pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Safety and Efficacy of Different Procedures of Colpocleisis: a Randomized Controlled Trial
NCT Number: NCT06482697
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pelvic Organ Prolapse
Interventions: PROCEDURE: total colpocleisis|PROCEDURE: partial colpocleisis (LeFort)
Sponsor: Lan Zhu
Sex: FEMALE
Age: OLDER_ADULT
Enrollment: 330
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-11

Summary:
Background: Pelvic organ prolapse (POP) is one of the most common benign gynecological diseases among middle-aged and elderly women, which severely affects the quality of life of patients. Colpocleisis for the treatment of POP has a high success rate and low incidence of complications. The classic colpocleisis is divided into total colpocleisis and partial colpocleisis (LeFort). However, there are no long-term follow-up large-scale randomized trials to compare the clinical efficacy, complications between the two surgical methods. This study aims to compare the incidence of surgical complications, objective surgical success rate, subjective satisfaction rate, pelvic floor symptom improvement rate, and regret rate in patients with pelvic organ prolapse treated by total colpocleisis and LeFort.

Methods: This trial is a prospective, multicenter, randomized, non-blinded non-inferiority trial, comparing the application of hysterectomy with total colpocleisis and LeFort in symptomatic pelvic organ prolapse patients with no need for vaginal sexual life, and aged ≥70 years. The primary outcome measure is the incidence of surgical complications, including perioperative and postoperative complications within 3 months, as well as the incidence of severe complications. Secondary outcomes include the objective surgical success rate, subjective satisfaction rate, pelvic floor symptom improvement rate, and regret rate at 3 months, 1 year, and 2 years post-surgery. This study is a non-inferiority study, based on the literature reports that the incidence of complications for colpocleisis and LeFort with hysterectomy are 11.4% and 7.0%, respectively, with a non-inferiority boundary value of 5%, α=0.025 (one-sided), β=0.2, and a ratio of 1:1 between the two groups. The sample size is calculated to be n=296, considering a 10% dropout rate, a total of 330 patients need to be included.

Discussion: This is a randomized multicenter clinical trial that will provide evidence to demonstrate the differences in complications and efficacy between colpocleisis and LeFort with hysterectomy.

Primary Outcome Measures: Surgical complication rate, The surgical complication rates include the incidence of complications during the perioperative period and within 3 months postoperatively, as well as the incidence of severe complications., at the perioperative period and three months of follow-up
CAR-T-cell Treatment for Untreated High Risk MANtle Cell Lymphoma
NCT Number: NCT06482684
Acronym: CARMAN
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Mantle Cell Lymphoma
Interventions: DRUG: KTE-X19|DRUG: Ibrutinib
Sponsor: Christian Schmidt, MD
Collaborators: Johannes Gutenberg University Mainz
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-15
Completion Date: 2031-12-31
Locations: University Hospital of Mainz, Mainz, Germany|Klinikum der Universität München, Munich, 81377, Germany

Summary:
First-line CAR-T-cell consolidation after an abbreviated induction with 2 cycles of Rituximab and Ibrutinib prior to CAR-T-cell treatment and followed by 6 months of maintenance with Ibrutinib in patients with high risk MCL.

Primary Outcome Measures: Failure Free Survival, Time from randomization to any discontinuation of the per protocol treatment due to stable or progressive disease during induction, stable disease at the end of induction, progressive disease at any time after end of induction treatment and death from any cause, whichever occurred first. Stable disease at end of induction is defined as failure event because it represents a regular indication for salvage treatment in MCL., From Randomization to any to any discontinuation of the per protocol treatment due to stable or progressive disease
Secondary Outcome Measures: Progression-free survival (PFS), from the date of response (CR or PR within 6 months from randomization) to progression or death from any cause|Complete remission (CR) rate, 6 months from randomization until end of trial|Time to first response, date of randomization to the date of first response (CR or PR)|Overall survival, day 1 after randomization until end of trial
The Effect of the Transection of the Omohyoid in the Incidence of Dysphagia in Patients
NCT Number: NCT06482632
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anterior Cervical Pain
Interventions: PROCEDURE: Discectomy of Omohyoid|PROCEDURE: Control group no discectomy of Omohyoid
Sponsor: University of Puerto Rico
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-07-15
Completion Date: 2026-05-29
Locations: Hospital Oncológico Dr. Isaac González Martínez, San Juan, 00935, Puerto Rico

Summary:
The investigators believe that the transection of the omohyoid during an anterior cervical discectomy and fusion decreases the incidence of dysphagia in patients who undergo this procedure when compared to patients who do not have the omohyoid transected.

