pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Effect of Developmental Care on Very Low Birth Weight Infants
NCT Number: NCT06515574
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intervention
Interventions: BEHAVIORAL: developmental care
Sponsor: Children's Hospital of Fudan University
Sex: ALL
Age: CHILD
Enrollment: 1600
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-15
Completion Date: 2027-12-01
Locations: Children's Hospital of Fudan University, Shanghai, Shanghai, 200032, China

Summary:
The goal of this clinical trial is to learn if developmental care works when implemented in very low birth weight infants. The main questions it aims to answer are:

* Does developmental care shorten the length of hospital stay in the very low birth weight infants?
* Does developmental care increase the opportunity of family centered care in the very low birth weight infants? The clinical trial will use a 36-month stepped-wedge cluster-randomised trial conducted across 40 Neonatal intensive care units . A developmental care bundle will be tailored to meet the identified needs of participating NICUs.

Primary Outcome Measures: Length of hospital stay, Length of hospital stay (in days), From the day admitted into the NICU until day on discharge, generally assessed up to 1 year
Secondary Outcome Measures: Skin to skin care duration, Skin-to-skin care, also known as kangaroo care, involves placing a newborn baby directly on a parent's bare chest. Record the duration of skin to skin care every day during the hospitalization by hours, From the day admitted into the NICU until day on discharge, generally assessed up to 1 year
Other Outcome Measures: Parental involvement duration, Parental involvement in our study is defined as the parents take part in the daily Care Activities (diapering, bathing, clothing and feeding for their babies).Record the duration of parental involvement every day during the hospitalization by hours, From the day admitted into the NICU until day on discharge, generally assessed up to 1 year
Prevalence of Teeth Discoloration , Associated Risk Factors and the Most Common Shade Among Group of Egyptian Population
NCT Number: NCT06515561
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Discoloration, Tooth
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 213
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-09

Summary:
"The aim of this study is to assess the prevalence of tooth discoloration and explore its associated risk factors, including local cultural practices or environmental conditions, among a group of adults aged 20 to 45 years in an Egyptian population sample. Moreover, we aim to identify the most common dental shades in the same sample."

Primary Outcome Measures: prevalence and severity of discoloration, assessment of the prevalence and severity of dental discoloration among adults in the study area., 3 months
Secondary Outcome Measures: risk factors and their association with discoloration, Identification of risk factors and their association with discoloration in the study population and knowing the most common teeth shade among the same group of population., 3 months|Most common teeth shade, determination of most common teeth shade usingVita classical shade guide, 3 months
Assessment the Efficacy of Vitamin D Mouth Rinse Versus Placebo in the Treatment of MIH
NCT Number: NCT06515548
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Molar Incisor Hypomineralization
Interventions: DRUG: Vitamin D3 mouth wash
Sponsor: Cairo University
Collaborators: MTI University
Sex: ALL
Age: CHILD
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2024-12
Locations: Cairo University, Faculty of Dentistry., Giza, 12613, Egypt

Summary:
In child patients with molar incisor hypo mineralization, Will Vitamin D mouth wash offer more success for patients with MIH as regards better MIH TNI index, decrease plaque accumulation, more gingival health and less bleeding on probing differentiated from placebo mouthwash?

Primary Outcome Measures: MIH TNI, 3 months|Gingival Index, 3 months|Plaque Index, 3 months
Secondary Outcome Measures: Bleeding on Probing, 3 months
Efficacy of Topical Tranexamic Acid in Reducing Blood Loss During CS in Patients With Placenta Previa
NCT Number: NCT06515535
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Placenta Previa
Interventions: DRUG: Topical tranexamic acid|DRUG: Intravenous tranexamic acid
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-24
Completion Date: 2024-12-31

Summary:
Objectives: To evaluate the efficacy of topical tranexamic acid applied on the placental bed after placental delivery to reduce blood loss during cesarean delivery in women with placenta previa.

Patients will be randomly assigned into two groups:

Group (A) - Study group (n=28): The topical tranexamic acid group will receive topical tranexamic acid after placental delivery applied on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9%, in addition to the IV infusion of 1g tranexamic acid (2 ampules 500ug) diluted with 20ml of 5% glucose administered just after delivery of the fetus.

Group (B) - Control group (n=28): The intravenous tranexamic acid group will receive only an IV infusion of 1g of tranexamic acid (2 ampules 500ug) diluted with 20 ml of 5% glucose administered just after delivery of the fetus.

