pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Enhanced Recovery After Surgery for Spine Fusion Surgeries in the Elderly
NCT Number: NCT06577389
Acronym: ERAS in Spine
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Spinal Stenosis
Interventions: OTHER: Enhanced recovery after surgery
Sponsor: Sixth Affiliated Hospital of Xinjiang Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01-01
Completion Date: 2028-12-31

Summary:
elderly patients in our hospital who received spinal fusion surgery after the year 2025 will receive ERAS treatment.

Primary Outcome Measures: ambulation time, 7 days
Secondary Outcome Measures: mean hospital length of stay, one month|cost of hosptial stay, 1 months
A PhaseⅠ/Ⅱ Study of Simmitinib or Irinotecan Liposomes Combined With DP303c in Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
NCT Number: NCT06577376
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Localized Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma|Expressing Human Epidermal Growth Factor Receptor-2 (HER-2)|Disease Progression After Receiving at Least One and at Most Two Lines of Systemic Treatment in the Past
Interventions: DRUG: DP303c|DRUG: Simmitinib tablets|DRUG: Irinotecan liposomes|DRUG: Paclitaxel or docetaxel or irinotecan
Sponsor: Shanghai Runshi Pharmaceutical Technology Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 252
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-26
Completion Date: 2027-08-26

Summary:
This study is divided into two parts: Cohort 1 and Cohort 2. Cohort 1 includes the dose escalation phase of DP303c combined with simmitinib, as well as the randomized controlled trial (RCT) phase of DP303c combined with simmitinib; Cohort 2 includes dose escalation/dose extension of DP303c combined with irinotecan liposomes, as well as RCT stage of DP303c combined with irinotecan liposomes.

Primary Outcome Measures: Dose-limiting toxicity(DLT) occurrence and incidence, Up to approximately 36 months after the first participant is enrolled|Adverse events (AE) occurrence and incidence, Up to approximately 36 months after the first participant is enrolled|Objective response rate (ORR) per RECIST 1.1, Up to approximately 36 months after the first participant is enrolled|Serious adverse events (SAE) occurrence and incidence, Up to approximately 36 months after the first participant is enrolled
Secondary Outcome Measures: Disease control rate (DCR) per RECIST 1.1, Up to approximately 36 months after the first participant is enrolled|Duration of response (DoR) per RECIST 1.1, Up to approximately 36 months after the first participant is enrolled|Progression free survival (PFS) per RECIST 1.1, Up to approximately 36 months after the first participant is enrolled|Overall survival(OS), Up to approximately 36 months after the first participant is enrolled|Blood drug concentration of DP303c, Up to approximately 36 months after the first participant is enrolled|Blood concentration of total anti-DP303c antibody, Up to approximately 36 months after the first participant is enrolled|Positive incidence of anti-DP303c antibody (ADA), Up to approximately 36 months after the first participant is enrolled|HER2 expression level, Up to approximately 36 months after the first participant is enrolled|Blood concentration of simmitinib, Up to approximately 36 months after the first participant is enrolled
A Survey of Maribavir Tablets in Participants With Cytomegalovirus Infection
NCT Number: NCT06577363
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cytomegalovirus (CMV)
Interventions: DRUG: Maribavir
Sponsor: Takeda
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-28
Completion Date: 2031-08-30

Summary:
This study is a survey in Japan of Maribavir tablets used to treat participants with Cytomegalovirus (CMV) infection refractory to existing anti-CMV therapy in organ transplantation (including hematopoietic stem cell transplantation).

The main aim of the study is to check if treatment with Maribavir can protect Japanese people against CMV infection, and to check side effect from the study treatment. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

During the study, participants with CMV infection will take Maribavir tablets according to their clinic's standard practice. The study doctors will check for side effects from Maribavir tablets for 27 weeks.

Primary Outcome Measures: Number of Participants who Experience at Least One Adverse Drug Reactions (ADRs), An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. Adverse drug reaction refers (ADR) to AE related to administered drug., Up to 27 weeks
Secondary Outcome Measures: Percentage of Participants With Confirmed CMV viremia Clearance, Confirmed CMV viremia clearance will be assessed based on plasma CMV DNA concentration in plasma or CMV positive antigen cell in blood., 27 weeks|Percentage of Participants Who Have a Response to CMV, as Assessed by the Investigator, Percentage of participants who have a response to CMV, as assessed by the investigator will be reported., 27 weeks|Percentage of Participants With Resistance to Maribavir Treatment, Based on treatment and observation in clinical practice, incidence of CMV resistance to this drug is evaluated., 27 weeks|Percentage of Participants With Graft Rejection, Percentage of participants With TEAEs of graft rejection will be reported., 27 weeks|Percentage of Participants With Graft-versus-host Disease (GVHD), Percentage of participants with TEAEs of GVHD will be reported., 27 weeks|Percentage of Participants With All-cause Mortality by the End of the Study, Percentage of participants who died during the entire study period will be reported., 27 weeks
Single and Multiple Ascending Doses of M5542 Administered in Healthy Volunteers
NCT Number: NCT06577337
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: BIOLOGICAL: M5542|BIOLOGICAL: Placebo
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sex: ALL
Age: ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09-05
Completion Date: 2025-12-15
Locations: Clinical Pharmacology Unit of Nuvisan GmbH, Neu-Ulm, Germany

