cyrilzakka/clinical-trials huggingface dataset:
Phitys I™ Percutaneous Left Ventricular Assist System Study

The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus intra-aortic balloon pump (IABP) for Circulatory Support during High-risk PCI.

This prospective, multi-center, randomized controlled clinical trial of the Percutaneous Ventricular Assist System is designed to measure the incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days after PCI.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old≤ patient age ≤90 years old AND patient is not in pregnancy or lactation;
2. Patients who have been evaluated by two or more cardiovascular surgeons as unsuitable for conventional surgery; or patients who have refused conventional surgery after adequate communication from the surgeon and who are at high risk for conventional surgery;
3. Left Ventricular Ejection Fraction (LVEF) ≤ 35% AND at least one of the following criteria:

   * Intervention on the last patent coronary conduit, or
   * Intervention on an unprotected left main coronary artery Or b) LVEF ≤ 30% and intervention in patient presenting with triple vessel disease.
4. Patient who can understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.

Exclusion Criteria:

1. Pre-procedure cardiac arrest within 24 hours of enrolment requiring CPR;
2. Pre-procedure ST-segment myocardial infarction within 24 hours of enrolment;
3. Patient is in cardiogenic shock;
4. Mural thrombus in the left ventricle;
5. Post-infarction ventricular septal rupture, or atrial septal or ventricular septal defects;
6. The presence of mechanical aortic or mitral valve or heart constrictive device;
7. The presence of aortic stenosis (aortic orifice area ≤1.5cm²)；
8. The presence of moderate to severe aortic or mitral or tricuspid insufficiency;
9. The presence of severe peripheral vascular disease that would preclude the placement of the percutaneous mechanical circulatory assist device;
10. Severe aortic diseases such as aortic dissection and aortic aneurysm;
11. Active infective endocarditis or other active infections;
12. Chronic renal insufficiency (creatinine clearance≤30ml/min);
13. Liver dysfunction (elevation of liver enzymes and bilirubin levels to ≥3xULN or INR≥2);
14. The presence of uncorrectable abnormal coagulation (platelet count≤75,000/mm\^3 or INR≥2.0 or fibrinogen≤1.50 g/l);
15. The presence of uncorrected moderate to severe anemia (hemoglobin \<90 g/L);
16. History of stroke or TIA within 1 month of enrolment;
17. Allergy or intolerance to contrast media, anticoagulant and antiplatelet drugs (e.g., bivalirudin, low molecular heparin, aspirin, clopidogrel, Ticagrelor, etc.);
18. Participation in clinical trials of other drugs or medical devices prior to enrollment that have not yet reached the primary outcome of research;
19. Patient with poor compliance and could not complete the study as required determined by the investigator.
Digital Health Intervention On Awareness Of Vaccination Against Influenza Among Adults With Diabetes

The study leveraged the Dario digital health platform to retrospectively analyze data from 64,904 users with diabetes assigned by the platform into three groups: Group A received previously studied monthly flu nudge messages; Group B received an adapted intervention with 2-3 monthly messages; Group C served as the control with no intervention. Surveys were conducted at baseline, three months, and six months to assess vaccination status, awareness of influenza risks, and recollection of educational content. Statistical analyses, including logistic regression, Chi-square tests, and t-tests, were used to evaluate differences between groups.

The goal of this study was to retrospectively evaluate the effectiveness of an adapted digital nudge intervention that was designed previously in an RCT setting to increase influenza vaccination rates for PWD in real world setting. The primary objective was to examine the difference in self-reported influenza vaccination rates in three groups: PWD who received the intervention using a previously published approach (group A), PWD who received an adapted digital intervention (group B) and PWD who received no intervention (group C or control). A secondary aim was to investigate whether the intervention led to differences in awareness and knowledge across study groups and examined the relationship between awareness of influenza risks and vaccination rates.

