cyrilzakka/clinical-trials huggingface dataset:
Proof of Concept Study Evaluating RNS60 in the Treatment of Relapsing Remitting Multiple Sclerosis

The purpose of this study is to determine whether RNS60 is effective in the treatment of RR-MS compared to interferon beta-1a.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females, aged between 18 and 50 years.
2. Diagnosis of RR-MS according to McDonald 2010 diagnostic criteria with a prior brain MRI that demonstrates lesions consistent with RRMS, both within the past year.
3. No evidence of relapse during the 60 days prior to enrollment.
4. EDSS score of 0-5 at screening.
5. Women of childbearing potential who have a negative pregnancy test (serum HCG) at screening.
6. Men or women of reproductive potential who commit to use adequate contraception during the study and for 1 month following the last day of treatment.
7. Subjects must be capable of understanding the purpose and risks of the study and provide written, informed consent.

Exclusion Criteria:

1. Diagnosis of Secondary Progressive MS, Primary Progressive MS or Progressive Relapsing MS.
2. Normal baseline brain MRI.
3. History of any clinically significant autoimmune disease: inflammatory bowel disease, diabetes, lupus or severe asthma.
4. Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated.)
5. Significant organ dysfunction, including cardiac, renal (eGFR ≤ 60 ml/min.), liver, central nervous system, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of normal), history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to enrollment.
6. Steroid therapy within 60 days prior to enrollment, with the exception of corticosteroids or ACTH for relapse treatment during the course of the study.
7. Known allergy to Gadolinium-DTPA
8. Therapy with any immunomodulatory drugs within 3 months prior to enrollment, including but not limited to interferons, glatiramir acetate, BG-12, teriflunomide, laquinimod and IV immunoglobulin.
9. Treatment at any time with immunosuppressive drugs such as cladribine, total lymphoid irradiation, monoclonal antibody treatment, mitoxantrone, Tysabri, fingolimod, cytoxan, methotrexate.
10. Participation in any investigational therapy within one year prior to enrollment, unless given approval by PI.
11. Known or suspected current or past alcohol or drug abuse within one year prior to enrollment.
12. Any medical, psychiatric or other condition that could result in a subject not being able to comply with protocol requirements.
A Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and Hypertension

The purpose of this clinical trial is to evaluate the efficacy and safety of dapagliflozin in patient with type 2 diabetes mellitus and hypertension


Eligibility Criteria:
Inclusion Criteria:

* Those diagnosed with type 2 diabetes mellitus accompanied by hypertension who are scheduled to be administrated Trudapa Tab. or Trudapa M SR Tab.
* Those who voluntarily signed a written personal information agreement to participate in this clinical study.
* Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion.

Exclusion Criteria:

* Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, pheochromocytoma, Cushing's syndrome and polycystic kidney disease, etc.)
* Those who have a history of taking dapagliflozin within 4 weeks of baseline (Visit 1)
* Those who are expected to need insulin prescription during the study period
* Pregnant women, breast-feeding women
Post-Op Lidocaine Patch

Randomized control trial evaluating use of lidocaine vs placebo patch for post-operative cesarean incision pain.

The purpose of this study is to determine if lidocaine patches decrease post-operative pain associated with cesarean births. While the Lidoderm lidocaine patch has been FDA approved for the treatment of skin pain, it has not been studied in women undergoing cesarean birth who experience postoperative pain. Even though this medication has been used in post-operative pain in published studies, the use of this medicine under these circumstances is still considered experimental. A lidocaine patch may provide added benefit for pain control in addition to standard medicines participants would receive after surgery, such as spinal, intravenous, and oral pain medications following cesarean delivery.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients who require a scheduled or non-urgent cesarean birth
* Patient able to receive neuraxial analgesia
* Patient able to give verbal and written consent for both cesarean birth and study

Exclusion Criteria:

* Patients requiring emergent cesarean birth
* Patients allergic to lidocaine or adhesive
* Patients who have already received an epidural during this admission or requiring general anesthesia for cesarean birth
* Patients using chronic oral neuromodulators
* Patients with cardiac disease or using anti-arrhythmic agents
* Patients with fibromyalgia or chronic pain syndromes such as rheumatoid arthritis, osteoarthritis, or lupus.
* Daily narcotic or opiate use for greater than the 2 months prior to enrollment in the study.
Preliminary Evaluation of the Safety and Tolerability of SPOT-mRNA01 Subcutaneously Administered in Healthy Subjects

This is a first-in-human, randomized, double-blind, placebo-controlled clinical study to evaluate the Safety and Tolerability of SPOT-mRNA01 injection in healthy adult volunteers.