Primary Outcome Measures: Amount of blood loss, amount of intraoperative blood loss during CS in patients with placenta previa, during operation
Secondary Outcome Measures: operative time, during operation
Evaluation of the Dimensional Alveolar Bone Changes in Immediate Post Extraction Implant Placement
NCT Number: NCT06515509
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Immediate Implant With Loading
Interventions: PROCEDURE: immediate implant placement with or without loading
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-07-16
Completion Date: 2024-07-16
Locations: Cairo University, Cairo, Egypt

Summary:
The aim of this study was to evaluate the dimensional alveolar bone changes in immediate post extraction implant placement with loading compared to immediate post extraction implant placement without loading in the maxillary premolar area . The main question it aims to answer is : Can immediate post extraction implant placement in the maxillary premolar area with loading achieve better alveolar bone dimensions than without loading?

Primary Outcome Measures: Height of alveolar bone crest, After the implants are placed, a series of digital radiographs are obtained at 0 , 3, and 6 months duration to study the changes in the amount of crestal bone level., 6 months
Secondary Outcome Measures: Implant stability, Implant stability quotient (ISQ) values were measured with an Osstell® (Integration Diagnostics AB, Gothenburg, Sweden), 6 months|Alveolar bone width, (CBCT) images are used for evaluation of alveolar bone width around all implant sides all over. At 0. 3, 6 month postoperative by using superimposition and subtraction method, 6 months|post-surgical patient satisfaction, Post-Surgical Patient Satisfaction Questionnaire (PSPSQ) composed of 3 questions is filled by the patient and numerical score is obtained, 6 months
A Clinical Trial to Examine the Efficacy of a Dietary Supplement to Improve the Health and Appearance of Hair.
NCT Number: NCT06515496
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hair Thinning|Hair Shedding
Interventions: DIETARY_SUPPLEMENT: Scale HLV Clinical Formula Hair Vitamins|OTHER: Placebo
Sponsor: Scale Media Inc
Collaborators: Citruslabs
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-26
Completion Date: 2024-09-26
Locations: Citruslabs, Santa Monica, California, 90404, United States

Summary:
This study evaluates the efficacy of Scale Media's HLV Clinical Formula Hair Vitamins on the health and appearance of hair, focusing on growth, volume, dullness, overall health, hair shedding, fullness, and strength. It is a randomized controlled trial with 50 female-at-birth participants experiencing self-perceived hair thinning.

Primary Outcome Measures: Reduction in Hair Shedding, Hair shedding will be measured through hair counts from the at-home comb test and hair health will be evaluated through expert dermatologist grading based on photos provided by participants., Baseline, Day 90, and Day 180
Secondary Outcome Measures: Improvement in Hair Health Perception, Participants' perceptions of the product's effect on overall hair health, including volume, dullness, fullness, and strength, will be evaluated through self-reported questionnaires., Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180
Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss
NCT Number: NCT06515483
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gingivitis|Supragingival Plaque
Interventions: DEVICE: Brushing and Flossing of teeth|OTHER: Brushing Only
Sponsor: Indiana University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09-03
Completion Date: 2024-12-15
Locations: Indiana University School of dentistry, Oral Health Research institute 415 Lansing Street, Indianapolis, Indiana, 46202, United States

Summary:
This will be a single-blind, single-center, parallel, randomized controlled clinical trial to evaluate the efficacy and safety of Floss Loops stretchable floss for the control of gingivitis and supragingival plaque removal between two groups, control (no-floss) and experimental (flossing with Floss Loops), during thirty (2 +/-) days.

Primary Outcome Measures: Dental Plaque Assessment, Dental plaque will be identified using a disclosing solution and scored using the Turesky modification of the Quigley and Hein Plaque Index (PLI). The index score will be between 0 to 5, with 0 = no plaque detected and 5= Plaque covering 2/3 or more of the crown of the tooth. The rest of the values are based on the amount of plaque covering the tooth. Each tooth, except the third molars, will be scored on six sites (Mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, and disto-lingual). The plaque score index for an individual is determined by adding all the individual scores and dividing the total score by the number of surfaces examined., Baseline and 30 days examination|Gingivitis Assessment, The comprehensive Löe \& Silness Index (GI) will be used. This index will assess the health of the gingiva based on the clinical appearance and the presence or absence of bleeding on probing (BOP). Each tooth will be visually assessed on six surfaces (Mesio-buccal, buccal, distobuccal, mesio-lingual, lingual, and disto-lingual). For the bleeding portion of the index, all the sites will be gently probed along the wall of the gingival sulcus. For the GI calculation, all the values for each tooth will be added and divided by the number of surfaces examined. A score would range from 0.1 to 3.0 (0.1-1.0= = mild inflammation; 1.1-2.0= = moderate inflammation; and 2.1-3.0= = severe inflammation), Baseline and 30 days examination
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTX-9341 in Advanced and/or Metastatic Breast Cancer
NCT Number: NCT06515470
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Breast Cancer
Interventions: DRUG: BTX-9341|DRUG: Fulvestrant|DRUG: BTX-9341
Sponsor: Biotheryx, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 82
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-03
Completion Date: 2027-12-31
Locations: Biotheryx Investigative Site, San Antonio, Texas, 78229, United States

