pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Evaluating the Feasibility of High-volume, Low-risk Penicillin Allergy De-labelling to Maximise Efficiency in a Resource-limited Setting
NCT Number: NCT06532448
Acronym: De-Label Me
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Penicillin Allergy
Interventions: DIAGNOSTIC_TEST: Single dose low-risk penicillin challenge
Sponsor: University Hospital Southampton NHS Foundation Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-10
Completion Date: 2025-10

Summary:
Plenty of studies have now established the safety of low-risk penicillin allergy de-labelling, but few have addressed how to organise de-labelling at the clinic level. This study will test the real world practicalities of running a de-labelling clinic optimised for maximum patient volume. The sheer number of patients with a penicillin allergy label, in contrast to relatively few allergy centres, makes demonstrating that such an approach can work extremely important for future antimicrobial stewardship.

Primary Outcome Measures: How can low-risk penicillin allergy de-labelling be delivered with maximal efficiency in a resource limited setting?, Successful operation of the high-volume clinic model, assessed via:

1. Number of patients reviewed and tested (if appropriate) within each allocated session
2. Evidence of acceptability to patients from feedback forms, 1 year
Study of Post-operative Complications After Laparoscopic Outpatient Nephrectomy
NCT Number: NCT06532422
Acronym: NEPHRAMBU
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Kidney Cancer
Interventions: PROCEDURE: Partial or total laparoscopic nephrectomy
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2026-09
Locations: Clinique de la Sauvegarde, Lyon, 69009, France

Summary:
The purpose of this study is to compare to assess the incidence of post-operative complications related to nephrectomy, which occur up to 1 month after the operation.

Primary Outcome Measures: Incidence of complications, The study will observe the incidence and describe the type, number, severity, duration and frequency of complications that may arise in the immediate post-operative period following ambulatory nephrectomy., 1 month
Comparison of Efficacy of Oral Amoxicillin Versus Intravenous Ceftriaxone
NCT Number: NCT06532409
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Community-acquired Pneumonia
Interventions: DRUG: Amoxicillin/CA|DRUG: IV ceftriaxone
Sponsor: RESnTEC, Institute of Research
Sex: ALL
Age: CHILD
Enrollment: 114
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-09-30
Locations: Children Hospital, Lahore, Punjab, 54000, Pakistan

Summary:
The efficacy of oral amoxicillin is considered equal to that of ceftriaxone in community-acquired pneumonia among children. Also, there are some factors that contradict the usage of ceftriaxone, like antibiotic resistance, adverse reactions, drug cost, and the and the chances of IV trauma and infection, which is a major problem in developing countries. Therefore, this study was planned to determine the efficacy of oral amoxicillin compared with intravenous (IV) ceftriaxone in the treatment of uncomplicated ceftriaxone in community acquired pneumonia in children less than 5 years of age.

Primary Outcome Measures: Free from fever, Efficacy will be labeled yes where fever symptoms are resolved (temperature = 98.6ºF) within 3 days., 3 days
A Study Evaluating Multiple Ascending Doses of QRL-101 in Healthy Participants
NCT Number: NCT06532396
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers
Interventions: DRUG: QRL-101|DRUG: Placebo
Sponsor: QurAlis Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2024-12-20
Locations: ICON plc. Van Swietenlaan 6, Groningen, 9728 NZ, Netherlands

Summary:
QRL-101-03 is a multiple ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of QRL-101 in healthy participants. QRL-101-03 is a follow-on study to QRL-101-01, an ongoing Phase 1, single ascending dose study to determine the safety, tolerability, and PK profile of QRL-101 after a single dose (ClinicalTrials.gov ID: NCT05667779).

Primary Outcome Measures: Number of participants with one or more treatment emergent adverse events and serious adverse events., A summary of treatment emergent adverse events (AEs), serious adverse events (SAEs), and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module., Baseline through Follow up (Day 10)
Secondary Outcome Measures: Pharmacokinetics (plasma): Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101, Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101, Baseline through Follow up Day 5|Pharmacokinetics (plasma): Maximum observed concentration of QRL-101, Maximum observed concentration (Cmax) of QRL-101, Baseline through Follow up Day 5|Pharmacokinetics (plasma): Time of maximum concentration of QRL-101, Time of maximum concentration (Tmax) of QRL-101, Baseline through Follow up Day 5|Pharmacokinetics (plasma): Concentration of QRL-101 before the next dose, Concentration of QRL-101 reached by a drug immediately before the next dose, Baseline through Follow up Day 5|Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101, Terminal elimination half-life of QRL-101, Baseline through Follow up Day 5
Implementing a Contingency Management Program Addressing Methamphetamine Use For and With the People of Hawaii
NCT Number: NCT06532370
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Methamphetamine Use
Interventions: BEHAVIORAL: Contingency Managment
Sponsor: Queen's Medical Center
Collaborators: National Institute of General Medical Sciences (NIGMS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-10-01

Summary:
The goal of this clinical trial is to use contingency management (CM) as an intervention tool to address methamphetamine use.

