pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Compare Wound Sampling Methods Efficacy in Microbiology Culture
NCT Number: NCT06460025
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Microbial Colonization|Infected Wound|Slough
Sponsor: Peking University Third Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 131
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-10-01
Completion Date: 2025-05-01
Locations: Peking University 3rd Hospital, Beijing, Beijing, 010, China

Summary:
Slough was a visible indicator of biofilm, which was the most available specimen from acute and chronic wounds. However, studies believed that slough were poorly accurate, and that the Levine swab was more recommended for sampling bacterial culture. This study aimed to compare slough with swab sample and analyze the consistency.

Primary Outcome Measures: cohen's k coefficient of Gram Stain between Slough and Swap Specimens, compare the difference of Gram Stain after bacterial culture between Slough and Swap Specimens, by using statistics of cohen's k coefficient，values of κ from The κ coefficients in 0.81 to 1 waeres interpreted as excellentalmost perfect concordance, with 0.61 to 0.80 asrepresented substantial, 0.41 to 0.60 as mean moderate, 0.21 to 0.40 as fair, and 0 to 0.20 as slight., Day 0, patients' the first site in wound healing center
Secondary Outcome Measures: cohen's k coefficient of Common pathogens between Slough and Swap Specimens, compare the difference of Common pathogens after bacterial culture between Slough and Swap Specimens, by using statistics of cohen's k coefficient，values of κ from The κ coefficients in 0.81 to 1 waeres interpreted as excellentalmost perfect concordance, with 0.61 to 0.80 asrepresented substantial, 0.41 to 0.60 as mean moderate, 0.21 to 0.40 as fair, and 0 to 0.20 as slight., Day 0, patients' the first site in wound healing center|agreements in microbiology cultivation between slough and swap, compare the agreement of pathogens after bacterial culture between Slough and Swap Specimens, by percentage., Day 0, patients' the first site in wound healing center
The Duration of Spinal Anaesthesia - a Prospective, Observational Cohort Study
NCT Number: NCT06459986
Acronym: Spinalrocks
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Orthopedic Disorder
Sponsor: Nordsjaellands Hospital
Collaborators: Aleris Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-03
Completion Date: 2026-04
Locations: Anæstesiologisk Afd, Hillerød, 3400, Denmark|Aleris-Ringsted, Ringsted, 4100, Denmark

Summary:
Today, surgery in an ambulatory setting is preferred for many reasons. Total hip and knee arthroplasty (THA and TKA) are now procedures where patients can be sent home on the same day of the surgical procedure. However, this requires substantial knowledge of factors affecting the length of hospital stay. In this prospective, observational cohort study, we will investigate factors that affect the duration of spinal anaesthesia which is often used in THA and TKA. The aim is to gather enough data to be able to determine how local anaesthetic volume and dose affect the duration of spinal anaesthesia. This will enable us to decide whether spinal anaesthesia is a good option when performing TKA and THA in an ambulatory setting.

Primary Outcome Measures: Duration of spinal anasthesia 1, Time from subarachnoid LA administration to Bromage score \< 3, 12 hours|Duration of spinal anaesthesia 2, Time from subarachnoid LA administration to Bromage score = 1, 12 hours
A Clinical Study of YL205 in Patients With Advanced Solid Tumors
NCT Number: NCT06459973
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Advanced Solid Tumors
Interventions: DRUG: intravenous (IV) infusion
Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 252
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-04
Completion Date: 2030-07-31
Locations: Jilin Provincial Cancer Hospital, Changchun, Jilin, China

Summary:
This study is a multicenter, open-label, phase I/II study of YL205 in China to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of YL205 in the following selected patients with advanced solid tumors.

Primary Outcome Measures: To evalue the DLTs, Approximately within 36 months|To evalue the TEAEs, Treatment Emergent Adverse Event, Approximately within 36 months|To evalue the TRAEs, Treatment Related Adverse Event, Approximately within 36 months|To evalue the serious adverse events (SAEs), Approximately within 36 months|Determination of the MTD of YL205 in the pivotal clinical study, Approximately within 36 months|Determination of the RED of YL205 in the pivotal clinical study, Approximately within 36 months|Determination of the RP2D of YL205 in the pivotal clinical study, Approximately within 36 months|Assessed ORR (the proportion of CR and PR) by the investigator per RECIST v1.1, Approximately within 36 months
Secondary Outcome Measures: Characterize the PK parameter AUC, area under curve (AUC), Approximately within 36 months|Characterize the PK parameter Cmax, maximum concentration (Cmax), Approximately within 36 months|Characterize the PK parameter Ctrough, minimum concentration at trough (Ctrough), Approximately within 36 months|Characterize the PK parameter Vd, volume of distribution (Vd), Approximately within 36 months|Characterize the PK parameter CL, plasma clearance (CL), Approximately within 36 months|Characterize the PK parameter Tmax, time to maximum concentration (Tmax), Approximately within 36 months|Characterize the PK parameter t1/2, half-life (t1/2), Approximately within 36 months|Assessed the disease control rate (DCR) per RECIST v1.1, (defined as the proportion of CR, PR, or stable disease (SD)), Approximately within 36 months|Assessed the duration of response (DOR) per RECIST v1.1, Approximately within 36 months|Assessed the time to response (TTR) per RECIST v1.1, Approximately within 36 months|Assessed the progression free survival (PFS) per RECIST v1.1, Approximately within 36 months|Assessed the depth of response (DpR) per RECIST v1.1, the percentage change in target lesion size, Approximately within 36 months|Assessed the overall survival (OS) per RECIST v1.1, Approximately within 36 months|Evaluate the corelaton between different levels of Napi2B expression and the sum of CR rate, PR rate and SD rate, Approximately within 36 months
Effect of Cyanoacrylate and Concentrated Growth Factor on Palatal Donor Site
NCT Number: NCT06459947
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Wound Healing|Pain|Patient Comfort
Interventions: PROCEDURE: Free gingival graft procedure
Sponsor: Yuzuncu Yıl University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-02
Completion Date: 2024-10-15
Locations: Van Yuzuncu Yil University, Van, 65080, Turkey

