cyrilzakka/clinical-trials huggingface dataset:
EPO-BUL-01 - Study of the Optimization of Anemia Management of EPREX (Epoetin Alfa) in Predialysis Patients With Chronic Renal Failure

The purpose of the study is to evaluate the effectiveness, safety and clinical outcome of Epoetin alfa with dosing regime in accordance with Summary of Product Characteristics in the treatment of anemia in predialysis.

Open-label, non-randomized, multicenter study for anemic patients with hemoglobin \<or=11 g/dl. The dose of epoetin alfa is the routine dosage regimen and is in accordance of the approved SmPC. That's why the study had in general two phases - first period: subcutaneous administration and second period:intravenous administration. The evaluation is made in 4 visits:baseline, 2 month (Visit 1), 4 month (Visit 2), 6 month (Visit 3), 9 month (Visit 4). Echographic evaluation - on baseline visit, Visit 3 and Visit 4.Baseline visit - weight, arterial pressure, Hemoglobin, Hematocrit, Erythrocytes, Middle Cells Volume, Middle Cells Hemoglobin, Middle Cells Hemoglobin Concentration, Transferrin, Creatinine, Clerans, Visit1, Visit 2, Visit 3, Visit 4 - Hemoglobin, Hematocrit, Erythrocytes, Middle Cells Volume, Middle Cells Hemoglobin, Middle Cells Hemoglobin Concentration. The dosage is in routine dosing regimen, the starting dose of epoetin alfa is 50 Units/kg body weight. The maintaining dose depends on hematological results. Administration - subcutaneous (during the first period), intravenous (second period). Duration of the study - 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Hb\<or= 11g/dl
* Females - using adequate contraceptive method

Exclusion Criteria:

* Patients with uncontrolled or severe cardiovascular disease, including recent myocardial infarction, uncontrolled hypertension or congestive heart failure
* treatment within the previous 6 months with epoetin alfa or any erythropoietin, known hypersensitivity to the product or to any of the ingredients
* patient not in line with the approved SmPC
A Study Comparing Remimazolam Tosilate and Propofol for Intravenous General Anaesthesia in Operations

The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as an intravenous general anaesthetic drug in operations and to determine its efficacy and safety profile comparing to propofol.

This is an multi-center，double-blinded，parallel and control study using Remimazolam or propofol for anesthesia in operations.Subjects are randomized to different treatment groups (including 3 for Remimazolam Tosilate and 1 for propofol) and anaesthetics are pumped contimuously into bodies.Analgesics and muscle relaxants are permitted during operations.Efficacy，safety and pharmacokinetic/pharmacodynamic profiles of Remimazolam Tosilate are to be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* subjects aged 18-60 years；
* intending to have non-emergency operations；
* ASA( American Society of Anesthesiologists) I or II；
* 18 kg/m²\<BMI(Body Mass Index)\<30 kg/m².

Exclusion Criteria:

* people with contraindications to general anaesthesia;
* one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
* history of recent use of narcotics,analgesics,anaesthetics and benzodiazepine hypnotics;
* history of severe cardiovascular disease;
* uncontrolled blood glucose level;
* cerebral disease or mental disorder;
* allergic to drugs used in the study;
* pregnant women or those in lactation period.
Pedicle Screws Placement Accuracy in Thoracolumbar Spine Using O-arm Navigation VS Standard Cervical Distractor Screws

Pedicle screw instrumentation is used nowadays mostly in spine fusion which is a surgical option for treating variety of conditions such as vertebral fractures, degenerative spine diseases, spine tumors and spine deformities. However, pedicle screws misplacement and breach may occur and be a great cause of morbidity. The breach rate can be as high as 20-39.8% but most of the time only small number is associated with complications. Surgeons use assistive technique to avoid screw breached and improve screw placement accuracy. Investigators aim in this study to compare accuracy of pedicle screws placement using two guidance techniques are O-arm navigation the latest assistive imaging technique that uses three-dimensional (3-D) real time images to allow the surgeons follow the screw's trajectory, and standard cervical distractor screws to mark the entry point and trajectory.


Eligibility Criteria:
Inclusion Criteria:

* Patients who need a thoracolumbar spine surgery that require pedicle screw insertion.

Exclusion Criteria:

* Patients whose surgeries in cervical spine
* Patients whose surgeries are for correction of deformities such as scoliosis and kyphosis, patients with infections or tumors.
The Effect of taVNS on the Prognosis of Patients Undergoing Pancreatoduodenectomy

To explore the effects of transcutaneous auricular vagus nerve stimulation (taVNS) during the perioperative period on the incidence of delayed gastric emptying after pancreatoduodenectomy and its possible mechanisms.

