pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Effect of Transcutaneous Electrical Nerve Stimulation on CIPN Symptoms
NCT Number: NCT06499103
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Interventions: DEVICE: Transcutaneous electrical nerve stimulation
Sponsor: Jordan University of Science and Technology
Collaborators: King hussein cancer foundation and center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-08-08
Completion Date: 2024-06-29
Locations: Jordan university of science and technology, Irbid, 21540, Jordan

Summary:
Background: Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common and debilitating survivorship conditions for patients with cancer, and one of the most common side effects of chemotherapy treatment. Unfortunately, there are no proven ways to prevent or treat CIPN. Transcutaneous electrical nerve stimulation (TENS) is a method that succeeded to treat different types of pain and needs more investigation on its effect on CIPN.

Aim : The aims of this study are to investigate the effect of TENS in reducing CIPN symptoms in patients with cancer and to investigate the relathionship between some of the patients' sociodemographic charestristics/ medical history and the levels of CIPN after treatment with TENS.

Method : A double blind parallel randomized controlled trial (RCT) will be used in this study to assess the effect of TENS on CIPN among patients with cancer treated with chemotherapy. Participants will be recruited from King Hussein Cancer Center (KHCC). 44 patients will be included in the study if they developed CIPN after the first cycle of chemotherapy treatment, were ≥18 years old, and were not previously received any session of TENS device and only on gabapentin drug currently. Patients will be randomly assigned to one of two groups, 22 patient for each group. The intervention group will receive the TENS sessions daily for 10 days and for 30 minutes each session. The control group will stay on gabapentin. CIPN will be assessed using the Arabic Version of the Chemotherapy-Induced Peripheral Neuropathy Assessment Tool. CIPN will be assessed three time during the study: first time will be pre-intervention, second time will be after 5 days of treatment and the third time will be at the end of the sessions.

Implication : The result will lead nursing to achieve optimal nursing care for all patients by controlling the pain level and improve other peripheral neuropathy symptoms .

Primary Outcome Measures: Effects of transcutaneous electrical nerve stimulation on chemotherapy-induced peripheral neuropathy symptoms: A randomized controlled trial, Participants scores in CTCAE and visual analog scales that measure the severity of adverse events of treatment and pain score.

Retrospectively, showed improvement in both groups. However the interventional group (TENS with gabapentin) showed a higher reduction in total scores of scales compared with control group., Baseline
Mirtazapine for Acute and Chronic Post Mastectomy Pain
NCT Number: NCT06499090
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Breast Cancer
Interventions: DRUG: Mirtazapine 30 MG|DRUG: Placebo
Sponsor: Assiut University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 62
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: PREVENTION
Start Date: 2024-07
Completion Date: 2027-12
Locations: south Egypt Cancer Institute Assiut University, Assiut, Egypt

Summary:
Our aim in this study will be to investigate the effect of mirtazapine on acute post-mastectomy pain manifested by total morphine consumption in first 24 hours and VAS score at rest and movement (primary outcomes). chronic neuropathic pain using LANSS Pain Scale (Leeds Assessment of Neuropathic Signs and Symptoms) and to evaluate the quality of recovery using the quality of recovery-40scoring system(QoR-40) (secondary outcomes) following modified radical mastectomy for breast cancer.

Primary Outcome Measures: The cumulative postoperative 24 h morphine consumption, 24 hours
Secondary Outcome Measures: The visual analogue score of pain intensity, VAS score of pain intensity at rest and arm movement (abduction of the arm of the operated side up to 90°) measured at (0, 2,4,8,12,16 and 24h) postoperatively., 24 hours|The quality of recovery-40 questionnaire, 1 means very poor recover and 40 very good recovery, 24 hours|Assessment of sedation level, Assessment of sedation level by the Modiﬁed Ramsay Sedation score, 24 hours|Assessment of chronic pain, Assessment of chronic pain will be done after the first, third and Sixth month post-operatively by LANSS to evaluate chronic pain in the Pain Clinic., 6 months|Depression score, Depression score by the Patient Health Questionnaire(PHQ9), 6 months
The Ace Avanteon Study - A Randomized Controled Trial
NCT Number: NCT06499038
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hip Osteoarthritis
Interventions: PROCEDURE: Total Hip Arthroplasty
Sponsor: Helse Møre og Romsdal HF
Collaborators: St. Olavs Hospital|JRI Orthopaedics Ltd
Sex: ALL
Age: OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-25
Completion Date: 2028-11-01
Locations: Kristiansund Hospital, Møre and Romsdal Hospital Trust, Kristiansund, Møre And Romsdal, 6508, Norway

Summary:
The goal of this randomized controled trial is to compare if using of ancillary screws yields equal results as no use of ancillary screws in the ACE acetabulum cup of a total hip arthroplasty. Further, the migration of the Avanteon stem over time will be assessed. Patients included are patients with hip osteoarthritis from 65-80 years old. The purpose of this study is to compare implant migration and early fixation of a hybrid hip replacement combining the uncemented ACE acetabular component and the cemented Avanteon femoral stem, by using CT based Radiostereometric Analysis, a new innovative method for evaluating implant migration. Our study may predict the long term survival of the implants used.

