong, PhD role: CONTACT phone: +852 2766 7268 email: [email protected] lat: 22.31667 lon: 114.18333 hasResults: False |
<|newrecord|> nctId: NCT06385457 id: 24-2933 briefTitle: The Effects of Mindhelper on Young People's Well-being, Psychological Functioning, and Intentions to Help-seeking overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2025-01-31 date: 2025-01-31 date: 2024-04-26 date: 2024-04-26 name: University of Southern Denmark class: OTHER name: TrygFonden, Denmark name: Danske Regioner name: Jascha Fonden name: Centre for Digital Psychiatry, Mental Health Services in the Region of Southern Denmark briefSummary: In this study the investigators will evaluate the effectiveness of Mindhelper.dk, which is the most comprehensive online youth mental health promotion service in Denmark. |
A minimum of 9,426 young people aged 15 to 25 will be recruited through social media and invited to participate in the study. When responding to the baseline questionnaire participants will be randomized to either the intervention or control group. The intervention group will receive information about Mindhelper.dk and inspiration on how to use Mindhelper through text-messages during the study period. The control group does not receive information about Mindhelper.dk, until after completion of the last follow-up questionnaire. |
Three follow-up questionnaires will then be sent to the participants 2 weeks, 6 weeks and 12 weeks after randomization. |
The investigators expect a small, positive effect on participants well-being and psychological functioning in intervention groups as compared to the control group. conditions: Mental Health Issue conditions: Well-Being conditions: Adolescents conditions: Young Adults conditions: Online Intervention conditions: Internet-Based Intervention conditions: Randomized Controlled Trial studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study. |
Young people will be recruited through social medias. When responding to the baseline questionnaire participants will be randomized to either the intervention or control group. |
The intervention group will receive information about Mindhelper.dk and inspiration on how to use Mindhelper through text-messages during the study period. The control group does not receive information about Mindhelper.dk, until after completion of the last follow-up questionnaire. |
Three follow-up questionnaires will then be sent to the participants 2 weeks, 6 weeks and 12 weeks after randomization. primaryPurpose: OTHER masking: SINGLE maskingDescription: The participants are partly masked. The control group will be masked; however, the intervention group will not be masked. |
There is no care provider nor outcome assessor as all measures are self-reported and collected through online questionnaires. |
Analyses of data and interpretation of results will be done masked. whoMasked: INVESTIGATOR count: 9426 type: ESTIMATED name: Mindhelper- A national youth mental health promotion website measure: General well-being measure by "The Well-Being Index WHO-5" (WHO5) measure: Psychological functioning, measure by "The Short Warwick-Edinburgh Mental Well-Being Scale" (SWEMWBS). measure: Intentions to help-seeking measure: Body Appreciation measured by the "2-items Short forms of the Body Appreciation Scale-2" (2-item BAS-2SF). sex: ALL minimumAge: 15 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: National Institute of Public Health (NIPH), University of Southern Denmark city: Copenhagen state: Copenhagen K zip: 1455 country: Denmark name: Sofie H Hoffmann role: CONTACT phone: 65 50 77 34 phoneExt: +45 email: [email protected] name: Lau C Thygesen role: CONTACT phone: 65 50 77 71 phoneExt: +45 email: [email protected] lat: 55.67594 lon: 12.56553 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-04-22 uploadDate: 2024-04-22T08:21 filename: SAP_000.pdf size: 353976 hasResults: False |
<|newrecord|> nctId: NCT06385444 id: 2024-HS-020 briefTitle: IVF Failure and Pregnancy Loss on Couples' Psychological Stress overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-06-01 date: 2024-04-26 date: 2024-04-26 name: The First Hospital of Jilin University class: OTHER briefSummary: The goal of this observational study is to learn about The purpose of this study was to compare the psychological differences between couples after IVF transplant failure and IVF pregnancy loss, including the differences in anxiety, depression, stress and post-traumatic stress between women and their spouses. The main question it aims to answer is: |
What are the psychological effects of IVF implantation failure and IVF pregnancy loss on women and the psychological differences between couples? Participants already taking IVF as part of their regular medical care will answer online survey questions about their joint pain for 1 years. conditions: Fertilization in Vitro conditions: Pregnancy Loss conditions: Psychological Stress conditions: Post-traumatic Stress studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED measure: As the number of failed IVF implants increases, does it increase the difference in anxiety and depression between couples? measure: As the number of failed IVF implants increases, does it increase the difference in fertility stress between couples? measure: Does pregnancy loss after IVF transplantation have a differential effect on anxiety and depression between couples? measure: Does pregnancy loss after IVF transplantation have a differential effect on post-traumatic stress responses between couples? sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: the first hospital of Jilin University city: Chang chun state: Jilin zip: 130000 country: China name: Qi Xi, doctorate role: CONTACT phone: 15804303801 email: [email protected] lat: 42.74694 lon: 126.24667 hasResults: False |
<|newrecord|> nctId: NCT06385431 id: Charm briefTitle: Obeservational Cohort for Evaluating Future Cardiovascular Disease With High Metabolic Risks acronym: Charm overallStatus: NOT_YET_RECRUITING date: 2024-04-28 date: 2026-04-30 date: 2026-04-30 date: 2024-04-26 date: 2024-04-26 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: Cardiovascular and metabolic diseases refer to a large category of cardiovascular diseases accompanied by a series of metabolic disorders (including dyslipidemia, obesity, abnormal glucose tolerance, diabetes, hypertension, thyroid dysfunction, etc.), which is the primary cause of death and disease burden of Chinese residents.The number of deaths from atherosclerotic cardiovascular disease (ASCVD) in China is about 2.4 million, accounting for 61% of the total cardiovascular deaths, accounting for more than 40% of the all-cause deaths. In Chinese patients with coronary heart disease, 52.9% are complicated with diabetes.Despite the 1.1 million coronary stents implanted in China, there has been no reduction in cardiovascular mortality, which highlights the importance of threshold advancement and the management of metabolic risk factors. |
