cyrilzakka/clinical-trials huggingface dataset:
Effect of Patient Management Based on Continuous Continuous Glucose Monitoring on Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes and Moderate to Severe Coronary Artery Stenosis

Patients with type 2 diabetes and moderate to severe coronary artery stenosis who were treated at Zhejiang Second Hospital and cooperative hospitals were randomly divided into a patient management group based on continuous continuous glucose monitoring (CGM) or a patient management group based on HbA1c. Both groups controlled cardiovascular risk factors according to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020) and the ADA Guidelines for the Prevention and Treatment of Diabetes (2023), and conducted HbA1c testing every 3 months. In the CGM-based glucose management group, CGM measurements will be performed at baseline and at 6, 12, 18, and 24 months. In the CGM-guided treatment group, the target TIR\>70%, TBR\<4%, TAR\<25%, and HbA1c\<7.0%; in the HbA1c-guided treatment group, the target HbA1c\<7.0%. The primary endpoint was major adverse cardiovascular events (MACE: CV death, nonfatal myocardial infarction, nonfatal stroke).


Eligibility Criteria:
Inclusion Criteria:

Male or female between 35 and 75 years old type 2 diabetes HbA1C: 7.5%-10% Moderate to severe coronary artery stenosis (the degree of stenosis of any major coronary artery is ≥50% as assessed by coronary angiography or coronary CTA) The blood sugar lowering regimen has been stable in the past 3 months Ability to understand the requirements of the study and provide informed consent

Exclusion Criteria:

Type 1 diabetes or other types of diabetes Acute myocardial infarction or stroke within the past three months Ketoacidosis, hyperosmolar hyperglycemic state Relative or absolute contraindications to contrast agent examinations such as severe renal insufficiency, contrast agent allergy, and hyperthyroidism Elective surgery planned within 2 years Preparing for pregnancy or becoming pregnant Life expectancy less than 2 years Skin allergies and other situations where CGM cannot be used Currently participating in other clinical studies
Velocity Vector Imaging in Patients With Moderate-to-Severe Aortic Regurgitation

Velocity Vector Imaging may provide reliable and detailed information on left ventricular segmental function in asymptomatic patients with moderate-to severe AR. This may help to identify subclinical myocardial dysfunction in order to operate early enough to prevent postoperative heart failure and restrict unnecessary early operation which could be associated with operative risks and mortality related to prosthetic valves.

Chronic aortic regurgitation (AR) is a progressive process which causes both left ventricular volume and pressure overload. While the volume overload is associated with the degree of the aortic regurgitant volume, the pressure overload occurs as a result of systemic hypertension developed due to increased stroke volume. In early stages, excentric hypertrophy occurs aiming to compensate the volume overload in the left ventricle. Therefore , ejection fraction remains in normal range despite the increasing volume overload. Left ventricular dilatation and impairment in ejection fraction only occur in the end stages of the disease. Asymptomatic patients with chronic aortic regurgitation (AR) have a good prognosis in the presence of preserved systolic function. Therefore it is a challenge to identify patients with subclinical left ventricular (LV) dysfunction. Velocity vector imaging (VVI) is a new echocardiographic method based on two dimensional gray scale imaging, which is angle independent and can provide more accurate data about cardiac function.

Eligibility Criteria:
Inclusion Criteria:

* Moderate-to-severe aortic regurgitation identified by Standard echocardiography.
* Chronic isolated aortic regurgitation
* Being asymptomatic ( Class 1 according to NYHA)
* Sinusal rhythm

Exclusion Criteria:

* Ejection fraction \< 50%
* Mitral valve disease accompanied to aortic regurgitation (patients with over mild degree of mitral regurgitation and stenosis
* Aortic stenosis
* Previous myocardial infarction, or the patients with \>50% coronary occlusion in any of the coronary arteries.
* Cardiomyopathies
* AV conduction disorders
* Chronic renal or hepatic insufficiency
* Malignities
Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial

This study is testing whether pathogen reduced platelets can control bleeding as well as non-pathogen reduced platelets (otherwise known as large volume delayed sampling).

