cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of a Diabetes Education Program Based on Tailored Interventions (Edep-Ti Study)

GOALS:

PRIMARY:

1. Analyze the overall impact of the proposed diabetes education program on metabolic control (HbA1c) and modifiable cardiovascular risk factors (lipid profile and blood pressure).

   SECONDARY:
2. Evaluate the effectiveness of the program on smoking habits and body mass index (weight, height).
3. Analyze the impact of the program on the quality of life related to health.
4. Check the effect on lifestyles: compliance levels of physical exercise and adherence to diet mediterranean.

DESIGN: Cluster randomized controlled trial

The reference population will be patients with a diagnosis of diabetes mellitus in treatment with oral antidiabetics, excluding the insulinized patients. They will then be randomly assigned by cluster, to the intervention group (individual education) or control (usual care) in the context of each health center participating in the project. After randomization centers, all professionals who decide to cooperate receive a training process on methodology for measuring results (clinical and questionnaire variables), while assigned to the experimental intervention, will also receive training on how to carry out the program of diabetologic education proposed. The follow-up period for both groups is 18 months obtained as clinical determinations: glycosylated hemoglobin (metabolic control), blood pressure, lipid profile, smoking and BMI; and as results reported by the patient through questionnaires: quality of life related to health, level of physical activity performed or adherence to the Mediterranean diet.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Type II Diabetes Mellitus diagnosed \<10 years and classified in a computerized clinical history with poor metabolic control and in treatment with oral antidiabetics.
* HbA1c\> 7% in the last control available (\<1 year); or poor control of one of the following cardiovascular risk factors (in the last year): SBP\> 140 mmHg or DBP\> 90 mmHg, or presence of tobacco habit or dyslipidemia (LDL-c \> = 100 mg / dL) or BMI\> 30; or in treatment with: ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, calcium channel blockers or diuretics and lipid-lowering drugs.

Exclusion Criteria:

* Diabetes Mellitus type 1
* Insulinized patients.
* Patients who have received some type of structured educational intervention in the last year according to the data obtained in their clinical history.
* Patients with some type of sensory or mental disability.
* Gestational diabetes.
* Patients with age equal to or greater than 75 years of age or minors.
* Patients with inability to travel to their Health Center.
Whole-Body Vibration for Functional Constipation

1. Aim: The aim of this trial was to determine whether whole-body vibration (WBV) induced via a non-invasive oscillation platform could improve symptoms and health-related quality of life (HRQOL) in patients with chronic functional constipation.
2. Methods: A single-blinded, randomized, control trial was performed in a single Hospital in Taiwan. Patients diagnosed with chronic functional constipation, as per the Rome III diagnostic criteria were included and randomized to either the WBV treatment or no treatment (control) group. The treatment group received six 15-minute sessions of WBV therapy over a two-week period. Patients received vibrations of 2 mm in amplitude at a frequency of 12 Hz. The primary outcome was assessed by the constipation severity instrument (CSI). The secondary outcome was improvements in HRQOL.


Eligibility Criteria:
Inclusion Criteria:

* met the Rome III criteria of constipation

Exclusion Criteria:

* pregnant
* cardiovascular disease
* cerebrovascular disease
* recently undergone major surgery
* hypothyroidism
* depressive disorder.
Flexibility, Efficacy, and Safety of a Foldable Capsular Vitreous Body in the Treatment of Severe Retinal Detachment

The purpose of this study is to determine the feasibility, primary safety and efficacy of foldable capsular vitreous body (FCVB) in the treatment of retinal detachment, based on the multi-center clinical trial.

Previous clinical trial have demonstrated that foldable artificial vitreous body (FCVB),with balanced salt solution (BSS) filled in 11 patients during three-months observation,or silicone oil filled in 4 patients during a six-month observation respectively, can be transplanted into the vitreous body easily, and performances good safety and efficacy in the treatment of severe retinal detachment.

Current multi-center clinical trial was to determine the feasibility, primary safety and efficacy of FCVB with silicone oil filled in the treatment of retinal detachment in 120 patients.

