pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Additional Effects of Sternocleidomastoid Release With SNAGS in the Management of Cervicogenic Headache
NCT Number: NCT06534606
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cervicogenic Headache
Interventions: PROCEDURE: Electrotherapy and physical agents|PROCEDURE: Headache SNAGs|PROCEDURE: Sternocleidomastoid Release
Sponsor: Foundation University Islamabad
Sex: ALL
Age: ADULT
Enrollment: 38
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2024-12-30
Locations: Foundation University College of Physical Therapy, Rawalpindi, Punjab, 46000, Pakistan

Summary:
Cervicogenic headache is a common type of headache in adults which causes disability and difficulty in everyday activities. According to the latest International Headache Society model, cervicogenic headache (CGH) is a secondary headache having C1-C2 dysfunction. SNAGs are highly effective in the treatment approach for these patients. Sternocleidomastoid muscle receive overactive tension from forward neck posture, increasing muscular fatigue and tone of muscles. This tension in SCM causes referred pain in the head and neck region. SNAGs are very effective but musculoskeletal impairments especially the tightness of sternocleidomastoid muscle still persist and can exacerbate symptoms. Manual therapy targeted to the SCM muscle may be effective for reducing headache and neck pain intensity and increasing performance of deep cervical flexors. Findings of this study will aid the therapists in choosing which technique to use while treating the patients. This will save therapist's time and effort as they will not be using the less effective treatment protocol. Furthermore, patient's time and investment will be used in the right direction.

Primary Outcome Measures: Pain intensity, Pain will be measured on the basis of Numeric Pain Rating Scale score., 2 weeks|Range of motion, Cervical rotation will be measured through CROM device, 2 weeks|Headache Disability, Headache Disability Index will be used, 2 weeks|Cervical Proprioception, Joint Position Error Test will be used, 2 weeks
Effects of Physical Therapy on Low Back Pain, Disc Height Index, Postural Stability, Disability, Gait and Function in Persons With Postero-lateral Disc Herniation
NCT Number: NCT06534593
Acronym: DISC-RELIEF
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Herniation, Disc|Low Back Pain
Interventions: OTHER: Standard medical treatment|DEVICE: Lumbar Traction|OTHER: Mckenzie Extension Protocol|DEVICE: Interferential Therapy|DEVICE: Heat Therapy|OTHER: Sustained Natural Apophyseal Glides (SNAGs)
Sponsor: Foundation University Islamabad
Sex: ALL
Age: ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-07
Completion Date: 2025-02-07
Locations: Foundation University Islamabad, Islamabad, Federal, Pakistan

Summary:
The current study aims to determine if physical therapy is significantly superior in improving postural stability, pain and function and disc height index in persons with discogenic low back pain, as compared to the standardized medical treatment.

Primary Outcome Measures: Back Pain, Pain will be measured via Visual Analogue Scale. A higher score signifies poor outcome., 2 weeks|Lumbar Range of Motion, Lumbar Range of Motion will be measured via inclinometer. A higher score signifies good outcome., 2 weeks|Postural Stability, Postural Stability will be measured via Biodex Balance System. A higher score signifies poor outcome., 2 weeks|Lumbar Disability, Lumbar Disability will be measured via Oswestry Disability Index., 2 weeks|Stride length, Stride length during gait will be analyzed using observational gait analysis. A greater stride length signifies better outcome, 2 weeks|Gait Velocity, Velocity during gait will be analyzed using observational gait analysis. A greater gait velocity signifies better outcome, 2 weeks|Cadence, Cadence during gait will be analyzed using observational gait analysis, which is number of steps per minute., 2 weeks|Disc height index, Disc height index will be analyzed using Magnetic Resonance Imaging. A greater disc height index signifies better outcome, 2 weeks
Body Composition, Growth, and Maturation of Triathletes
NCT Number: NCT06534567
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diet Habit|Body Weight Changes
Interventions: OTHER: Mediterranean Diet|OTHER: Physical activity
Sponsor: University of Alicante
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-11-01
Completion Date: 2025-11-30
Locations: Faculty of Health Sciences. University of Alicante., San Vicente Del Raspeig, Alicante, 30690, Spain

Summary:
The goal of this observational study is to determine if physical activity and the adherence to a Mediterranean diet have a relationship with body composition, growth, and maturation status in youth triathletes. The main question it aims to answer is:

• Is body composition (fat and muscle) determined primarily by growth and biological maturation or by physical activity and the Mediterranean diet in youth triathletes? Participants already have been evaluated in body composition, mediterranean diet adherence and practical of physical activity during 3 years.