The data was collected between September 2022 and March 2023 to evaluate the effectiveness of an adapted digital nudge intervention designed to increase influenza vaccination rates among people with diabetes (PWD) in a real-world setting. The intervention builds on a previously conducted randomized controlled trial (RCT). Users were automatically assigned to three groups via the customer engagement platform using a randomization algorithm to assign each selected user to one of the test variations. This ensured that each user had an equal chance of being placed in any of the groups.

The three groups are defined as follows: group A received flu nudge messages as described previously in a randomized clinical trial with one message given each month for six months; Group B received similar messages that were adapted in frequency with 2-3 messages per month for six months and matched the Dario platform's user experience; group C received no flu nudges (Control). No compensation was offered. The intervention messages included education and recommendations related to the importance of getting flu vaccination in the diabetes population.

Eligibility Criteria:
Inclusion Criteria: subjects from the United States utilizing a Dario application who reported in the app during registration that they had a diagnosis of type 1 or 2 diabetes and who were active on the platform (logged into the app) during the 12-month period up to Sep 2022.

Exclusion Criteria: subjects that are not using Dario platform
Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients

This Phase III, randomized, balanced, parallel-group, multicenter trial aims to evaluate the effect of vaginal radiofrequency on symptoms of vaginal dryness at six months. The study compares vaginal radiofrequency treatment with non-hormonal hydration therapy in a population of patients undergoing adjuvant hormonal therapy with aromatase inhibitors, with or without LHRH agonists, for breast cancer.

Patients will be randomly assigned to one of two parallel treatment groups until the six-month assessment:

The first group will receive the reference treatment, which consists of local hydration using a hyaluronic acid-based treatment applied three times a week. Additionally, investigators may incorporate supportive measures at their discretion, such as physiotherapy or vaginal dilators.

The second group will receive the same reference treatment combined with vaginal radiofrequency therapy. This intervention consists of three sessions, each spaced 4 to 6 weeks apart.

This study aims to see if vaginal radiofrequency therapy can help reduce vaginal dryness in women receiving hormone therapy for breast cancer.

The participants are divided into two groups:

One group will use a non-hormonal vaginal moisturizer (hyaluronic acid) three times a week. If needed, they can also use other supportive treatments like physiotherapy or vaginal dilators.

The other group will receive the same moisturizer treatment but will also have three sessions of vaginal radiofrequency therapy, with each session spaced 4 to 6 weeks apart.

After six months, researchers will compare the two groups to see if vaginal radiofrequency provides additional benefits in relieving vaginal dryness.

Eligibility Criteria:
INCLUSION CRITERIA :

* Patient over 40 years
* Presenting disabling vaginal dryness symptoms despite well-administered local moisturizing treatment, attested by a vaginal dryness score ≥3
* Patient undergoing adjuvant treatment for breast cancer
* Patient treated with aromatase inhibitors +/- LHRH agonist for at least 3 months with a planned remaining duration of at least 12 months
* Patient affiliated to a social security organization
* Patient having signed the informed consent for the present study

EXCLUSION CRITERIA:

* Contraindications related to the radiofrequency technique:

  * Ongoing urinary tract infection
  * Pacemaker
  * IUD intrauterine device
  * Pregnancy
* Mucocutaneous disease with vulvovaginal localization: infection, sore, scleratrophic lichen, psoriasis, eczema, etc.
* Neurodegenerative disease with perineal involvement
* Current or recent treatment (within the last 12 months) with other physical methods: vaginal laser, photobiomodulation, PRP injection, hyaluronic acid injection or lipo-modeling.
* Pregnant or breast-feeding women
* Patients under guardianship or trusteeship.
High-intensity Interval Exercise in Rheumatoid Arthritis