Participants will go through total hip arthroplasty, and be followed by CT-RSA, plain x-rays and patients reported outcome measures.

Primary Outcome Measures: Translation, Proximal Y migration acetabular cup measured by CT-RSA, 2 years
Secondary Outcome Measures: Rotation, Rotation XYZ measured by CT-RSA, 2 years|Migration, Anterior and axial XZ migration acetabular cup measured by CT-RSA, 2 years|MTPM, MTPM of acetabular cup, 2 years|Stem Tr, Subsidence of stem, 2 years|XZ translation of Avanteon stem, Migration, 2 years|XYZ rotation, Rotation of stem in 3 dimensions, 2 years
Other Outcome Measures: Difference precision, Precision CT-RSA measured by double investigations at 2 different dose levels, 3 months|PROMs, Patient reported outcome measures like EQ-5D-5L, OHS, VAS, FJS and HOOS, 2 years
Treatment of Relapsed or Refractory t(8; 21) AML With Targeted AML1-ETO Neoantigen Cytotoxic T Cells (CTL)
NCT Number: NCT06499025
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: AML|t(8;21)|Neoantigen
Interventions: BIOLOGICAL: targeted AML1-ETO neoantigen cytotoxic T cells (CTL)|DRUG: Cyclophosphamide injection|DRUG: Decitabine Injection|DRUG: Liposome mitoxantrone
Sponsor: BGI, China
Collaborators: Shenzhen University General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-01
Completion Date: 2027-12-30
Locations: Shenzhen University General Hospital, Shenzhen, Guangdong, China

Summary:
1. To evaluate the safety and tolerability of targeted AML1-ETO neoantigen cytotoxic T cells (CTL) in the treatment of relapsed or refractory acute myeloid leukemia .
2. To evaluate the effectiveness of targeted AML1-ETO neoantigen cytotoxic T cells (CTL)，by the complete response rate(CRR) and overall survival (OS) followed.

Primary Outcome Measures: Safety assessment (Evaluation of treatment-related adverse events according to CTCAEv5.0), To determine the incidence of AE and SAE in clinical trials, From preconditioning or cell reinfusion to one year after cell reinfusion or the initiation of other antitumor therapy or the discontinuation of the trial for other reasons, whichever occurred first.
Secondary Outcome Measures: Complete response rate, The total number of subjects with complete response (CR) confirmed and the proportion of subjects in the corresponding analysis set, Up to 48 weeks|Overall survival (OS), The time from cell transfusion to death who have completed the prescribed dose. If the sujects is lost to follow-up, the last known date of surival wil be OS deletion time, Up to 72 weeks
Factors Influencing Physiological Hyperopia in Children
NCT Number: NCT06498947
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myopia Progression
Interventions: OTHER: This study was observational with no intervention.
Sponsor: Beijing Tongren Hospital
Sex: ALL
Age: CHILD
Enrollment: 1006
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2026-12-31
Locations: Beijing Tongren Hospital, Beijing, Beijing, 100005, China

Summary:
The trend of myopia in children and its low age is a major social and public health problem in China. More seriously, retinopathy associated with high myopia has become the number one cause of irreversible blinding eye disease in adults in some parts of China. Physiological hyperopia has a protective effect on preventing the onset of myopia, and is one of the strongest predictors of myopia on its own, which is significant in curbing myopia from occurring at a younger age and preventing the development of high myopia before adulthood. However, it is not yet known how the physiological hyperopia changes in childhood, the stage at which the critical inflection point occurs, which key factors lead to the rapid fading of the physiological hyperopia and progression to myopia, and the strength of its effect. In the early stage of the study, the research group established a prospective cohort of preschoolers based on natural population sampling, which included a total of 2109 preschoolers aged 3-6 years from 22 kindergartens in a district in Beijing, and completed a 2-year follow-up, obtaining exploratory results on the changing pattern of physiological hyperopia and key influencing factors in younger children. The group will add new samples to the existing whole cohort sampling cohort and adopt the design scheme of prospective nested case-control study to determine the changing trend of fading trajectory of physiological hyperopia in school-age children, key inflection points and key risk factors, so as to provide new techniques for the prevention and control of childhood myopia.

