pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Aerobic Training on Cardio-respiratory Fitness and Health Related Quality of Life
NCT Number: NCT06539520
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemiplegia, Spastic
Interventions: OTHER: Aerobic training program|OTHER: Selected physical therapy program for post stroke patients
Sponsor: Adly A Adam
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: 2024-05-01
Completion Date: 2024-10
Locations: El-Tahrir st.- in front of Ben El-Sarayat, Ad Doqi Al Giza, Giza Governate, Giza, 002, Egypt

Summary:
Stroke is a major health problem among Egyptian population; an obvious raise in stroke prevalence in all Egyptian governorates. Most stroke survivors commonly develop disabilities those were correlated with restricted physical activity levels. Stroke survivors' cardio-respiratory fitness has several negative impacts such as elevated risk of being affected by other cardiovascular diseases. So, the current study will be conducted to cover the lack in literature concerning the effect of aerobic training on cardiovascular endurance in stroke survivors aiming to faster recovery and reduce the risk of cardiac dysfunction and recurrent strokes.

Primary Outcome Measures: 6-Minutes walk test, A sub-maximal exercise test will be used to assess aerobic capacity and endurance, and functional capability of stroke survivors. 6-Minutes walk test requires stop watch, measuring/ trundle wheel, 30 meter stretch of unimpeded walk way, 2 cones, pulse oximeter, and Borg breathlessness scale. It has excellent reliability, validity, and responsiveness. Its' gained scoring values will be expressed in meters that if more indicates better recovery., Baseline of the study, and after 16 weeks at the end of the study.
Secondary Outcome Measures: Stroke Impact Scale, A stroke-specific, self-reported, health status measure. It is designed to assess multi-dimensional stroke outcomes involving strength (4 items), hand function (5 items), activities of daily living/ instrumental activities of daily living (10 items), mobility (9 items), communication (7 items), emotion (9 items), memory (7 items), and participation (8 items). The over score ranged from Zero indicating no recovery up to 100 indicating full recovery, Baseline of the study, and after 16 weeks at the end of the study.
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
NCT Number: NCT06539507
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Netherton Syndrome
Interventions: DRUG: BCX17725|DRUG: Placebo
Sponsor: BioCryst Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-07
Locations: Investigative site, Brisbane, Queensland, Australia

Summary:
This is a first-in-human, Phase 1/1b, 3-part study that includes the evaluation of safety, tolerability, pharmacokinetics (PK), and immunogenicity of BCX17725 when administered via single and multiple doses in healthy adult participants (Parts 1 and 2), and multiple doses in participants with Netherton Syndrome (Part 3).

Primary Outcome Measures: Incidence of treatment-emergent adverse events (TEAEs), Incidence of TEAEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) from screening through end-of-study (EOS) in each study part, From screening through EOS (ie, through Day 78 in Parts 1 and 3, and Day 106 in Part 2)
Secondary Outcome Measures: Maximum observed serum concentration (Cmax), Cmax of BCX17725, Up to Day 64 (Part 1), Day 92 (Part 2), and Day 78 (Part 3)|Time to maximum observed serum concentration (Tmax), Time to Cmax of BCX17725, Up to Day 64 (Part 1), Day 92 (Part 2), and Day 78 (Part 3)|Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUC0-t), AUC0-t of BCX17725, Up to Day 64 (Part 1), Day 92 (Part 2), and Day 78 (Part 3)|Terminal elimination half-life (t1/2), Terminal elimination half-life (t1/2) of BCX17725, Up to Day 64 (Part 1), Day 92 (Part 2), and Day 78 (Part 3)|Number of participants who are anti-drug antibody (ADA)-positive (baseline and post-baseline) and number of participants who have treatment-emergent ADAs, Incidence of ADAs to BCX17725, Day 1 pre-dose and up to Day 64 (Part 1), Day 92 (Part 2), and Day 78 (Part 3)
Active Surveillance for the Treatment of Low-Risk Basal Cell Carcinoma in Elderly Patients
NCT Number: NCT06539468
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Skin Basal Cell Carcinoma
Interventions: OTHER: Best Practice|OTHER: Educational Activity|OTHER: Patient Observation|OTHER: Survey Administration
Sponsor: University of Michigan Rogel Cancer Center
Sex: ALL
Age: OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2025-02-28
Locations: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109, United States

Summary:
This clinical trial evaluates whether active surveillance (AS) is a safe and comfortable alternative to standard of care (SOC) treatment for elderly patients with low-risk basal cell carcinoma (LR-BCC). Basal cell carcinoma is a type of slow-growing skin cancer that has a very low risk of spreading inside the body (metastasis) or death. Basal cell skin cancers that are smaller across than a nickel in size and located on the trunk or limbs are particularly low risk to overall health. Active surveillance - watching and not treating unless the cancer worsens - has been shown to be a generally safe way to manage LR-BCC. Despite this, many doctors do not feel comfortable discussing this option with patients due to a lack of studies comparing it to standard of care treatment. Standard of care treatment for LR-BCC can include "scrape and burn" (electrodesiccation and curettage), surgical resection, Mohs surgery, and other approaches. These treatments can carry risks like post-operative bleeding and wound infection, and they do not always improve tumor-related quality of life. Active surveillance may be a safe and comfortable alternative to SOC treatment for elderly patients with LR-BCC.