Cardiovascular performance and overall fitness can be improved by high-intensity aerobic activity, and these benefits may be achievable by persons with rheumatic diseases. The investigators hypothesize that a 12-week high-intensity interval exercise program will provide substantial improvements in cardiovascular function, inflammation and symptoms affecting quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis disease according to the American College of Rheumatology (ACR)/ The European Alliance of Associations for Rheumatology (EULAR) 1987/2010 criteria
* Disease duration \>1 year
* Age (range 20-60 years)
* Stable medication on anti- rheumatic drugs for \>3 months
* Low-to-moderate disease activity (\<5.1) according to the Disease activity score 28 (DAS28)

Exclusion Criteria:

* Cerebrovascular diseases
* Diabetes
* Severe hypertension
* Chronic obstructive pulmonary disease or other severe pulmonary diseases
* Other severe diseases that may be associated with adverse events or restrict participation in high-intensity exercise
* Arthroplasty of large joints
* Inability to manage Cardiopulmonary Exercise Testing (CPET)
* Pregnancy
* Already participating in regular aerobic or strength exercise at a high intensity level (\>1 hours/ week) during the last 6 months
* Inability to speak or read Swedish.
Autologous Adipose Stem Cells and Platelet Rich Plasma Therapy for Patients With Knee Osteoarthritis

Adipose stem cells and platelet rich plasma can regenerate the injured cartilage.

The proposed study is two centers, unblinded, non randomized, phase I/II trial in which the patients will be treated with a single dose of autologous stromal vascular cells (SVF) in combination with platelet rich plasma (PRP).

This study aimes to evaluate the clinical efficiency of autologous adipose tissue-derived MSC transplantation in patients with confirmed osteoarthritis at grade II and III. Adipose tissue is isolated from the belly, and used for extraction of the SVF. The SVF is mixed with activated platelet-rich plasma before injection. The clinical efficiencies are evaluated by the pain score (VAS), Lysholm score, and MRI findings. SVF is isolated from about 100 mL of adipose tissue, and PRP is prepared from 20 mL of peripheral blood. Total injection volume will be about 5-10 mL. The total number of SVF to be injected is 1.0 x 10(7) to 5 x 10(7).

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years and ability to understand the planned treatment.
* Idiopathic or secondary osteoarthritis of the knee with grade 2, 3 radiographic severity

Ability and willingness to undergo liposuction

Exclusion Criteria:

* Pregnant women or cognitively impaired adults.
* Presence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging.
* Inflammatory or postinfectious arthritis.
* More than 5 degrees of varus or valgus deformity.
* Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age.
* Intraarticular corticosteroid injection within the previous 3 months.
* A major neurologic deficit.
* Serious medical illness with a life expectancy of less than 1 year.
* Prior admission for substance abuse
* Body Mass Index (BMI) of 40 kg/m2 or greater
* Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent
* In the opinion of the investigator or the sponsor the patient is unsuitable for cellular therapy
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Glatiramer Acetate (GA) on the Retinal Nerve Fiber Layer (RNFL) and Visual Function in Patients With a First Episode of Acute Optic Neuritis (AON). (Octagon)

The main objective of the study is to determine whether glatiramer acetate 20 mg once daily reduces the amount of axonal loss in the optic nerve after a first event of acute optic neuritis compared to placebo patients and to generate data supporting the potential neuroprotective effect of glatiramer acetate in a human in vivo model of axonal loss.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 45 years
* Isolated, unilateral, first acute optic neuritis (AON) event consistent with inflammatory demyelinization, not explained by other etiologies. Onset of AON is defined by the presentation of visual disturbances.
* Able to provide written informed consent prior to enrollment
* Willing and able to comply with the protocol requirements for the duration of the study
* For women of child bearing potential:

  * A negative urine pregnancy test o
  * Willing to practice an acceptable method of birth control •
* Willing to receive a steroidal regimen

Exclusion Criteria:

* A diagnosis of clinically definite multiple sclerosis (MS) (Clinically Definite Multiple Sclerosis)
* Current use of any approved disease modifying agents for treatment of MS
* Prior clinical episode of optic neuritis in either eye
* Bilateral AON
* Inability to undergo study evaluations in both eyes
* Known ocular or neurological conditions or abnormalities other than refractive error that impair visual function
* Retrogeniculate visual loss
* Refractive error of greater than +6 or -6 diopters
* Neuromyelitis Optica (Devic's disease)
* Systemic diseases that cause inflammatory optic neuropathy, including but not limited to Sarcoidosis, Systemic lupus erythematosus (SLE), Wegener's Granulomatosis, Syphilis, human immunodeficiency virus (HIV)
* Known ocular conditions that preclude dilation
* Any condition that may interfere with performance of Optical Coherence Tomography (OCT): corneal, lens or fundoscopic abnormality, a co-morbid ocular condition not related to optic neuritis as detected on the OCT reading
* Any condition that precludes administration of Glatiramer Acetate, such as a known history of sensitivity to mannitol
* Diabetes Mellitus Types I or II
* Gastric bypass surgery
* Current use of chemotherapy or radiotherapy
* Treatments that may cause visual loss such as plaquenil, anti-tubercular agents, interferon (IFN)-alpha therapy, monoclonal antibodies Cardiac medications that may affect visual evaluations such as digitalis, amiodarone, quinine
* Ongoing treatment with steroids (for longer than 10 days) within the last 3 months
* Significant or unstable medical, systemic, psychiatric or logistical condition that affects the patient's ability to give informed consent or to complete the study procedures
* Use of an investigational drug within 30 days prior to randomization
Vienna Vascular Liver Disease Study

The aim of this Register Trial is to systematically study the epidemiology, risk factors, liver function as well prognosis of patients with vascular liver diseases. Furthermore, important clinical parameters will be assessed in order to evaluate patients' coagulation status and in order to develop new biomarkers derived from blood, urine, stool or ascites of patients as well as histological samples from the upper / lower GI-tract or the liver in order to better understand the natural history of vascular liver diseases.

We will include patients with vascular liver diseases, including

* portal vein thrombosis (PVT)
* Budd-Chiari Syndrome (BCS)
* Heredetary Hemorrhagic Teleangiectasia (HHT, or Osler-Rendu Disease)
* Noncirrhotic-portal hypertension (NCPH) and Porto-sinusoidal vascular disorder
* Cirrhosis cardiaque if the fulfill inclusion/exclusion criteria and provide written informed consent. Participation in the biobank is optional for the patients. In particular, we will study the natural course of the patients in regard to hepatic decompensation (ascites, variceal bleeding, hepatic encephalopathy), need for intensified treatment (TIPS, ICU, liver transplantation) and survival.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a vascular liver disease by imaging (sonography, CT, MRI), transient elastography or liver histology
* PVT: Portal vein thrombosis
* NCPH: non-cirrhotic Portal Hypertension
* PSVD: porto-sinusoidal vascular disorder
* BCS: Budd-Chiari-Syndrome
* SOS: sinusoidal occlusive disease
* HHT: hereditary hemorrhagic teleangiectasia
* CIRCAD: cirrhosis cardiaque
* Age \>18 years and \<100 years
* Written informed consent obtained

Exclusion Criteria:

- withdrawal of written informed consent
Effect of Back School and Supervised Walking in Sedentary Women With Chronic Low Back Pain

Do Back School and/or supervised walking improve reported pain and spine flexibility in sedentary women with chronic low back pain (LBP)?

From August 2002 to March 2004, one hundred nineteen volunteers sedentary women with chronic LBP and age ranging from 32 to 60 years old, randomly allocated to four groups of participants assigned as Back School (BS; N=28), Supervised Walking (W; N=32), Back School and Supervised Walking (BS+W; N=29), and Control Group (CG; N=30) were submitted to interventions once a week for 5 consecutive weeks and followed for up to 6 months. The groups BS, W, and BS+W received LBP-targeted lectures and on-place practical sessions of each respective intervention. CG received print information about LBP and 5 different lectures unrelated to LBP.

