cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effectiveness of Photodynamic Therapy in the Treatment of Lesions of the Lichen Planus Type in the Oral Mucosa and Its Diagnostics With the Use of Autofluorescence, in Various Wavelength Ranges, in Combination With the Use of Texture Analysis and Fractal Dimension

Lesions of the lichen planus type within the oral mucosa are now considered a potentially cancerous condition. One of the minimally invasive methods of treating these lesions is photodynamic therapy, and the gold standard in therapy is topical steroid administration

Lichen planus shows an irregular shape, which is quite difficult to measure objectively, which is important in assessing the effectiveness of treatment.

Patients will be treated in protocol split mouth with the treatment of lesions on one cheek with a steroid (on an adhesive plaster) and on the other - photodynamic therapy with a foot sensitizer in the form of a methylene blue also on an adhesive plaster The treatment evaluation procedure will consist of taking a series of intraoral photographs. These photos will be taken at each visit. This procedure will involve taking pictures traditionally in "white" light and in the spectrum of 405 nm, 460 nm and 405 + 460 nm (using the unique feature of the prototype laser - emission of two wavelengths simultaneously) in order to induce autofluorescence of the mucosa and treated lesions to better visualize them

A prospective, randomized, single-blind 12-week clinical trial of full contralateral split-mouth in patients with bilateral erythematous or erosive lichen planus in the mouth.On one side, the OLP lesion eligible for treatment was subjected to photodynamic therapy using methylene blue in four sessions every 2 days.

olp on the other side was treated with the administration of the steroid triamcinolone for 8 days

The clinical evaluation of the evolution of OLP eruptions was performed within 12 weeks of qualifying for treatment: at baseline, at the end of both treatments (day 8) and after the next 11 weeks

Eligibility Criteria:
Inclusion Criteria:

* histological diagnosis of OLP
* non smoker
* no diabetes melitus
* no hepatitis

Exclusion Criteria:

* diabetes melitus
* hepatitis
* occurrence dysplasia in the histopathological specimen;
* use of lichenoid reaction inducing medication and presence of amalgam fillings nearby the lesions;
* interventions for OLP in the previous 12 weeks;
* pregnant or breastfeeding women;
* proved or suspected hypersensitivity to any of the chemicals used in the treatment
Long Term Follow-up Observational Study in Patients Treated with Gene-Modified T-Cell Therapy

This is a prospective long-term follow-up (LTFU) study to evaluate the long-term safety and survival benefit for patients who received at least one of CARsgen's GM T cell product in a clinical trial or as a commercially available product. In this study, patients will be followed for up to 15 years after last GM T-cell infusion for the evaluation of delayed adverse events (AEs), vector persistence, potential risk for integration, and survival time due to GM T-cell exposure.

As recommended by Health Authorities guidelines for human gene therapy products containing an integrated transgene, during the LTFU for 15 years after infusion, the information of the enrolled patients will be collected, including medical history, physical and laboratory-related examination data, AEs, survival information, etc. AEs recorded will include new malignancy, new or exacerbation infection, new or exacerbation neurological disease, new or exacerbation autoimmune disease etc. Samples will be obtained according to the schedule of activities, and laboratory tests will be conducted or preserved for future use.

All participants are recommended to be followed at least every six months for the first 5 years, and annually from the 6th year until at least 15 years or until informed consent withdrawal, loss to follow-up, or death, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

- 1. All patients who have received at least one GM T-cell infusion in the parent clinical study or in the post-approval setting.

2. Patients must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For patients incapable of providing consent, the signed ICF of their legally accepted guardians must be obtained.

Exclusion Criteria:

* There are no specific exclusion criteria for this study.
The Effects of a Novel Lifestyle Intervention Program on Insulin Sensitivity in Type 2 Diabetes

Moderate weight reduction by a moderately hypocaloric very-low-fat diet resulted in normalization of fasting hyperglycemia and reversal of hepatic insulin resistance in patients with poorly controlled type 2 diabetes. The Diabetes Remission Clinical Trial (DiRECT) revealed that utilizing a total diet replacement by a low-energy formula diet for 3 months led to a 15 kg or more weight loss in 24% participants and diabetes remission 46% of the participants. To date it remains unknown whether similar results can be achieved with a natural, non-formula based diet in connection with an educative smartphone application and telephone coaching