Primary Outcome Measures: Enrollment in part B (Part A), Will evaluate the associations between baseline characteristics and the primary outcome of enrollment in part B (up to accrual target for 100 subjects) by logistic regression. Baseline characteristics include demographics, clinical data, patient-reported measures, baseline comfort with active surveillance (AS), and interest in enrollment in part B. The clinical research coordinator will assign each participant in part A a value of 1 if enrolled in part B or 0 if not enrolled (up to accrual target of 100 subjects for part B)., 6 months|Satisfaction with AS/standard of care (SOC) (Part B), Will compare the satisfaction of participants randomized to AS versus SOC as measured by five-point Likert scale., At week 52
Analysis of Liver Injury Risk Factors in a Multiethnic Population Treated With Antituberculosis Drugs
NCT Number: NCT06539455
Acronym: TUBILI
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tuberculosis Infection
Interventions: DRUG: standard anti-TB treatment
Sponsor: Stefania Cheli
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 127
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-05
Completion Date: 2024-09-30
Locations: ASST Fatebenefratelli Sacco, Milan, 20157, Italy

Summary:
Tuberculosis (TB) is the world's second leading cause of death from a single infectious agent after COVID-19. In 2022, TB was estimated to have affected 10.6 million people, of whom 1.3 million died because of it, despite the WHO's implementation of the "End TB" program. Although the gold standard therapy is effective, it may lead to adverse events, among which hepatotoxicity is the most common. Due to its frequency, severity, and potential outcome, anti-TB drug-induced liver injury (DILI) is extremely concerning. Despite decades of use and the large number of patients exposed to anti-TB drugs worldwide, the pathogenesis underlying DILI remains poorly understood. Investigation of drug-related, host genetic, and environmental factors associated with hepatotoxicity susceptibility, as well as studies examining potential mechanisms causing DILI, may help clinicians develop strategies for reducing the incidence of hepatotoxicity. The aim of this study was to determine host- and drug-related risk factors and their association with hepatotoxicity in a multiethnic population in order to enable early identification of individuals with increased susceptibility to anti-TB DILI. An improved understanding of these factors may help to predict and prevent the occurrence of DILI and develop more effective treatments.

Primary Outcome Measures: The occurrence of anti-TB DILI (number of participants with DILI), Association between risk factors (drug- and host-related factors) and the incidence of DILI.

Evaluation of patient characteristics associated with the development of DILI. DILI was defined by: 1) AST or ALT level \> 5 times the ULN in patients with absence of symptoms or with total BIL level \> 2 times the ULN, or 2) AST or ALT level \> 3 time the ULN and total BIL level \> 3 times the ULN in patients who show symptoms compatible with hepatitis., 6-12 month
Secondary Outcome Measures: The prevalence of early hepatotoxicity experience, Evaluate the characteristics of patients who first experienced anti-TB DILI., 6-12 month
Clinical Study to Evaluate Efficacy and Safety of ANT-301 in Patients With Knee Osteoarthritis in Grade III/IV by K/L
NCT Number: NCT06539429
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Osteoarthritis, Knee
Interventions: BIOLOGICAL: ANT-301
Sponsor: Anterogen Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 6
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-08
Locations: Seoul National University, Seoul, 03080, Korea, Republic of

Summary:
This is a phase I open study to evaluate the efficacy and safety of ANT-301 in patients with knee osteoarthritis K\&L Grade III/IV.

Primary Outcome Measures: Safety assessment, Number of Adverse events and Laboratory Abnormalities, Week 2, 4, 8, 12, 24 and Month 12
Secondary Outcome Measures: Pain improvement according to VAS scale measurements, The VAS scale ranges from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse pain., Baseine, Week 4, 8, 12, 24 and Month 12|IKDC score, IKDC subjective knee evaluation form scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)., Baseline, Week 4, 8, 12, 24 and 12 months|WOMAC questionnaire score, Difference in WOMAC questionnaire scores between baseline and each visit, Baseline, Week 4, 8, 12, 24 and 12 months
Mixed Reality in MitraClip Implantation: Preliminary Case Series
NCT Number: NCT06539416
Acronym: MIMIC
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mitral Regurgitation
Interventions: PROCEDURE: MitraClip implantation
Sponsor: Nemocnice AGEL Trinec-Podlesi a.s.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 14
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2025-03-30

Summary:
The study aims to evaluate the impact of mixed reality (MR) technology, particularly using Hololens 2.0 and specialized software for three-dimensional DICOM image visualization, on MitraClip implantation procedures. This preliminary case series includes a comparative analysis of four MitraClip implantations, assessing procedural efficiency, radiation exposure, and operator stress through both physiological and subjective measures.