Primary Outcome Measures: Neck Disability Index, This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life., 6 months|Dysphagia Short Questionnaire- "The Dysphagia Questionnaire, a 10-point rating scale, were 1 is the minimum value, 10 is the maximum value, and the higher scores means the worse outcome and lower scores are the better outcomes. In the Dysphagia questionnaire the patients provide an assessment of the severity of dysphagia symptoms experienced., 6 months
Secondary Outcome Measures: Neck Circumference, Measurement of neck circumference in centimeters, Pre operation|Body Mass Index, Measure the body mass index of the patient, Pre Operation
Effects of Creatine and Rehabilitation Programin Athletes With Patellar Tendinopathy
NCT Number: NCT06482619
Acronym: CREATINE_TEN
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Creatine|Patellar Tendinopathy
Interventions: DIETARY_SUPPLEMENT: Creatine supplementation|DIETARY_SUPPLEMENT: Placebo
Sponsor: Universidad Pontificia Comillas
Collaborators: Universidad de Córdoba|University of Bologna|Technical University of Madrid|Lavras University
Sex: MALE
Age: ADULT
Enrollment: 26
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-01-01
Completion Date: 2023-11-01
Locations: Universidad Pontificia Comillas, Madrid, Spain

Summary:
The aim of this study are to analyze the effect of creatine ingestion in pain, histological properties of the tendon, body composition, strength and vertical jump performance in athletes with patellar tendinopathy that follow a physical rehabilitation program that include eccentric exercise combined with stretching and extracorporeal shock wave therapy.

Primary Outcome Measures: Pain evaluation, For assessing pain, the Victorian Institute for Sports Assessment - Patella (VISA - P), the most widely used patient-reported outcome measure (including symptom severity), was administered . The VISA - P will be scored with a maximum of 100 points and the higher scores indicate better function, and it shows sensible to identify improvements in therapeutic interventions among patients with tendinopathies., 8-weeks|Tendon thickness., Thickness Tendon of the injuried knee/s was analyzed with ultrasound (GE VENUE 40, Portable Ultrasound, CA, USA), and a linear translator. Participants were positioned supine with a 30º knee flexion (using a roller under the knees), reducing the "locking" of the patella in the femur as in full extension. Ultrasound gel was applied and evaluated by placing the probe longitudinally; in pathological tendons it is the only way to determine the distance of the measurement point from the insertion of the tendon. Thus, subsequent measurements were always made from the same point., 8-weeks
Secondary Outcome Measures: Neuromuscular function, Participants performed a neuromuscular test battery consisted in measuring vertical jump capacity (i.e., countermovement jump) and knee extension muscle strength muscular strength in a knee extension machine (Selection Leg Extension, Technogym, Cesena, Italy) with a 5 maximum number of repetitions (5-RM), 8-weeks
Periapical Healing in Response to Endodontically Treated Teeth With Different Sealing Cement
NCT Number: NCT06482593
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Apical Periodontitis
Interventions: DRUG: Zinc-Oxide Eugenol Sealer|DRUG: AH-Plus Epoxy Resin Sealer|DRUG: Bio-C Sealer
Sponsor: Institucion Universitaria Colegios de Colombia
Sex: ALL
Age: ADULT
Enrollment: 72
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-08-01
Completion Date: 2024-09-30
Locations: Dental Clinics of the University College of Colombia, Bogotá, Cundinamarca, 111711, Colombia

Summary:
The goal of this clinical trial is to conduct an in vivo study that allows to compare the periapical healing process of 3 different sealing cements through CBCT, as well as implement the evaluation of these lesions through volumetric measurements to provide high-level scientific information and thus have the possibility of being applied in the clinical dental practice, in patients attending UNICOC dental clinics between 2023 and 2024. The main question it aims to answer is:

* Do bioceramic sealer promote faster periapical healing due to their better sealing capacity and high bio-compatibility?
* Are there no differences between endodontic sealers in terms of apical healing? If there is a comparison group: Researchers will compare Bio-C Sealer (Bioceramic sealer) Zinc-oxide eugenol sealer and AH-Plus epoxy resin sealer to evaluate periapical healing after a six months follow-up of conventional endodontic therapy.

Coronal permanent restoration must be performed no later than 15 days after endodontic therapy.

Primary Outcome Measures: Volumetric Periapical Healing, Changes of the three-dimensional volume of the periapical lesion of endodontic origin, Six months follow-up
The Effect of Different Exercises on Lower Extremity Performance in Flexible Flatfoot
NCT Number: NCT06482580
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Flexible Flatfoot
Interventions: OTHER: PNF exercise|OTHER: Clam exercise|OTHER: Short-foot exercise
Sponsor: Mustafa Kemal University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-30
Completion Date: 2024-09-30
Locations: Gazi University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Çankaya, 06540, Turkey

Summary:
In the study, the effects of two different strengthening exercises combined with short foot exercise on lower extremity functional performance and muscle strength will be examined and compared in adults aged 18-45 years with flexible flatfoot. This study was designed as an experimental, 3-arm, parallel group, double-blind randomized controlled study that included a 6-week intervention period.