The main objectives are to:

* Gather effectiveness data on a pilot a CM program for participants in Hawaii who use methamphetamine following hospitalization due to traumatic injury
* To assess participant perspectives on engaging with a CM program based at a Level 1 Trauma Center. Researches will assess both patient-reported and biologically-confirmed medium-term program effectiveness and conduct qualitative interviews with participants post-program.

Participants will:

* Visit a follow-up clinic up to three times per week to complete urinalysis following discharge from the trauma unit
* Complete Treatment Effectiveness Assessments at 6 and 12-weeks
* Engage in a qualitative interview at the end of the CM program

Primary Outcome Measures: TEA Outcomes at 6 and 12-weeks, Treatment Effectiveness Assessment (TEA): This assessment asks individuals to respond to changes in four domains following a drug treatment program: substance use, health, lifestyle, and community. The score for each domain can range from 1 (no change or not much) to 10 (much better), for a total score of 4-40. This score allows for the prioritization of each participants values, and therefore does not require strict abstinence to demonstrate benefit from drug treatment., From enrollment to the end of treatment at 12-weeks
Secondary Outcome Measures: Qualitative Outcomes, Interviews will be conducted as semi-structured interviews using a priori interview guides. Interviews will be transcribed and analyzed using a Template Analysis approach. Two coders will conduct coding of the interview data to ultimately identify themes that will be used as the basis for interpretation. The final analysis of the qualitative data will include contrasts and comparisons made across interviews to examine overlaps and divergences across any relevant sub-samples (e.g., sex, age). Results will present thematic patterns, how frequently each code occurs, and any contradictory evidence., At the end of treatment at 12-weeks
Other Outcome Measures: Urine Analysis Results, Study personnel will ask participant to complete a urine analysis screen. Following completion of the urinalysis, study personnel will use a test strip to determine if the sample is methamphetamine negative or positive. Results will be documented., From enrollment to the end of treatment at 12-weeks
An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer
NCT Number: NCT06532344
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Metastatic Pancreatic Cancer
Interventions: DRUG: ONO-7913|DRUG: ONO-4538|DRUG: Oxaliplatin|DRUG: Levofolinate|DRUG: Irinotecan|DRUG: Fluorouracil
Sponsor: Ono Pharmaceutical Co. Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-07-30
Completion Date: 2025-05-31
Locations: National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan|Kanagawa Cancer Center, Yokohama-shi, Kanagawa, Japan|Seirei Hamamatsu General Hospital, Hamamatsu-shi, Shizuoka, Japan|Juntendo University Hospital, Bunkyō-Ku, Tokyo, Japan|The University of Tokyo Hospital, Bunkyō-Ku, Tokyo, Japan|The Cancer Institute Hospital ofJFCR, Koto-ku, Tokyo, Japan|Kyorin University Hospital, Mitaka-shi, Tokyo, Japan|Keio University Hospital, Shinjuku-Ku, Tokyo, Japan|National Cancer Center Hospital, Chuo Ku, Japan

Summary:
To investigate the tolerability and safety of ONO-7913 and ONO-4538 used in combination with modified FOLFIRINOX (mFFX therapy), the standard of care, as first-line treatment in patients with metastatic pancreatic cancer.

Primary Outcome Measures: Dose-limiting toxicities（DLT）, 28 days|Adverse event(AE), UP to 30 days after the last dose
Secondary Outcome Measures: Pharmacokinetics（serum concentration of ONO-7913）, Through study completion, an average of 6 months|Pharmacokinetics（serum concentration of ONO-4538）, Through study completion, an average of 6 months|Overall response rate (ORR), Through study completion, an average of 6 months|Disease control rate (DCR), Through study completion, an average of 6 months|Overall survival (OS), Through study completion, an average of 6 months|Progression-free survival (PFS), Through study completion, an average of 6 months|Duration of response (DOR), Through study completion, an average of 6 months|Time to response (TTR), Through study completion, an average of 6 months|Best overall response (BOR), Through study completion, an average of 6 months|Percentage of change in the sum of tumor diameters of target lesions, Through study completion, an average of 6 months|Maximum percentage of change in the sum of tumor diameters of target lesions, Through study completion, an average of 6 months|Changes in tumor markers (CEA and CA19-9), Through study completion, an average of 6 months
A PhaseⅠStudy of ONO-7475 in Combination With ONO-4538 and Gemcitabine Plus Nab-paclitaxel (GnP), the Standard of Care, and ONO-7475 in Combination With GnP in Patients With Pancreatic Cancer
NCT Number: NCT06532331
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Metastatic Pancreatic Cancer
Interventions: DRUG: ONO-7475|DRUG: ONO-4538|DRUG: Nab-paclitaxel|DRUG: Gemcitabine
Sponsor: Ono Pharmaceutical Co. Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 87
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-12-06
Completion Date: 2028-03-31
Locations: Aichi Cancer Center, Nagoya-shi, Aichi, Japan|National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan|Kanazawa University Hospital, Kanazawa-shi, Ishikawa, Japan|Kanagawa Cancer Center, Yokohama-shi, Kanagawa, Japan|Osaka International Cancer Institute, Osaka-shi, Osaka, Japan|Seirei Hamamatsu General Hospital, Hamamatsu-shi, Shizuoka, Japan|Juntendo University Hpspital, Bunkyo-ku, Tokyo, Japan|The University of Tokyo Hospital, Bunkyo-ku, Tokyo, Japan|The Cancer Institute Hospital Of JFCR, Koto-Ku, Tokyo, Japan