Eligibility Criteria:
Inclusion Criteria:

1. age range from 18 to 65, Refractive error less than ±3D
2. Corrected visual acuity less than 0.05
3. ocular axial length is 16 to 25mm
4. severe retinal detachment that can not be treated by current artificial vitreous body:

   1. Severe unilateral ocular perforating injuries, compounded retinal or choroidal detachments resulted from retinal rupture or retinal choroidal hemorrhage.
   2. Severe unilateral ocular rupture injuries result in retina or choroid defect.
   3. Giant posterior scleral rupture injuries that can not be repaired.
   4. Silicone oil can't be taken out for a long time with incomplete reattachment.
   5. Participants have undergone retinal detachment surgery and silicone oil tamponade twice or more, however, retina is re-detachment after silicone oil removal.
5. Participants can understand the aim of this clinical trial and sign the informed consent form

Exclusion Criteria:

1. Participants have a silica gel allergy or scar diathesis
2. entophthalmia
3. uveitis
4. The contralateral eye suffered from intraocular surgery
5. uncontrollable the other eye diseases
6. Corrected visual acuity of contralateral eye less than 0.4
7. Proliferative diabetic retinopathy
8. the lens of target eye is transparent
9. Serious heart, lung, liver and kidney dysfunction
10. pregnancy, preparation for pregnancy during clinical trial and breast-feeding female
11. drug abuse or alcoholism
12. participated the other drug or medical devices clinical trial before screening of this trial
13. Any research doctors consider that the condition of participants will hinder the clinical trial--Prone to mental stress, loss control of mood, depression etc.
14. Patient adherence is so poor that study procedures can not be finished
In Vivo Damage Induced bu UV in the Epidermis of the Scalp

Squamous cell carcinomas (SCC) are the second most common skin cancer in humans. The incidence of SCCs in the USA in 2012 was estimated at 700,000 casesSCCs have a metastatic course in 3% to 5% of cases that is of poor prognosis. In men, the SCCs of the scalp represent the most frequent location of the head and neck, the 3rd location of the whole body. The SCCs of the scalp are more undifferentiated than in other locations. In addition, actinic keratoses of scalp, precursors of SCC, are more resistant to treatment than in other areas. These particularities of the SCCs of the scalp suggest the existence of specific factors at the epidermis level of the scalp.

UV-induced damage to DNA is the defining event in skin photocarcinogenesis. It has already been shown that DNA damage induced by UV and the kinetics of repair of this damage may vary with age or phototype of patients, but the topographic variation of DNA damage has never been studied, although it is known that gene expression in skin cells may differ from one region of the body to another.

the hypothesis is therefore that the particular characteristics of KAs and SCCs at the scal level could be explained by an increased sensitivity to UV-induced damage. It is planned to study UV-induced damage and its repair at the scalp level in humans compared to the forearm.


Eligibility Criteria:
Inclusion Criteria:

* Male subject
* Subject aged 40 to 60 years
* Subject of phototype III or IV
* Subject with no skin lesions on the scalp and forearms
* Subject who has not been exposed to the sun for at least 1 month
* Subject affiliated to social security
* Subject who signed the informed consent form

Exclusion Criteria:

* Subjects with photosensitivity,
* Subject taking photosensitizing drugs
* Subjects with a history of skin cancer
* Subjects with abnormal healing
* Subjects with immunosuppression
Evaluation of Non-Compressive Myelopathy in a Sample of Egyptian Patients

An observational study will be conducted in the Department of Neurology at AlAzhar University Hospitals To study the etiological factors of non-compressive myelopathy in a sample of Egyptian patients

Myelopathy is a collective term referring to any pathologic condition or neurologic deficit related to the spinal cord. Myelopathies are a frequent and potentially disabling neurologic emergency.(Sarbu et al., 2019).

Diseases of the spinal cord often have devastating consequences and imaging studies are indispensable for their diagnosis. The diagnostic approach must be based on the clinical context, the time elapsed since the onset of symptoms and signs, and the imaging findings (Herrera et al., 2020).