Summary:
The study will evaluate the safety, tolerability, immunogenicity and pharmacokinetics (PK) of single ascending doses (SAD) and multiple ascending doses (MAD) of M5542 in healthy participants. This study will be conducted in 2 parts: Part A (SAD) and Part B (MAD).

Primary Outcome Measures: Part A: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Up to Day 85|Part B: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Up to Day 113|Part A: Number of Participants with Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs, Up to Day 85|Part B: Number of Participants with Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs, Up to Day 113
Secondary Outcome Measures: Part A and Part B: Pharmacokinetic (PK) Serum Concentrations of M5542, Part A: Pre-dose up to 1344 hours post-dose; Part B: Pre-dose up to 2688 hours post-dose|Part A and B: Number of Participants with Anti-Drug Antibodies (ADA) Against M5542, Part A: Pre-dose up to Day 57; Part B: Pre-dose up to Day 113
Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis)
NCT Number: NCT06577311
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cutaneous Squamous Cell Carcinoma
Interventions: COMBINATION_PRODUCT: Aminolevulinic acid hydrochloride 10% topical gel with Red Light
Sponsor: The Center for Clinical and Cosmetic Research
Collaborators: Biofrontera, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-14
Completion Date: 2025-08
Locations: Center for Clinical and Cosmetic Research, Aventura, Florida, 33180, United States

Summary:
The goal of this clinical trial is to test how safe and effective it is to treat early form of cancer cells found in the upper skin layer of the face, using a light-sensitive gel used in combination with a light source.

The main questions this trial aims to answer are:

* to confirm using laboratory testing, how much of the affected facial skin cancer section the treatment was able to remove, and;
* seeing how many participants had no remaining affected facial skin cancer sections after treatment.

Participants who qualify will be asked to complete 14 visits in total and will receive a total of two treatments, after voluntarily consent has been given.

Primary Outcome Measures: Number of participants with histological clearance of treated SCCis lesion., Histological clearance is defined as the absence of detectable evidence of SCCis tumor cell nests by the central pathology reports, an average of 12 weeks
Secondary Outcome Measures: Number of participants with clinical clearance of treated SCCis lesion, Complete Clinical Clearance will be measured by the Investigator and is defined as when there is no clinically visible lesion remaining at the site, an average of 12 weeks|Size of the lesion, Changes noted in the size of the treated SCCis lesion site, measured by the longest diameter., Up to 16 weeks|Local Skin Response Scale, Observations and changes noted in the aesthetic appearance (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/ Pustulation, Erosion/ Ulceration) of thetreated isSCC lesion will each be graded on a scale of 0 to 4, with 0 as no presenceand 4 as a severe outcome., Up to 16 weeks
Title of Manuscript: Development and Internal-external Validation of a Comprehensive Model for Predicting Risk of Post-RFA Recurrence in HCC Patients
NCT Number: NCT06577272
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hepatocellular Carcinoma
Sponsor: Tian'an Jiang
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 6000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2024-11
Locations: The First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, 310003, China

Summary:
Background A predictive model for post radiofrequency ablation (RFA) recurrence in patients with Hepatocellular carcinoma (HCC) that incorporates variables like sleep quality and psychological factors can provide more time to prevent the recurrence. Our aim is to investigate the relationship between these factors and post-RFA recurrence, and to construct a predictive model includes these highly preventable factors.

Methods We collected data from HCC patients who underwent RFA for the first time from January 1, 2015, to July 2023, assessing their sleep quality, anxiety, and depression levels. We employed Restricted cubic splines (RCS), mediation analysis, Cox proportional hazards model, Elastic network Cox proportional hazards, Competitive risk model to ascertain the relationship between these factors and post-RFA recurrence. We then constructed a predictive model incorporating these factors, and evaluated the model's performance through internal and external validation datasets partitioning by time period.