24 patients with type 2 diabetes from the German Diabetes Study (GDS) with less than 4 years disease duration and not receiving insulin were included in this study. Before the start of the intervention, participants documented their dietary intake by recording a food diary. During the 12-week intervention participants were asked to adhere to a real food-based low-calorie diet supported by an app-guided digital education program as well as a low-calorie recipe book and received weekly coaching calls by nutritionists. Patients were instructed to adhere to a balanced low calorie diet during the intervention. Nutritionists provided structured behavior change focusing on dietary advice, adherence to logging dietary intake and tracking weight. At first visit, patients installed the Changing Health App (Changing Health, Newcastle, UK) and completed an app-based digital education program. This program focused on type 2 diabetes education and behavioral change in combination with weight tracking and dietary monitoring. Patients used the app throughout the study and adherence was monitored via logins. Comprehensive testing before and after the intervention comprised a mixed-meal tolerance test and liver fat.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* Existing diagnosis of type 2 diabetes
* Individuals who use a smartphone or PC to install the app
* Individuals who are able to communicate in German

Exclusion Criteria:

* Physical disability that leads to a significant lack of mobility (wheelchair, walking aid, walking stick, cane or crutches)
* Insulin therapy
Optimizing Care Transition Process for Older Colorectal Surgery Patients

The goal of this study to test if a care transition intervention designed for older colorectal surgery patients would improve outcomes after discharge. It will assess the feasibility of the intervention.

The period following discharge poses particularly high risks for older colorectal surgery patients. Nearly a quarter of these patients are readmitted within a month of discharge due to a variety of issues including medication errors, surgical complications, imbalance in fluid or nutrition, or worsening of pre-existing chronic diseases.Recognizing the complex interplay of these factors, it isa more comprehensive approach is imperative to improve post- operative patient care. Geriatrics co-management programs incorporate interdisciplinary patient management approaches and geriatric principles to improve outcomes in older surgical patients.The OSCAR program is an integrated care model developed by geriatricians in collaboration with colorectal surgeons that combines geriatrics co-management with postoperative surgical care for older colorectal surgery patients. The care transition intervention (CTI) is a well-established care transition model that focuses on four domains at discharge: 1) medication self-management, 2) the personal health record, 3) timely primary care/specialty care follow-up, and 4) knowledge of red flags that indicate a worsening in condition. CTI involves interactions with a trained transition coach, both in-person visits and phone calls over four weeks. In this study, the goal is to bridge the gap between inpatient and post-discharge phases and mitigate the risk of hospital readmissions through adaptation and combination of the core components of a geriatric surgery core co-management (OSCAR) program with the core components of a care transition (CTI) program by applying an implementation research approach. By customizing OSCAR co-management model with the CTI intervention model, the investigators will leverage their strengths and, efficiently address the unique requirements of both patients and the healthcare environment. The investigators will conduct a pilot feasibility hybrid type I implementation effectiveness trial of OSCAR-CTI.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>65 years old)
* Scheduled to undergo an elective colorectal surgery procedure
* Ability to provide informed consent

Exclusion Criteria:

* Emergent, non-elective colorectal procedures
* Non-English Speaking
Comparison of O-type Hybrid Knife and IT Knife in ESD

By combining injection and dissection capability together, O-type Hybrid knife could possibly shorten the endoscopic submucosal dissection procedure for upper gastrointestinal neoplasms.

Endoscopic submucosal dissection (ESD) has been accepted as an minimal invasive alternative to surgery for localized early upper gastrointestinal neoplasms recently. However, the procedure remains to be technically challenging and time consuming. Many modified methods or newly developed devices were developed to simplify the procedure. A new insulated tip dissecting knife (O-type Hybrid knife) has been recently developed with both injection and lateral cutting capability. The aim of this study was to investigate whether ESD procedure could be shortened with this new device.

Eligibility Criteria:
Inclusion Criteria:

* Gastric or esophageal adenoma or early cancer which is eligible for conventional ESD indications
* The patients who agreed informed consent

Exclusion Criteria:

* Recent drug history of anticoagulant or antiplatelet agent within 7 days
* Recurrent gastric or esophageal adenoma or early cancer
* Pregnant or breast feeding patients.
Effect of the Pelvic Loin Musculature Training on the Dynamic Hip Stabilization

Introduction: The stability of the pelvis is of great importance in body balance as a whole, can be improved by training the pelvic muscles fillet (MLP), which is characterized by low intensity isometric synchronous and the deep muscles of the trunk. This study aims to determine the effect of a stability program target, with the training of the MLP region on pelvic stability.

This study aims to determine the effect of a stability program target, with the training of the MLP region on pelvic stability. Materials and Methods: We recruited 20 volunteers of both sexes were randomly divided into control group (CG) and training group (TG). The evaluations were performed before and after training the MLP. The training was held four isometrics series with a time of 30 seconds with 30 seconds rest in between reps during 10 sessions distributed twice weekly.

Eligibility Criteria:
Inclusion Criteria:

* considered individuals of both sexes, aged 18 and 35
* absence of low back pain
* lack of musculoskeletal dysfunction in the lower limbs
* have never participated in any stabilization training program of the MLP region
* agree to the Terms Informed consent form (ICF) and the sign voluntarily.