Patients are recruited one week prior to the start of the trial, during which they are informed about the experimental protocol and associated risks. After obtaining informed consent and signatures, they are enrolled as study participants. Patients who meet the trial criteria are randomly assigned in a 1:1 ratio to the control group (sham taVNS group) and the intervention group (taVNS group, with taVNS intervention starting 30 minutes prior to anesthesia induction and continuing until the end of surgery, terminating after the removal of the endotracheal tube in the PACU), in a double-blind manner (with taVNS intervention and postoperative follow-up conducted by different researchers).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Diagnosed with pancreatic tumors or periampullary tumors by imaging or pathology and scheduled for pancreaticoduodenectomy;
* No distant metastases and tumors are resectable;
* Classified as American Society of Anesthesiologists (ASA) physical status I to III;
* Capable of understanding the study procedures and various assessment scales and able to effectively communicate with the researchers;
* Willing to participate in the study and provide written informed consent.

Exclusion Criteria:

* Patients with other malignant tumors;
* Patients who have undergone chemotherapy or radiotherapy before surgery;
* Patients with chronic organ dysfunction;
* Patients with a history of gastrectomy or other gastric surgeries;
* Patients diagnosed with chronic gastrointestinal inflammation, peptic ulcers, or a history of gastroparesis, pyloric, or other gastrointestinal obstructions;
* Patients with a history of autonomic dysfunction (e.g., peripheral neuropathy, vagotomy, thyroid dysfunction, amyloidosis, asthma, heart failure, renal dysfunction, or alcoholism);
* Patients with implanted stimulators (e.g., pacemakers, implanted vagus nerve stimulators, deep brain stimulators, spinal cord stimulators), cochlear implants, or metallic implants (excluding dental work);
* Patients who recently used prokinetic agents, cholinergic or anticholinergic drugs, or hormones;
* Patients who received vagus nerve stimulation or acupuncture within 1 month before the study;
* Patients with skin damage or dermatological conditions at the stimulation site;
* Patients with a preoperative heart rate below 60 beats per minute;
* Patients unable to cooperate with assessments;
* Patients participating in other clinical trials.
Iconographic Registry of Pancreatobiliary Endoscopy Procedures

The aim of the TAILOR-EUS study (Iconographic Registry of Bilio-Pancreatic Endoscopic Ultrasound Procedures) is to establish a clinical registry comprising images and videos generated during endoscopic procedures conducted for the investigation of pancreatic diseases (PD). The study will compile historical, pathological, and imaging data from approximately 12,000 patients (2,000 retrospectively and 10,000 prospectively) who underwent endoscopic ultrasound procedures for inflammatory pancreatic conditions (e.g., acute, recurrent, chronic pancreatitis), autoimmune bilio-pancreatic diseases (e.g., autoimmune pancreatitis), neoplastic bilio-pancreatic conditions, and screenings for individuals at high risk of developing such diseases at the Bilio-Pancreatic Endoscopy and Endoscopic Ultrasound Unit of the IRCCS San Raffaele Hospital between 2000 and 2027.

Participants have undergone or will undergo the standard diagnostic pathway appropriate for their conditions as part of routine clinical practice. All instrumental examinations and endoscopic ultrasound procedures are integral to the standard diagnostic and therapeutic approach for pancreatic diseases.


Eligibility Criteria:
Inclusion Criteria:

* Suspected or confirmed diagnosis of inflammatory pancreatic disease (e.g., acute, recurrent, or chronic pancreatitis) or autoimmune bilio-pancreatic disease (e.g., autoimmune pancreatitis) or bilio-pancreatic neoplastic disease, necessitating an endoscopic ultrasonography procedure.
* Age over 18 years.
* Ability to provide informed consent.

Exclusion Criteria:

* Pregnancy and breastfeeding status.
* Contraindications to the endoscopic ultrasonography procedure
Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients

The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the immune system and is expected to prevent further destruction of the beta-cells by stimulating regulatory responses, without causing immunological suppression.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of type 1 diabetes for up to 3 months at screening
* Insulin dependency
* Fasting C-peptide levels \>= 0.22 nmol/L
* Presence of at least 1 of the diabetes-related autoantibodies (IA-2A, GAD or IA)

Exclusion Criteria:

* Pregnancy or intent to conceive in the next 2 years
* Significant diseases that could affect response to treatment, such as tumors, psychiatric disorders, substance abuse, severe allergies or diabetes-related complications.
* Patient has immune deficiency or receives immuno-suppressive or cytotoxic drugs.
PCSK9 Inhibitors in the Progression of Aortic Stenosis

Investigators plan evaluate whether PCSK9 inhibitors, a medication that can lower lipoprotein(a) and control dyslipidemia, can inhibit the progression of aortic stenosis, through a randomized controlled trial.

