pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure
NCT Number: NCT06555848
Acronym: CERTITUDE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Osteomyelitis
Interventions: DEVICE: CERAMENT G
Sponsor: BONESUPPORT AB
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 128
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2032-10
Locations: Bone Infection Unit, Nuffield Orthopaedic Centtre, Oxford University Hospitals, MHS, Oxford, OX37HE, United Kingdom

Summary:
The study is a prospective cohort study of subjects where CERAMENT G was used as part of the surgical treatment of osteomyelitis in a single stage procedure.

Primary Outcome Measures: Composite Endpoint, Overall subject success requires all four of the following at 36 months post-op:

* absence of a reinfection of the original site of osteomyelitis;
* absence of purulent drainage and wound dehiscence/breakdown
* absence of a secondary surgical intervention, e.g., grafting or removal of residual CERAMENT G at the original site; and,
* a lack of serious adverse events associated with incomplete new bone formation, including pathologic fracture of the treated limb, 36 months|Co-Primary Endpoint, A trend showing increasing new bone formation and decreasing CERAMENT G as determined by a comparison of baseline and interim post-operative timepoint radiographic evaluations out to 36 months post-operative, 36 months
Secondary Outcome Measures: Radiographic Succcess, Radiographic success at 36 months, defined as CERAMENT G resorption and new bone formation (a minimum of mean void-filling of 74% in the subject population) as determined by comparison of the immediate post-op radiographs to those at 36 months, 36 months|Clinical Success, Clinical success at 36 months, defined as:

Maintenance or improvement in function (i.e., no decrease of PRO(s) in the SF-12 score between post-operative and 36 months follow-up), 36 months
Effect of Flexibility on Postural Stability
NCT Number: NCT06555835
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Healthy
Sponsor: Bezmialem Vakif University
Collaborators: Atlas University
Sex: ALL
Age: ADULT
Enrollment: 64
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-05
Completion Date: 2024-11-15
Locations: Bezmialem Vakif University, Istanbul, Turkey

Summary:
Postural stability has an important role for functional movements, injury prevention and the performance of many athletic skills. Therefore, it is very important to understand the factors that affect postural stability. The aim of this study is to investigate the effect of lower extremity flexibility on postural stability in healthy individuals.

Primary Outcome Measures: Passive straight leg raise test, Test is performed in the supine position. Measurement of hip flexion angle is performed with a universal goniometer at the end point of the movement., Baseline|Passive ankle dorsiflexion range of motion, During the measurement, individuals are in a supine position. The ankle joint range of motion measurement is performed with a universal goniometer., Baseline|Postural stability, Biodex Balance System (Biodex Medical Systems, Inc. USA) will be used in the dynamic single leg stance test and sensory integration of balance clinical test evaluations. Lower scores indicate better stability and higher scores mean poor balance., Baseline
A Study to Investigate Multiple Ascending Doses of AZD5004 in Healthy Participants
NCT Number: NCT06555822
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Participants
Interventions: DRUG: AZD5004|DRUG: Placebo
Sponsor: AstraZeneca
Sex: ALL
Age: ADULT
Enrollment: 15
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-01-10
Locations: Research Site, Brooklyn, Maryland, 21225, United States

Summary:
The main purpose of this study is to assess the safety, tolerability, and pharmacokinetic (PK) of AZD5004 administered as multiple oral doses in healthy participants.

Primary Outcome Measures: Number of participants with adverse events (AEs) and serious adverse events (SAEs), To assess the safety and tolerability of AZD5004 following oral multiple ascending doses in healthy participants., From screening (Day -28) to last follow up visit (Day 120)
Secondary Outcome Measures: Maximum observed plasma (peak) drug concentration (Cmax) of AZD5004, To characterize the Cmax of multiple ascending doses of AZD5004 in healthy participants., From Day 1 to last follow up visit (Day 120)|Area under the concentration-curve from time zero to the last quantifiable concentration (AUClast), To characterize the AUClast of multiple ascending doses of AZD5004 in healthy participants., From Day 1 to last follow up visit (Day 120)|Area under concentration time curve in the dosing interval (AUCtau), To characterize the AUCtau of multiple ascending doses of AZD5004 in healthy participants., From Day 1 to last follow up visit (Day 120)|Amount of unchanged drug excreted into urine from time t1 to time t2 (Ae[t1-t2]), To characterize the Ae(t1-t2) of multiple ascending doses of AZD5004 in healthy participants., From Day 1 to last follow up visit (Day 120)|Percentage of dose excreted unchanged in urine from time t1 to time t2 (fe[t1-t2]), To characterize the fe(t1-t2) of multiple ascending doses of AZD5004 in healthy participants., From Day 1 to last follow up visit (Day 120)|Renal clearance (CLR), To characterize the CLR of multiple ascending doses of AZD5004 in healthy participants., From Day 1 to last follow up visit (Day 120)|Percentage change from Baseline in body weight (kg), To assess the effects of AZD5004 compared to placebo on body weight change from baseline., Baseline (Day 2) to Days 49, 91 and 106|Absolute change from Baseline in body weight (kg), To assess the effects of AZD5004 compared to placebo on body weight change from baseline., Baseline (Day 2) to Days 49, 91 and 106|Percentage change from Baseline in BMI (kg/m^2), To assess the effects of AZD5004 compared to placebo on body weight change from baseline., Baseline (Day 2) to Days 49, 91 and 106|Absolute change from Baseline in BMI (kg/m^2), To assess the effects of AZD5004 compared to placebo on body weight change from baseline., Baseline (Day 2) to Days 49, 91 and 106
Evaluation of Artesunate in Infants Being Treated for Severe Malaria
NCT Number: NCT06555809
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Malaria
Interventions: DRUG: Artesunate Injection
Sponsor: Amivas (US), LLC
Sex: ALL
Age: CHILD
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-31
Completion Date: 2030-02-28
Locations: Hôpital Cochin Port Royal, Paris, 75014, France