Summary:
This study is PhaseⅠstudy to examine tolerability and safety of ONO-7475 in combination with ONO-4538 and gemcitabine plus nab-paclitaxel (GnP), the standard of care, and safety of ONO-7475 in combination with GnP in patients with metastatic pancreatic cancer as first-line treatment

Primary Outcome Measures: Dose-limiting toxicities (DLT), 28 days|Adverse event (AE), Up to 28 days after the last dose
Secondary Outcome Measures: Pharmacokinetics (Plasma concentration of ONO-7475), Up to Cycle16|Pharmacokinetics (Plasma concentration of ONO-4538), Through study completion, an average of 6 months|Anti-ONO-4538 antibody, Through study completion, an average of 6 months|Objective Response Rate (ORR), Through study completion, an average of 6 months|Disease Control Rate (DCR), Through study completion, an average of 6 months|Overall Survival (OS), Through study completion, an average of 1 year|Progression-Free Survival (PFS), Through study completion, an average of 6 months|Duration of Response (DOR), Through study completion, an average of 6 months|Time to Response (TTR), Through study completion, an average of 6 months|Best Overall Response (BOR), Through study completion, an average of 6 months|Percent change in the sum diameters of the target lesions, Through study completion, an average of 6 months|Maximum percent change in the sum diameters of the target lesions, Through study completion, an average of 6 months|CEA, Through study completion, an average of 6 months|CA19-9, Through study completion, an average of 6 months
Comparative Study Between Platelet Rich Plasma and Steroid Injection in Trigger Finger Treatment
NCT Number: NCT06532318
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Trigger Finger Disorder
Interventions: BIOLOGICAL: Platelet rich plasma|DRUG: Pfizer Depo-medrol
Sponsor: Obafemi Awolowo University Teaching Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-07-24
Completion Date: 2025-06-23

Summary:
The goal of this clinical trial is to learn if platelet rich plasma works to treat early stage trigger finger in adults. It will also learn about the safety platelet rich plasma. The main questions it aims to answer are:

Does platelet rich plasma lower the pain associated with trigger finger of participants? Does it improve the hand grip strength and Q DASH score of participants? Researchers will compare platelet rich plasma to Depo-Medrol steroid (a known standard of care for early stage trigger finger) to see if platelet rich plasma works to treat early trigger finger.

Participants will:

Take platelet rich plasma or a depo-medrol steroid intralesional injection at recruitment into the intervention Visit the clinic once every 4 weeks for checkups and parameter measurements. Investigator will will keep a record of participants progress in symptom remission

Primary Outcome Measures: symptom resolution post injection, reduction of pain using VAS and absence snapping of finger, 3 months
Secondary Outcome Measures: Hand grip strength, measured grip using hand dynamomter, 3 month|Q- DASH score, 11-item self reported disability questionnaire that consider upper extremity as one functional unit, 3month
Randomised Controlled Trial on Using Active Warming to Prevent Newborn Hypothermia After Caesarean Delivery
NCT Number: NCT06532266
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Newborn; Hyperthermia
Interventions: DEVICE: TechTrade Ready Heat Half Body Temperature Management Blankets|OTHER: Control
Sponsor: The University of Hong Kong
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2023-11-01
Completion Date: 2026-06-30
Locations: Department of Obstetrics and Gynaecology, Hong Kong, Hong Kong, 852, China

Summary:
Despite the enormous advantages that skin-to-skin contact (STSC) and Delaying Cord Clamping (DCC) bring, newborns can lose heat quickly if they are not thermally protected. In the first 10-20 minutes after birth, newborns can experience a body temperature drop of between 2°C to 4°C if they are not properly dried and covered. In 2014, Horn et al. published a research paper regarding the incidence and prevention of newborn hypothermia after Caesarean delivery. The findings showed up to 80% of newborns become hypothermic if only warm towels (passive insulation) were used during STSC after Caesarean delivery. Evidence also shows higher hypothermia rates in infants born by Caesarean section than vaginal birth.

