pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)
NCT Number: NCT06530732
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Alzheimer's Disease
Interventions: PROCEDURE: Deep Cervical lymphatlc-Venous Anastomosis Surgery|DRUG: Lecanemab
Sponsor: Zhejiang Provincial People's Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-08-30
Locations: Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 310014, China

Summary:
The goal of this clinical trial is to To demonstrate the Safety and Efficacy of dcLVA Surgery for the Treatment of Alzheimer's Disease. Patients who meet the inclusion and exclusion criteria and consent to participate will be randomly assigned to either the experimental group (receiving dcLVA surgery plus standard medication) or the control group (receiving standard medication alone)

Participants will:

Undergo cognitive assessment and brain MRI assessment; Undergo a lumbar puncture; Undergo an injection of 20ml of gadodiamide contrast agent at a concentration of 0.5 mmol/L (1ml gadodiamide: 20ml 0.9% saline).

Primary Outcome Measures: The change in the sum of Clinical Dementia Rating Scale (CDR) scores at 12-month in relative to baseline

Primary Outcome Measures: The rate of change in the total score of the Clinical Dementia Rating Scale, The change in the sum of Clinical Dementia Rating Scale (CDR) scores at 12-month in relative to baseline , using the Chinese version of the CDR scale, with a score range of 0-3 points for each item.The total score ranges from a minimum of 0 points to a maximum of 18 points, where a higher score indicates a worse outcome., Time Frame: baseline,7 days post-surgery,3-month,6-month and 12-month
Effect of Esketamine on Anxiety State in Patients Undergoing Abdominal Tumor Surgery
NCT Number: NCT06530706
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety State|Esketamine
Interventions: DRUG: Esketamine|DRUG: normal saline
Sponsor: Zhejiang Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-05
Completion Date: 2025-09-20
Locations: Zhejiang cancer hospital, Hangzhou, Zhejiang, China

Summary:
To evaluate whether esketamine can relieve anxiety in patients undergoing abdominal tumor surgery.

Primary Outcome Measures: Whether esketamine can reduce anxiety status in patients with anxiety, assessed by Hamilton anxiety scale. The score ranges from 0 to 56, while the higher score means a more anxious state., 1 day before surgery, 3 days after surgery, 1 month after surgery
Secondary Outcome Measures: To explore whether esketamine can improve sleep status, assessed by Athens Insomnia Scale. Athens Insomnia Scale ranges from o to 24, with a higher score means a worse sleep status., 1 day before surgery, 1,2 and 3 days after surgery, 1 month after surgery|To explore whether esketamine can improve life quality, assessed by QoR-15 (quality of recovery-15). The score ranges from 0 (bad quality) to 150 (good quality)., 1 day before surgery, 3 days after surgery, 1 month after surgery
Broadband Collaborative Pulse Ablation Instrument Treating Malignant Pulmonary Nodules
NCT Number: NCT06530667
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Neoplasm Malignant|Secondary Lung Cancer
Interventions: DEVICE: broadband collaborative pulse ablation
Sponsor: Shanghai Zhongshan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2025-07-31
Locations: Zhongshan Hospital, Fudan University, Shanghai, Shanghai, 200032, China

Summary:
Effectiveness safety and feasibility of the broadband collaborative pulse ablation instrument in treating malignant pulmonary nodules

Primary Outcome Measures: Ablation success rate, Ablation success rate = (numbers of nodule be completely ablated) / (numbers of nodule be ablated). Contrast-enhanced CT examination showed no significant enhancement of the nodule ablation area, and the nodule was considered to be completely ablated., 1 month after ablation
Secondary Outcome Measures: Nodule ablation time, The time taken for nodule ablation is recorded according to the time displayed by the ablation instrument, Immediately after ablation|Complete ablation rate, Ablation success rate = (numbers of nodule be completely ablated) / (numbers of nodule be ablated). Contrast-enhanced CT examination showed no significant enhancement of the nodule ablation area, and the nodule was considered to be completely ablated, 3 months after ablation|Nodule recurrence rate, Ablation recurrence rate = (numbers of nodule recurrence) / (numbers of nodule be ablated). Contrast-enhanced CT showed the presence of an enhancement foci within the area of nodule ablation, and the nodule was considered to be recurrence., 6 months after ablation|Adverse events, Adverse Events as assessed by NCI CTCAE V5.0 (Safety and Tolerability), Up to 6 months
Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery.
NCT Number: NCT06530641
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Cardiac Surgery|Cardioplegia|Heart Arrest
Interventions: DRUG: Custodiol Htk Soln|DRUG: Buckberg Cardi-Braun
Sponsor: Lourdes Montero Cruces
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2026-12
Locations: Hospital Clínico San Carlos, Madrid, 28040, Spain

Summary:
Phase IV clinical trial of a single-blind, prospective and longitudinal randomized intervention comparing patients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia versus Buckberg blood cardioplegia.