Myelopathies may be compressive or non-compressive, regarding to subarachnoid space obstruction (Kundu et al., 2018).

Noncompressive myelopathy (NCM) is described as "spinal cord involvement without detectable clinical and radiological evidence of spinal cord compression causing neurological deficit (Thangaraj et al., 2019).

There have been a few studies that have investigated Noncompressive myelopathy (NCM) in Africa as part of nontraumatic myelopathy. With very few studies focusing on NMOSD, Most of them focus on extrinsic compression and infectious diseases as important causes of myelopathy (Musubire et al., 2021) Comprehensive data on Egyptian patients with Non-compressive myelopathy (NCM) in the light of newer diagnostic criteria and serological tests are lacking. No study has been conducted to study the clinico-radiological profile of Non-compressive myelopathy (NCM) so far. In this study, we are putting an effort to convey our experience on etiological pattern of Non-compressive myelopathy (NCM) with special reference to its radiological features.

Eligibility Criteria:
Inclusion Criteria:

- Patients with acute, subacute, or chronic neurologic dysfunction (motor and sensory deficit, sphincteric involvement, and a well-defined upper sensory segmental level) consistent with myelopathy (with or without coexisting encephalopathy, neuropathy, or radiculopathy).

Exclusion Criteria:

* 1) Patients of myelopathy who did not undergo magnetic resonance imaging (MRI) of the spinal cord. 2) Spinal cord compression on MRI explaining patient's neurologic dysfunction. 3) History of previous trauma, acute coma and patients with definite cerebral symptoms incompatible with spinal pathology (e.g., aphasia, hemianopia, neglect, facial involvement). 4) Motor neuron disease (MND) 5)Degenerative ataxias.
ERAdicate S. Aureus in Patients With Bacteremia and Endocarditis

This study evaluates safety and tolerability of endolysin-derived LSVT-1701 (tonabacase) as an add-on to standard of care (SOC) antibiotic therapy for the treatment of patients with complicated Staphylococcus aureus bacteremia (SAB), including left- and right-sided infective endocarditis (IE).


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 to 90 years
* Index blood culture collection within 96 hours prior to enrollment positive for S. aureus
* Experienced at least one sign or symptom related to SAB within past 96 hours prior to enrollment
* Known or suspected left- and/or right-sided endocarditis by modified Duke criteria and/or known or suspected complicated SAB
* Required duration of SOC antibiotic therapy ≤ 42 days

Exclusion Criteria:

* Previous receipt of LSVT-1701 or CF-301 (exebacase)
* Known hypersensitivity to kanamycin or other aminoglycosides
* Treatment with any potentially effective (anti-S. aureus) systemic antibiotic for \> 96 hours within 7 days before enrollment. Exception: Persistent S. aureus bacteremia after 96 hours of prior appropriate systemic antistaphylococcal antibiotic, and/or resistance to the prior systemic antibiotic
* Treatment with dalbavancin or oritavancin within the previous 90 days
* Known or suspected brain abscess or meningitis
* Community acquired pneumonia, nosocomial pneumonia because of pathogens other than S. aureus, or known polymicrobial bacteremia
* Presence of an intravascular infection source or extravascular material that cannot be removed within 96 hours after enrollment
Efficacy of Oral Administration of Trehalose in Patients With Parkinson Disease

Parkinson's disease (PD) is a neurodegenerative disease characterized by the neurodegeneration of substance nigra pars compacta (SNpc) and the formation of alpha-synuclein protein aggregates in neurons. Although most PD patients are sporadic, it is now clear that genetic factors contribute to the pathogenesis of PD. Indeed, LRRK2 G2019S mutation is one of the most common causes of familial PD. The phenotype corresponding to this mutation is a late-onset form of PD characterized by the accumulation of the N-ethylmaleimide sensitive factor (NSF) in neurons. It is due to a dysfunction of the physiological autophagy processes occurring at cellular level, mainly affecting autophagy mediated by chaperone proteins (Chaperon Mediated Autophagy, CMA), responsible for the clearance of alpha synuclein at the lysosomal level. This condition, although sensitive to treatment with L-DOPA and dopamine agonists, does not currently have any specific therapy.