Primary Outcome Measures: Changes in Body Composition, Change in body composition (fat mass and muscle mass) by anthropometric evaluation, 5 years
Secondary Outcome Measures: Physical Activity Level, Low, moderate or high, 5 years|Mediterranean Diet Adherence, Low, moderate or high, 5 years|Biological Maturation Status, early, average or late maturers, 5 years
Improving Gout Care After an ED Visit
NCT Number: NCT06534554
Acronym: CARE-Gout
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gout
Interventions: BEHAVIORAL: Patient Navigation
Sponsor: University of Alabama at Birmingham
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-06-18
Completion Date: 2026-06-01
Locations: University of Alabama at Birmingham, Birmingham, Alabama, 35205, United States

Summary:
The prevalence of gout has been steadily increasing over several decades and is correlated with the rising burden of obesity, chronic cardiac and renal disease; all conditions overrepresented in the Southeastern U.S. - particularly in African Americans. Through a novel post-emergency department visit intervention, we aim to improve the care patients with gout receive, both during acute exacerbations and long-term. A secondary goal of the project is to concurrently enhance participation of minorities in biomedical research in the Deep South.

Primary Outcome Measures: Follow-Up Visit Addressing Gout within 3 Months, Proportion of patients that have a follow-up visit addressing gout in the 3-month period after the ED visit., 3 months
The Effect of Tomatis Auditory Stimulation in Children and Adolescents With NDDs
NCT Number: NCT06534515
Acronym: TomatisOn
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neurodevelopmental Disorders
Interventions: DEVICE: Tomatis auditory stimulation
Sponsor: Babes-Bolyai University
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-12-01
Completion Date: 2024-09-30
Locations: Andeea Robe, Floresti, Cluj, 407280, Romania

Summary:
The current study aims to explore the preliminary efficacy of the Tomatis method on auditory processing in children with NDDs.

Primary Outcome Measures: Air conduction thresholds, % Spatialization errors in air conduction, Change from baseline AC (time 0) at immediately after the intervention (time 1)|Bone conduction thresholds, % Spatialization errors in Bone conduction, Change from baseline BC(time 0) at immediately after the intervention (time 1)
Secondary Outcome Measures: Developmental Disability Children's Global Assesment Scale total score, Developmental Disability Children's Global Assesment Scale total score(highest score 100; superior functioning; lowest score 1: extreme impairment), Change from baseline DD_CGAS (time 0) at immediately after the intervention (time 1)
Study of the Pharmacokinetics, Safety, and Tolerability of ZONISADE in Children 1 Month to 17 Years of Age With Partial-onset Seizures
NCT Number: NCT06534502
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Seizures|Seizures, Focal|Seizure, Partial Onset|Seizure Disorder, Partial|Seizure, Partial|Epilepsies, Partial|Epilepsy
Interventions: DRUG: Zonisamide Oral Product
Sponsor: Azurity Pharmaceuticals
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-06

Summary:
The purpose of this research is to determine the optimal dose, safety and tolerability of zonisamide oral suspension in children ages 1 month to 17 years of age who have partial-onset (focal) seizures. The study consists of four periods: a Screening Period (about 14 days), a Titration Period (8 weeks), a Maintenance Period (4 weeks), and a Follow-Up Period (1 week).

Primary Outcome Measures: Concentration of serum zonisamide, The concentration in serum of zonisamide following administration of zonisamide oral suspension, 100 mg/5 ml, Up to 15 weeks
Secondary Outcome Measures: Incidence of treatment-emergent adverse events (TEAEs), Incidence of treatment-emergent adverse events (TEAEs), serious and non-serious, reported throughout the study., Up to 15 weeks|Number and/or percentage of participants who discontinued the study because of adverse events, Number and/or percentage of participants who discontinued the study because of adverse events, Up to 15 weeks|Number and/or percentage of participants who required zonisamide dose reduction because of TEAEs., Number and/or percentage of participants who required zonisamide dose reduction because of TEAEs., Up to 15 weeks
Other Outcome Measures: Change from baseline in seizure frequency, Change from baseline in seizure frequency, Up to 15 weeks
Effectiveness of Education Given to Patients With Hemodialysis Patients
NCT Number: NCT06534476
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nurse's Role
Interventions: OTHER: Education
Sponsor: Zeynep Yildirim
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-04-11
Completion Date: 2024-01-12
Locations: Ataturk University, Erzurum, Yakutiye, 25100, Turkey

Summary:
This study was conducted to investigate the effects of education given to patients receiving hemodialysis treatment on self-care agency and fluid control. This study has a pre-test-post-test quasi-experimental design. A total of 54 hemodialysis patients who met the inclusion criteria were included in the study.