Summary:
This is essentially a laboratory study that is an addendum to an ongoing prospective Phase 4 multicenter observational study titled: "Safety and Efficacy of Artesunate in Pregnant Women and Infants (ARTEMUM)" being conducted in France. Infants, the parents of whom provided consent to have data collected from their child as part of the ARTEMUM study, will have an additional blood sample collected when other standard of care blood specimens are collected during the 2-day period after the start of intravenous (IV) artesunate treatment. A maximum of 4 samples will be taken and plasma will be isolated and stored frozen until analysis for plasma artesunate and dihydroartemisinin (DHA) concentrations. Red blood cells will also be frozen for further analysis (for example Kelch-13 mutations). In addition, a standard of care blood sample will be collected approximately one month post treatment for clinical laboratory tests.

Primary Outcome Measures: Change in concentration of artesunate in blood plasma samples, Change in concentration of artesunate in blood plasma samples collected as part of standard of care, Approximately at 5 minutes, 30 minutes, 90 minutes, and 4 hours after artesunate intravenous injection|Change in concentration of dihydroartemisinin in blood plasma samples, Change in concentration of dihydroartemisinin in blood plasma samples collected as part of standard of care, Approximately at 5 minutes, 30 minutes, 90 minutes, and 4 hours after artesunate intravenous injection
Secondary Outcome Measures: Safety, as measured by the number of participants with adverse events, Safety, as measured by the number of participants with adverse events, During standard of care treatment with intravenous artesunate|Tolerability, as measured by the number of doses of artesunate administered to each participant, Tolerability of artesunate treatment, as measured by the number of doses of artesunate administered to each participant, During standard of care treatment with intravenous artesunate
Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer
NCT Number: NCT06555796
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Prostate Cancer|High-risk Biochemical Recurrence|High Risk Biochemical Recurrence of Non-metastatic Castration-sensitive Prostate Cancer|Non-metastatic Castration-sensitive Prostate Cancer
Interventions: DRUG: Xaluritamig
Sponsor: Amgen
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-24
Completion Date: 2029-03-24

Summary:
The main objective of this study is to evaluate the safety and tolerability of xaluritamig monotherapy in adult participants with high-risk biochemical recurrent (BCR) nonmetastatic castration-sensitive prostate cancer (nmCSPC).

Primary Outcome Measures: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs), Events categorized as adverse events (AEs) starting on or after first dose of investigational product (xaluritamig) as determined by the flag indicating if the AE started prior to the first dose on the Events Electronic Case Report Form (eCRF) and including 30 days after the last dose of investigational product (xaluritamig) or end of study date, whichever is earlier., Up to approximately 2 years|Number of Participants Experiencing Treatment-related Adverse Events (TRAEs), A TRAE is any TEAE that per investigators' review has a reasonable possibility of being caused by the investigational product (xaluritamig) determined by the flag indicating an event may have been caused by the investigational product (xaluritamig) on the Events eCRF. In the unlikely event that the flag is missing, the TEAE will be considered related., Up to approximately 2 years
Secondary Outcome Measures: Time to Prostate-specific Antigen (PSA) Progression, Up to 54 months|Number of Participants With a PSA 50 Response, Up to approximately 54 months|Number of Participants With a PSA 90 Response, Up to approximately 54 months|Duration of PSA 50 Response, Up to approximately 54 months|Duration of PSA 90 Response, Up to approximately 54 months|Number of Participants With Undetectable PSA, 6, 12, 24, and 36 months|Time to Initiation of Androgen Deprivation Therapy or Androgen Receptor Directed Therapy, Up to approximately 54 months|Time to First use of new Anticancer Therapy, Up to approximately 54 months|Time to Metastatic Disease/Progression, Up to approximately 54 months|Time to Symptomatic Progression, Up to approximately 54 months|Time to First Symptomatic Skeletal Event, Up to approximately 54 months|Metastasis-free Survival (MFS), 12, 24, and 36 months|Number of Participants Completing Xaluritamig Monotherapy Treatment, Up to approximately 36 months|Maximum Serum Concentration (Cmax) of Xaluritamig, Up to approximately 19 months|Time to Cmax (Tmax) of Xaluritamig, Up to approximately 19 months|Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Xaluritamig, Up to approximately 19 months|Terminal Half-life (t1/2) of Xaluritamig, Up to approximately 19 months
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects with Narcolepsy Type 2
NCT Number: NCT06555783
Acronym: Vibrance-2
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Narcolepsy Type 2
Sponsor: Alkermes, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-26
Completion Date: 2025-09