Primary Outcome Measures: myopia, Myopia in this study was defined as an equivalent spherical lens degree ( SER ) error (sphere+1/2 cylinder) of at least - 0.5 diopters(D) in either eye., 1 year
Secondary Outcome Measures: Myopia Prevalence, Myopia is defined as a spherical equivalent refractive (SER) (sphere + 1/2 cylinder) of at least -0.5 diopter (D) in either eye., 3 year|The change in ocular axis length, The change in ocular axis length was calculated by subtracting each year's measurement from the previous year's measurement., 3 year|The change in anterior chamber depth, Calculate the change in anterior chamber depth by subtracting each year's measurement from the previous year's measurement., 3 year|The change in corneal curvature, Calculate the change in corneal curvature by subtracting each year's measurement from the previous year's measurement., 3 year|The change in the ratio of axial length to corneal curvature, Calculate the change in the ratio of axial length to corneal curvature by subtracting each year's measurement from the previous year's measurement., 3 year
An Observational Study to Learn More About the Use of Darolutamide as a Part of a Combination Therapy in Belgian Men With Metastatic Hormone-Sensitive Prostate Cancer in Routine Medical Care
NCT Number: NCT06498921
Acronym: BELBEQA
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Metastatic Hormone-sensitive Prostate Cancer
Interventions: OTHER: Darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel
Sponsor: Bayer
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2024-09-15
Locations: Many locations, Multiple Locations, Belgium

Summary:
This is an observational study in which only observations from routine clinical practices will be made. Participants will not receive any advice on treatment or any changes to healthcare as a part of the study.

In this study, medical records data of Belgian men with metastatic hormone sensitive prostate cancer (mHSPC) who had received or are receiving treatment with darolutamide in combination with androgen deprivation therapy (ADT) and docetaxel will be studied.

mHSPC is a cancer of the prostate gland, a male reproductive gland found below the bladder. Metastatic means that the cancer has spread to other parts of the body. Hormone-sensitive means it can be treated with hormone-therapy such as androgen deprivation therapy (ADT).

ADT lowers the level of androgens, male hormones, and slows down the growth of cancer cells. However, in some cases, ADT alone is not sufficient for the treatment of mHSPC and doctors recommend a combination of treatments.

The study drug darolutamide, in combination with ADT and docetaxel is an approved treatment for mHSPC. Darolutamide aims to work by blocking the androgens signals to slow the growth of the cancer cells. Docetaxel is a medicine used to treat different types of cancer and works by stopping the growth and spread of cancer cells.

The main purpose of this study is to learn more about the real-world use of darolutamide in combination with ADT and docetaxel in Belgian men with mHSPC.

To do this, researchers will study the following information about participants who are already prescribed this combination treatment by their treating doctors in real-word condition:

* Participants' cancer characteristics before starting the treatment, and
* Participants' treatment history The data will be collected between July 2024 to September 2024, from eligible participants' medical records.

Study doctors will only look at the medical records of adult men with mHSPC in Belgium.

In this study, only available data from routine care will be collected. No visits or tests are required as part of this study.

Primary Outcome Measures: Description of baseline characteristics of patients under real-word conditions, at baseline
Secondary Outcome Measures: The average treatment duration with darolutamide (Nubeqa, BAY1841788), up to 22 months|The therapeutic value of darolutamide (Nubeqa, BAY1841788), up to 22 months
Intracervical Balloon Placement With Nitrous Oxide Administration
NCT Number: NCT06498908
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Labor Pain|Induced; Birth
Interventions: DRUG: Nitrous oxide|DRUG: Oxygen
Sponsor: Maimonides Medical Center
Sex: FEMALE
Age: ADULT
Enrollment: 162
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-15
Completion Date: 2025-09-01
Locations: Maimonides Medical Center OB/GYN, Brooklyn, New York, 11220, United States

Summary:
This randomized controlled trial aims to compare the effectiveness of nitrous oxide versus oxygen in facilitating the successful placement of a Foley balloon catheter for cervical ripening and induction of labor.

Primary Outcome Measures: success rate of intracervical balloon placement, successfull placement of intracervical ripening ballon on first attempt, 15 minutes
Secondary Outcome Measures: Pain Relief, Patients reported a pain score of a three or less for the duration of the procedure, 15 minutes
Lung Ultrasound Score as Post Operative Predictive Value of Pulmonary Complications in Living Liver Transplant Recipient
NCT Number: NCT06498895
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pulmonary Complication|Post Operative Complication
Interventions: RADIATION: lung ultrasound
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT
Enrollment: 25
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-10
Completion Date: 2025-07-10

Summary:
The aim of this study is to determine if lung ultrasound score has a strong predictive value for post operative pulmonary complications in living liver transplant recipient

Primary Outcome Measures: lung ultrasound score, first 24 hours
Press Needle Acupoint Stimulation Combined With Breast Massage on the Initiation of Lactogenesis II
NCT Number: NCT06498882
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lactation Induced
Interventions: OTHER: Press Needle Acupoint Stimulation Combined with Breast Massage|OTHER: routine care
Sponsor: Qingdao Municipal Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 132
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-12-28
Completion Date: 2024-06-21
Locations: Qingdao Municipal Hospital, Qingdao, Shandong, 266000, China

Summary:
This RCT aimed to rigorously evaluate the combined effects of press needle acupuncture and breast massage on accelerating the onset of lactogenesis II, thereby optimizing breastfeeding outcomes and maternal health post-cesarean delivery. It involved 136 mothers who had cesarean sections at this facility along with their healthy single-born infants.