Summary:
The purpose of this study is to test BTX-9341 alone or in combination with fulvestrant (a currently marketed medication for breast cancer) in participants with advanced and/or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. The study includes a dose escalation part (Part A) where small groups of participants will receive increasing doses of BTX-9341 or BTX-9341 + fulvestrant followed by a dose expansion part (Part B) where participants will receive the dose of BTX-9341 selected in Part A + fulvestrant.

Primary Outcome Measures: Safety and Tolerability of BTX-9341, Frequency and severity, incidence of treatment-emergent and treatment-related adverse events using NCI-CTCAE v5.0, Up to 28 days after last dose of BTX-9341|Part A: Number of Participants With Dose Limiting Toxicities (DLTs), DLT rate in Cycle 1, 28 days|Part A: Determine MTD/MED of BTX-9341 in monotherapy, Based on CTCAE v5.0 assessment of adverse events, Approximately 1 year from study start|Part A: Determine MTD/MED of BTX-9341 in combination therapy, Based on CTCAE v5.0 assessment of adverse events, Approximately 18 months from study start|Part B Combination Therapy: Objective Response (OR) rate, OR is the confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 as determined by Investigator assessment, Approximately 18 months from start of Part B
A Clinical Trial to Evaluate the Efficacy of an Oral Supplement in Supporting Vision and Eye Health
NCT Number: NCT06515457
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Inflammation Symptoms|Eye Dryness|Eye Health
Interventions: DIETARY_SUPPLEMENT: Eye Empower
Sponsor: Bio Nature Health
Collaborators: Citruslabs
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-22
Completion Date: 2024-06-01
Locations: Citruslabs, Santa Monica, California, 90404, United States

Summary:
This study aims to evaluate the efficacy of BioNatureHealth's Eye Empower supplement in supporting vision and eye health. It is a virtual, single-group trial lasting 3 weeks. Participants will take three capsules of the supplement daily and complete questionnaires at Baseline, Week 1, Week 2, and Week 3 to assess visual clarity, dryness, symptoms of inflammation, and sensitivity to blue light.

Primary Outcome Measures: Improvement in Visual Clarity, Participants will report on their visual clarity through self-reported questionnaires. The questionnaires will evaluate changes in visual clarity from baseline., Baseline, Week 1, Week 2, and Week 3|Reduction in Eye Dryness, Participants will self-report changes in eye dryness through questionnaires administered at specific intervals during the study. Parameters include the frequency and severity of dry eye symptoms., Baseline, Week 1, Week 2, Week 3|Reduction in Symptoms of Inflammation, Participants will self-report changes in symptoms of eye inflammation through questionnaires administered at specific intervals during the study. Parameters include redness, irritation, and discomfort., Baseline, Week 1, Week 2, Week 3|Reduction in Sensitivity to Blue Light, Participants will self-report changes in sensitivity to blue light through questionnaires administered at specific intervals during the study. Parameters include the degree of discomfort experienced when exposed to blue light from screens and other sources., Baseline, Week 1, Week 2, Week 3
Secondary Outcome Measures: Improvement in Overall Eye Health, Participants will report on their overall eye health through self-reported questionnaires. The questionnaires will assess changes in symptoms such as eye dryness, symptoms of inflammation, and sensitivity to blue light., Baseline, Week 1, Week 2, and Week 3
Myocardial Injury After Radical Nephrectomy
NCT Number: NCT06515431
Acronym: MANE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myocardial Injury
Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators: University of Sheffield
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-18
Completion Date: 2025-06
Locations: Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, S10 2JF, United Kingdom

Summary:
Kidney removal for cancer (nephrectomy) is a major operation. People can develop heart complications during or after surgery, especially if they are older or already have heart disease. One form of heart damage is called myocardial injury (MINS). This can be detected with a simple and easily available blood test. Unlike a heart attack, MINS doesn't cause changes in the electrical tracing of the heart (ECG) and it typically doesn't cause symptoms like pain. However, it can lead to heart problems and a stroke after surgery. We do not know how many people having a nephrectomy develop MINS. It is important to know if people are at high risk of MINS to help decide future treatment.

There are a few different ways of carrying out nephrectomy surgery. These can be traditional open surgery, keyhole surgery or robotic surgery. We know that MINS is more likely if there has been a lot of bleeding during the operation, but other factors are also important. Therefore, it's important to monitor the relationship between blood loss, rates of MINS and method of surgery.