Summary:
The aim of this planned randomized controlled clinical study is to evaluate the morbidity of the palatal donor area after free gingival graft (FGG) operations. In this study, wound healing and pain levels in the palatal region will be evaluated after cyanoacrylate and concentrated growth factor (CGF) applications.

Primary Outcome Measures: VAS, The patient is given a form to record the post-operative pain level in the palatial area with Visual analogue scale (VAS). The VAS is a scale that rates pain severity from 0 to 10. (0 = no pain to 10 = severe pain), The pain level is recorded every hour for the first 8 hours after the operation, and on the 2nd, 3rd, 4th, 5th, 6th, 7th days after the operation.|Epithelialization, Hydrogen peroxide is used to detect epithelialization in the donor area after the operation. If epithelialization is not completed, H2O2 affects the catalase enzyme in the connective tissue and releases water and oxygen. Thus, clinically, it forms blisters on the palatal wound surface. Epithelialization scores will be divided into three groups: absent, partially epitheliazed and completely epithelialized., The epithelialization is examined on the 7th, 14th, 21st, and 28th days
Secondary Outcome Measures: Number of analgesic drugs, Patients are asked to note the number of analgesics they took for pain during the first week., Number of analgesic drugs is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.|Healing Index, The Healing Index is recorded with a 5-level score ranging from 1 (very poor) to 5 (excellent)., The Healing Index is recorded on the 7th day.|Color Match, The color match is evaluated by Visual analogue scale (VAS). (0: no color match, 10: perfect color match), The color match is evaluated on the 7th, 14th, 21st and 28th days.|Secondary Bleeding, Post-operative bleeding in the palatal region is noted. The patient notes the postoperative bleeding status of the palatal area. Bleeding scores are recorded as yes or no., Post-operative bleeding is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.
Clinical Outcomes of Cardiovascular Disease
NCT Number: NCT06459934
Acronym: CLEAR
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiovascular Diseases|Heart Failure|Coronary Artery Disease
Sponsor: Xinjiang Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2028-12-31
Locations: The First Affiliated Hospital of Xinjiang Medicial University, Ürümqi, Xinjiang, 830000, China

Summary:
This study is a prospective, single center cohort study that primarily registers the clinical characteristics, outcomes, and influencing factors of patients with different types of cardiovascular diseases. Evaluate multiple examination indicators of patients at baseline, 1 year and longer, and follow up on the incidence of major cardiovascular and cerebrovascular adverse events, heart failure readmission, death, and other endpoint events.