Primary Outcome Measures: Operator stress indicator 1, difference of cortisol levels in mmol/l, Measured pre-procedure, immediately post-procedure|Operator stress indicator 2, heart rate variability of operator in BPM, During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure.|Operator stress indicators 3, QTc interval in ms, During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure.|Subjective assessments 1, NASA TLX questionnaire with weighted score - method assesses work load on five 7-point scales, Administered immediately post-procedure.|Subjective assessments 2, STAI Y questionnaire with varies from a minimum score of 20 to a maximum score of 80, Administered immediately post-procedure.|Subjective assessments 3, SSQ questionnaire with assign a score from 0-3 for each of the sixteen items on the SSQ, Administered immediately post-procedure.
Secondary Outcome Measures: Procedural efficiency, time of procedure, From the beginning of the MitraClip implantation procedure until the completion of the procedure, measured in real-time, typically ranging from 1 to 3 hours.|Radiation time exposure, Fluoroscopy Time (in minutes), From the start of the MitraClip implantation procedure until the end of fluoroscopy use, measured in real-time throughout the duration of the procedure, typically ranging from 30 to 120 minutes.|Radiation dose exposure, Dose Area Product (DAP) through the procedure in Gy·cm², From the start of the MitraClip implantation procedure until the end of fluoroscopy use, measured in real-time throughout the duration of the procedure, typically ranging from 30 to 120 minutes.
Is Sedation Necessary for Transforaminal Epidural Injections?
NCT Number: NCT06539390
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pain, Chronic
Interventions: OTHER: Transforaminal Epidural Injections?
Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-24
Completion Date: 2024-09-01
Locations: Kanuni Sultan Süleyman Training and Research Hospital, Istanbul, 34000, Turkey

Summary:
Radicular low back pain due to disc herniation is frequently observed. There are rest, medical treatments, physical medicine modalities, interventional procedures for pain and surgical options in the treatment of lumbar disc herniations. Epidural interventional methods can be applied safely and effectively in patients who do not respond to conservative treatment. Transforaminal epidural steroid injections (TFESE) are frequently used in the interventional treatment of lumbosacral radicular low back pain. TFESE is applied targetedly under fluoroscopy guidance in disc herniation. Therefore, the chance of success increasesTFESE, which is considered a minimally invasive procedure today, is frequently preferred in interventional pain treatments. TFESE can be performed with or without sedation, depending on the preference of the physician and the patient, the patient's comorbidities, the infrastructure of the hospital and the health presentation. There are conflicting and limited studies on whether sedation is necessary in interventional pain procedures.

Primary Outcome Measures: Is Sedation Necessary for Transforaminal Epidural Injections?, numerical rating scala, five months
Living Donor Liver Transplantation for Intrahepatic Cholangiocarcinoma
NCT Number: NCT06539377
Acronym: LIVINCA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Living Donor Liver Transplantation|Liver Transplantation|Neoadjuvant Therapy
Interventions: PROCEDURE: Living donor liver transplantation
Sponsor: Jena University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 6
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2031-10-01

Summary:
This study is supposed to make liver transplantation available for treatment in well selected patients suffering from non-resectable intrahepatic cholangiocarcinoma. Donor organ shortage is currently the main problem for organ transplantation world-wide. Thus, the particular indication "non-resectable intrahepatic cholangiocarcinoma" is currently excluded in terms of transplantation. Given those circumstances, transplantation via living donation might be the best option. This procedure does not reduce the deceased donor organ supply because living donation is the primary treatment option in these patients (not subsidiary).

Primary Outcome Measures: Five year overall survival, Survival from time of transplantation to time of death or last follow up, Five years
Secondary Outcome Measures: Recurrence-free survival, Survival from time of transplantation to time of death or first evidence of recurrence to disease, Five years|Donor and Recipient morbidity, Donor and Recipient morbidity (both according to the Clavien-Dindo classification), Five years
Effects Of Different Periodontal Treatments On Quality Of Life In Patients With Periodontitis
NCT Number: NCT06539364
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Quality of Life
Interventions: DIAGNOSTIC_TEST: Quality of life surveys were conducted
Sponsor: Izmir Katip Celebi University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2019-08-08
Completion Date: 2021-10-05
Locations: Izmir Katip Çelebi University Department of Periodontology, İzmir, Çiğli, 35640, Turkey

Summary:
In this study, the quality of life of patients with stage 3 grade C periodontitis who underwent surgical and non-surgical periodontal treatments was evaluated. Patients were compared based on their quality of life using OHIP-14 and OHRQoL-UK questionnaires, as well as a VAS scale, against those who did not receive periodontal treatment, those who received only phase 1 treatment one month prior, and those who underwent periodontal surgical treatment three months prior.