STSC will begin while Caesarean section continues. Newborns will be clothed in a cotton hat and diaper. Newborns will be placed on bare chest of mother, horizontally, in prone position. The head of the newborn will turn laterally, making the nose and mouth unobstructed. Newborns' hands are not swaddled and are free to move to allow exploration to facilitate first feeding. In both groups, infants will be covered from head-to-toe with 3 layers of 100% cotton woven blankets, taken from a 70°C heating cabinet. For the "intervention group", thermal blanket will be placed on top of the cotton blanket. Newborn will be first covered with conventional warm blanket then adding the thermal blanket on top. The thermal blanket will be placed inside a "pillowcase" like cotton blanket to avoid direct contact with mother or newborn.

Primary Outcome Measures: Newborn hypothermia, Body temperature below 36.5°C, after 20 minutes of skin to skin contact after Caesarean delivery or at the cessation of using active or conventional warming method before completion of 20 minutes of STSC, whichever happens first.
Long-term Safety Trial with NVDX3
NCT Number: NCT06532253
Acronym: X3LTFU
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Distal Radius Fractures|Degenerative Lumbar Spondylolisthesis
Sponsor: Novadip Biosciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-22
Completion Date: 2036-03

Summary:
An study evaluating the long-term safety of all patients previously treated with NVDX3.

Primary Outcome Measures: Long-term safety of the NVDX3 implant, Description of all SAEs, NVDX3 related AEs and AE of special interest, Between screening (V0) and 120 months post-core study (V10)
Methylene Blue for the Treatment of Septic Shock
NCT Number: NCT06532240
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Septic Shock
Interventions: DRUG: Methylene Blue|DRUG: Placebo
Sponsor: Northern Jiangsu People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 76
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-05
Completion Date: 2026-09
Locations: Northern Jiangsu people's hospital, Yangzhou, Jiangsu, 225000, China

Summary:
The purpose of this study is to evaluate the efficacy and safety of methylene blue among adult patients with septic shock.

Primary Outcome Measures: Time to shock reversal, Time to shock reversal was defined as the time from randomization to shock reversal.Reversal of shock was defined as the maintenance of a systolic blood pressure of at least 90 mmHg without vasopressor support for at least 24 h., 90 days after randomization
Secondary Outcome Measures: 28-day mortality, All-cause mortality at day 28 after randomization, 28 days after randomization|90-day mortality, All-cause mortality at day 90 after randomization, 90 days after randomization|ICU mortality, All-cause mortality at ICU discharge, 90 days after randomization|Hospital mortality, All-cause mortality at hospital discharge, 90 days after randomization
Other Outcome Measures: ICU length of stay, Time in days until ICU discharge, 90 days after randomization|hospital length of stay, Time in days until hospital discharge, 90 days after randomization|ICU-free days up to day 28, Total number of days alive and free of ICU stay during the 28 days after randomization., 28 days after randomization|vasopressor-free days up to day 28, Total number of days alive and free of vasopressor during the 28 days after randomization., 28 days after randomization|ventilator support-free days up to day 28, Total number of days alive and free of ventilator support during the 28 days after randomization., 28 days after randomization|CRRT-free days up to day 28, Total number of days alive and free of CRRT during the 28 days after randomization., 28 days after randomization|72h lactate, lactate level at 72h after randomization, 72 hours after randomization|72h Delta SOFA, Initial SOFA score at enrollment-SOFA score after 72 h;If the patient discharged within 72 h after being enrolled in the study, the SOFA score at discharge was used for the analysis., 72 hours after randomization|72h P/F, P/F at 72h after randomization, 72 hours after randomization
AspergillusOne-Health: Deciphering Azole Resistance in Aspergillus Fungi Using a One Health Approach
NCT Number: NCT06532227
Acronym: AspergillusOH
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Aspergillus Fumigatus Infection
Interventions: OTHER: No intervention
Sponsor: Nantes University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2028-08-01

Summary:
During a two year prospective study onpatients from department's hospitals and centralized by the pneumology department Nantes CH,all respiratory clinical samples will be cultivated for Aspergillus isolation (2900Aspergillusisolates) as standard care. The azole susceptibility pattern of isolates will be determined to itraconazole, voriconazole by subculture on azole- enriched medium at 35°c as primary screen and resistance confirmed by EUCAST Reference metho.In parallel, the relevance of detecting resistance (TR34 and TR46) directly in culture-negative BAL respiratory samples by a qPCR method will be studied in an attempt to reach a greater exhaustiveness of the resistance phenomeno. In case of azole-resistant isolate,patient data such as the underlying disease,date and site of Aspergillus isolation,disease classification,previous azole drug exposure,and home and work geographic allocation,occupation of the patient will be collecte. For all other aspergillus occurrences, underlying disease, previous azole drug exposure,home and work location of the patient will be collected in an attempt to identify risk factor.