Exclusion Criteria:

* the study of abandonment by a participant
* the disagreement with the terms of IC and its not signing
* the volunteer does not understand the implementation of dynamic hip stabilization test
* present cramps or pain during the test and / or training
* historical column in injury, knee and / or ankle.
Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)

The purpose of this study is to evaluate the efficacy and safety of gefapixant in participants with recent onset chronic cough (duration \>8 weeks after onset of cough symptoms) for \<12 months and a diagnosis of refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in improving cough-related quality of life measured as change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12.


Eligibility Criteria:
Inclusion Criteria:

* Chest radiograph or CT thorax (within 1 year of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease, in the opinion of the principal investigator or the subinvestigator
* Has chronic cough (defined as duration of \>8 weeks after onset of cough symptoms) for \<12 months prior to the screening visit (\<14 months after onset of cough symptoms)
* Has a diagnosis of refractory chronic cough or unexplained chronic cough
* Female participants are not pregnant, not breastfeeding, not of childbearing potential, or agree to follow contraceptive guidance

Exclusion Criteria:

* Is a current smoker
* Has given up smoking within 12 months of screening
* Is a former smoker with a smoking history greater than 20 pack-years (1 pack of 20 cigarettes per day for 20 years)
* Has a history of respiratory tract infection or recent change in pulmonary status within 4 weeks of screening
* Has a history of chronic bronchitis, defined as cough that produces \>1 tablespoon of phlegm, that occurs every day for at least 3 months in a row
* Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or cervical cancer
* Is a user of recreational or illicit drugs or a recent history (within the last year) of drug or alcohol abuse
* Has a history of anaphylaxis or cutaneous adverse drug reaction to sulfonamide-containing drugs
* Has a known allergy to gefapixant or its excipients
* Has donated or lost ≥1 unit (\~300 mL) of blood within 8 weeks prior to first dose of gefapixant
* Has previously received gefapixant
* Is currently participating or has participated in an interventional clinical study within 30 days of participating in this current study
Fluvastatin Versus Hepatitis C Virus

This is a dose finding and efficacy trial for fluvastatin versus hepatitis C.

Four different oral doses of fluvastatin will be used for 14 days and the viral load of hepatitis C will be measured weekly. This has been extended to different doses for 9-12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* HCV RNA positive

Exclusion Criteria:

* Testing positive for alcohol or marijuana
Surgery With Implantable Biodegradable Carmustine (BCNU) Wafer Followed by Chemo for Patients With Recurrent Glioblastoma Multiforme

The purpose of this research study is to try and identify a more effective treatment plan to improve survival rates for patients with a recurrent Glioblastoma Multiforme (GBM) brain tumor that can be removed by brain surgery.

The study will record what effects (good and bad) the combination of surgery with chemotherapy wafers inserted in the spot where the patient's tumor was during your surgery and post-operative chemotherapy has on the patient and their survival rate over the next 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically proven diagnosis of GBM in the past with MRI findings compatible with disease recurrence. Multifocal disease is permitted.
* Must have had prior treatment with standard doses of Temodar
* KPS \>50; ECOG \<3
* Predicted life expectancy of \> 3 months
* Study entry must be within 5 weeks of surgical resection

Exclusion Criteria:

* Prior exposure to VEGF inhibitors or Irinotecan
* Intracranial bleed as defined by CT or MRI less than 6 months prior to entry
* GI bleed less than 6 months prior to entry
* Uncontrolled concurrent illness that would limit compliance with study requirements
Autonomic Recalibration

The goal of this clinical trial is to learn if Autonomic Recalibration works to reduce sympathetic dominance to alleviate dysfunctional myofascial pain. The main questions it aims to answer are:

How is the Autonomic Nervous System (ANS) affected during Autonomic Recalibration Treatment (ART)? How are myofascial tissue properties impacted from ART?

Participants will:

Have 2 treatments of ART on consecutive days. Wear sensors to track HRV (heart rate variability) and GSR to verify autonomic recalibration.

Measure changes in range of motion by wearing a Rokoko motion capture suit. Measure changes in muscle stiffness through shear wave elastography.