Primary Outcome Measures: Comparison of the composite event, Comparison of the composite event of death, perioperative AMI, low cardiac postoperative output with need for ionotropics, and AKIN-III acute kidney failure, 90 days after the intervention
Secondary Outcome Measures: Differences in the incidence of elevation of Troponin, Comparison of the elevation of Troponin I US at 12 and 24 hours after the procedure., 90 days after the intervention|Differences in the 90-day mortality rate, Comparison of 90-day postoperative mortality, 90 days after the intervention|Differences in the incidence of low cardiac postoperative output, Comparison of low cardiac postoperative output event with need for ionotropic drugs in the first 24 hours., 90 days after the intervention|Differences in the incidence of acute kidney failure event, Comparison of AKIN-III acute kidney failure event, 90 days after the intervention|Differences in the incidence of acute myocardial infarction, Comparison of perioperative AMI incidence, 90 days after the intervention|Differences in the incidence of major bleeding event, Comparison of major bleeding event or life-threatening or disabling hemorrhage., 90 days after the intervention|Differences in the incidence of the need of transfusion, Comparison of the need for transfusion of blood products (absolute number) in the first 48 hours., 90 days after the intervention|Differences in the incidence of prolonged mechanical ventilation, Comparison of the need for prolonged mechanical ventilation for \>24h., 90 days after the intervention|Differences in the incidence of neurological complications, Comparison of type 1 and type 2 neurological complications., 90 days after the intervention|Differences in the incidence of postoperative atrial fibrillation., Comparison of the incidence of postoperative atrial fibrillation., 90 days after the intervention|Differences in the overall survival rate at 90 days., Comparison of overall survival at 90 days., 90 days after the intervention
Investigation of MP Pollution in the Human Respiratory System and Its Relationship to Lung Cancer
NCT Number: NCT06530615
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer
Interventions: PROCEDURE: Bronchoalveolar Lavage (BAL) during Bronchoscopy
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-05
Completion Date: 2026-07
Locations: Moffitt Cancer Center, Tampa, Florida, 33612, United States

Summary:
This project will study and characterize Microplastic (MP) burden in the lungs of patients undergoing Bronchoalveolar Levage (BAL) in thoracic clinics at Moffitt.

Primary Outcome Measures: Characterization of Microplastic (MP) Burden in the Lungs, Microplastic (MP) Burden in the Lungs will be determined by the results of the Bronchoscopy/Bronchoalveolar Lavage (BAL).

MPs isolated from Bronchoalveolar Fluid (BALF) will be characterized using Raman spectroscopy (RS). RS is a vibrational spectroscopy technique based on the inelastic scattering of light that provides information on the molecular vibrations of a system in the form of a vibrational spectrum. The Raman spectrum is akin to a fingerprint of chemical structure allowing identification of the components present in the sample.

For each sample, data will be generated on the presence or absence of MPs, total number of MPs, and polymer subtype distribution of MPs identified in the samples., Up to 24 Months
Secondary Outcome Measures: Concentration of Microplastics (MPs) in Lung Cancer Patients, Concentration of Microplastics (MPs) will be determined by the number of MPs identified in 10-mLs of Bronchoalveolar Fluid (BALF)., Up to 24 Months|Concentration of Microplastics (MPs) in Non-Lung Cancer Patients, Concentration of Microplastics (MPs) will be determined by the number of MPs identified in 10-mLs of Bronchoalveolar Fluid (BALF)., Up to 24 Months
Effects of Tupler's Technique on the Management of Diastasis Rectus Abdominis.
NCT Number: NCT06530589
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diastasis Rectus Abdominis
Interventions: OTHER: Tupler's Technique|OTHER: Traditional Exercises
Sponsor: Riphah International University
Sex: FEMALE
Age: ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-01
Locations: Allied Hospital Faisalabad, Faisalābad, Punjab, 38000, Pakistan|Madinah Teaching Hospital Faisalabad, Faisalābad, Punjab, 38000, Pakistan

Summary:
Diastasis Rectus Abdominis is the condition in which two abdominal muscles rectus abdominis separated and cause widening and thinning of Linea alba. The Tupler's Technique is Evidence Based intervention for the management of Diastasis Rectus Abdominis. The purpose of this study is to see the Effectiveness of Tupler's Technique on the Management of Diastasis Rectus Abdomins in Post-Partum Females.