Primary Outcome Measures: Environmental risk factors, Identify the "macro" environmental risk factors for acquiring azole-resistant aspergillus., 24 months
Secondary Outcome Measures: Describe the management and evolution of resistant, Clinical information from each additional patient visit and presence or absence of resistant Aspergillus in home samples., 48 months|Risk factors, Identify individual risk factors linked to the immediate environment in the patient's home, drug management, between cases and matched controls, etc.., 48 months
Clinical Retrospective Study Analysis of Postoperative Complications Following Hepatectomy
NCT Number: NCT06532214
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Liver Failure|Liver Dysfunction
Interventions: DIAGNOSTIC_TEST: International Study Group for Liver Surgery (ISGLS)
Sponsor: Nanfang Hospital, Southern Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2025-12-31
Locations: Nanfang Hospital, Guangzhou, Guangdong, 510515, China

Summary:
Hepatectomy is a crucial surgical method for treating liver diseases such as liver cancer, hepatic hemangiomas, and biliary stones. Although hepatectomy has achieved significant therapeutic effects, postoperative complications remain an inevitable issue. Complications following hepatectomy include liver failure, hepatic vascular thrombosis, wound infection at the hepatic incision, and bile leakage, among others. These complications pose a serious threat to patients' health and life, and also increase the waste of medical resources and the cost of treatment. Currently, research on postoperative complications of hepatectomy mainly focuses on small sample studies from a single center, and most studies only focus on a specific complication, lacking comprehensive and systematic analysis. Therefore, it is necessary to conduct a retrospective study analysis of complications related to hepatectomy to more comprehensively and objectively understand the incidence, risk factors, prevention, and treatment of postoperative complications, providing clinical doctors with more scientific treatment plans and guidance.

Primary Outcome Measures: Post-hepatectomy liver failure (PHLF), PHLF is commonly diagnosed and classified according to the criteria of the International Study Group for Liver Surgery (ISGLS), utilizing markers of liver function measured on or after postoperative day 5 (POD5)., On and after the 5th postoperative day
Secondary Outcome Measures: mortality, The patient died postoperatively, During 30 days after surgery
Effects of Su Jok Therapy on Pain, Fatigue, Nausea-Vomiting and Spiritual Well-Being
NCT Number: NCT06532201
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer|Chemotherapy
Interventions: OTHER: Su jok seed therapy
Sponsor: Muş Alparlan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 68
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-01
Completion Date: 2025-01-01

Summary:
This study aims to examine the effects of sujok therapy on pain, fatigue, nausea-vomiting and spiritual well-being levels in patients receiving chemotherapy. The following questions are being answered;

* Does sujok therapy affect pain levels in cancer patients?
* Does sujok therapy affect fatigue levels in cancer patients?
* Does sujok therapy affect nausea-vomiting levels in cancer patients?
* Does sujok therapy affect spiritual well-being levels in cancer patients?

Primary Outcome Measures: "VAS" will be used to determine the pain levels of cancer patients., Pain levels for cancer patients, 2 months|"Cancer Fatigue Scale" will be used to determine the fatigue levels of cancer patients., Fatigue levels for cancer patients, 2 months|"Rhodes nausea-vomiting and retching index" will be used to determine the nausea-vomiting levels of cancer patients., Nausea-vomiting levels for cancer patients, 2 months|"Spiritual Well-Being Scale" will be used to determine the spiritual well-being levels of cancer patients., Spiritual well being levels for cancer patients, 2 months
Efficacy of Hypno-ear-acupuncture on Insomnia in Advanced Cancer Patients
NCT Number: NCT06532188
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Oncology|Insomnia|Symptoms and Signs
Interventions: PROCEDURE: Hypno-ear-acupuncture|PROCEDURE: Sham Hypno-ear-acupuncture
Sponsor: Medical University of Graz
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2024-12-31
Locations: Medical University of Graz, Graz, Styria, 8036, Austria

Summary:
This randomized controlled trial aims to test if a combination of medical hypnosis and ear acupuncture improves sleep quality in patients with advanced cancer during a hospital stay in a palliative care unit.

Patients submitted to our palliative care unit will receive a medical hypnosis and ear acupuncture on the second day of their stay. Sleep quality will be measured using validated patient-reported outcome measures at baseline and after 7 days. Additionally, the use of sleep medication will be documented as a secondary outcome.

The intervention will be compared to a sham medical hypnosis and ear acupuncture to see if the effect of the true intervention has a unique effect.

Primary Outcome Measures: Richards-Campbell Sleep Questionnaire (RCSQ), Change in Patient-reported outcome measure assessing the sleep quality on five sleep related items using a visual analoge scale Range: 0-100mm (Visual Analog Scale) Domains/items: 5 (Sleep depth, Sleep latency, Awakenings from sleep, Ability to return to sleep, Sleep quality) Total score: mean score of all 5 domains (0-100) Interpretation: higher scores reflect better sleep quality, Baseline and after seven days
Secondary Outcome Measures: Edmonton symptom assessment scale (ESAS), Change in Patient-reported outcome measures assessing nine different symptoms on a numerical rating scale Range: 0-10 (Numerical Rating Scale) Domains/items: 9 (pain, fatigue, drowsiness, nausea, annorexia, breathlesness, depression, anxiety, well-being) Total score: mean score of all 9 domains (range: 0-10) Interpretation: higher scores reflect higher symptom burden, Baseline and after seven days|Patient health questionnaire 9 (PHQ-9), Change in Patient-reported outcome measure assessing depressive symptoms using 9 items describing the Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) criteria of depression.

