pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
HER2 Expression of HER2 Affibody-based PET/CT to Predict Response in Bladder Cancer Patients Treated With ADC
NCT Number: NCT06548529
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HER2 Positive or Suspicious Positive Tumors
Interventions: RADIATION: HER2 expression of PET imaging
Sponsor: Peking University Cancer Hospital & Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06-01
Completion Date: 2028-12-01
Locations: uEXPLORER total-body PET/CT scanner (United Imaging, China), Beijing, China

Summary:
To use the molecular PET radionuclide (F-18) labelled HER2 Affibody to evaluate the predictive and prognostic value of HER2 expression in bladder cancer patients treated with HER2 ADC

Primary Outcome Measures: SUV, The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT, 4 years
Maxillary Labial Frenectomy: Diode Lasers Versus Surgical Scalpel
NCT Number: NCT06548516
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: High Frenum Attachment
Interventions: PROCEDURE: Control group (conventional scalpel surgery)|PROCEDURE: Diode laser group
Sponsor: Necmettin Erbakan University
Sex: ALL
Age: ADULT
Enrollment: 43
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2024-09
Locations: Necmettin Erbakan University, dentistry Faculty, Konya, Turkey

Summary:
The goal of this clinical trial is to determine if diode laser treatment can improve post-operative outcomes compared to conventional scalpel technique in systemically healthy, non-smoking adults aged 18-45 years with aberrant papillary frenum attachment. The main questions it aims to answer are:

Does diode laser treatment result in lower post-operative pain compared to the conventional scalpel technique? Does diode laser treatment result in better periodontal healing outcomes compared to the conventional scalpel technique? Researchers will compare the diode laser surgery group to the conventional scalpel surgery group to see if there are differences in pain and healing.

Participants will:

Undergo a frenectomy procedure using either a diode laser or a conventional scalpel.

Receive oral hygiene instructions and post-operative care recommendations. Have their periodontal parameters measured at baseline, 6 weeks, and 6 months post-operation.

Record their pain levels using a visual analogue scale on specified post-operative days.

Primary Outcome Measures: Postoperative pain, Pain will be evaluated using the visual analogue scale (VAS).The scale will be comprised of a horizontal line with values ranging from '0' to '10', where '0' indicates the absence of pain and '10' indicates the presence of severe discomfort., postoperative days 1, 3, 7, 14, 21, and 28.|Postoperative tissue healing, Tissue healing will be assessed by Z.T.E using the following scoring system:

* Score 1: Complete epithelialization
* Score 2: Incomplete epithelialization
* Score 3: Presence of ulcer
* Score 4: Tissue defect or necrosis, postoperative days 7 and 30 after surgery,
Interpretable Machine Learning Models for Prognosis in Gastric Cancer Patients
NCT Number: NCT06548464
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Stomach Neoplasms|Gastrectomy|Machine Learning
Sponsor: Chang-Ming Huang, Prof.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 18000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2024-08-06
Locations: Chang-ming Huang, Fuzhou, Fujian, 350001, China

Summary:
This multicenter, retrospective cohort study aimed to develop and validate an explainable prediction model for prognosis after gastrectomy in patients with gastric cancer.

Primary Outcome Measures: Survival, Assessment of overall survival outcomes in gastric cancer patients after gastrectomy., Up to 5 years after surgery
Secondary Outcome Measures: Early Recurrence, Incidence of cancer recurrence within 2 years after gastrectomy., Within 2 years after surgery|Late Recurrence, Incidence of cancer recurrence occurring more than 2 years after gastrectomy., From 2 years up to 5 years after surgery|Postoperative Complications, Incidence and severity of complications following gastrectomy., Within 30 days after surgery|Neoadjuvant Treatment Efficacy, Assessment of tumor response to neoadjuvant therapy before gastrectomy., From initiation of neoadjuvant therapy to surgery (typically 2-3 months)|5-Year Survival Rate, Percentage of patients alive 5 years after gastrectomy., 5 years after surgery
The Impact of PDD During TURB for NMIBC
NCT Number: NCT06548438
Acronym: TUR_BLUE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Bladder Cancer
Interventions: PROCEDURE: Transurethral resection of the bladder performed with PDD tecnique and Hexvix
Sponsor: A.O.U. Città della Salute e della Scienza
Collaborators: Photocure
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-01
Completion Date: 2027-09-01

Summary:
The goal of this clinical trial is to learn if photodynamic diagnosis (PDD) performed using violet light after intra-vesical instillation of hexaminolaevulinic acid (Hexvix 85mg/50ml) is more sensitive than the standard white light tecnique in detection of malignant bladder tumour.

