cyrilzakka/clinical-trials huggingface dataset:
Intra-laryngeal Implant for Treatment of Chronic Aspirations

This study evaluates the medical device Newbreez LD is designed to protect the lower airways from saliva, liquids and food aspirations in tracheotomized patients suffering from chronic aspirations that require specific care and may lead to complications, including inhalation pneumonia.

Patients suffering from swallowing disorders characterized by chronic aspirations (repeated episodes of aspirations defined as penetration of material - liquids, food, saliva, into the respiratory system due to a malfunctioning of the swallowing mechanism) are subject to pathologies and pulmonary insufficiencies. The risks of aspiration pneumonia or suffocation are significantly greater if the patient is not able to expectorate and thus engages the vital prognosis. There are several methods to treat chronic aspirations: the least invasive methods involve adopting postures and/or positions of the body during swallowing and adapting food textures; when these treatments are insufficient there is the need to recur to more advanced ones to protect the airways and keep the patient on a sufficient nutrition.

For these severe cases, heavier surgical methods can be also considered. These methods lead to important anatomical changes, with a variable degree of reversibility, up to irreversibility (eg total laryngectomy). Among surgical methods, there is also an implant of a tracheotomy cuffed cannula that allows patient to breathe through a hole in the trachea. The efficacy of this solution is highly controversial as reported by numerous studies and several adverse effects are reported on the tracheal duct.

Due to the interest of a prosthetic treatment and the disadvantages of the current methods and devices, PROTiP Medical has developed a closed intra-laryngeal implant: NewBreez LD. This device is innovative because its geometry has been optimized to conform totally to the anatomy of the larynx with the aim to ensure a sealing against saliva, liquids and food aspirations.

Eligibility Criteria:
Inclusion Criteria:

* Swallowing disorders characterized by chronic aspirations;
* Tracheotomy performed, inter alia, in the management of swallowing disorders;
* Aged over 18;
* Willing and able to comply with the requirements of the study;
* Informed consent signed;
* Affiliated patient or beneficiary of the social security system.

Exclusion Criteria:

* Do not implant in patients with incomplete cricoid cartilage (surgery or other);
* Do not implant in patients with tracheotomy performed by cricothyroidectomy or between cricoid cartilage and the 1st tracheal ring;
* Do not implant in patients with tracheal lumen in the 1st tracheal ring, the lateral and anteroposterior diameters of which are less than 11 mm;
* Do not implant in patients with tight trismus;
* Do not implant in subjects less than 18 years of age;
* Do not implant in patients with bleeding disorders;
* Do not implant in patients contraindicated to general anesthesia.
TARGET GCAT Registry

A longitudinal post-marketing surveillance registry nested within the UK GCA Consortium that assesses the effectiveness and safety of tocilizumab in controlling refractory or relapsing forms of GCA in patients who require escalation of therapy to reach sustained remission. Half the patients recruited will have been prescribed tocilizumab (cases) and the other half will be prescribed alternative therapies (controls).

There are four study visits over 18 months: baseline, 6 months, 12 months and 18 months. At each visit data is collected on demographics; diagnosis and investigations; previous and concomitant medications; medical history; co-morbidities, vital signs; smoking and alcohol; disease activity and damage; routine laboratory tests; reason for starting escalation therapy. Safety data is collected on an ongoing basis.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have a diagnosis of GCA and be eligible for the UK GCA Consortium study
* Willing and able to consent
* Have refractory or relapsing GCA as defined by the NHS England commissioning statement for tocilizumab.
* Require treatment escalation
Sexuality After Different Mode of Deliveris

Pregnancy and delivery usually affect the general women's quality of life. Some studies have reported that sexual health may be affected by the mode of delivery. More than 70% of pregnant women prefer C-section due to several reasons point out the fear of pain and complications of vaginal delivery as the most common reasons.

Aim of the work: To explore the relationship between quality of life and the possible sexual dysfunction after normal vaginal in comparison to cesarean section deliveries.


Eligibility Criteria:
Inclusion Criteria:

* Primiparas women who had been delivered by either vaginal or cesarean section about 6-12months.
* All included women should be officially married

Exclusion Criteria:

* Women with history of sexual dysfunction
* Women with history of any pelvic surgery apart from Cesarean.
* history of anti-depressive drug therapy.
* history of genital prolapse
* history of Diabetes mellitus
* loss of any family member or unfaveorouble neonatal outcome or childdeath
* Divorce experience
* family problems and cases who were not interested in participation
Design of New Personalized Therapeutic Approaches for Diffuse Large B-cell Lymphoma

