cyrilzakka/clinical-trials huggingface dataset:
An Exploratory Study of Deep Cervical Lymphovenous Bypass (LVB) in Alzheimer's Disease

The main pathological mechanism of Alzheimer's Disease (AD) is the abnormal deposition of amyloid-beta (Aβ) and tau proteins in the brain. Recent studies indicate that these two proteins are primarily cleared through the glymphatic system-meningeal lymphatic vessels-deep cervical lymphatic vessels pathway. Lymphatic circulation disorders in elderly patients can directly lead to the abnormal deposition of these proteins. Deep cervical lymphovenous bypass can improve lymphatic circulation and effectively treat lymphedema. This project aims to verify the effectiveness of 'deep cervical lymphovenous bypass' in treating AD, offering a new surgical treatment method to improve cognitive impairment and the quality of life for AD patients.

Alzheimer's Disease (AD) is a progressive neurodegenerative disorder that insidiously begins. Clinically characterized by memory impairment, aphasia, apraxia, agnosia, and other symptoms, it poses a severe threat to the quality of life of the elderly and brings a heavy burden to society and families. To date, there are no effective methods to prevent, halt, or cure AD. Therefore, there is an urgent need to explore new treatment approaches.

The definition of the glymphatic system and the discovery of meningeal lymphatic vessels (MLV) have overturned the traditional view of the immune privilege of the central nervous system, offering new clues and hope for the study and treatment of many brain diseases, including AD. The main pathological mechanism of Alzheimer's Disease (AD) is the abnormal deposition of amyloid-beta (Aβ) and tau proteins in the brain. Recent research indicates that these two proteins are primarily cleared through the glymphatic system-meningeal lymphatic vessels-deep cervical lymphatic vessels pathway, and lymphatic circulation disorders in elderly patients can directly lead to the abnormal deposition of these proteins. Deep cervical lymphovenous bypass can improve lymphatic circulation and effectively treat lymphedema. This project aims to verify the effectiveness of 'deep cervical lymphovenous bypass' in treating AD, providing a new surgical method to improve cognitive impairment and the quality of life for AD patients.

Eligibility Criteria:
Inclusion Criteria:

1. The age ranged from 60 to 80 years, and the time from initial diagnosis to enrollment was more than 12 months
2. The estimated survival time is more than 12 months;
3. The clinically diagnosed patients with mild to severe Alzheimer's Disease;
4. The imaging examination has the correlation diagnosis evidence;
5. Volunteer to participate in the project and sign an informed consent form with the guardian.

Exclusion Criteria:

1. Complicated with other severe systemic underlying diseases;
2. Unable to tolerate general anesthesia;
3. The pregnant women;
4. Recent severe infection or infectious diseases within 4 weeks;
5. Unable to complete the evaluator or refused to complete the one-year clinical follow-up.
6. Refusal to participate
Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis

This randomised trial plans to compare oral tofacitinib with intravenous cyclosporine in patients with acute severe ulcerative colitis who have failed to respond to intravenous steroids


Eligibility Criteria:
Inclusion Criteria:

Patients admitted with Acute severe ulcerative colitis as defined by Modified Truelove and Witts Criteria WITH Failure to respond to intravenous steroids (Hydrocortisone 100 mg IV QID OR IV Methylprednisolone 60 mg IV OD) as defined by

* Day 3 non-response as per Oxford criteria (stool frequency of \> 8/day, OR stool frequency between 3-8 with CRP \> 45 mg/L PLUS
* Ongoing activity as defined by Partial Mayo Score of \> 3 (rectal bleeding sub-score of \>1)
* Decision to start second line therapy (within 5-7 days of starting intravenous steroids)

Exclusion Criteria:

* Age \<18, Age \> 65 years

  * E1 disease (involvement distal to rectosigmoid junction only)
  * Crohn's disease
  * Contraindication to intravenous cyclosporine or oral tofacitinib