Patients will be randomised to:

* Transurethral resection of the bladder (TURB) with a standard white light tecnique
* TURB with the PDD tecnique using the study drug Hexvix

Primary Outcome Measures: Residual disease and/or upstaging, Compare the completeness of TURB with PDD vs TURB with WL in terms of proportion of patients with residual disease and/or upstaging at re-TURB, 6 to 8 weeks from the intervention
Secondary Outcome Measures: Number of Participants diagnosed with malignant lesions, Compare the detection of malignant lesions between PDD and WLC using high-definition (HD) equipment during both primary TURB and re-TURB, 6 to 8 weeks from the intervention|The European organization for reasearch and treatment of cancer quality of life questionnaire for patients with non-muscle invasive bladder cancern, The scale range from 24 (better outcome) to 96 (worse outcome), from date of randomization until 20 weeks from randomization|EQ-5D-5L, The scale range from 5 (better outcome) to 25 (worse outcome), from date of randomization until 20 weeks from randomization|EQ VAS, A self-rating question of overall health status, measured on a 0 (worse outcome) to 100 (better outcome) visual analogue scale, from date of randomization until 20 weeks from randomization|Adverse events, Assess treatment changes and adverse events associated with each technique, from date of randomization until 20 weeks from randomization
Smartphone Based Tele-rehabilitation on Functional Capacity and Sleep Quality Among Coronary Heart Disease Patients.
NCT Number: NCT06548425
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coronary Heart Disease
Interventions: OTHER: Smart Phone Based Cardiac Telerehabilitation|OTHER: Center based cardiac Rehabilitation
Sponsor: Riphah International University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 38
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-06-15
Completion Date: 2024-12
Locations: Yusra Rehabilitation Center, Rawalpindi, Punjab, 46000, Pakistan

Summary:
To determine the effectiveness of smartphone based tele-rehabilitation on functional capacity and sleep quality among coronary heart disease patients.

Primary Outcome Measures: Pittsburgh Sleep Quality Index, The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The PSQI has a high test-retest reliability and a good validity for patients with cardiac patients. Changes from the baseline will be measured., 8 week|Duke Activity Status Index, The Duke Activity Status Index (DASI) is an assessment tool used to evaluate the functional capacity of patients with cardiovascular disease (CVD), such as coronary artery disease, myocardial infarction, and heart failure. In clinical practice, DASI can be used to assess the effects of medical treatments and cardiac rehabilitation as well. Positive responses are summed up to get a total score, which ranges from 0 to 58.2. Higher scores would indicate a higher functional capacity. Changes from the baseline will be measured., 8 week|6 Minute walk test, six-minute walk test as a measure of functional status or fitness Before you begin to walk, the researchers will take a participant's blood pressure, pulse, and oxygen saturation using a pulse oximeter. Participants will get the instructions below. For six minutes, the contestants will walk as far as they can. to a chair or cone at your usual speed, then turn around. and will keep going back and forth for another six minutes. Distance will be measured in meters. Changes from the baseline will be measured., 8 week
CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers
NCT Number: NCT06548412
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Metastatic Biliary Tract Cancer
Interventions: DRUG: Gemcitabine|DRUG: Cisplatin|DRUG: Durvalumab|DRUG: CTX-009
Sponsor: M.D. Anderson Cancer Center
Collaborators: Compass Therapeutics, Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2029-05-01
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
To evaluate combination therapy of adding CTX-009 to the standard therapy GCD as first-line therapy in patients with unresectable or mBTC.

Primary Outcome Measures: Safety and Adverse Events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year
Longitudinal Study on Bacterial Production of LPC and LPA in Patients With Inflammatory Bowel Disease
NCT Number: NCT06548399
Acronym: Long-IBD
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Inflammatory Bowel Diseases|Crohn's Disease|Ulcerative Colitis
Sponsor: McMaster University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-01
Completion Date: 2024-12-01
Locations: McMaster University, Hamilton, Ontario, L8S 4L8, Canada

Summary:
The purpose of this study is to investigate whether the gut bacteria in IBD patients cause ongoing abdominal pain, even when the disease is calm. Many inflammatory bowel disease (IBD) patients have this pain, regardless of whether their disease is active or not. This might be linked to an imbalance in gut bacteria. Certain IBD patients with persistent abdominal pain experience increased sensitivity in their gut due to bacteria producing LPC and LPA. Our goal is to explore the connection between bacterial LPC/LPA levels and symptoms in IBD patients with long-lasting abdominal pain. Additionally, we aim to pinpoint the specific bacteria responsible for producing LPC/LPA, which in turn causes chronic abdominal pain in these patients.