In Europe diffuse large B-cell lymphoma (DLBCL) is a rare disease whereas in Italy it is not. Approximately 40% of DLBCL patients has refractory disease or will relapse after initial response. In onco-hematology, a role for gut microbiota (GM) in mediating immune activation in response to chemotherapy, has been suggested. In this scenario, the Investigators hypothesized that GM could play an important role in DLBCL prognosis and response to treatment, establishing a connection between lifestyle and clinical response. The project is aimed to the study of the functional GM layout in association with specific patterns of treatment response in de novo DLBCL undergoing standard first line chemo-immunotherapy. Results may build the scientific basis to design new and personalized intervention strategies (both in treatment approach and in life-style recommendations), to enhance clinical response and reduction of disease refractoriness through modulation of the gut microbial ecosystem.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Patients affected by histologically confirmed diffuse large B-cell lymphoma
3. Patients amenable for therapy with RCHOP (RCHOP is the standard first line therapy for DLBCL and it scheduled regardless of participation in present study).
4. Patients must provide written informed consent.

Exclusion Criteria:

1. Concomitant second malignancy, other than lymphoma.
2. Previous anti-lymphoma therapy.
3. Pregnancy or breastfeeding.
4. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
Gene Therapy(FT-003) for Wet AMD

The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with neovascular age-related Macular Degeneration (nAMD). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.

FT-003 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (nAMD). Neovascular AMD is the main cause of blindness among elderly individuals. The available therapies for treating nAMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. Administration of FT-003 has the potential to treat nAMD by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Subjects that are willing and able to follow study procedures;
* Female or male patients 50-80 years old at the time of signing the ICF;
* Clinically diagnosed with nAMD;
* Presence of active CNV
* The best corrected visual acuity (BCVA) of the studied eye is 24-73 letters;

Exclusion Criteria:

* •Presence of any other intraocular diseases other than nAMD in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.
Adherence and Long-term Effect of OROS Methylphenidate (CONCERTA): A Follow-up Study

The objectives of this study are to investigate:

1. the evolution of ADHD symptoms, remission rate of ADHD, social and school function, and familial relationship;
2. the adherence to CONCERTA, treatment modality, and average treatment duration during the 3-year follow-up period; and
3. the effect of medication on the changes of neuropsychological functioning.

Attention-deficit/hyperactivity disorder (ADHD) is a common impairing disease among children and adolescents. Methylphenidate, a stimulant, is effective in treating these patients. OROS methylphenidate (CONCERTA) provides ADHD patients a more convenient and safer treatment approach than immediate-release methylphenidate (IR-MPH). However, there is little information of long-term effect and adherence to CONCERTA. At the NTUH Taiwan, a randomized clinical trial of OROS MPH was performed 3 years ago and 64 subjects were included and treated with either IR MPH or OROS MPH followed by OROS MPH. Therefore, we purpose this study to follow up these patients, exploring the adherence rate to CONCERTA, symptoms evolution, and outcomes among these patients.

Overview of Study Design: There will be two stages of this study. All study procedures will be performed after obtaining informed consent.

Stage I: Medical charts of these subjects will be reviewed to obtain information about CONCERTA adherence (also including dosage, treatment duration, clinic visits, missing visits etc.), psychiatric co-morbidities, and other treatment approaches subjects received after the previous study. Subjects will be visited (Visit 1) and the information of baseline characteristics and reasons for discontinuing CONCERTA (if applicable) will be recorded. The assessments will included parent or teacher ratings on the Conner's Teacher and Parent Rating scales (CPRS-R:S, CTRS-R:S), the SNAP-IV rating scale, the SKAMP rating scale, investigator ratings on the Kiddie-SADS-E, Clinical Global Impression and the Social Adjustment Inventory for Children and Adolescents (SAICA); and neuropsychological assessments (Conner's Continuous Performance Test, CPT, and Cambridge Neuropsychological Test Automated Batteries, CANTA B) will be performed to these subjects.

Stage II: All subjects enrolled into stage one will be followed for the next 6 months. Medication for ADHD treatment may be used to these subjects based on investigators' clinical judgments. Subjects will visit clinics in week-24 (Visit 2). The same assessments at Visit 1 will be performed at Visit 2. In addition, the adherence to treatment, adverse events, overall satisfaction to treatment, and academic performances during these 6 months will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who participated the randomized clinical trial for CONCERTA on NTUH.
* Subjects whose parents/caregivers can complete the questionnaires during the study and can assist to finish the assessment properly during the study;
* Subjects whose parent(s) or guardian(s) has signed and dated an informed consent for the subject to participate in the study.

Exclusion Criteria:

* No.
A Study of the Safety and Efficacy of Multiple Doses of ABT-089 in Subjects With Alzheimer's Disease

The purpose of this study is to compare the safety and efficacy of 2 mg, 4 mg, and 20 mg of ABT-089 BID to placebo in adults with Alzheimer's disease.