This is a pilot clinical trial to assess the post-operative bleeding in children who receive pathogen-reduced (PR) platelet transfusions versus standard (large volume delayed sampling - LVDS) platelet transfusions both during and for 24 hours following cardiopulmonary bypass surgery.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 0 up to and including 18 years of age
* Undergoing elective cardiopulmonary bypass surgery
* Are planned to have a chest tube placed in the operating room prior to chest closure

Exclusion Criteria:

* \>/=19 years of age
* Preterm infants (less than 38-week gestational age at time of surgery)
* On extracorporeal membrane oxygenation (ECMO) or ventricular assist device prior to surgery
* Family requests limitation of blood products (i.e. Jehovah's Witness)
* Congenital bleeding disorder
* Are planned to require ECMO post-op
* Previously enrolled in the study
Termination of Pregnancy With Mifepristone and Misoprostol Versus Sulprostone

The purpose of this study is to determine which medical treatment is the most effective to terminate a pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women by whom a termination of pregnancy is desired.

Exclusion Criteria:

* Women with liver/kidney disease
* Women on long-term use of corticosteroids (\> 6 months)
* Cardiovascular problems
* Therapy-resistant diabetic women
* Therapy-resistant asthma/bronchitis
* Thalassemia
* Ulcerative colitis
* Peptic ulcer disease
* Glaucoma
* Porphyria
* Allergic reaction to prostaglandin or mifepristone
* Women with a prior caesarian section or women with contractions at the start of the study
A Study to Evaluate the Effect of Spinal Cord Stimulation (SCS) on Painful Diabetic Peripheral Neuropathy (pDPN)

The purpose of the study is to evaluate the effects of stimulation parameters on clinical outcomes of Spinal Cord Stimulation (SCS) in the treatment of chronic, intractable limb pain resulting from painful Diabetic Peripheral Neuropathy (pDPN).


Eligibility Criteria:
Key Inclusion Criteria:

* Clinical diagnosis of diabetes mellitus, according to International Diabetes guidelines.
* Willing and able to comply with all protocol-required procedures and assessments/evaluations.
* Eligible candidate for SCS from a surgical, cognitive, psychological and psychiatric standpoint per site's routine screening process and based on investigator judgement.
* Subject signed a valid, EC-approved informed consent form (ICF) provided in local language.

Key Exclusion Criteria:

* Primary etiology for lower limb neuropathic pain not due to Diabetic Peripheral Neuropathy (DPN).
* Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study.
* Currently implanted with an active implantable device(s) (e.g., pacemaker, drug pump).
* A female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.
Virtual Rehabilitation and Conventional Therapeutic Exercises in the Treatment of Individuals Post Stroke

The purpose of this study is to determine the effects of the use the Nintendo Wii® (NW) and conventional therapeutic exercises in the rehabilitation of balance and gait of the post-stroke patients and the impact on quality of life.

This Randomised clinical trial (RCT) has longitudinal and prospective feature, held at the Neurosciences Clinic located at the Clinic Professor Francisco Magalhães Neto the HUPES Complex / Federal University of Bahia from June 2015 until June 2017.

In the initial evaluation were obtained by a trained examiner and blinded to the allocation of participants, all personal data of all patients, as well as evaluations of balance, gait, and quality of life through specific validated scales:

1. Berg Balance Scale (BBS);
2. Tinetti Gait Scale (TGS)
3. Quality of Life Scale Specific for stroke (QLSSS) ;

The investigators employ a program of conventional therapeutic exercises and virtual rehabilitation with NW, for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 years, of both sexes; clinical diagnosis of stroke confirmed by neurological assessment report or neuroimaging;
* a stroke at least 6 months prior to the study
* the ability to walk independently with or without an assistive device;
* absence of visual or auditory deficits as reported by the subject.

