cyrilzakka/clinical-trials huggingface dataset:
Patients With Diabetic Neuropathy Who Receive Physiotherapy Treatment Will Have a Decrease in Diabetic Foot Ulcers

This study evaluates the effects of a physiotherapy protocol (manual therapy and exercise) in the prevention of diabetic foot ulcers in patients with diabetic neuropathy. A group of participants will receive a physiotherapy protocol added to their usual medical treatment and the other group will not receive physiotherapy treatment.

Neuropathic diabetic patients present alterations in joint mobility, plantar pressures and ankle and foot function, characteristics related to the development of ulcers.

In previous studies, it has been observed that physiotherapy protocols have produced improvements in joint mobility, magnitude of plantar pressures, distribution of plantar pressures, and improved function in the ankle and foot.

A 12-week progressive physiotherapy protocol composed of manual therapy and exercise could produce changes in foot and ankle characteristics in diabetic neuropathic patients related to tissue damage, resulting in a reduction in ulcerations.

Eligibility Criteria:
Inclusion Criteria:

* Participants with diabetes mellitus type 1 or type 2
* Patients with diabetic neuropathy
* Patients with no previous history of ulcers
* Patients with no previous history of lower limb amputations

Exclusion Criteria:

* Patients with neurological or orthopedic problems that make walking difficult (spasticity, cerebral palsy, poliomyelitis, rheumatoid arthritis)
* Severe vascular complications (arterial or venous ulcers)
* Patients with critical ischemia
* Patient who need walking aids (canes, crutches, splints etc.)
* Patients with a history of neuropathy with different etiology from diabetes mellitus.
* Patients with peripheral nervous lesions (traumatic origin, associated with surgical procedures, compression of spinal roots, plexus palsy, herpes zoster, polyradiculopathy, etc.)
A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma

This study will enroll approximately 160 adult participants who have relapsed or refractory (r/r) iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is made from the participants own white blood cells which are genetically modified and grown to fight cancer. An objective response rate of 70% is targeted.

All enrolled participants will be screened for eligibility then will undergo leukapheresis to collect white blood cells for manufacturing. In preparation for the infusion with axicabtagene ciloleucel, participants will undergo conditioning chemotherapy with cyclophosphamide and fludarabine for 3 days to help the study treatment be effective. After the product is manufactured and conditioning chemotherapy period is complete, participants will be infused with axicabtagene ciloleucel and then monitored in a hospital for a minimum of 7 days. After completing at least 60 months (FL participants) or at least 24 months (MZL participants) of assessments in this study since the initial axicabtagene ciloleucel infusion and after agreement by the Sponsor, participants will transition to a long-term follow-up (LTFU) study, KT-US-982-5968 where they will complete the remainder of the 15 year follow-up assessments.

Eligibility Criteria:
Key Inclusion Criteria:

1. Individual has \[follicular lymphoma or marginal zone lymphoma that has progressed after at least 2 lines of treatment with combination chemoimmunotherapy\] (e.g. R-bendamustine, R-CHOP).
2. Individual has \[measurable disease\].
3. Individual has no known presence or history of central nervous system (CNS) involvement by lymphoma.
4. If individual is on conventional systemic therapy or systemic inhibitory/stimulatory immune checkpoint therapy, individual is able to stop conventional therapy 2 weeks or 5 half-lives, whichever is shorter, or immune checkpoint therapy 3 half-lives prior to planned leukapheresis.
5. Individual has Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and adequate renal, hepatic, pulmonary, and cardiac function
6. Individual is not pregnant or breastfeeding (female individuals only) and is willing to use birth control from the time of consent through 12 months following chimeric antigen receptor (CAR) T cell infusion (both male and female individuals).

Key Exclusion Criteria:

1. Transformed follicular lymphoma (FL) or marginal zone lymphoma (MZL)
2. Small lymphocytic lymphoma
3. Histological Grade 3b FL
4. Individual will have undergone autologous transplant within 6 weeks of planned leukapheresis or has undergone allogeneic transplant.
5. Individual has evidence of involvement of the heart by lymphoma or requirement for urgent therapy due to ongoing or impending oncologic emergency (e.g. mass effect, tumor lysis syndrome, etc.)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures

The purpose of this study is to examine the safety of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.