Summary:
The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.

Primary Outcome Measures: Change in Mean Sleep Latency (MSL) on the Maintenance Wakefulness Test (MWT), Baseline to Week 8
Secondary Outcome Measures: Change in Epworth Sleepiness Scale (ESS), Participants will be asked to complete the ESS, reporting on the level of sleepiness they experienced over the past 7 days., Baseline to week 8|Incidence of adverse events, Up to 21 weeks
Ultra Rapid GEnome Sequencing
NCT Number: NCT06555731
Acronym: URGES
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Whole Genome Sequencing
Interventions: GENETIC: Ultra rapid genome sequencing
Sponsor: CMC Ambroise Paré
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 4
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2024-11-10
Locations: Institut Rafaël, Levallois-Perret, Ile-De-France, 92300, France

Summary:
Next-generation sequencing (NGS) has revolutionized the field of genomics, allowing the detection of genetic abnormalities for diagnostic or therapeutic purposes. Turnaround times for exome or genome sequencing results have decreased to an average of 3 to 6 months.

An increasing number of diagnostic and therapeutic fields are benefiting from the advancements in ultra-rapid sequencing. In some situations, a shorter turnaround time may be useful for making therapeutic and/or interventional management decisions.

This study aims to explore the feasibility of very rapid whole-genome sequencing, ultra-rapid genome sequencing (URGES) in 72 hours, that could benefit patients with cancer or rare diseases.

Primary Outcome Measures: Time (in hours) for long read human genome sequencing and data interpretation, Time (in hours) to complete a long-read human genome sequencing, from the extracted DNA to the molecular and clinical results, 72 hours
Secondary Outcome Measures: Sequencing coverage, \>30 X respective to refseq BED, 72 hours|Sequencing depth, \>30 X respective to refseq BED, 72 hours|Number of variants called appropriately or not, 72 hours
Peer Support Program in Chronic Kidney Patient
NCT Number: NCT06555718
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Peer Review|Hemodialysis Complication|Nurse's Role|Health-Related Behavior
Interventions: BEHAVIORAL: The Peer Support Program|BEHAVIORAL: Standart care
Sponsor: Acibadem University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-01-11
Completion Date: 2025-01-30
Locations: Canan Yüksel Acar, Istanbul, 34752, Turkey

Summary:
The main advantage of patient-to-patient peer counseling is that it benefits both the client and the peer mentors as real and authentic experiences are shared. Since both individuals go through similar experiences, they can share common feelings. Although there are studies in the literature showing the effectiveness of peer support groups in different patient groups, studies on chronic kidney disease patients are limited. There are no studies on the effects of these programs on caregivers. This study will be conducted to examine the effects of peer support program applied to chronic kidney patients on patient outcomes and caregivers.

Primary Outcome Measures: Adaptation to the disease., "End Stage Renal Disease Adaptation Questionnaire (ESRD-AQ)" Total score varies between 0 and 1200. As the score obtained from the scale increases, the level of treatment compliance increases., The scale will be completed before the intervention and at 3, 7 and 9 weeks.
Secondary Outcome Measures: Self-Care, "Chronic Dialysis Patients' Self-Care Agency (SCA)" Scores obtained from the scale are between 0-44. As the score decreases, it is evaluated as self-care power is not good., The scale will be completed before the intervention and at 3, 7 and 9 weeks.
Other Outcome Measures: Patient outcomes, "Data collection form for patients (The target Kt/V in dialysis patients is between 1.2-1.4. , Kt/V(K - urea dialyzer clearance, t - dialysis time, V - urea volume of distribution))", The Kt/V value of all patients calculated before the intervention and the change in the value measured 3, 7 and 9 weeks after the intervention will be completed by the researcher.|Caregivers on Care Burden, "Caregiver Burden Scale for family caregivers of hemodialysis patients" Sub-dimension scores, internal consistency of 0.87, 0.70, 0.76, 0.70, 0.70 and 0.53 indicate an increase in care burden., The scale will be completed by the patients before the intervention and at 9th week.
Effect of Omega 3 Supplementation on the Heart Rate Variability in Obese Children
NCT Number: NCT06555705
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity, Childhood
Interventions: OTHER: Placebo|DIETARY_SUPPLEMENT: Omega 3
Sponsor: Cairo University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-03
Completion Date: 2024-09-03
Locations: Hoda Atef Abdelsattar Ibrahim, Cairo, Egypt|Hoda Atef Abdelsattar Ibrahim, Cairo, Egypt