Primary Outcome Measures: Digital nylon caliper to measure inter-recti Distance, Digital nylon caliper is the valid and reliable instrument to measure the inter-recti distance and inter-recti distance will be measured at three levels. at the level of umbilicus, 4.5cm above umbilicus and 4.5cm below umbilicus., Before intervention, after 3 weeks and after 6 weeks.|Oswestry low bac pain disability Questionnaire, This is a valid tool to assess back pain and this questionnaire has 10 sections and we grade level of disability according to grading criteria. 0-4shows no disability, 5-14 shows mild disability, and 15-24 shows moderate disability, and 25-34 shows severe disability and grade 35-50 means completely disabled., Before intervention, after 3 weeks and after 6 weeks.|Numeric Pain rating scale, By using this scale we will measure the intensity of back pain. i scores pain from 0-10. 0 means no pain, 5 means moderate pain and 10 means severe pain., Before intervention, after 3 weeks and after 6 weeks.|Maternal post-partum quality of life instrument (MPQOL-I), This questionnaire has 5 domains. psychological, reltion with family and friends, relation with spouse, socioeconomic and health related domain and we can assess every domain of female life., Before intervention, after 3 weeks and after 6 weeks.
Thalidomide for the Symptomatic Large Granular Lymphocytic Leukemia
NCT Number: NCT06530576
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: T-LGL Leukemia|NK-LGL Leukemia
Interventions: DRUG: Thalidomide and methotrexate
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-10
Completion Date: 2027-07-01
Locations: Institute of Hematology & Blood Diseases Hospital, Tianjin, Tianjin, 300020, China

Summary:
There is currently no standard first-line treatment for LGLL. The investigators used the TPM regimen (thalidomide + prednison + methotrexate ) to treat LGLL since 2020, enrolling a total of 54 patients and achieving an overall response rate (ORR) of 88.9% and a complete response (CR) rate of 75.9%. To further explore this hypothesis, the investigators designed this study to observe the efficacy of thalidomide monotherapy in patients with symptomatic LGLL. The investigators speculate that thalidomide plays a major role in the significant improvement of the TPM regimen compared to the MTX regimen.

Patients with LGLL are treated with thalidomide at 50 to 100 mg. If the desired response is not achieved at specific time points, methotrexate is added. Thalidomide monotherapy is administered for up to 3 courses, and the TM regimen can also be used for up to 3 courses. The overall response rate with thalidomide monotherapy serves as the primary study endpoint.

Primary Outcome Measures: Overall response rate, complete remission rate+ partial remission rate, up to 5 years
Secondary Outcome Measures: The safety of thalidomide, Incidence of adverse events, serious adverse events and significant adverse event, up to 5 years|Complete remession rate, Hematological PR was defined as an improvement in blood counts ANC \> 0.5 × 109/L; HGB increased by \>1 g/dL; PLT \> 50 × 109/L, up to 5 years|The rate of improvement in efficacy after TM combination, The effectiveness of the TM regimen is measured by subtracting the response rate of single-agent thalidomide, up to 5 years|Progression-free survival, Progression-free survival, up to 5 years|Overall survival, The time from the start of treatment to the patient's death from any cause, up to 5 years|Duration of remission, the time from response to progression/death (P/D), up to 5 years
PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas
NCT Number: NCT06530550
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lymphoma, T-Cell|NK-LGL Leukemia|T-LGL Leukemia
Interventions: DRUG: PI3K inhibitor
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 51
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-10
Completion Date: 2028-07-10
Locations: Institute of Hematology & Blood Diseases Hospital, Tianjin, Tianjin, 300020, China

Summary:
Indolent T/NK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from T/NK cells, characterized by slow growth and proliferation, but currently remain incurable. For indolent T/NK-cell lymphomas that are unresponsive to first-line treatment, there are few treatment options available and the prognosis is poor. This study is an open-label, prospective clinical trial aimed at evaluating the feasibility, efficacy, and safety of PI3K inhibitors in the treatment of relapsed/refractory indolent T/NK-cell lymphomas. Patients will be treated with Linperlisib or Duvelisib, with an expected overall response rate of 60% for PI3K inhibitor treatment.

Primary Outcome Measures: Overall response rate, complete remission rate+ partial remission rate, up to 5 years
Secondary Outcome Measures: The safety of PI3K inhibitors, Incidence of adverse events, serious adverse events and significant adverse event, up to 5 years|Complete remession rate, Hematological PR was defined as an improvement in blood counts ANC \> 0.5 × 109/L; HGB increased by \>1 g/dL; PLT \> 50 × 109/L, up to 5 years|Duration of remission, the time from response to progression/death (P/D), up to 5 years|Time to response, from the start of treatment to the first observed partial remission, up to 5 years|Progression-free survival, the time from treatment initiation until disease progression or death, up to 5 years|Overall survival, The time from the start of treatment to the patient's death from any cause, up to 5 years|Disease control rate, the proportion of patients whose tumors have not progressed after treatment over a specific period of time. Specifically, DCR includes the percentage of patients who achieve complete response (CR), partial response (PR), and stable disease (SD)., up to 5 years
Cilostazol vs. Aspirin in Acute Non-cardioembolic Stroke With Cerebral mIcrobleeds
NCT Number: NCT06530537
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Cerebral Microbleeds|Stroke
Interventions: DRUG: Cilostazol|DRUG: Aspirin
Sponsor: Zhejiang Provincial People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 848
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-18
Completion Date: 2031-08-30
Locations: Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 310014, China

Summary:
The purpose of this clinical trial is to demonstrate that cilostazol is non-inferior to aspirin in terms of efficacy and safety for the secondary prevention of stroke in patients with acute non-cardioembolic ischemic stroke who have concurrent microbleeds. Researchers will compare the medication cilostazol with aspirin to assess its efficacy and safety in these patients.