Primary Outcome Measures: obtain survey results, obtaining survey results to see the impact on patients' quality of life, Baseline (T1), 3 weeks after non-surgical periodontal treatment (T2), and 12 weeks after surgical periodontal treatment (T3).
A Pilot Study to Finetune Skin Processing Procedures in Recent Vaccinees, Prior to GeKoSkimm Study Initiation (GeKoSkimm-pilot)
NCT Number: NCT06539351
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Yellow Fever
Interventions: OTHER: Skin biopsy
Sponsor: Institute of Tropical Medicine, Belgium
Sex: ALL
Age: ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2024-10

Summary:
This pilot study aims to optimize the sample processing techniques for collecting and analyzing skin biopsies obtained from individuals routinely vaccinated against yellow fever. By addressing logistical challenges early, risks will be mitigated and the main study's efficiency will be enhanced.

In order to do so, 15 participants will be identified at the ITM polyclinic after receiving a yellow fever vaccination. Participants will be invited to one study visit at the ITM Clinical Trial Site (CTS) 28 days after vaccination to collect blood samples, skin punch biopsies and a minimally-invasive microbiopsy at the site of vaccination. To investigate the ideal location for the skin punch biopsies, participants will be divided in 3 groups; in the first 5 participants the biopsies will be taken directly on the vaccination site, for the next 5 participants, the biopsies will be taken at +/- 3 cm distance from the vaccination site, and for the last five participants, the biopsies will be taken at +/- 10 cm distance from the vaccination site.

Primary Outcome Measures: Optimize sample processing for optimal cell yield, To test the sample processing flow. This involves evaluating the efficiency and practicality of sample collection, preservation, and analysis protocols to ensure optimal cell yield., 1 day
Secondary Outcome Measures: Absolute number of YFC-specific TRM cells per skin biopsy, Using different skin dissociation protocols, the absolute number of YFV-specific TRM cells that can be isolated out of 4mm punch biopsy skin samples, as determined by flow cytometry., 1 day|percentage of YFC-specific TRM cells per skin biopsy, Using different skin dissociation protocols, the percentage of YFV-specific TRM cells that can be isolated out of 4mm punch biopsy skin samples, as determined by flow cytometry., 1day
Safety of INT2104 in Participants Aged 18 Years and Older Who Have B-cell Cancer That Came Back After Prior Treatment
NCT Number: NCT06539338
Acronym: INVISE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Lymphomas Non-Hodgkin's B-Cell|Precursor Cell Lymphoblastic Leukemia-Lymphoma
Interventions: GENETIC: INT2104
Sponsor: Interius BioTherapeutics Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2031-03
Locations: Peter MacCallum Cancer Centre, Melbourne, Australia|Westmead Hospital, Westmead, Australia

Summary:
The purpose of this first-in-human study is to evaluate the safety of INT2104 when administered to humans in a broad population of participants with refractory/relapsing B-cell malignancies. Preliminary efficacy information may also be obtained.

INT2104 is a gene therapy delivering a transgene for a chimeric antigen receptor (CAR) specific for CD20 (CAR20). The lentiviral vector is designed to generate CAR T and CAR Natural Killer (NK) cells inside the body following intravenous (IV) administration.

Study details include the following:

* The study duration will be 5 years
* The treatment duration will be a one-time intravenous (IV) infusion of INT2104

Primary Outcome Measures: Number of Participants With Adverse Events as Assessed by CTCAE v5.0, Number of Participants With Adverse Events as Assessed by CTCAE v5.0, 28 days|Number of Participants With Adverse Events as Assessed by CTCAE v5.0, Number of Participants With Adverse Events as Assessed by CTCAE v5.0, 90 days|Number of Participants With Adverse Events as Assessed by CTCAE v5.0, Number of Participants With Adverse Events as Assessed by CTCAE v5.0, 2 years|Number of participants experiencing Cytokine Release Syndrome (CRS), Number of participants experiencing Cytokine Release Syndrome (CRS), 28 Days|Number of participants experiencing Immune Effector Cell Neurotoxicity (ICANS), Number of participants experiencing Immune Effector Cell Neurotoxicity (ICANS), 28 Days|Number of participants experiencing dose-limiting toxicities (DLTs), Number of participants experiencing dose-limiting toxicities (DLTs), 28 Days
Socket Preservation - A Randomized Clinical Implementation in a Student Setting
NCT Number: NCT06539299
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alveolar Bone Loss|Dental Implant|Bone Augmentation
Interventions: PROCEDURE: Socket Preservation
Sponsor: Sigmund Freud PrivatUniversitat
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 51
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-03-01

Summary:
Preserving the ridge dimension after tooth extraction aims to avoid the need for bone augmentation procedures before implant placement. This study aims to show that socket preservation procedure is a safe, easy and predictable method that stabilizes the bone situation when late implantation is planned.