Primary Outcome Measures: All cause death, Death caused by various reasons., 1 year.|Cardiac death, Death caused by cardiac reasons., 1 year.|Main adverse cardiovascular events（MACE）, The composite endpoint for hospitalization for heart failure, non fatal myocardial infarction, and cardiac death., 1 year.|Heart failure, Heart failure (HF) is defined according to the diagnostic criteria for HF. Briefly, HF was defined as typical signs and symptoms of HF (NYHA class III or IV), as well as a history of myocardial infarct (MI) or with advanced coronary artery disease including severe 3-vessel disease and chronic total occlusion or other Organic heart disease., 1 year.|Stroke, Stroke was defined as a sudden onset of vertigo, numbness, aphasia, or dysarthria caused by cerebrovascular disease, including hemorrhage, embolism, thrombosis, or aneurysm rupture, and persisting for \> 24 hours, 1 year.
Secondary Outcome Measures: Main adverse cardiovascular and cerebrovascular events（MACCE）, The composite endpoint for hospitalization for heart failure, non fatal myocardial infarction, cardiac death, and stroke., 1 year.|Main adverse cardiovascular and cerebrovascular events（MACCE）, The composite endpoint for hospitalization for heart failure, non fatal myocardial infarction, cardiac death, and stroke., 3 years.|All cause death, Death caused by various reasons., 3 years.|Cardiac death, Death caused by cardiac reasons., 3 years.|Main adverse cardiovascular events（MACE）, The composite endpoint for hospitalization for heart failure, non fatal myocardial infarction, and cardiac death., 3 years.|Heart failure, Heart failure (HF) is defined according to the diagnostic criteria for HF. Briefly, HF was defined as typical signs and symptoms of HF (NYHA class III or IV), as well as a history of myocardial infarct (MI) or with advanced coronary artery disease including severe 3-vessel disease and chronic total occlusion or other Organic heart disease., 3 years.|Stroke, Stroke was defined as a sudden onset of vertigo, numbness, aphasia, or dysarthria caused by cerebrovascular disease, including hemorrhage, embolism, thrombosis, or aneurysm rupture, and persisting for \> 24 hours, 3 years.
Efficacy and Safety of Neoadjuvant Sintilimab Plus FLOT Versus Sintilimab Plus SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer
NCT Number: NCT06459921
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Neoadjuvant Chemotherapy|Sintilimab|Locally Advanced Gastric Cancer
Interventions: DRUG: SOX+Sintilimab|DRUG: FLOT+Sintilimab
Sponsor: Xijing Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2028-12-31

Summary:
This study aims to investigate the efficacy and safety of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer. The research design is intended to observe the comparison of conversion therapy effects, disease-free survival, R0 resection rate, and safety evaluation between the two groups.

Primary Outcome Measures: The rate of radical (R0) resection after neoadjuvant therapy, efficacy of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer., From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days
Secondary Outcome Measures: adverse event, adverse event caused by FLOT, SOX or Sintilimab treatment, which were coded using the Medical Dictionary Regulatory Activities version 20.1 and adverse event grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events, From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days|disease-free survival, from diagnosis to recurrence or death, From date of diagnosis until the first documented recurrence or death, assessed up to 60 months
Biochemical Role of Long Non-coding RNA MALAT 1 and Serum Tumor Necrosis Factor Alpha in Bronchial Asthma Patients.
NCT Number: NCT06459895
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Bronchial Asthma
Interventions: DIAGNOSTIC_TEST: Long non-coding MALAT1 gene expression assay:
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 194
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-16
Completion Date: 2024-06-10
Locations: Sohag University Hospital, Sohag, Egypt

Summary:
Bronchial asthma affects more than a quarter of a billion people worldwide. It is responsible for over 1000 deaths a day, of which the majority are preventable (Levy, 2015).

Asthma is a common heterogeneous disease characterized by chronic airway inflammation. It is defined by the history of variable respiratory symptoms, such as shortness of breath, chest tightness, wheezes, and cough, together with variable expiratory airflow limitation. Airflow limitation may later become persistent (GINA, 2023).

The diagnosis of asthma is based on the history of these characteristic symptoms and evidence of variable expiratory airflow limitation from bronchodilator reversibility testing or other tests (GINA, 2023).

Primary Outcome Measures: Long non-coding MALAT1 gene expression assay:, Gene expression assay by RT-PCR reaction, 2 MONTHS
Secondary Outcome Measures: TNF-alpha, measured in serum by ELISA, 2 MONTHS
NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer
NCT Number: NCT06459869
Acronym: FORTRESS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Locally Advanced Rectal Cancer (LARC)
Interventions: DRUG: NG-350A IV administration|DRUG: Capecitabine oral administration|RADIATION: Radiotherapy
Sponsor: Akamis Bio
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-15
Completion Date: 2029-01-30

Summary:
The FORTRESS trial (NG-350A-03) is an open-label, single-arm, and multicentre trial of NG-350A in combination with chemoradiotherapy (CRT) in adult patients with locally advanced rectal cancer (LARC) and at least one risk factor for local or distant recurrence.

Primary Outcome Measures: Proportion of patients achieving a clinical complete response (cCR), 12 weeks after initiating NG-350A in combination with chemoradiotherapy (CRT)
Secondary Outcome Measures: Incidence and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0, 1-3 years|Clinical response (CR) outcome, 12, 18, and 36 weeks after initiating NG-350A plus chemoradiotherapy (CRT)|MRI-based tumor regression grade (mrTRG), 12, 18, and 36 weeks after initiating NG-350A plus chemoradiotherapy (CRT)
Combined Effects of Balloon Blowing Therapy With Percussion in Patients With Pneumonia
NCT Number: NCT06459856
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pneumonia
Interventions: OTHER: Balloon blowing|OTHER: Percussion
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-30
Completion Date: 2024-07-10
Locations: University of Lahore Teaching hospital, Lahore, Punjab, 54000, Pakistan

