pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Caries Inhibitory Effect of Nano Silver and Tri Calcium Phosphate Varnishes Among Visually Impaired Children
NCT Number: NCT06576960
Acronym: Prevention
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Caries
Interventions: DRUG: Nano silver fluoride varnish and tri calcium phosphate varnish
Sponsor: Hadeer Mohammed Abd El wahab
Collaborators: Tanta University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2022-10-11
Completion Date: 2023-04-13
Locations: Faculty of dentistry, Tanta, Tanta City, 31527, Egypt

Summary:
Assessment of pH,streptococcus mutants count, lactobacillus count and immunoglobulin A among visually impaired children after nano silver varnish application it tri calcium phosphate phosphate varnish application

Primary Outcome Measures: Salivary PH, Salivary power of hydrogen at baseline, one month, 3months and six months after intervention, 6 months|Salivary streptococcus mutants count, Count of bacteria at baseline, one day, 3months and six months after intervention, 6months|Lactobacillus count, Count of bacteria at baseline, one day, 3months and six months after intervention, 6 months|Immunoglobulin A, Level of immunoglobulin A at saliva at baseline, one day, 3months and 6 months after intervention, 6months
Early TIPS in Patients With Liver Cirrhosis and Ascites
NCT Number: NCT06576934
Acronym: eTIPS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Liver Cirrhosis|Ascites Hepatic|Portal Hypertension
Interventions: PROCEDURE: Transjugular intrahepatic portosystemic shunt (TIPS)
Sponsor: University Hospital Freiburg
Collaborators: Jena University Hospital|Johannes Gutenberg University Mainz|University Hospital Muenster|University Hospital, Bonn|University Hospital Munich (LMU)|Hannover Medical School|University of Leipzig|University Hospital, Aachen|University Hospital Lübeck
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 134
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2029-02-15

Summary:
The aim of this clinical trial is to compare the safety and efficacy of transjugular intrahepatic portosystemic shunt (TIPS) implantation with standard treatment (diuretic medications, and if necessary, paracenteses) in patients with liver cirrhosis and development of ascites as the first decompensating event.

By creating a shunt between the liver vein and the portal vein, blood is diverted from the portal vein directly into the hepatic vein, which results in a reduction of pressure in the portal vein so that development of ascites is reduced.

Primary Outcome Measures: Transplantation-free survival (TFS), The primary objective of this study is to assess a survival benefit in patients with early allocation to TIPS implantation in comparison to patients with standard medical treatment (SMT)., Through study completion, an average of 12 months
Secondary Outcome Measures: Time to ascites with need for paracenteses, Assessment of the duration until the next paracentesis after randomisation occurs to compare the efficacy of TIPS implantation compared to standard medical treatment., Through study completion, an average of 12 months|Assessment of quality of life, Quality of life assessed with the SF-36 and CLDQ (chronic liver disease questionnaire) before TIPS implantation/study inclusion, 6 and 12 months after randomisation., Through study completion, an average of 1 year: at study inclusion, at 6 and 12 months after randomisation|Rate of TIPS implantation in the standard medical treatment group, Need for TIPS implantation (recurrent ascites or variceal bleeding) in the standard medical treatment group., Through study completion, an average of 12 months|Rate of TIPS dysfunction, Development of TIPS dysfunction in the TIPS group, Through study completion, an average of 12 months
Nutrition Practice in Critically Ill Adults - an Observational Study
NCT Number: NCT06576895
Acronym: NUTRIENT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Critical Illness
Interventions: OTHER: No intervention
Sponsor: Australian and New Zealand Intensive Care Research Centre
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-26
Completion Date: 2027-12-31
Locations: Monash University, Melbourne, Victoria, 3004, Australia

Summary:
To determine the role of nutrition in recovery from critical illness, current practice must first be understood. However, no benchmarking process currently exists for nutrition practice during critical illness, from ICU admission to hospital discharge. This vital gap requires addressing.

The aim of this study is to inform and re-design models of nutrition care and generate research priorities for the future by obtaining data on nutrition provision and practice and that of consumer preference for nutrition care.

Primary Outcome Measures: Nutritional outcomes, Protein and energy prescription and provision, Up to day 28 of hospitalization|Nutritional outcomes, Use of Enteral Nutrition (EN), Up to day 28 of hospitalization|Nutritional outcomes, Parenteral Nutrition (PN), Up to day 28 of hospitalization|Nutritional outcomes, Oral intake and oral nutrition supplements, Up to day 28 of hospitalization|Nutrition service delivery in the ICU and ward setting, Levels of staffing available and service provision for nutrition care in the ICU and on the ward, Up to day 28 of hospitalization|Descriptions of nutrition prescription, delivery and service variability across ANZ, Comparison of nutrition care between participating hospitals, Up to day 28 of hospitalization|Patient-centred outcomes, Duration of hospital stay, Up to day 28 of hospitalization|Patient-centred outcomes, Mortality, Up to day 28 of hospitalization|Patient-centred outcomes, Discharge destination, Up to day 28 of hospitalization
7 Days Vs. 14 Days of Vonoprazan-based Triple Therapy for H. Pylori Eradication
NCT Number: NCT06576882
Acronym: VOTE-HP
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Helicobacter Pylori Infection|Gastritis|Vonoprazan|Adolescents
Sponsor: Alexandria University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 326
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2024-11-01