Primary Outcome Measures: three-dimensional bone changes, horizontal bone dimension changes, measured after six months after extraction|three-dimensional bone changes, vertical bone dimension changes, measured after six months
Dentin Hypersensitivity - Varnish or Laser?
NCT Number: NCT06539286
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dentin Hypersensitivity
Interventions: DEVICE: Laser Irradiation
Sponsor: Sigmund Freud PrivatUniversitat
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-02
Completion Date: 2024-12-14

Summary:
Dentin hypersensitivity is a common condition described as a short and sharp pain caused by thermal, evaporative, tactile, osmotic, or chemical stimuli to exposed dentin that cannot be related to another defect or dental pathology. The variety of treatment options and products on the market might seem overwhelming. This study aims to show that laser treatments are efficient in reducing pain scores compared to a desensitizing agent (Gluma). 80 patients with at least two hypersensitive teeth will be enrolled in this study. Patients will be divided randomly into four groups (control group (Gluma), laser group 1 (2.94 µm wavelength), laser group 2 (1064 nm wavelength), laser group 3 (970 nm wavelength)). Visual Analog Scale will be measured before treatment, right after treatment, one week after treatment, one month after treatment, three months after treatment. Mixed Anova's and descriptive analysis will be used for statistical evaluation.

Primary Outcome Measures: Visual Analog Scale changes, Patients will rate pain score with VAS. Pain scores will be evaluated before treatment, right after treatment, one week later, one month later and three months later, three months
Exosome Treatment in Androgenetic Alopecia
NCT Number: NCT06539273
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Androgenetic Alopecia|Exosomes
Interventions: DRUG: Exosome Complex, RNA
Sponsor: Yeditepe University Hospital
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2024-05-05
Locations: Yeditepe University Kozyatagi Hospital, Istanbul, Atasehir, 34752, Turkey

Summary:
This study aims to elucidate the effect of "foreskin-derived mesenchymal stromal cells derived exosome" injection into the scalp on hair density in patients with androgenetic alopecia and the contribution of this treatment on patient satisfaction.

Primary Outcome Measures: Hair density, Increase in hair density (number of hair/cm2), 4th and 12th weeks
Secondary Outcome Measures: Patient satisfaction survey, Increase Patient satisfaction in 4th and 12th weeks, 4th and 12th weeks
MRP Verses PNF On Pain, Foot Drop, Gait And Functional Mobility In Hemiplegic Patients.
NCT Number: NCT06539247
Acronym: CEMRA-PNF
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|Pain|Gait, Drop Foot|Foot Drop|Hemiplegia
Interventions: COMBINATION_PRODUCT: Motor Relearning Program with Electrical Muscle Stimulation (MRA + EMS)|COMBINATION_PRODUCT: Proprioceptive Neuromuscular Facilitation Technique with Electrical Muscle Stimulation (PNF + EMS)
Sponsor: University of Lahore
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 68
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-28
Completion Date: 2025-02
Locations: University of Lahore, Lahore, Punjab, 54590, Pakistan

Summary:
This single blinded randomized control study aims to determine the comparative effectiveness of two rehabilitation approaches for improving pain, foot drop, gait, and functional mobility in patients with hemiplegia. The study will recruit 68 patients diagnosed with hemiplegia who meet specific inclusion criteria. Both groups will receive a treatment program lasting eight weeks, with assessments at baseline, week four, and week eight. The study will measure various outcomes as gait analysis, foot drop grading, functional ability and pain assessment. This study aims to contribute to evidence-based practice in stroke rehabilitation by comparing the effectiveness of motor relearning and PNF approaches for improving gait, pain, and functional mobility in hemiplegic patients. The findings may help guide therapists in selecting the most appropriate intervention for individual patients.