Primary Outcome Measures: The Self-Rating Anxiety Scale (SAS)24 was used to investigate the anxiety levels of patients, It consists of 20 questions, and the sum of all responses represents the raw total score. The raw total score is multiplied by 1.5 to obtain the standard total score. A standard total score of ≥50 is used to diagnose anxiety. The Self-Rating Depression Scale (SDS)25 was used to assess the depression levels of patients. It also consists of 20 questions, and the sum of all responses represents the raw total score. Similar to the SAS, the raw total score is multiplied by 1.5 to obtain the standard total score. A standard total score of ≥53 is used for diagnosing depression., This study prospectively collected patients diagnosed with HCC from 2015 to 2023 according to the diagnostic criteria in China's guidelines for Primary liver Cancer Diagnosis and Treatment
Study to Assess Relative Bioavailability of BMS-986435 Formulations in Healthy Adult Participants
NCT Number: NCT06577259
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Participants
Interventions: DRUG: BMS-986435
Sponsor: Bristol-Myers Squibb
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-14
Completion Date: 2025-01-21

Summary:
The purpose of this study is to assess the relative bioavailability of BMS-986435 tablet formulations in healthy adult male and female participants.

Primary Outcome Measures: Maximum observed plasma concentration (Cmax), Up to 105 days|Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)], Up to 105 days|Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)], Up to 105 days
Secondary Outcome Measures: Area under the plasma concentration-time curve truncated at 72 hour [AUC(0-72h)], Up to 105 days|Time of maximum observed concentration [Tmax], Up to 105 days|Apparent terminal half-life [T-HALF], Up to 105 days|Incidence of adverse events (AEs), Up to approximately 5 months|Incidence of serious adverse events (SAEs), Up to approximately 5 months|Incidence of participants with vital sign abnormalities, Up to 105 days|Incidence of participants with physical examinations abnormalities, Up to 105 days|Incidence of participants with electrocardiogram (ECG) abnormalities, Up to 105 days|Incidence of participants with clinical laboratory abnormalities, Up to 105 days
Assessment of the Effect of Periodontal Disease Prediction System on Oral Hygiene Motivation
NCT Number: NCT06577246
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Motivational Interviewing|Computer-Aided Design|Periodontal Diseases
Interventions: PROCEDURE: scaling root planing|BEHAVIORAL: Three-Dimensional Animation (video1-2)|BEHAVIORAL: Three-Dimensional Animation (video 3)|BEHAVIORAL: Periodontal Disease Prediction (PDP)
Sponsor: Bezmialem Vakif University
Collaborators: Abant Izzet Baysal University|The Scientific and Technological Research Council of Turkey
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2021-06-01
Completion Date: 2023-07-24
Locations: Bezmialem Vakıf University, Istanbul, Fatih, 34000, Turkey

Summary:
The aim of this trial is to evaluate the effect of patient specific periodontal disease prediction (PDP) system, a part of motivational interview, (MI) on probing depth (PD), Rustogi modified Navy Plaque Index (RMNPI), and papillary bleeding index (PBI) scores in patients with periodontitis following non-surgical periodontal therapy.

Primary Outcome Measures: rustogi modified navy plaque index (RMNPI), RMNPI was assessed using a specialized plaque staining agent on each of the nine sites on both buccal and lingual tooth surfaces. The individual mean PI was calculated by scoring the presence of plaque at each site as '1' and its absence as '0', then dividing by the total number of surfaces evaluated. Using this index, PI can be separately calculated for the entire mouth (A-I), the gingival margin (A-C), interproximal areas (D and F), and surfaces that come into contact with dental floss (A, C, D, and F), baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months
Secondary Outcome Measures: Probing depth (PD), PD measurements was evaluated at six regions of each tooth, baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months|bleeding on probing (BoP), BoP associated with PD measurements was evaluated at six regions of each tooth as presence/absence and recorded as %., baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months|papillary bleeding index (PBI), PBI is calculated by scoring the papillae in the facial/buccal and palatinal/lingual regions of each tooth based on the presence or absence of bleeding from probing and the overall condition of the gingiva. The average PBI value for an individual was calculated by dividing the total sum of the values by the number of papillae assessed., baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months|Gingival ındex (GI), Each tooth's mesial, distal, buccal, and lingual gingival margins are evaluated. These values are then summed and divided by four. This process calculates the Gingival Index (GI) for each tooth. When the total of these values is divided by the number of teeth, the individual's GI score is obtained., baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months
Superior Hypogastric Nerve Plexus Block With Bupivacaine After Robotic Resection of Endometriosis
NCT Number: NCT06577233
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Endometriosis
Interventions: DRUG: Bupivacaine Hydrochloride|DRUG: Normal saline
Sponsor: Baylor College of Medicine
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-28
Completion Date: 2025-07-31
Locations: Texas Childrens Hospital Pavilion for Women, Houston, Texas, 77030, United States

Summary:
Endometriosis is a condition that causes significant pelvic pain and affects 10-15% of reproductive age women. Treatment options area both medical and surgical for pain relief, however with surgical options, past studies have demonstrated a higher risk of surgical complications as well as higher postoperative pain scores in women with endometriosis. Despite attempts to limit narcotic pain medications with enhanced recovery after surgery (ERAS) protocols, persistent opioid use after surgery is a national crisis, and it is important to explore multimodal options for pain relief. Various studies have shown improvement in pain with use of superior hypogastric nerve blocks in gynecologic surgery, but these effects have not yet been examined in the setting of a minimally invasive endometriosis resection.