Primary Outcome Measures: Medial longitudinal arch height, Medial longitudinal arch height will be evaluated with the navicular drop test., 6 weeks|Static foot posture, Static foot posture will be evaluated with Foot Posture Index-6., 6 weeks
Secondary Outcome Measures: Isometric muscle strength, Abductor hallucis, flexor digitorum brevis, flexor hallucis brevis, 4-way ankle muscles and hip abductor/external rotator isometric muscle strength will be evaluated using a digital hand-held dynamometer., 6 weeks|Lower extremity functional performance, With plantar flexor focused endurance performance heel raise test; with dynamic balance Y balance test; Single leg forward jump performance will be evaluated with the single leg hop for distance test., 6 weeks
Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.
NCT Number: NCT06482554
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Apathy|Schizophrenia|Schizophrenia; Psychosis
Interventions: DRUG: Lumateperone 42 mg|DRUG: Risperidone 2 mg
Sponsor: Louisiana State University Health Sciences Center Shreveport
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2026-12
Locations: LSU Health Shreveport, Shreveport, Louisiana, 71101, United States

Summary:
This study is looking to determine if Lumateperone improves motivation in patients with schizophrenia or schizoaffective disorders who show high levels of apathy as judged by AES-C-Apathy (Apathy Evaluation Scale - Clinician - Apathy) assessment and to examine a possible correlation between improvement in apathy scores and changes in elements of the PANSS (Positive and Negative Syndrome Scale) due to treatment with Lumateperone.

Primary Outcome Measures: Change in AES-C Score, Difference between the mean change in the AES-C score from baseline (V1) to Week 8 (V3) for 42 mg/day lumateperone vs. current antipsychotic medication., 8 weeks
Secondary Outcome Measures: Change in PANSS Score, Difference between the mean change in the PANSS score from baseline (V1) to Week 8 (V3) for 42 mg/day lumateperone vs. current antipsychotic medication., 8 weeks|Change in BPRS Score, Difference between the mean change in the BPRS (Brief Psychiatric Rating Scale) score from baseline (V1) to Week 8 (V3) for 42 mg/day lumateperone vs. current antipsychotic medication., 8 weeks|Correlations between AES-C and PANSS Scores, Correlation between the AES-C score at Week 8 (V3) and negative symptoms score from PANSS at Week 8 (V3) for 42 mg/day lumateperone in comparison to current antipsychotic medication., 8 weeks
Efficacy and Safety Of AGE ZERO™ EXOSOMES To Treat Men and Women With Androgenetic Alopecia
NCT Number: NCT06482541
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Androgenetic Alopecia
Interventions: COMBINATION_PRODUCT: 5 billion exosomes and saline solution microneedling|COMBINATION_PRODUCT: 50 billion exosomes and saline solution microneedling
Sponsor: Levit Dermatology
Collaborators: ResilielleTM Age ZeroTM Exosomes|Dorisca Research Consulting, LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-08
Locations: Levit Dermatology, Brooklyn, New York, 11235, United States

Summary:
The purpose of this study is to determine whether Wharton's Jelly mesenchymal stem cell-derived exosome microneedling on the scalp is an effective treatment for Androgenetic Alopecia (pattern hair loss).

Primary Outcome Measures: Hair count, Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device, Evaluated on monthly visits for a year|Hair thickness, Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device, Evaluated on monthly visits for a year|Hair color, Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device, Evaluated on monthly visits for a year
Secondary Outcome Measures: Adverse events, Patients will self-report adverse events on a questionnaire on a scale of 1-10, with 1 being minimal discomfort and 10 being worst discomfort ever experienced., Participants will self-report adverse events during monthly visits for the entire 1-year duration|Self-reported hair changes, Patients will self-report impressions of hair growth changes on each treatment area on a scale of -10 to 10, with -10 being extreme worsening of hair loss and 10 being extreme regrowth. Patients will scale impressions of hair thickness, hair density, hair color, hair growth speed, hair texture, and overall satisfaction with therapy applied to each treatment area., Patients will self-report on questionnaire during monthly visits for the entire 1-year duration
Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue
NCT Number: NCT06482515
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Neoplasms|Blood Cancer|Fatigue|Diet Habit|Survivorship|Fasting, Intermittent
Interventions: BEHAVIORAL: Time-restricted eating|BEHAVIORAL: Nutrition counseling
Sponsor: University of Maryland, Baltimore
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 96
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10
Completion Date: 2030-10
Locations: University of Maryland, Baltimore, Baltimore, Maryland, 21201, United States