Eligibility Criteria:
Inclusion Criteria:

* Have completed the maintenance period of the P09-004 study.
* Continue to be treated with a stable dose of 1 to a maximum of 3 approved concomitant AEDs.
Αdherence and Persistence to Oral Anticoagulation in ΑF Patients With Previous Ischemic Stroke

The aims of this project are to:

1. investigate the adherence and persistence to anticoagulation (and in specific, to VKAs and NOACs) in AF patients with previous ischemic stroke;
2. identify predictors of poor adherence and persistence and
3. assess whether the SAMe-TT2R2 score predicts adherence and persistence to anticoagulation

Patients with ischemic stroke and atrial fibrillation (AF) have a high risk of stroke recurrence, which is the highest among all other pathogenetic subtypes of stroke. This risk is substantially reduced with anticoagulant treatment. For many decades, vitamin-K antagonists (VKA) were the only anticoagulant choice for these patients. However, a number of limitations such as narrow therapeutic window, need for frequent INR measurements and consequent dose adjustments, risk of haemorrhagic complications, food-drug and drug-drug interactions, and others, have undermined the use of anticoagulation by both patients and physicians with apparent influence on the risk of stroke recurrence. During the last decade, four non-vitamin K antagonist oral anticoagulants (NOAC) have been successfully introduced and showed superior safety and efficacy profile than VKAs, more convenient dosing schemes (i.e. no need for adjustments) and minimum interactions with food and drugs. These advantages of NOACs vs. VKAs may have obvious implications to patient adherence to treatment and, consequently, to the efficacy of secondary stroke prevention. Nevertheless, there are only very scarce data available yet that the adherence and persistence to NOACs is higher than the adherence and persistence to VKAs in the specific population of patients with ischemic stroke and atrial fibrillation.

Recently, the SAMe-TT2R2 score has been introduced as a means to identify those AF patients who have inadequate quality of anticoagulation with VKAs expressed as Time within Therapeutic Range (TTR)5. In specific, VKA-anticoagulated AF patients with a SAMe-TT2R2 score of 0-2 are expected to have a TTR \>65%, whereas patients with a score of \>2 are expected to have lower TTR levels. In this context, one could hypothesize that increased SAMe-TT2R2 score may be associated with inadequate adherence and persistence to VKAs. Other parameters associated with inadequate adherence and persistence in the general AF population include education, employment, social status, and cognitive function. However, this is not well investigated in the specific population of patients with previous stroke where other conditions such as age and functional neurological status may also play an important role in adherence and persistence.

Eligibility Criteria:
Inclusion Criteria:

* Previous ischemic stroke
* Atrial fibrillation
* Age \>18 years
* Informed consent

Exclusion Criteria:

-
Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block

Abdominal wall hernias are common, with a prevalence of 1.7% for all ages and 4% for those aged over 45 years. Inguinal hernias account for 75% of abdominal wall hernias, with a lifetime risk of 27% in men and 3% in women. Repair of inguinal hernia is one of the most common operations in general surgery

The peripheral nerve block usage is increasing in popularity because it decreases pain as estimated by visual analogue scores/numerical rating pain scores postoperatively and decreases the need for postoperative analgesic usage thereby reducing opioid induced side effects like postoperative respiratory depression, nausea, vomiting, NSAID induced gastritis etc. Nerve blocks also shorten Post-Anesthesia Care Unit stay time, and also increases patient satisfaction .

Ultrasound-guided peripheral nerve blocks including ilioinguinal/ iliohypogastric nerve block and transversus abdominis plane block have been widely used and considered as effective traditional techniques for postoperative analgesia in inguinal hernia repair .

In recent years, the quadratus lumborum (QL) block is proposed to be an alternative regional block for both upper abdominal surgery and lower abdominal surgery.