Primary Outcome Measures: Self-Care Ability Scale, Self-care ability scale, developed by Besey Ören in 2010, consists of 22 items and five sub-dimensions. These dimensions are; drug use (1, 2, 3, 4, 5, 18), diet (8, 9, 10, 11, 12), hygienic care (15, 16, 17, 19), mental state (20, 21, 22) and self-monitoring (6,7,13, 14). The scale is a 3-point Likert type (0: I never apply, 1: I sometimes apply, 2: I always apply). Items 12, 20, 21, 22 on the scale are scored negatively. The scores obtained from the scale range from 0 to 44. According to the scale, as the scores obtained increase, the self-care ability of patients receiving dialysis treatment increases., Up to 8 weeks|Fluid Control Scale in Hemodialysis Patients, Fluid control scale in hemodialysis patients, developed by Coşar and Çınar in 2012 consists of 24 items and three sub-dimensions. These sub-dimensions are; knowledge (1-7), behavior (8-18) and attitude (19-24). The scale is a 3-point Likert type (1: Disagree, 2: Undecided, 3: Agree). Items 7, 18, 19, 20, 21, 22, 23 and 24 in the scale are scored negatively. Scores obtained from the scale range from 24 to 72. As the score obtained increases, the patients' compliance with fluid control increases., Up to 8 weeks
The Effects Of Therapeutic Plasma Exchange (TPE) On Age Related Biomarkers And Epigenetics
NCT Number: NCT06534450
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Aging
Interventions: DEVICE: Sham|DEVICE: Therapeutic Plasma Exchange|DRUG: IVIG
Sponsor: Dobri Kiprov
Collaborators: CIRCULATE, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2022-09-12
Completion Date: 2025-08
Locations: Global Apheresis, Mill Valley, California, 94941, United States

Summary:
The goal of this clinical trial is to assure the safety of long term therapeutic plasma exchange (TPE) with and without Intravenous Immunoglobulin (IVIG) and its effects on biomarkers and epigenetic biologic clocks in forty individuals. The main question is to assure the safety from long term TPE using changes in clinical and laboratory outcomes and also evaluating changes on additional blood biomarkers and epigenetic clocks during and after TPE treatment. Researchers will compare the TPE treatment group to the Sham treatment group to identify changes due to TPE. Participants will receive six TPE or Sham treatments over one of two treatment schedules and may receive IVIG with treatment.

Primary Outcome Measures: Adverse events and unanticipated events total for TPE safety, The primary objective is to assure the safety of long term TPE, through study completion, an average of 1 year|Rate of change to blood epigenetic clock from TPE, The objective is to compare the rate of change to the blood epigenetic clock from TPE., through study completion, an average of 1 year
Secondary Outcome Measures: Change in hand grip strength, The objective is to compare changes in hand grip strength from TPE, after study completion, an average of 2 years|Change in time up and go test, The objective is to compare changes in the time up and go test from TPE, after study completion, an average of 2 years|Change in balance time, The objective is to compare changes in balance time from TPE, after study completion, an average of 2 years|Change in short-form health survey score, The objective is to compare changes in short-form health survey scores from TPE, with higher scores being better, after study completion, an average of 2 years
Clinical Impact of Enhanced Risk Assessments in Women With a BRCA1/2 Mutation, CARE Study
NCT Number: NCT06534424
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome
Interventions: OTHER: Best Practice|PROCEDURE: Biospecimen Collection|OTHER: Counseling|PROCEDURE: Discussion|PROCEDURE: Genotyping|PROCEDURE: Molecular Risk Assessment|OTHER: Questionnaire Administration
Sponsor: Ohio State University Comprehensive Cancer Center
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 152
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2018-01-01
Completion Date: 2025-12-31
Locations: Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States|Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, 84112, United States

Summary:
This clinical trial evaluates the impact of enhanced risk assessments on knowledge, perceptions, and decisional conflict about cancer prevention in women with a BRCA1 or BRCA2 mutation. BRCA1/2 mutation carriers have a much higher risk of developing breast and ovarian cancer. Due to the high risk of cancer, mutation carriers are provided guidelines on more intensive screening and preventative surgeries such as bilateral mastectomy and bilateral salpingo-oophorectomy. Doctors want to learn if a more personalized risk assessment impacts the patients' risk perceptions and comfort with decision-making around cancer prevention behaviors.

Primary Outcome Measures: Decisional conflict Regarding Cancer Risk Management, Decisional conflict regarding cancer risk management will be measured via a questionnaire. Comparison of this measure between the enhanced and standard arms adjusting for stratified randomization will be made using linear regression. The alpha level for the outcome will be 0.05., Up to 3 months
Clinical and Radiographic Outcomes of Implant-supported Prostheses With Cantilever Extensions After 10 Years of Function
NCT Number: NCT06534398
Acronym: Cantilevers
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Dental Implants
Interventions: DEVICE: Dental implant prosthesis with cantilever extension
Sponsor: Aristotle University Of Thessaloniki
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 19
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2024-07-30
Locations: Aristotle University of Thessaloniki, School of Dentistry, Thessaloníki, Thessaloniki, 54124, Greece

Summary:
A retrospective examination was performed on patients who had received treatment with dental implants supporting a prosthesis with a cantilever extension for at least 10 years of function.