Control group received routine care. On the basis of the control group, press needle acupoint stimulation and breast massage were administered to the intervention group. The main outcome indicators included the sensation of milk coming in, defined as the time to stage II lactogenesis. Additionally, milk quality was assessed 72 hours after birth, focusing on the content of protein, fat, lactose, minerals, and water. Secondary outcomes tracked include the number of breastfeeding sessions within the first 72 hours, the milliliters of formula provided to the infant during this period, and the percentage of mothers exclusively breastfeeding after 72 hours.

Primary Outcome Measures: time to stage II lactogenesis, The main outcome indicators included the sensation of milk coming in, defined as the time to stage II lactogenesis. Participants were asked to report the approximate time they noticed their breasts feeling 'noticeably fuller' using a numeric scale: 1 indicated 'no change since giving birth, '3 denoted 'noticeably fuller,' and 5 represented 'uncomfortably full' (Lian et al., 2022)., 0-96 hours after delivery|milk quality, Milk quality was assessed 72 hours after birth, focusing on the content of protein, fat, lactose, minerals, and water., 72 hours after delivery
Secondary Outcome Measures: number of breastfeeding sessions, Secondary outcomes tracked include the number of breastfeeding sessions within the first 72 hours (breastfeeds, 0-24 hours, 24-48 hours, 48-72 hours), a) 0-24 hours, 24-48 hours, 48-72 hours after delivery|milliliters of formula provided to the infant, Secondary outcomes tracked include the milliliters of formula provided to the infant during this period (formula fed to infant, 0-24 hours, 24-48 hours, 48-72 hours), 0-24 hours, 24-48 hours, 48-72 hours after delivery|percentage of mothers exclusively breastfeeding, Secondary outcomes tracked include the percentage of mothers exclusively breastfeeding after 72 hours., 72 hours after delivery
The Effect of Ketamine on Sleep Quality in Patients Undergoing Colonoscopy
NCT Number: NCT06498869
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep
Interventions: DRUG: Ketamine Hcl 50Mg/Ml Inj
Sponsor: Kocaeli City Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 164
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-07-30
Completion Date: 2024-12-30
Locations: Kocaeli City Hospital, Kocaeli, Izmit, 41100, Turkey

Summary:
Sedation typically begins with 2 mg of midazolam (0.025-0.1 mg/kg), followed by propofol given initially at 0.5-1.0 mg/kg bolus doses, with additional 0.25-0.5 mg/kg boluses as needed every 1-3 minutes to maintain sedation. Depending on clinical judgment, ketamine may be added to minimize propofol doses due to its minimal respiratory depression effects, administered at 0.25-0.50 mg/kg.

In the study protocol, participants undergo comprehensive assessments using the Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale, Numeric Rating Scale for Sleep Quality, and Richards Campbell Sleep Questionnaire on the procedure day, conducted in person.

Participants are randomized into two groups: one receiving midazolam and propofol (control group), and the other receiving ketamine in addition to midazolam and propofol.

Procedure duration and medication doses are meticulously recorded. Post-procedure, patients with a Modified Aldrete Score of 10 are transferred to the recovery unit. Participant data are documented, with follow-up conducted via phone 7 days post-procedure. Participants are reassessed using the aforementioned scales after the procedure, concluding the initial follow-up. The effects of ketamine on sleep quality will be evaluated by comparing the values of the mentioned scales before and after the procedure.

Primary Outcome Measures: Effects of Ketamine on Sleep Quality Scores, Ketamine, a dissociative anesthetic commonly used in medical and veterinary settings, has shown potential benefits for sleep quality, particularly in individuals with chronic pain or depression. Its primary mechanism involves blocking NMDA receptors in the brain, which not only provides anesthesa and pain relief but also impacts brain regions responsible for regulating sleep. Pittsburgh sleep quality index 0-21. RICHARD CAMPBELL sleep quality 0-100.SLEEP QUALITY NUMERICAL RATING SCALE 0-10., Postoperative at 7.day
Saline Infusion Test in Hyponatremia
NCT Number: NCT06498856
Acronym: SITH
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hyponatremia
Interventions: OTHER: Isotonic saline infusion
Sponsor: University Hospital, Akershus
Collaborators: Hormone Laboratory, Aker University Hospital, Oslo, Norway
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2028-12

Summary:
Observational study of biochemical volume biomarker levels in response to a standardized intravenous isotonic saline infusion in patients with hyponatremia.

Primary Outcome Measures: Copeptin plasma levels, Changes in copeptin levels in response to isotonic saline infusion, 240 minutes
Application of CTA-based Radiomic Phenotyping of PCAT and Fluid Dynamics in Atherosclerotic Disease (APPLE)
NCT Number: NCT06498830
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Computed Tomography Angiography|Inflammation of Adipose Tissue|CFD
Sponsor: Jinling Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-17
Completion Date: 2024-12-30
Locations: Research Institute Of Medical Imaging Jinling Hospital, Nanjing, Jiangsu, 210018, China

Summary:
This study (APPLE study) intends to retrospectively enroll more than 2000 patients who who underwent ≥2 coronary computed tomography angiography (CCTA) with ≥3 months interval from 11 hospitals in more than 4 provinces in China.