We aim to recruit 120 participants undergoing nephrectomy to see how many develop MINS and to compare blood loss between different ways of surgery. Patients will be asked to consent to have blood tests on the day of and the day after surgery. This test will be added to routine hospital blood tests (and so no extra samples are needed). These results will show how many patients are diagnosed with MINS after nephrectomy. Around 90 days after the surgery, their quality of life and any further heart or breathing problems will also be recorded.

We hope to identify the rates of and risk factors for MINS, so future patients can be spared this complication of surgery.

Primary Outcome Measures: Proportion of patients undergoing radical nephrectomy with evidence of myocardial injury (MINS), This will be defined as a raised troponin level \>99th percentile upper reference limit on any sample taken within 72 hours following the operation., 72 hours post surgery
Secondary Outcome Measures: Occurrence of intraoperative and post-operative blood transfusion, 72 hours post surgery|Number of days out of hospital, 90 days post surgery|Rate of major adverse cardiac events (MACE), MACE events are defined as (myocardial infarction, stroke, arrhythmia, cardiac arrest, and cardiac related death, 90 days post surgery|Impact on quality of life, assessed by EQ-5D-5L questionnaire completed by patients, 90 days post surgery
TIA Scores' Mortality Predictions and Recurrent TIA and Stroke Prediction
NCT Number: NCT06515392
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stroke, Ischemic|Transient Ischemic Attack
Sponsor: Saglik Bilimleri Universitesi
Collaborators: Ankara Etlik City Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2025-06-01
Locations: Etlik City Hospital, Ankara, Yenimahalle, 06170, Turkey

Summary:
Our study adopts a prospective design. Our research aims to determine the significance of ABCD2, ABCD3-I, Canadian TIA Score, and NIHSS Score in predicting the likelihood of ischemic stroke within 30 days in patients presenting to the emergency department with transient ischemic attack (TIA)

Primary Outcome Measures: recurrent TIA or stroke, recurrent TIA within 30 days of follow-up, 30 days
Emergency Department Management of Patients With Renal Infarction
NCT Number: NCT06515379
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Renal Infarct|Renal Infarction - Venous|Renal Infarction - Arterial
Sponsor: Saglik Bilimleri Universitesi
Collaborators: Diskapi Teaching and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-15
Completion Date: 2024-05-15
Locations: Diskapi Teaching and Research Hospital, Ankara, Altindag, 06110, Turkey

Summary:
The aim of this study is to investigate laboratory parameters from medical records of patients diagnosed with renal infarction in our emergency clinic to establish early diagnostic indicators. Additionally, we will evaluate imaging methods such as CT or CT angiography and identify mortality-morbidity markers to contribute to the literature.

Primary Outcome Measures: Renal Infarction, patients diagnosed with renal infarction, 9 years
MAP( Mean Arterial Pressure) and Mortality Relation in Patients With Heart Failure
NCT Number: NCT06515366
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Failure
Sponsor: Saglik Bilimleri Universitesi
Collaborators: Ankara Etlik City Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 280
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2025-06-01
Locations: Etlik City Hospital, Ankara, Yenimahalle, 06170, Turkey

Summary:
Aim of this observational study is to evaluate the relationship between mean arterial pressure (MAP) and mortality in patients presenting to the emergency department with acute heart failure, focusing on emergency department monitoring and subgroup presentations. Our goal is to determine the impact of subgroup characteristics on mortality among patients presenting with heart failure in the emergency department, and to assess the predictive value and significance of MAP in predicting mortality.

Primary Outcome Measures: mortality, patients having mortaility within 1 month of follow up, 1 month
Secondary Outcome Measures: re-hospitalization, patients being re-hospitalized within 1 month after discharge from hospital, 1 month
Gastrointestinal Bleeding and Atmospheric Pressure Relationship
NCT Number: NCT06515353
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atmospheric Pressure; Adverse Effect|GastroIntestinal Bleeding
Sponsor: Saglik Bilimleri Universitesi
Collaborators: Ankara Etlik City Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-05
Completion Date: 2024-11-05
Locations: Etlik City Hospital, Ankara, Yenimahalle, 06170, Turkey

Summary:
This study aims to investigate whether atmospheric pressure has an effect on upper gastrointestinal bleeding (UGIB), which includes causes such as peptic ulcer disease, esophagitis, gastritis, gastrointestinal varices, Mallory-Weiss tears, and gastric cancer. The goal is to determine the impact of atmospheric pressure and gather information on its role in high-risk UGIB.