SPOT-mRNA01 (collagen 1 alpha 1 (COL1A1) mRNA-loaded by Extracellular vesicles （EVs）) can induce collagen protein grafts in dermal tissue, thereby supplementing collagen and reducing wrinkle formation in collagen-depleted skin. Therefore, SPOTmRNA01 can provide a source of human collagen intradermally for cosmetic anti-aging use.

This is a first-in-human randomized, double-blind, placebo-controlled, single-dose, dose ascending, exploratory clinical study to evaluate the Safety and Tolerability of SPOT-mRNA01 administered by subcutaneous injection to healthy adult volunteers.

Biopsies will be used to detect the expression of collagen in the skin of the injection area.

Eligibility Criteria:
Inclusion Criteria:

Aged 18 to 75 years inclusive at the time of informed consent.

Exclusion Criteria:

1. Any transient or chronic skin condition, disorder, or infection within 20 cm of the target areas before treatment that, in the opinion of the investigator, may confound study results.
2. History of laser treatment or chemical peels or any cosmetic anti-aging treatments to the target areas within six months of the study treatment.
3. History of surgical procedures to target areas, including removal of benign or malignant skin cancers that, in the opinion of the investigator, may confound study results.
4. Participant with a history of heavy smoking, alcohol or drug abuse or steroid treatment.
5. Pregnant or breast-feeding females.
6. History of anaphylaxis or allergic reactions to any constituent of the study product and/or local anesthetics, and/or history of severe abnormal drug reaction.
7. Those who have participated in clinical trials of other investigational drugs within 3 months before the study treatment.
8. Those who are not suitable for subcutaneous injection and biopsy.
9. Any condition that the investigator or primary physician believes may not be appropriate for participating the study.
Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population.

Hearing aids restore efficiently some auditory functions in age-related hearing loss (ARHL or presbycusis) providing to the elderly an access to oral communication and a return to social life. However, a most of the assessments of their efficacy focus on speech recognition. Spatial hearing and localization are anothers important auditory functions merely evaluated.

The purpose of this study is to evaluate the hearing aids benefits for spatial hearing.

The main objective is to evaluate the hearing aids benefits for spatial hearing with a multidisciplinary approach combing psychophysics, and Positron Emission Tomography (PET) brain imaging in a before/after experimental design. The novelty of the proposal is both theoretical and methodological: the team aim is to identify neural correlates of spatial hearing after hearing rehabilitation and evaluate the evolution of spatial hearing abilities once subjects with presbycusis are fitted with hearing aids. The assessment of spatial hearing processing will rely on both a virtual visuo-auditory 3D immersive platform and functional neuroimaging using PET scan. This project will provide crucial elements for understanding and improving the rehabilitation of age-related hearing loss.

Eligibility Criteria:
Inclusion Criteria:

For presbyacusics subjects:

* Subjects aged over 50 with a difference in symmetrical audiometric thresholds (\< 15 dB) between the two ears and requiring hearing aids
* Affiliation to a social security scheme or equivalent
* Acceptance of the protocol and signature of the consent form

For older people with normal hearing:

* Subjects matched in age (+/- 2 years) and gender with the presbycusis group
* Affiliation to a social security scheme or equivalent
* Acceptance of the protocol and signature of the consent form
* Subjects with normal hearing, with hearing thresholds of 20 dB \< 2kHz and 40 dB \< 4kHz

For young people with normal hearing:

* Subjects aged between 18 and 40 years old,
* Symmetric normal hearing
* Affiliation to a social security scheme or equivalent
* Normally hearing subjects with audiometric thresholds \< 20 dB
* Acceptance of the protocol and signature of the consent form

Exclusion Criteria:

* Persons under a legal protection regime for adults (safeguard of justice, guardianship, curator ship, institutionalized, or under mandate for future protection)
* History of associated neurological pathology
* Contraindications to PET
* Cognitive impairment confirmed by the Montreal Cognitive Assessment (MOCA) test (for presbyacusic subjects and normal-hearing elderly subjects)
* Taking psychotropic drugs
* History of epilepsy
* Pregnant or breastfeeding woman
* Participation in another intervention protocol
The Effect of Incentive Spirometry Added to Routine Physiotherapy Program on Hemodynamic Responses and Hospital Stay in Patients With COPD Exacerbation

COPD; it is a common, preventable and treatable disease that is associated with increased chronic inflammatory responses in the airways and lungs against harmful gases and particles, and that it manages progressive airflow. The definition of exacerbation is defined as an acute onset with a change in where daily differences in the main symptoms occur and which may occur with the presence of drugs. The number of exacerbations in the course of the disease is between 1-3 years on average. Routine physiotherapy treatment in COPD exacerbation is expected to increase lung volume and effective removal of airway secretions. The concept of physiotherapy programs is vibration, thoracic expression exercise, positive expiratory pressure therapy and gait programs.