In recent years, the new concept of cardiovascular and metabolic diseases has been actively promoted at home and abroad, and the focus of prevention and treatment strategy of cardiovascular and metabolic diseases has been called for.The project proposed the concept of co-treatment of metabolic diseases based on disorders of blood pressure regulation, disorders of glucose metabolism and disorders of lipid metabolism. Subjects eligible for cardiovascular and metabolic diseases were screened, their past medical records were registered, education and diagnosis and treatment management were conducted. conditions: Metabolic Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 8000 type: ESTIMATED name: observational study measure: incidence rate of cardiovascular and metabolic diseases measure: treatment rate of cardiovascular and metabolic diseases measure: control rate of cardiovascular and metabolic diseases. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06385418 id: WST-CRC-202404 briefTitle: Fluorouracil Treatment Via Colon for Colorectal Cancer overallStatus: RECRUITING date: 2024-05-01 date: 2028-05-01 date: 2029-05-01 date: 2024-04-26 date: 2024-04-26 name: The Second Hospital of Nanjing Medical University class: OTHER briefSummary: Fluorouracil (5-FU) is a commonly used drug for colorectal cancer (CRC). Thermosensitive hydrogel presents a promising carrier for 5-FU to address challenges encountered with traditional administration methods. We propose an integrated approach utilizing colonic transendoscopic enteral tubing to cover the entire colon flexibly, coupled with a thermo-sensitive gel to enhance the adhesion of 5-FU. This clinical trial aims to assess the feasibility, safety, and efficacy of this approach for treating CRC. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Colonic local administration of fluorouracil with enhanced adhesion measure: Objective response rate (according to RECIST1.1, investigator assessment) measure: Progression-free survival measure: Overall survival measure: Disease control rate (according to RECIST1.1, investigator assessment) measure: Drop period to ensure operation resection measure: Converted resection rate measure: Actual R0 resection rate measure: The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210011 country: China name: Faming Zhang, MD, PhD role: CONTACT lat: 32.06167 lon: 118.77778 hasResults: False |
<|newrecord|> nctId: NCT06385405 id: 2024y0423 briefTitle: Electroencephalography-based Precise Repetitive Transcranial Magnetic Stimulation Treatment overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-05 date: 2024-04-26 date: 2024-04-26 name: Shanghai Mental Health Center class: OTHER name: National Natural Science Foundation of China name: Shanghai Municipal Science and Technology Commission name: Shanghai Jiao Tong University School of Medicine briefSummary: This study will focus on the hypothesis that repetitive transcranial magnetic stimulation (TMS) based on EEG personalized modulation may be more effective in promoting symptomatic relief of major depressive disorder (MDD), and will rely on the platform of neuroimaging and function brain imaging of Shanghai Mental Health Center (SMHC), an authoritative institution in the field of mental health. We will eventually facilitate optimization of physical therapy for major depressive disorder (MDD). conditions: Major Depressive Disorder (MDD) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To test the hypothesis that repetitive transcranial magnetic stimulation based on individualized EEG modulation may be more effective in promoting symptomatic relief of major depressive disorder (MDD), patients were tested in a parallel controlled trial.During the treatment period, patients will be randomly grouped into the precision group, which will be treated with rTMS based on personalized modulation of EEG data, and the conventional group, which will be treated with TMS at a frequency of 10 Hz to stimulate the left dorsolateral prefrontal cortex (DLPFC). primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Individualized alpha frequency Transcranial Magnetic Stimulation (αTMS) Treatment name: 10Hz-frequency TMS treatment over the left dorsolateral prefrontal cortex (DLPFC) measure: the effective rate measure: complete remission rate measure: alpha band spectral connectivity in electroencephalogram (EEG) parameters measure: Evaluation of therapeutic effect sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Mental Health Center city: Shanghai state: Shanghai zip: 200030 country: China name: TianHong Zhang, Doctor role: CONTACT phone: 13127577024 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06385392 id: A23-354 briefTitle: Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-26 date: 2024-04-26 name: HealthPartners Institute class: OTHER briefSummary: The proposed system (haptic module and insole device) for daily in-community use that detects the occurrence of freezing of gait (FOG) in people with Parkinson's disease (PD). and triggers external cueing stimuli to unfreeze the individual. The purpose of the overall Phase II study is to: (1) Develop a production ready system, (2) Develop a companion mobile app for the proposed system and refine previously developed FOG detection algorithms, and (3) Validate the proper operation of the system and demonstrate its efficacy through lab and in-community testing. This study will focus on validating the system and demonstrating efficacy through in-community testing. conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 36 type: ESTIMATED name: Haptic module and insole device measure: To validate the haptic module and insole device system and evaluate its efficacy with an in-community clinical trial. sex: ALL minimumAge: 45 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Struthers Parkinson's Center city: Golden Valley state: Minnesota zip: 55427 country: United States name: Research Coordinator role: CONTACT phone: 651-495-6363 email: [email protected] lat: 45.00969 lon: -93.34912 facility: HealthPartners Neuroscience Center city: Saint Paul state: Minnesota zip: 55130 country: United States name: Clinical Trial Coordinator role: CONTACT phone: 651-495-6363 email: [email protected] lat: 44.94441 lon: -93.09327 hasResults: False |