Primary Outcome Measures: Gait analysis, The Dynamic Gait Index is a standardized tool used to assess gait function in individuals with lower extremity impairments. It evaluates 8 components of gait, with higher scores indicating better gait quality., 8 weeks (baseline, fourth week and then at the end of the 8 week)|Foot Drop, Manual Muscle Testing (MMT) scores is a standardized test that assesses muscle strength on a 5-point scale (0 = no contraction to 5 = normal strength). This will be used specifically for the affected leg's dorsiflexor muscles., 8 weeks (baseline, fourth week and then at the end of the 8 week)
Secondary Outcome Measures: Functional Ability, The Motor Assessment Scale (MAS) is a clinical tool used to evaluate functional abilities in various daily activities. Higher scores indicate greater functional independence., 8 weeks (baseline, fourth week and then at the end of the 8 week)|Pain intensity, The Numeric Pain Rating Scale (NPRS) Score is a simple tool where participants rate their pain intensity on a numerical scale (e.g., 0 = no pain, 10 = worst pain imaginable)., 8 weeks (baseline, fourth week and then at the end of the 8 week)
Angiotensin II Stress Test. Renin Kinetics During Treatment of Vasoplegic Shock With Angiotensin II.
NCT Number: NCT06539234
Acronym: TENSINTEST
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Shock|Vasoplegic Syndrome
Sponsor: University Medical Centre Maribor
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-09-01
Locations: Medical ICU, University Medical Centre Maribor, Maribor, 2000, Slovenia|Surgical ICU, University Medical Centre Maribor, Maribor, 2000, Slovenia

Summary:
Shock is a life-threatening condition which can cause multiple organ failure and even death. One characteristic of shock is low blood pressure which is managed with drugs called vasopressors. Most frequently used vasopressors are noradrenaline, vasopressin and recently also angiotensin II. Angiotensin II is present in the body and has a physiological role in maintaining blood pressure in healthy persons. Renin is an enzyme and a key factor in angiotensin II production in the body. In patients with shock, there is a lack of angiotensin II and an excess of renin in the body. Due to the literature renin has the potential to be a marker of severity of shock. Synthetic angiotensin II is used in patients with shock in whom we cannot normalize the blood pressure with noradrenaline and vasopressin. Regarding scientific data, the use of synthetic angiotensin II reduces the dose of noradrenaline and vasopressin and the incidence of acute kidney injury. The aim of our study is to find out what is the relation between the concentration of renin before and 6 hours after the start of using angiotensin II in patients with shock and their clinical outcome. Since not all patients with shock are responding to angiotensin II, the aim of our study is also to find out which patients could benefit most from synthetic angiotensin II.

Primary Outcome Measures: organ failure free days, days alive without the need of vasopressors, ventilators, or dialysis, 0-30 days|ICU free days, 30 minus the number of days in the ICU, 0-30 days
Secondary Outcome Measures: duration of the need for vasopressors, time in which vasopressors are needed, 0-30 days|mechanical ventilation need, time of mechanical ventilation (invasive and/or noninvasive), 0-30 days|dyalisis need, time of eventual need for dyalisi´s, 0-30 days|renin trend, renin concentration before and 6 hours after the start of angiotensin II infusion, 0-6 hours
Sphingolipids in Asthma Pathogenesis
NCT Number: NCT06539221
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Asthma
Sponsor: Peking University Third Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-09-01
Locations: Peking university third hospital, Beijing, Beijing, 100191, China

Summary:
The study aims to investigate the relationship between the small molecule metabolite sphingolipids and asthma clinical features and explore its involvement in asthma pathogenesis.

Primary Outcome Measures: lipidomics, collect blood for lipidomic analysis and in vitro assays, Day 1
A Phase I/IIa，Open-label, Single Ascending Dose and Dose-expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of YOLT-201 in Patients With Transthyretin Amyloidosis Polyneuropathy (ATTR-PN) or Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
NCT Number: NCT06539208
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Transthyretin Amyloidosis Polyneuropathy|Transthyrexin Amyloidosis Cardiomyopathy
Interventions: DRUG: YOLT-201
Sponsor: YolTech Therapeutics Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 31
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-23
Completion Date: 2026-06-30
Locations: Peking Union Medical College Hospital, Beijing, Beijing, 100000, China|The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410000, China|The First Affiliated Hospital, School of Medicine, Zhejiang University, Hanzhou, Zhejiang, 310000, China

Summary:
This study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of YOLT-201 in participants with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN) and participants with hereditary transthyretin amyloidosis with cardiomyopathy (ATTRv-CM).

Primary Outcome Measures: Safety and Tolerability, Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), through week 104
DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (TAI-SHAN9)
NCT Number: NCT06539195
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
Interventions: DRUG: DZD8586|DRUG: DZD8586|DRUG: DZD8586
Sponsor: Dizal Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-13
Completion Date: 2028-04
Locations: Research Site, Hefei, Anhui, 230031, China|Research Site, Beijing, Beijing, 100083, China|Research Site, Guangzhou, Guangdong, 510060, China|Research Site, Nanning, Guangxi, 530016, China|Research Site, Zhengzhou, Henan, 450003, China|Research Site, Wuhan, Hubei, 430023, China|Research Site, Changsha, Hunan, 410031, China|Research Site, Nanjing, Jiangsu, 210009, China|Research Site, Dalian, Liaoning, 116021, China|Research Site, Jinan, Shandong, 250117, China|Research Site, Linyi, Shandong, 276002, China|Research Site, Xi'an, Shanxi, 710061, China|Research Site, Chengdu, Sichuan, 610041, China|National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, Tianjin, 300020, China|Research Site, Tianjin, Tianjin, 300181, China|Research Site, Hangzhou, Zhejiang, 310009, China

Summary:
This study will treat patients with DLBCL whose disease comes back or is not responding to prior therapy. This study will assess the anti-tumor activity of DZD8586 as monotherapy. It will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body.