Summary:
The study aims to test the efficacy of 7 days vs. 14 days of Vonoprazan-triple therapy in the eradication of Helicobacter Pylori infection in adolescents and young children.

Primary Outcome Measures: H. Pylori eradication rate, Number of participants who will achieve a negative H. pylori antigen detection test after the end of therapy., 4 weeks after completion of treatment
Secondary Outcome Measures: Adverse events during treatment., Type and frequency of treatment-related adverse effects in both arms, From first dose of treatment until 7 or 14 days of treatment regimen assigned.
Timing of Tourniquet Release, A Prospective Randomized Trial
NCT Number: NCT06576869
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Injury
Interventions: PROCEDURE: Upper extremity orthopedic surgeries.
Sponsor: Orlando Health, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 214
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2022-06-02
Completion Date: 2023-05-09
Locations: Orlando Health Jewett Orthopedic Institute, Orlando, Florida, 32806, United States

Summary:
This will be a prospective randomized clinical trial comparing clinical outcome measures in patients who undergo elective upper extremity surgery when tourniquet is dropped prior to closure as opposed to when tourniquet is dropped after closure. The study will compare objective data obtained intraoperatively as well as standard clinical outcome measures such as pain scores at routine follow up.

Primary Outcome Measures: Visual analog pain scale, Visual number scale to rate pain., 2 weeks, 10 weeks and 6 months.|Quick DASH form, Assessment of symptoms and ability to perform certain activities., 2 weeks, 10 weeks, 6 months.|Hematoma assessment, Performed by MD, assessment of the presence of a hematoma and if present, it is measured., 2 weeks, 10 weeks, 6 months.|Satisfaction with surgery, Patient to rate their satisfaction with their surgery and to indicate whether or not they would recommend the surgery to family/friends with the same condition., 2 weeks, 10 weeks, 6 months.
Salivary Markers in Periodontal Disorders
NCT Number: NCT06576856
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Periodontal Disease, Staging, Salivary Markers, Diagnosis, Disease Onset
Interventions: OTHER: This is an observational study, no intervention is anticipated.
Sponsor: Midwestern University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-11-06
Completion Date: 2024-10-10
Locations: Midwestern Univerity, Downers Grove, Illinois, 60515, United States

Summary:
The swelling of the gum, or periodontitis, is the leading cause for tooth loss, and currently affects up to 65 million adults only in the United States. One of the reasons for the widespread of periodontitis is because currently there are no definitive methods to detect the onset of gum disease. This lack of foresight impedes medical professionals to enact any preventive measures before the disease already manifests itself.

We wish to expand our understanding towards the development of periodontitis by studying the expression and activity of salivary markers that have been associated with advanced stages of the disease, wherein the supporting tissues of tooth (periodontium) are already irreversibly destroyed. We hypothesize that a progressive shift in the expression of such salivary markers can indicate a change or evolution of periodontitis staging.

In specific, we seek to establish a quantifiable relationship among levels of salivary proteases called MMPs, level of metal ions in different stages varying from health to periodontitis. The overall goal of this proposal is to enhance the predictability of periodontitis, as we are currently unable to diagnose the disease until the manifestation of its clinical signs and symptoms.

Primary Outcome Measures: Matrix Metalloproteases (MMPs) Salivary Levels, Levels of MMPs assessed by different immuno-assays., October 2024|Levels of Metal Ions, Levels of metal ions assessed by Inductively Coupled Plasma Dynamic Reaction Cell Mass Spectrometer, October 2024
Secondary Outcome Measures: Potential Correlation of MMPs, Metal Ions and Peridontitis Staging, The relationship between salivary MMPs and identified metal ions for all cohorts (periodontally healthy and periodontitis-affected individuals) will be determined by multiple regression analyses., October 2024
INDV-6001 Multiple-Dose Pharmacokinetic Study
NCT Number: NCT06576843
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Moderate to Severe Opioid Use Disorder
Sponsor: Indivior Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 122
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-10

Summary:
The current study will evaluate the pharmacokinetics, safety, and tolerability of INDV-6001 following multiple doses in participants with opioid use disorder in order to select optimum dosing regimens for future studies. Prior to receiving INDV-6001, participants will be stabilised on 12-16 mg of transmucosal BUP (SUBOXONE®) or will transition from a monthly maintenance dose of subcutaneous extended-release BUP (SUBLOCADE®). This study will also evaluate the use of alternative injection sites (thigh, back of upper arm), which may be desirable in this patient population for the anticipated extended durations of treatment.