Exclusion Criteria:

* score \<24 on the Mini Mental State Examination;
* other associated neurological conditions;
* other orthopedic injuries that could impair mobility and make the execution of the proposed activity impossible;
* participation in other physical rehabilitation programs.
Vitamin Mix (B6, B9, B12, And Choline) For Glaucoma Patients

This study aims to determine whether a combination of vitamins (B6, B9, B12, and choline) can help protect the eyes of people with glaucoma and slow vision loss. The study will assess whether these vitamins support retinal cells and maintain or improve their function.

Adults aged 18 and older with primary open-angle glaucoma (including normal-tension glaucoma) or pseudoexfoliation glaucoma, and those with mild to moderate glaucoma, may be eligible. Participants must meet specific medical criteria and cannot take additional vitamin supplements during the study.

Participants will be randomly assigned to one of two groups: one group will take a daily vitamin supplement (B6, B9, B12, and choline) for one year, along with standard glaucoma care, while the other will continue standard care without extra vitamins. The vitamins used are well tolerated at selected doses, with possible mild side effects such as an upset stomach or tingling sensations. They will visit the clinic five times over 12 months (at the start, and at 3, 6, 9, and 12 months) for routine eye tests, including measuring eye pressure, checking vision and visual fields, taking scans of the eye's nerve layers (OCT), and completing an electroretinogram (ERG) to assess retinal function. Blood samples will also be collected.

If the vitamins are effective, this could provide an additional strategy alongside current eye pressure lowering treatments to reduce vision loss.


Eligibility Criteria:
Eligibility Criteria

Inclusion Criteria:

Patients with the following characteristics will be eligible for inclusion in the trial:

* 18 years or older at the time of inclusion
* Diagnosis of Primary Open-Angle Glaucoma (POAG), Normal Tension-Glaucoma (NTG) or Pseudoexfoliation Glaucoma (PEXG) in one or both eyes diagnosticed by an ophthalmologist.
* Best corrected Snellen VA of 0.3 or better in the study eye(s)
* Two or more reliable VF tests with less than 15% false positives

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from participation in the study:

* Visual field damage worse than -16dB in the study eye(s)
* Eye pressure greater than 35 mmHg in study eye(s) on either of two measurement occasions or a mean pressure of 30 mmHg over two occasions
* Any disease affecting retinal function
* Neurological or other non-glaucomatous conditions that may affect the visual field
* Inability to perform visual field examination
* Unwillingness to stop any intake of multivitamins or B vitamin substances
* Known allergy or intolerance to B-vitamins
* Previous eye surgery, except for uncomplicated cataract surgery
* Pregnant or breastfeeding women
* Women of childbearing potential who do not use reliable contraception
* Any disease or condition likely to prevent long-term follow-up
* Cancer diagnosis within the last 5 years (except treated squamous cell carcinoma)
* History of liver disease or stomach ulcers
* Inability to understand and speak Swedish or English
Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole

The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion / (VMT) including macular hole with ocriplasmin.

The present study is designed to assess anatomical and functional outcomes following a single intravitreal injection of ocriplasmin 0.125mg in subjects with symptomatic vitreomacular adhesion (VMA)/ (VMT) including macular hole.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years of age or older and of either gender
* Presence of vitreomacular adhesion
* Best corrected visual acuity (BCVA) of 20/32 or worse in study eye
* BCVA of 20/800 or better in the non-study eye

Exclusion Criteria:

* History or current evidence of proliferative retinopathy, exudative age-related macular degeneration (AMD) or retinal vein occlusion in the study eye
* Any vitreous hemorrhage or any other vitreous opacification which precludes the visualization of the posterior pole by visual inspection OR adequate assessment of the macula by spectral-domain optical coherence tomography (SD-OCT) in the study eye
* Macular hole of \> 400 µm diameter in the study eye
* Presence of epiretinal membrane (ERM)
* Aphakia in the study eye
* High myopia (more than 8D) in study eye
* History of rhegmatogenous retinal detachment in either eye
* History of vitrectomy in the study eye
* Previous participation in this trial or prior administration of ocriplasmin in the study eye
TDCS in People with Subthreshold Depression

This study evaluates the effects of multi-session transcranial direct current stimulation on loneliness, mood and depressiveness in people with subthreshold depression.