Eligibility Criteria:
INCLUSION CRITERIA:

* Current diagnosis of probable Alzheimer's disease.
* ADAS-cog score of at least 12 and MMSE score of 10 to 26.
* Non-smoker
* Must have legally authorized representative and a reliable caregiver. The caregiver and legally authorized representative may be the same person.
* Fluent in English.

EXCLUSION CRITERIA:

* Use of cholinesterase inhibitors or any other drugs to treat Alzheimer's disease in the last 6 weeks.
* Has clinically significant or uncontrolled medical condition other than Alzheimer's disease.
* Nursing home resident.
Stroke Imaging Package Study of Intracranial Atherosclerosis ( SIPS-ICAS )

A prospective, multicenter, cohort study to explore the stroke mechanisms of symptomatic intracranial atherosclerosis, the dynamic changes under aggressive medical treatment and their associations with clinical events using conventional MRI sequences plus high-resolution magnetic resonance (HR-MRI).

1. First-ever stroke patients attributed to intracranial artery stenosis (\> 50% or occlusion) within 7 days after onset will be prospectively enrolled in our study and undergo new imaging technique package assessment at baseline.
2. The imaging technique package includes conventional cranial MRI （T1,T2,T2 FLAIR,DWI), cranial magnetic resonance angiography (MRA),high-resolution magnetic resonance (HR-MRI) and susceptibility weighted imaging (SWI) or T2\*-weighted imaging.
3. Enrolled patients are recommended to receive aggressive medical management consisted of Aspirin (100 mg daily) and Clopidogrel (75 mg daily) for 3 months and Rosuvastatin (20mg daily) for at least 6 months as well as traditional risk factors management.
4. Patients were followed up for mRS score, stroke recurrence, medication compliance and laboratory examination including blood routine tests, liver functions and creatine kinase et al at 3 months, 6 months and 12 months after stroke onset. Additionally, patients are required to retake new HRMRI imaging of brain at 6 months.Remote patient education by We-Chat will be performed.
5. Our study aims to explore the stroke mechanisms of symptomatic intracranial atherosclerosis, the dynamic changes under aggressive medical treatment and their associations with clinical events using conventional MRI sequences plus HR-MRI.

Eligibility Criteria:
Inclusion Criteria:

1. Age 35-80 years old
2. First-ever stroke patients confirmed by diffusion weighted imaging (DWI) attributed to intracranial artery stenosis (\> 50%) within 7 days after onset.
3. Patients with stable vital signs.
4. Patients who have underwent thrombolytic/intravascular therapy are allowed to enroll in the study.

Exclusion Criteria:

1. Patients with \> 50% ipsilateral carotid artery stenosis, cardiac embolism ,and any other stroke etiologies such as vasculitis, dissection or other causes.
2. Patients with absolute/relative contraindication to MRI (including but not confined to metal in the body and claustrophobia).
3. Patients who cannot comply with MRI exam.
4. Patients who decline the consent.
Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy

The ICE Study study will compare standard therapy (thoracic epidural) versus a novel approach (Cryoanalgesia combined with thoracic epidural) in subjects undergoing unilateral thoracotomy.

The ICE Study is a single institution pilot study designed to compare standard therapy (i.e., thoracic epidural) versus a novel approach (i.e., Cryoanalgesia combined with thoracic epidural) to address the need for better management of acute and long-term pain in the general thoracic surgery patient population. The study's primary objective will be to demonstrate if the new intraoperative pain management approach \[i.e., intercostal Cryoanalgesia in conjunction with thoracic epidural\] provides superior short-term and long-term analgesia efficacy in patients undergoing unilateral thoracotomy as compared to the current institutional standard of care (i.e., thoracic epidural). Patients will be randomized in a 1:1 design.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral thoracotomy for non-cardiac surgery
* Age 18-85 years of age; male or female
* Acceptable surgical candidate including use of general anesthesia
* Willing and able to provide written informed consent
* Willing and able to return for scheduled follow-up visits

Exclusion Criteria:

* Prior major surgery within the last 6-months
* Documented psychiatric disease
* Documented chronic pain syndrome
* Current use of prescription opioids
* Documented history of substance abuse
* Functional disability or impairment (ECOG score = 0 or 1)
* Current pregnancy
* Patients currently enrolled in another research study that could directly affect results of either study
* Physical or mental condition that would interfere with patient's self-assessment of pain
* A medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conduct of the study or interferes with the pain assessments
Validation of Ipswich Touch Test for Diabetic Peripheral Neuropathy Screening in Primary Care

The goal of this observational study is to assess the accuracy of screening for diabetic peripheral neuropathy by comparing the Ipswich touch test with the 10-g monofilament test in patients diagnosed with type 2 diabetes.

The main question it aims to answer is:

How does the accuracy of the Ipswich Touch Test for identifying peripheral neuropathy compare to the traditional 10-g monofilament test?

Participants underwent both the Ipswich touch test and the 10-g monofilament test.