Eligibility Criteria:
Inclusion Criteria:

* Age range 30 to 60 years old
* LBP without any known organic cause for at least 3 months of duration
* Less than 90 minutes per week of regular physical activity of any intensity

Exclusion Criteria:

* Any known organic cause of LBP
A Study to Evaluate the Effects of a Single-Dose and Repeat-Administration of Intranasal Esketamine on On-Road Driving in Participants With Major Depressive Disorder

The primary purpose of this study is to evaluate the effect of a single 84-milligram (mg) dose of intranasal esketamine compared to placebo, on next day driving performance and repeated administration of 84 mg intranasal esketamine on same-day driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to adhere to the prohibitions and restrictions specified in this protocol
* If a woman, must have a negative serum beta human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test on Day 1 of Period 1 in Part A and prior to study drug administration in Part B
* Comfortable with self-administration of intranasal medication and able to follow instructions provided
* Normal visual acuity (corrected or uncorrected)
* Based on self-report, able to consume an amount of alcohol that typically produces a blood alcohol concentration (BAC) of 0.05 percent (that is, 2 to 3 alcoholic drinks ingested within 2 hours on a single occasion)

Exclusion Criteria:

* Current or prior diagnosis of psychosis/psychotic or bipolar disorder
* Primary sleep disorder, such as insomnia, requiring pharmacological intervention at Screening
* Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or Day 1 of Period 1 as deemed appropriate by the investigator
* Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening or Day 1 of Period 1 as deemed appropriate by the investigator
* History of moderate or severe use disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV or DSM-5) criteria within 1 year before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening and Day 1 of Period 1
Pancreas-sparing Duodenectomy Versus Pancreatoduodenectomy for Early-stage Periampullary Carcinoma

The purpose of this study is to investigate the feasibility, safety, and long-term prognosis of pancreas-sparing duodenectomy with regional lymphadenectomy in the treatment of early-stage (pTis/pT1/pT2) periampullary carcinoma with or without lymph node metastasis

Pancreaticoduodenectomy (PD) is commonly used for periampullary carcinoma (PC). In recent years, morbidity and mortality rates following PD have decreased, but the operative stress induced by pancreatectomy is considerable. Less-invasive surgery should thus be elected for PC without pancreatic and diffuse lymph node involvement. From the perspective of organ-preserving resection, pancreas-sparing duodenectomy (PSD) represents an attractive option for selected periampullary tumors, and offers an alternative to PD.

Previous reports have described PSD for benign, premalignant and some selected malignant conditions of duodenum, and have emphasized this procedure as a safe and effective treatment associated with good quality of life. However, use of PSD for PC is still controversial.Available data about PSD for PC and published data from the follow-up evaluation in the literature are still limited.

Given the fact that 20%-60% pT1/pT2 patients have regional lymph node metastasis, regional lymph node dissection should be essential for PC. However, lymphadenectomy has never been promoted as a regular procedure of PSD.The aim of the present study was to investigate the feasibility, safety, and long-term results of PSD with regional lymphadenectomy for early-stage (pTis/pT1/pT2) periampullary cancers.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven periampullary carcinoma (including cancers of distal common bile duct, ampulla or papilla of Vater)
* Pre- and intra-operative stage(CT, EU stage):pTis or pT1 or pT2, N0 or N1, M0
* ASA score: \< 3
* Liver function:Child-Pugh A
* No history of other cancers
* No history of preoperative chemotherapy or radiotherapy
* Written informed consent

Exclusion Criteria:

* There are concurrent cancers or the patients have been treated due to other type of cancers before diagnosed as periampullary carcinoma
* Pre- and intra-operative stage: more advanced than T2,or with remote metastasis
* The Patients received other non-surgical therapy, such as chemotherapy, immunotherapy, radiotherapy or endoscopic therapy
* The Patients received upper abdominal surgery
* ASA score: ≥ 3
* Liver function:Child-Pugh B or C
* Pregnancy patients