Primary Outcome Measures: Objective Response Rate assessed by investigators, Assessed up to 2 years
Secondary Outcome Measures: Incidence of adverse events, 30 days after the last dose, assessed up to 2 years
DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)
NCT Number: NCT06539182
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Interventions: DRUG: DZD8586|DRUG: DZD8586|DRUG: DZD8586
Sponsor: Dizal Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 155
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-29
Completion Date: 2028-03
Locations: Research Site, Hefei, Anhui, China|Research Site, Beijing, Beijing, 100053, China|Research Site, Beijing, Beijing, 100191, China|Research Site, Guangzhou, Guandong, 510280, China|Research Site, Guangzhou, Guandong, 510515, China|Research Site, Zhengzhou, Henan, China|Research Site, Wuhan, Hubei, China|First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, Jiangsu, China|Research Site, Changchun, Jilin, China|Research Site, Dalian, Liaoning, China|Research Site, Shenyang, Liaoning, China|Research Site, Jinan, Shandong, China|Research Site, Linyi, Shandong, China|Research Site, Shanghai, Shanghai, China|Research Site, Taiyuan, Shangxi, China|Research Site, Tianjin, Tianjin, 300020, China|Research Site, Tianjin, Tianjin, 300060, China

Summary:
This study will treat patients with CLL/SLL whose disease comes back or is not responding to prior therapy, or if they can not bear side effects of the prior treatment. This study will assess the anti-tumor activity of DZD8586 as monotherapy. It will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body.

Primary Outcome Measures: Objective Response Rate assessed by investigators, assessed up to 2 years
Secondary Outcome Measures: Incidence of adverse event, 30 days after the last dose, assessed up to 2 years
FLOWER: Following Longitudinal Outcomes With Epidemiology for Rare Diseases
NCT Number: NCT06539169
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Alpha-Thalassemia|Beta-Thalassemia|Amyloidosis|Amyotrophic Lateral Sclerosis|Creutzfeld-Jakob Disease|Cystic Fibrosis|Duchenne Muscular Dystrophy|Early-Onset Alzheimer Disease|Ehlers-Danlos Syndrome|Huntington Disease|Gaucher Disease|GM1 Gangliosidosis|Myasthenia Gravis|Pompe Disease|Sickle Cell Disease|Transthyretin Amyloid Cardiomyopathy|Rare Diseases
Sponsor: xCures
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-10
Completion Date: 2026-06-10
Locations: xCures, Los Altos, California, 94022, United States

Summary:
FLOWER is a completely virtual, nationwide, real-world observational study to collect, annotate, standardize, and report clinical data for rare diseases. Patients participate in the study by electronic consent (eConsent) and sign a medical records release to permit data collection. Medical records are accessed from institutions directly via eFax or paper fax, online from patient electronic medical record (EMR) portals, direct from DNA/RNA sequencing and molecular profiling vendors, and via electronic health information exchanges. Patients and their treating physicians may also optionally provide medical records. Medical records are received in or converted to electronic/digitized formats (CCDA, FHIR, PDF), sorted by medical record type (clinic visit, in-patient hospital, out-patient clinic, infusion and out-patient pharmacies, etc.) and made machine-readable to support data annotation, full text searches, and natural language processing (NLP) algorithms to further facilitate feature identification.

Primary Outcome Measures: Progression Free Survival (PFS), 5 Years|Overall Survival (OS), 5 Years
Prescribing Appropriateness of Thrombo-prophylaxis in Intensive Care Unit of Tertiary Hospital
NCT Number: NCT06539156
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: DVT
Interventions: OTHER: DVT prophyllaxis
Sponsor: Ain Shams University
Collaborators: Egyptian Chinese University|Teachers Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2024-12-01
Locations: Teachers Hospital, Cairo, 4270020, Egypt

Summary:
Hospitalized patients are at high risk of venous thromboembolism (VTE), and the appropriate use of thromboprophylaxis can significantly reduce the incidence of VTE in high-risk patients. We investigated the pattern of VTE prophylaxis administration among elderly medical patients and assessed its appropriateness based on the American College of Chest Physicians (ACCP) recommendations. Methods A cross-sectional single-center study will be conducted between July 2024 and December 2024, including hospitalized (\> 48 h), (≥ 60 years), medical and surgical patients, and excluding patients receiving anticoagulant for other reason, having contraindication to thromboprophylaxis, or had VTE diagnosed within 48 h. The Padua and caprine prediction scores will be used to determine the patients' risk for VTE, and thromboprophylaxis use will be assessed against the ACCP recommendations.