Primary Outcome Measures: the formation and regression of any atherosclerotic plaque on the follow-up CCTA, the formation and regression of any atherosclerotic plaque (Yes/No), 1 day
Secondary Outcome Measures: Total plaque volume, Total plaque volume, 1 day
Testing a Scalable Model of the Cholera Hospital-Based Intervention for 7 Days (CHoBI7)
NCT Number: NCT06498817
Acronym: CHoBI7
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diarrhea Infectious|Cholera
Interventions: BEHAVIORAL: Standard Recommendation|BEHAVIORAL: CHoBI7 Scale-Up Program
Sponsor: Johns Hopkins Bloomberg School of Public Health
Collaborators: Research Training and Management International (RTMI)|United States Agency for International Development (USAID)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-19
Completion Date: 2026-12-31
Locations: Manikganjg Sadar (District) Hospital, Manikganj, 1800, Bangladesh

Summary:
The findings from previous recent randomized controlled trials of The Cholera Hospital Based Intervention for 7 Days (CHoBI7) demonstrated that this intervention was effective in significantly reducing symptomatic cholera infections, diarrheal disease, and stunting among young children in intervention households, and had significant sustained impacts on handwashing with soap behaviors and improved water quality 12 months post intervention. Therefore, the investigators next step in the transition to scale is to: (1) To tailor the CHoBI7 program for delivery in rural health facilities and market test the CHoBI7 Program to determine the feasibility of providing a modified water, sanitation, and hygiene (WASH) package with only a soapy water bottle and chlorine tablets in both urban and rural settings through formative research and engagement of key stakeholders (Formative Research Phase); and (2) To evaluate the effectiveness of delivering the CHoBI7 program in district hospitals and sub-district health complexes in rural areas in terms of increases in WASH behaviors and decreases in diarrheal disease by conducting a randomized controlled trial (RCT) (Intervention Implementation and Evaluation Phase).

Primary Outcome Measures: Rate of Handwashing with soap at stool and food related events, Rate of patient household members handwashing with soap at stool and food related events measured measured using a 5 hour structured observation tool in the household using form developed by the investigators., 3 months|Number of constructed homemade handwashing stations, Household construction of homemade handwashing station, 3 months
Secondary Outcome Measures: Number of participants with diarrhea, Number of participants with self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period), 3 months|Amount of free chlorine concentration in stored drinking water, mg/Liter, 3 months|Number of stored drinking water samples with E. coli, Number of stored drinking water samples with E. coli, 3 months|Water, sanitation, and hygiene (WASH) psychosocial factors, Water, Sanitation, and Hygiene (WASH) psychosocial risk factor questionnaire. 5-point scale (0 = \[almost\] never/0-1 times out of 10-1 = \[almost\] always/9-10 times out of 10). with higher scores indicating higher handwashing frequency., 3 months
The Blood Patch in the Management of Intracranial Hypotension
NCT Number: NCT06498804
Acronym: BPIH
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Intracranial Hypotension
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-05
Completion Date: 2024-12-05
Locations: Service d'Anesthésie Réanimation médecine Péri-Opératoire - CHU de Strasbourg - France, Strasbourg, 67091, France

Summary:
Intracranial hypotension results from leakage and/or hypotension of cerebrospinal fluid. It can be spontaneous or secondary to a dural puncture complicating perimedullary anesthesia or a lumbar puncture. The incidence remains low with less than 1% post spinal puncture (25 gauge needle), but is observed more frequently following a lumbar puncture, up to 36% with a 20 or 22 gauge needle. Accidental puncture of the dura mater with a 17 gauge needle used for epidural anesthesia is associated with postpuncture headaches in 75-80% of cases. Classically, symptoms appear 24 to 48 hours after the puncture and consist of very intense, postural, fronto-occipital headaches which may be associated with cranial nerve symptoms such as visual or hearing disturbances or vertigo. Among the risk factors are the size and type of the needle, age under 60 and female gender. About 90% of PDPH are self-limiting within 7-10 days.

Primary Outcome Measures: Descriptions of professional practices in the management of intracranial hypotension by blood patch at the University Hospitals of Strasbourg, This retrospective study focuses on the description of the practices of doctors at the Strasbourg University Hospital in the management of intracranial hypotension by blood patch., Through study completion, an average of 2 months
Etiology and Prognosis of sICH Based on Hemorrhage Location
NCT Number: NCT06498778
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Spontaneous Intracerebral Hemorrhage
Sponsor: Jinling Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 698
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-07-01
Completion Date: 2023-05-31
Locations: Jinling Hospital, Nanjing, Jiangsu, China

Summary:
The investigators retrospectively collected participants with spontaneous cerebral hemorrhage(sICH) from January 2015 to December 2019 for training and internal validation. Clinical and imaging data were collected. Modified Rankin Scale (mRS) scores were determined good outcome as "mRS = 0-2", poor outcome as "mRS = 3-6". The location features of sICH were extracted by symptom mapping. Noncontrast computed tomography images of patients and hematoma masks were registered with standard human brain templates to identify specific affected brain regions. Then a probability map of hemorrhage for different causes and prognosis is generated. PyRadiomics was used to extract the radiomic features, integrate radiomic and clinical features into multiple logistic regression models, and develop and validate optimal etiological and prognostic models. Further tests were performed in an independent cohort. The area under the working characteristic curve (AUC), sensibility, specificity were used to evaluate the reliability of the model.