Primary Outcome Measures: Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 injection, AUCtau for Cohorts 1-6, Up to 260 days|Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 injection, Cmax for Cohorts 1-6, Up to 260 days|Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 injection, Tmax for Cohorts 1-6, Up to 260 days|Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 injection, Cmin for Cohorts 1-6, Up to 260 days|Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 injection, Ctrough for Cohorts 1-6, Up to 260 days|Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 injection, Cavg for Cohorts 1-6, Up to 260 days|Steady-state ratio of peak to trough plasma concentrations over a dosing interval) (% fluctuation) of buprenorphine following INDV-6001 injection, % fluctuation for Cohorts 1-6, Up to 260 days
Secondary Outcome Measures: Assessment of the safety and tolerability of INDV-6001 injection, Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs leading to discontinuation, fatal TEAEs, and AEs of special interest (AESIs) for Cohorts 1-6, Up to 260 days
Intraoperative Methadone for Pediatric Tonsillectomy Pain
NCT Number: NCT06576830
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Pain, Postoperative|Tonsillar Hypertrophy|Tonsillitis|Pediatric Sleep Apnea|Sleep-Disordered Breathing
Interventions: DRUG: Methadone|DRUG: Fentanyl/Hydromorphone
Sponsor: Duke University
Collaborators: National Institutes of Health (NIH)
Sex: ALL
Age: CHILD
Enrollment: 440
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2029-09-30
Locations: Duke University Medical Center, Durham, North Carolina, 27710, United States

Summary:
The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following tonsillectomy surgery in children and adolescents.

Primary Outcome Measures: Number of participants who required rescue opioid administration in the PACU (post-anesthesia care unit), Binary (yes/no) need for opioid in the PACU, Up to 6 hours post surgery
Secondary Outcome Measures: Total amount of opioid medication administered, Postoperative opioid use expressed in morphine milligram equivalents per kilogram, Up to 7 days post surgery|Opioid administration in the PACU (post-anesthesia care unit), Postoperative opioid use in the recovery room expressed in morphine milligram equivalents per kilogram, Up to 6 hours post surgery|Opioid administration post PACU (post-anesthesia care unit), Postoperative opioid use after PACU discharge expressed in morphine milligram equivalents per kilogram, Up to 7 days post surgery|Evaluation of participant's pain as measured by Numeric Pain Rating Scale, Numeric Pain Rating Scale, 0-10. 0 no pain, 10 worst possible pain, Up to 7 days post surgery|Number of participants with adverse event in the PACU (post-anesthesia care unit), Adverse events will only include those that are determined to be related to the study drugs., Up to 6 hours post surgery
High-intensity Interval Circuit Training in People With Parkinson Disease
NCT Number: NCT06576817
Acronym: PD HIIT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease
Interventions: OTHER: High intensity circuit exercise class
Sponsor: Pacific Northwest University of Health Sciences
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-02-15
Completion Date: 2026-08
Locations: Pacific Northwest University of Health Sciences, Yakima, Washington, 98901, United States

Summary:
The goal of the study is to compare different types of high intensity circuit exercises over an 8-class training series in people with Parkinson disease. The main question it aims to answer is:

-Does including arm and hand exercises with leg exercises improve reaction time, balance, functional measures, gait speed and quality of life? This group will be compared to a group that only does leg exercises. Participants will be asked to participate in 8 high intensity circuit exercise classes.

Primary Outcome Measures: Trail making Test Parts A and B (timed, higher scores mean worse outcome), Cognitive and fine motor skills, 8-10 weeks|Activity-specific Balance Confidence Scale (0-100%, higher scores mean better outcome), Balance confidence self-report, 8-10 weeks|Timed Up and Go, Balance and function, 8-10 weeks|10 meter Walk Test, Gait Speed, 8-10 weeks|6 minute walk test, endurance, 8-10 weeks|9-hole peg test (timed, higher scores mean worse outcome), fine motor, 8-10 weeks|Parkinson's Disease Questionnaire - Short Form (8) (Score 0-32, higher scores mean worse outcome), Quality of Life, 8-10 weeks
Eccentric Cycling Exercise on Mitochondrial Function of Lymphocyte
NCT Number: NCT06576804
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Eccentric Exercise Training
Interventions: BEHAVIORAL: Eccentric cycling training|BEHAVIORAL: Concentric cycling training
Sponsor: Chang Gung Memorial Hospital
Sex: MALE
Age: ADULT
Enrollment: 33
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-01-01
Completion Date: 2022-08-01
Locations: Chang Gung University, Taoyuan, 333, Taiwan

Summary:
Eccentric cycling exercise (ECE) features lower metabolic demand and higher improvement of muscle strength compared to traditional concentric cycling exercise (CCE). Mitochondria can regulate energy metabolism and adaptive immune quality in T lymphocytes. However, the effects of ECE on mitochondrial functions in T-lymphocytes have not yet been established.

