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NCT ID: NCT05042128 Active, not recruiting - Clinical trials for Pancreatic Ductal Adenocarcinoma

The ASCEND Study: Gemcitabine and Nab-Paclitaxel With CEND-1/LSTA1 or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma

ASCEND
Start date: April 13, 2022
Phase: Phase 2
Study type: Interventional

The purpose of the ASCEND clinical trial is to measure the effect of adding CEND-1/LSTA1, compared to placebo, to chemotherapy (gemcitabine and nab-paclitaxel) in patients who have untreated metastatic pancreatic cancer. The study will assess the duration which the cancer remained stable or improved, the number of patients who responded to treatment, overall survival, side effects and quality of life.

NCT ID: NCT05119582 Active, not recruiting - Clinical trials for Cutaneous Neurofibroma

HIFU Treatment of Cutaneous Neurofibromas in Neurofibromatosis Type 1: Safety and Efficacy

cNF-HFU2101
Start date: April 13, 2022
Phase: N/A
Study type: Interventional

The overall objective is to demonstrate safety and efficacy of HIFU treatment of cutaneous neurofibromas located close to the surface of the skin in patients with the genetic disease Neurofibromatosis Type 1. The study will use a new investigational equipment that has been specially developed for dermatological therapy. The study includes 20 patients in total distributed between the two centers, each having a minimum of 8 cutaneous neurofibromas eligible for treatment. All participants are adults (over 18 years) of both sexes. The new treatment method is based on focusing intensive ultrasound just below the skin surface. This creates a very fast localized heating in small and very well-defined volumes containing neurofibroma tissue. This heating destroys or weakens the tissue, and the body's natural processes will subsequently transport affected cells away through the lymphatic and vascular systems. During the healing-process, the rejected tissue is replaced by new skin cells that are not expected to be fibrous. The treatment is intended to be carried out without breaking the skin surface, and open wounds are therefore avoided. This is an essential advantage of the method compared to all existing therapies, which are based on physical removal of tumors through an open skin surface (e.g. surgery or laser therapy). Complications with risk of pain, infection and scarring will therefore be significantly reduced with the new proposed method. The treatment is carried out by sending focused ultrasound from the handpiece of the equipment into the target area with neurofibromas. The equipment is set to send doses of approximately 150 milliseconds (0.15 seconds). The skin area and HIFU doses can be followed on the system computer screen and will be placed side-by-side with approximately 1-2 millimeter spacing. To achieve good energy transfer from handpiece to skin, ordinary ultrasound gel is used. There are no other special pre-treatments or preparations for the process. HIFU treatment is expected to be less painful than other treatments used. The treatment is quick, and typically takes less than 1 minute for a each area the size of a typical neurofibroma.

NCT ID: NCT05138068 Active, not recruiting - Clinical trials for Social Anxiety Disorder

Social Anxiety MDMA-Assisted Therapy Investigation

SAMATI
Start date: April 13, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, open-label delayed treatment study to assess the safety and effect of MDMA-assisted therapy in treating 20 participants diagnosed with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype. This study will obtain an estimate of effect size for two experimental sessions of MDMA-assisted therapy for the treatment of social anxiety disorder on measures of safety, social anxiety, functional outcomes, psychiatric symptoms, and putative mechanisms of action. The primary outcome for this study will be the Liebowitz Social Anxiety Scale (LSAS) administered by a blinded Independent Rater (IR). Other assessments, including physiological, self-report, and behavioral tasks will be used to assess other exploratory variables. An additional aim of the trial will be the development of a treatment manual for MDMA-AT for SAD for future research.

NCT ID: NCT05242497 Active, not recruiting - Clinical trials for Lumbar Spinal Stenosis

Effectiveness and Safety of Pharmacopuncture Therapy for Patients With Lumbar Spinal Stenosis

Start date: April 13, 2022
Phase: N/A
Study type: Interventional

This is 1:1 pragmatic randomized controlled trials in a parallel-grouped, multi-centered design that investigated pharmacopuncture therapy for patients with lumbar spinal stenosis, compared to the conservative treatments including physiotherapy and pharmacological treatments.

NCT ID: NCT05260021 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both

SURPASS-PEDS
Start date: April 13, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both. The overall study will last about 60 weeks with up to 14 clinic visits and 6 phone visits. Clinic visits will include blood sample collection, physical exam and questionnaire.