<|newrecord|> nctId: NCT06385379 id: WQ21-2301 briefTitle: Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study) overallStatus: RECRUITING date: 2024-04-30 date: 2025-12-31 date: 2030-12-31 date: 2024-04-26 date: 2024-04-26 name: Hangzhou Endonom Medtech Co., Ltd. class: INDUSTRY briefSummary: A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/pseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study) conditions: Aortic Arch Aneurysm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system measure: Rate of all-cause mortality and major stroke within 12 months after surgery measure: Rate of immediate technical success following surgery measure: Rate of aortic aneurysm progression under control measure: Incidence of Type I or Type III endoleak measure: Incidence of aortic covered stent graft displacement measure: Postoperative branch vessel patency rate measure: Rate of conversion to thoracotomy or secondary intervention measure: Rate of major adverse events measure: Rate of aortic aneurysm-related mortality measure: Incidence of severe adverse events measure: Incidence of device-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Anzhen Hospital, Capital Medical University status: RECRUITING city: Beijing country: China name: Zhong Chen role: CONTACT lat: 39.9075 lon: 116.39723 facility: Chinese PLA Gencral Hosptial status: RECRUITING city: Beijing country: China name: Wei Guo role: CONTACT phone: 13910758706 lat: 39.9075 lon: 116.39723 facility: The First Hospital of Jilin University status: RECRUITING city: Changchun country: China name: Yongsheng Gao role: CONTACT lat: 43.88 lon: 125.32278 facility: Xiangya Hospital of Central South University status: RECRUITING city: Changsha country: China name: Wei Wang role: CONTACT lat: 28.19874 lon: 112.97087 facility: West China Hospital of Sichuan University status: RECRUITING city: Chengdu country: China name: Jia Hu role: CONTACT lat: 30.66667 lon: 104.06667 facility: Guangdong Provincial Hospital of Traditional Chinese Medicine status: RECRUITING city: Guangzhou country: China name: Xiaoping Fan role: CONTACT lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital ,Sun Yat-sen University status: RECRUITING city: Guangzhou country: China name: Guangqi Chang role: CONTACT lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Harbin Medical University status: RECRUITING city: Harbin country: China name: Baodong Xie role: CONTACT lat: 45.75 lon: 126.65 facility: Shandong Provincial Hospital status: RECRUITING city: Jinan country: China name: Xuejun Wu role: CONTACT lat: 36.66833 lon: 116.99722 facility: The First People's Hospital of Yunnan Province status: RECRUITING city: Kunming country: China name: Kunmei Gong role: CONTACT lat: 25.03889 lon: 102.71833 facility: The Second Affiliated Hospital Of Nanchang University status: RECRUITING city: Nanchang country: China name: Weimin Zhou role: CONTACT lat: 28.68396 lon: 115.85306 facility: Nanjing First Hospital status: RECRUITING city: Nanjing country: China name: Xin Chen role: CONTACT lat: 32.06167 lon: 118.77778 facility: The First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing country: China name: Yongfeng Shao role: CONTACT lat: 32.06167 lon: 118.77778 facility: The Affiliated Hospital Of Qingdao University status: RECRUITING city: Qingdao country: China name: Mingjin Guo role: CONTACT lat: 36.06488 lon: 120.38042 facility: Shanghai Chest Hospital status: RECRUITING city: Shanghai country: China name: Dan Zhu role: CONTACT lat: 31.22222 lon: 121.45806 facility: Zhongshan Hospital, Fudan University status: RECRUITING city: Shanghai country: China name: Weiguo Fu role: CONTACT lat: 31.22222 lon: 121.45806 facility: The First Affiliated Hospital of China Medical University status: RECRUITING city: Shenyang country: China name: Shijie Xin role: CONTACT lat: 41.79222 lon: 123.43278 facility: Xiamen Cardiovascular Hospital status: RECRUITING city: Xiamen country: China name: Xijie Wu role: CONTACT lat: 24.47979 lon: 118.08187 facility: The First Affiliated Hospital of PLA Air Force Military Medical University status: RECRUITING city: Xian country: China name: Jian Zuo role: CONTACT lat: 34.25833 lon: 108.92861 facility: First Affiliated Hospital of Zhengzhou University status: RECRUITING city: Zhengzhou country: China name: Zhen Li role: CONTACT lat: 34.75778 lon: 113.64861 hasResults: False |
<|newrecord|> nctId: NCT06385366 id: GS_NP1 briefTitle: Developing & Evaluating Models for Early Predicting Obstetrical Diseases in Pregnant Women by Non-invasive Prenatal Test overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-05-06 date: 2025-06-06 date: 2024-04-26 date: 2024-04-26 name: Gene Solutions class: INDUSTRY name: Medical Genetics Institute (MGI) briefSummary: This is Observational study, aiming to investigate the potentiality of cffDNA and cfRNA by a non-invasive test, in combination with clinical characteristics, to establish models for early screening and predicting high-risk pregnancy of PE, SPB, and GDM in Vietnam. conditions: Pregnant With Complication conditions: Preeclampsia conditions: Preterm Birth conditions: Gestational Diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1105 type: ESTIMATED measure: Characteristics of pregnant women at 1st trimester (9-13 weeks 6 days of gestation) measure: Characteristics of pregnant women at recruitment measure: Define the significant differences between cases and controls measure: The development of learning machine models measure: Evaluation of the developed models sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06385353 id: 2022-CHITS-003 id: 2023-A02652-43 type: OTHER domain: ID-RCB number briefTitle: DVT Burden and the Risk of Post-thrombotic Syndrome acronym: DVT-Burden overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-04-26 date: 2024-04-26 name: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer class: OTHER name: Assistance Publique Hopitaux De Marseille name: F-CRIN INNOVTE Research Network briefSummary: Post-thrombotic syndrome (PTS) is the most common chronic complication of deep vein thrombosis (DVT), with major consequences for patient quality of life and cost of management. Identifying patients at high risk of developing PTS could be useful for its prevention and may lead to more appropriate therapeutic strategies to reduce its incidence and severity. |
Prognostic tools for predicting risk are very useful for choosing the optimum treatment and improving patient management and are a preliminary step before developing predictive models useful for determining sensitivity to treatment. At present, although several prognostic markers and models have been proposed, it is still difficult to predict who will develop a PTS or a moderate to severe PTS. The development of PTS is multifactorial and depends largely on the extent and severity of venous obstruction which supports the theory of thrombosis burden (DVT-Burden) as a potential prognostic marker for PTS. It therefore seems important to study the association between thrombosis burden and the occurrence of PTS. |
The Venous Volumetric Index or VVI (Ouriel 1999) will be used for quantifying DVT-Burden. The VVI was constructed by calculating the volume from the diameter and length of 14 venous segments from the calf veins to the inferior vena cava. The VVI has been validated for its ability to discriminate between symptomatic and asymptomatic DVT and has shown superior performance to other methods for quantifying DVT. |