Method: A total of 33 healthy sedentary males were randomized and divided into ECE (n=11), CCE (n=11), and control groups (n=11). These subjects progressively performed CCE or ECE from 60% to 80% maximal workload on a bicycle ergometer for 40 min/day, 5 days/week for 6 weeks. A graded exercise testing and an isokinetic strength test were conducted to evaluate cardiopulmonary fitness and muscle strength, respectively. Phenotypes and mitochondrial respiratory capacity in T lymphocyte were analyzed using flow cytometry and high-resolution respirometer, respectively.

Primary Outcome Measures: Mitochondrial function of lymphocyte, Evaluate bioenergetic health index (BHI) of mitochondria in lymphocyte by using a high resolution respirometer., 12 weeks
Secondary Outcome Measures: Cardiopulmonary fitness, The graded exercise test (GXT) on a bicycle ergometer was performed. The GXT comprised 2 min of unloaded pedaling followed by a continuous increase in the work rate of 30 watt per 3-minute until exhaustion (i.e., progressive exercise to maximal O2 consumption), 12 weeks
Urethral Rotation Angles and Foot Pronation Mechanical Changes in Postmenopausal Women
NCT Number: NCT06576791
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Stress Urinary Incontinence
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-09-04
Completion Date: 2022-01-01
Locations: Rovan Elbesh, Giza, 12651, Egypt

Summary:
Stress urinary incontinence (SUI) occur secondary to increased intra abdominal pressure, that directed the researchers to study the mechanical changes in urethra and bladder that associated with it. However, these urethral mechanical changes may be related to other mechanical changes in the body.

Primary Outcome Measures: 1- Measuring urethral rotation angles by transperineally ultrasound TPUS, TPUS was performed using a Toshiba US machine with a 3.5 MHz electronic micro convex array probe. The bladder was comfortably partially filled with urine (about 150 mL)., 3 months|2- foot pronation, drop test, 3 months
Secondary Outcome Measures: weight, kg, 3 months
The Effect of Fiber-Reinforced Composites on Quality of Life and Bone Height in Maxillary Implant Arches
NCT Number: NCT06576778
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Edentulous Alveolar Ridge
Interventions: PROCEDURE: PROVSIONALIZATION
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 8
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-11

Summary:
The aim of this study is assessing the effect of provisionalization with a glass fiber composite framework on patients' quality of life and bone height changes before the insertion of a definitive PEKKTON framework of screw-retained maxillary implant-supported prosthesis at a one-year follow-up period.

Primary Outcome Measures: Oral health related to quality of life, A translated form from a validated questionnaire will be used to address the Egyptian population; all patients have to answer the same questionnaire. Each answer will be given a score from 0 to 4 where the lesser the score the better the quality of life, data will be collected, and privacy will be ensured., 1 year
Secondary Outcome Measures: Bone height changes assessments, Digital periapical radiographs (Digora System) at the time of implant loading, three months, six-months, one year post-operatively will be done utilizing periapical radiographs following the standardized long cone paralleling technique and evaluated. For further standardization, the same x-ray machine will be used at 8 milliamperes and 70 kilovolts for 0.6 seconds with a focal film distance of 35 cm.

Marginal bone height changes around the implants will be evaluated using the measurement software system supplied with the Digora radiographs system., 1 year
Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD0780
NCT Number: NCT06576765
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hepatic Impairment
Interventions: DRUG: AZD0780
Sponsor: AstraZeneca
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-08
Completion Date: 2024-11-27
Locations: Research Site, Hialeah, Florida, 33014, United States|Research Site, Orlando, Florida, 32809, United States|Research Site, San Antonio, Texas, 78215, United States

Summary:
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of AZD0780 with moderate and possibly mild hepatic impairment in comparison to a matched healthy control group.