Primary Outcome Measures: gastrointestinal bleeding, patients administered to emergency department with gastrointestinal bleeding, 24 hours
Effects of Corticosteroid Use on Restoration of Spontaneous Circulation in Cardiac Arrest Patients
NCT Number: NCT06515327
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiopulmonary Arrest|Corticosteroids Adverse Reaction
Sponsor: Saglik Bilimleri Universitesi
Collaborators: Ankara Etlik City Hospital|Etimesgut Military Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-08-01
Locations: Etlik City Hospital, Ankara, Yenimahalle, 06170, Turkey

Summary:
We aim to investigate the effects of pre-arrest corticosteroid use for any reason on the time of return of spontaneous circulation in patients experiencing witnessed cardiac arrest, either in-hospital or out-of-hospital. Additionally, we plan to study the effects of corticosteroid use on post-ROSC administration of vasoactive agents, required dosage of vasoactive agents and number of vasoactive agents needed in order to reach targeted blood pressure levels.

Primary Outcome Measures: return of spontaneous circulation, patients with return of spontaneous circulation within 20 minutes of cardiopulmonary resuscitation, 20 minutes after cardiac arrest
HRYZ-T102 TCR-T Cell for AFP Positive Advanced HCC and Other Solid Tumors
NCT Number: NCT06515314
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hepatic Cell Carcinoma
Interventions: BIOLOGICAL: AFP Specific T Cell Receptor T Cells
Sponsor: HRYZ Biotech Co.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-10
Completion Date: 2027-08-10
Locations: Zhongshan Hospital Affiliated to Fudan University, Shanghai, Shanghai, China

Summary:
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of HRYZ-T102 TCR-T Cell in patients with AFP positive advanced hepatocellular carcinoma and other solid tumors refractory to prior systematic treatments.

Primary Outcome Measures: Adverse events and serious adverse events, Incidence of adverse events and serious adverse events, 2 years|DLT, Dose-limiting toxicity, 2 years
Secondary Outcome Measures: Objective Response Rate（ORR）, The percentage of subjects with PR or CR assessed by RECIST 1.1., 2 years|Disease Control Rate (DCR), The percentage of subjects with a confirmed CR, PR, or stable disease (SD) assessed by RECIST 1.1., 2 years|Duration of response (DoR), Subjects who show a confirmed CR or PR as assessed by RECIST 1.1., 2 years|Time to response (TTR), Time from date of T-cell administration to first documented evidence of confirmed (CR or PR) as assessed by RECIST 1.1., 2 years|Progression-Free Survival（PFS）, The length of time from enrollment until the time of progression of disease, 2 years|Overall Survival (OS), The interval of time between the date of T-cell infusion and the date of death., 2 years|Duration of TCR T cells in-vivo persistence, Blood samples were collected to measure persistence of infused HRYZ-T102, 2 years|Concentration of Cytokines (IL-2、IL-6、IL-10、TNFα、IFNγ), Collect blood samples and analyze for presence of cytokines (IL-2、IL-6、IL-10、TNFα、IFNγ) at specified intervals before and after treatment with HRYZ-T102., 2 years
Other Outcome Measures: Number of Subjects with positive anti-drug antibodies (ADA), Serum samples will be collected to analyze for the presence of ADAs using validated immunoassays, 2 years|Number of subjects with replication competent lentivirus (RCL), RCL exposure will be assessed by polymerase chain reaction (PCR) based assay., 2 years|T cell subgroup in peripheral blood, Collect blood samples and analyze for T cell subgroup by flow cytometry at specified intervals before and after treatment with HRYZ-T102., 2 years
Safety and Efficacy of Anti-BCMA-GPRC5D CAR-T Cells Therapy in the Treatment of r/r MM
NCT Number: NCT06515262
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Relapsed/Refractory Multiple Myeloma
Interventions: BIOLOGICAL: Anti-BCMA-GPRC5D CAR-T cells infusion
Sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Collaborators: Guangzhou Bio-gene Technology Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-12
Locations: Sanbin Wang, Kunming, Kunming, Yunnan, 650100, China

Summary:
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of bispecific BCMA-GPRC5D CAR-T cells in patients with relapsed or refractory multiple myeloma who received three or more lines of therapy.