This study aim to assess the performance of baseline DVT-burden estimated by the VVI score on ultrasound for predicting the occurrence and the severity of PTS as assessed by the Villalta scale at 6 months. conditions: Postthrombotic Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 400 type: ESTIMATED name: Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome measure: Presence of moderate to severe Post-thrombotic Syndrome (PTS) measure: Thrombosis burden measure: Presence of moderate to severe PTS adjusted to other prognostic factors at baseline measure: Thrombosis burden adjusted to other prognostic factors at baseline measure: Presence of moderate to severe PTS adjusted to other prognostic factors at baseline and during follow-up measure: Thrombosis burden adjusted to other prognostic factors at baseline and during follow-up measure: Time to complete resolution of the thrombus as a function of thrombosis burden at baseline measure: Presence of moderate to severe PTS at baseline and at follow-up visits measure: Thrombosis burden at baseline and at follow-up visits measure: Disease specific health related quality of life measure: General health related quality of life measure: Coagulation and fibrinolysis markers measure: Fibrinolytic and pro-coagulant activities of microvesicles/microparticles sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier de Carcassonne city: Carcassonne state: Aude zip: 11010 country: France name: Géraldine PAOLI-CAZANAVE role: CONTACT email: [email protected] lat: 43.21667 lon: 2.35 facility: Cabinet libéral city: Martigues state: Bouches-du-Rhône zip: 13500 country: France name: Damien DIAS role: CONTACT email: [email protected] lat: 43.40735 lon: 5.05526 facility: Cabinet libéral city: Ajaccio state: Corse-du-sud zip: 20090 country: France name: Jean-François SECONDI role: CONTACT email: [email protected] lat: 41.91888 lon: 8.73811 facility: Cabinet libéral city: Ajaccio state: Corse-du-sud zip: 20090 country: France name: Céline DE MARI role: CONTACT email: [email protected] lat: 41.91888 lon: 8.73811 facility: Centre Hospitalier Universitaire de Brest city: Brest state: Finistère zip: 29069 country: France name: Benjamin ESPINASSE role: CONTACT email: [email protected] lat: 48.3903 lon: -4.48628 facility: Clinique Rive Gauche city: Toulouse state: Haut-Garonne zip: 31076 country: France lat: 43.60426 lon: 1.44367 facility: Hospices Civils de Lyon, Hôpital Edouard Herriot city: Lyon state: Rhône zip: 69003 country: France name: Judith CATELLA role: CONTACT email: [email protected] lat: 45.74848 lon: 4.84669 facility: Centre Hospitalier Universitaire Amiens Picardie city: Amiens state: Somme zip: 830054 country: France name: Simon SOUDET role: CONTACT email: [email protected] lat: 49.9 lon: 2.3 facility: Centre Hospitalier de Fréjus/Saint-Raphaël city: Fréjus state: Var zip: 83600 country: France name: Hatem BOUGHIDA role: CONTACT email: [email protected] lat: 43.43286 lon: 6.73524 facility: Polyclinique Les Fleurs city: Ollioules state: Var zip: 83190 country: France name: Anaïs CORNE role: CONTACT email: [email protected] lat: 43.13517 lon: 5.848 facility: Centre cardio-vasculaire Esterel city: Saint-Raphaël state: Var zip: 83700 country: France lat: 43.42332 lon: 6.7735 facility: Cabinet libéral city: Sanary-sur-Mer state: Var zip: 83110 country: France name: Colin RICHARD role: CONTACT email: [email protected] lat: 43.11783 lon: 5.80007 facility: Cabinet libéral city: Six-Fours-les-Plages state: Var zip: 83140 country: France name: Sophia BENSEDRINE role: CONTACT email: [email protected] lat: 43.1 lon: 5.85 facility: Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer city: Toulon state: Var zip: 830054 country: France name: Jean-Noël POGGI role: CONTACT email: [email protected] lat: 43.12442 lon: 5.92836 facility: Centre Hospitalier d'Avignon city: Avignon state: Vaucluse zip: 84000 country: France name: Olivier GRAS role: CONTACT email: [email protected] lat: 43.94834 lon: 4.80892 hasResults: False |
<|newrecord|> nctId: NCT06385340 id: CentroDerm_LRP22003 briefTitle: Investigation of the Effect of Lipikar Baume AP+M overallStatus: NOT_YET_RECRUITING date: 2024-04-23 date: 2024-09-30 date: 2024-10-31 date: 2024-04-26 date: 2024-04-26 name: CentroDerm GmbH class: NETWORK briefSummary: Application of Lipikar Baume AP+M at least twice daily for 4 weeks on one of the two arms according to a randomization scheme The purpose of this study is to observe the skin barrier function, transepidermal water loss and microbial changes in study participants with actinic field damage of both arms. |
It's a randomized, evaluator blinded, intra-individual controlled study conducted in one center in Germany, in adult subjects having AK (grade I to III) lesions on the forearms and back of hands and meeting specific inclusion/exclusion criteria. |
A total of 20 subjects will be enrolled. |
The study design consists in 4-week evaluation period, with 2 visits per subject: Screening/Baseline (Day 0, Day 28 (end of Lipikar Baume AP+M application)). conditions: Actinic Keratoses studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: It's a randomized, evaluator blinded, intra-individual controlled study conducted in one center in Germany, in adult subjects having AK (grade I to III) lesions on the forearms and back of hands and meeting specific inclusion/exclusion criteria. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Lipikar Baume AP+M measure: Skin hydration measured by Corneometrie measure: Transepidermal water loss measured by Tewameter® measure: Aktinic keratosis area and severity index (AKASI) measure: S. aureus colonization and S. epidermidis colonization (application area) measure: Subjects's skin aspect measure: Absolute lesion count by application site measure: Olsen Grade evaluation: percentage of lesion with improvement at least 1 grade at D28 by application site measure: Number of new lesions on application area over the study period by application site measure: Symptom severity score: percentage across individual scores at each visit by application site measure: modified Treatment Satisfaction Questionnaire for Medication-9 (mTSQM-9) measure: Compliance (percentage of subjects using topical agents at all intended days, 90% of days or 75% of days) measure: Pictures at all time points sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06385327 id: ABI-5366-101 briefTitle: A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 With Recurrent Genital Herpes overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-07 date: 2025-07 date: 2024-04-26 date: 2024-04-26 name: Assembly Biosciences class: INDUSTRY briefSummary: This study is designed