Summary:
Evidence shows that omega-3 fatty acids lower blood triglyceride levels, lower blood pressure, enhance insulin sensitivity, and improve heart rate variability (HRV) measures, all of which may be indicators of cardiovascular health.As a result, omega-3 fatty acid supplementation may be a low-cost strategy with little adverse effects for obese youngsters, perhaps delaying the development of chronic cardiovascular illnesses.

Primary Outcome Measures: The effect of omega-3 on heart rate variability that is represented in the root mean square of successive differences of the heart rates ( RMSSD ) in obese children, Obese children will be examined for the effect of Omega-3 supplementation on heat rate variability, 3 months
Evaluation of the Clinical Effectiveness and Safety of Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction
NCT Number: NCT06555692
Acronym: SCderm
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer Female|Breast Reconstruction
Interventions: BIOLOGICAL: Transplant acellular dermal matrix(ADM)
Sponsor: DOF Inc.
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-04
Completion Date: 2025-12-31
Locations: Soon Chun Hyang University Hospital, Seoul, 04401, Korea, Republic of

Summary:
This is the multi-centered, open, prospective and retrospective study of up to total 120 subjects in breast reconstruction surgery with applying acellular dermal matrix(ADM). The aim of the study is to ascertain any difference in the rate of complications between the test group of undergoing breast reconstruction with SC Derm and the control group of taking breast reconstruction with other ADM products.

Primary Outcome Measures: Assessment of Breasts by Independent Investigator Using a 5-Point Likert Scale, Cosmetic outcome evaluation: Independent evaluation by two specialists for breast shape, size, symmetry, nipple position, and scar using standardized breast photos taken before surgery and at 6 months after surgery.

Evaluation: Evaluate the score for each item using a 5 point Likert scale

1. Shape : Very dissatisfied \< Dissatisfied \< Neutral \< Satisfied \< Very Satisfied
2. Volume : Very dissatisfied \< Dissatisfied \< Neutral \< Satisfied \< Very Satisfied
3. Symmetry : Very dissatisfied \< Dissatisfied \< Neutral \< Satisfied \< Very Satisfied
4. Nipple-areolar Complex : Very dissatisfied \< Dissatisfied \< Neutral \< Satisfied \< Very Satisfied
5. Scar : Very dissatisfied \< Dissatisfied \< Neutral \< Satisfied \< Very Satisfied, 6 months after surgery
Secondary Outcome Measures: Subject's Satisfaction Assessment, The patients' self-assessment of their satisfaction with the surgical outcomes at one month and 6 months visit of post-operation., Beaseline to 6 months|Baker's grade of capsular contracture, The occurrence of capsular contracture will be assessed clinically at the same follow-up visits (1 month and 6 months post-surgery).

Grade I: Breast is normally soft and appears natural Grade II: Breast is a little firm but appears normal Grade III: Breast is firm and appears abnormal Grade IV: Breast is hard, painful, and appears abnormal, 6 months after surgery|Complication Assessment, Evaluate the frequency and incidence rate of most commonly occurred complications of infection, skin necrosis, seroma, hematoma, implants removal., from the operation day to 6 months after surgery
Evaluation of a Predictive Score for the Onset of Moderate to Severe Alcohol Withdrawal Syndrome, the PAWSS, in a Population of Intensive Care Patients at Brest University Hospital
NCT Number: NCT06555679
Acronym: PAWSS-ICU
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Alcohol Withdrawal Syndrome
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 403
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-06-27
Completion Date: 2023-06-26
Locations: CHRU Brest, Brest, 29200, France

Summary:
alcohol use disorder (AUD) is a very common condition in patients admitting in ICU's. Brutal stop of alcohol consumption may lead to a withdrawal syndrome, wich is associated with a worse outcome for ICU patients (longuer ICU and hospital stays, use of mechanical ventilation, traumas). The aim of this study is to valid a score (PAWSS : prediction of alcohol withdrawal syndrome (AWS) scale) to predict at admission mild to severe AWS in ICU patients population.