Recently, in a mouse model carrying the LRRK2 mutation, it has been demonstrated that treatment with trehalose is able to reduce the accumulation of NSF deposits in neurons of various brain areas such as the substantia nigra, striatum, cortex and hippocampus. The reduction of protein aggregates correlates with intracellular molecules related to the activation of apoptotic processes in damaged neurons. Moreover, it has been found a significant improvement in motor and cognitive performance. The aim of the present study is to evaluate the safety and tolerability of trehalose in two groups of patients affected by idiopathic PD and PD carrying the LRRK2 mutation, respectively. Moreover, the investigators will collect preliminary data on the effect that this molecule potentially has on disease course in both groups. The treatment duration will be 24 weeks and the overall study duration approximately 12 months. The populations observed will be composed of subjects affected by idiopathic PD and familial PD carrying the genetically confirmed LRRK2 mutation. Enrolled subjects will daily take trehalose in oral administration. Safety will be assessed by detecting any adverse events and analyzing blood chemistry parameters. The effect of trehalose will be evaluated through periodic clinical examinations, including the administration of specific scales and questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent;
* PD diagnosis according to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (UKPDS);
* Age between 18 and 80 years (inclusive);
* Hoehn \& Yahr staging \> 1;

Exclusion Criteria:

* Inability to provide written informed consent;
* Diagnosis of other concomitant neurodegenerative disease;
* Concomitant treatment with drugs similar to trehalose;
* Hypersensitivity or intolerance to the active substance administered;
* Severe swallowing problems;
* Participation in other interventional studies within 30 days from the screening;
* Other medical conditions that can interfere with results or endanger the participant.
Non-drug Interventions for Migraines

This proposal describes a randomized controlled pilot trial investigating feasibility, safety, and migraine frequency in patients with migraines who undergo an 8 week mindfulness based stress reduction (MBSR) program compared to a wait-list control group.

Preliminary research has shown MBSR to be effective in chronic pain syndromes and other mind/body interventions have shown good promise in the treatment of headaches. A randomized controlled trial (RCT) of yoga in migraine without aura patients by John and colleagues showed that yoga resulted in a significant decrease in headache frequency, pain index, and symptomatic medication usage compared to a self-care group. This RCT demonstrated that patients with headaches may benefit from a mind-body intervention. However, their yoga protocol was not specified, and participants were instructed to practice the technique only during the prodromal phase of a headache (prior to the pain becoming severe), so as an abortive intervention at the time of a headache. Thus, the investigators of this trial are proposing to evaluate the effect of MBSR on adults with migraines compared to an education control group. This study will add to the John study because, unlike many other mind-body interventions, MBSR offers the distinct advantage of a standardized protocol that has been used both clinically and in numerous research studies across a wide variety of conditions. Furthermore, MBSR teaches participants a daily practice that, if effective, could serve as a prophylactic intervention.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of migraine (International Classification of Headache Disorders-II);21
* 4-14 days with migraines/month
* ≥one year of migraines
* ≥18 years
* Able and willing to attend weekly sessions and willing to participate in daily mindfulness assignments, up to 30-45 min/day
* Agreeable to participate and to be randomized to either group
* Fluent in English (since the treatment groups will be run in English)
* Good general health with no additional diseases expected to interfere with the study

Exclusion Criteria:

* Current regular meditation/yoga practice
* Any major systemic illness or unstable medical or psychiatric condition (e.g. suicide risk) requiring immediate treatment or that could lead to difficulty complying with the protocol
* Diagnosis of medication overuse headache (International Classification of Headache Disorders-II);19
* Current or planned pregnancy or breastfeeding
* New prophylactic migraine medicine started within 4 weeks of the screening visit
* Unwilling to maintain stable current doses of migraine medicines for the duration of trial
* Failure to complete baseline diary recordings of migraine activity and medication use
Group-based Cardiac Rehabilitation on Patients With Coronary Artery Bypass Graft Surgery

1. To determine the effect of Moderate intensity continuous training on Pulmonary function of CABG patients.
2. To determine the effect of MICT on aerobic Capacity of CABG patients.