    * Renal failure, uncontrolled hypertension, seizure disorder,and uncorrected hypomagnesemia (\<1.5 mg/L)
    * Previous thrombosis, or prothrombotic state, on oral contraceptive, history of herpes zoster, active TB, active hepatitis, past opportunistic infections, h/o diverticulitis, Age \>50 plus at least one cardiac risk factor
  * Patient wants treatment with intravenous infliximab or wants surgery
  * Underlying sepsis or active infection (Enteric infections, Clostridium difficile, active hepatitis B or C, Tuberculosis, zoster, CMV disease)
  * Toxic megacolon, previous dysplasia or any indication of immediate surgery
  * Known malignancy
  * Pregnancy or Lactation
  * Unwilling to provide consent or for follow-up
Treatment of Peripheral Neuropathic Pain

Peripheral neuropathic pain is a disabling chronic pain condition that is difficult to treat. Repetitive transcranial magnetic stimulation (rTMS) to the motor cortex is a treatment method with growing evidence in its ability to alleviate neuropathic pain. This also applies to new deep rTMS coils which permits stimulation of larger cortical areas and with deeper penetration. The aim of this study is to investigate the analgesic efficacy of 5 days of deep rTMS compared to sham stimulation. We will also assess effects of deep rTMS on sleep, psychological fatctors, everyday functioning, and executive functioning.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age
* Peripheral neuropathic pain related to postherpetic neuralgia, peripheral nerve injury, limb amputation, polyneuropathy or radiculopathy, fulfilling the criteria for probable or definite neuropathic pain (Finnerup et al. 2016)
* Usual pain intensity at least 4/10 over the past 24 hrs using the numerical scale of the BPI at screening
* Daily pain
* Pain for at least 3 months
* Stable pharmacological treatment for pain or no pharmaceutical treatment at least 1 month prior to inclusion participation
* Ability to follow throughout the whole duration of the study

Exclusion Criteria:

atients with phantom limb pain after limb amputation

* Any clinically significant or unstable medical or psychiatric disorder
* Subjects protected by law (guardianship or tutelage measure)
* History of or current substance abuse (alcohol, drugs)
* Pending litigation
* Contraindication to rTMS (past severe head trauma, history of epilepsy or ongoing epilepsy, active cerebral tumour, past neurosurgical intervention, intracranial hypertension, implanted devices not compatible such as cardiac pacemaker and neurostimulator, cochlear implants, pregnancy or lactation. All women of childbearing age will be required to have negative pregnancy test at inclusion and to be using contraception)
* Pain conditions more severe than peripheral neuropathic pain
* Inability to understand the protocol or to fill out the forms
* Other ongoing research protocol or recent past protocol within one month before the inclusion
Attitude Change Of Hearing Health Professionals On Bone-Anchored Hearing Devices Over Time In a Developing Country

This study aims to examine shifts in attitudes about bone-anchored hearing instruments (BAHIs) among hearing health professionals over a period of time.

A survey was designed to assess the knowledge and attitude of participants concerning BAHIs. The survey was administered in both 2019 and 2023 at various conferences, with the questionnaires placed on chairs in different rooms. Responses were collected from Otorhinolaryngologists and audiologists for analysis.

Eligibility Criteria:
Inclusion Criteria:

Working as a licensed health professional as a medical doctor or an audiologist -

Exclusion Criteria:

None

-
Early-access Avacopan in Real-world ANCA-associated Vasculitis

The current study proposal aims to investigate the clinical practice variation of the initial use of avacopan for AAV patients in Europe. The study will describe patient characteristics and organ-specific clinical benefit of avacopan treatment in a unique, first-experience cohort of AAV patients. By studying the clinical practice variation of first-experience avacopan treatment, this study will be uniquely positioned to identify pivotal issues on the real-life implementation of avacopan treatment. These observational data can ultimately serve to address current knowledge gaps on avacopan treatment in AAV patients, improve the care and drug-access for AAV patients with avacopan treatment and generate new areas of research.

Objective: Analyse the clinical practice variation of the early access use of avacopan in real-world treated patients with ANCA-associated vasculitis.