Depression-prone individuals will be invited and allocated to three groups, either the personalised transcranial direct current stimulation (tDCS) group, the conventional tDCS group, or the sham control group. After screening and at baseline prior to the tDCS sessions, participants will complete tests and questionnaires on depression symptoms, loneliness and mood, and they will also receive functional magnetic resonance imaging (MRI) in a 3-Tesla MRI scanner. There will be a total of 10 sessions to be completed after the screening and baseline measures. For both personalised tDCS group and the conventional tDCS group, tDCS with 2 milliampere (mA) intensity will be delivered for 20 minutes in each session. For sham control group, the protocol will be similar, except that the stimulation only happens in the first 30 seconds in each session. Especially for participants allocated to the personalised tDCS group, the stimulation site for each individual in this group may vary, depending on their brain activations and connectivity. The anodal stimulation sites for participants allocated to the conventional tDCS group and the sham control group will be F3 within the left DLPFC. Immediately after and also 3-months after completing the 10 sessions, participants will be invited to complete again tests and questionnaires on depressive symptoms in addition to loneliness and mood, and they will also receive functional MRI scanning in the 3T MRI scanner. Participants will also be prompted to self-report daily their loneliness and mood levels throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* No histories of learning impairment, major psychiatric disorders including Major Depressive Disorder or neurological disorders
* At least primary school education
* Subthreshold depression

Exclusion Criteria:

* On medication or treatments within 2 weeks prior to the beginning of the study that would affect the individual's brain, cognitive and affective functions
Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer

The purpose of this research study is to determine if the combination of chemotherapy and hormone therapy is safe and helpful for patients who plan to have their high-risk prostate cancer surgically removed. Some physicians believe that patients with high risk cancer that is located in one area, may have an early but small spread of the cancer outside of the prostate, and perhaps even to distant organs. Therefore, better treatments for the entire body are needed to improve the ability of surgery or other local therapies to cure prostate cancer. Since chemotherapy is beginning to demonstrate increasing activity in advanced prostate cancer patients, it is possible that using chemotherapy combined with hormonal therapy earlier in the course of localized but high risk patients might improve the outcomes for these patients.

* Participants will receive treatment in the outpatient clinic, where the docetaxel chemotherapy will be placed in a bag of fluid and will be given by vein every three weeks. Participants will take Decadron (dexamethasone) by mouth 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel. They will also take estramustine and casodex by mouth at home. Zoladex (or lupron) will be given subcutaneously (under the skin) 4 times every three months. They will also be started on coumadin beginning at the time of the first docetaxel infusion and continuing until 3 weeks after the 4th cycle of chemotherapy.
* After 2 months (or cycles) of therapy, participants will be evaluated in order to assess the response and toxicity of treatment, including a review of medical history, physical examination, blood tests, including PSA. If there is no evidence of progression or excessive toxicity, treatment will continue for 2 more months in the same manner.
* At the end of 4 months of chemotherapy, participants will be reassessed by the medical oncologist and urologist regarding surgery to remove the prostate.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Potential candidate for radical prostatectomy
* Any of the following: a) clinical stage T3 patients, b) Serum PSA greater than or equal to 20 ng/ml, c) Gleason score 8-10, d) Clinical T2 disease and either MRI evidence of seminal vesicle involvement or Gleason 4+3 cancer with either 5 or 6 biopsies positive
* ECOG Performance Status 0-1
* WBC \> 3,000 ul
* HCT \> 30%
* PLT \> 100,000/ul
* LFTS within normal limits

Exclusion Criteria:

* Prior hormones, radiation or chemotherapy for prostate cancer
* Myocardial infarction within 1 year, significant change in anginal pattern within last 6 months, current congestive heart failure (NYHA Class 2 or higher), or deep venous thrombosis within 1 year
* Evidence of active infection
* Significant peripheral neuropathy
Outcome After Avascular Necrosis of the Femoral Head in Young Patients

1. The course of AVN between Initial diagnosis and total hip replacement (THA) is analysed. The impact of early interventions versus conservative therapy in AVN before THA will be evaluated.
2. The short and long term outcomes of AVN patients undergoing THA with respect to complications, reoperations and quality of life are investigated. Potential risk factors for adverse outcomes will be investigated.