An incentive spirometer is a simple, inexpensive device to adjust lung tissue re-expansion by increasing lung volumes and diaphragmatic mobility, providing maximal inspiration with termination control without a resistive loading. In COPD patients, the use of incentive spirometry is to increase alveolar ventilation and oxygenation in lifestyle.

There are a limited number of studies in the literature regarding the results of the use of incentive spirometry in COPD patients. The results of postoperative results of incentive spirometry in COPD patients were tried and established on pulmonary complications, diseases, postoperative dyspnea perception and lifestyle. The importance of the investigator's research; this is the first study to evaluate hemodynamic responses and hospitalization plans of incentive spirometer and routine physiotherapy program in COPD exacerbations.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with COPD exacerbation
* Hemodynamically stable
* To be conscious and voluntarily agree to participate in the study

Exclusion Criteria:

* Existence of neurological, cardiovascular and musculoskeletal problems to prevent exercise
* Having chronic respiratory disease other than COPD
Optimal Prostate Study

To compare the toxicity, rate of local control, biochemical failure rate and quality of life of three different radiotherapy techniques (moderate hypofractionation, stereotactic body radiotherapy (SBRT) and standard radiotherapy plus 2 fractions of SBRT (BOOSTER)

Participants must have histologically proven prostate adenocarcinoma, good performance status and suitable for high dose radiotherapy. There are two groups of participants:

Group 1: eligible participants will be randomised to have either moderate hypofractionation or standard radiotherapy plus SBRT (BOOSTER). Participants in this group must be able to have MRI, prostate fiducial markers (gold markers)and hydrogel insertion. Fiducial markers will be used to locate the prostate accurately during radiation treatment. Hydrogel is a temporary gel being injected into the space between the prostate and rectum to reduce the dose of radiation received by the rectum to minimise side effects from the treatment.

Group 2: eligible participants will be randomised to have either moderate hypofractionation or SBRT.

Participants will be reviewed for side effects. A Safety Committee will be formed containing multi-disciplinary team members. All serious adverse will be reported to the principal investigator and Human Research Ethics Committee within 24 hours.

Eligibility Criteria:
Inclusion criteria

* Histologically proven prostate adenocarcinoma
* PSA obtained within three months prior to enrolment
* ECOG performance status 0 to 2
* Ability to understand and the willingness to sign a written consent
* Suitable for high dose irradiation to the prostate

To be eligible for the arm containing Stereotactic Booster alone approach patient must have the following

* No contraindication to MRI such as pacemaker and severe claustrophobia
* Patient must be able to have fiducial markers placed in the prostate
* Patient must be able to have hydrogel insertion at the same time as fiducial markers
* Must have IPSS less than 15

Exclusion criteria

* Previous pelvic radiotherapy
* Prior total prostatectomy
* Unwilling or unable to give informed consent
Effect of Abrupt Plavix® Discontinuation on Platelet Function

The well established importance of regular administration of antiplatelet drugs stands on firm grounds, as large meta-analyses have shown these therapies to significantly reduce the risk of death. Plavix® (clopidogrel) is widely used following coronary angioplasty, to reduce the risk of periprocedural thrombotic complications, for up to one year. As the current recommendations suggest clopidogrel use for no longer than one year, the drug is normally discontinued within that period. In the limited state of knowledge on antiplatelet drug withdrawal, an early sound of alarm has risen from early thromboembolic complications reported after the interruption of antiplatelet treatment used in prevention of ischemic vascular disease. Although little information is available, discontinuation of thienopyridines has been associated with increased thromboembolic complications, mainly acute stent thrombosis. These complications may signal a platelet sensitization effect to aggregating stimuli by antiplatelet drugs taken chronically.

The current study aims to evaluate the impact of clopidogrel discontinuation on platelet function, in order to shed light on underlying mechanisms leading to increased risk of acute thrombo-occlusive events.


Eligibility Criteria:
Inclusion Criteria:

* Group 1: Patients suffering from stable CAD scheduled to discontinue clopidogrel therapy at least one month after stent implantation
* Group 2: Stable clopidogrel-naïve CAD patients
* Patients willing to participate in the study and to sign the informed consent form

Exclusion Criteria:

* Acute coronary syndrome or revascularization in the last 3 months prior to enrolment
* Concurrent ingestion of nonsteroidal anti-inflammatory drugs (NSAIDs, including COX-2 selective anti-inflammatory drugs), ticlopidine, dipyridamole, warfarin or acenocoumarol
* Major surgical procedure within 1 month before enrolment
* Platelet count outside the 100 000 to 450 000/μL range
* Hematocrit \< 25% or haemoglobin \< 100 g/L
* Patient undergoing dialysis for chronic renal failure
Comparison Study of Usual Care vs. Usual Care Plus Community Intervention to Manage Type 2 Diabetes

The overall purpose of this research is to examine and compare the effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with Type 2 Diabetes Mellitus and multiple chronic conditions and their family caregivers. Once the study is complete, the investigators will be able to determine if there is any measurable difference in self-care management between usual care plus the intervention versus usual care alone.