Primary Outcome Measures: AUClast, Area under plasma concentration-time curve from time zero to the last measurable concentration, Day 1 to Day 11|AUCinf, Area under plasma concentration-time curve from zero to infinity, Day 1 to Day 11|Cmax, Maximum observed plasma concentration, Day 1 to Day 11
Secondary Outcome Measures: Number of participants with adverse events (AEs), To assess the safety and tolerability of a single oral dose of AZD0780 in participants with moderate and mild (optional) hepatic impairment and those with normal hepatic function, Day 1 to Day 11|Number of participants with abnormal Vital signs, abnormal ECGs, and abnormal physical examination findings, To assess the safety and tolerability of a single oral dose of AZD0780 in participants with moderate and mild (optional) hepatic impairment and those with normal hepatic function, Day 1 to Day 11|Number of participants with abnormal laboratory tests results, To assess the safety and tolerability of a single oral dose of AZD0780 in participants with moderate and mild (optional) hepatic impairment and those with normal hepatic function, Day 1 to Day 11|Tmax, Time to reach maximum observed plasma concentration, Day 1 to Day 11|PK parameters (t1/2λz), Terminal elimination half-life, Day 1 to Day 11|PK parameters (CL/F), Apparent plasma clearance, Day 1 to Day 11|PK parameters (Vz/F), Apparent volume of distribution during the terminal phase, Day 1 to Day 11|PK parameters (AUC0-96), Area under the plasma concentration-time curve from time zero to 96 hours, Day 1 to Day 5|PK parameters (CLR), Renal clearance of drug from plasma, Day 1 to Day 11|PK parameters (Ae), Amount excreted in urine, Day 1 to Day 11|PK parameters (fe), Fraction of dose excreted in urine, Day 1 to Day 11
Other Outcome Measures: Multi-omics Analysis, To explore how multi-omics variations, including genetics, may affect clinical parameters, risk, and prognosis of diseases and the response to medications. Exploratory endpoints are related to the data generated from multi-omics analysis, including genetics, which may be part or all of the participant's genetic information., Day 1
B Vitamin Supplementation to Chiropractic Management of Chronic LBP: Pilot Clinical Trial (VCLBP)
NCT Number: NCT06576739
Acronym: VCLBP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Recurrent Low Back Pain
Interventions: PROCEDURE: Spinal Manipulation
Sponsor: University of Western States
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11-15
Completion Date: 2025-10-01
Locations: University of Western States, Portland, Oregon, 97230, United States

Summary:
The purpose of this investigation is to assess the effects of a combination of B vitamins (B6 \[pyridoxine\],, B9 \[folate\], and B12 \[cyanocobalamin\] upon the efficacy and duration of spinal manipulation in its treatment of chronic low back pain. Outcome measures over a 12-week period include disability (the Oswestry Disability Index), pain (the Quadruple Visual Analog Scale), and quality of life (Short Form 36 Scale). A total of 60 patients are to be recruited by a single practicing chiropractor who will randomize consenting patients into two groups of 30, one of which will take 3 tablets of the Standard Process folic acid B12 and one tablet of Standard Process B6 Niacinamide between 8:30 - 10:30 am each day and the other 4 tablets of placebo fabricated by Standard Process. Both groups will receive treatments from their chiropractor in the manner they would normally experience as patients. Outcomes will be measured 2 weeks prior to commencing the protocol (baseline), at baseline, immediately upon commencing the protocol, and at one, 2, and 3 months following.. Hypotheses are as follows:

HO: Differences in the Oswestry Disability Index (primary outcome) between the experimental and placebo groups will not be clinically and statistically significant at 3 months of treatment.

HA: Differences in the Oswestry Disability Index (primary outcome) between the experimental and placebo groups will be clinically and statistically significant at 3 months of treatment.

Secondary outcomes will be evaluated in the same manner.

Primary Outcome Measures: Oswestry Disability Index, Validated paper questionnaire, 2 weeks prior to basel;ne, at baseline; time 0 immediately after first chiropractic treatment; 30 days, 60 days, and 90 days immediately after chiropractic treatment
Secondary Outcome Measures: Quadruple Visual Analog Scale, Validated paper questionnaire, 2 weeks prior to baseline; at baseline; time 0 immediately after first chiropractic treatment; 30 days, 60 days, amnd 90 days after chiropractic treatment|Short Form (SF-36) Health Survey, Validated paper questionnaire, 2 weeks prior to baseline; at baseline; time 0 immediately after first chiropractic treatment; 30 days, 60 days, and 90 days after chiropractic treatment
Combined Genome and RNA Sequencing for Genetic Diagnosis of Parkinsonism
NCT Number: NCT06576713
Acronym: ParkOmic
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson's Disease
Interventions: DIAGNOSTIC_TEST: Combiner whole genome and RNA sequencing
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 14
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-12-01
Completion Date: 2027-01-01

Summary:
Despite the increasing availability and advances in the analysis of high-throughput DNA sequencing, the majority of patients with early-onset or familial parkinsonism remain without a molecular diagnosis.

Studying the genetic forms of parkinsonian syndromes presents numerous clinical, scientific and therapeutic interests. In clinical practice, identifying the genetic cause in a patient allow to provide genetic counseling and estimate the risk of recurrence in their relatives. Establishing correlations between the genotype and phenotype of patients with genetically determined parkinsonism, allow to better anticipate the evolution of the disease, or even to highlight biomarkers during the presymptomatic phases. Finally, the proteins encoded by the genes implicated in familial parkinsonism represent potential therapeutic targets likely to be modulated by neuroprotective pharmacological agents, even in sporadic Parkinson's disease.