Primary Outcome Measures: Mean bone loss, Mean bone loss measured from the difference of the bone levels at time of implant placement compared to the time of examination, 10 years at least
Secondary Outcome Measures: Mean Probing Depth, The average probing depth at the time of examination at each implant site, 10 years at least|Biologic complications, Recording of biologic complications around implants (health, peri-implant mucositis, peri-implantitis, 10 years at least|Technical complications, Recording of prosthetic complications encountered at the dental prostheses with cantilever extensions, 10 years at least
The Clean Air Study: HEPA Purifiers to Improve Indoor Air Quality and Health in Rural Alaska Homes
NCT Number: NCT06534385
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Air Pollution, Indoor
Interventions: DEVICE: Air purifier
Sponsor: Alaska Native Tribal Health Consortium
Sex: ALL
Age: CHILD
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2025-01-01
Completion Date: 2026-04-01

Summary:
Alaska Native children experience a high burden of respiratory disease, especially those in the Yukon-Kuskokwim (YK) Delta. Studies have shown that things like wood stove use, poor ventilation, and indoor tobacco smoke exposure can lead to poor indoor air quality inside the children's homes. This leads to more frequent and more severe respiratory infections in children.

In the Yukon-Kuskokwim (YK) Delta, it's common for homes to have exposure to woodstoves and tobacco use. Both of these activities affect indoor air quality in homes. We know that high efficiency particulate air (HEPA) purifiers can reduce particulate matter and make air quality better. One way that we measure air quality is through particulate matter (PM2.5). One of the few studies that looked at this in the YK Delta found that PM2.5 levels that were nearly twice as high as homes with woodstoves in other states. We believe it is important to reduce the PM2.5 in YK Delta homes. However, the few studies that looked at HEPA purifiers in rural Alaska did not include homes where smokers lived.

We know that breathing air with PM2.5 harms the lungs. We also know that HEPA filters can reduce PM2.5, which can mean reducing cough and wheeze in people with chronic lung conditions. We want to learn how HEPA filters work in homes with woodstoves or where a smoker lives, as it's likely these homes may have more PM2.5 than other homes. We expect that using HEPA filters will make the indoor air better and will mean decreased respiratory symptoms.

We plan to include 15 households with a child less than 5 years old in the family. Households that join will be asked to:

* Set up study equipment in their homes.
* Run the study equipment for 12 weeks and do a weekly report of child's respiratory symptoms by phone or text.
* Return the air-quality monitor equipment to the study team and keep the HEPA filters.

Primary Outcome Measures: Indoor particulate matter (PM2.5) concentrations, Mean weekly home indoor particulate matter (PM2.5) concentrations, 12-weeks
Secondary Outcome Measures: Reported symptom-free days, paired analysis of mean symptom-free days with no reported respiratory symptoms, 12-weeks
The Food Effect on Pharmacokinetics of DA-302168S
NCT Number: NCT06534346
Acronym: DA168
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Overweight and Obesity
Interventions: DRUG: 15 mg DA-302168S tablet
Sponsor: Chendu DIAO Pharmaceutical Group CO., LTD.
Sex: ALL
Age: ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-18
Completion Date: 2024-09
Locations: Gulou Hospital Affiliated to Nanjing Medical University, Nanjing, Jiangsu, 210008, China

Summary:
This study will be conducted to determine the effect of food on the pharmacokinetics characteristic of DA-302168S following administration of a DA-302168S tablet with and without a high-fat meal.

Primary Outcome Measures: Cmax, Peak Plasma Concentration of DA-20168S, Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Tmax, Tmax will be determined from the observed plasma concentration data., Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|AUC0-t AUC0-t, AUC, calculated using linear up/ log down trapezoidal method from time zero to time t, where t is the time of the last measurable concentration., Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.
Secondary Outcome Measures: Number of participants with adverse events (AEs), Incidence,duration and severity of adverse events according to NCI-CTCAE v5.0., 13 days|Concentration of blood glucose, Fasting and postprandial blood glucose will be measured., Pre-dose and postdose on day 1 and day 6.
Contribution of Ultrasonography in Patellofemoral Pain Syndrome
NCT Number: NCT06534333
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Quality of Life|Pain
Interventions: OTHER: Ultrasonography
Sponsor: Ankara City Hospital Bilkent
Sex: ALL
Age: ADULT
Enrollment: 54
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-01
Completion Date: 2024-07-01
Locations: Çorum Erol Olçok Research and Training hospital, Çorum, Turkey

Summary:
Patellofemoral pain syndrome (PFPS) is a common cause of knee pain in adults younger than 60 years. . In this study, we aimed to evaluate the medial and lateral cartilage thickness the medial and lateral retinaculum thickness and the medial and lateral patellofemoral distance using ultrasonography and to compare with healthy controls. We also aimed to investigate the relationship between the measurements obtained in the PFPS group and pain intensity, functional scoring, and quality of life.