The goal of this clinical trial is to determine if a superior hypogastric nerve plexus block with 0.25% bupivacaine hydrochloride can decrease postoperative pain and opioid requirements in patients undergoing robotic assisted resection of endometriosis for the first week after surgery.

Researchers will perform a superior hypogastric nerve plexus block by either injecting 0.25% bupivacaine hydrochloride (investigative treatment) or normal saline (placebo) in subjects who are undergoing a robotic assisted resection of endometriosis.

To determine if postoperative pain is reduced, the subject will be asked to rate their pain score on the Visual Analog Scale (VAS) at 0 hours, 2 hours and 4 hours postop while in the Post-anesthesia Care Unit (PACU). They will then document their pain score each day on a form provided to them for 7 days after surgery.

To determine the effect of this research study on postoperative opioid requirements, the subject will be asked to fill out a form documenting how many tablets of an opioid medication they took each day for a total of 7 days after surgery.

Primary Outcome Measures: Postoperative pain, Postoperative pain levels as characterized by the Visual Analog Scale (VAS), Postoperative pain level documented at 0, 2 and 4 hours after surgery, then once a day for 7 days after surgery.
Secondary Outcome Measures: Opioid use, The amount of opioid medication used in the immediate postoperative period in morphine milligram equivalents, The first 7 days after surgery
Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS) Asian/Asian American Women Supplement
NCT Number: NCT06577220
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cervical Cancer|Human Papillomavirus Infection
Interventions: BEHAVIORAL: Telephone Recall|BEHAVIORAL: Mailed HPV Self-Sampling Kit|BEHAVIORAL: Patient Navigation
Sponsor: Baylor College of Medicine
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SCREENING
Start Date: 2023-09-28
Completion Date: 2026-02-28
Locations: Harris Health System, Houston, Texas, 77030, United States

Summary:
Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. This study is a supplement to increase representation of Asian and Asian American women in a pragmatic clinical trial that evaluates if mailing and testing self-sampled kits for high-risk human papillomavirus (HPV) can cost-effectively increase screening participation among underserved minority women in a safety-net health system.

Primary Outcome Measures: Primary screening participation, completion and return of a mailed self-sample HPV testing kit that is adequate for testing (i.e., does not produce unsatisfactory results) or attendance for clinic-based screening, [Time Frame: within 6 months of randomization
Secondary Outcome Measures: Screening tests results, Results of HPV test using self-collected samples (positive, negative, or inadequate), Time Frame: within 6 months of randomization|completion of clinical follow-up among women with an abnormal screening test result, Electronic medical record (EMR)-confirmed attendance for colposcopy among participants who had a positive test by clinic-based screening; EMR- confirmed attendance for colposcopy or subsequent clinic-based screening among those who had a positive test by self-sampling, Time Frame: within 12 months of screening test result
Other Outcome Measures: Detection of cervical precancer, Histologically-confirmed cervical intraepithelial neoplasia grade II or greater (CIN2+), [Time Frame: within 12 months of screening test result]|Treatment of cervical precancer, Treatment of histologically-confirmed cervical intraepithelial neoplasia grade II or greater (CIN2+) per American Society for Colposcopy and Cervical Pathology guidelines, [Time Frame: within 6 months of diagnosis]
Pattern and Outcome of Children Admitted in Emergency Unit of Assuit Children University Hospital Hospital
NCT Number: NCT06577207
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pediatric Emergency Medicine
Interventions: OTHER: Initial investigations for all cases
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 93
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01
Completion Date: 2027-01

Summary:
In the present work, we aim to

1. Describe the pattern of patients admitted to Emergency unite at Assiut University Child Hospital (AUCH) and classify them according to age ,distribution ,most common presenting complain, effect of seasonal variation on causes of admission ,prognosis till discharge of the patient to home or refer him to specific unit in pediatric hospital and associated chronic disease.
2. Describe factors affecting mortality rate

Primary Outcome Measures: classification of pediatric patient in emergency room, classification of pediatric patient in emergency room according to age distribution

,most common presenting complain, effect of seasonal variation on causes of admission ,prognosis till discharge of the patient to home or refer him to specific unit in pediatric hospital and associated chronic disease., baseline
Secondary Outcome Measures: search for factors affect mortality rate, search for factors affect mortality rate, baseline
A Single-Center, Single-Arm Study of Neoadjuvant Short-Course Radiotherapy Concurrent With IL-2 Followed by Sequential Immunotherapy With CAPOX Combined With PD-1 Antibody and IL-2 for Locally Advanced Rectal Cancer
NCT Number: NCT06577194
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Rectal Cancer|Advanced Solid Tumor
Interventions: DRUG: Sintilimab + IL-2 Combined with Capox|RADIATION: Short-course radiotherapy
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2027-10-31