Research Goal

To examine the comparative effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with T2DM and Multiple Chronic Conditions and their family caregivers.

Objectives

1. To determine if a 6-month, IP, community-based intervention improve self-management compared with usual primary care services?
2. To compare the effectiveness of the intervention on HRQoL, physical activity, nutritional status, depression, anxiety, diabetes parameters (blood glucose levels \[HbA1c, hypoglycemic episodes\]), diabetes-related complications, number of vascular events, social support number of falls, fall risk and medication safety with usual primary care services?
3. To determine the effectiveness of the intervention on HRQoL of family caregivers compared with usual primary care?
4. To assess whether or not the intervention improves clinical practice behaviours?
5. To determine the 6-month costs of use of health services of the intervention compared with usual care, from a social perspective?
6. To identify which subgroups of older adults with T2DM and MCC benefit most from the intervention?
7. To determine the effectiveness of the intervention based on sex/gender and region?
8. To determine the overall feasibility and acceptability of an IP community-based health promotion intervention and what can be identified as barriers and facilitators to implementation?

Eligibility Criteria:
Inclusion Criteria:

* older adults aged 65+
* live in the local vicinity of a participating Diabetes Education Program
* were referred to their Diabetes Education Program within the past 24 months
* competence in English (or access to a translator)
* intention to continue living in the area for the next 6 months
* two reported chronic conditions in addition to T2DM. Individuals with newly diagnosed T2DM as well as those who were already receiving treatment for T2DM will be eligible for inclusion in the study.

Exclusion Criteria:

* score of 20 or less in Montreal Cognitive Assessment (MoCA) test AND without access to a substitute decision maker to sign consent (Score of 20 or less is not in itself an exclusion).
Endoscopic Third Ventriculostomy vs. Ventriculoperitoneal Shunt in Idiopathic Normal Pressure Hydrocephalus (ENDOVEST)

The aim of this single-center, two-arm, open-labeled, randomized controlled clinical study is to compare two surgical interventions, endoscopic third ventriculostomy and ventriculoperitoneal shunt, in treating idiopathic normal pressure hydrocephalus in terms of clinical improvement.

Idiopathic normal pressure hydrocephalus (iNPH) primarily affects elderly individuals, with prevalence rates of approximately 1.4% among those over 65 years and 5.9% among those over 80 years old. It is characterized by fluid buildup in the brain with normal cerebrospinal fluid pressure and is unique among neurodegenerative disorders in its potential for successful treatment. Common symptoms include difficulty walking, urinary incontinence, and cognitive decline, which significantly impact quality of life.

The standard treatment involves inserting a ventriculoperitoneal shunt (VPS) to drain cerebrospinal fluid, achieving a 75% success rate in improving symptoms. However, VPS has a drawback: a high rate of revision surgery (approximately 18% during follow-up). An alternative treatment is endoscopic third ventriculostomy (ETV), which avoids placing foreign materials and thus eliminates risks associated with shunt malfunction and infections. ETV is an established neuroendoscopic procedure mainly used to treat non-communicating hydrocephalus, typically due to aqueduct stenosis.

This study aims to compare ETV and VPS for the treatment of iNPH to investigate whether ETV leads to fewer complications while achieving a comparable rate of postoperative symptom improvement.

Eligibility Criteria:
Inclusion Criteria:

* \>40 years of age
* Symptom duration ≥3 months, \<24 months
* No antecedent head trauma, ICH, meningitis, or other cause of secondary hydrocephalus
* MUST show gait/balance disturbance, PLUS cognition impairment AND/OR urinary dysfunction.
* Ventricular enlargement (Evans Index \> 0.3) not attributable to cerebral atrophy or congenital enlargement
* No macroscopic obstruction to cerebrospinal fluid (CSF) flow Spinal Tap-Test
* Opening pressure (on lateral decubitus): \<24cmH2O
* Clinical improvement in at least one of the main symptoms after 40-50ml withdrawal of CSF

Exclusion Criteria:

* ≤40 years of age
* No informed consent
* Other neurologic, psychiatric or general medical condition which is sufficient to explain the presenting symptoms.
* Previous cranial neurosurgical interventions
* Other associated dementia syndromes
* Incapacity to walk
* Pregnancy and breastfeeding women