Participants will:

Take the medication cilostazol or aspirin daily as part of an antiplatelet drug therapy.

Have baseline data and follow-up data collected at the time of hospital admission, and then at 3 months, 6 months post-discharge, and annually thereafter up to 4 years.

Have the primary endpoint set as stroke recurrence, with secondary endpoints being composite vascular events. Safety events will include moderate to severe hemorrhage and bleeding at any site.

Primary Outcome Measures: The rate of recurrent stroke, Head CT,Brain MRI,Cognitive Evaluation, Time Frame: baseline ,3-month,6-month, and every 1 year, follow-up time up to 4 years
Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery
NCT Number: NCT06530524
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Head Neck Cancer|Xerostomia Following Radiotherapy
Interventions: DRUG: OnabotulinumtoxinA|DRUG: Placebo
Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Collaborators: Lady Davis Institute|McGill University Health Centre/Research Institute of the McGill University Health Centre
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-10-01
Completion Date: 2027-12-01
Locations: McGill University, Montreal, Quebec, Canada

Summary:
Head and neck cancer care, including tumors of the mouth, nose, throat and voice box, often requires radiation for cure to be achieved. Despite advances in radiation, 40% to 60% of patients experience a significant dry mouth (xerostomia) following radiotherapy. Several factors are associated with severe xerostomia including older age, advanced stage disease and tumor location. Currently, no pragmatic treatment strategy exists to reduce the risk of radiation-related xerostomia in patients with head and neck cancer. The investigators propose the use of a botulinum neurotoxin injected into the at-risk salivary glands before radiation as a strategy to preserve salivary gland function during radiation treatments and reduce xerostomia.

Primary Outcome Measures: Xerostomia-related quality of life, University of Washington Quality of Life questionnaire (higher score is better), Pretreatment, 6 and 12 months from treatment completion
Secondary Outcome Measures: Unstimulated salivary function using salivary gland scintigraphy, Measurement of unstimulated salivary gland flow prior to initiation of therapy and at 12 months from completion of therapy, Pretreatment and 12 months from treatment completion
Polatuzumab, Rituximab and Orelabrutinib Combination Regimen (PRO) in the Treatment of Elderly Frail Patients With Treatment-naive Non-GCB DLBCL
NCT Number: NCT06530511
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
Interventions: DRUG: Polatuzumab vedotin|DRUG: Rituximab|DRUG: Orelabrutinib
Sponsor: Affiliated Hospital of Nantong University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-08-01
Locations: Jiangsu Province Hospital, Nanjing, China

Summary:
This prospective, single-arm, multicenter clinical study aims to enroll 30 frail elderly patients with Non-GCB DLBCL. This study is to evaluate the preliminary efficacy and safety of the combination of Polatuzumab, Rituximab, and orelabrutinib in this population. The primary endpoint is CR rate after induction therapy.

Primary Outcome Measures: CRR, Complete response rate (CRR) at the end of Induction treatment (6 cycles), 6 months
Secondary Outcome Measures: ORR, Overall response rate (ORR) at the end of Induction treatment (6 cycles), 6 months|2y-PFS rate, defined as the time from the start of treatment to the first documented Disease progression or Death; patients who have not experienced an event at the time of analysis will be censored at the date of the most recent disease assessment, 24 months|OS, defined as the time from the start of treatment to the Death of death from any cause; patients who had not experienced an event at the time of analysis were censored at the date the patient was last known to be alive, 24 months|EFS, defined as the time from the start of treatment until Disease progression/relapse, Death from any cause, or the start of next-line Lymphoma therapy (NALT); patients who have not experienced an event at the time of analysis will be censored at the date of the most recent disease assessment, 24 months|Safety profile, defined as the incidence of Adverse event (AEs) that occurred from the date of the first dose of Carcinoma until 30 days after discontinuation of study drug or PD or initiation of new anti-safety therapy, whichever occurred first, and defined as all Adverse event that occurred after the patient received the study regimen; defined as the incidence of treatment-related AEs that were considered by the investigator to be related to Salvage therapy, Transplant, and consolidation therapy after the patient received the study regimen, 24 months
Other Outcome Measures: Potential predictive factors, defined as clinical and biological factors at baseline or during the treatment that might be associated with treatment efficacy and safety and was performed to screen out populations that would benefit more from this protocol., 24 months
Diagnostics of Clinical Hyperandrogenism
NCT Number: NCT06530498
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anovulation|PCOS
Interventions: DIAGNOSTIC_TEST: Assessment of the severity of hirsutism using the visual modified Ferriman-Gallwey scale|DIAGNOSTIC_TEST: Assessment of the severity of endogenetic alopecia using the visual Ludwig Scale
Sponsor: Jagiellonian University
Sex: FEMALE
Age: ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-08
Completion Date: 2025-12-31
Locations: Jagiellonian University Medical College, Krakow, 31-501, Poland

Summary:
The optimal cut-off value for diagnosing hirsutism in the modified Ferriman-Gallwey (mFG) point scale in the Polish population is not known. The correlation of mFG with the severity of androgenetic alopecia in the Ludwig scale (LS) is not known.