Summary:
A Single-Center, Single-Arm Study of Neoadjuvant Short-Course Radiotherapy Concurrent with IL-2 Followed by Sequential Immunotherapy with CAPOX Combined with PD-1 antibody and IL-2 for Locally Advanced Rectal Cancer

Primary Outcome Measures: Response Rate, To evaluate whether short-course radiotherapy combined with IL-2, followed by the CAPOX regimen and PD-1 and IL-2 immunotherapy, can increase the complete response (cCR or pCR) rate in patients with locally advanced rectal cancer., 24 weeks
Effect of HCG on Endometrial Preparation in Frozen Embryo Transfer
NCT Number: NCT06577181
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: IVF
Interventions: DRUG: hCG
Sponsor: Assiut University
Collaborators: Banon fertility center
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-10
Completion Date: 2026-05-10
Locations: Assiut university, Assiut, 77777, Egypt

Summary:
Intramuscular injection of HCG to prepare endometrium for frozen embryo transfer

Primary Outcome Measures: Clinical pregnancy, Presence of at least one gestational sac inside the uterus 28 days after embryo transfer, 2months
Menstrual Pattern Within Six Months of Levonogestrel IUS Insertion
NCT Number: NCT06577168
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Contraception
Interventions: OTHER: Levonogestrel Intrauterine system (LNG-IUS)
Sponsor: Assiut University
Sex: FEMALE
Age: ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-12-01
Completion Date: 2026-05
Locations: Assuit University, Assiut, 088, Egypt

Summary:
The purpose of this study is to systematically calculate the mean number of bleeding-only, spotting-only, and bleeding and/or spotting days experienced by a population of reproductive aged,52 mg levonogestrel Intrauterine System(LNG-IUS) users.

Primary Outcome Measures: Mean number of days with menstrual bleeding changes, This include calculating the average number of days per month with bleeding-only, spotting-only,and bleeding and/or spotting in reproductive aged women using a 52 mg levonogestrel Intrauterine system (LNG-IUS) within the first six months ofuse, according to World Health Organization standards., Six months after insertion of levonogestrel Intrauterine system
Spinal Nalbuphine for Analgesia in Total Hip Arthroplasty
NCT Number: NCT06577155
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Total Hip Arthroplasty|Analgesia
Interventions: DRUG: Levobupivacaine|DRUG: Levobupivacaine plus nalbuphine
Sponsor: Asklepieion Voulas General Hospital
Collaborators: Anastasios Mpontozis
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-06

Summary:
60 patients ASA I-III, undergoing total hip arthroplasty were randomly assigned, into one of two groups, namely group E (n=30), where levobupivacaine will be administeral intrathecally ; and group N (n=30), where levobupivacaine plus nalbuphine will be administeral intrathecally. All patients will receive a standardized multimodal analgesic regimen, including a PENG block and PCA morphine. Morphine consumption during the first 24 hours postoperatively will be measured and additionally the investigators will record: Time of morphine first dose administration, NRS scores in static and dynamic conditions in 4 hours, 6 hours, 12 hours, 18 hours, 24 hours, 36 hours and 48 hours postoperatively, complications, patient satisfaction and duration of hospitalization.

Primary Outcome Measures: Morphine consumption, 24 hours|NRS scores, 48 hours
Secondary Outcome Measures: sensory block level, 1 hour|motor block level, 1 hour|sensory block onset, 1 hour|motor block onset, 1 hour|sensory block duration, 4 hours|motor block duration, 4 hours|Complications, 24 hours
Effects of Ladder Training Versus Plyometric Training Program
NCT Number: NCT06577129
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sports Physical Therapy
Interventions: OTHER: Ladder training|OTHER: Plyometric training
Sponsor: Riphah International University
Sex: FEMALE
Age: ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-06-01
Completion Date: 2024-08-01
Locations: Riphah International University, Lahore, Punjab, 54000, Pakistan

Summary:
A team sport such as cricket consists of irregular sequences of high- and low-intensity motions utilising different metabolic pathways. Athlete performance in this sport is correlated with every facet of physical fitness, including muscular strength, agility, speed, anaerobic power (vertical leap), and aerobic capacity. All aspects of physical fitness, such as aerobic capacity, anaerobic power (vertical leap), agility, speed, and muscular strength, are related to success in this sport. Plyometric training that is repetitive and intermittent has been recommended as a useful tactic for cricket-specific training regimens. Plyometric exercise training is a type of workout regimen designed to enhance nervous system functioning and generate powerful, quick movements, ultimately improving sports performance. Plyometric training aims to increase muscular explosiveness, which enables an athlete to run more quickly, leap higher, or exert force more quickly. Because it takes into account the aspects of strength, power, balance, agility, coordination, core and joint stability, foot speed, hand-eye coordination, response time, and mobility, ladder training is a multidirectional kind of exercise. During ladder training, the four fundamental abilities utilized are running, skipping, shuffling, and leaping. These ladders are lightweight and portable, making them easy to carry and use both indoors and outdoors. The player's footwork will be significantly enhanced, leading to an increase in quickness, agility, and coordination following consistent use of various speed ladder training.