Eligibility Criteria:
Inclusion Criteria:

* Males and females post CABG patients with ages of 40 to 60 years postoperatively.
* The patient with Post Op-Day 5.

Exclusion Criteria:

* Patients who have a history of other Cardiac disorders that interfere with daily life before surgery and those having congenital cardiac anomalies, Tetralogy of Fallot.
* Musculoskeletal and neurological disorders.
* Age more than 60 and less than 40
Augmentation of Exposure Using Positive Mental Rehearsal in Individuals With Increased Social Anxiety

Efficacy of an optimized exposure therapy training is investigated in individuals with heightened social anxiety. Participants will undergo a one-session standardized exposure training, followed by either standard or positive mental rehearsal of the exposure experience. The efficacy is measured by symptom improvement according to subjective ratings one week later.

Exposure therapy is widely recognized as the gold-standard treatment for anxiety disorders, but its clinically significant response rates remain around 50%. Thus, innovative approaches are needed to improve the efficacy of exposure therapy. One strategy is the mental rehearsal of exposure treatment as a way of supporting the retrieval and consolidation of the exposure memory, which has been demonstrated to be an effective supplement to exposure therapy in a recent study. New conceptualizations also emphasize the role of reward processing and its importance in extinction learning. Several strategies have been proposed to target these reward processes to improve the outcomes of exposure therapy. The present study will examine the use of a positive-focused rehearsal strategy. Participants in the optimized exposure group will engage in an imaginal recounting task focusing on the positive aspects (i.e. emotions, thoughts, behavior) of the exposure. Rehearsal of the positive aspects may increase positive affect, with positive mood thought to be associated with deeper mental rehearsal of stored information. Therefore, the efficacy of using positive mental rehearsal (i.e., imaginal recounting) post-exposure will be investigated, with the use of standard mental rehearsal as an active control group. Participants will be asked to repeat the rehearsal experience at home at two-day intervals. Post-treatment assessment will be conducted one week later. The study will be conducted on healthy participants with an elevated level of social anxiety. The aim of this randomized controlled trial in healthy individuals with increased social anxiety is to investigate whether optimized exposure training (exposure + positive mental rehearsal) is more effective in reducing fear of social interaction compared to an active control group (exposure + mental rehearsal).

Eligibility Criteria:
Inclusion Criteria:

* Elevated score on Social Interactions Anxiety Scale (SIAS) \> 26

Exclusion Criteria:

* Current psychotherapeutic/psychiatric treatment
* Plans to start psychotherapeutic/psychiatric treatment in upcoming weeks
* Current suicidal intent
* Severe cardiovascular, respiratory or neurological diseases
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPA

The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)

This is a Phase 2, randomized, assessor-blinded active controlled study. This study comprises two cohorts:

* A lead-in cohort enrolling participants to receive rapcabtagene autoleucel
* A randomized cohort with participants receiving either rapcabtagene autoleucel or comparator.

After end of study (EOS), participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up (LTFU) period lasting up to 15 years after rapcabtagene autoleucel infusion. This LTFU will be described in a separate study protocol.

Eligibility Criteria:
Key inclusion criteria:

1. Men and women, aged ≥18 and ≤ 75 years with a diagnosis of GPA or MPA according to the American College of Rheumatology/ European League Against Rheumatism 2022 (ACR/EULAR 2022) classification criteria
2. Positive test for ANCA-autoantibodies
3. GPA and MPA participants with severe active disease

Key exclusion criteria:

1. Any condition that could prevent a complete washout of medications or could otherwise make the participant ineligible for anti-CD19 CAR-T therapy and further participation in the study
2. Hypersensitivity and/or contraindications to any product to be given to the participant as part of the study protocol
3. Other systemic autoimmune diseases requiring therapy
4. Any medical conditions that are not related to GPA/MPA that would jeopardize the ability of the participant to tolerate CD19 CAR-T cell therapy
5. Inadequate organ function