Summary:
Cancer-related fatigue affects at least 30-90% of patients with cancer, depending on the type of cancer and their treatment(s) (e.g., chemotherapy, radiation). It is not relieved by sleep or rest, and it sometimes can persist for years after a person's cancer was treated. The fatigue can be so bad that people cannot return to work, hobbies, family roles, or other daily activities, thereby greatly reducing quality of life. The causes of this fatigue are unknown, and we currently do not have anything that can reliably prevent or cure the fatigue. However, there are recent data suggesting that circadian rhythm, or a person's internal body clock, may be disrupted by the cancer experience and contribute to fatigue. Food intake is an external cue that can entrain circadian rhythm. We recently showed that cancer survivors are willing and able to eat all their food within a 10-hour eating window-a practice called time-restricted eating. Herein, we are testing time-restricted eating against a control group (matched for time-, attention, and expectancy) to see if time-restricted eating can indeed alleviate cancer-related fatigue. All participants will be asked to use the myCircadianClock smartphone app to log their food intake and weekly body weight measurements. The participants assigned to the time-restricted eating group will be asked to eat all their food in a 10-hour window during the day. People can choose their start time based on their schedule and preferences, but we ask that the window is the same for the whole study (e.g., 7am-5pm,9:30am-7:30pm). Black coffee and unsweetened tea are allowed before the eating window, and water and medicines are allowed at all times. The participants in the control group will meet with a nutritionist to discuss the American Cancer Society nutrition guidelines in cancer survivorship; they will not be restricted to when they can eat. Participants in both groups will give us valuable information regarding how diet is related to the experience of fatigue. The purpose of this study is to test the effects of a 12-week TRE intervention vs. an unrestricted eating pattern on fatigue, the sustainability of the program at 24 weeks, and the effects of TRE on circadian rhythm and sugar metabolism.

Primary Outcome Measures: Fatigue, Multidimensional Fatigue Symptom Inventory-Short Form; the total MFSI-SF score ranges from -24 to 96 with a higher score indicating higher levels of fatigue, baseline, 6 weeks, 12 weeks
Accurate Prostate Cancer Following Using Low-Field MRI (Low-PRISM)
NCT Number: NCT06482489
Acronym: Low-PRISM
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer
Interventions: DEVICE: Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).
Sponsor: University of Lausanne Hospitals
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 74
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-07-31

Summary:
This study compares the effectiveness of low-field MRI (0.55T) with high-field MRI (3T) in prostate cancer screening and image quality. It consists of three phases: optimizing the low-field MRI protocol with healthy volunteers, evaluating image quality in patients with metallic artifacts (like hip prostheses), and assessing low-field MRI in patients with suspicious prostate lesions found on high-field MRI.

Primary Outcome Measures: Evaluate the diagnostic accuracy of 0.55T MRI in detecting prostate suspicious lesions using the PI-RADS grading score, with the results of as the reference standard., Assess the overall quality of prostate MR images obtained with 0.55T compared to 3T MRI in patients with suspected prostate cancer, using metrics of SNR, CNR and the PI-QUAL scaling score.

Evaluate the diagnostic accuracy of 0.55T MRI in detecting prostate suspicious lesions using the PI-RADS grading score, with the results of a targeted prostate biopsy as the reference., 9 months
Secondary Outcome Measures: Protocol optimization on healthy volunteers, Assess image quality at 3T MRI and optimize the trade-off between quality and scan time., 1 month|Image quality on patients with metal implants, Compare 0.55T and 3T MRI image quality in patients with implants and suspected prostate cancer, assessing PI-QUAL scaling., 9 months
Medical Students' Evaluation of Dyslipidemia and LIPoprotein(a) Study
NCT Number: NCT06482476
Acronym: MEDLIP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Insight Into the Prevalence of Elevated Lp(a) Among Greek Medical Students
Interventions: DIAGNOSTIC_TEST: Measurement of Lp(a) levels
Sponsor: University of Ioannina
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 246
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06
Completion Date: 2024-10
Locations: University Hospital of Ioannina, Ioánnina, Ioannina, 45000, Greece

Summary:
This cross-sectional study aims to determine the prevalence of elevated Lp(a) levels among volunteer medical students at the Faculty of Medicine, University Hospital of Ioannina, Greece. Data collected will include demographic information, family and medical history, as well as lifestyle habits, and the study aims to provide valuable insights into the prevalence of elevated Lp(a) among Greek medical students.

Primary Outcome Measures: Lp(a) elevated, At time of measurement|Lp(a) beneath cut-off, At time of measurement
Improving Vaccine Acceptance Through EHR Integrated Patient- and Provider-Facing Decision Support
NCT Number: NCT06482450
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vaccine Hesitancy|Vaccine Refusal
Interventions: OTHER: LetsTalkShots (patient-facing CDS)|OTHER: LetsTalkShots (provider-facing CDS)|OTHER: Appointment Reminder Message
Sponsor: Johns Hopkins Bloomberg School of Public Health
Collaborators: Children's Healthcare of Atlanta|Emory University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2025-07
Completion Date: 2026-06
Locations: Children's Healthcare of Atlanta Hughes Spalding Primary Care Clinic, Atlanta, Georgia, 30303, United States

Summary:
The goal of this project is to establish the technical feasibility of a scalable, integrated platform to improve patient informed decision-making and increase vaccine uptake and to evaluate the effectiveness of the integrated platform to improve vaccine uptake.