Primary Outcome Measures: Modified Rankin Scale (mRS) scores, Good outcome as "mRS = 0-2", poor outcome as "mRS = 3-6", follow-ups at twelve months post sICH event
Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy
NCT Number: NCT06498739
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Erector Spinae Plane Block|Modified Radical Mastectomy
Interventions: DRUG: Erector spinae plane block(15 ml bupivacaine 0.5%)|DRUG: Erector spinae plane block (15 ml bupivacaine 0.5% and 15ml normal saline)
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-03-01
Completion Date: 2024-09-01
Locations: Cairo Univesity, Cairo, 11311, Egypt

Summary:
Comparing the perioperative analgesic effect of two different volumes of local anesthetic solution in erector spinae plane block in patients undergoing modified radical mastectomy. A randomized comparative study.

Primary Outcome Measures: Total morphine consumption, Rescue analgesia will be provided in the form of intravenous morphine 3 mg boluses if the patient indicates visual analogue scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed.

Visual Analogue Scale (VAS) (0 represents "no pain" while 10 represents "the worst pain imaginable")., 24 hours postoperative
Secondary Outcome Measures: Time 1st rescue analgesia, All patients will receive paracetamol 1gm and intravenous ketorolac 30mg will be provided as a part of multimodal analgesia. Rescue analgesia will be provided in the form of intravenous morphine 3 mg boluses if the patient indicates visual analogue scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed.

Visual Analogue Scale (VAS) (0 represents "no pain" while 10 represents "the worst pain imaginable")., 24 hours postoperative|Pain score, Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").it will be assess at 0 , 4, 8, 12, 16, 20 and 24 hours postoperatively., 24 hours postoperative
Role of Transcranial Doppler and Magnetic Resonance Angiography for Future Management of Sickle Cell Anemia CNS.
NCT Number: NCT06498726
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Blood Disease|Brain Injuries
Interventions: DEVICE: transcranial doppler
Sponsor: Eman Abdul-Hai
Sex: ALL
Age: CHILD, ADULT
Enrollment: 18
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-10-01

Summary:
This study aimed to determine the Predictive Value of Transcranial Doppler and Magnetic Resonance Angiography for Future Management of Sickle Cell Anemia.

Specific aims are:

Demonstrate silent parenchymal and vascular brain changes that are incidentally observed in neurologically free SCD children using screening TCD and MRA in Pediatric Hematology unit at Assiut University Hospital

Detect any abnormality with vasculopathy, arterial occlusion and old SCI. Strokes in children with SCD can be prevented by checking a transcranial Doppler (TCD) ultrasound,MRA and providing blood transfusions to children with abnormal blood flow on the TCD and detect Silent cerebral and cerebrovascular changes in SCD.

Primary Outcome Measures: silent parenchymal and vascular brain changes in Sickle cell disease., the main outcome variable which is to demonstrate silent parenchymal and vascular brain changes that are incidentally observed in neurologically free SCD children using screening TCD and MRA, TWO YEARS
Patient Controlled Administration of Liquid Acetaminophen
NCT Number: NCT06498713
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pain|Pain, Postoperative
Interventions: DRUG: Acetaminophen 650 mg Oral Tablet|DRUG: Acetaminophen 650mg Liquid|DEVICE: CADD pump
Sponsor: Yale University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-08
Locations: Yale New Haven Hospital at St. Raphael's Campus, New Haven, Connecticut, 06520, United States

Summary:
This is a proof of concept pilot study investigating the feasibility and acceptability of patient controlled oral medication administration, using the commonly used and low risk medication in the hospital, oral acetaminophen.