Primary Outcome Measures: Evaluation of PAWSS statistic performances to predict AWS in ICU patients, Evaluation of sensitivity, specificity, positive and negative predictive values of PAWSS to predict moderate or severe AWS (defined by a CIWA greater than or equal to 8), the first 5 days of hospital stay
Secondary Outcome Measures: Creation of a new score, the PAWSS-ICU, able to predict AWS in ICU patients, To this end, the characteristics of the \[no weaning/minimal weaning\] and \[moderate weaning/severe weaning\] groups will be compared, in order to identify significant differences between these two groups, and thus enable the creation of a new score.

On an exploratory basis :

* assess the incidence of alcohol misuse and withdrawal syndrome in our population,
* assess the incidence of complications in the population with moderate to severe withdrawal (trauma, occurrence of pneumopathy, need for mechanical ventilation),
* assess length of hospital stay and in-hospital mortality.

Translated with DeepL.com (free version), during ICU stay
Other Outcome Measures: Evaluation of alcohol use disorders (AUD) ans AWS in our population, AUD definition for our study :

* AUD is mentionned in patient's medical record
* heavy alcohol use (more than 3 drinks a day for a men ant more than 2 drinks a day for a woman)
* harmful use : physical or psychological complications of alcohol use (liver cirrhosis, depression, ...), during ICU stay
Practice of Scuba Diving by as Many People as Possible: Effect of Medical Assessment to Provide a Suitable and Individualised Framework for Practice (Plongée Santé)
NCT Number: NCT06555666
Acronym: Healthy-diving
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Diving Barotrauma
Sponsor: University Hospital, Brest
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 85
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-08-16
Completion Date: 2021-11-15
Locations: CHU de Brest, Brest, 29609, France

Summary:
The study focuses on the practice of recreational scuba diving by people who have obtained medical advice for their practice in the hyperbaric and underwater medicine department of the Brest University Hospital. These people may have no health problem or on the contrary consult because they have a pathology and want a medical advice on the impact of this health problem on their practice: this is the case for about the half of these consultants.

For the latter, there are no data concerning the relevance of a medical advice response and a proposal for an appropriate technical practice framework (restriction of dive depth, duration, etc.). A relevant answer results in a practice without diving accidents or decompensation of the pathology and a decision accepted and respected by the practitioner.

This study aims to analyze the state of health of the service's consultants and medical recommendations formulated at the end of this consultation, by retrospective analysis of the consultation files, and to interview the consultants on their practice of diving, their state of health and any problems encountered since their consultation.

The purpose is to validate the hypothesis that a practice of underwater diving is possible and beneficial, with an acceptable risk in case of a risk factor or pathology using a framework of advice and restrictions of adapted and individualized practice ("sport for health").

Primary Outcome Measures: injury during diving practice since the consultation, type and number of diving injury, 1 month
Secondary Outcome Measures: evolution of health status, qualitative scale : new pathology, worse, stable or better, 1 month|evolution of the chronic pathology, qualitative scale : worse, stable, recurrence or remission, 1 month|duration of physical or sport practice per week, in hours per week, 1 month|medical recommendation respect, for each participant, comparison between the medical recommended practice framework and the actual practice declared; then percentage of participant that indicate following the medical recommendation, 1 month|number of dives carried out since the consultation, average number per year of practice, 1 month
The Effect of Video-based Multimedia Information Before Amniocentesis on Pain, Anxiety and Pregnancy Outcomes
NCT Number: NCT06555653
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Amniocentesis|Video Information
Interventions: OTHER: Video based multimedia information
Sponsor: Başakşehir Çam & Sakura City Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 160
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-01
Completion Date: 2024-06-20
Locations: Basaksehir Cam and Sakura City Hospital, İstanbul, Turkey

Summary:
The goal of this clinical trial is to assess the effect of video-based multimedia information before amniocentesis on pain, anxiety and pregnancy outcomes

Primary Outcome Measures: To assess the effect of video based information on pain levels, Subjects were assigned to receive video-based MMI or traditional written information (controls). A standard amniocentesis procedure was performed on all patients by the same perinatology physicians. After amniocentesis a visual analog scale was used to evaluate pain., 01.12.2023- 01.04.2024|To assess the effect of video based information on anxiety, Subjects were assigned to receive video-based MMI or traditional written information (controls). Anxiety levels were assessed at the first admission using the State and Trait Anxiety Inventory-State (STAI-S). After MMI and written information, STAI-S was repeated before the procedure., 01.12.2023- 01.04.2024|To assess the effect of video based information on ease of procedure, Subjects were assigned to receive video-based MMI or traditional written information (controls). A standard amniocentesis procedure was performed on all patients by the same perinatology physicians. After amniocentesis, a Likert scale was used to evaluate the ease of the procedure and patient satisfaction,, 01.12.2023- 01.04.2024|To assess the effect of video based information on pregnancy outcome, Subjects were assigned to receive video-based MMI or traditional written information (controls).The birth outcomes were compared between the two groups in terms of live birth, termination of pregnancy, and intrauterine death., 01.12.2023- 01.04.2024
Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction
NCT Number: NCT06555614
Acronym: ADM
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer Female|Breast Reconstruction
Interventions: OTHER: Acellular Dermal Matrix(ADM)
Sponsor: DOF Inc.
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-13
Completion Date: 2027-02-28
Locations: Seoul National University Hospital, Seoul, 03080, Korea, Republic of

Summary:
The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been washed with detergents in patients undergoing breast reconstruction surgery with implants due to the breast cancer.