Range: 0-3 (categorial rating: 0 = "not at all", 3 = "nearly every day" Domains/items: 9 (interest/pleasure in doing things, feeling down or depressed, sleep-related problems, low energy or fatigue, eating problems, self-worth, ability to concentrate, psychomotor problems, thoughts of suicide) Total score: sum of all items (range: 0-27) Interpretation: higher scores reflect higher depressive symptoms, Baseline and after seven days|Use of additional medication, Use of sleep medication (benzodiazepines) and analgesics (opioids, non-opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), From baseline to end of study (total seven days)
Effects of Su Jok Seed Therapy Application on Pain, Anxiety and Psychological Resilience in Patients Hospitalized in the Oncology Ward
NCT Number: NCT06532175
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer|Cancer Pain
Interventions: DEVICE: Su-Jok
Sponsor: Muş Alparlan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-01
Completion Date: 2024-10-01

Summary:
The aim of this clinical trial is to determine the effects of su jok seed therapy on pain, anxiety and psychological resilience in patients hospitalized in the oncology ward. This study seeks answers to the following questions; Does su jok seed therapy affect the pain levels of cancer patients? Does su jok seed therapy affect the anxiety levels of cancer patients? Does su jok seed therapy affect the Psychological resilience levels of cancer patients? There will be an experimental and control group in the study and the effectiveness of sujok application will be examined.

A total of 8 sessions of su jok seed therapy will be applied to the experimental group, twice a week for a month. No intervention will be made to the control group.

Individuals over 18 years old, without communication problems and diagnosed with cancer will be included in the sample.

Primary Outcome Measures: Pain levels of cancer patients will be evaluated using VAS., Pain levels of cancer patients, 2 months|Anxiety levels of cancer patients will be evaluated using the "State Anxiety Scale"., Anxiety levels of cancer patients, 2 months|Psychological resilience levels of cancer patients will be evaluated using the "Brief Psychological Resilience Scale"., Psychological resilience levels of cancer patients, 2 months
The PRICE Trial: Pain Reduction for Intrauterine Contraception Experiment
NCT Number: NCT06532162
Acronym: PRICE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Contraception
Interventions: DRUG: 1% Lidocaine Paracervical Block|DRUG: Normal Saline Paracervical Injection
Sponsor: Mount Sinai Hospital, Canada
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 246
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2022-06-30
Completion Date: 2024-10
Locations: Mount Sinai Hospital, Toronto, Ontario, M5G1Z5, Canada

Summary:
Intrauterine devices (IUDs) are a highly effective form of reversible contraception with a less than 1% failure rate. They can be easily placed in the office and require little maintenance care. However, despite their benefits, pain during insertion remains a barrier for patient uptake. Currently there is no standard of care for pain management during IUD insertion. The aim of this study is to determine whether local anesthetic, in the form of injecting 1 percent lidocaine into the cervicovaginal junction, reduces pain during insertion. Participants will be randomly assigned to receive 1 percent lidocaine, placebo, or no injection. All patients presenting for IUD placement, regardless of indication, will be offered participation in the study. Following IUD placement, patients will be asked to rate their pain at key "pain points" during the procedure as the primary outcome. Other outcomes collected will include provider-related complications, length of time to place IUD, and overall patient and provider satisfaction.

Primary Outcome Measures: Global Pain Score, Patient-reported overall pain score on the 100 mm Visual Analogus Scale (VAS). A score of 0 mm is the minimum, 100 mm is the maximum, with higher scores indicating more pain (i.e. worse outcome)., Immediately following the procedure
Secondary Outcome Measures: Pain at specific pain points, Patient-reported pain score at specific pain points during the procedure, on the 100 mm Visual Analogus Scale (VAS). A score of 0 mm is the minimum, 100 mm is the maximum, with higher scores indicating more pain (i.e. worse outcome)., Baseline, after injection or placebo, tenaculum placement, uterine sounding, IUD insertion, 1 minute post-procedure|Immediate complications following the procedure (i.e. vasovagal response, dizziness, local anesthetic toxicity syndrome), Provider reported based on events during the procedure, Immediately following the procedure|Length of time for analgesia, Stopwatch, Immediately following administration of the intervention, placebo, or control|Length of time for IUD placement, Stopwatch, Immediately following the procedure|Patient satisfaction, Survey-related questions, based on Likert scale and yes/no answers, Immediately following the procedure|Difficulty of IUD placement, Provider reported on Likert scale, 1 is minimum (least diffiult) and 5 is maximum (most difficult). Higher scores are worse outcome as they are more difficult.
ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer
NCT Number: NCT06532149
Acronym: EROS
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: NSCLC Stage IV|Sex Disorder|Hypogonadism, Male|Erectile Dysfunction
Interventions: DRUG: Alectinib|DRUG: Brigatinib|DRUG: Lorlatinib 100 mg|DRUG: Osimertinib|DRUG: Sotorasib|DRUG: Dabrafenib|DRUG: Trametinib|DRUG: Selpercatinib|DRUG: Pembrolizumab|DRUG: Cemiplimab|DRUG: Nivolumab|DRUG: Carboplatin|DRUG: Pemetrexed|DRUG: Paclitaxel
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-05
Completion Date: 2026-09-30
Locations: Fondazione Policlinico Gemelli IRCCS, Rome, 00168, Italy