Primary Outcome Measures: Participant enrollment rate, The percentage of participants that enroll, up to 12 months|Participant adherence to the study protocol, Percentage of participants that withdraw from treatment group, i.e. switch from patient controlled liquid group to the nurse-administered pill control group, up to 12 months|Nurse Questionnaire, Nurse ranking of patient controlled liquid oral acetaminophen vs. nurse-administered pill acetaminophen. (Mean score, Total Scale of 0-10: 0: much worse; 5:same; 10: much better), Study day 0, 1, 2 and 3
Secondary Outcome Measures: Mean daily acetaminophen consumption, Mean daily acetaminophen consumption in milligrams collected using the electronic medical record, 12 months|Mean Pain score, Participants will be asked via Pain Diary to rate their pain using numeric pain scores from 0 to 10, 0 as no pain, 10 is the worst possible., 12 months|Mean time to medication delivery, Medication delivery: Mean time in minutes from the time when pain medication requested by the participant to the time pain medication is delivered, 12 months
Intraoperative Subanesthetic Ketamine Versus Dexmedetomidine Infusion for Prevention of Post-traumatic Stress Disorder After Traumatic Brain Surgeries
NCT Number: NCT06498700
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Subanesthetic Ketamine Dexmedetomidin
Interventions: DRUG: ketamine|DRUG: dexmedetomidine
Sponsor: Zagazig University
Sex: ALL
Age: ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2025-03-15
Locations: Faculty of Medicine,Zagazig University, Zagazig, El Sharkia, 44519, Egypt

Summary:
Prevention of Post-traumatic Stress Disorder after traumatic Brain surgeries by using either subanesthetic ketamine or dexmedetomidine infusion.

Primary Outcome Measures: (PTSD), To measure the change in PTSD symptom severity using the PTSD Checklist, 6 months
Secondary Outcome Measures: VAS, postoperative pain, (24 hours, 48 hours, and 1 month)|postoperative delirium, using the confusion assessment method criteria, twice daily for 3 days
Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma With Donafenib in Combination With Envafolimab
NCT Number: NCT06498622
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hepatocellular Carcinoma
Interventions: DRUG: Donafenib + Envafolimab
Sponsor: Anhui Provincial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-20
Completion Date: 2027-05-20
Locations: No.2 People's Hospital of Fuyang city, Fuyang, Anhui, 236015, China|Anhui province hospital, Hefei, Anhui, 230000, China

Summary:
This is a multi-center, single arm study to evaluate the efficacy and safety of donafenib in combination with envafolimab treatment in patients with high risk of recurrent hepatocellular carcinoma after radical surgery.

Primary Outcome Measures: RFS, Recurrence Free Survival \[Time Frame: Observation period 24 month\] RFS was defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC or death from any cause, whichever first occurred., Observation period 24 months
Secondary Outcome Measures: OS, Overall Survival (OS）\[Time Frame: 24 months\] OS is defined as the time from the date of curative resection until death due to any cause., 24 months|2-year RFS rate, 2-year Recurrence Free Survival Rate (2-year RFS rate) \[Time Frame: Observation period 24 months\] 2-year RFS rate is defined as the proportion of patients alive and free of recurrence at 2 years after curative resection., Observation period 24 months|2-year OS rate, 2-year Overall Survival (OS）Rate \[Time Frame: 24 months\] 2-year RFS rate is defined as the proportion of patients alive at 2 years after curative resection., 24 months|AEs, Adverse Events (AEs) \[ Time Frame: 24 months \] The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0, 24 months
Assessment of the Efficacy of Microosteoperforations Versus Injectable Platelet-rich Fibrin During Orthodontic Leveling and Alignment of Mandibular Incisors
NCT Number: NCT06498609
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Effect of Platelet Rich Fibrin Versus Microosteoperforation Compaed to Control Group Toothmovement
Interventions: BIOLOGICAL: iprf|PROCEDURE: MOPs with leveling and alignment
Sponsor: Al-Azhar University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-01
Completion Date: 2024-12-01
Locations: Alazhar University, Cairo, Egypt

Summary:
The aim of this prospective clinical study will be to compare the efficacy of micro osteoperforations versus injectable platelet-rich fibrin during orthodontic leveling and alignment of mandibular incisors.

Primary Outcome Measures: assessment of acceleration of leveling and alignment of mandibular incisors, rate of leveling and alignment, post interventional at 4months
Effect of Ultrasound-guided Erector Spinae Plane Block on Postoperative Pain and Sleep Quality of Infants With Congenital Pulmonary Cystic Disease After Thoracoscopic Surgery
NCT Number: NCT06498583
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cystic Adenomatoid Malformation of Lung, Congenital|Bronchopulmonary Sequestration|Bronchogenic Cyst
Interventions: DRUG: Ropivacaine|PROCEDURE: erector spinae plane block|PROCEDURE: Incision infiltration of local anesthesia
Sponsor: Lei Xiaoming
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-02
Locations: Second Affiliated Hospital of Xi 'an Jiaotong University, Xi'an, Shanxi, 710004, China

Summary:
This study intends to evaluate the effect of erector spinae plane block on postoperative analgesia and sleep quality in infants with congenital cystic pulmonary disease after thoracoscopic surgery, and provides reference for perioperative pain treatment in children.