The aim of the study is to determine the cut-off point for the diagnosis of hirsutism and to assess the correlation of the mFG scale score with the LS of androgenetic alopecia severity.

Primary Outcome Measures: Comparison of the severity of hirsutism in the PCOS and HPOD groups, Comparison of the mFG score in the PCOS and HPOD groups, up to 6 months|Comparison of the severity of endogenetic alopecia in the PCOS and HPOD groups, Comparison of the LS score in the PCOS and HPOD groups, up to 6 months|Calculation of cut-off point for diagnosing hirsutism in the study population, The cut-off point for diagnosing hirsutism will be calculated using the receiver operating characteristic curve, up to 6 months|Assessment of diagnostic convergence of mFG and LS scales in diagnosing clinical hyperandrogenism, The correlation of mFG and LS scale scores in the study population will be assessed using standard statistical methods, up to 6 months
Post Discharge Trial to Enhance Immunity in Severely Malnourished Children
NCT Number: NCT06530485
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Child Malnutrition
Interventions: DIETARY_SUPPLEMENT: Microbiota-directed food|DIETARY_SUPPLEMENT: Khichuri
Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators: Washington University School of Medicine
Sex: ALL
Age: CHILD
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-01
Completion Date: 2025-12-31

Summary:
The goal of this study is to evaluate the efficacy of microbiota-directed food in comparison to zinc with micronutrient powder and Khichuri on changes in circulating immune cells (monocytes, T cells, B cells, and NK cells) in malnourished children after recovery from acute infection.

The study aims to answer the research question:

Does microbiota-directed food (MDF) compared to zinc with micronutrient powder (MNP) and Khichuri therapy enhance immunity in children with severe acute malnutrition? The researcher will compare the effectiveness of microbiota-directed food (MDF) versus zinc with micronutrient powder (MNP) and Khichuri therapy to see if MDF enhances immunity in severely malnourished children.

Severely malnourished children will:

* Receive microbiota-directed food (MDF) or zinc with micronutrient powder (MNP) and Khichuri every day for 12 weeks.
* Phenotyping of circulating immune cells (NK cells, T cells, B cells) will be conducted using flow cytometry and fluorescence-activated cell sorting techniques.

Primary Outcome Measures: NK cells, Differences in the proportion and activity of circulating NK cells between the groups 12 weeks after the intervention, measured by flow cytometry/fluorescence-assisted cell sorter (FACS)., 12 weeks
Secondary Outcome Measures: Circulating immune cells, Differences in the proportion of circulating immune cells (NK cells, T cells, B cells) before and after the interventions, 12 weeks|Cytokines and chemokines, Differences in the levels of pro-inflammatory and anti-inflammatory cytokines and chemokines in circulation, which can provide insights into the functional status of immune cells, 12 weeks|Micro biocidal capacity, Differences in the micro biocidal capacity (oxidative burst) of neutrophils and monocytes., 12 weeks|Rate of weight gain, Rate of weight gain between the intervention groups over the 12-weeek intervention period., 12 weeks|Diarrhea and pneumonia, Incidence of acute diarrhea and pneumonia during the study period., 12 weeks|Gut microbiota, Composition and evolution of gut microbiota over the 12-weeek intervention period., 12 weeks|Case fatality rate, Case fatality rate within 12 weeks post discharge., 12 weeks|Anthropometric recovery, Anthropometric recovery from SAM: anthropometric recovery will be defined as reaching a WLZ of \>-2 (for those admitted with WLZ \<-2) and or MUAC \>12.5 (for those admitted with MUAC \<12.5 cm)., 12 weeks
SMART PHONE ADDICTION AND ELBOW JOINT PERFORMANCE
NCT Number: NCT06530446
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: To Investigate the Relationship Between Smartphone Addiction and Elbow Joint Performance , Specially ms Strength, Proprioception and Functional Abilities
Interventions: OTHER: one group. observational study
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-04-01

Summary:
smart phone addiction negatively impacted the pain in the muscles of the neck, shoulder, elbow, and the hand. the negative impact of prolonged smartphone use has shown an association between smartphone addiction and musculoskeletal pain in different areas of the body. Caution should be taken towards the safe implementation of smartphone use (Ahmed et al., 2022).