The blockade of ilioinguinal/iliohypogastric nerves in the anterior abdominal wall has improved postoperative analgesia after open inguinal hernia repair and many other procedures.

The Quadratus Lumborum (QL) Block is a regional anesthetic technique which described by anesthesiologist "DR Rafael Blanco" in 2007. Quadratus Lumborum block allows the local anesthetic agent to spread between the posterior aspect of the Quadratus Lumborum muscle and the middle layer of the Thoracolumbar fascia, which is nearer to the thoracic paravertebral space. It has four approaches based on the point of drug deposition in relation to quadratus lumborum muscle. Drug is deposited on the anterolateral, posterior, anterior to the Quadratus Lumborum muscle in the three approaches. In fourth approach drug is deposited intramuscularly. It provides postoperative analgesia for longer duration .

Eligibility Criteria:
Inclusion Criteria:

1. all patients undergoing elective or emergent unilateral inguinal hernia repair
2. Patients scheduled for unilateral inguinal hernia repair

Exclusion Criteria:

1. Patient refusal.
2. Contraindication to neuraxial block.
3. neuromuscular diseases (as myopathies, myasthenia gravies).
4. Hematological diseases, bleeding or coagulation abnormality.
5. Uncontrolled Psychiatric diseases,
6. Local skin infection and sepsis at site of the block.
7. Known intolerance to the study drugs.
8. Body Mass Index \> 40 Kg/m2,
9. Unstable cardiovascular condition
Role of Inflammatory Markers in Sepsis

A diagnostic and prognostic study, in which the expression of CD64 in activated neutrophils and CD64 and IL17A regulatory T cells in patients with sepsis will be evaluated as a probable marker for sepsis as a primary objective


Eligibility Criteria:
Inclusion Criteria:

* Cancer patients admitted to the surgical ICU following cancer related surgeries and diagnosed with sepsis

Exclusion Criteria:

* Refusal of patient or patient guardian to participate.
* Intraoperative massive blood loss and massive blood transfusion
* Patients with impaired preoperative kidney or liver function tests
Sick Leave, Work Disability and Quality of Life in Korean Patients With Inflammatory Bowel Diseases

Inflammatory bowel diseases (IBD) is a chronic inflammatory condition of the gastrointestinal tract that significantly affects quality of life of patients.

Several studies have reported that the loss of work productivity is significantly higher than that of the general population due to disease-related symptoms and various factors in patients with inflammatory bowel disease in Western countries, but there is few data in Korea.

Therefore, this study is to assess the effect of disease on sick leave, work disability and health related quality of life in Korean patients with inflammatory bowel disease by using validated questionnaires.

First, the investigators will estimate the prevalence of work disability in patients with inflammatory bowel disease using the Work Productivity and Activity Index (WPAI), that have been validated in patients with inflammatory bowel disease.

Secondary, the predictor of work productivity impairment in patients with inflammatory bowel disease and distribution of type and severity of work disability will be identified.

Third, the investigators will explore the correlation between the quality of life and psychosocial aspects (anxiety disorder, depression) of patients with inflammatory bowel disease.

One year later, the same questionnaire will be surveyed repeatedly in the same participants under usual care to investigate the changes in patient-reported outcome measures.

Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with inflammatory bowel disease (Crohn's disease and ulcerative colitis) at Kyung Hee University Hospital

Exclusion Criteria:

1. Patients who do not agree to fill out the questionnaire.
2. Patients who can not fill out the questionnaire themselves.
3. Patients who can not understand the questionnaire.
The Role of Mechanical Diagnosis and Therapy in the Management of Concussion

The purpose of this study is to examine the role of a Mechanical Diagnosis and Therapy (MDT) examination in identifying participants diagnosed with concussion who display a directional preference compared to who don't display a directional preference.

Directional preference describes the clinical phenomenon where a specific direction of repeated movement and / or sustained position results in a clinically relevant improvement in symptoms. This improvement is usually accompanied by an improvement in function or mechanics or both. Its presence and relevance is determined over 2-3 visits. This study aims to identify the proportion of participants with concussion who present with a directional preference during the course of physical therapy. A secondary aim of this study is to investigate whether directional preference is associated with the eventual patient related outcomes following care.