BACKGROUND: Diabetic foot, a severe complication of diabetes, significantly impairs the quality of life of affected individuals. However, it can be prevented through screening for loss of protective sensation in the foot. Currently, standard screening methods still require specialized equipment and trained medical professionals.

OBJECTIVES: The aim of this study is to assess the accuracy of screening for diabetic peripheral neuropathy by comparing the Ipswich touch test with the 10-g monofilament test in patients diagnosed with type 2 diabetes.

METHODS: This diagnostic study with a cross-sectional design focused on a group of 274 patients with type 2 diabetes who were receiving services at Nong Khantee Subdistrict Health Promoting Hospital in Phra Phutthabat District, Saraburi Province. Participants underwent both the Ipswich touch test and the 10-g monofilament test. Statistical analysis included evaluating sensitivity, specificity, negative predictive value, positive predictive value, negative likelihood ratio, positive likelihood ratio, and Cohen's kappa statistic to assess the diagnostic reliability of the Ipswich touch test.

Eligibility Criteria:
Inclusion Criteria:

* being 18 years old or older, having type 2 diabetes
* being able to communicate in Thai by speaking and listening.

Exclusion Criteria:

* AIDS
* Alcoholism
* Any cancer
* Cerebrovascular disease
* Chronic foot ulcers, or having foot or toe amputation.
* Chronic kidney disease stage 4 and 5
* Cirrhosis
* Malnutrition
* Neurological disease
* Thyroid hormone deficiency
Prediction of Postoperative Pain by Injection Pain of Propofol

Postoperative pain is a significant postoperative problem and it could be persistent if proper management is not provided. However, each patient shows different intensity of pain and different sensitivity to analgesics even if they underwent same procedures. Therefore, it would be useful to find the way to predict the postoperative pain sensitivity.

Propofol, a popular anesthetic agent, induces pain during injection, which can not completely prevented by opioid or lidocaine in some patients. This is considered to be related to patient's pain sensitivity and it might be associated with postoperative pain sensitivity.

Therefore, the relation of propofol injection pain and postoperative pain intensity will be explored.


Eligibility Criteria:
Inclusion Criteria:

* America Society of Anesthesiologists class I-II
* Laparoscopic cholecystectomy

Exclusion Criteria:

* Pregnancy
* Illiteracy
Autoimmunity and Coronary Artery Disease - Ancillary to CARDIA

To test the primary hypothesis that individuals with pre-clinical connective tissue disease related autoimmunity are more likely to demonstrate subsequent development of sub-clinical coronary artery disease.

BACKGROUND:

Connective tissue diseases have been identified as risk factors for coronary artery disease (CAD). Patients with connective tissue diseases such as rheumatoid arthritis and systemic lupus erythematosus have a high prevalence of CAD and are younger than expected at the onset of CAD. It has been proposed that the association between these connective tissue diseases and CAD is related to inflammation. Furthermore, circulating autoantibodies have been identified in CAD and it has been hypothesized that CAD may have autoimmune features. Circulating autoantibodies exist prior to connective tissue disease development and the presence of such autoantibodies in asymptomatic individuals is a predictor of future clinical connective tissue disease. Although the association between connective tissue disease and CAD has been established, an association between pre-clinical circulating autoantibodies and early CAD has not yet been explored.

DESIGN NARRATIVE:

To test this hypothesis, the following specific aims are proposed using the CARDIA database: 1) Determine the association between autoimmunity measured in stored sera collected in 1992 and the subsequent development of sub-clinical CAD measured in 2000 and 2005. 2) Assess whether autoimmunity measured in 1992 predicts future increased levels of C-reactive protein (CRP) and whether the relationship between autoimmunity and CAD is mediated by CRP level. These aims will be accomplished by a team of investigators within the Division of Rheumatology and Department of Preventive Medicine at Northwestern University. The CARDIA database is a product of the Coronary Artery Risk Development in Young Adults (CARDIA) study, a prospective cohort of 5108 subjects followed since 1985 for development of novel cardiac risk factors. With its extensive epidemiologic database and stored serum collected serially and available from 3500 individuals over the past 20 years, the CARDIA study is an ideal resource for this study.

Eligibility Criteria:
No eligibility criteria
Effects of an Online Hearing Support for First-time Hearing Aid Users

The goal of this randomised controlled trial is to test a online hearing support for first-time hearing aid users. The main questions it aims to answer are short- and long-term effects on the emotional and social consequences of hearing loss that the participants experience, use of communications strategies, experienced listening in complex sound environments and perceived effectiveness and satisfaction with hearing aids.


Eligibility Criteria:
Inclusion Criteria:

* Adults \> 20 years of age that are eligible for hearing aids
* Access to a computer, tablet and/or smartphone with internet
* Access to a Swedish BankID or equivalent

Exclusion Criteria:

* Inability to read and understand Swedish