Primary Outcome Measures: trochlear cartilage thickness, three months
Safety, Tolerability and Pharmacokinetic Characteristics Evaluation of DA-302168S Tablets
NCT Number: NCT06534320
Acronym: DA168
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Overweight and Obesity
Interventions: DRUG: DA-302168S|DRUG: Placebo of DA-302168S|DRUG: DA-302168S|DRUG: Placebo of DA-302168S
Sponsor: Chendu DIAO Pharmaceutical Group CO., LTD.
Sex: ALL
Age: ADULT
Enrollment: 152
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-18
Completion Date: 2025-06-30
Locations: Gulou Hospital Affiliated to Nanjing Medical University, Nanjing, Jiangsu, 210008, China

Summary:
To Evaluate the Safety, Tolerability and Pharmacokinetics on DA-302168S Tablets in Randomized, Double-blind, Placebo-controlled Single-dose and Multiple-dose ascending Phase I Clinical Trials in Healthy Subjects.

Primary Outcome Measures: Safety and Tolerability, Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0., SAD up to Day 5 and MAD up to Day 9.
Secondary Outcome Measures: Peak Plasma Concentration (Cmax), Plasma samples were collected at different points for pharmacokinetic analysis., Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.|Tmax, Plasma samples were collected at different points for pharmacokinetic analysis., Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.|AUC0-t, Plasma samples were collected at different points for pharmacokinetic analysis., Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.|AUC0-∞, Plasma samples were collected at different points for pharmacokinetic analysis., Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.|t1/2, Plasma samples were collected at different points for pharmacokinetic analysis., Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.|CL/F, Plasma samples were collected at different points for pharmacokinetic analysis., Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.|Vd/F, Plasma samples were collected at different points for pharmacokinetic analysis., Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.|Kel, Plasma samples were collected at different points for pharmacokinetic analysis., Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
Effect of Non-pharmacological Anti-anxiety Exercises on Perceived Stress and Cortisol Level Before Elective Per Cutaneous Transluminal Coronary Angioplasty
NCT Number: NCT06534294
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Percutaneous Transluminal Coronary Angioplasty
Interventions: OTHER: reflexology|OTHER: breathing exercise|OTHER: standard care
Sponsor: October 6 University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-03-02
Completion Date: 2024-07-12
Locations: Al Ryada University for Science and Technology, Sadat, Menofia, 32897, Egypt

Summary:
Effect of non-pharmacological anti-anxiety exercises on Perceived Stress and cortisol level before elective percutaneous transluminal coronary angioplasty

Primary Outcome Measures: Cortisol Levels, 2 tubes of blood samples (5 mL) will take from the patients in all groups on an empty stomach between 08:30 and 10:00 in the morning and 30 minutes after the application to determine the cortisol level, At subject enrollment "single session"|Distress Thermometer, It is a visual analog scale consisting of only 1 question that patients can apply on their own. On the scale, there is a thermometer with numbers from 0 to 10. A score of 0 indicates that the individual has no distress, and a score of 10 indicates distress at the highest limit., At subject enrollment "single session"
Pilot Study of BAO-G Technique in TAAA Endovascular Repair
NCT Number: NCT06534281
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Aortic Aneurysm, Thoracoabdominal
Interventions: PROCEDURE: BAO-G
Sponsor: Peking Union Medical College Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-01-01
Completion Date: 2035-12-31
Locations: Peking Union Medical College Hospital, Beijing, 100730, China

Summary:
Multi-Branch AOrtic Reconstruction With G-iliac System (BAO-G) Technique is a novel technique of endovascular repair of thoracoabdominal aortic aneurysm, which using off-the-shelf iliac branched devices to reconstruct the visceral branches. This study aims to evaluate the safety and efficacy of BAO-G in thoracoabdominal aortic aneurysm endovascular repair.

Primary Outcome Measures: Rate of visceral branch patency, the patency of visceral branches measured by radiological test, Month 0, 3, 6, 12, and annually after surgery|Incidence of endoleak, The incidence of endoleak measured by radiological test, Month 0, 3, 6, 12, and annually after surgery|Incidence of re-operation, The incidence of re-operation for any adverse events, confirmed by medical record and outpatient follow up, Month 0, 3, 6, 12, and annually after surgery
Secondary Outcome Measures: Incidence of organ ischemia, Incidence of organ ischemia, measured by physical examination and radiological test, Month 0, 3, 6, 12, and annually after surgery|Incidence of acute kidney injury, The incidence of acute kidney injury, measured by serum creatinine level, perioperative period|Incidence of acute liver function injury, The incidence of acute liver function injury, measured by serum transaminase level, perioperative period|Incidence of acute pancreatitis, The incidence of acute pancreatitis, measured by serum amylase level, perioperative period
Study on Postoperative Adrenal Function Assessment in Patients With Primary Aldosteronism
NCT Number: NCT06534268
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Primary Aldosteronism
Sponsor: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2026-07-30