Eligibility Criteria:
Inclusion Criteria:

* Age = 13 - 65
* Complaints of neck pain, headache, or dizziness associated with a diagnosis of concussion or mild TBI
* Ability to read/write English
* Referral from physician

Exclusion Criteria:

* Age less than 13 or greater than 65
* Cause of symptoms is result of a work-related accident or motor vehicle accident
* Receiving concurrent treatment from a chiropractor or massage therapist
* Glasgow Coma Scale less than 12
* Lesion on head CT/MRI
* Focal neurological deficits associated with serious spinal pathology (fracture, infection, tumor, vertebrobasilar insufficiency)
* Inability to or unwilling to exercise as part of usual PT care
* Unable to read/write English
* History of osteopenia/osteoporosis or cancer
A Study in Participants With Obesity or Overweight With at Least One Weight-related Comorbidity

A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 compared with placebo, given once a week as subcutaneous injection for 36 weeks, in male and female participants of at least 18 years of age who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and at least one weight-related comorbidity

The study will comprise of:

A screening period of maximum 28 days

A treatment period of 36 weeks

A follow up period after last dose of study drug

This study will consist of 4 cohorts. Approximately 231 eligible participants will be randomized to AZD6234 or placebo

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age
* BMI of (a) ≥ 30 kg/m2, or (b) ≥ 27kg/m2 and have a current diagnosis of at least 1 weight-related comorbidities (treated or untreated)
* A stable body weight for 3 months prior to Screening (±5% body weight change)

Exclusion Criteria:

* Have obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome
* Has received prescription or non-prescription medication for weight loss within the last 3 months prior to Screening
* Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier)
* History of type 1 diabetes mellitus or T2DM
Efficiency of 4-aminopyridin (Fampyra) on Gait, Vision, Cognition, Fatigue and Micturation in Patients With Multiple Sclerosis

The aim of the study is to assess improvement in visual evoked potential, cognition, fatigue, micturation and walking impairment under 3 months of Fampyra treatment


Eligibility Criteria:
Inclusion Criteria:

All patients who according to the compound's Norwegian prescription guidelines are deemed eligible for the study, i.e. MS patients with impaired walking as determined by an EDSS 4-7. They do not need a past history of optic neuritis, cognitive failure, fatigue or difficulties micturating.

Exclusion Criteria:

MS patients with contraindications to the compound according to the prescription guidelines.

Patients who have been exposed to Fampyra in the past Patients with an MS attack within last 3 months
AI-Generated WhatsApp Reminders vs. No Reminders: Impact on Oral Health in Young Adults

This randomized controlled trial aims to evaluate the effectiveness of artificial intelligence-generated WhatsApp reminders on improving oral hygiene practices among individuals aged 20-40 years visiting the periodontal clinic at El-Qasr El-Ainy Dental Hospital. Participants will be randomly assigned to either receive health education followed by AI-generated WhatsApp reminders over a 3-month period or to a control group receiving health education only. The primary outcome is the presence of white spot lesions, assessed using the modified Gorelick White Spot Lesion (WSL) index. Secondary outcomes include the presence of dental plaque, measured by the Plaque Index (PI). This study seeks to determine whether AI-generated reminders can enhance oral hygiene adherence compared to standard health education alone.


Eligibility Criteria:
Inclusion Criteria:

* Received a non-surgical periodontal treatment and oral hygiene instructions.
* Own a smartphone with WhatsApp installed.
* Willing and able to provide informed consent to participate in the study.

Exclusion Criteria:

* Individuals with pre-existing oral health conditions requiring specialized care.
* Patients who received surgical periodontal interventions.
* Participation in another oral health or diet-related study.
* Individuals who do not use WhatsApp or are unwilling to receive messages through the platform.
Family Influences to Prevent Childhood Obesity

The main goal of this project is to develop, deliver, and assess the efficacy of a parent-centered educational program (4-Health) designed to prevent preteen children from becoming overweight.