The combination of repetitive movements, poor posture, and over-use of mobile phones for texting or playing games, without taking rest breaks, can cause injury to the nerves, muscles, and tendons in the fingers, hands, wrists, arms, elbows, shoulders, and neck, which if ignored, may lead to long-term damage (Kleinert CM .,2011). Staying stationary for hours with the same hand and elbow movements while using mobile phones not only disrupts the posture of the individual but also causes inefficiency at work (Ulusam et al., 2015). Thus, their prolonged use significantly affects the quality of life as well as the activities of daily life of the individual (Lee et al .,2015 and Awasthi et al ., 2020).No previous study has investigated the link between smartphone addiction and elbow joint performance, to the authors' knowledge. Therefore, the primary purpose of this study will be to determine the relationship between smartphone addiction and elbow joint performance.

Primary Outcome Measures: MS strength, Hand-held dynamometer (Lafayette ), 6 months
Enhanced Community First Responder System Evaluation in Singapore
NCT Number: NCT06530433
Acronym: TCPR-Link
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Out-Of-Hospital Cardiac Arrest
Interventions: DEVICE: CPRCard + TCPR Link App and Web|DEVICE: CPRCard Only
Sponsor: Singapore General Hospital
Collaborators: Duke-NUS Graduate Medical School
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 165
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-01
Completion Date: 2028-12-31

Summary:
The rise in out-of-hospital cardiac arrest (OHCA) cases in Singapore highlights the need for effective bystander cardiopulmonary resuscitation (BCPR). Despite many lay responders performing CPR, survival rates with good neurological outcomes have not significantly improved, prompting research into the quality of CPR as a critical factor. The study by Gallagher EJ et al. showed a significant survival improvement with high-quality CPR.

To address this, the Unit of Pre-hospital and Emergency Research (UPEC) trained thousands of community first responders (CFRs) in simplified CPR techniques using hands-only and DA-CPR methods. A significant innovation is the CPRcard®, developed by Laerdal in Norway, which offers real-time feedback on the quality of chest compressions. However, only 36% of CFRs using the CPRcard® achieved the desired compression standards, indicating room for improvement.

The study proposes enhancing CFR support with information communication technology (ICT), enabling two-way audio and one-way video communication between CFRs and dispatchers. This aims to reduce stress among responders, increase their willingness to engage with OHCA alerts, and improve CPR quality.

The clinical trial in Singapore will compare the current system against the enhanced CFR support system (eCSS), focusing on the real-time relay of CPR performance data, communication ease, and implementation factors. The high-quality CFR and OHCA registries in Singapore provide a robust setting for this research, aiming to enhance CPR delivery and improve OHCA outcomes through technology and real-time support.

Primary Outcome Measures: Good Chest Compression Depth (4-6cm), OHCA events achieving great proportions of adequate compressions (achieving depth within the target range of 4-6 cm), Throughout chest compression before handing over to EMS (up to 24 hours)
Secondary Outcome Measures: Survivor discharging rate, Return of spontaneous circulation (ROSC) at scene or at emergency department; survival to discharge; neurologically intact survival, Throughout Hospital Admission (up to 1 year)
The Usefulness of the New EHS/AHS Classification of Primary Umbilical Hernias in the Selection of Method of Their Treatment
NCT Number: NCT06530420
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Retrospective Analysis of Material From the Hospital Database
Interventions: PROCEDURE: Umbilical hernia repair surgery
Sponsor: Brothers Hospitallers Hospital in Cracow
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1087
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-14
Completion Date: 2025-12-20
Locations: Hospital of the Brothers Hospitallers of Saint John of God, Kraków, Poland

Summary:
The aim of the study is to assess the usefulness of the new classification of primary umbilical hernias in the choice of treatment of patients.

The study is conducted as a retrospective analysis of material from the hospital database

Primary Outcome Measures: Incidence of umbilical hernia recurrence, 20.12.2025
Comparison of the Immediate Effects of Lower Extremity Static Stretching Exercises on Vertical Jump
NCT Number: NCT06530407
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stretch
Interventions: OTHER: Static streching exercise
Sponsor: Halic University
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2024-07-10
Locations: Halic University, Istanbul, Turkey

Summary:
The aim of this study is to compare the immediate effects of lower extremity static stretching exercises on vertical jump in sedentary individuals based on gender.

Primary Outcome Measures: Vertical jump height, DSY was measured with a wireless jumping platform (Ezejump, Australia). Participants were subjected to three squat jump tests on this platform with free intervals between repetitions and the maximum value obtained from the test was recorded as the vertical jump height., at baseline and immediately after the lower extremity static stretching exercise program
Effects of Pilates Exercises Applied With Face-to-Face and Telerehabilitation on Menstrual Pain
NCT Number: NCT06530381
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Menstrual Pain
Interventions: OTHER: Pilates Exercises With Face-to-Face|OTHER: Pilates Exercises With Telerehabilitation
Sponsor: Halic University
Sex: FEMALE
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2024-09-10
Locations: Halic University, Istanbul, Turkey

Summary:
Pain is one of the most common symptoms of menstrual syndrome that significantly affects quality of life. The aim of our study is to compare the effect of Pilates on menstrual pain and the effectiveness of the applications within themselves.