to assess safety, tolerability, and pharmacokinetics (PK) of single ascending dose (SAD) of ABI-5366 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-5366 in Part B in participants seropositive for Herpes Simplex Virus Type 2 (HSV-2) with recurrent genital herpes. Effect of food will also be evaluated in Part A. conditions: Recurrent Genital Herpes Simplex Type 2 studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 146 type: ESTIMATED name: ABI-5366 name: ABI-5366 Placebo measure: Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results measure: Area Under the Plasma Concentration Time Curve (AUC) of ABI-5366 measure: Maximum Observed Plasma Concentration (Cmax) of ABI-5366 measure: Time to Cmax (Tmax) of ABI-5366 measure: Apparent Terminal Elimination Half Life (t 1/2) of ABI-5366 measure: Apparent Systemic Clearance (CL/F) of ABI-5366 measure: Apparent Volume of Distribution (Vz/F) of ABI-5366 measure: Dose normalized AUCs and Cmax of ABI-5366 measure: SAD Cohorts: Comparison of plasma AUC and Cmax between fasted and fed treatments measure: MAD Cohorts: If applicable, comparison of plasma PK profiles and parameters with and without loading doses measure: MAD Cohorts: Difference in viral shedding rate (number of anogenital swabs positive for HSV-2 DNA/total number of swabs) across treatments measure: MAD Cohorts: Difference in mean and median HSV-2 DNA copies/mL for swab samples positive for HSV-2 DNA across treatments measure: MAD Cohorts: Difference in the proportion of swab samples with HSV-2 DNA >4 log10 copies/mL across treatments (number of swabbing samples with HSV-2 DNA >4 log10 copies/mL / total number of swabs obtained) measure: MAD Cohorts: Difference in number of shedding episodes during the swabbing period across treatments measure: MAD Cohorts: Difference in duration of shedding episodes during the swabbing period across treatments measure: MAD Cohorts: Difference in subclinical shedding rate (number of swabs positive for HSV-2 DNA in the absence of lesions/total number of swabs in the absence of lesions) across treatments measure: MAD Cohorts: Difference in lesion rate during the swabbing period across treatments measure: MAD Cohorts: Difference in lesion duration during the swabbing period across treatments measure: MAD Cohorts: Difference in recurrence rate (number of reappearances of lesions during the swabbing period/total days assessed) across treatments sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: New Zealand Clinical Research city: Auckland country: New Zealand name: Study Principal Investigator role: CONTACT lat: -36.84853 lon: 174.76349 hasResults: False |
<|newrecord|> nctId: NCT06385314 id: Degirmenci1499 briefTitle: A Cross Sectional Study on Dental Anxiety and State Anxiety Related to Removal of Fixed Partial Dentures overallStatus: COMPLETED date: 2022-09-05 date: 2023-11-25 date: 2023-12-29 date: 2024-04-26 date: 2024-04-26 name: Abant Izzet Baysal University class: OTHER briefSummary: This study aims to evaluate the effect of the clinical removal of fixed partial dentures (FPDs) on oral health-related quality of life (OHRQoL) and the anxiety values of individuals and to determine the risk factors of high anxiety levels. 300 participants were included in this study. Six different reasons for the clinical removal of FPDs (oral examination, denture renewal, root canal treatment, tooth extraction, periodontal treatment, and composite filling restoration) were defined. Questions pertaining to the United Kingdom Oral Health-Related Quality-of-Life Measure (OHQoL-UK), the Modified Dental Anxiety Scale (MDAS), and the Spielberger State-Trait Anxiety Inventory - State (STAI-S) and Trait (STAI-T) were answered. conditions: Dental Anxiety studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 300 type: ACTUAL name: Collecting data with oral health related quality of life, dental anxiety and state anxiety measure: United Kingdom Oral Health-Related Quality-of-Life Measure measure: Modified Dental Anxiety Scale measure: Spielberger State Anxiety Inventory measure: Spielberger Trait Anxiety Inventory sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kubra Degirmenci city: Bolu country: Turkey lat: 40.73583 lon: 31.60611 hasResults: False |
<|newrecord|> nctId: NCT06385301 id: Lung_disease_6MWD_SOT briefTitle: Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy With Chronic Lung Diseases overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-11 date: 2024-04-26 date: 2024-04-26 name: University of Zurich class: OTHER briefSummary: The investigators aim to study the effect of SOT in subjects with chronic lung disease in submaximal exercise. conditions: Lung Disease Chronic conditions: Lung Diseases, Interstitial conditions: Lung Diseases, Obstructive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Each participant is its own control primaryPurpose: OTHER masking: NONE count: 14 type: ESTIMATED name: 6-minute walk distance (6MWD) test on ambient air name: 6-minute walk distance test with supplemental oxygen (approximately 3l/min, nasal) measure: 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air measure: SpO2 at rest and peak 6MWD with SOT vs. ambient air measure: Heart rate at rest and peak 6MWD with SOT vs. ambient air measure: Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air measure: Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air measure: Blood pressure at rest and peak 6MWD with SOT vs. ambient air sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Zürich city: Zurich zip: 8091 country: Switzerland name: Silvia Ulrich, Prof. Dr. role: CONTACT phone: 0041 44 255 22 20 email: [email protected] name: Mona Lichtblau, Dr. role: CONTACT phone: +41442552220 email: [email protected] name: Silvia Ulrich, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False |
<|newrecord|> nctId: NCT06385288 id: 268/2021BO2 briefTitle: Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcomas overallStatus: RECRUITING date: 2021-07-21 date: 2026-07-21 date: 2031-07-21 date: 2024-04-26 date: 2024-04-26 name: University Hospital Tuebingen class: OTHER briefSummary: "Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcoma" is a prospective study with additional translational research using preoperative and postoperative tissue, blood sampling and advanced imaging. conditions: Soft Tissue Sarcoma Adult studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE maskingDescription: Open Label count: 30 type: ESTIMATED name: Blood and tissue collection for immunological studies, advanced imaging. name: neoadjuvant Therapy measure: Description of the cellular immune status via flow-cytometrie from collected blood samples measure: Description of the cellular immune status on tissue samples ussing komplex immunohistochemie measure: Measurement of the cellular free DNA from collected blood samples measure: Measurement of HMGB1 from collected blood samples measure: Evaluation of morphological tumor characteristics (size, diffusion) with weekly MRIs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Tuebingen status: RECRUITING city: Tübingen state: Baden-Württemberg zip: 72076 country: Germany name: Vlatko Potkrajcic, MD role: CONTACT phone: +49 7071 29 phoneExt: 82165 email: [email protected] name: Cihan Gani, MD role: CONTACT phone: +49 7071 29 phoneExt: 82165 email: [email protected] lat: 48.52266 lon: 9.05222 hasResults: False |