Primary Outcome Measures: Incidence Rate(%) of Major Short-Term Complications Over 12 Weeks Post-Application of ADM, The primary endpoint is to compare and evaluate the incidence rate(%) of major short-term complications over 12 weeks following the application of acellular dermal matrix (ADM)., From the day of operation of breast reconstruction to 12weeks
Ubiquinone vs. Ubiquinol Supplementation
NCT Number: NCT06555575
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: IVF
Interventions: DRUG: Ubiquinone 200 Mg Oral Capsule|DRUG: Ubiquinol 100 MG Oral Capsule
Sponsor: Trio Fertility
Sex: FEMALE
Age: ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-01
Locations: Trio Fertility, Toronto, Ontario, M5G 2K4, Canada

Summary:
The objective of this study is to determine if ubiquinol will result in improved reproductive outcomes in older women at a reduced oral dose compared to current standard treatment with ubiquinone.

Primary Outcome Measures: Fertilized oocyte percentage, The primary outcome measure will be percentage of fertilized oocytes reaching the blastocyst stage (day 5 or 6 in culture), Through study completion, an average of 1 year.
Secondary Outcome Measures: coQ10 level, CoQ10 levels in plasma and follicular fluid, through study completion, an average of 1 year|Protein structural change, Rate of structural changes occurring in proteins of the follicular fluid and granulosa (GC) or cumulus (CC) cells representing oxidative stress, through study completion, an average of 1 year|MII oocyte percentage, Percentage of MII oocytes per total oocytes retrieved, normal 2PN fertilization rate, through study completion, an average of 1 year|Reproductive outcome, Number of day 3 embryos and ongoing pregnancy rate, through study completion, an average of 1 year
Activating the Cholinergic Anti-Inflammatory Pathway in Healthy Volunteers and People With Inflammatory Arthritis
NCT Number: NCT06555562
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Psoriatic Arthritis|Rheumatoid Arthritis|Ankylosing Spondylitis
Interventions: DEVICE: Ultrasound Stimulation|DEVICE: Non-active ultrasound stimulation
Sponsor: Surf Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-15
Completion Date: 2027-10
Locations: Tekton Research, Austin, Texas, 78745, United States|UT Health, Houston, Texas, 77030, United States

Summary:
This study is designed to investigate whether non-invasive ultrasound (US) that is optimized for stimulation and can elicit an anti-inflammatory response in people with Inflammatory Arthritis as compared to a sham intervention. The primary endpoint is the change in pro-inflammatory cytokines in blood drawn before and after US. Each participant receives 4 experimental US sessions, one of which is randomly assigned to be placebo.

Primary Outcome Measures: Tumor Necrosis Factor Alpha Concentration Differences, Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS., Baseline to 2 hours and 24 hours post therapy
Secondary Outcome Measures: Interleuken 1b Concentration Difference, Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS., Baseline to 2 hours and 24 hours post therapy|Interleuken 6 Concentration Difference, Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS., Baseline to 2 hours and 24 hours post therapy
Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain in Primary Dysmenorrhea: a Pilot Study
NCT Number: NCT06555549
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Primary Dysmenorrhea
Interventions: DRUG: DEH113|DRUG: Placebo
Sponsor: EMS
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-02

Summary:
This study aims to evaluate the preliminary efficacy and safety of DEH113 in the Treatment of Menstrual Cramps Pain Associated with Primary Dysmenorrhea.

Primary Outcome Measures: Sum of Total Pain Relief (TOTPAR) over 0-4, 0-6 and 0-8 hours post-dose, Pain relief will be evaluated considering the Sum of Total Pain Relief (TOTPAR) over 0-4, 0-6 and 0-8 hours post-dose. Pain relief will be evaluate using a Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief)., 4, 6 and 8 hours post-dose|Sum of Pain Intensity Difference (SPID) over 4, 6 and 8 hours post-dose, Sum of Pain Intensity Difference (SPID) over 4, 6 and 8 hours post-dose. The pain intensity will be assessed using a Categorical 4-point scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain)., 4, 6 and 8 hours post-dose
Secondary Outcome Measures: Pain intensity (PI) over time, PI score assessed 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose|Use of rescue medication, Proportion of participants who used rescue medication in the first 8 hours after the first drug intake and time elapsed between the last drug intake and the first administration of rescue medication., 8 hours post-dose|Patients' Global Impression of Change (PGIC), Patients' Global Impression of Change (PGIC) will be assessed after 8 hours post-dose or immediately before the intake of rescue medication, 8 hours post-dose
e-Health Care Method for Patients With Osteogenesis Imperfecta (Tele OI)
NCT Number: NCT06555536
Acronym: Tele OI
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteogenesis Imperfecta
Interventions: OTHER: Tele OI
Sponsor: Paulo Humberto Mem Martendal Vallandro Costa
Sex: ALL
Age: CHILD, ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-10-20
Completion Date: 2023-10-20
Locations: Santa Casa de São Paulo, São Paulo, Sao Paulo, 01221-020, Brazil