Primary Outcome Measures: Padua score for medical patients, Venous thromboembolism Risk assessment (Scores 0-3 are low risk and do not warrant prophylaxis. Scores ≥4 are high risk for VTE and subsequent complications; recommendation for thromboprophylaxis.), within 24 hours of ICU admission|Caprini score for surgical patients, Venous thromboembolism Risk assessment (Total score of 0-1: Low risk of VTE Total score of ≥3: High/moderate risk of VTE ), within 24 hours of ICU admission
Secondary Outcome Measures: Bleeding risk assessment, within 24 hours of ICU admission|Direct Anticoagulant cost, sum of costs related to the anticoagulant administration for DVT Prophylaxis, within 24 hours of ICU admission till ICU discharge(at least 48 hours)|Adverse drug reaction cost, sum of costs related to the Adverse drug reaction for DVT Prophylaxis, within 24 hours of ICU admission till ICU discharge (at least 48 hours)
Analgesia From Conscious Sedation Versus Paracervical Block for Manual Vacuum Aspiration
NCT Number: NCT06539143
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Effect of Drug
Interventions: DRUG: Lidocaine
Sponsor: Darlington-Peter Chibuzor Ugoji
Sex: FEMALE
Age: ADULT
Enrollment: 81
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-06-27
Completion Date: 2023-09-26
Locations: AEFUTHA, Abakaliki, Ebonyi, 480101, Nigeria

Summary:
Miscarriage is one of the major causes of early pregnancy losses. Incomplete miscarriage is a major cause of maternal morbidity and mortality. Analgesia from both conscious sedation and paracervical could be utilized during manual vacuum aspiration of first trimester incomplete miscarriage. The objectives of this study are to review the existing studies and to compare analgesia from conscious sedation with that of paracervical block among women selected for manual vacuum aspiration following first trimester incomplete miscarriages in Alex Ekwueme Federal University Teaching Hospital, Abakaliki \[AEFUTHA\].

Primary Outcome Measures: Mean pain score using the Visual analogue scale, The primary outcome measure is the mean pain score of the participants in the study groups., Pain and side effects experienced following the use of the analgesic agents at about 10 minutes, 2 hours, 6 hours, 12 hours and 24 hours following the procedure was noted. Higher score showed more pain and lower score showed lower pain
Medical Practices and Representations of People From Haiti in French Guiana
NCT Number: NCT06539130
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Social Representations of Infectious Diseases
Sponsor: Centre Hospitalier de Cayenne
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 83
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-05-30
Completion Date: 2023-05-22
Locations: Centre Hospitalier de Cayenne, Cayenne, 97300, French Guiana

Summary:
This is an observational, cross-sectional, qualitative study of the population of Haitian origin living in French Guiana and the professionals working with them

Primary Outcome Measures: Description of social representations of HIV and HBV infections among migrant population from Haïti, To describe the social representations of HIV and HBV infections and their impact on use of traditional medecine among migrant population from Haïti, using qualitative questionnaire, At inclusion
Secondary Outcome Measures: Description of living conditions of migrants from Haïti, To describe living conditions and health seeking behavior of migrants from Haïti after their arrival in French Guiana using a qualitative questionnaire, At inclusion|Description of difficulties to access health care and health prevention, To describe difficulties met by migrants from Haïti after their arrival in French Guiana to access health care and health prevention using a qualitative questionnaire, At inclusion|Description of food insecurity situations met by migrants from Haïti, To describe food insecurity situations and coping strategies met by migrants from Haïti after their arrival in French Guiana using a qualitative quesitonnaire, At inclusion|Description of social and health professionals representations on migrants from Haïti, To describe representations from health and social professionals working with migrants from Haïti usng a qualitative questionnaire, At inclusion
Early Initiation of Oral Feeding Versus Traditional Feeding Post Caesarean Section
NCT Number: NCT06539117
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Complication|Postoperative
Interventions: OTHER: Early feeding post caesarean section
Sponsor: Darlington-Peter Chibuzor Ugoji
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 153
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-04-15
Completion Date: 2023-12-15
Locations: AEFUTHA, Abakaliki, Ebonyi, 480101, Nigeria

Summary:
Early initiation of oral feeding, within 6-12 hours post-caesarean section, has been noticed to be well tolerated by patients and helps them recover fast. Our study aimed to evaluate the tolerability, safety and benefits of early oral feeding post-caesarean section.

Primary Outcome Measures: Rate of tolerability of oral sips, This was the rate of tolerability of oral sips especially in the first 48 hours post surgery as shown by absence of complications such as nausea, vomiting, abdominal distention and paralytic ileus., 48hours