Primary Outcome Measures: Vaccination rate, Proportion of vaccines due that are administered at the index appointment, Baseline
Secondary Outcome Measures: Days undervaccinated, The sum of all days during which the child was undervaccinated for 1 or more doses of any vaccine(s). Undervaccination begins (per Lumen et al) starting 1 month after the initial due date of a vaccine (e.g. if a patient has not yet received a 2-month vaccine, then days undervaccinated begin accumulating when the child turns 3 months old)., Through 24 months of age|Patient Adoption as assessed by proportion of successful texts sent, Proportion of successfully sent text messages with links to patient-facing CDS that are clicked on and have questionnaires answered., Up to one year|Provider Adoption as assessed by proportion of orders opened, Proportion of provider-facing best practice advisory (BPA) alerts in which the provider opens the order set for all vaccines due., Up to one year
Cream Containing Sericin and Turmeric in Psoriasis Patients
NCT Number: NCT06482398
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Psoriasis
Interventions: DRUG: Sericin extract and turmeric extract cream|DRUG: Triamcinolone acetonide 1% Cream
Sponsor: Chulalongkorn University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-07-31

Summary:
Psoriasis lesion is divided into two parts. Half of the lesion will apply cream containing sericin and turmeric and another will apply steroid cream (control). The samples will be apply two times a day for 8 weeks. Psoriasis area and severity index, physician global assessment, body surface area of lesion, dermatology life quality index, Itching score, adverse reaction are evaluated before, after using the samples for 4 and 8 weeks.

Primary Outcome Measures: Psoriasis Area and Severity Index, Physician will evaluate the psoriasis lesion using Psoriasis Area and Severity Index. The score is graded 0 to 72 (low score means less severity and high score means high severity)., 8 weeks
Secondary Outcome Measures: Physician Global Assessment, Physician will evaluate the psoriasis lesion using Physician Global Assessment score (0 to 6, 0 means completely cleared, except for possible residual nonerythematous discoloration and 6 means condition worsened)., 8 weeks|Body surface area of lesion, Physician will evaluate body surface area of psoriasis lesion in percentage. (low percentage means the lesion area decrease and high percentage means the lesion area increase)., 8 weeks|Dermatology Life Quality Index, Patients will assess dermatology life quality score (0 to 30, 0 means high life quality and 30 means low life quality)., 8 weeks|Itching score, Patients will assess itching score using visual analogue scale (0 to 10, 0 means low severity and 10 means high severity)., 8 weeks
Transmasculine Quality of Life and Sexual Function at Pre and Post Gender-affirming Hormonal Therapy
NCT Number: NCT06482385
Acronym: transmen
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Transgender Men
Sponsor: Chulalongkorn University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-15
Completion Date: 2024-05-31
Locations: Chulalongkorn University, Pathum Wan, Bangkok, 10260, Thailand

Summary:
The goal of this prospective observational study is to evaluate the short-term effect of testosterone therapy on these issues among hormone naïve TM individuals.

The main questions that aim to answer are :

1. Comparison quality of life in transgender men at pre and post testosterone therapy
2. To evaluate the most affected domain of quality of life (QOL) and FSFI of this participants

Participants will be ask to complete two questionnaires: the World Health Organization Quality of Life BREF THAI (WHO-QOL-BREF-THAI) and the FSFI (female sexual function index) before testosterone administration and both questionnaires will be re-evaluated at 12 weeks after initiation of testosterone therapy

Primary Outcome Measures: quality of life from WHOQOLBREFTHAI questionnaire in transgender men after testosterone therapy, quality of life reporting from WHOQOLBREFTHAI questionnaire in transgender men after testosterone therapy, 3 months
Secondary Outcome Measures: To evaluate the most affected domain of WHOQOLBREFTHAI questionnaire of this participants, To evaluate the most affected domain of quality of life (WHOQOLBREFTHAI questionnaire) of this participants, 3 months|To evaluate the sexual function from Thai version of Female sexual function index questionnaire of this participants, To evaluate the FSFI from Thai version of Female sexual function index questionnaire of this participants, 3 months
A Pilot Study of Repetitive Transcranial Magnetic Stimulation
NCT Number: NCT06482372
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|Mirror Therapy|Transcranial Magnetic Stimulation
Interventions: DEVICE: transcranial magnetic stimulation
Sponsor: Cheng-Hsin General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 69
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2027-06-30

Summary:
Stroke patients often have long-term upper limb dysfunction. Currently, there is still no specific clinical treatment for nerve damage. After acute treatments of stroke, patients' motor ability can only improve by spontaneous recovery of brain and rehabilitation treatment.

Transcranial magnetic stimulation uses a magnetic field pulse generated by a coil outside the skull to pass through the skull. It uses the principle that magnetic electricity can generate currents, which activates nearby brain areas or changing the relationship between the left and right brains. Transcranial magnetic stimulation is a non-invasive, safe treatment.

Mirror therapy is an emerging rehabilitation method in recent years. As mirror therapy, therapists ask the patient to place the affected hand behind the mirror while looking at the image reflected by the unaffected upper limb. During mirror therapy, patients have to perform upper limb activities and imagine that the affected upper limb is performing the same action.