Primary Outcome Measures: postoperative FLACC score, 2, 4, 6, 12, 24, 48 hours after operation
Secondary Outcome Measures: Postoperative sleep quality score, The Pittsburgh Sleep Quality Index was used to evaluate the sleep quality of children 7 days after surgery., 1, 2, 3, 4, 5, 6, 7 days after operation|Number of participants with emergence agitation as assessed by PAED, The Pediatric Anesthesia Emergence Delirium (PAED) was used to evaluate emergence agitation after extubation in post-anesthesia care unit., from extubation to the child is sent back to the ward, an average of 40 minutes|the amount of postoperative rescue analgesia ( with a FLACC score of >4), ibuprofen (5-10mg/kg) was intravenously administered as rescue analgesia., 2, 4, 6, 12, 24, 48 hours after operation
Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus
NCT Number: NCT06498570
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cornea Ectasia
Interventions: DEVICE: Intracorneal rings
Sponsor: Sohag University
Sex: ALL
Age: ADULT
Enrollment: 23
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-01-01
Completion Date: 2024-01-10
Locations: Elshimaa A.Mateen, Sohag, Egypt

Summary:
Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus

Primary Outcome Measures: K1 and K2 post-operative by Pentacam, Flat and Steep K in Diopter post ring implantation, one year
Postoperative Analgesis in Total Knee Arthroplasty
NCT Number: NCT06498557
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Knee Arthroplasty
Interventions: OTHER: Peripheral nerve block methods
Sponsor: Samsun University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-22
Completion Date: 2024-09-09
Locations: SAMSUN UNIVERSITY Samsun Training and research hospital, Samsun, Turkey

Summary:
Postoperative analgesic treatment methods are applied to patients who have undergone knee arthroplasty. These applications are a routine part of the procedure. It is medically and ethically necessary. Postoperative analgesia applications are started during the intraoperative period and continued during the postoperative period. The analgesia protocol to be used is shaped by the characteristics of the patient and the skill and experience of the anesthesiologist. The scientifically accepted method is multimodel analgesia protocols. These protocols cover a wide range from paracetamol to opioids to peripheral and central blocks (methods such as suprainguinal fascia iliac block (SFIP), adductor block (ACB) and infiltration analgesia (IPACK) applied between the posterior elements of the knee and the popliteal artery). Our aim in this study is to evaluate the effects of analgesia protocols applied to patients undergoing knee arthroplasty surgery on inflammatory biomarkers (such as neutrophil lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR), systemic immune inflammation score (SII), lactate) obtained from routine blood and blood gas examinations in the first 24 hours of the postoperative period.

Primary Outcome Measures: Postoperative pain, Pain levels of patients will be evaluated with the Numerical Pain Scale (NRS) in the first 24 hours postoperatively., postoperative 24 hours
Secondary Outcome Measures: inflammatory mediators, NLR, preoperative 24 hours|inflammatory mediators, PLR, preoperative 24 hours|inflammatory mediators, SII, preoperative 24 hours|inflammatory mediators, Lactate, preoperative 24 hours
HighCycle Study: Effect of High Altitude on Sleep Disordered Breathing in Women Related to Their Menstrual Cycle Phase
NCT Number: NCT06498544
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sleep-Disordered Breathing
Interventions: OTHER: Exposure to 3600 m
Sponsor: University of Zurich
Collaborators: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov|University Hospital Heidelberg|Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
Sex: FEMALE
Age: ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2025-12-31
Locations: National Center for Cardiology and Internal Medicine, Bishkek, 720040, Kyrgyzstan

Summary:
Prospective cohort study investigating the menstrual cycle phase (MCP) dependent sleep disordered breathing (SDB) in women travelling to 3600 m.

Primary Outcome Measures: Nocturnal oxygen saturation (SpO2), MCP-related difference in altitude-induced change in the mean nocturnal oxygen saturation measured by pulse oximetry., Night 1 at 760 m and Night 1 at 3600 m
Secondary Outcome Measures: Nocturnal oxygen desaturation index (ODI), MCP-related difference in altitude-induced change in the ODI (number of ∆SpO2 \>3% per hour time in bed measured by pulse oximetry)., Night 1 at 760 m and Night 1 at 3600 m|Nocturnal oxygen desaturation index (ODI), MCP-related difference in altitude-induced change in the ODI (number of ∆SpO2 \>3% per hour time in bed measured by pulse oximetry)., Night 1 at 760 m and Night 2 at 3600 m|Apnea/hypopnea index (AHI), MCP-related difference in altitude-induced change in the mean number of apneas/hypopneas per hour., Night 1 at 760 m and Night 1 at 3600 m|Apnea/hypopnea index (AHI), MCP-related difference in altitude-induced change in the mean number of apneas/hypopneas per hour., Night 1 at 760 m and Night 2 at 3600 m|Subjective sleep quality, MCP-related difference in altitude-induced change in subjective sleep quality assessed by a 100-mm visual analog scale., Night 1 at 760 m and Night 1 at 3600 m|Subjective sleep quality, MCP-related difference in altitude-induced change in subjective sleep quality assessed by a 100-mm visual analog scale., Night 1 at 760 m and Night 2 at 3600 m|Nocturnal oxygen saturation (SpO2), MCP-related difference in altitude-induced change in the mean nocturnal oxygen saturation measured by pulse oximetry., Night 1 at 760 m and Night 2 at 3600 m