Primary Outcome Measures: Visual Analog Scale (VAS), VAS is used for subjective assessment of pain. VAS scores are evaluated on a scale of 1-10. 1-3 indicates mild pain, 4-6 indicates moderate pain, 7-8 indicates severe pain, and 9-10 indicates very severe and unbearable pain.Individuals with VAS\>5 are included in the study., at baseline and at week 6.|Short-Form 36 (SF-36), The SF-36 scale is used for quality of life assessment. This scale basically includes 8 subject scales. Each subject title is scored between 0-100. The scale has positive scoring, as the score increases, the quality of life also increases., at baseline and at week 6.|Menstrual Attitude Scale (MAS), MAS is used to evaluate symptoms in the premenstrual/menstrual period. MAS consists of 5 main topics and a total of 33 sub-items. MAS is a scale that includes both positive and negative items., at baseline and at week 6.
Effect of a Calisthenic Exercises on Premenstrual Symptoms
NCT Number: NCT06530368
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Menstrual Pain
Interventions: OTHER: Calisthenic home exercise programs
Sponsor: Halic University
Sex: FEMALE
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-15
Completion Date: 2024-05-15
Locations: Halic University, Istanbul, Turkey

Summary:
The aim of this study is to examine the effects of an eight-week calisthenic home exercise program on premenstrual symptoms, pain and sleep quality in young women.

Primary Outcome Measures: Premenstrual Syndrome Scale (PMSS), The scale, which is widely used in the clinic, has 44 questions that women mark considering "the state of being in the period one week before menstruation". The lowest score that can be obtained from the scale is 44; the highest score is 220. In addition, PMS severity classes can be created according to the scores obtained from the scale. Accordingly, a score of 88 and above from PMSS indicates severe PMS symptoms, and a score below 88 indicates mild PMS symptoms. Individuals who scored 88 and above from the scale were included in our study., at baseline and at week 8.|Visual Analog Scale (VAS), VAS is a simple, practical, valid, reliable and repeatable measure that evaluates the pain felt by scoring it between 0-10. Participants were asked to score the pain intensity they felt between 0-10 for each of the abdominal region, lumbar region and general body pain., at baseline and at week 8.|Pittsburgh Sleep Quality Index (PSQI), The PSQI questionnaire used to assess sleep quality includes 18 items for scoring. A total PSQI score between 0-4 indicates good sleep quality, and a score between 5-21 indicates poor sleep quality., at baseline and at week 8.
Comparison of the Non-Dominant Hands of Pianists and the Dominant Hands of Individuals Who Do Not Play Instruments
NCT Number: NCT06530355
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Hand
Interventions: OTHER: The same evaluation methods were used for both groups.
Sponsor: Halic University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-10
Completion Date: 2024-07-10
Locations: Halic University, Istanbul, Turkey

Summary:
The aim of this study is to compare the non-dominant hands of pianists with the dominant hands of individuals who do not play an instrument in terms of skill and reaction time.

Primary Outcome Measures: Edinburgh Hand Preference Questionnaire, Used to determine hand dominance. The survey's answer options; the results of the survey were evaluated according to Geschwind's score as follows, in line with the answers given.

* strong right-handers +80 to +100 points
* weak right-handers +20 to +75 points
* ambidextrous -15 to +15 points,
* weak left-handers -20 to -75 points
* strong left-handers -80 to -100 points, at baseline|Nine-Hole Peg Test, It was used to evaluate fine manual skills against time. The participant was asked to place 9 3.2 cm long sticks into the holes on the platform as quickly as possible with his hand and the time from the start command to the last stick was recorded. Then, he was asked to collect the sticks in order with the same hand and the time to remove all the sticks was recorded in seconds., at baseline|Nelson Hand Reaction Test, It was used to evaluate reaction time. It consists of a ruler graduated in time. The tester held the ruler by the end between the thumb and index finger of the subject and then released the ruler. The upper point where the subject grasped the ruler with his fingers was recorded., at baseline
Effect of Hamstring Muscle Length on Lunge Distance in Fencing Athletes
NCT Number: NCT06530342
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Athletic Injuries
Interventions: OTHER: The same evaluation methods were used for both groups.
Sponsor: Halic University
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-15
Completion Date: 2024-05-15
Locations: Anatolian Archery and Fencing Club, Istanbul, Turkey

Summary:
The aim of this study was to determine the effect of hamstring muscle length on lunge distance in fencing sword athletes.