Myofascial pain contributes to opioid misuse and opioid use disorder. Alternative non-drug therapies for myofascial pain, such as osteopathic manipulative treatment, are critical areas of research. An unexplored approach in osteopathic manipulative treatment is recruiting the regulatory assistance of the autonomic nervous system (ANS) to alleviate myofascial pain. Autonomic Recalibration Technique (ART) is a manual and behavioral approach that employs osteopathic principles in addressing the neurobiological mechanisms that regulate myofascial pain. Our central hypothesis is that ART utilizes ANS regulation to restore myofascial function and alleviate chronic myofascial pain. The scientific premise of this proposal is the need to document mechanistic evidence that the ANS can be recruited to alleviate and eliminate pain by employing osteopathic principles. While elements of this approach have been employed by various practitioners, including manual and integrative clinicians including osteopaths, the innovation is to combine a manual bottom-up approach to shut down sympathetic tone, and a top-down approach to address trauma-based triggers that propagate pain. If successful, these preclinical data will be used in future grants to propose a clinical trial of ART as an additional technique in osteopathic manipulative treatment to provide an alternative to surgical or drug treatment of chronic myofascial pain.

Eligibility Criteria:
Inclusion Criteria:

* dysfunctional myofascial pain, i.e., ongoing pain not relevant to an acute perturbation (e.g., recent injury) or known underlying condition (e.g., cancer).

Exclusion Criteria:

* known skin allergies to gel as found in common cosmetic or household products
* can't make treatment appointments on two consecutive days
* myofascial pain is deemed functional (normal response to acute injury or ongoing pathology)
* lacking a COVID-19 vaccination and a booster shot.
Effect of Soleus Muscle Push Ups on Oxidative Stress and Inflammatory Markers, Soleus Endurance, and Adipocytokines Between Type 2 Diabetic, Overweight/Obese and Normal Weight Individuals.

The study aims to investigate the impact of Soleus Push Ups (SPU) on Soleus Muscle endurance, Oxidative Stress Markers, Inflammatory markers and Adipocytokines among people in the United Arab Emirates. This will be a pre-post intervention study with participants divided into three groups: Lean normal metabolic profile, metabolically healthy overweight/obese, and patients with Type 2 Diabetes Mellitus. Assessment of anthropometry and body composition, Soleus Muscle Endurance, blood tests for Inflammatory Markers, Oxidative Stress Markers, and Adipocytokines will be conducted pre and post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* Residents of UAE, both males and females
* Ages 20-50 years
* Uncomplicated Type 2 Diabetic on meds,
* Normal lean BMI
* Overweight and Obese

Exclusion Criteria:

* Recent orthopedic surgery in the LLs
* Pain in the LLs starting from Hips to Ankle.
* Presence of Varicose Veins in the LLs
* Present History of any cardiovascular condition
* Pregnant females
* Morbid Obesity
* Diabetics undergoing Insulin therapy only
* Smokers and alcohol consumption
Follow up Study(Phase 1) to Evaluate Safety of Autologous Bone Marrow Derived MSCs in Erectile Dysfunction

This is a 5year (+-30 days) long term follow up study to evaluate the safety of autologous bone marrow derived mesenchymal stem cell in erectile dysfunction subject who participated in and completed the Phase 1 trials (refer to ClinicalTrials.gov.Identifier: NCT02344849).

This is a 5year (+-30 days) long term follow up study to evaluate the safety of autologous bone marrow derived mesenchymal stem cell in erectile dysfunction subject who participated in and completed the Phase 1 trials (refer to ClinicalTrials.gov.Identifier: NCT02344849).

This trial is planned to evaluate the safety of autologous bone marrow derived mesenchymal stem cell in patients with erectile dysfunction subject. Subjects who signed this follow-up observation informed consent form will participate in a safety assessment (tumor marker test, Serious Adverse Events, cancer incidence, recurrence of prostate cancer and vital sign).

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who treated with Mesenchymal stem cell and enrolled the phase 1 study(NCT02344849).
2. Subjects who can agree to participate in the long term observation study by oneself.

Exclusion Criteria:

* Not Applicable
A Hospital-based Postnatal Parent Education Intervention About Infant Immunizations

Immunization injections are the most common recurring painful medical procedure undertaken in childhood. Numerous evidence-based and feasible interventions are available to mitigate immunization pain, however, there is low uptake of these interventions in clinical practice, revealing a knowledge-to-care gap between what is known about pain and pain management. This is a 4-year single-centre, randomized, parallel 3-group add-on trial that will enrol 3420 mothers hospitalized following the birth of an infant at Mount Sinai Hospital (MSH) in Toronto. The trial will evaluate and compare the impact of two levels of intensity of maternal education about pain management during infant immunizations ('low': pamphlet vs. 'high': pamphlet + video) compared to placebo control after the birth of an infant on maternal behaviour during future infant immunizations at up to 6 months of age (use of analgesic interventions), maternal knowledge and attitudes about pain and pain management up to 6 months after birth.


Eligibility Criteria:
Inclusion Criteria:

* mothers rooming in with infants on postnatal ward

Exclusion Criteria:

* mothers with significant psychiatric conditions
* mothers unable to communicate in English
* mothers sharing room whereby another mother already participated