Primary Outcome Measures: Vertical Jump test, Players stand up against a wall and use the hand that is closest to the wall to measure how high they can reach while standing. Then, using their arms and legs to propel their body higher, they do a vertical leap. The score, which is determined by subtracting their standing reach height from their jump height, is best of three attempts., 8 weeks|30 Yard dash test, A 30-yard sprint is required for the test, with the front foot on or behind the starting line and the shoulders parallel to the floor. Once you have held the starting stance for two seconds, you are not allowed to rock. Timing starts when the timing mechanism is triggered or the initial motion takes place., 8 weeks|Agility T test, The subject starts at cone A, runs to cone B, sprints there, touches the base of cone B with their right hand, shuffles sideways to cone C, then to cone D, runs back to cone B, and repeats the process until they reach cone A. The timer stops when they pass over cone A., 8 weeks
Open-Label Extension Study for Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001
NCT Number: NCT06577116
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Chronic Spontaneous Urticaria
Interventions: DRUG: AK006 IV
Sponsor: Allakos Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-28
Completion Date: 2026-04
Locations: Site 601-002, Cincinnati, Ohio, 45236, United States

Summary:
An open label extension (OLE) study offered to subjects with Chronic Spontaneous Urticaria that have completed the AK006-001 (NCT06072157) Part C referred to as the Main study portion of the study. Qualified subjects will receive up to four doses of the study drug (AK006) through an intravenous infusion every 4 weeks. There is a 16-week follow up period once all the scheduled infusions have been completed. Subjects will be follow for evaluation of safety, tolerability, PK, immunogenicity, and clinical response.

Primary Outcome Measures: Incidence of adverse events (AEs), treatment-emergent adverse events, serious adverse events, adverse events of special interest, AEs leading to discontinuation, Through study completion, approximately 30 weeks|Incidence of clinically significant abnormal laboratory values, ECGs, and vital signs, Through study completion, approximately 30 weeks
Secondary Outcome Measures: AK006 serum concentrations, Through study completion, approximately 30 weeks|AK006 Anti-drug Antibodies (ADAs), Number of participants with positive or negative AK006-ADAs., Through study completion, approximately 30 weeks
The Analgesic Effect of Pericapsular Nerve Group Block With Lateral Femoral Cutaneous Nerve Block and Pericapsular Nerve Group Block With Supra-inguinal Fascia Iliaca Block in Hip Hemiarthroplasty
NCT Number: NCT06577103
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pericapsular Nerve Group Block|Lateral Femoral Cutaneous Nerve Block|Supra-inguinal Fascia Iliaca Block|Hip Hemiarthroplasty
Interventions: OTHER: Pericapsular nerve group block (PENG) with supra-inguinal fascia iliaca block (SIFIC)|OTHER: Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN)
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-02
Completion Date: 2025-06-01
Locations: Ain Shams University, Cairo, 11591, Egypt

Summary:
The aim of this study is to investigate the efficiency of preoperative and post-operative analgesia by pericapsular nerve group block (PENG) block with supra-inguinal fascia iliaca block (SIFIC) block compared with PENG block with lateral femoral cutaneous nerve block (LFCN) block in ease of giving a sitting position for spinal anesthesia and reducing narcotic consumption during the first 24 hour post-operatively and functional recovary by using the Visual analogue scale (VAS) of pain.