Summary:
Pneumonia is an infection of the lungs that is caused by bacteria, viruses, fungi, or parasites. It is characterized primarily by inflammation of the alveoli in the lungs or by alveoli that are filled with fluid (alveoli are microscopic sacs in the lungs that absorb oxygen). The symptoms of pneumonia can develop suddenly (over 24-48 hours) or may show more slowly, over several days. Common symptoms of pneumonia are likely to have a cough which can be dry, or may produce phlegm (thick mucus) that is yellow, green, brownish or bloodstained and breathing difficulty, wheezing and chest tightness where the rate will be high and the rhythm will be rapid and shallow. This activity encourages deep breathing, allowing a patient body to relax. Explain the patient that this exercise will help him or he can feel more relaxed. Make the patient to imagine that he/she is blowing up a balloon. Ask him/her to take in a deep breath; steadily and slowly blow up the huge balloon. See the balloon getting bigger, and bigger. Now ask the patient to close the eyes and imagine the balloon floating into the air. Let the patient continue blowing of balloons until he or she gets relaxed and calm. Percussion is a technique involving rhythmic tapping or clapping on the chest or back, serves as a means to move and loosen retained secretions within the airways. This mechanical intervention helps in removing mucus from the bronchial walls, and facilitates its expectoration and clearance.

Primary Outcome Measures: FEV1(Forced Expiratory Volume per second), Pulmonary Function Test using Digital Spirometer, Pre and post after 1 week|FVC (Forced Vital Capacity), Pulmonary Function Test using Digital Spirometer, Pre and Post after 1 week|FEV1/FVC, Pulmonary Function Test using Digital Spirometer, Pre and Post after 1 week|CASA-Q (Cough and Sputum Assessment Questionnaire), To assess the Level of Cough and Sputum, Pre and post after 1 week|Auscultatory Breath Sound, To assess the breath sound, pre and Post after 1 week
Effects Of of Pursed Lip Breathing and Coordinated Breathing in Adult Patients With COPD
NCT Number: NCT06459843
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Obstructive Pulmonary Disease
Interventions: OTHER: pursed lip breathing techniques|OTHER: coordinated breathing technique
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-01-15
Completion Date: 2024-07-15
Locations: Jinnah Hospital, Lahore, Punjab, 54000, Pakistan

Summary:
COPD is the chronic lung condition characterized by the damage and enlargement of the air sacs in the lungs, leading to breathing difficulties. A blockage may develop, which traps air inside your lungs. The patient shows clinical manifestation of cough, wheezing, chest tightness, shortness of breath. This research of randomized clinical trial will check the combined effects of pursed lip breathing and coordinated breathing techniques to improve aerobic capacity and dyspnea in patients with COPD by taking sample of 54 patients through convenience sampling and randomly allocating them to two groups A and B out of which A will receive pursed lip breathing with aerobic exercise for 4 times per week for 4 week and duration will be 45-60 min, B will receive coordinated breathing with aerobic exercise for 4 times per week for 4 weeks. And duration will be 45-60 min.Pre and post training outcomes of aerobic capacity and dyspnea will be measured through Six minute walk test and dyspnea Borg scale, and Saint George respiratory questionnaire. The data will be analyzed through SPSS 21.

Primary Outcome Measures: Six minute walk test, Patients were instructed to walk back and forth at their own pace in a 35 m corridor. A physiotherapist supervised the test through the course, telling the patient the remaining exercise time every 2 min, baseline and fourth week|Borg dyspnea scale, Dyspnea during the test was evaluated with the modified Borg dyspnea score. Pulmonary function test, inspiratory capacity, and dyspnea score, together with the walking distance were recorded before and after walking. Modified Borg scale is valid patient self-report scale for measuring breathlessness after exercise with the scaling from 0 to 10., baseline and fourth week
Effects of Electro Dry Needling Versus Dry Needling in Levator Scapulae Syndrome
NCT Number: NCT06459804
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neck Syndrome
Interventions: PROCEDURE: Electro Dry Needling|PROCEDURE: Dry Needling
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2024-09-30
Locations: Aqsa Clinic, Lahore, Punjab, 54000, Pakistan

Summary:
Mechanical neck pain is posteriorly occurring non-specific pain that originates from the superior nuchal line and extends to the first thoracic vertebrae. It is exacerbated by sustained neck postures, neck movements or cervical muscle palpation. The aim of study will be to compare the effects of Electro Dry Needling and Dry Needling on pain, muscle strength, disability and range of motion in patients with Levator Scapulae Syndrome.

Primary Outcome Measures: Numeric pain rate scale (NPRS), The NPRS is a segmented numeric version in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. the NPRS is anchored by terms describing pain severity extremes.

The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")., upto 3 weeks|Neck Disability index (NDI), The results of this questionnaire have been utilized to evaluate the disability. It consists of 10 items: 7 linked to activities of daily living, 2 to pain, and 1 to concentration. From 0 to 5, each item received a score. Higher scores corresponded to more disability, and the total score was reported as a percentage., upto 3 weeks|Universal Goniometer, An instrument called a goniometer is used to measure a joint's range of motion. Physical therapists typically use a goniometer to measure a range of motion. At the initial evaluation, the therapist can determine the possible range of motion using a goniometer .