Summary:
This study employs a prospective, single-center, open, observational research design to evaluate postoperative adrenal cortical function in patients with primary aldosteronism (PA) and to explore indicators predicting postoperative adrenal insufficiency and their predictive efficacy

Primary Outcome Measures: The gender and age of the participants, age in years and sex (female or male) of patients, 1 day|Participant's weight and height, BMI(body mess index) in kg/m\^2= (weight in kg) /(height in m)\^2, 1 day|Patients' baseline hormone level, serum hormone level, 1day|Number of Participants with baseline glucose metabolic levels, glucose metabolism, lipid metabolism, liver and kidney function, electrolytes, etc, 1 day|Patients' hormone levels at 0 minutes and 120 minutes after preoperative ACTH stimulation test, cortisol and aldosterone levels, 1day|Patients' hormone levels at 0 minutes and 120 minutes after postoperative ACTH stimulation test, cortisol and aldosterone levels, 1day|Number of Participants with baseline lipid metabolic levels, blood lipid levels, 1day|Patients' baseline glucose metabolic levels, 0-minute、30-minute、60-minute 、120-minute and 180-minute blood glucose levels after OGTT, 1day|Number of Participants with baseline electrolytes levels, sodium, potassium, chloride, calcium, and phosphorus ion levels, 1day|Number of Participants with baseline kidney function levels, Creatinine, blood urea nitrogen (BUN), and uric acid levels, 1day
Secondary Outcome Measures: the changes of hormone levels after surgical management, cortisol and aldosterone serum hormone level, 1day|Number of Participants with changes of lipid metabolic levels after surgical management, blood lipid levels, 1day|the changes of glucose metabolic levels after surgical management, 0-minute、30-minute、60-minute 、120-minute and 180-minute blood glucose levels after OGTT, 1day|Number of Participants with changes of kidney function levels after surgical management, Creatinine, blood urea nitrogen (BUN), and uric acid levels, 1 day
Implication of Genetic Variations in Long Intergenic Non-coding RNA 00511 (LINC00511) in Colorectal Cancer
NCT Number: NCT06534242
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Colorectal Cancer
Sponsor: Ain Shams University
Collaborators: Academy of Scientific Research and Technology
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-20
Completion Date: 2023-11-26
Locations: Faculty of pharmacy, Ain Shams University, Advanced Biochemisrty Research Lab, Cairo, Egypt

Summary:
As, there is a lack of information about the association between LINC00511 SNP(s) variants and CRC susceptibility, so this study was undertaken to address whether these SNPs would increase CRC risk or could predict its prognosis. The aim of this study was to investigate the association between LINC00511 SNPs (rs17780195 or rs9906859 and rs1558535) and CRC susceptibility and/or pathogenesis in addition to finding out the interaction between these SNPs and clinicopathological factors such as histopathological type, tumor size, lymph node metastasis and tumor grade.

Primary Outcome Measures: Exploring whether LINC00511 SNP(s) variants influence CRC susceptibility by performing an observational study employing Egyptian CRC patients', evaluating the associations between LINC00511 SNPs (rs17780195 or rs9906859, and rs1558535) and CRC risk, By using Taqman SNP genotyping assay, One year|Exploring if LINC00511 SNPs could predict CRC prognosis, with odds ratio (OR) and 95% confidence interval (CI) under credible genetic models., by statistical analysis, 3 months
Impact of Preoperative Endoscopic Ultrasound-guided Fine-needle Aspiration in Cholangiocarcinoma Patients
NCT Number: NCT06534229
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cholangiocarcinoma Patients
Interventions: DIAGNOSTIC_TEST: Endoscopic ultrasound-guided fine-needle aspiration
Sponsor: Asian Institute of Gastroenterology, India
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-25
Completion Date: 2026-08-25
Locations: AIG Hospitals, Hyderabad, Telangana, 500032, India

Summary:
Primary objective of this study is to evaluate the number of patients with positive LN detected by EUS and precluded from further surgical interventions.

Secondary objective of this study is to evaluate the EUS-related adverse events.

Primary Outcome Measures: Lymph node detection by EUS, Primary objective of this study is to evaluate the number of patients with positive LN detected by EUS and precluded from further surgical interventions., 2024 - 2026
Role of Intestinal Ultrasound in Treat to Target Strategy in the Management of Inflammatory Bowel Disease : the IUS-TTT Study
NCT Number: NCT06534216
Acronym: IUS-TTT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Crohn Disease|Ulcerative Colitis
Interventions: DIAGNOSTIC_TEST: Intestinal ultrasound
Sponsor: Asian Institute of Gastroenterology, India
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-05
Completion Date: 2026-03-04
Locations: Asian Institute of Gastroenterology, Hyderabad, Telangana, 500082, India

Summary:
This study aims to evaluate the role of bedside Intestinal Ultrasound (IUS) as a cost-effective, non-invasive, and well-tolerated procedure within the Treat-to-Target strategy for managing Inflammatory Bowel Disease (IBD). Despite its growing use, therapeutic targets for IUS-guided treatment remain inadequately defined. The study will investigate the feasibility of IUS in monitoring transmural response and remission, and its potential to predict clinical and biochemical responses at 3 months, as well as mucosal healing at 6 and 12 months. By incorporating IUS into routine clinical care, we aim to enhance disease management and optimize therapeutic outcomes for patients with ulcerative colitis and Crohn's disease.