In this work,investigators aimed at elucidating the missing genetic causes of parkinsonism through the application of combined RNA and whole genome sequencing.

Primary Outcome Measures: Genetic diagnosis rate, To estimate the rate of genetic diagnoses obtained by genome sequencing coupled with RNA sequencing within a cohort of patients presenting with early onset or familial parkinsonian syndromes without molecular diagnosis., 18 months
Secondary Outcome Measures: Genes implicated, Estimate the proportion of patients carrying pathogenic or probably pathogenic variants in each of the genes identified in this work, 18 months|Contribution of RNA sequencing, Estimate the proportion of pathogenic or probably pathogenic variants detected secondarily thanks to the contribution of RNA sequencing and not identified by analysis of the genome taken in isolation., 18 months|Genotype and Phenotype correlation, Estimate the proportion of patients presenting specific clinical, biological and imaging characteristics for each identified genetic cause (genotype/phenotype correlation)., 18 months|New genetic causes, Describe new molecular mechanisms of parkinsonian syndromes., 18 months|Tolerance, Estimate the proportion of patients experiencing an adverse event related to the procedure., 18 months|New associated genes, Describe new genes associated with parkinsonian syndromes., 18 months
Effect of Procyanidins in Leaky Gut Repairing in IBD
NCT Number: NCT06576700
Acronym: EcoVitis
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ulcerative Colitis in Remission
Interventions: BIOLOGICAL: Grape Seed Extracts
Sponsor: University of Padova
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-15
Completion Date: 2026-06-12
Locations: Edoardo Vincenzo Savarino, Padua, 35128, Italy

Summary:
The goal of this clinical trial is to learn if the Grape Seed Extract Ecovitis, featuring low monomeric catechins content and a high concentration of oligo-polymeric procyanidins, could modulate the Gut Microbiota composition of Ulcerative Colitis patients during the remission phase. The main questions it aims to answer are:

Does Ecovitis improve the microbiota composition in patients with Ulcerative colitis? Is the intestinal permeability affected? What about the variation in the quality of life?

Participants will:

Take 2 capsules/day of Ecovitis for eight weeks Visit the clinic two times for checkups, serum collection, and Questionaire.

Primary Outcome Measures: ● Evaluation of the gut microbiota composition and variation (microbiota test), Collection of faecal sample for the assessment of the faecal microbiota composition ribosomal ribonucleic acid ( rRNA16S) The 16S rRNA gene is a bacterial ribosomal gene and a part of the 30S subunit which is used in the identification, characterization, and classification of various bacteria. Samples were normalized, pooled, and run on Illumina MiSeq , in order to evaluate the composition of gut microbiota in terms of bacterial diversity ( alfa and beta) and abundance and any variability associated with the treatment., 9 months
Secondary Outcome Measures: ● Evaluation of intestinal permeability (Leaky Gut-Zonulin test ), The serum zonulin test allows for the evaluation of intestinal permeability, as zonulin, a protein produced by intestinal cells, when released, causes an increase in the permeability of tight junctions., 10 months|● Evaluation of quality of life IBDQ ( test IBDQ), The validated IBDQ-32 test, consisting of 32 questions related to the quality of life of IBD patients, will be proposed., 10 months
Neurophysiology of Ankle Instability
NCT Number: NCT06576687
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ankle Injuries
Interventions: OTHER: Physical Rehabilitation
Sponsor: University of Nebraska
Sex: ALL
Age: ADULT
Enrollment: 42
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2027-12
Locations: University of Nebraska-Omaha, Biomechanics Research Building, Omaha, Nebraska, 68182, United States

Summary:
The goal of this study is to determine functional and neurophysiological differences between subgroups of chronic ankle instability (CAI) to allow for the development of evidence-based rehabilitation which may improve patient outcomes. The main questions are:1) determine the differences among CAI subgroups on performance of a traditional side-hop test and neurocognitive hop test, 2) determine the differences in neurophysiological response and motor control between chronic ankle instability subgroups during a lower limb and an ankle specific task, and 3) determine the underlying neurophysiological effects of a 4-week neurocognitively enhanced balance training protocol among CAI subgroups.