<|newrecord|> nctId: NCT06385275 id: H-44897 briefTitle: The Role of Vitamin K on Knee Osteoarthritis Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-12 date: 2026-12 date: 2024-04-26 date: 2024-04-26 name: Boston University class: OTHER name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) briefSummary: The appropriate form and dosing of vitamin K to benefit relevant outcomes in knee osteoarthritis (OA) are not known. In intervention studies for conditions other than knee OA (e.g., prevention of cardiovascular disease), the most commonly used forms and doses include phylloquinone (vitamin K1; 1000µg or 500µg daily) or menaquinone-7 (MK-7 or vitamin K2; 360µg daily). However, whether these doses are adequate to increase vitamin K to levels that ameliorate risk of adverse OA outcomes is not known. Furthermore, although some studies suggest enhanced bioavailability of MK-7 over vitamin K1, as well as extra-hepatic effects, whether this is relevant for an older population with knee OA is not known, |
The overall goal of this pilot randomized clinical trial (RCT) is to test different subtypes and doses of vitamin K supplementation in older adults with knee OA and to measure changes in relevant biochemical measures. conditions: Osteo Arthritis Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A stratified permuted block randomization will be used to assign 55 participants in a 1:1:1:1 ratio to each intervention arm. A random allocation sequence will be generated by computer in blocks of 4 or 8, stratified by sex and race. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Use of a placebo from Johnson Compounding Pharmacy (Waltham, MA) of similar appearance and taste to the vitamin K supplements will allow for masking of participants, the study PI, and other study team members to the treatment allocation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 55 type: ESTIMATED name: Vitamin K1 500 µg name: K1 1000 µg name: Vitamin K2 (MK-7) 360 µg name: Placebo measure: Change in uncarboxylated matrix Gla protein (ucMGP) levels measure: Change in phylloquinone levels measure: Sufficient phylloquinone levels measure: Change in menaquinone-7 (MK-7) levels measure: Study adherence measure: Participant acceptability of intervention sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Boston Medical Center, Rheumatology Clinic city: Boston state: Massachusetts zip: 02118 country: United States name: Jean Liew, MD MS role: CONTACT phone: 617-358-9655 email: [email protected] lat: 42.35843 lon: -71.05977 hasResults: False |
<|newrecord|> nctId: NCT06385262 id: Pro00114645 briefTitle: TOP 2301: Neoadjuvant Chemo for NSCLC overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-06-30 date: 2028-06-30 date: 2024-04-26 date: 2024-04-29 name: Duke University class: OTHER name: Regeneron Pharmaceuticals briefSummary: In this open-label, two-arm, randomized phase 2 clinical trial, patients with clinical stage 1B-3A non-small cell lung cancer (NSCLC) will receive neoadjuvant chemotherapy and cemiplimab every 3 weeks for 3 cycles with or without alirocumab every 4 weeks prior to surgery. |
Eligible patients will be randomized with equal allocation to two treatment groups. Permuted block randomization algorithm will be used for treatment assignment with stratification factors: stage (1B, 2A, 2B, 3A), and performance status (0 vs. 1). |
The study hypothesis is that the addition of alirocumab to neoadjuvant chemoimmunotherapy will make tumor cells more immunogenic to cytotoxic T cells, resulting in an increase in complete pathologic responses in surgically resected tumor. conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 126 type: ESTIMATED name: Alirocumab name: Cemiplimab name: Chemotherapy measure: Compare pathologic complete response (pCR) rate for neoadjuvant chemotherapy plus cemiplimab versus chemotherapy, cemiplimab, and alirocumab. measure: Assess the preliminary efficacy of chemotherapy and cemiplimab with alirocumab as determined by objective response rate (ORR) measure: Assess the preliminary efficacy of chemotherapy and cemiplimab with alirocumab as determined by disease-free survival (DFS) measure: Assess the preliminary efficacy of chemotherapy and cemiplimab with alirocumab as determined by overall survival (OS) measure: Determine the safety of neoadjuvant chemotherapy and cemiplimab with alirocumab in early-stage non-small cell lung cancer (NSCLC) measure: Determine the tolerability of neoadjuvant chemotherapy and cemiplimab with alirocumab in early-stage non-small cell lung cancer (NSCLC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06385249 id: NAV-0012 briefTitle: An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents overallStatus: RECRUITING date: 2024-04-03 date: 2024-10 date: 2024-12 date: 2024-04-26 date: 2024-04-26 name: Wellspect HealthCare class: INDUSTRY briefSummary: The study is designed to deliver further information on clinical benefit, patients' satisfaction, and perception of handling and to confirm safety of Navina Mini when used in children and adolescents. conditions: Bowel Dysfunction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: Navina Mini measure: Overall patient satisfaction measure: Incomplete bowel emptying measure: Episodes of fecal incontinence measure: Level of independence measure: Perception of handling of the device measure: Safety outcome sex: ALL minimumAge: 3 Years maximumAge: 17 Years stdAges: CHILD facility: H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset status: RECRUITING city: Linköping country: Sweden name: Peter Wide role: CONTACT phone: +46101031341 email: [email protected] name: Jenny Axelsson role: CONTACT phone: +46101032432 email: [email protected] lat: 58.41086 lon: 15.62157 hasResults: False |
<|newrecord|> nctId: NCT06385236 id: 804913 id: R01HL161362 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL161362 briefTitle: Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping acronym: EPIPHANY overallStatus: RECRUITING date: 2024-02-19 date: 2027-06-30 date: 2028-01-31 date: 2024-04-26 date: 2024-04-26 name: University of California, San Diego class: OTHER name: Mayo Clinic name: Yale University name: University of Arizona name: Harvard University name: Brigham and Women's Hospital name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: In this study, a new method will be used to evaluate response to 2 approved biologic therapies, and assess how well each patient responds to each asthma treatment. This study will measure the response to these treatments using genomic and biologic measurements obtained from participants biosamples. |