Primary Outcome Measures: Incidence of adverse events(AE) after infusion, The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome are graded by American Society for Transplantation and Cellular Therapy (ASTCT) criteria., within 2 years after infusion
Secondary Outcome Measures: Overall Response Rate (ORR), Overall Response Rate (ORR) is defined as the proportion of subjects achieving strict complete remission(sCR), complete response(CR), very good partial response(VGPR） and partial response(PR)., within 2 years after infusion|Concentration of CAR-T cells, Concentration of CAR-T cells measured by Flow cytometry after CAR-T infusion, Days 1,4, 7, 10, 14 ,21,28and months 2, 3, 6, 9, 12,18,24 after infusion|Progression-free survival(PFS), Progression-free survival(PFS) refers to the time from cell reinfusion to the first assessment of tumor progression or death from any cause., within 2 years after infusion|Overall survival(OS), Overall survival (OS) refers to the time from the time the patient received an infusion of CAR-T cells until death (from any cause)., within 2 years after infusion
Efficacy and Safety of Bowel Preparation for Patency Capsule in CD Patients Who Previously Failed Patency Capsule
NCT Number: NCT06515171
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Crohn Disease|Crohn Disease of Small Intestine
Sponsor: Shmuel Kivity, MD
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-09-11
Completion Date: 2025-07-01
Locations: Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Summary:
The goal of this observational study is to evaluate the success rate of a second bowel preparation protocol for patency capsule (PC) in Crohn Disease (CD) patients who failed to pass an initial protocol PC on a previous attempt.

The main question it aims to answer is what is the percentage of patients successfully passing the second PC test, among those who failed the first attempt.

Participants who will fail the PC test will be scheduled for another test with a different preparation protocol.

Participants will be asked to report capsule expulsion and send a photo for documentation or report the result of the abdominal X-ray preformed 28-30 hours post swallowing.

.

Primary Outcome Measures: Rate of second PC passaging, The percentage of patients successfully passing the second PC test, among those who fail the first attempt., 3 years
Secondary Outcome Measures: PC retention, The rate of PC retention, 3 years|VCE retention, The rate of VCE retention, 3 years|Positive PC passage, The rate of positive PC in CD patients, 3 years|Risk factors, Risk factors for positive PC, 4 years
High-volume Versus Standard Volume Plasma Exchange in Patients With Acute Liver Failure With Cerebral Edema
NCT Number: NCT06515145
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Liver Failure|Cerebral Edema
Interventions: PROCEDURE: High Volume Therapeutic Plasma Exchange compared to standard volume therapeutic plasma exchange
Sponsor: Institute of Liver and Biliary Sciences, India
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-03-01
Locations: Institute of Liver & Biliary Sciences, New Delhi, Delhi, 110070, India

Summary:
In this prospective randomized controlled trial Investigator aim to evaluate the impact of high versus standard volume plasma-exchange in patients with acute liver failure with cerebral edema and clinical outcomes. ALF who meet the inclusion and exclusion criteria within the first 12 hours will be randomized into two groups

Interventional - High-volume plasma exchange Active Comparator - Standard volume plasma exchange

Expected outcome of the project-.

1. Primary end points: Time to improvement in cerebral edema
2. Secondary end points:

To study the adverse events of therapy (volume overload, pulmonary complications, allergic reactions) etc.

Transplant-free survival at day 21

Primary Outcome Measures: Time to improvement in cerebral edema, Time to improvement in Cerebral Edema defined as sustained reduction in ammonia with resolution of Hepatic encephalopathy., 7 Days
Secondary Outcome Measures: To study the adverse events of therapy, Adverse Events- Pulmonary complications, allergic reactions, hypotension, etc, 21 Days|Transplant-free survival at day 21, Time to death and liver transplant will be recorded, 21st day
Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC
NCT Number: NCT06515093
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Foot Ulcer|Venous Leg Ulcer
Interventions: OTHER: SanoGraft|OTHER: PelloGraft
Sponsor: Surgenex
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-23
Completion Date: 2025-08-02
Locations: ILD Research, Vista, California, 92801, United States

Summary:
The purpose of this study is to compare Pellograft to standard of care modalities in treating diabetic foot ulcers in human subjects, and to compare Sanograft to standard of care in treating venous leg ulcers. The study will demonstrate wound healing outcomes with comparators including time to wound epithelialization, decrease in wound size, and total number of study product applications towards healing outcome. This information is important to the Centers for Medicare and Medicaid Services (CMS) and other payors in determining coverage policy and reimbursement for this product category.

Primary Outcome Measures: 100% epithelialization, 100% epithelialization of wound within 12 weeks (DFU) or 16 weeks (VLU) of initial treatment application. Wound closure is complete with confirmation of 100% epithelialization, no drainage, and no need for additional dressings., 12 weeks (DFU) or 16 weeks (VLU)
Secondary Outcome Measures: Time to Healing, Time to Healing (from initial application of study product to 100% epithelialization of wound), 12 weeks (DFU) or 16 weeks (VLU)
Other Outcome Measures: Quality of Life via subject questionnaire, Qualify of Life at 2-week post closure follow-up via SF-36 Questionnaire, 2-weeks post wound closure
Predicting Outcomes Using Infra-red SEnsors, a Feasibility Study.
NCT Number: NCT06515080
Acronym: PORPOISE-F
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: General Anesthetic Drug Adverse Reaction
Interventions: DIAGNOSTIC_TEST: Near Red Infrascopy
Sponsor: Uppsala University
Sex: ALL
Age: CHILD
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-07-31

Summary:
The aim of this study is to investigate if it is feasible to use a protocol in which avoiding oxygen desaturation in the brain during general anaesthesia can reduce the risk of negative postoperative behavior changes in children.