Primary Outcome Measures: Degree of pain, Degree of pain will be assessed by visual analogue score (VAS). VAS ranging from 0 to 10, where 0 is no pain and 10 is maximum pain. It will be assessed preoperatively first after the block application then postoperatively, at post anesthesia care unit (PACU) and then 2, 6 ,12 ,18 ,24 hours postoperatively., 24 hours postoperatively
Secondary Outcome Measures: The ease of giving a sitting position for spinal anesthesia (EOSP), The ease of giving a sitting position for spinal anesthesia (EOSP) will be assessed by the EOSP score .EOSP was assessed on the scale of 0-3 (0 = unable to position, 1 = patient had abnormal posturing due to pain and required support for positioning, 2 = mild discomfort but does not require support for positioning, 3 = optimal condition where the patient was able to position himself, Intraoperatively|The total dose of nalbuphine consumption, When visual analogue score (VAS) \>/=4, patients will receive injection nalbuphine 10 mg/70 kg (with maximum dose 160 mg over 24 hours) intravenously., 24 hours postoperatively|The number of patients who needed rescue analgesia, Number of patients who needed rescue analgesia will be recorded, 24 hours postoperatively|Ablility to walk with support within 24 hours, The ability of patients to walk with support will be recorded, 24 hours postoperatively
Study to Evaluate the Effect on Obesity of Once Weekly Nimacimab Injection and Once Weekly Nimacimab Injection Co-administered With Semaglutide Injection Versus Placebo
NCT Number: NCT06577090
Acronym: CBeyond
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Obesity
Interventions: BIOLOGICAL: Nimacimab injection|BIOLOGICAL: Nimacimab placebo injection|COMBINATION_PRODUCT: semaglutide injection
Sponsor: Skye Bioscience, Inc.
Collaborators: Bird Rock Bio Sub, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-21
Completion Date: 2025-11
Locations: Principal Investigator, Louisville, Kentucky, 40213, United States

Summary:
This is a proof-of-concept study to assess the safety and efficacy of Nimacimab Injection compared to an active and placebo injection control.

Primary Outcome Measures: Percent change in body weight, Percent of participants who have a reduction in body weight, Baseline and Week 26 and Week 38|AEs including SAEs and AEs of special interest, Nature, frequency and severity of AEs including SAEs and AEs of special interest, Baseline through Week 38
Secondary Outcome Measures: Change in body composition, Change in body composition quantified by DEXA (DXA) scan., Baseline to Week 26 and Week 38|Change in waist circumference, Effect of semaglutide injection versus once weekly Nimacimab Injection co-administered with semaglutide injection on waist circumference, Baseline to Week 26 and Week 38
Other Outcome Measures: Change in lean versus fat mass ratio, Change in lean versus fat mass ratio measured by DEXA (DXA) scan., Baseline to Week 26 and Week 38|Sleep stage quantification, Effect of Nimacimab injection 200 mg once weekly compared to placebo injection utilizing the Dreem 3S 5-channel dry-electrode headband in a sub-set of participants, to measure brain waves at each 30-sec epoch and process raw EEG data and accelerometer data to provide automatic sleep staging according to the AASM classification, Week 12, 24 and 34
Efficacy/ Safety of Product CM9241GRU in Patients With Perennial Allergic Rhinitis
NCT Number: NCT06577077
Acronym: RESPIRE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Interventions: DRUG: Product CM9241GRU|DRUG: Placebo
Sponsor: Ache Laboratorios Farmaceuticos S.A.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 432
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-08

Summary:
To evaluate the efficacy and safety of CM9241GRU versus placebo in the treatment of perennial allergic rhinitis.

Primary Outcome Measures: Absolute reduction in the evening reflective total nasal symptom score (rTNSS), Absolute reduction in the evening reflective total nasal symptom score (rTNSS) evaluated 14 days after starting treatment compared to the baseline evening rTNSS., 14 days
Sacral Erector Spinae Block for Pilonidal Sinus Surgery
NCT Number: NCT06577064
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Operative Pain
Interventions: PROCEDURE: Sacral erector spinae plane block
Sponsor: Menoufia University
Sex: ALL
Age: ADULT
Enrollment: 62
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-01
Completion Date: 2024-08-01
Locations: Faculty of Medicine Menoufia University, Cairo, Governorate, 32511, Egypt

Summary:
The incidence of pilonidal sinus disease (PD) is estimated to be around 26/100,000 individuals mostly men.PD can cause the development of abscess or a draining sinus tract and that may lead to a loss of productive power and long-term morbidity.Different surgical technique approaches were proposed for treatment with different rates of success.

Primary Outcome Measures: Pain score, NRS scor for post operative pain scale from 0 to 100, 24 hours
Secondary Outcome Measures: Opioid consumption., Total opioid consumbtion in mg, 24 hours|Lower limb motor affection, Modified Bromage scale for motor affection from 1 to 6, 24 hours|Adverse effects, Side effect as nausea, vomiting, itching will be recorded, 24 hours
Evaluation of Eustachian Tube Function With 226 and 1000 Hz Probes in Children Undergoing Tonsillectomy ± Adenoidectomy
NCT Number: NCT06577051
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tonsillar Hypertrophy|Eustachian Tube Dysfunction|Tympanic Membrane Disorder|Eustachian Tube Dysfunction of Both Ears
Interventions: DIAGNOSTIC_TEST: Eustachian tube function test with 226 and 1000 Hz probes
Sponsor: Sumeyra DOLUOGLU
Sex: ALL
Age: CHILD
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-20
Completion Date: 2024-11-30
Locations: Ankara Etlik City Hospital, Ankara, 06010, Turkey