The study is to describe the course of avascular necrosis (AVN) of the femoral head from initial diagnosis and to collect data on treatment options and the further course in these cases. The duration from initial diagnosis of AVN to joint replacement as total hip arthroplasty (THA) will be analysed and the course after joint replacement with potential short- and long-term complications will be evaluated.

The impact of THA after AVN on activities of daily living will be assessed by Euroquol 5 Dimensions (EQ-5D-5L) and Hip disability and Osteoarthritis Outcome Score (HOOS) questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* MRI of the hip available from diagnosis at the USB or KSBL Liestal
* Informed Consent

Exclusion Criteria:

* Insufficient knowledge of project languages (English, German, French)
Rotational Thromboelstometry (ROTEM) change_colloid_total Hip Replacement Arthroplasty

The investigators administered different kinds of colloids before transfusion of red blood cell to patient undergoing total hip replacement arthroplasty. The investigators will compare the differences of changes in rotational thromboelastometry (ROTEM) data among them.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as avascular necrosis of hip and undergoing total hip replacement arthroplasty

Exclusion Criteria:

* hematologic disease
* anticoagulant medication
* preoperative hemoglobin \< 10 g/dl
* renal disease
* pulmonary disease (pulmonary edema, effusion)
* cardiovascular disease (coronary heart disease, congestive heart failure)
Premotor Cortex: A New Target for Stroke Motor Rehabilitation

The goal of the study is to determine the effect of repetitive transcranial magnetic stimulation (rTMS) over the premotor cortex on training-related improvements in motor performance and associated neural plasticity.

Motor training is an important part of recovery after stroke. During motor training, stroke patients practice performing a movement and become better at performing the trained movement over time. Repetitive transcranial magnetic stimulation (rTMS), which uses magnetism to excite neurons near the surface of the brain, may further improve performance. Healthy adults made larger training-related improvements in their motor performance when they received rTMS over the primary motor cortex during motor training. There is evidence that the premotor cortex may be a more effective target than the primary motor cortex for rTMS for some stroke survivors. In the current study, the investigator will determine the effect of rTMS over the premotor cortex on training-related improvements in motor performance in healthy adults.

Eligibility Criteria:
Inclusion Criteria:

Motor training only (pilot participants):

* Have the ability to give informed, written consent
* Be aged 18-80 years old
* Be right-handed using the Edinburgh handedness inventory
* Have intact cognitive abilities (score higher than 75th percentile on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS))
* No current depression (score less than 7 on the Hamilton Depression Rating Scale (HDRS))
* No neurological disease
* No contradictions to Transcranial Magnetic Stimulation (TMS)
* TMS over the extensor carpi ulnaris (ECU) hotspot must evoke a motor evoked potential (MEP) in the ECU muscle
* MEP amplitude must increase by at least 20% as the TMS intensity increases
* The subjects must be comfortable when receiving TMS of all strengths.

Remaining study participants:

* Have the ability to give informed, written consent
* Be aged 55-80 years old
* Be right-handed using the Edinburgh handedness inventory
* Have intact cognitive abilities (score higher than 75th percentile on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS))
* No current depression (score less than a 7 on the Hamilton Depression Rating Scale (HDRS))
* No neurological disease
* No contradictions to Transcranial Magnetic Stimulation (TMS)
* TMS over the extensor carpi ulnaris (ECU) hotspot must be able to evoke a motor evoked potential (MEP) in the ECU muscle
* MEP amplitude must increase by at least 20% as the TMS intensity increases
* The subjects must be comfortable when receiving TMS of all strengths.

Exclusion Criteria:

* Impaired cognitive abilities (score lesser than 75th percentile on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS))
* Current depression (score more than 7 on the Hamilton Depression Rating Scale (HDRS))
* Neurological disease
* Has a contradiction to TMS
* MEP cannot be evoked with TMS in the ECU muscle
* Inability to tolerate one or more TMS strengths