Primary Outcome Measures: Correlation between daily abdominal pain and stool LPC/LPA levels, From enrolment to the end of data/sample collection period at 3 weeks
Secondary Outcome Measures: Correlation between daily abdominal pain and urine LPC/LPA levels, From enrolment to the end of data/sample collection period at 3 weeks|Correlation between daily abdominal pain and abundance of LPC/LPA producing bacteria in the stool, From enrolment to the end of data/sample collection period at 3 weeks
Other Outcome Measures: Associations between weekly average stool LPC/LPA levels and overall gastrointestinal symptoms, anxiety, depression and stress., From enrolment to the end of data/sample collection period at 3 weeks
Feasibility and Accuracy of a Novel Pleural Drain Gas Analyzer in Detecting Air Leaks
NCT Number: NCT06548386
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Air Leak From Lung|Pneumothorax
Interventions: DEVICE: Pleural gas analysis
Sponsor: Lung Healing Technologies Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 33
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-10
Completion Date: 2025-12
Locations: Endeavor Health, Evanston, Illinois, 60201, United States

Summary:
The goal of this study is to assess the clinical feasibility of a novel, reusable, low cost gas analyzer that detects breath in chest drains in order to diagnose and heal air leaks. The investigators have developed prototype gas analyzers that attach to the outlet of any analog chest drain, and can be connected temporarily to the sampling port. They detect breath by measuring CO2, O2, and pressure, in order to supplement the information provided by the bubbles in the water seal.

Primary Outcome Measures: Accuracy alone, Whether gas analysis can accurately assess for air leak, One year
Secondary Outcome Measures: Using VI as well, Comparison of accuracy in air leak assessment between gas analysis and visual inspection, One year
Assessment of Diagnostic Adequacy of AI-assisted Point-of-Care Echocardiography Among Anesthesiology Trainees
NCT Number: NCT06548373
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anesthesia
Interventions: DIAGNOSTIC_TEST: Artificial Intelligence-assisted Point-of-Care Echocardiography
Sponsor: Loma Linda University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-13
Completion Date: 2025-09
Locations: Loma Linda University Troesch Medical Center, Loma Linda, California, 92354, United States

Summary:
This pilot study serves to assess the diagnostic adequacy of Artificial Intelligence (AI)-guided point-of-care. Focused echocardiography examinations will be obtained by Anesthesiology trainees and assessed by an expert Cardiologist Echocardiographer. AI-guided echocardiography examinations will be compared to each other. AI-guided and non-AI-guided echocardiography examinations will also be compared.

Primary Outcome Measures: Echocardiogram Evaluation, Cardiologist will review AI-assisted echocardiogram images obtained by residents for diagnostic image quality. A rating of "Yes" will represent a diagnostically accurate result and a rating of "No" will represent an image that is not adequate for diagnostic purposes., Within 24 hours of AI-guided examination completion
Secondary Outcome Measures: Change in length of time of AI-assisted echocardiogram procedure, Assessment of time to complete the standardized point-of-care focused echocardiography examination will be determined by comparing time stamps on the first and last image sequence recorded. Change in this interval will be assessed between the tenth and first studies performed., Change in time of individual examination completion between the first AI-guided echocardiography examination performed and the tenth AI-guided echocardiography examination performed, typically one month post-enrollment|Change in echocardiogram examination image quality through comparison of AI-guided and non-AI-guided echocardiogram examination, After the 10th AI-guided point-of-care focused echocardiography examination is completed, the trainee will complete a standardized point-of-care focused echocardiography examination using a standard (not AI-guided) system. Assessment of echocardiogram adequacy, time to complete the examination, and Concordance between the trainee and Cardiologist assessments will be analyzed as described above., Change in time between the tenth AI-guided echocardiography examination performed and the non-AI guided cardiography examination performed, typically two months post-enrollment
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
NCT Number: NCT06548360
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: NonSegmental Vitiligo
Interventions: DRUG: Ruxolitinib Cream|DRUG: Vehicle Cream
Sponsor: Incyte Corporation
Sex: ALL
Age: CHILD
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11-18
Completion Date: 2027-03-13

Summary:
The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.