Summary:
In children undergoing tonsillectomy ± adenoidectomy without eustachian dysfunction, the objective is to control tubal functions with tympanometry utilising probes at 226 Hz and 1000 Hz, as well as measuring the ipsilateral and contralateral acoustic reflexes with a 226 Hz probe. An eustachian function test with a 226 Hz probe (automatic Williams test) and play audiometry are to be conducted on young children, while pure tone audiometry is to be conducted on older children, in the preoperative period, on the first day after surgery and in the second week after surgery. The primary objective is to ascertain whether the tubal functions, which are hypothesised to be impaired on the first day, return at the latest in the second week, with all tests evaluating the eustachian tube both directly and indirectly. The secondary objective is to determine whether this recovery occurs earlier with the 226 Hz probe or the 1000 Hz probe.

Primary Outcome Measures: Evaluation the functionality of the eustachian tube with odiometric tests, Evaluation the functionality of the eustachian tube, which was presumed to be compromised on the initial post-adenotonsillectomy day, and ascertainment whether it had recuperated by the second week. Tympanometry with 226 and 1000 Hz probes, eustachian function test with 226 Hz probe, ipsi and contralateral acoustic reflexes with 226 Hz probe and pure tone-play audiometry were performed in all patients one day before the operation. All tests were repeated on postoperative day 1 before the patient was discharged. All tests were repeated at the 2nd postoperative week., 14 days
Secondary Outcome Measures: Evaluation the functionality of the eustachian tube with tympanometry the 226 Hz and 1000 Hz probes, It was investigated which of the 226 Hz and 1000 Hz probes used in these tests detected earlier recovery findings., 21 days
Potential Risk Factors and Predictive Model Construction of OBL During SMILE
NCT Number: NCT06577012
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Myopia|Small-incision Lenticule Extraction (SMILE) Surgery
Interventions: PROCEDURE: Small incision lenticule extraction
Sponsor: Second Affiliated Hospital of Nanchang University
Sex: ALL
Age: ADULT
Enrollment: 4678
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2024-08-01
Locations: The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330000, China

Summary:
To explore the prediction of OBL by deep learning model in SMILE surgery

Primary Outcome Measures: The area of patients with opaque bubble layer in the SMILE surgeries, The area of patients with opaque bubble layer were observed during the SMILE surgeries., Day 0
Secondary Outcome Measures: Deep learning model, Predictive performance of deep learning model on the OBL in SMILE surgeries., Day 0|ResNet model, Predictive performance of ResNet model on the OBL in SMILE surgeries., Day 0|Vgg19 model, Predictive performance of Vgg model on the OBL in SMILE surgeries., Day 0|U-net model, Predictive performance of U-net model on the OBL in SMILE surgeries., Day 0
Sensor-based Balance Training With Exergaming Biofeedback
NCT Number: NCT06576999
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke, Ischemic
Interventions: DEVICE: Sensor-based Balance Training|OTHER: Usual Balance Trainging
Sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 21
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-05-01
Completion Date: 2024-07-31
Locations: Santa Lucia Foundation, Rome, 00179, Italy

Summary:
The purpose of this study is to evaluate the effects of a sensor-based balance training with exergaming feedback on balance skills in chronic stroke patients.

Primary Outcome Measures: The Berg Balance Scale (BBS), The BBS is a clinical scale used to quantitatively assess balance ability after stroke. Range score from 0 to 56 points, a higher score represents an improvement., Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)|The Canadian Neurological Scale (CNS), The CNS is a clinical scale used to quantitatively assess neurological status of stroke patients. Range score from 1.5 to 11.5, a higher score represents an improvement., Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)|The National Institutes of Health Stroke Scale (NIHSS), The NIHSS Clinical scale used to quantitatively assess neurological status of stroke patients. Range score from 0 to 42, a lower score represents an improvement., Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)|The Barthel Index (BI), The BI is a clinical scale used to quantitatively assess functional independence after stroke. Range score from 0 to 100 points, a higher score represents an improvement., baseline (t0); 4weeks (t1 - end of treatment); 8weeks (t2 - 1 month follow-up)|The Rivermead Mobility Index (RMI), The RMI is a questionnaire used to quantify mobility disability after stroke. Range score from 0 to 15 points, a higher score represents an improvement., Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)|Postural stability, Postural stability has been recorded via a stabilometric platform to evaluate the oscillations of patients while standing in the upright position with open/closed eyes. The lenght of the Center of Pressure (CoP) has used to assess the change in postural stability. A reduction in the CoP represents an improvement., Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)
Other Outcome Measures: The Pittsburgh Rehabilitation Participation Scale (PRPS), The PRPS is a clinician-rated instrument to assess participation of patients during therapies. Range score 1 to 6, a higher score represents higher motivation., Recorded at the end of each session (10 sessions administered in 4 weeks)