Study design: Observational cohort study Study population: AAV patients treated with avacopan.

Main study parameters/endpoints:

* Describe physician's treatment indications for starting avacopan
* Describe AAV patients clinical characteristics
* Describe the concomitant treatment strategies employed with avacopan
* Describe clinical outcomes of avacopan treatment
* Investigate determinants of clinical benefit as well as non-response and/or relapse within the study cohort

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of GPA or MPA
* Treatment (initiation) with avacopan
* Informed consent for use of medical data

Exclusion Criteria:

* If there is no AAV disease activity present that can be supported by an objectifiable clinical measure or assessment
* If a subject is below 16 years old
A Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Due to Inflammatory Bowel Disease

Treatment with iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency anaemia due to inflammatory bowel disease and comparison of the incidence of hypophosphatemia

Existing IV iron complexes differ in relation to the compounds capability to induce unintended hypophosphatemia to a degree defined as medical significant.

This trial is designed evaluate the effect of IV iron isomaltoside compared to IV ferric carboxymaltose on phosphate in subjects with IDA due to inflammatory bowel disease .

Eligibility Criteria:
Inclusion Criteria include:

* Men or women ≥ 18 years
* Subjects diagnosed with IBD
* Hb \< 13 g/dL
* Body weight ≥ 50 kg
* S-ferritin \<100 ng/mL
* eGFR ≥ 65 mL/min/1.73 m2
* S-phosphate \> 2.5 mg/dL
* Oral iron preparations are ineffective or cannot be used or where there is a clinical need to de-liver iron rapidly
* Willingness to participate and signing the Informed Consent Form (ICF)

Exclusion Criteria include:

* Anaemia predominantly caused by factors other than IDA according to Investigator's judgment
* Hb ≥ 10 g/dL and body weight \< 70 kg
* Hemochromatosis or other iron storage disorders
* Known hypersensitivity reaction to any component of iron isomaltoside or ferric carboxymaltose
* Previous serious hypersensitivity reactions to any IV iron compounds
* Treatment with IV iron within the last 30 days prior to screening
* Treatment with erythropoietin or erythropoietin-stimulation agents, red blood cell transfusion, radiotherapy, and/or chemotherapy within the last 30 days prior to screening
* Received an investigational drug within the last 30 days prior to screening
* Planned surgical procedure within the trial period
* hepatic enzymes \> 3 times upper limit of normal
* Surgery under general anaesthesia within the last 30 days prior to screening
* Any non-viral infection within the last 30 days prior to screening
* Alcohol or drug abuse within the past 6 months
* Untreated hyperparathyroidism
* Kidney transplantation
* Conditions that interfere with the subject's ability to understand the requirements of the trial and/or presumable non-compliance
* Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements
* Pregnant or nursing women.
Intratympanic N-Acetylcysteine for Prevention of Cisplatin-induced Ototoxicity.

Although many intratympanic agents have been attempted, N-Acetylcysteine (NAC) appears to be the most promising and is a powerful, commonly used anti-oxidant. The goal of this prospective phase 2 randomized controlled trial is to determine the optimal dosage and effectiveness of intratympanic NAC injection in reducing hearing loss in head \& neck cancer patients receiving cisplatin chemotherapy with curative intent.

A prospective randomized controlled trial phase 1 using a standard 3+3 design, followed by a randomized controlled phase 2 to determine dosage, safety, and efficacy of intratympanic NAC to treat hearing loss in head \& neck patients receiving high-dose cisplatin chemotherapy. Participants will complete various pre-treatment hearing tests. One ear will be randomly chosen for the experimental treatment and the other ear will serve as the control ear. Participants will receive intratympanic NAC injections 60 minutes prior to their scheduled chemotherapy sessions in the experimental ear. The control ear will not receive any injection. Follow up hearing tests will be performed 2 months following completion of their primary cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