Summary:
Although many phase III clinical trials evaluate the quality of life as a secondary endpoint, male sexuality remains a neglected topic in oncology research. In light of the long-term efficacy of new-generation anticancer treatments for ANSCLC (i.e. targeted therapies and immunotherapy), there is a paucity of data about any detrimental effect on fertility and sexuality that could complicate the therapy proposal, especially in young patients.

The aim of this trial is to assess incidence of endocrine toxicity and sexual dysfuction in male patients receiving active treatment for ANSCLC

Primary Outcome Measures: Incidence of treatment-related sexual dysfuction in male patients with ANSCLC, Percentage of patients who reported any sexual health disorders after treatment start, From treatment start up to 1 year
Secondary Outcome Measures: Incidence of treatment-related hypogonadism in male patients with ANSCLC, Percentage of patients who reported reduction of testosterone levels after treatment start, From treatment start up to 1 year|Incidence of treatment-related erectile dysfuction in male patients with ANSCLC, Percentage of patients who erectile dysfuction after treatment start, From treatment start up to 1 year
Mechanisms of Improving Fecal Continence Muscles Motor Function
NCT Number: NCT06532123
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fecal Incontinence
Interventions: DEVICE: continence muscles resistance device
Sponsor: Medical College of Wisconsin
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 340
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-10
Completion Date: 2029-10
Locations: Medical College of Wisconsin, Milwaukee, Wisconsin, 53086, United States

Summary:
The investigators hypothesize that different continence muscles have different fatigue characteristics and fatigue induced by resisted contractions will result in significant increase in contractility of the continence muscles and improvement of fecal incontinence severity.

Primary Outcome Measures: anal pressure, Maximum squeeze pressure, mean squeeze pressure and anal squeeze contractile integral, during kegel like exercise|anal pressure, Maximum squeeze pressure, mean squeeze pressure and anal squeeze contractile integral, after 6 weeks' exercise, during kegel like exercise|Vaginal pressure, Maximum squeeze pressure, mean squeeze pressure and vaginal squeeze contractile integral, during kegel like exercise|Vaginal pressure, Maximum squeeze pressure, mean squeeze pressure and vaginal squeeze contractile integral, after 6 weeks' exercise, during kegel like exercise|Fecal Incontinence severity, Vaizey Incontinence Score to quantify the severity of fecal incontinence. The Vaizey score is a validated tool and consists of two scoring systems with a five-point scale, which evaluates type and frequency of solid/liquid stool loss, flatus incontinence and impact on quality of life. Vaizey score ranges from 0 to 24, with 0 indicating perfect continent and 24 suggesting complete incontinence., before and after 6 weeks' exercise|Quality of life measure, The investigators will use Fecal Incontinence Quality of Life scale (FIQOL).FIQOL is used to evaluate psychometric health-related quality of life parameters in fecal incontinence patients. The score is arranged on four psychosocial scales: lifestyle, coping/behavior, depression/self-perception, and embarrassment, and contains a total of 29 different items. Subscale scores range from 1 to 5 and are the average response to all items on the scale., before and after 6 weeks' exercise
Gut Microbiota in Chronic GI Diseases
NCT Number: NCT06532110
Acronym: ChronicGI
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Microbiota
Interventions: OTHER: Endoscopy/Colonoscopy
Sponsor: McMaster University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 260
Study Design: Observational Model: |Time Perspective: p
Start Date: 2012-10-01
Completion Date: 2026-11-01
Locations: McMaster University, Hamilton, Ontario, L8S 4L8, Canada

Summary:
The study involves characterizing the microbiota of patients with IBS, functional diarrhea, IBD, severe motility disorders and celiac disease.

This will be complemented by a translational phase of human-mouse hybrid experiments in which germ-free mice will be colonized with feces from these patients with different GI disease and non-disease controls and we will compare symptoms, microbiota composition and histological changes in the gut and in the brain of the mice.