As mentioned above, transcranial magnetic stimulation and mirror therapy improve the recovery of stroke patients by two different ways. Currently, there are no studies that combine these two treatments. Therefore, our study hopes to initially explore the efficacy of transcranial magnetic stimulation and the efficacy of transcranial magnetic stimulation combined with mirror therapy.

Primary Outcome Measures: Fugl-Meyer Assessment (FMA) - upper extremity, FMA would be recorded for evaluate patients' motor function of hand., week 0, week 6, week 12|Nine-hole peg test, Nine-hole peg test would be used to measure finger dexterity., week 0, week 6, week 12|Action research arm test, Action research arm test would be used to assess upper extremity performance including coordination, dexterity and functioning., week 0, week 6, week 12|Box and block test, Box and block test would be used to assess unilateral gross manual dexterity., week 0, week 6, week 12|Functional independence measurement, Functional independence measurement would be recorded to assess a patient's level of disability as well as a change in patient status in response to rehabilitation or medical intervention., week 0, week 6, week 12
MT-3534 Clinical Pharmacology Study in Healthy Adult Male Volunteers
NCT Number: NCT06482346
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Adult Male Volunteers
Interventions: BIOLOGICAL: MT-3534|BIOLOGICAL: Placebo
Sponsor: Mitsubishi Tanabe Pharma Corporation
Sex: MALE
Age: ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2025-07
Locations: Clinical Research Hospital Tokyo, Shinjuku-ku, Tokyo, 160-0004, Japan

Summary:
This study is planned to investigate the safety, tolerability, and pharmacokinetics when a single intravenous dose of MT-3534 or a placebo is given to healthy adult male volunteers.

Primary Outcome Measures: Number of subjects with adverse events, up to Day 85|Number of subjects with adverse reactions, up to Day 85|Serum concentrations of MT-3534, up to Day 85
Timing of Resumption of Direct Oral Anticoagulants Following Polypectomy
NCT Number: NCT06482333
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postpolypectomy Bleeding
Interventions: OTHER: Time for resumption of DOAC
Sponsor: The University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 194
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-12-31
Locations: Queen Mary Hospital, the University of Hong Kong, Hong Kong, Hong Kong

Summary:
The goal of this prospective randomized non-inferiority trial is to compare two different resumption time of Direct Oral Anticoagulants (DOACs) after colonoscopic polypectomy. We hypothesize that early resumption of DOACs after colonoscopy and polypectomy is associated with comparable post-polypectomy bleeding rate to those with delayed resumption. This study aims to compare the post-polypectomy bleeding risk of two different timing of resuming DOACs (Day 0 vs Day 2):

Primary Outcome Measures: Post-polypectomy bleeding, both major and clinically relevant non-major bleeding (CRNMB), within 30 days after polypectomy during colonoscopy
Secondary Outcome Measures: Occurrence of thromboembolic events within 30 days, Occurrence of thromboembolic events within 30 days, within 30 days after polypectomy during colonoscopy
Diagnostic Accuracy in the Detection of Arrhythmias of Patient Recorded ECGs With Smart WATCH TIMEly Performed During Palpitations
NCT Number: NCT06482320
Acronym: WATCHinTIME
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Arrhythmia
Interventions: DIAGNOSTIC_TEST: Recording EKG traces on the smartwatch
Sponsor: University Hospital of Ferrara
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-01
Completion Date: 2025-10-01
Locations: Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, 44124, Italy

Summary:
Approximately 100 patients with heart palpitations over the age of 22, in possession of smartwatches capable of recording a single-lead ECG will be enrolled.

The study plans to evaluate the performance in the diagnosis of arrhythmia of single-lead ECGs self-recorded by patients during heart palpitations using a smartwatch.

Primary Outcome Measures: Compare the accuracy of physician rhythm interpretation vs interpretation of 1-lead ECG generated provided by the Watch., Compare the accuracy of physician rhythm interpretation vs interpretation of 1-lead ECG generated provided by the Watch, 3 month after the enrollment|Assessment of diagnostic accuracy of 1-lead ECGs interpretation for different cardiac arrhythmias (compared to standard ecg or h24-h holter), Assessment of diagnostic accuracy of 1-lead ECGs interpretation for different cardiac arrhythmias (compared to standard ecg or h24-h holter), 3 month after the enrollment
Secondary Outcome Measures: Compare the accuracy of automatic AF detection of the Watch versus a cardiologist interpretation of a 12-lead ECG (gold-standard), Compare the accuracy of automatic AF detection of the Watch versus a cardiologist interpretation of a 12-lead ECG (gold-standard), 3 month after the enrollment|evel of agreement of measured interval duration between the Watch 1-lead ECG and a 12-lead ECG., evel of agreement of measured interval duration between the Watch 1-lead ECG and a 12-lead ECG., 3 month after the enrollment
Molecular Imaging of DNA Damage Response by [18F]-Olaparib PET
NCT Number: NCT06482307
Acronym: [18F]-olaparib
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)
Interventions: DIAGNOSTIC_TEST: [18F]-olaparib PET scan
Sponsor: University Medical Center Groningen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-10
Completion Date: 2025-10
Locations: University Medical Center Groningen, Groningen, 9713 GZ, Netherlands

Summary:
This is a single-centre, non-randomized, two-stage design, proof-of-concept study evaluating the radiolabelled PARP inhibitor \[18F\]-olaparib als potential tracer for imaging of tumour PARP expression by PET.