We will recruit children from at least five centres around the world for this feasibility study. Brain oxygenation will be monitored with Near Red Infrascopy (NIRS) which is like a saturation monitor placed on the forehead of the child during anesthesia. The anesthesia is done as per routine, but we will ask the anesthesiologist to record what actions they took when there were signs of decreasing oxygen saturation in the brain. We will also ask the parents to fill in a questionnaire with 25 questions about changes in their child's behavior 7 days after the operation.

Primary Outcome Measures: the incidence of technical problems with NIRS monitoring and the parental noncompliance with PHBQ reporting. Checklist, The primary outcome is the feasibility, From the beginning of the anesthesia until 30 days postoperatively
Secondary Outcome Measures: CrsO2, Cerebral regional oxygen saturation monitored with NIRS, From immediately before anesthesia induction until a few minutes after extubating up to 10 minutes|Negative postoperative behavior changes (NPOBC), Negative postoperative behavior changes detected by asking the parents to report changes of behavior assessed with the Post Hospitalization Behavior Questionnaire (PHBQ) at day 7 and day 30 postop, 7 to 30 days postoperatively
Effect of Back Massage on ınfertılıty Stress, Sexual satısfactıon and marrıage Harmony ın ınfertılıty Couples
NCT Number: NCT06515067
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sexual Activity|Infertility|Stress
Interventions: OTHER: back massage|OTHER: no ıntervention
Sponsor: TC Erciyes University
Sex: ALL
Age: ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-11-26
Completion Date: 2023-11-20
Locations: Erciyes Üniversitei, Kayseri, 38000, Turkey

Summary:
This study aimed to investigate the effect of back massage on infertility stress, sexual satisfaction and marital harmony in infertile couples.

It aims to answer the question "Does back massage increase sexual satisfaction and marital harmony in infertile couples?" They will apply infertile chirt back massage and then answer survey questions about sexual satisfaction and marital harmony.

Primary Outcome Measures: İnfertility stress scale for measuring infertility stres, It is a scale developed by Schmidt (2006) to evaluate the stress experienced by infertile couples. The scale is a four-point Likert type (1: not at all, 4: very much), consists of 3 dimensions and 14 items., 2 mouths|Marital Adjustment Scale, The scale not only measures general marital satisfaction or quality, but also evaluates relationship style on issues such as expression of emotions, family budget, agreement or disagreement on issues such as sexuality and social rules, leisure activities, conflict resolution, and trust., 2 mounths|Golumbuok Rust Sexual Satisfaction Scale, The scale is a measurement tool to evaluate the quality of sexual intercourse and sexual dysfunctions. The total score obtained gives a general idea about the quality of sexual functions, and the subscale scores provide more detailed information about the aspects of the relationship. There are two separate forms prepared for men and women, each consisting of 28 items., 2 Mounths
Secondary Outcome Measures: COMPI coping with infertility stress scale, The scale, developed to measure coping strategies with certain stressors related to infertility, consists of 19 items. In the scale, items 1 to 17 are evaluated on a 4-point Likert scale, and items 18 and 19 are evaluated on a 3-point scale., 2 mouths
Isometric Exercise for Hypertension
NCT Number: NCT06515054
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension
Interventions: BEHAVIORAL: wall squat|BEHAVIORAL: passive stretching
Sponsor: Chinese University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-20
Completion Date: 2025-08-31
Locations: School of public health and primary care, Hong Kong, Hong Kong

Summary:
Background: Isometric resistance exercises (IREs) have great potential to improve blood pressure (BP) control.