By evaluating response to 2 different biologic therapies, this study has the potential to provide an in-depth understanding of the mechanisms underlying severe asthma that will inform and change treatment decisions, and may ultimately lead to a change in the way that asthma patients are evaluated for potential personalized therapies and maximize the probability that the subject will respond to treatment. conditions: Moderate to Severe Asthma studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study is significant in determining molecular disease endotypes in a large group of moderate to severe asthmatics. By evaluating within-person genomic level changes and response to 2 different biologic therapies, this study has the potential to provide an in-depth understanding of the mechanisms underlying severe asthma that will inform and change treatment decisions. primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Dupilumab name: Benralizumab measure: Predicting asthma outcomes and therapeutic responses measure: Responses to the biologic therapies at the single cell level measure: Unique asthma subgroups clinical and molecular endotype approaches measure: Asthma Control Questionnaire (ACQ) measure: CompEx events measure: Asthma Quality of Life Questionnaire (AQLQ) measure: Forced expiratory volume in 1 second (FEV1) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic status: RECRUITING city: Scottsdale state: Arizona zip: 85259 country: United States name: Karalyn Folmes, Ph.D. role: CONTACT phone: 480-301-4298 email: [email protected] name: Gene R Bleecker, MD role: PRINCIPAL_INVESTIGATOR name: Deborah A Meyers, PhD role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: University of California, San Diego status: RECRUITING city: La Jolla state: California zip: 92093 country: United States name: Asthma Research Team role: CONTACT phone: 619-431-0995 email: [email protected] name: Kelan Tantisira, MD role: PRINCIPAL_INVESTIGATOR name: Praveen Akuthota, MD role: PRINCIPAL_INVESTIGATOR lat: 32.84727 lon: -117.2742 facility: Yale University status: RECRUITING city: New Haven state: Connecticut zip: 06520 country: United States name: Katherine Spaulding role: CONTACT phone: 203-737-5572 email: [email protected] name: Geoffrey L Chupp, MD role: PRINCIPAL_INVESTIGATOR lat: 41.30815 lon: -72.92816 hasResults: False |
<|newrecord|> nctId: NCT06385223 id: DSRB 2023/00680 briefTitle: A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-07-01 date: 2026-12-31 date: 2024-04-25 date: 2024-04-25 name: Institute of Mental Health, Singapore class: OTHER name: National University of Singapore briefSummary: The Investigators propose to carry out a randomized, double-blind trial to compare the clinical efficacy of an individualized connectome-guided accelerated iTBS vs an anatomically-guided (Beam F3) accelerated iTBS. The study team will recruit both inpatients and outpatients who had been referred for TMS for the treatment of depression. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Beam F3 targeted accelerated iTBS name: Individualized connectome-guided accelerated iTBS measure: Montgomery-Åsberg Depression Rating Scale measure: Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) measure: Montreal Cognitive Assessment (MoCA) measure: EQ-5D (EuroQol) measure: Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF) measure: TMS induced changes in resting-fMRI functional connectivity sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06385210 id: 22SM7855 briefTitle: Barriers to Routine Surgical Video Recording overallStatus: COMPLETED date: 2024-04-01 date: 2024-04-24 date: 2024-04-24 date: 2024-04-25 date: 2024-04-26 name: Imperial College London class: OTHER briefSummary: In order to improve the implementation of routine surgical video recording, the researchers want to understand what the challenges associated with the uptake of this technology are. The aim of this study is to explore the barriers faced by key stakeholders including the surgical care team, information governance, and patients within the field of surgical video reporting. The data from this qualitative study will allow the researchers to understand better the challenges associated with uptake of surgical video recording. This will allow the researchers to develop strategies to overcome these challenges and subsequently improve uptake of surgical video recording which will promote safer and more transparent surgery. conditions: Minimally Invasive Surgery conditions: Laparoscopic Surgery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 15 type: ACTUAL name: Semi structured interviews measure: Stakeholder perceived barriers to surgical video recording sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Surgery and Cancer city: London zip: W2 1NY country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False |
<|newrecord|> nctId: NCT06385197 id: 170886-HMO-CTIL briefTitle: Improving the Effect of Multiple Sclerosis Drugs by Chronobiology overallStatus: COMPLETED date: 2022-05-08 date: 2023-06-01 date: 2023-06-02 date: 2024-04-25 date: 2024-04-25 name: Hadassah Medical Organization class: OTHER briefSummary: A trial for evaluating the ability to improve the effect of dimethyl fumarate in patients with Multiple Sclerosis (MS) by chronobiology A controlled-randomization dosing regimen administered to patients with MS and provided by a designated app. The treatment limitations of time interval is pre-defined according to approved therapeutic windows. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A controlled-randomization dosing regimen administered to patients with MS and provided by a designated app. The treatment limitations of time interval is pre-defined according to approved therapeutic windows. primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 8 type: ACTUAL name: App randomizing dosing regimen measure: safety assessment sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hadassah Medical Center city: Jerusalem country: Israel lat: 31.76904 lon: 35.21633 hasResults: False |