Primary Outcome Measures: Side-hop test, Amount of time it takes to hop medially and laterally across a 30-cm gap ten times. This is measured in time, greater times equals worse performance., Baseline and post-rehabilitation (six weeks total)|Choice-reaction hop test, Participants hop on a mat medially and laterally across a 30-cm gap ten times, using visual cues to direct their movement to one of two squares on each side. This is measured in time, greater times equals worse performance., Baseline and post-rehabilitation (six weeks total)|Inversion-eversion force control, Test to determine force control accuracy at 50% maximal contraction for eversion and inversion. Outcome measure is non-linear analysis Lyapunov exponent (LyE) which measures to the quality, or the natural, inherent fluctuations in movement. Greater values indicate reduced neuromuscular control., Baseline and post-rehabilitation (six weeks total)
Secondary Outcome Measures: Cumberland Ankle Instability Tool (CAIT), Cumberland Ankle Instability Tool, scored out of 30, min=0, maximum=30, higher scores are a better outcome., Baseline and post-rehabilitation (six weeks total)|Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) Scale, Foot and Ankle Ability Measure Activities of Daily Living Scale; scored as a percentage min=0%, maximum=100%, higher scores are a better outcome., Baseline and post-rehabilitation (six weeks total)|Foot and Ankle Ability Measure Sport (FAAM-Sport) Scale, Foot and Ankle Ability Measure Sport Scale; scored as a percentage min=0%, maximum=100%, higher scores are a better outcome., Baseline and post-rehabilitation (six weeks total)
Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology: Examination of Surgeon Behavior and Post-operative Outcomes
NCT Number: NCT06576661
Acronym: ELITE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Kidney Stone|Nephrolithiasis
Interventions: DEVICE: INTRARENAL PRESSURE MONITORING VISIBLE
Sponsor: University of Kansas Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-06-01
Locations: University of Kansas Medical Center, Kansas City, Kansas, 66160, United States

Summary:
The goal of this study is to evaluate the influence of real-time intrarenal pressure measurement availability on surgeons' behavior during ureteroscopy while using the ureteroscope LithoVue Elite.

Primary Outcome Measures: Scores on NOTSS tool, To compare behavior and decision making scores on NOTSS tool between surgeons who did the surgery with and without intrarenal pressure monitoring., 1 Day
Secondary Outcome Measures: Post operative pain, To compare post operative pain between surgeons who did the surgery with and without intrarenal pressure monitoring., 1 day|Infection rates, To compare post operative infection rates between surgeons who did the surgery with and without intrarenal pressure monitoring., 7 days
PERIodontal Disease, Microbiota and Miscarriage
NCT Number: NCT06576622
Acronym: PERI2M
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Miscarriage|Parodontitis
Interventions: OTHER: biological sampling
Sponsor: University Hospital, Toulouse
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-01
Completion Date: 2026-11-01

Summary:
Cross-sectional non-interventional observational pilot study recruiting women whom had repeated miscarriages (= at least 3 miscarriages).The information will be collected during a routine maintenance, complete oral clinical and radiological examination (assessment carious, periodontal, mucosal and functional), which is part of the routine assessment in the service of odontology from Toulouse University Hospital.

Saliva and subgingival plaque samples, classically carried out in routine dental surgery as part of the health check-up oral, will be used to carry out bacterial assays.

Primary Outcome Measures: average quantity of Porphyromonas gingivalis, estimate the average quantity of Porphyromonas gingivalis (Pg) in saliva patients who have had recurrent miscarriages (3 consecutive miscarriages \< 14 weeks of amenorrhea), AT INCLUSION = T0
Secondary Outcome Measures: microbiological composition, microbiological composition of the saliva in women having had repeated miscarriages :

Salivary samples by sputum (1 per patient). The patient will retain her saliva for 1 minute in the mouth and it will be collected in a sterile bottle (approximately 5 ml)., AT INCLUSION = T0|microbiological composition, microbiological composition of the subgingival plaque in women having had repeated miscarriages

Samples of subgingival plaque in the periodontal sulcus (assessed during periodontal probing) using sterile paper points (minimum 3 and maximum 10 per patient) inserted for 30 seconds into the periodontal sulcus then put in a tube sterile. The plate collection is done by capillary action on the paper tip, a very small quantity is thus taken., AT INCLUSION = T0
Effectiveness of INJEX Versus Traditional Syringe During Restoration of Primary Teeth
NCT Number: NCT06576609
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Child Behavior
Interventions: DEVICE: INJEX [ Needle less anesthesia]
Sponsor: University of Jazan
Sex: ALL
Age: CHILD
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-02-16
Completion Date: 2024-06-30
Locations: College of Dentistry, Jazan, 45142, Saudi Arabia

Summary:
The main purpose of this study is to make a comparison between pain perception levels and the behavior of patients during the restoration process in children between a needleless local anesthetic system (INJEX) and the conventional syringe technique. The main purpose of this study is to make a comparison between pain perception levels and the behavior of patients during the restoration process in children between a needleless local anesthetic system (INJEX) and the conventional syringe technique.