Primary Outcome Measures: Hamstring Muscle Length, The athlete was positioned supine with the hip joint at 90 degrees of flexion and was asked to perform active knee extension. The waist and the knee that was not being measured were fixed to the bed. The athlete was asked to slowly extend the knee, and the measurement was recorded with a goniometer at a level where there was no tremor in the knee., at baseline|Lunge Distance, Lunge distance was evaluated by measuring the distance between the position of the front foot on the ground in the anguard position and the new position of the front foot on the ground after the lunge, using a tape measure., at baseline
Short-Term Effects of Ischemic Compression Applied in Addition to Classical Massage in the Treatment of Trigger Points
NCT Number: NCT06530329
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Trigger Point Pain, Myofascial
Interventions: OTHER: Classical massage|OTHER: Ischemic compression
Sponsor: Halic University
Sex: FEMALE
Age: ADULT
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-03-15
Completion Date: 2024-06-15
Locations: Halic University, Istanbul, Turkey

Summary:
The aim of our study was to investigate the short-term effects of ischemic compression applied in addition to classical massage for the treatment of myofascial trigger points on the upper trapezius muscle in women on pain, functionality and quality of life.

Primary Outcome Measures: Visual Analog Scale, Pain assessment was made with Visual Analog Scale (VAS). The subjects were informed that the number '0' on a 10 cm horizontal line indicated 'no pain' and the number '10' indicated 'unbearable pain'. The subjects were asked to mark the pain they felt on the VAS scale for 3 different areas, namely trapezius pain, neck pain and headache, and the points they marked were recorded as the severity of pain in cm. VAS measurements were performed twice in total, before and after treatment., at baseline and at week 2.|Active Range of Motion, Active Range of Motion (AROM) measurement was evaluated using a universal goniometer. While the patient was in a sitting position, the pivot point, fixed arm and movable arm of the goniometer were placed in the specified reference areas. The patient was asked to actively perform neck flexion, extension, right-left lateral flexion and right-left rotation movements and the values at the end of the movements were recorded in degrees. AROM measurements were performed twice in total, before and after treatment., at baseline and at week 2.|Short-Form 36, The Short Form-36 (SF-36) scale was used to assess quality of life. The lowest score represents the worst health status. SF-36 measurement was performed twice, before and after treatment., at baseline and at week 2.
RET Inhibitor for Neoadjuvant Therapy in Locally Advanced RET-altered Thyroid Cancer
NCT Number: NCT06530316
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Thyroid Cancer
Interventions: DRUG: RET Inhibitor|PROCEDURE: Surgery
Sponsor: Fudan University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-18
Completion Date: 2029-12-31
Locations: Fudan Univeristy Shanghai Cancer Center, Shanghai, China

Summary:
This study is a multicenter observational study. Patients receive neoadjuvant therapy with RET inhibitors in the real world, and those who can undergo surgery after neoadjuvant therapy receive surgical treatment. The aim of the study is to determine the efficacy and safety of RET inhibitors for neoadjuvant therapy in locally advanced RET-altered thyroid cancer.

Primary Outcome Measures: R0/1 resection rate, 1 year
Secondary Outcome Measures: Objective Response Rate, ORR, 1 year|Disease Control Rate，DCR, 1 year|Time to objective response，TTR, 1 year|Progression Free Survival，PFS, 5 years|Overall Survival，OS, 5 years|Adverse Events, During RET inhibitor treatment, up to 5 years
Biological Tumor Infiltrating Lymphocytes Therapy With Immunotherapy for Colon and Rectum Cancer
NCT Number: NCT06530303
Acronym: BAH248
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Colorectal Cancer|Colon Cancer|Rectum Cancer
Interventions: BIOLOGICAL: Tumor Infiltrating Lymphocytes (TIL)|DRUG: Cyclophosphamide|DRUG: Fludarabine|DRUG: Interleukin-2|DRUG: Pembrolizumab
Sponsor: Essen Biotech
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 85
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-29
Completion Date: 2026-12-28
Locations: District One Hospital, Beijing, Beijing, 086-373, China

Summary:
This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) and Aldesleukin (interleukin-2, IL-2) immunotherapy in patients with advanced or metastatic refractory colon and rectal cancer (colorectum). TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response, while Aldesleukin will be used to further stimulate the TILs. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to provide a novel, personalized treatment option for patients with limited therapeutic alternatives.

Primary Outcome Measures: Adverse Events, To characterize the safety profile of (TIL) and natural autologous TIL in patients with advanced solid tumors who were failed to standard treatment as assessed by incidence of adverse events., 6 months
Secondary Outcome Measures: Objective Response Rate (ORR), Proportion of patients with response per Response Evaluation Criteria in Solid Tumors, Up to 36 months|Disease Control Rate (DCR）, Percentage of patients that meet CR, PR and SD criteria set in this study, Up to 36 months|Duration of Response (DOR), The time length between the first confirmed objective response to the treatment and the subsequent disease progression, Up to 36 months|Progression-Free Survival (PFS), The time length between TIL infusion and confirmed subsequent disease progression, Up to 36 months