<|newrecord|> nctId: NCT06385184 id: NCR234859 briefTitle: Social & QoL Behaviors in Parkinson's Disease overallStatus: RECRUITING date: 2024-03-08 date: 2025-12-31 date: 2025-12-31 date: 2024-04-25 date: 2024-04-25 name: Gregory Wallace class: OTHER briefSummary: Adults with Parkinson's Disease experience an array of challenges and changes in daily living, behaviors, and functioning throughout the progression of their condition. The investigators want to learn more about the effects of Parkinson's Disease on individuals' social behavior and quality of life (QoL) compared to people of the same age without Parkinson's Disease. conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 500 type: ESTIMATED name: No Intervention measure: Subjective Quality of Life measure: Social Behavior measure: Activities of Daily Living measure: Mental Health measure: Cognition sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The George Washington University status: RECRUITING city: Washington state: District of Columbia zip: 20052 country: United States name: Gregory Wallace, PhD role: CONTACT phone: 202-994-8285 email: [email protected] lat: 38.89511 lon: -77.03637 hasResults: False |
<|newrecord|> nctId: NCT06385171 id: FFA-BTX-1 briefTitle: Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-08-01 date: 2027-01-05 date: 2024-04-25 date: 2024-04-25 name: Global Aesthetics LLC class: OTHER briefSummary: A study conducting to see how well a treatment called Botulinum Toxin Type A works for reducing facial wrinkles. The study will help us understand if this treatment is safe and effective for making wrinkles on the face less noticeable. conditions: Wrinkle studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Botulinum toxin type A measure: Change in facial wrinkles and Lines measure: Facial Appearance measure: Assessment of Wrinkle Severity measure: Assessment of Skin Reaction sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Global Aesthetics LLC city: Cisco state: Texas zip: 76437 country: United States lat: 32.38819 lon: -98.97923 facility: Global Aesthetics LLC city: Lubbock state: Texas zip: 79413 country: United States name: Otis Scroggins, BS, CNA role: CONTACT phone: 806-370-7428 email: [email protected] lat: 33.57786 lon: -101.85517 hasResults: False |
<|newrecord|> nctId: NCT06385158 id: GenSci074-101 briefTitle: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Dose Escalation of GS1-144 Tablets and the Effects of Food on the Pharmacokinetics of GS1-144 in a Chinese Population overallStatus: RECRUITING date: 2024-04 date: 2024-07 date: 2024-08 date: 2024-04-25 date: 2024-04-25 name: Changchun GeneScience Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: A Phase I clinical study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral dose escalation of GS1-144 tablets and the effects of food on the pharmacokinetics of GS1-144 in a Chinese population conditions: Vasomotor System; Labile conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 110 type: ESTIMATED name: GS1-144 tablet measure: Part 1:Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) measure: Part 2: Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). measure: Part 3: Number of Participants With TEAEs and SAEs measure: Part1,Part2 and Part3 AUC0-t- Area Under the Drug Concentration-time Curve From Time 0 to the Last Sample Collection Time t for GS1-144 measure: Part 1 , Part2 and Part 3: AUC0-infinity- Area Under the Drug Concentration-time Curve From 0 to Infinity for GS1-144 measure: Part 1, Part2 and Part 3: Cmax- Maximum Observed Plasma Concentration for GS1-144 measure: Part 1 Part2 and Part 3: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for GS1-144 measure: Part 1 Part2 and Part 3:: T1/2- Terminal Half-life for GS1-144 measure: Part 1 Part2 and Part 3: CL/F- Apparent Clearance for GS1-144 measure: Part 1 Part2 and Part 3: Vd/F- Apparent Volume of Distribution for GS1-144 measure: Cmax,ss- Observed Maximum Concentration at Steady State for GS1-144 measure: Part 3: Cmin,ss- Observed Minimum Concentration at Steady State for GS1-144 measure: Part 3: Tmax,ss- Time of Cmax at Steady State for GS1-144 measure: Part 3: Cavg,ss- Average Concentration at Steady State for GS1-144 measure: Part 3: AUC0-τ- Area Under the Drug Concentration-time Curve During the Dosing Interval at Steady State for GS1-144 measure: Part 3: CLss/F- CL for Bioavailability at Steady State for GS1-144 measure: Part 3: T1/2,ss- Terminal Half-life at Steady State for GS1-144 measure: Part 3: Accumulation Ratio for GS1-144 measure: Part 1: Baseline and placebo-adjusted changes in ∆∆QTc and other ECG parameters after oral administration of GF1-144 in healthy subjects sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huashan Hospital, Fudan University status: RECRUITING city: Shanghai state: Shanghai zip: 200040 country: China lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06385145 id: GenSci004-107 briefTitle: A Bioavailability Study of Two Different PEG-rhGH Preparations. overallStatus: NOT_YET_RECRUITING date: 2024-05-08 date: 2024-07-13 date: 2024-12-26 date: 2024-04-25 date: 2024-04-25 name: Changchun GeneScience Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations. conditions: Pediatric Growth Hormone Deficiency (PGHD) studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 16 type: ESTIMATED name: PEG-rhGH with new preparation (T) name: PEG-rhGH with present preparation (R) measure: Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation measure: Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-inf)) of PEG-rhGH with present and new preparation measure: Pharmacokinetics (Area under the concentration-time curve from time zero to the time of the last quantifiable (AUC0-last)) of PEG-rhGH with present and new preparation measure: Safety and tolerability (Number of participants with treatment-related adverse events) measure: Peak Plasma Concentration (Cmax) of Insulin-like growth factor-1 (IGF-1) with present and new preparation measure: Area under the concentration-time curve from time zero to time infinity (AUC0-inf) of Insulin-like growth factor-1 (IGF-1) with present and new preparation measure: Anti-drug antibody (Number of Participants with positive ADA) sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Chengdu Xinhua Hospital city: Chengdu state: Sichuan zip: 610000 country: China name: Xiaolan Yong, Doctor role: CONTACT phone: +862860212136 email: [email protected] lat: 30.66667 lon: 104.06667 hasResults: False |
<|newrecord|> nctId: NCT06385132 id: 6447 briefTitle: Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer acronym: APPOINT overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-30 date: 2025-10-31 date: 2024-04-25 date: 2024-04-25 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Approximately 30% of cancer patients may experience psychopathological disorders. The most common psychopathological disorders in cancer patients are mood disorders, anxiety, depression, adjustment disorders, and suicidal ideation. Among depressive disorders, mixed depression, with the simultaneous presence of symptoms of both depressive and manic polarity, is associated to higher levels of chronicity, functional impairment and suicidality. These disorders can also be worsened by loneliness and demoralization. |
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