Primary Outcome Measures: Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75), ≥75% improvement in facial Vitiligo Area Scoring Index., Week 24
Secondary Outcome Measures: Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50), ≥50% improvement in facial Vitiligo Area Scoring Index., Week 24|Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90), ≥90% improvement in facial Vitiligo Area Scoring Index., Week 24|Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50), ≥50% improvement in total body Vitiligo Area Scoring Index., Week 24|Percentage change from baseline in F-BSA, Facial body surface area (F-BSA) takes into account the facial depigmented areas as a percentage of the total body area., Week 24|Number of Treatment Emergent Adverse Events (TEAEs), TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug., Up to Week 52 and 30 days|Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50), ≥50% improvement in facial Vitiligo Area Scoring Index., Week 52|Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75), ≥75% improvement in facial Vitiligo Area Scoring Index., Week 52|Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90), ≥90% improvement in facial Vitiligo Area Scoring Index., Week 52|Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50), ≥50% improvement in total body Vitiligo Area Scoring Index., Week 52|Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI25), ≥25% improvement in total body Vitiligo Area Scoring Index., Week 24 and Week 52|Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75), ≥75% improvement in total body Vitiligo Area Scoring Index, Week 24 and Week 52|Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90), ≥90% improvement in total body Vitiligo Area Scoring Index, Week 24 and Week 52|Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations, Trough is defined as the concentration reached by a drug immediately before the next dose is administered., Weeks 6, 24, 30 and 52
A Phase II/III Study of Linperlisib Plus CHOP Versus CHOP in Patients With Newly Diagnosed Peripheral T Cell Lymphoma
NCT Number: NCT06548347
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Peripheral T Cell Lymphoma
Interventions: DRUG: Linperlisib
Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 606
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-10
Completion Date: 2029-09-30

Summary:
This is a Phase II/III, international multiple center study to evaluate the efficacy, safety, and PK of Linperlisib plus CHOP and CHOP in adult patients with Newly Diagnosed Peripheral T Cell Lymphoma.

Primary Outcome Measures: Overall response rate, Study treatment will continue until unacceptable toxicity or documented disease progression, or for 2 years, whichever is earlier.|progression-free survival, Study treatment will continue until unacceptable toxicity or documented disease progression, or for 2 years, whichever is earlier.
The Effectiveness of Lumber Regression Technique on Disc Bulge Randomized Control Trial
NCT Number: NCT06548334
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Disc Disease
Interventions: COMBINATION_PRODUCT: Advanced Physiotherapy|OTHER: Conventional Physiotherapy Techniques
Sponsor: Superior University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-10-01
Completion Date: 2024-09-30
Locations: Nemat Hospital & Heart Center, Manga Mandi, Lahore, Punjab, Pakistan

Summary:
Lumbar disc bulges lead to considerable pain and disability in affected individuals, with current interventions lacking consistency of outcomes. The lumbar regression method offered a hopeful, noninvasive option.

Primary Outcome Measures: Roland Morris disability questionnaire, The Roland-Morris low back pain and disability questionnaire (RMD) was utilised to evaluate the quality of life prior to and following the completion of the treatment. This questionnaire has demonstrated strong validity and reliability. The score is measured on a scale of 0 to 24, and percentage scores were calculated for each participant. Greater scores indicate a greater level of disabilities. Its sensitivity is 95%, and its specificity is 69%., 12 Months|Straight Leg Raise, The normal angle for an SLR is from 0-35 degrees, which signifies the least amount of strain. Stretched from 35-70 degrees, sciatic nerve root stretching is achieved, and possible problems such as herniated disc or radiculopathy may be evidenced. 70- 90 degrees reflect highest normal flexibility: it may be related to hip joint pathology or some other conditions which are not a result of nerve injury. During both the first evaluation and the final therapy, the SLR was assessed using a digital inclinometer (clinometer) installed on a Techno Camon 20 Android phone. The digital inclinometer has been found to exhibit high levels of reliability and validity, 12 months
Benefits of Extracorporeal Shockwave Therapy to Reduce Spasticity in Stroke/CP
NCT Number: NCT06548321
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke, Cerebral
Interventions: DIAGNOSTIC_TEST: Extracorporeal Shockwave Therapy
Sponsor: Superior University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 28
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-10-01
Completion Date: 2024-09-30
Locations: Clinical setups Sargodha,Lahore,BWN, Lahore, Pakistan

Summary:
This Study will help to explain us that ExtracorporealShockwave therapy can reduce spasticity in Stroke Patient,help them to restore their abilities and ROM.Therapy reduces dependency rate of patient.Also seen this therapy shows reduction in spasticity of CP child population.Improving the motor recovery.