Primary Outcome Measures: Change in management, Change in management after intestinal ultrasound as compared to standard of care at different time points (3, 6 and 12 months), 12 months
Secondary Outcome Measures: Prediction of clinical and biomarker response, Prediction of clinical and biomarker response at 3 months by 2-6 weeks intestinal ultrasound, 3 months|Prediction of clinical and biomarker remission, Prediction of clinical and biomarker remission at 6 months by 2-6 weeks and 3 months intestinal ultrasound, 6 months|Prediction of transmural response, Prediction of transmural response at 3, 6 and 12 months by 2-6 weeks, 3 months and 6 months intestinal ultrasound, 12 months|Prediction of transmural remission, Prediction of transmural remission at 12 months by 2-6 weeks, 3 months and 6 months intestinal ultrasound, 12 months|Prediction of endoscopic response and remission, Prediction of endoscopic response and remission at 6-12 months, 12 months
VITAL - the Heart Failure With Reduced Ejection Fraction Sub-study
NCT Number: NCT06534151
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Failure With Reduced Ejection Fraction
Interventions: DEVICE: CRT implantation
Sponsor: University College, London
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2028-12-31
Locations: Royal Free Hospital NHS Trust (RFH), London, United Kingdom

Summary:
Heart failure affects over 1 million people in the United Kingdom. Approximately 50% have heart failure with reduced ejection fraction (HFrEF), a condition where the heart muscle does not contract properly. If the right and left chambers (called 'ventricles') of the heart are not pumping at the same time, devices called cardiac resynchronisation therapy (CRT) can be inserted to encourage the ventricles to pump together, reducing heart failure symptoms and helping people to live longer.

CRT devices are made of wires which are placed into the ventricles through the blood vessels that carry blood to and from the heart. However, one third of patients do not show any improvement following CRT insertion, and another third show only a partial improvement. Doctors cannot accurately predict who will respond well, meaning patients may undergo a procedure with no benefit, being exposed to risks including bleeding and infection.

Virtual models of a patient's heart and blood vessels, known as a 'digital twin', can be generated using artificial intelligence. These models can be used to predict a patient's response to a procedure without them having to undergo the procedure first, meaning patients can avoid being exposed to risks.

30 patients with HFrEF who have been selected to have CRT implanted by their consultant cardiologist will be recruited. Before having their procedure patients will attend University College London (UCL) for tests including a blood test, urine test, magnetic resonance imaging (MRI) scan of the heart, ultrasound of the heart, a 5-minute heart recording and a 6- minute walking/ stepping test. After the CRT is implanted, the patient's response to the device will be assessed with a blood test, a 6-minute walking/ stepping test and a heart ultrasound scan 3 and 6 months after the procedure. The virtual models will be used to determine if a patient's response to CRT can be accurately predicted.

Primary Outcome Measures: Ejection fraction measured by 3-dimensional echocardiography, An ultrasound of the heart that measures how well the heart muscle is contracting., 3 months|6-minute step/walk test, An assessment of how may steps a patient can take in 6 minutes, 3 months|6-minute step test, An assessment of how may steps a patient can take in 6 minutes, 6 months|Ejection fraction measured by 3-dimensional echocardiography, An ultrasound of the heart that measures how well the heart muscle is contracting., 6 months|Blood test, Blood test to measure N-terminal pro-brain natriuretic peptide level which is related to heart failure severity., 6 months
Exercise Inhibit Innate Immune Response and Ameliorate Chronic Pancreatitis
NCT Number: NCT06534138
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Chronic Pancreatitis
Interventions: BEHAVIORAL: Physical exercise
Sponsor: Changhai Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 121
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-18
Completion Date: 2024-03-24
Locations: Changhai Hospital, Shanghai, Shanghai, 200433, China

Summary:
The goal of this observational study is to learn about the effects of different physical exercise on disease progression in patients with chronic pancreatitis. The main question it aims to answer is:

Can physical exercise alleviate the disease progression of chronic pancreatitis?

Currently, the investigators have followed up with participants through a telephone questionnaire for six months to investigate whether the participants have engaged in physical exercise and to assess the disease progression of chronic pancreatitis.