Primary Outcome Measures: To identify different patterns of intestinal microbiota in patients diagnosed with chronic gastrointestinal disorders or controls, To identify different patterns of intestinal microbiota in patients diagnosed with inflammatory bowel disease, microscopic colitis, functional diarrhea, severe motility disorders, celiac disease and irritable bowel syndrome and to compare it with non-disease controls., October 2013 - October 2026
Secondary Outcome Measures: To study the effect of microbiota on the immune system, Through colonization of germ free mice with human feces from the different groups of patients and controls., October 2013 - October 2026|To compare luminal microbiota composition vs. mucosa-associated microbiota composition in patients diagnosed with IBD, IBS, microscopic colitis, functional diarrhea, severe motility disorders and celiac disease and non-disease controls., Assessed by stool samples and aspirates, representative to the luminal composition; and the intestinal tissue (biopsies) representative of the mucosa, October 2013 - October 2026|To assess and compare the metabolic activity of gut bacteria of IBD, IBS, microscopic colitis, severe motility disorders, functional diarrhea and celiac disease patients and non-disease controls, Through assessing different bacteria derived metabolites, such as short-chain fatty acids, October 2013 - October 2026
Initial Effect Size Estimation of a Smartwatch-based Intervention for Physical and Behavioral Activation in Depressed Patients
NCT Number: NCT06532097
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Depression
Interventions: BEHAVIORAL: Physical and behavioral smartwatch-based activation
Sponsor: Max-Planck-Institute of Psychiatry
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 53
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-03-01
Completion Date: 2024-01-31
Locations: Max Planck Institute of Psychiatry, Munich, Bavaria, 80805, Germany

Summary:
It is well known that physical activity interventions have a robust, if small-to-moderate effect on the amelioration of chronic diseases, including major depressive disorder (MDD) (Singh et al. 2023). At the same time, behavioral activation is one of the most effective components of digital cognitive-behavioral therapy for depression (Furakawa et al. 2021). Here we leveraged smartwatches to provide an interactive tool for delivering a mixed intervention of physical and behavioral activation, with the former addressing physical activity level and the latter pleasant activities including and beyond physical activity (e.g., social, relaxing activities). Moreover, given the relationship with physical activity level, we additionally incorporated digital insomnia exercises that have also shown promising effects in the amelioration of depression. Our primary aim was to estimate the effects of our digital smartwatch-based intervention in a small sample of depressed patients.

Primary Outcome Measures: PHQ-9, Patient Health Questionnaire, pre to post: 12 weeks
Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen
NCT Number: NCT06532084
Acronym: SoraGVL
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Myeloid Leukemia, in Relapse|Myelodysplastic Syndromes|Chronic Myeloid Leukemia|Myeloproliferative Neoplasm
Interventions: DRUG: Sorafenib
Sponsor: St. Petersburg State Pavlov Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 88
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-22
Completion Date: 2028-05
Locations: RM Gorbacheva Research Institute, Saint Petersburg, 197022, Russian Federation

Summary:
This is a single-center randomized open-label phase II clinical trial to compare relapse prophylaxis with sorafenib and observation after graft-versus-host disease prophylaxis with post-transplantation bendamustine and cyclophosphamide in high-risk myeloid malignancies. This is an intention to treat study, where randomization is performed at first documentation of CR after engraftment.

Primary Outcome Measures: Event-free survival, Kaplan-Meier estimate of either relapse or secondary graft failure or death from all causes, 2 years
Secondary Outcome Measures: Overall survival, Kaplan-Meier estimate of death from all causes, 2 years|Cumulative incidence of primary and secondary graft failure, Cumulative secondary graft failure, competing risk is death and relapse, 365 days|Incidence of HCT-associated adverse events, Toxicity assessment is based on presence of NCI CTC AE 5.0 event grades 3-5. Veno-occlusive disease incidence and severity assessment is based on EBMT criteria 2020. Transplant-associated microangiopathy incidence assessment is based on Harmonization criteria. All toxicity measurements will be aggregated as severity scores., 180 days|Infectious complications, including analysis of severe bacterial, fungal and viral infections incidence, proportion of patients, requiring systemic treatment for bacterial, viral and fungal diseases, 180 days|Cumulative incidence of acute GVHD grade II-IV, 125 days, Cumulative incidence of patients with acute GVHD II-IV grade, competing risk is death, relapse and graft failure|Cumulative incidence of moderate and severe chronic GVHD, Cumulative incidence of patients with moderate and severe chronic GVHD according to NIH 2015 criteria, competing risk is death, relapse and primary graft failure, 2 years|Non-relapse mortality analysis, Cumulative incidence of patients with mortality without hematological relapse of malignancy, 2 years|GVHD-relapse-free survival analysis, Kaplan-Meier estimate of death, acute GVHD grade III-IV, severe chronic GVHD or relapse, 2 years|Cumulative incidence of relapse, Cumulative incidence of patients with relapse, competing risk is non-relapse mortality, 2 years