Primary Outcome Measures: Modified Ashworth Scale MAS, The Ashworth Scale method of grading spasticity, working with Cerebral Palsy and Stroke patients. The original Ashworth scale was a 5 point numerical scale that graded spasticity from 0 to 4, with 0 being no resistance and 4 being a limb rigid in flexion or extension. In 1987, while performing a study to exam interrater reliability of manual tests of elbow flexor muscle spasticity, Bohannon and Smith modified the Ashworth scale by adding 1+ to the scale to increase sensitivity. Since its modification, the modified Ashworth scale (MAS), has been applied in clinical practice and research as a measure of spasticity., 12 Months
Comparison of Corneal Incision Versus Toric Intraocular Lens Techniques Used in Cataract Surgery
NCT Number: NCT06548308
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cataract Surgery
Interventions: DIAGNOSTIC_TEST: Corneal Incision|OTHER: Toric Intraocular
Sponsor: Superior University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 368
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2020-10-01
Completion Date: 2024-09-30
Locations: Zubaida eyecare center sabzazar, Lahore, Pakistan

Summary:
Eyesight and quality of life improves in patients after refractive cataract surgery because this surgery treats myopia, hyperopia and presbyopia except astigmatism. In order to make a patient spectacle free Ophthalmologists use different methods during cataract surgery to minimize astigmatism.

Primary Outcome Measures: postoperative visual acuity, The postoperative visual acuity and refractive outcomes between patients undergoing cataract surgery with corneal incision and those with toric IOL implantation., 12 Months|effectiveness of astigmatism correction, Investigate the effectiveness of astigmatism correction achieved by both toric iol and corneal inscion technique and determine the degree of residual astigmatism in both groups after followups ., 12 months
Effects of mCIMT vs CT on Upper Extremity Motor Function and ADLs in Chronic Stroke Patients
NCT Number: NCT06548295
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Stroke
Interventions: BEHAVIORAL: modified constraint induced movement therapy (mCIMT)|COMBINATION_PRODUCT: conservative treatment
Sponsor: Superior University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 26
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-10-01
Completion Date: 2024-09-30
Locations: Little angles home aziz bhati shaheed road opposit junior aps, Sialkot, Pakistan

Summary:
"Cerebral palsy (CP) affects gross motor function variably, with the spastic type notably impacting movement, coordination, and balance. Research highlights that spastic CP, characterized by muscle stiffness, can severely hinder activities like walking and running.

Primary Outcome Measures: Barthal index, Barthel Index (BI) stands out as a widely utilized measure for assessing basic activities of daily living (ADL). Scores of 0-20 indicate "total" dependency. Scores of 21-60 indicate "severe" dependency. Scores of 61-90 indicate "moderate" dependency., 12 Months|The use of FMA-UE, measureing comprising 30 items for motor function and 3 items for reflex function, provides a comprehensive evaluation of motor abilities .

In regards to UE feature, 33 elements evaluate motor function, six items assess sensitivity and proprioception, while the last 24 points rate joint pain and mobility.

Every item of the assessment scale is marked on an ordinal level, from 0 to 2; the 0 value corresponds with the impossibility to perform a movement, and 2 represents the ability to perform a complete and adequate movement, 12 months
Efficacy of Acceptance and Commitment Therapy for the Management of Quality of Life in Patients Post Myocardial Infarction
NCT Number: NCT06548282
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Psychological Distress|Type D Personality|Medication Adherence|Quality of Life
Interventions: OTHER: Acceptance and commitment therapy
Sponsor: Fatima Jinnah Women University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-06-21
Completion Date: 2024-09-21
Locations: Armed Forces Institute of Cardiology, Rawalpindi, Punjab, 46000, Pakistan|Rawalpindi Institute of Cardiology, Rawalpindi, Punjab, 46000, Pakistan

Summary:
The present study aims to investigate the efficacy of acceptance and commitment therapy for the management of quality of life in patients post-myocardial infarction

Primary Outcome Measures: World Health Organization Quality of Life Scale Urdu Version, It has 26 items and four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains quality of life and general health items. The minimum value is 26 and the maximum value is 130. Higher scores on the scale indicate higher quality of life and low scores indicate low quality of life., 3 months
The Clinical Application of Clostridium Butyricum Miyairisan for Motor and Non-motor Symptoms in Parkinson's Disease
NCT Number: NCT06548256
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Clostridium Butyricum Miyairi|Parkinson Disease
Interventions: DRUG: Miyarisan-BM (Clostridium Butyricum Miyairi)
Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-10-31
Completion Date: 2026-12-31
Locations: Kaohsiung Medical Univeristy Hospital, Kaohsiung city, Taiwan

Summary:
This is an open-label, single-center, non-randomized study to assess the efficacy of Clostridium Butyricum Miyairi on the motor and non-motor symptoms of Parkinson's disease