Previous studies suggest that parents can play a key role in preventing childhood obesity. Program objectives are to increase parents' knowledge and skills related to nutrition, physical activity, and best parenting practices. Developed from a successful existing program, the proposed program will include a novel classroom curriculum coupled with outside exercises, online resources, and a strong social support network. The curriculum will be developed with input from stakeholders during year 1 and implemented during years 2 and 3. The target groups are children and parents participating in 4-H Youth Development Programs in Montana. Intervention effectiveness will be assessed by comparing objective and self-report data between-groups (intervention vs. control) and within-groups (pre- to post-intervention and at 6 month follow-up). Physiological measures, including resting heart rate, blood pressure, body weight and age- and gender-specific BMI z-scores of children, are expected to show significant improvement among children of parents receiving the intervention compared to a mailed written materials control group. In addition, positive changes are anticipated in outcome measures provided by parents and children, including levels of daily physical activity and specific food and nutrition behaviors. Positive changes in parents' attitudes about diet, body image, and their perceived feeding practices before versus after intervention and at 6 month follow-up are also expected. This project will lead to improved understanding of how parents influence child obesity and improved interventions to prevent obesity.

Eligibility Criteria:
Inclusion Criteria:

* Parent of 8-12 year old child in 4-H Youth Development Programs in Montana
* Child of parent enrolled in study

Exclusion Criteria:

* Parent of child age outside the 8-12 year old range at start of trial
Study To Evaluate the Efficacy, Safety and Tolerability of E2027 (Hereinafter Referred to as Irsenontrine) in Participants With Dementia With Lewy Bodies

This study will be conducted to compare Irsenontrine to placebo on the cognitive endpoint of Montreal Cognitive Assessment (MoCA) and the global clinical endpoint of Clinician's Interview Based Impression of Change Plus (CIBIC-Plus) Caregiver Input in participants with dementia with Lewy bodies after 12 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 50 to 85 years, inclusive at time of consent.
* Meet criteria for probable dementia with Lewy bodies (DLB) (as defined by the 4th report of the DLB Consortium).
* Mini-Mental State Examination greater than or equal to (≥)14 and less than or equal to (≤) 26 at Screening Visit.
* Has experienced visual hallucinations during the past 4 weeks before Screening Visit.
* If receiving acetylcholinesterase inhibitors (AChEI), must have been on a stable dose for at least 12 weeks before Screening Visit, with no plans for dose adjustment during the study. Treatment-naive participants can be entered into the study but there should be no plans to initiate treatment with AChEIs from Screening to the end of the study.
* If receiving memantine, must have been on a stable dose for at least 12 weeks before Screening Visit, with no plans for dose adjustment during the study. Treatment naive participants can be entered into the study but there should be no plans to initiate treatment with memantine from Screening to the end of the study.
* Must have an identified caregiver or informant who is willing and able to provide follow-up information on the participant throughout the course of the study.
* Provide written informed consent. If a participant lacks capacity to consent in the investigator's opinion, the participant's assent should be obtained, as required in accordance with local laws, regulations and customs, plus the written informed consent of a legal representative should be obtained (capacity to consent and definition of legal representative should be determined in accordance with applicable local laws and regulations). In countries where local laws, regulations, and customs do not permit participants who lack capacity to consent to participate in this study, they will not be enrolled.

Exclusion Criteria:

* Any neurological condition that may be contributing to cognitive impairment above and beyond those caused by the participant's DLB, including any comorbidities detected by clinical assessment or magnetic resonance imaging (MRI).
* History of transient ischemic attacks or stroke within 12 months of Screening.
* Modified Hachinski Ischemic Scale greater than (\>) 4.
* Parkinsonian (extrapyramidal) features with Hoehn and Yahr stage 4 intravenous or higher.
* Any major psychiatric diagnosis, including schizophrenia, bipolar disorder and current major depressive disorder as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition.
* Geriatric Depression Scale score \> 8.