Summary:
This work seeks to formalize the association between the use of technology and the effective treatment of patients with Osteogenesis Imperfecta, which has not yet been explored in the literature; and aims to prove functional improvement in patients, using the MIF scale (Functional Independence Measure) and telemedicine care in addition to telephysiotherapy; to reduce the cost of treatment, allowing the patient to be treated without leaving their home and bringing greater effectiveness to the follow-up of these patients.

Primary Outcome Measures: Change Functional Independence Measure (FIM) in OI patients using e-Health, Demonstrate functional improvement of patients, using the FIM scale (Functional Independence Measure) before and after 1 year of intervention using telemedicine care in addition to telephysiotherapy remotely. This scale (FIM) ranges from 7 (minimum and worse outcome) to 126 (maximum and better outcome) and includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition. The tool (FIM) is used to assess a patient's level of disability as well as a change in patient status in response to rehabilitation or medical intervention., 1 year
Trigger Point Injection in Patients With Myofascial Pain Syndrome
NCT Number: NCT06555523
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Injection Site|Fibromyalgia
Interventions: OTHER: Ultrasound guided injection|OTHER: Blinded injection
Sponsor: Firat University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2024-09-20
Locations: Songul, Elazığ, 23100, Turkey

Summary:
This study aims to compare the effectiveness of blinded versus ultrasound-guided trigger point injections into the trapezius muscle in patients with FMS. Seventy-five patients with FMS will participate in this study. They will be randomly assigned to one of two groups: one group received ultrasound-guided trigger point injections, while the other group received blinded trigger point injections. Both groups will follow the same home exercise regimen, which included stretching and posture exercises targeting the trapezius and pectoral muscles. The effectiveness of the treatments was evaluated one month post-treatment. The assessment tools will include the Fibromyalgia Impact Questionnaire (FIQ) for function, the Visual Analog Scale (VAS) for pain, the Beck Anxiety Inventory (Beck-A) for anxiety, and the Neck Disability Questionnaire (NDQ) for neck disability.

Primary Outcome Measures: Pain assessment, The pain levels of the patients in the last week will be questioned using a 0-10 cm long Visual Analog Scale (VAS). "0" indicated that the patient have no pain and "10" indicated that the patient's pain is unbearably severe, 1 minute
Secondary Outcome Measures: Neck disability assessment, Neck Disability Questionnaire will be used. It consists of 10 questions questioning the effect of neck pain on pain sensitivity, personal care, weight lifting, reading, headaches, concentration, work/study, driving, sleep and social activities., 2 minutes|Functional assessment, Fibromyalgia Impact Questionnaire will be used. The FIQ is a 10-item scale that evaluates the health status and physical function of patients with fibromyalgia syndrome., 2 minutes
Preoperative Edema is a Significant Risk Factor for Post-hepatectomy Complications
NCT Number: NCT06555510
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Patients Who Underwent Hepatectomy for Liver Neoplasms
Interventions: OTHER: InBody
Sponsor: Kochi University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 414
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2023-12-31
Locations: Takehiro Okabayashi, Kochi, 781-8555, Japan

Summary:
Aims: The relationship between bioelectrical impedance analysis (BIA) results and post-hepatectomy complications is unknown. This study aimed to identify the risk factors for post-hepatectomy complications from the BIA results.

Methods: This prospective, observational cohort study reviewed the data of patients who underwent hepatectomy between March 2018 and December 2022. The patients were matched using the following propensity score covariates: biliary enteric anastomosis and major hepatectomy. Risk factors for postoperative complications were investigated in a matched cohort.

Primary Outcome Measures: incidence of post-hepatectomy complications, through study completion, 1year, incidence of post-hepatectomy complications
Topical 1% Methotrexate Gel Versus Clobetasol Propionate in Patients With Psoriasis
NCT Number: NCT06555497
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Pilot Study|Psoriasis
Interventions: DRUG: topical 1% methotrexate gel|DRUG: clobetasol propionate 0.05% ointment
Sponsor: Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2022-01-01
Completion Date: 2023-12-31
Locations: Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium, Caloocan, Metro Manila, 1427, Philippines

Summary:
A pilot study on the formulation of topical methotrexate was conducted. Patients after baseline evaluation were randomly placed into either topical 1% methotrexate gel or clobetasol propionate 0.05% ointment which was applied for 6 weeks. PASI score was assessed at two-week intervals for a total of eight weeks. Blood chemistry parameters, whole abdomen ultrasound, and adverse drug reactions while on treatment and after eight weeks were monitored as secondary outcome measures.