Primary Outcome Measures: MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3, Part 3 of this scale assesses motor performance in 33 items. Each item is scored on a scale of 0 (normal) to 4 (severe), with a total score range of 0 to 132, and higher scores mean the patient's situation is worse., 0, 3, 12, 15, 24 months|Hamilton Depression Rating Scale (HAM-D), This scale assesses non-motor symptoms in 17 items, the total scale value is 50 (Scores 0 to 7 mean normal, 8 to 13 mean mild depression, 14 to 18 mean moderate depression, 19 to 22 mean severe depression, and ≥23 mean very severe depression)., 0, 3, 12, 15, 24 months|Hamilton Anxiety Scale (HAM-A), This scale assesses non-motor symptoms in 14 items. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where ≤17 indicates mild anxiety severity, 18-24 indicate mild to moderate anxiety severity, 25-30 indicate moderate to severe anxiety severity, \>30 indicate severe anxiety., 0, 3, 12, 15, 24 months
Act With Nature: Promoting Planetary Well-being
NCT Number: NCT06548243
Acronym: AWN
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Well-Being, Psychological
Interventions: BEHAVIORAL: Act with Nature Programme
Sponsor: JAMK University Of Applied Sciences
Collaborators: Tampere University|University of Surrey
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 158
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-01-31
Completion Date: 2025-09
Locations: Institute of Rehabilitation, JAMK University of Applied Sciences, Jyväskylä, 40100, Finland|Tampere University, Tampere, 33100, Finland

Summary:
The research investigates the effects of nature-based programme (Act with Nature; AWN) in promoting psychological well-being and pro-environmental behaviour among working age participants in Finland. Our research deepens understanding of how coping with environment-related emotions and nature connectedness are connected to human wellbeing and pro-environmental behaviour. The psychological wellbeing and pro-environmental behaviour are investigated with self-report measures and analysed with quantitative and qualitative methods. The project will provide a new programme (AWN) for combining individual well-being and behaviour change. The results can provide a theoretical framework and working model for health professionals to intervene and support people in adapting to environmental crises and coping with stress.

Primary Outcome Measures: Emotional wellbeing, Health related quality of life (RAND): emotional wellbeing dimension, the scores range from 1 to 6 and some items are recoded. Higher total score refers to better emotional wellbeing., 6 months|Mental wellbeing, Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS), the scores range from 1 to 5, a higher scores refers to better mental wellbeing., 6 months|Pro-environmental behaviour, Self-report scale of the frequency of pro-environmental actions. Items refering to pro-environmental actions during one month are responded on a scale ranging from 1 to 5. Items refering to pro-environmental actions during the past year are responded on a scale 1 (yes) and 2 (no). Some items are recoded and all items include an option for "doesn't apply to me". A higher total score refers to more self-reported pro-environmental behaviour., 6 months
Secondary Outcome Measures: Behavioural Willingness, Willingness to act pro-environmentally, the scores range from 1 to 4. A higher score refers to more willingness to act pro-environmentally., 6 months|Affect regulation, Measure of Affect Regulation Styles (MARS), the scores range from 1 to 6 and all items include an option for "doesn't apply to me". A higher score refers to a higher efficiency in affect regulation styles., 6 months
A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
NCT Number: NCT06548230
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Myelodysplastic Syndrome(MDS)|Acute Myelogenous Leukemia (AML)
Interventions: DRUG: Nadunolimab|DRUG: Azacitidine|DRUG: Venetoclax
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2029-12-01
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
To evaluate safety and determine the recommended Phase II dose (RP2D). We hypothesize that targeting leukemia stem/progenitor cells (LSCs) with nadunolimab (IL1RAP antibody) alone or in combination with current therapies of azacitidine (HMA) and venetoclax (Bcl-2 inhibitor), is an effective treatment strategy for high-risk MDS and AML, and with a clinical trial we will establish the safety and the early efficacy of this approach.

Primary Outcome Measures: Safety and Adverse Events, Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year
A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors
NCT Number: NCT06548217
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced or Metastatic Solid Tumors
Interventions: DRUG: ONO-4538HSC
Sponsor: Ono Pharmaceutical Co. Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 31
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-07
Completion Date: 2028-02-29
Locations: National Cancer Center Hospital, Chuo-ku, Tokyo, Japan|The Cancer Institute Hospital Of JFCR, Koto-ku, Tokyo, Japan

Summary:
This is a multicenter, open-label, uncontrolled, phase I study to evaluate the tolerability, safety, pharmacokinetics, and efficacy of ONO-4538HSC administered subcutaneously in participants with advanced or metastatic solid tumors. This study consists of the tolerability confirmation part to determine the recommended dose for Japanese participants by evaluating the DLTs and the expansion part to evaluate the safety and pharmacokinetics and to explore the efficacy.