Primary Outcome Measures: Dosimetry assessment, Assess dosimetry, most optimal time point for imaging (Stage I), and safety of \[18F\]olaparib PET (Stage I + II), 6-12 months|Correlation between tumour uptake and expression, Determine the correlation between tumour \[18F\]-olaparib uptake and tumour PARP-1 expression levels on tumour biopsy (Stage I + II)., 12-18 months
Secondary Outcome Measures: Evaluation of changes in tumour uptake, Evaluate changes in tumour \[18F\]-olaparib uptake, as a read-out of DNA damage, during treatment with platinum-based chemoradio-therapy, and its correlation with changes in PARP protein expression (Stage II)., 12-18 months
CIVETTA: Correlating Inflammatory Values of FEno, SympToms, SpuTum and Lung Function in Asthma
NCT Number: NCT06482294
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Asthma
Interventions: DRUG: Salbutamol|DRUG: Fluticason either Beclometasone or Budesonide
Sponsor: Università degli Studi di Ferrara
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-18
Completion Date: 2025-07-01
Locations: Research Centre on Asthma and COPD, University of Ferrara, Ferrara, 44121, Italy

Summary:
Single-center, interventional, open-label, randomized phase II study aimed at describing the changes in airway inflammation at the onset of asthma symptoms that lead to the use of rapid acting bronchodilator (RABD) as a rescue medication in a mild to moderate asthma population. The study will assess whether there are differences in the airway inflammation profile in patients using a reliever medication containing ICS (anti-inflammatory rescue strategy) compared to a reliever medication containing only a bronchodilator for symptom relief (Non anti-inflammatory rescue strategy).

Primary Outcome Measures: To evaluate airway inflammation characteristics and changes at the onset of asthma symptoms requiring as-needed therapy (RABD) and the impact of inhaled steroid therapy in addition to RABD on airway inflammation, Inflammation will be assessed as FeNO levels after an anti inflammatory rescue medication compared to a non anti inflammatory rescue medication therapy repeatedly measured up to 48 hours at defined intervals, Patients are asked to perform repeated measurements of airway inflammation from the onset of symptoms to 48 hours after the administration of the rescue medication.
Secondary Outcome Measures: Change in FEV1, The change in FEV after administration of an anti-inflammatory rescue medication and a non-anti-inflammatory rescue medication., Patients are asked to perform repeated measurements of FEV1 from the onset of symptoms to 48 hours after the administration of the rescue medication.|change in Visual Analogue Scale (VAS) scale., The change in VAS scale, used to measure the intensity of symptoms (0 lowest intensity, 10 highest intensity) after administration of an anti-inflammatory rescue medication and a non-anti-inflammatory rescue medication., Patients are asked to perform repeated measurements of VAS scale from the onset of symptoms to 48 hours after the administration of the rescue medication.
Other Outcome Measures: Change in sputum eosinophils count, The change in sputum eosinophils count after administration of an anti-inflammatory rescue medication and a non-anti-inflammatory rescue medication., Patients are asked to perform repeated sputum collections from the onset of symptoms until 48 hours after the administration of the rescue medication.
COVID-19 and Childhood Cancer
NCT Number: NCT06482281
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: COVID-19|Childhood Cancer|Childhood Leukemia, Acute Lymphoblastic
Sponsor: Karolinska Institutet
Collaborators: The Swedish Research Council|The Swedish Childhood Cancer Fund
Sex: ALL
Age: CHILD, ADULT
Enrollment: 100000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2025-12-31
Locations: Karolinska Institutet, Stockholm, 17177, Sweden

Summary:
The investigators will first examine the impact of the COVID-19 pandemic on childhood cancer patients in Sweden and Denmark, both regarding susceptibility to severe COVID-19 among long-term childhood cancer survivors, and, for those diagnosed with childhood cancer during the pandemic, whether the path through primary care to cancer diagnosis as well as short-term survival has changed. Second, the investigators will study childhood cancer incidence before, during and after the pandemic with the particular aim to test the hypothesis regarding an infectious disease etiology for acute lymphoblastic leukemia.