Range of motion: Side flexion and Rotation of neck measured with Goniometer., upto 3 weeks
Efficacy of Personalized Tumorogram-based Therapy in Cancer Established From Patient-derived Organoid
NCT Number: NCT06459791
Acronym: AVATAR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metastatic Breast Cancer
Interventions: PROCEDURE: Biopsy
Sponsor: Institut Curie
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2028-09-30
Locations: Institut Curie, Paris, 75005, France|Hôpital Saint-Louis - AP-HP Senopole, Paris, 75010, France|Institut Curie, Saint-Cloud, 92210, France

Summary:
A biopsy of a breast tumor lesion will be performed for processing to establish avatars (patient-derived organoids -PDO). A personalized tumorogram for each patient will be provided, based on the results of the drug screening (= tumor predicted as sensitive, intermediate, resistant or non-evaluable for each drug tested). Patients with an informative tumorogram will receive one of the recommended treatments (line N+1) in the event of tumor progression, administered according to standard procedures and validated at medical meetings specific to each center, and their fate will be monitored.

Primary Outcome Measures: Tumor response rate, Evaluation in the cohort of patients treated according to the informative tumorogram: tumor response rate within 6 months of the start of this treatment.

Tumor response is defined as partial or complete response, assessed based on radiological criteria (RECIST v1.1) or clinical criteria where applicable., 6 months
Secondary Outcome Measures: Comparison of response rate between both the arms, Comparison of response rate and PFSn+1 (recommended treatment) with response rate and PFSn+1 of patients who did not have an established tumorogram;, 6 months|Organoid cultures achievement, Percentage of achievement of a PDO, 6 months|Tumorograms performance, Percentage of informative tumorograms versus number of tumorograms returned, 6 months|Overall survival, Comparison of overall survival (OSn+1, defined as the time between the start of treatment on line n+1 and death) between patients treated according to the tumorogram and patients without a tumorogram and treated according to the guidelines., up to 18 months
Piezo-ICSI to Improve the Developmental Potential of Fertilized Oocytes in Aged Infertility Women With Assisted Reproductive Technology
NCT Number: NCT06459778
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Infertility, Female|Intracytoplasmic Sperm Injections
Interventions: DEVICE: Piezo-ICSI
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sex: FEMALE
Age: ADULT
Enrollment: 147
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-20
Completion Date: 2026-05
Locations: Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School, Nanjing, Jiangsu, 210008, China

Summary:
The goal of this clinical trial is to test Piezo-ICSI on improving oocyte fertilization and embryo development in elderly infertile patients undergoing intracytoplasmic sperm injection (ICSI). The main question it aims to answer is whether Piezo-ICSI could improve oocyte fertilization and embryo development. Participants requested ICSI are asked to randomly culture equal numbers of oocyte and embryo with or without Piezo-ICSI. At the time of injection, two or more mature oocytes were split into two groups (i) conventional ICSI and (ii) Piezo-ICSI (50:50 split).

Primary Outcome Measures: fertilization rate post intracytoplasmic sperm injection, The primary outcome measure was the fertilization rate 16-18 hours post intracytoplasmic sperm injection, 16-18 hours post intracytoplasmic sperm injection
Mi2000 Totally Implantable Cochlear Implant (Mi2000 TICI)
NCT Number: NCT06459765
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hearing Loss, Sensorineural
Interventions: DEVICE: Mi2000 TICI
Sponsor: MED-EL Elektromedizinische Geräte GesmbH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-07
Completion Date: 2025-03
Locations: AKH Wien, Wien, 1090, Austria|UZA Antwerpen, Antwerp, 2650, Belgium|CHU Liège, Liège, 4000, Belgium|LMU Munich, München, Bavaria, 81377, Germany|UKW Würzburg, Würzburg, Bavaria, 97080, Germany|The Institute of Physiology and Pathology of Hearing, Nadarzyn, 05-830, Poland

Summary:
The goal of this clinical trial is to test the Mi2000 Totally Implantable Cochlear Implant in a population of candidates for a cochlear implant. The main question it aims to answer is, whether the device is able to improve speech perception compared to the pre-operative score.