* Advanced stage head and neck cancer
* Receiving high dose systemic cisplatin (100mg/m2) with concurrent radiation therapy as part of their curative intent treatment
* Willing to provide informed consent
* ECOG performance status 0-2
* Histological confirmation of squamous cell carcinoma

Exclusion Criteria:

* Age less than 18
* Metastatic disease
* Tympanic membrane perforation or the presence of tympanostomy tubes as this may impact the retention and absorption of NAC when inserted into the middle ear
* Preexisting severe to profound sensorineural hearing loss (unilateral or bilateral)
* Pretreatment interaural discrepancy of greater than 10dB at three frequencies
* History of Meniere's or fluctuating hearing loss
* Previous hypersensitivity to NAC
* Patient unable to follow the protocol for any reason
Evaluation of Parenting Interventions to Decrease Family Risk for Child Maltreatment

The purpose of this research is to evaluate specific parenting programs that aim to improve the family's ability to keep children physically safe and emotionally secure. We would like to learn more about how the treatments actually help families and to find out how an intervention that focuses on child health and safety compares with one that focuses on the parent and child relationship. We also want to determine whether participating in one program type versus the other results in further reports for child maltreatment.


Eligibility Criteria:
Inclusion Criteria:

* resident of Durham, NC
* a child between the ages of 0-7 was the focus of the Department of Social Services report
* child's caregiver was the focus of the report
* Child Protective Services report occurred on or after June 1, 2004
* family is English speaking
* Sexual abuse was not "confirmed" or "highly suspicious" during an evaluation

Exclusion Criteria:

* Child Protective Services report of sexual abuse that was "confirmed" or "highly suspicious"
Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease

This is a phase II, multicenter, randomized, double-blind, placebo-controlled trial in which subjects with intermittent claudication (IC) will be randomized to receive a single treatment of VLTS-934 (84 mL, or a total of 420 mg poloxamer 188) or placebo (84 mL saline) administered as 21 intramuscular (IM) injections of 2 mL each, bilaterally into the lower extremities during one procedure to evaluate the safety, tolerability, and potential activity of VLTS-934 as compared with a saline placebo.

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial in which subjects with IC will be randomized to receive a single treatment of VLTS-934 (84 mL, or a total of 420 mg poloxamer 188) or placebo (84 mL saline) administered as 21 intramuscular (IM) injections of 2 mL each, bilaterally into the lower extremities during one procedure to evaluate the safety, tolerability, and potential activity of VLTS-934 as compared with a saline placebo.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of peripheral arterial disease in both legs
* History of exercise limiting symptoms

Exclusion Criteria:

* Lower limb revascularization surgery with 2 months of study entry
* Diagnosis of critical limb ischemia
Using Focus Groups to Explore Perceptions of Adults With Low Socioeconomic Status Regarding the NutriQuébec Study

NutriQuébec is a web-based prospective cohort study aiming to monitor and analyse the evolution of Québec population eating habits through annual questionnaires. The recruitment and retention of participants with low socioeconomic status (SES), known to be more hard to reach and recruit into health studies, will be major challenges in obtaining a representative sample of the Québec population.

The purpose of this study is to identify the behavioural, normative and control beliefs of individuals from low SES regarding a hypothetical participation in the NutriQuébec study. Their preferences regarding recruitment methods as well as their concerns about the security, use and share of data will also be identified.

Four moderator facilitated focus groups will be conducted in community centres (n=28 participants). The focus groups will be recorded, transcribed and coded by two coders using NVivo.

Four focus groups will be conducted in three community centers (n=6 to 8 participants/group; n=28 participants). First, all participants will read and sign the consent form. They will also complete a sociodemographic questionnaire. Then, the moderator will conduct the discussion using a semi-structured interview guide, based on the construct of the Theory of Planned Behaviour. The interview guide has been developed to identify the beliefs that determine the participants' attitudes (advantages/disadvantages), subjective norms (approval/disapproval of important others) and perceived behavioral control (facilitators/barriers) related to a hypothetical participation in the NutriQuébec study. The participants will also be questioned about their preferences regarding the recruitment as well as their concerns about the security, use and share of data. The focus groups will be recorded and transcribed. Two coders will perform the codification independently using NVivo 10.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years of age and older)
* Living in the Québec City Metropolitan Area
* Attending one of the three community centers where the focus groups will be conducted
* Be able to answer questionnaires in French