Methods: This is a pilot randomized controlled trial that will involve 50 patients with hypertension (HT) who do not meet the current physical activity guidelines defined by the World Health Organization. Participants will be randomly assigned in a 1:1 ratio using stratified and blocked randomization to either the IRE (wall squat) group or stretching exercise (active control) group. A well-structured, widely accepted, and validated 24-week wall squat program (2 minutes per exercise, 2 minutes of rest between sets, and 3 sessions per week) will be implemented, as it has been commonly used in previous research. All patients will be followed up for 24 weeks. Control group will receive exact same treatment except that IRE is replaced by frequency-matched and time-matched stretching exercise. The primary outcome measure will be rate of recruitment. Secondary outcomes will include BP parameters from 24-hour ambulatory BP monitoring

Primary Outcome Measures: rate of recruitment, number of people recruited per month, through study completion, an average of 1 year
Secondary Outcome Measures: Blood pressure parameters, 24-hour, daytime and nighttime blood pressure from 24-hour ambulatory systolic and diastolic blood pressure measurement, 24-week after recruitment|Carotid-femoral pulse wave velocity, analysed by applanation tonometry using SphygmoCor (AtCor Medical Pty Ltd) with the accompanying SphygmoCor Software Suite (SphygmoCor System), 24-week after recruitment|flow-mediated velocity (FMD), FMD will be performed using a high-resolution linear artery transducer couple with a software (FMD suite, Quipu, Italy) that automatically detect and measure the brachial artery diameter and will be performed according to international guidelines, 24-week after recruitment
Effects of Museum Visits on Neurocognitive Well-being
NCT Number: NCT06515041
Acronym: ABC
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy Volunteers
Interventions: OTHER: brain well-being
Sponsor: University Hospital, Caen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06-30
Completion Date: 2029-06-30
Locations: Caen University Hospital, Caen, France

Summary:
The effects of art on health and well-being have been the subject of increasing exploration in recent years. In 2019, the World Health Organization proposed a literature review analyzing the links between art, health (defined as a state of good functioning) and well-being. Currently, the majority of research has focused on populations presenting pathologies (somatic, neurological or psychiatric), very often in older adults. Furthermore, exposure to art (unlike the practice of an artistic activity) still remains under-investigated. However, recent publications (review and longitudinal study) suggest that attending museums would be associated with an increase in well-being, in people with or without pathology.

Supported by the Blood \& Brain @ Caen Normandy Scientific Interest Group and the Museum of Fine Arts as part of the Millennium festivities of the city of Caen, the partnership between three Caen laboratories and a Parisian laboratory enabled the drawing of this innovative research which will aim to measure the effects of visiting a museum dedicated to painting on well-being in healthy adults. It will also involve identifying the cerebral, cognitive and socio-emotional processes associated with these effects, via comprehensive and ecologically adapted measurements.

Through understanding the mechanisms specific to exposure to art which promote well-being, this research could have implications for:

1. Promote synergy between cultural and health policies.
2. Design museum experiences as close as possible to human functioning.
3. Open up to new perspectives such as the role of exposure to art in maintaining good health, with the possibility in the longer term of considering research on other arts, other populations, in a lifespan approach.
4. Open up to other studies of the same type involving pairs of patients and caregivers, young people and seniors, etc.

Primary Outcome Measures: Effect of museum visit on wellbeing, We will use a well established UCL museum wellbeing measures used to assess levels of psychological wellbeing arising from a situation., before and after the first visit and the second one|Effect of museum visit on eyes tracking, eyes tracking glasses will be used to evaluate where the volunteers is looking on pictorials, during each visit, 1 and 2|Effect of museum visit on NIRS, NIRS, non invasive evaluation of frontal brain oxygenation allowing a follow-up of brain emotions, during each visit, 1 and 2|Effet of museum visit on heart rate, Non invasive evaluation of heart rate, during each visit, 1 and 2
A Trial of HRS-9813 in Healthy Volunteers
NCT Number: NCT06514963
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers
Interventions: DRUG: HRS-9813|DRUG: Placebo
Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Sex: ALL
Age: ADULT
Enrollment: 74
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-24
Completion Date: 2024-11-10
Locations: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China

Summary:
The purpose of this phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-9813 in healthy volunteers.

Primary Outcome Measures: Safety: incidence of adverse event (AE), serious adverse event (SAE), 7 days (SAD), 14 days (MAD)
Secondary Outcome Measures: PK parameter of HRS-9813: Area under the concentration time curve (AUC), Days 1-9|PK parameter of HRS-9813: Maximum Plasma Concentration (Cmax), Days 1-9|PK parameter of HRS-9813: Time to maximum plasma concentration (Tmax), Days 1-9|PK parameter of HRS-9813: Half-life (t1/2), Days 1-9|PK parameter of HRS-9813: Apparent clearance (CL/F), Days 1-9|PK parameter of HRS-9813: Apparent volume of distribution (Vz/F), Days 1-9|PK parameter of HRS-9813: Accumulation ratio (Racc), Days 1-9|PK parameter of HRS-9813: Cumulative amount excreted (Ae) in the urine, Days 1-2|PK parameter of HRS-9813: Fractional excretion (fe) in the urine, Days 1-2|PK parameter of HRS-9813: Renal clearance (CLR), Days 1-2