Participants will undergo cochlear implantation and fitting, and will be asked to perform the following tests pre- and post-operatively:

* Word test in quiet
* Sentence test in noise
* Audiograms
* Health Utilities Index 2 and 3 (HUI2\&3), a generic quality-of-life questionnaire
* Nijmengen Cochlear Implant Questionnaire (NCIQ), a disease specific quality-of life questionnaire
* Speech, Spatial and Qualities of Hearing Scale (SSQ12), a disease specific questionnaire
* Hearing Implant Sound Quality Index (HISQUI19), a sound quality questionnaire

Primary Outcome Measures: Word Test in Quiet, Word test in quiet, Pre-op to 6 months after first fitting
Secondary Outcome Measures: Health Utility Index Mark 3 (HUI3), Generic Quality of Life, Pre-op to 6 months after first fitting|Nijmegen Cochlear Implant Questionnaire (NCIQ), Disease specific Quality of Life, Pre-op to 6 months after first fitting
Other Outcome Measures: Word test in quiet, Word test in quiet, through study completion, an average of 6 months after first fitting|Sentence Test in Noise, Oldenburg Matrix Test, 3- and 6-months after first fitting|Speech, Spatial, Quality of Hearing (SSQ12), Speech, Spatial and Quality of hearing scale, through study completion, an average of 6 months after first fitting|Hearing Implant Sound Quality Index (HISQUI), Sound quality questionnaire, through study completion, an average of 6 months after first fitting|Audiograms, Audiograms, through study completion, an average of 6 months after first fitting
Combined Effects of Visceral Manipulation and Noble Technique on Post-partum Females With Diastasis Recti
NCT Number: NCT06459752
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diastasis Recti
Interventions: OTHER: visceral manipulation and noble technique|OTHER: noble technique
Sponsor: Riphah International University
Sex: FEMALE
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2024-09
Locations: DHQ Hospital Toba Tek Singh, Toba Tek Singh, Punjab, 36050, Pakistan

Summary:
Diastasis recti is characterized by an abnormal expansion of the gap between the medial sides of the rectus abdominis muscle and a lengthening of the linea alba (increased inter-recti distance). It is mainly caused by excessive intra-abdominal pressure. The abdominal muscles and connective structures expand from the growing uterus during pregnancy. Low back pain is a prevalent complaint that can result from various factors, including weakened core muscles and functional disability. The aim of the study would assess of combined effect of visceral manipulation and noble technique on Inter-rectal distance, low back pain and functional disability in post-partum females with diastasis recti.

Primary Outcome Measures: Pain: NPRS, The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). Cronbach's alpha value of NPRS is 0.88, 6th week|disability: Quebec Back Pain Disability Scale (QBPDS), The Quebec Back Pain Disability Scale (QBPDS) measures the extent to which people with low back pain have difficulty with everyday activities. The questionnaire is composed of 20 items on daily activities. The items were selected from 6 relevant subdomains of functional skills for patients with low back pain., 6th week|Muscle separation: Digital nylon calipers, The Digital nylon calipers are a valid tool for measuring IRD above the umbilicus. For the caliper measurements with the abdominal muscles at rest, the participant was positioned in hook-lying, arms down by the side, with 1 pillow placed beneath the head. The examiner palpated the medial borders of the right and left rectus abdominis muscle bellies at the marked locations. The inside measurement jaws of the digital nylon calipers were positioned at the locations of the palpating fingers. The intra-class correlation coefficient values exceeded 0.75 for the digital calipers., 6th week
Effect of Sacral Erector Spinae Plane Block on Hemorrhoid and Pilonidal Sinus Surgery
NCT Number: NCT06459739
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain, Acute Post-Operative|Pilonidal Sinus|Hemorrhoids|Anesthesia
Interventions: PROCEDURE: sacral ESPB
Sponsor: Erzi̇ncan Binali Yildirim Uni̇versi̇tesi̇
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-09-01
Completion Date: 2024-04-01
Locations: Erzincan Binali Yildirim university, Erzincan, 24100, Turkey

Summary:
Introduction: This study investigated the efficacy of sacral erector spinae plane block (ESPB) for managing postoperative pain and reducing opioid consumption in patients undergoing hemorrhoid and pilonidal sinus (PS) surgery.

Primary Outcome Measures: Postoperative pain, Numeric rating scale evaluation after surgery. Use 0 to 10 points with 0 no pain 5 moderate pain and 10 severe pain., 0.5,2,8,24 hours
Secondary Outcome Measures: Opioid consumption, Admission of tramadol as a rescue analgesia, 0.5,2,8,24 hours
Multiplex Respiratory PCR Results in Diabetic Pneumonia Cases
NCT Number: NCT06459713
Acronym: PCR
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Multiplex Respiratory PCR Results in Diabetic Pneumonia Cases
Interventions: DIAGNOSTIC_TEST: multiplex respiratory polymerase chain reaction test
Sponsor: Hisar Intercontinental Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 151
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-01
Completion Date: 2024-05-30
Locations: Hisar Intercontinental Hospital, Istanbul, 34768, Turkey

Summary:
Multiplex respiratory polymerase chain reaction (PCR) test has gained wide acceptance as an alternative to conventional culture methods for the detection of the causative agent of community-acquired pneumonia (CAP). The aim of this study is to evaluate the positivity and to determine the causative agent of CAP using multiplex respiratory PCR test in patients with diabetes mellitus.