Exclusion Criteria:

None
The Exploration of an Active Training Tool to Reduce Weight Bias Among Students Pursuing a Healthcare-related Degree

An open-label parallel RCT will be conducted among 220 students pursuing a health-related degree at Ariel university. The intervention tool will be based on the constructive social learning model and will include a short lecture on obesity, scenarios simulating a meeting between health professionals and patients with obesity that will be presented by professional role-players and include varying degrees of weight bias, stigma and discrimination, and an open discourse with a patient with obesity. The tool's development will be carried out throughout recommended steps including a comprehensive literature review, preparation of a preliminary draft of the plan, evaluation of the planned intervention tool in terms of content validity, and a pilot testing of the tool among n=15 students from the target population.

The control group will receive a short-written document on obesity. This study will utilize an embedded mixed-method approach. At baseline, one- and six- weeks post-intervention both groups will be asked to fill an anonymous online survey which will include demographics, weight and body perception, knowledge about obesity, the Anti-Fat Attitudes questionnaire, the Short-Form of Fat-Phobia scale, and the Weight-Implicit Association-Test. Moreover, in-depth interviews will be conducted among 15 participants from each group.


Eligibility Criteria:
Inclusion Criteria:

* undergraduate students pursuing a healthcare-related degree including nutrition science, health systems management, communication disorders, physiotherapy, occupational therapy, and nursing at Ariel university
* age ≥18 years
* willingness to participate in the study.
Monocentric Retrospective Observational Study; Analysis of Gore Excluder ACS Device Using Numerical Simulation

andated when the risk of rupture is low and interventional treatment is offered to patients at high risk of rupture. Rupture risk is driven by aneurysm diameter and growth rate. Aneurysms with diameter greater than 55 mm and/or growth rate greater than 1 cm per year are at high risk of rupture. Open surgery and endovascular treatment are the two types of interventions. Open repair consists in replacing the aneurysmal part of the aorta using a synthetic fabric prosthesis after the abdomen has been opened and the aorta clamped. This invasive procedure is associated with a 3-10% post-operative mortality. Endovascular repair (EVAR) consists in excluding the aneurysm sac by inserting a self-expanding prosthesis (called stent-graft) through very small groin incisions, without abdominal opening nor aortic clamping. This minimally invasive procedure is associated with a significantly reduced post-operative mortality (around 1%) . However, hostile proximal neck anatomy including high angulation is associated with higher rates of type IA endoleak, reintervention and long-term mortality . For this reason, a conformable design of the Excluder stent-graft has been engineered with initial satisfactory results in patients with highly angulated or short necks . However, these satisfactory results have been obtained in carefully selected patients from experienced centers and a tool demonstrating adequate apposition of the Gore ACS is lacking. Study Device Description Numerical simulation has been used successfully to predict stent-graft behavior during FEVAR . Preliminary studies have also demonstrated to applicability of the technology to standard infrarenal devices , including in the setting of very tortuous anatomies9 . The potential of numerical simulation to predict stent-graft apposition of Gore ACS in highly angulated necks appears very promising to enhance patient selection.


Eligibility Criteria:
Inclusion Criteria:

The patient:

1. Is age ≥18 at the time of inclusion.
2. Underwent EVAR with ACS Gore Excluder
3. AAA proximal neck angulation superior to 60 degrees
4. Pre-op CT and post-operative/follow-up CT available

Exclusion Criteria:

1. Slice thickness of Pre-op or post-op / follow-up CT superior to 2mm.
2. Non-injected or poorly injected pre-operative CT-scan precluding technical feasibility of the aortic digital twin
3. Absence of post-operative or follow-up CT-scan
4. Patient refusal of his personal information/medical data to be used in the context of the study