Primary Outcome Measures: Severe COVID-19, Defined as:

* death with COVID-19 listed as a cause of death
* hospitalization, or admission to intensive care unit, because of COVID-19 (main diagnosis) or respiratory problems (main diagnosis) AND COVID-19 as secondary diagnosis, Up to 3 years|Childhood cancer survival, Overall survival after a childhood cancer diagnosis, After three and twelve months after the cancer diagnosis and three years after cancer diagnosis|Number of contacts before childhood cancer diagnosis, Number of healthcare contacts (including primary care) the year before the cancer diagnosis, One year before cancer diagnosis|Childhood cancer incidence, Age standardized incidence rates for childhood cancer and cancer subtypes (particularly acute lymphoblastic leukemia) in Sweden and Denmark during and after the pandemic and compare it to the 5 years preceding the pandemic, From 2015
Transplantation of Human iPS Cell-derived Dopaminergic Progenitors (CT1-DAP001) for Parkinson's Disease (Phase I/II)
NCT Number: NCT06482268
Acronym: CT1-DAP001
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: PD - Parkinson's Disease
Interventions: COMBINATION_PRODUCT: Human induced pluripotent stem cell-derived dopaminergic progenitors (CT1-DAP001)
Sponsor: University of California, San Diego
Collaborators: Sumitomo Pharma America, Inc.|Kyoto University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 7
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-06-01
Completion Date: 2028-05
Locations: University of California, San Diego, La Jolla, California, 92037, United States

Summary:
To evaluate the safety and efficacy of transplantation of human induced pluripotent stem cell-derived dopaminergic progenitors, CT1-DAP001, into the corpus striatum in patients with Parkinson's disease

Primary Outcome Measures: ACCEPTABILITY, Assessed by presence or absence of graft expansion (\> 3 cm3) in the brain at 24 months after transplantation, 24 months|SAFETY, Incidence and severity of treatment emergent adverse events assessed by graft expansion and size in the corpus striatum., 24 months
Secondary Outcome Measures: QUALITY OF LIFE, Assessed by dyskinesia score, measured as the change in dyskinesia score from Baseline to each post-transplantation time point., 24 months|ACCURACY, Assessed by FDOPA (MRI) of tissue expansion The expansion on MRI will be assessed at each time point of measurement

* day before transplantation,
* immediately after transplantation,
* day after transplantation,
* 4 weeks, 12 weeks, 6 months, 18 months, (if clinically indicated)
* 12 months, 24 months after transplantation, 24 months|MDS-UPDRS Part III totalscore (at OFF time), This endpoint is defined as the change in UPDRS Part III score at OFF time from Baseline to each post-transplantation time point. The efficacy will be assessed based on MDS-UPDRS Part III total score at OFF time at 24 months after cell transplantation.

1. Excellent response defined as a decrease of ≥ 5
2. Good response defined as a decrease of 0 to 4, 24 months|MDS-UPDRS Part III totalscore (at ON time), This endpoint is defined as the change in UPDRS Part III score at ON time from Baseline to each post-transplantation time point., 24 months|Average daily ON duration (with or without dyskinesia) and OFF duration, This endpoint is defined as the change in daily ON duration (with or without dyskinesia) or OFF duration from Baseline to each post-transplantation time point., 24 months|L-dopa equivalent dose, This endpoint is defined as the change in L-dopa equivalent dose from Baseline to 4 weeks, 12 weeks, 6 months, 12 months, 18 months, or 24 months after transplantation.

Formula to convert to the L-dopa dose:

L-dopa 100 mg = pramipexole salt 1 mg = ropinirole 5 mg = rotigotine 7.5 mg = bromocriptine 10 mg = pergolide 1 mg = cabergoline 1.5 mg = selegiline 10 mg = amantadine 100 mg = apomorphine 10 mg, 24 months
"Evidence of the Use of Virtual Reality Versus Manual Therapy and Therapeutic Exercise in Rotator Cuff Injury"
NCT Number: NCT06482255
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rotator Cuff Injuries
Interventions: OTHER: manual therapy and therapeutic exercise|OTHER: manual therapy and therapeutic exercise and virtual reality
Sponsor: University of Alcala
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 108
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2024-11

Summary:
This study evaluates the effectiveness of virtual reality (VR) compared to manual therapy and therapeutic exercise in treating rotator cuff injuries. It involves 108 participants divided into two groups: one receiving VR combined with manual therapy and therapeutic exercise, and the other receiving only manual therapy and therapeutic exercise. The study spans 10 weeks, with assessments at the beginning, midpoint, and end. Variables measured include quality of life, perceived pain, shoulder disability, strength, pain intensity, and shoulder mobility. The aim is to determine if VR provides better outcomes in these variables compared to conventional treatments.

Primary Outcome Measures: Perceived pain and disability regarding the shoulder, continuous metric quantitative variable. To measure it the investigators will use the SPADI questionnaire that takes values from or to 10 in each question. Reliability is greater than 0.7, with ranges between 0.7 and 0.9, 10 weeks|strength, continuous metric quantitative variable and the investigators will measure it using the dynamometer. It has a reliability of 0.90%, making it a useful force measurement instrument., 10 weeks|Active shoulder mobility, continuous metric quantitative variable. The investigators will use an inclinometer to assess flexion, extension, rotation, abduction and adduction., 10 weeks