Primary Outcome Measures: Dose-limiting toxicities (DLT), 28 days|Adverse event (AE), UP to 100 days after the last dose
Secondary Outcome Measures: Pharmacokinetics（serum concentration of Nivolumab）, Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)
Other Outcome Measures: Overall response rate (ORR), Through study completion, an average of 6 months|Disease control rate (DCR), Through study completion, an average of 6 months|Overall survival (OS), Through study completion, an average of 6 months|Progression-free survival (PFS), Through study completion, an average of 6 months|Duration of response (DOR), Through study completion, an average of 6 months|Time to response (TTR), Through study completion, an average of 6 months|Best overall response (BOR), Through study completion, an average of 6 months|Percentage of change in the sum of tumor diameters of target lesions, Through study completion, an average of 6 months|Maximum percent change in the sum diameters of the target lesions, Through study completion, an average of 6 months|Anti-Nivolumab antibody, Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)|Anti-rHuPH20 antibody, Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)
Effect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction: A Randomized Clinical Trial
NCT Number: NCT06548204
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
Interventions: DRUG: Fexofenadine Hydrochloride 60mg bid|OTHER: Placebo|DRUG: Fexofenadine Hydrochloride 120mg bid
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 165
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-09

Summary:
The purpose of this study was to evaluate the efficacy and safety of fexofenadine hydrochloride on the basis of standard treatment after PCI in STEMI patients.

Primary Outcome Measures: Late gadolinium enhancement/Left ventricular mass (LGE/LV%), LGE/LV% will be assessed by CMR, 6 months after myocardial infarction
Secondary Outcome Measures: Left ventricular ejection fraction (LVEF), LVEF will be assessed by CMR, 6 months after myocardial infarction|Left ventricular internal dimension in systole/body surface area (LVIDs/BSA%), LVIDs will be assessed by CMR and BSA will be calculated by height and weight, 6 months after myocardial infarction|Left ventricular internal dimension in diastole/body surface area (LVIDd/BSA%), LVIDd will be assessed by CMR and BSA will be calculated by height and weight, 6 months after myocardial infarction|BNP, Analysis of differences of BNP, 6 months after myocardial infarction|VO2 max, Analysis of VO2 max, 6 months after myocardial infarction|SAQ scale score, Analysis of SAQ scale score, 6 months after myocardial infarction|Drug-associated adverse reaction, Heart, nerve system, mental system, digestive system and immune system reactions, 1 month, 3 months and 6 months after myocardial infarction|Incidence of MACE, Incidence of death, acute myocardial infarction and shock., 1 month, 3 months and 6 months after myocardial infarction
T-DXd Versus THP for Medium-risk HER2-positive Early Breast Cancer
NCT Number: NCT06548178
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: HER2-positive Breast Cancer
Interventions: DRUG: T-DXd|DRUG: THP
Sponsor: Fudan University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 242
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2028-09
Locations: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China

Summary:
This study (EXTEND trial) is a multicentre, interventional, prospective, randomised, open-label, controlled neoadjuvant, phase 2 trial evaluating the efficacy and safety of T-DXd monotherapy vs. standard-of-care docetaxel+ trastuzumab + pertuzumab (THP) in medium-risk (lymph node negative with a primary tumour stage T2) HER2-positive early breast cancer.

Primary Outcome Measures: Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery, pCR rate after neoadjuvant treatment, defined as the proportion of participants who have no evidence by H\&E staining of residual invasive disease in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0) by investigator assessment following completion of neoadjuvant therapy., Up to approximately 1 year
Secondary Outcome Measures: Safety including adverse events (AEs), severe adverse events (SAEs) and adverse events of special interest (AESI)., Incidence of AEs, SAE, AESIs (interstitial lung disease, LVEF decrease), AEs resulting in study intervention interruption and discontinuation, etc., Up to approximately 1.5 years|Event-free survival (EFS) rate at 12, 24, 36-month, EFS is defined as time from date of randomisation until disease progression precluding initial surgery, invasive disease recurrence (local, regional, distant, or contralateral), or death from any cause., Up to approximately 3 years|Invasive disease-free survival (IDFS) rate at 12, 24, 36-month, IDFS is defined as time from surgery until invasive disease recurrence (local, regional, distant, or contralateral), or death from any cause., Up to approximately 3 years|European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 Questionnaire (QLQ-C30) score, The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Individual responses are given on a 4-point scale (1=Not at All to 4=Very Much), with a lower score indicating a better outcome., Up to approximately 3 years|EORTC Breast Cancer-Specific QoL Questionnaire (QLQ-BR45) score, The EORTC-QLQ-BR45 is a 45-item questionnaire developed to assess the quality of life of breast cancer patients. Individual responses are given on a 4-point scale (1=Not at All to 4=Very Much), with a lower score indicating a better outcome., Up to approximately 3 years
Physiological Reaction After Food Intake
NCT Number: NCT06548165
Acronym: NutriPulse
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Physiological Reactivity to Cues
Interventions: DEVICE: Wearable
Sponsor: University of Ulm
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2026-10
Locations: Universityhospital Ulm, Ulm, 89081, Germany