Primary Outcome Measures: Diabetic patients are at greater risk for developing CAP. Multiplex respiratory PCR test is an important method for identifying the causative agent of CAP rapidly., September 2021 and June 2023
Inspiratory Muscle Training in Postmenopausal Women
NCT Number: NCT06459674
Acronym: MRS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postmenopausal Symptoms|Aging|Obesity
Interventions: DEVICE: PrO2 Fit (IMT Trainer)
Sponsor: Indiana University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-02-07
Completion Date: 2025-07-31
Locations: Indiana University, Bloomington, Indiana, 47405, United States

Summary:
This study is being conducted by the Department of Kinesiology within the School of Public Health at Indiana University Bloomington. The purpose of this study is to better understand how inspiratory muscle strength training affects cardiovascular health and mood disturbance in postmenopausal women.

Primary Outcome Measures: Duration, Duration, reported in seconds, to reach 63% of steady-state V̇O2 during a fixed-workload treadmill task. This technique is performed using breath-by-breath open-circuit spirometry and captures the V̇O2 fast component occurring in the transition from standing rest to treadmill walking., Baseline, within 48 hours of completing intervention
Secondary Outcome Measures: Distance Traveled, Distance traveled, reported in meters, during a 6-minute walk test. The assessment offers reliable and valid insight concerning exercise capacity in older women., Baseline, within 9 days of completing intervention
Other Outcome Measures: Cerebral Vascular Reactivity, Cerebral vascular function will be measured in vivo evidenced by changes in cerebral blood flow velocity \[i.e., reactivity (cm/s/mm Hg)\] of the middle cerebral artery in response to randomized hypercapnic gas exposure., Baseline, within 9 days of completing intervention
The Bowel Movement Monitoring (BoMoMo) Study
NCT Number: NCT06459661
Acronym: BoMoMo
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Dietary Exposure
Interventions: OTHER: Diet
Sponsor: Leeds Beckett University
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2024-06-30
Locations: Beverley O'Hara, Leeds, LS1 3HE, United Kingdom

Summary:
The link between what people eat and how it affects faecal output (poo) has been understudied. Most of the research that has looked at the link between diet, bowel movements and overall health has studied different types of fibre extracted from foods (e.g., fibre extracted from carrots), rather than foods in the form that they are consumed.

It is necessary for scientists to investigate the relationship between food as people usual eat it (e.g., a carrot) and bowel movements, as this information is key to understanding the relationship between what people eat and overall health.

The investigators would like to understand the relationship between intake of certain foods and faecal output. This will help to develop a chart, similar to the United Kingdom National Health Service urine colour hydration chart. The chart will allow people to know, by looking at their poo, whether they are eating enough of the foods that will keep them healthy. By monitoring and measuring participants' bowel movements, and providing information about diet, participants will provide the data we need for this research.

Primary Outcome Measures: Faecal weight, Average weight of faeces, 5 days
Secondary Outcome Measures: Faecal bulk, Volume of faeces, 5 Days
Other Outcome Measures: Time to pass stool, Number of seconds taken to pass stool, 5 Days|Stool type, Average Bristol Stool Form Scale type (Type 1-7 nominal scale; types 3,4,5 are considered the 'normal range'), 5 Days
Migraine Attack Pain Phase Prediction Study
NCT Number: NCT06459635
Acronym: PREDI-CRISIS
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Migraine|Migraine Headache|Migraine Disorders|Migraine Without Aura|Migraine With Aura
Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Collaborators: Hospital Vall d'Hebron|Hospital Universitario Donostia|Hospital Universitario Marqués de Valdecilla|Hospital Clínico Universitario Lozano Blesa|Hospital Universitario La Fe|Hospital Clínico Universitario de Valladolid
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-09
Completion Date: 2025-12
Locations: Hospital Universitario de La Princesa, Madrid, 28006, Spain

Summary:
The study of the ability to predict pain in a migraine attack, through premonitory symptoms and through an ambulatory monitoring device through real-time recording of hemodynamic variables, is one of the strategic lines of research of the unit. of Headaches at the Hospital de La Princesa since 2013 together with the Complutense and Polytechnic University of Madrid. Their results have been reflected in various publications (Pagán J, et al. Sensors 2015; Gago-Veiga AB, et al. J Pain Res 2018) and have promoted the creation of several invention patents.

Primary Outcome Measures: Development of a prediction strategy for the onset of migraine, Develop a prediction strategy for the onset of migraine attacks in patients with episodic migraine, based on hemodynamic and clinical variables of migraine attacks., From the beginning of treatment, which is the initial visit, to 2 months of follow-up
Secondary Outcome Measures: Posibility of predict the onset of pain in a migraine attack, To analyze whether it is possible to predict the onset of pain in a migraine attack, through ambulatory and non-invasive monitoring of physiological variables., From the beginning of treatment, which is the initial visit, to 2 months of follow-up|Individualized prediction algorithm, Implement an individualized prediction algorithm that allows real-time prediction of the symptomatic phase of the migraine attack., From the beginning of treatment, which is the initial visit, to 2 months of follow-up|Effectiveness of the prediction model, Measure the effectiveness of the prediction model both at the individual level and in a large group of patients., From the beginning of treatment, which is the initial visit, to 2 months of follow-up
Predictive Factors in Chronic Rhinosinusitis With Nasal Polyps
NCT Number: NCT06459622
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Interventions: DIAGNOSTIC_TEST: Serum IL_25 and eosinophils in nasal polyp tisuee
Sponsor: Katrina Atef Habashy
Collaborators: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07
Completion Date: 2025-05

Summary:
The study will be conducted to identify factors predicting the response of chronic rhinosinusitis with nasal polyps ( CRSwNP) to oral corticosteroids.