NCT ID: NCT05737784 Active, not recruiting - Epilepsy Clinical Trials

A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy

Start date: April 13, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this trial is to learn about the effect of PRAX-222 in pediatric participants with early onset SCN2A developmental and epileptic encephalopathy (DEE), aged 2 to 18 years.

NCT ID: NCT05826639 Active, not recruiting - Biliary Stricture Clinical Trials

A Study of Endobiliary Radiofrequency Ablation in Malignant Biliary Obstructions

Start date: April 13, 2023
Phase:
Study type: Observational

The purpose of this study is to assess the impact of temperature-sensitive radiofrequency ablation (RFA) immediately before biliary stent placement on duration of biliary stent patency and re-intervention free survival. This is a research study meant to collect information to help other patients with malignant biliary strictures in the future.

NCT ID: NCT05875233 Active, not recruiting - Clinical trials for Polycystic Ovary Syndrome

A Study to Evaluate the Effect of Elix Cycle Balance and Daily Harmony on Polycystic Ovary Syndrome

Start date: April 13, 2023
Phase: N/A
Study type: Interventional

This is a virtual, open-label, 2-armed study that will last 6 months. All participants will take the supplements daily and complete questionnaires at baseline and at the end of weeks 4, 8, 12, 16, 20, and 24 (study may be concluded at week 20 if results are seen earlier). The study will involve 70 participants with polycystic ovary syndrome (PCOS), 35 who are on hormonal birth control, and 35 who are not. A subgroup of 20 participants from the non-birth control group, who experience hormonal acne/frequent hormonal breakouts will provide photographs of the face for expert skin grading at baseline, week 12, week 20, and week 24 (if the study is continued until week 24). Questionnaires will be used to monitor changes in the menstrual cycle (regularity, frequency, predictability), bloating, fluid retention, weight gain, mood (mood swings, anxiety, mental clarity/focus, brain fog), pain, fatigue, acne, facial/bodily hair, and sleep quality. Expert skin grading will be carried out by a dermatologist to monitor changes in acne and skin clarity indicative of systemic effects of androgen excess. Likert scale responses will be statistically compared from baseline to each check-in. Participant responses on product feedback will be presented as % scores.

NCT ID: NCT06324370 Active, not recruiting - Clinical trials for Pharmacological Action

Exploratory Pharmacokinetic Study of Virgin Coconut Oil (VCO)

Start date: April 13, 2023
Phase: N/A
Study type: Interventional

This is a balanced, open-label, single- and multiple-dose pharmacokinetic (PK) study of virgin coconut oil (VCO) among healthy Filipino male adults 18-45 years of age in Dasmariñas, Cavite. This study aims to determine the rate and extent of absorption of virgin coconut oil (VCO) administered in healthy male human study participants under fed conditions in single and multiple doses and to monitor the safety and tolerability of virgin coconut oil (VCO) following the standard protocol developed by the De La Salle Medical and Health Sciences Institute (DLSMHSI).

NCT ID: NCT06368778 Active, not recruiting - Physical Therapy Clinical Trials

Real-Time Biofeedback on Partial Weightbearing Training

Start date: April 13, 2023
Phase:
Study type: Observational

The purpose of this study is to investigate the effectiveness of a biofeedback device (Loadsol) in training healthy subjects to comply with partial weightbearing, and to compare its outcomes with the standard of care training. Partial weightbearing is an essential component of rehabilitation and recovery for many orthopedic patients, yet it remains challenging for individuals to accurately gauge their weightbearing restrictions without proper guidance and feedback. The primary objective of the study is to determine whether the use of the biofeedback device (Loadsol) can reduce the time it takes for healthy subjects to learn and comply with partial weightbearing, compared to traditional training methods. The Loadsol device provides real-time auditory feedback on the individual's weightbearing status, potentially enhancing the learning process and adherence to weightbearing restrictions. Secondary objectives of the study include: Assessing the compliance of subjects with weightbearing restrictions in both the biofeedback and standard of care training groups, and comparing the results to identify any significant differences in adherence to the prescribed weightbearing limitations. Evaluating subject satisfaction with the training methods, as measured through questionnaires and the use of Patient-Reported Outcomes Measurement Information System (PROMIS) tools. This evaluation will help determine if the biofeedback device (Loadsol) leads to higher levels of satisfaction among subjects compared to the standard of care training. By examining these objectives, this study aims to provide valuable insights into the potential benefits of using a biofeedback device in partial weightbearing training, and to establish whether its implementation can lead to improved outcomes in learning, compliance, and overall patient satisfaction.