. The main questions it aims to answer are:

1. To evaluate pain perception for restoration of primary molars with a needle free system in a pediatric population.
2. To evaluate pain perception for restoration of Primary molars with needle syringe \[Traditional syringe system\] method in a pediatric population
3. Time required to deliver anesthesia using needle free system vs Needle syringe \[ traditional syringe system\] Participants who enrolled in the study will be anesthetized according to the respective groups i,e INJEX (needle free system) and traditional dental needle system and restoration will be done.

Primary Outcome Measures: FLACC, FLACC gives an observational pain scale during the delivery of anesthesia, during and immediately after the delivery of anesthesia]|Wong Baker Scale, Used to self-assess and effectively communicate the severity of pain they may be experiencing, During and immediately after the delivery of anesthesia
Secondary Outcome Measures: FBRS, Frankel behaviour rating scale, before the delivery of anesthesia, during the delivery of anesthesia and after the delivery of anesthesia|Pulse rate, comfort and patient acceptance during treatment, Before the delivery of anesthesia, immediately after the delivery of anesthesia, and 1 minute after the delivery of anesthesia|Time of local anesthesia administration, comfort and patient acceptance during treatment, during the delivery of anesthesia
Apnoeic Oxygenation During Pediatric Tracheal Intubation: a Randomized Controlled, Single-blinded Clinical Trial
NCT Number: NCT06576596
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anesthesia|Airway Complication of Anesthesia|Anesthesia; Adverse Effect
Interventions: OTHER: apnoeic Oxygenation
Sponsor: University Hospital Heidelberg
Sex: ALL
Age: CHILD
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-02
Completion Date: 2025-08-31
Locations: Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University,, Heidelberg, Baden-Wuerttemberg, 69120, Germany

Summary:
The goal of this randomized, controlled, single-blinded clinical trial is to evaluate the effectiveness of apnoeic Oxygenation in pediatric anesthesia. The main question it aims to answer are:

primary outcome measure: Can the use of apnoeic oxygenation reduce the rate of oxygen saturation drops?

secondary outcome measure:

* Is there a difference in first-pass-success between the groups?
* Differences in the time until the drop in saturation between the two groups.
* What is the incidence of anaesthesia-related complications (e.g. aspiration, -hypoxia, circulatory failure, etc.)?

The study participants are randomised 1:1 into two groups. Either in the control group without the use of apnoeic oxygenation or in the intervention group with the use of apnoeic oxygenation.

Primary Outcome Measures: Can the use of apnoeic oxygenation reduce the rate of falls in oxygen saturation?, The main aim of anaesthesia is to avoid a drop in saturation during induction of anaesthesia. This time until the drop in oxygen saturation is described as the so-called 'safe apnoea time'., The time frame refers only to the induction of anaesthesia and subsequent airway management.
Secondary Outcome Measures: Is there a difference in 'first-pass-success' between the groups?, Differences in the 'first-pass-succes' of intubation between the two groups are highlighted here., The time frame refers only to the induction of anaesthesia and subsequent airway management.|Differences in the time to saturation drop between the two groups, Here, the time until the oxygen saturation drops between the two groups is measured in seconds and compared., The time frame refers only to the induction of anaesthesia and subsequent airway management.|What is the incidence of anaesthesia-related complications (e.g. aspiration, hypoxia, circulatory failure, etc.)?, Complications during anaesthesia induction and airway management are recorded and compared between the groups., The time frame refers only to the induction of anaesthesia and subsequent airway management.
Evaluation and Modification of Surgeon Ergonomics in the Operation Room Using Artificial Intelligence Analytics
NCT Number: NCT06576570
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Work Related Upper Limb Disorder|Musculoskeletal Pain
Interventions: BEHAVIORAL: Education presentation of surgical ergonomics|BEHAVIORAL: Summary of Ergonomic Measurement System
Sponsor: University of Florida
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-15
Completion Date: 2026-12-31
Locations: UF Health at Shands Hospital, Gainesville, Florida, 32610, United States|UF Health Shands Hospital at the University of Florida, Gainesville, Florida, 32610, United States

Summary:
The study is working to identify actions of surgeons in the operating room that can contribute to work-related musculoskeletal disorders. This includes poor positioning and time spent in poor positioning while working in the operating room. The study is also looking to determine if fatigue plays a role in work-related musculoskeletal disorders and whether an education intervention will change ergonomic risk.

Primary Outcome Measures: Determine Ergonomic Risk Through Video-based Analysis calculated by an artificial intelligence software and evaluator assessment of Rapid Upper Limb Assessment (RULA) and Rapid Entire Body Assessment (REBA), determine the ergonomic risk experienced by surgical attendings and residents during open and laparoscopic surgery measured through video-based analysis of, 1 year
Secondary Outcome Measures: Change in Ergonomic Risk After Reviewing Video Capture and Risk Data, determine if there is any change in ergonomic risk after reviewing video capture and risk data collated through artificial intelligence algorithms, 1 year