Primary Outcome Measures: Physical Exercise Can Alleviate the Disease Progression of Chronic Pancreatitis., The investigators collected data on patients' exercise time and modalities through telephone questionnaires. The impact of exercise on patients with chronic pancreatitis was determined by assessing VAS scores., Six months
Evaluation of the Know Your OQ™ Oral Health Literacy Tool in an Indian Population
NCT Number: NCT06534112
Acronym: KYOQIN
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Oral Health Literacy
Sponsor: Colgate Palmolive
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-20
Completion Date: 2024-06-08
Locations: IPSOS Research Private Limited, Mumbai, India

Summary:
This was a research study to evaluate the effectiveness of the questionnaire "Know Your OQ™" (Know Your Oral Health Quotient™) in changing people's level of knowledge about oral health in India and to evaluate the readability, understanding and ease of completion of the questionnaire "Know Your OQ™".

Primary Outcome Measures: Changes in Knowledge, Attitude, Practice (KAP), Change in Knowledge, Attitude, and Practice before and after exposure to the Know Your OQ™ tool. Day minus 3: Pretest Knowledge, Attitude, Practice (KAP) \& Demographics, Day 0: Know Your OQ, Day 0 Immediate follow up: Post-test Comprehension Questionnaire, Week 1 follow up: Post test Knowledge, Attitudes and Practices Questionnaire, Baseline, Intervention, Immediate Follow-Up, 1 week Follow-Up
Balance Ability of Older Women With a History of Falls
NCT Number: NCT06534099
Acronym: Balance
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Falls
Interventions: OTHER: Control|OTHER: Experimental
Sponsor: Cheng Liang
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 71
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-01-05
Completion Date: 2023-07-05
Locations: Chengdu Sport University, Chengdu, Sichuan, 610041, China

Summary:
This study aims to investigate the effects of regular practice of Chinese fitness Qigong, Wuqinxi, on the balance ability of older women with a history of falls. Participants in the experimental group (n=35) and the control group (n=36), matched for age, height, and weight, were included in the study. The experimental group underwent a 24-week (3 times per week, 70 minutes per session) Wuqinxi exercise regimen. Changes in dynamic and static balance abilities of the participants were tested at weeks 0, 12, and 24. A 24-week Wuqinxi exercise regimen increased the static and dynamic balance abilities in both directions for older women with a history of falls. Compared to 12 weeks, a longer Wuqinxi exercise regimen further enhanced the static balance ability in the open-eye state.

Primary Outcome Measures: Balance Ability Testing, The balance ability tests were conducted on three occasions: at baseline, at the 12th week, and at the 24th week. The Good Balance balance testing device, manufactured in Finland, was used for all participants, which has been demonstrated to have good reliability and validity. Both static and dynamic balance tests were conducted with participants standing on the test platform using a stopwatch to measure the time that participants could stand on one leg with eyes open and closed., 24 weeks
MB-105 in Patients With CD5 Positive T-cell Lymphoma
NCT Number: NCT06534060
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lymphoma, T-Cell
Interventions: BIOLOGICAL: Genetic: MB-105
Sponsor: March Biosciences Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-02
Completion Date: 2029-12

Summary:
This is a single arm, two-stage, Phase 2, open-label, multicenter study of MB-105 in patients with CD5 Positive (CD5+) Relapsed / Refractory T-cell Lymphoma (r/r TCL). This study will apply a Simon two-stage optimal design.

Primary Outcome Measures: Incidence of adverse events adverse events, Incidence, severity, causal relationship of adverse events (AEs) per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, 26 months|Objective response rate (ORR), Best objective response rate (ORR) per independent central review as defined by rate of complete response (CR) and PR using the 2014 Lugano criteria and 2022 Global criteria., 26 months
Secondary Outcome Measures: Best overall response (BOR) per central review, 26 months|Objective response rate (ORR) per investigator., 26 months|Best overall response (BOR) per investigator, 26 months|Duration of response (DOR), Duration of Response (DOR), defined as time from first observation of response to the time of disease progression or death, whichever comes first (per investigator and by central review)., 26 months|Progression-free survival (PFS), Progression-free survival (PFS), defined as time from administration of MB-105 to the time of disease progression or death, whichever comes first (per investigator and by central review)., 26 months|Insidence of adverse events during the safety monitoring period for acute toxicities, * All AEs from leukapheresis up to Day 30.
* Related AEs from MB-105 infusion to Day 90 (i.e. excluding only AEs that are clearly an expected event from underlying condition or non-study related treatment).
* SAEs and all-cause mortality from MB-105 infusion to EOS at Month 24., 26 months|Overall survival (OS), Overall survival (OS), defined as time from administration of MB-105 to death., 26 months|Rate of successful study product release of MB-105, Rate of successful study product release of MB-105, defined as the percentage of MB-105 treatments released for clinical use vs the number of leukapheresis harvests performed and/or vs number of batches started., 26 months|Rate of successful study product administration, 26 months|CAR T persistence, anti-CAR T immune responses, and levels of endogenous T-cells over time, 26 months|Rate of hematopoietic stem cell transplant (HSCT) after MB-105 treatment, 26 months|Time to hematopoietic stem cell transplant (HCST) after MB-105 treatment, 26 months