Primary Outcome Measures: Change in Psoriasis Area and Severity Index (PASI) score computed, Psoriasis Area and Severity Index scores range from 0 to 72. In general, the higher the PASI score, the more severe is the disease, 8 weeks
Secondary Outcome Measures: Change in baseline laboratory results, blood urea nitrogen (BUN), 8 weeks|Change in baseline laboratory results, creatinine, 8 weeks|Change in baseline laboratory results, alanine aminotransferase (ALT), 8 weeks|Change in baseline laboratory results, aspartate aminotransferase (AST), 8 weeks|Change in baseline laboratory results, whole abdomen ultrasound, 8 weeks
Acute Effects of Supplemental Oxygen on Memory Testing in Healthy Adult Volunteers
NCT Number: NCT06555484
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cognition
Interventions: DEVICE: Cross Over Assignment Supplemental Oxygen and Supplemental Air
Sponsor: Inogen Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-28
Completion Date: 2024-12
Locations: Two Liberty Place, Philadelphia, Pennsylvania, 19102, United States

Summary:
Forty healthy adults (i.e., not recruited with respect to any particular diagnosis) are each alternately provided with supplemental oxygen and air via nasal cannula at about 6 Liters per Minute (LPM), while completing memory tests.

Primary Outcome Measures: 2 back Memory test performance, # correct on 2-back test, At baseline and 5 mins post-intervention exposure|Memory test performance, New Medical Icons Spatial Test, At baseline and 5 mins post-intervention exposure
A Single-arm, Phase II Exploratory Study of Sintilimab in Combination With Chemoradiotherapy in Elderly Patients With Locally Advanced Gastric Cancer
NCT Number: NCT06555471
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Gastric Cancer
Interventions: DRUG: Sintilimab|DRUG: S-1|DRUG: Capecitabine|RADIATION: Extraperitoneal radiation therapy
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-06
Completion Date: 2027-12-31
Locations: Jiangsu Province Hospital, Nanjing, Jiangsu, 210029, China

Summary:
This trial is a prospective, single-arm, single-centre, phase II clinical study to explore the efficacy and safety of sintilimab in combination with chemoradiation in subjects over 75 years of age with advanced gastric cancer.

Participants will:

Take sintilimab (200mg iv q3w d1) combined with chemoradiation. The application of chemotherapy based on investigator's assessment, and if so, S-1 (po d1-d14，q3w； according to body surface area ：\<1.5m\^2 40mg/time；1.5\~1.8m\^2 50mg/time；\>1.8m2 60mg/time) or capecitabine （1000mg/m2 Bid po d1-14，q3w，Reduce or discontinue depending on the condition of the subject.); Radiotherapy：once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy. Radiation therapy starts from the first cycle of Sintilimab Injection combined with chemotherapy.

Subjects undergo an initial assessment of imaging, physical status, quality of life, and relevant laboratory tests after completion of 3 cycles of sintilimab combination chemotherapy, followed by assessments every 2 months, and after 3 full assessments, assessments every 3 months are initiated.

Primary Outcome Measures: Objective response rate (ORR), Proportion of participants in complete and partial remission, 24 months|Disease control rate (DCR), the proportion of patients who achieve tumor relief (PR+CR) and stable disease (SD), 24 months|Duration of response (DoR), the time from onset of response to progression or death due to any reason, whichever occurs earlier, 24 months|Progression free survival (PFS), the time from initiation of treatment to the occurrence of disease progression or death, whichever occurs earlier., 24 months
Secondary Outcome Measures: Overall survival, the time from initiation of treatment to death caused by any reasons., 24 months|Adverse reactions, According to the adverse event data of CTCAE version 5.0, 24 months
The Effect of Sedation on Rebound Pain in Knee Arthroplasty
NCT Number: NCT06555458
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Total Knee Arthroplasty|Sedation
Sponsor: Ankara City Hospital Bilkent
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2023-11-19
Completion Date: 2024-07-25

Summary:
Dexmedetomidine is often used for sedation procedures. It has also been shown to have a pain-protective effect. Researchers predicted that using dexmedetomidine for sedation in total knee arthroplasties performed under spinal anesthesia would reduce the frequency of rebound pain and pain scores.

Primary Outcome Measures: Rebound pain VAS scores and incidence of rebound pain, Rebound pain-defined as transient acute postoperative pain within 12-24hrs that ensues following resolution of sensory blocked., 48 hours after surgery