Summary:
The goal of this clinical trial is to clarify the normal response of the body after food intake.

Therefore, participants will wear three wearables for two weeks and document their food intake via an app- and picture-based protocol.

Primary Outcome Measures: Electrocardiogram, Changes in heart rate variability in response to food intake. Assessed through Vivalink ECG wearable that measures a continuous 3-channel ECG., 2 weeks|Pulserate, Changes in pulsrate and pulse interval in response to food intake. CardioWatch wearable uses photoplethysmography to measure pulse waves, 2 weeks|Body temperature, Changes in body temperature in response to food intake. Vivalink ECG and Cardio Watch continuously measure the skin temperature. CardioWatch is also able to determine the body core temperature via a heat flux sensor. For women, body core temperature can be measured with the trackle wearable., 2 weeks|Skin conductance, Changes in skin conductance in response to food intake. CardioWatch wearable continuously measures the skin conductance, 2 weeks|Glucose level, Changes in glucose levels in the interstitium in response to food intake. FreeStyle libre sensors continuously measure the glucose levels., 2 weeks
Secondary Outcome Measures: Physical Activity, The wearables Vivalink ECG and CardioWatch contain an accelerometer to continuously assess activity, intensity and body position., 2 weeks|Food intake, Assessed through photo-documentation of consumed food, 2 weeks
Other Outcome Measures: Correlation of physiological measures (electrocardiogram, pulserate, body temperature, skin conductance, glucose level), Correlation of the obtained physiological measures (electrocardiogram, pulserate, body temperature, skin conductance, glucose level) among each other and with food quantity and quality will be assessed, 2 weeks|Sex differences, Differences in the obtained physiological measures between sexes will be analyzed., 2 weeks|Correlation with glycemic and insulin sensitivity, Correlation of the obtained physiological measures among with glycemic, lipidemia, and insulin sensitivity will be analyzed., 2 weeks
AQUALIS:QoL of CLL Patients Treated With Acalabrutinib in France, Retrospective Study Based on Data From PLATON Database
NCT Number: NCT06548152
Acronym: AQUALIS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Lymphocytic Leukemia
Sponsor: AstraZeneca
Collaborators: Hospitalidee|Hospitalidee has been asserted to be a valid organization name by UHToulouse
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-30
Completion Date: 2025-12-31

Summary:
QoL is often not assessed in real-world studies; hence, there is limited understanding about the real-world QoL of patients diagnosed with CLL. Besides, studies evaluating QoL have largely focused on comparing treated and untreated populations. In particular, QoL of patients treated with acalabrutinib has not been evaluated in a real-life setting.

The aim of this study is to describe the QoL of CLL patients treated with acalabrutinib between the treatment initiation and twelve months after, in a real-life setting.

Primary Outcome Measures: To measure QoL score of CLL patients treated with acalabrutinib, from treatment initiation and up to 12 months, * Overall scores and scores in each domain of QoL questionnaires (EORTC-QLQ-C30 ) at acalabrutinib treatment initiation and at 3, 6, 9 and 12 months after initiation
* Proportion of patients with an increase, a decrease, or no change in QoL scores over time (between each time point), from treatment initiation and up to 12 months
Secondary Outcome Measures: To describe QoL and precisely the level and evolution of all symptoms, * Patients demographics (age, gender...) at acalabrutinib treatment initiation
* Clinical characteristics at acalabrutinib treatment initiation (CLL diagnosis, Binet classification, comorbidities of interest)
* Clinical characteristics quarterly up to 12 months (disease status)
* Score is calculated with standardized EORTC-CLL17 questionnaire At acalabrutinib treatment initiation and at 3, 6, 9 and 12 months after initiation, from treatment initiation and up to 12 months