Primary Outcome Measures: Serum IL-25 is measured to releave the relation between them and the response of CRSwNP to oral corticosteroids, Serum IL-25 is related to the effect of corticosteroids on CRSwNP, Baseline
Other Outcome Measures: Eosinophils in nasal polyp tissue, Eosinophils is related to the inflammatory process of CRSwNP, Baseline
Effect of Protein Supplementation on Craving in Subjects Hospitalised for Addiction Treatment
NCT Number: NCT06459609
Acronym: CRAVPROT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Addiction
Interventions: DIETARY_SUPPLEMENT: protein supplementation
Sponsor: Centre Hospitalier de PAU
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-09-01

Summary:
Moncentric pilot study conducted in the addictology department of the Pau Hospital, designed to demonstrate the benefit of protein supplementation on craving in patients with a substance use disorder at the start of their treatment for addiction.

This study will be conducted according a crossover design with a one-week phase with protein supplementation (P) and a one-week phase without protein supplementation (SP).

Primary Outcome Measures: Evolution of craving for the main substance, Evaluation of the evolution of craving for the main substance in patients with a substance use disorder in association with protein supplementation. It will be a self-assessment by the patient, using a visual analogue craving scale ranging from 1 'no craving' to 7 'extreme craving'., This outcome will be assessed twice a day (morning and afternoon) from day 8 to day 21, during the period with and without protein supplementation.
Secondary Outcome Measures: Food craving evolution, Food craving will be assessed by patient self-assessment using a visual analogue craving scale ranging from 1 'no craving' to 7 'extreme craving'., This outcome will be assessed twice a day (morning and evening) from Day 8 to Day 21 during the period with and without protein supplementation.|Consumption of hyperpalatable foods, Consumption of hyperpalatable foods will be assessed by patient self-evaluation, twice a day from D8 to D21 during the period with and without protein supplementation, using a visual scale assessing the extent to which the patient consumed hyperpalatable foods outside of meals, this scale ranging from 1 'not at all' to 7 'very much'., This outcome will be assessed every day from Day 8 to Day 21 during the period with and without protein supplementation.|Influence of the severity of addiction, Influence of the severity of addiction measured using the Addiction Severity Index (ASI) questionnaire, Evaluation at the inclusion|Influence of psychiatric comorbidities, Influence of psychiatric comorbidities (mood disorders and anxiety disorders) assessed using the MINI (Mini International Neuropsychiatric Interview), Evaluation at the inclusion
Evaluation of Self-Mediated Alternatives for Risk Testing Education and Return of Results
NCT Number: NCT06459583
Acronym: eSMARTER
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alzheimer Disease
Interventions: OTHER: eHealth Platform|OTHER: Videoconference Telehealth Platform
Sponsor: Banner Health
Collaborators: National Institute on Aging (NIA)|University of Pennsylvania
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08
Completion Date: 2025-11

Summary:
This randomized non-inferiority study will evaluate self-directed scalable electronic health platform (eHealth) methods for communicating Alzheimer's gene and biomarker results compared to videoconference telehealth disclosure with healthcare providers, as well as characterize the impacts of learning this information on the participant.

Primary Outcome Measures: Anxiety as measured by the PROMIS Anxiety scale, T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure)|Knowledge of Genetic Disease as measured by an 8-item scale adapted from the Cancer Genetics Knowledge Scale and ClinSeq Knowledge Scale, T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure)|Disease-specific distress as measured by an 8-item scale adapted from the Impact of Events Scale, T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure)
Secondary Outcome Measures: Depression as measured by the Patient Health Questionnaire - 9 (PHQ-9), 0-7 days, 6 weeks, 6 months|Psychological wellbeing as measured by a 14-item scale adapted from the Psychological Wellbeing Scale, 6 months|Perceived risk of Alzheimer's as measured by a scale adapted from the REVEAL Study, 0-7 days, 6 weeks, 6 months|Impact of disclosure as measured by the 16-item IGT-AD scale, 0-7 days, 6 weeks, 6 months|Subjective cognitive concerns as measured by the 14-item Cognitive Function Instrument, 6 months|Stigma as measured by the 6-item Stigma Impact Scale, 0-7 days, 6 weeks, 6 months