Aortic valve disease is the most common form of heart valve disease and is a major burden to society. Aortic valve disease is also expected to become more prevalent with the aging. Among aortic diseases, 'aortic stenosis (AS)', which is a narrowing of the aortic valve, and leads to symptoms of heart failure and sometimes death.

For treatment of AS, the valve in replaced in a surgical to percutaneous method. Regardless of the method, valve replacement has its potential costs and complications that is an important issue that needs to be solved. Therefore, controlling the progression of AS and increasing the efficacy of medical therapy before valvular replacement is needed, is an important medico-social problem.

Regarding the pathophysiology of AS, an elevation of lipoprotein(a) and dyslipidemia have been reported to be associated with the progression of cardiovascular calcification.

PCSK9 inhibitors, which is a medication that can control both lipoprotein(a) and dyslipidemia may be a effective medication to control the progression of AS.

Therefore, investigators will perform a randomized control trial, to compare the effect of PCSK9 inhibitors vs. placebo in its influence to AS progression.

Eligibility Criteria:
Inclusion Criteria:

1. The patient agrees to participate in this study by signing the informed consent form. Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.
2. The patient has a working diagnosis of aortic stenosis (mild to moderate), and has fair treatment compliance.

Exclusion Criteria:

1. Age under 19 years old
2. Hypersensitivity to PCSK9 inhibitor
3. LDL cholesterol \< 70mg/dL at baseline
4. Poor treatement compliance (The patient will need to visit the out-patient clinic every 2-weeks for medication)
5. Positive pregnancy test or is known to be pregnant
6. Any other reason the investigator deems the subject to be unsuitable for the study (e.g., Active malignant tumor, Any life-threatening condition with life expectancy less than 6months, etc.)
7. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study
Clinical Usefulness of Fractional Flow Reserve Measurement for Significant Stenosis in Proximal Coronary Artery

Fractional flow reserve (FFR) is a pressure-wire-based index that is used during coronary angiography to assess the potential of a coronary stenosis to induce myocardial ischemia. Recent ESC guidelines referred to the usefulness of FFR extensively when noninvasive stress imaging is contraindicated, non-diagnostic, or unavailable. However, FFR requires additional manipulation with maximal and stable hyperemia by intravenous adenosine. More routine use of FFR for all angiographically significant stenoses would add considerable time, cost, and complexity to each PCI procedure and might also increase the risk of catheter-related complications such as coronary dissection and perforation. Although the guideline mentioned that FFR may not be useful in very high grade lesions (angiographically \>90%) which always have an FFR \<0.80, it have not been revealed yet proper criteria to predict FFR \<0.80 obtained by angiographic parameters including degree of stenosis, lesion location and vessel size. It would be valuable to find more precise criteria available by conventional angiography for discrimination of functional stenosis in way to reduce the risk of additional procedure. For the purpose, the investigators will perform FFR in the lesions with significant stenosis (\>70% diameter stenosis by visual estimation) and compare the angiographic parameters and FFR values in the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 19 years old
* Typical angina
* Stable or unstable angina pectoris
* At least one or more major epicardial coronary arteries with significant stenosis (\>70% diameter stenosis by visual estimation on angiogram) confined to the proximal portion of left anterior descending artery, left circumflex artery, or right coronary artery
* Reference vessel diameter of target lesion ≥3.0 mm
* Normal LV ejection fraction (≥50%) without wall motion abnormality by echocardiography

Exclusion Criteria:

* Previous myocardial infarction
* Previous coronary bypass graft surgery
* Cardiogenic shock
* Multiple lesions in the vessel of interest
* Contraindication or hypersensitivity to adenosine or contrast media
* Reduced coronary blood flow (TIMI flow grade \<3) in the vessel of interest
* Heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesions
* Pregnant women or women with potential childbearing
* Inability to understand or read the informed content
Mealtime or Post-meal Dosing of URLi in Medtronic 780G Hybrid Closed Loop System

This is a pilot study to compare premeal to postmeal dosing of ultra rapid lispro insulin (URLi) used in a MiniMed 780G system hybrid closed loop system. Subjects with type 1 diabetes mellitus (T1DM) already using a 780G hybrid closed loop system with URLi will be included. After signing a remote digital informed consent, a baseline record of the MiniMed 780G system will be downloaded from the Medtronic digital platform (Carelink system \[1\]) and subjects will be asked to fill an online questionnaire regarding their time of insulin dosing preferences and a 3-day online food diary \[2\]. During the intervention period subjects will be asked to provide a bolus dose of insulin only at the end of meals for up to 4 weeks. During the last week of the intervention period, subjects will be asked to fill out a 3-day online food diary \[2\]. At the end of the intervention period- a Carelink report \[1\] will be collected remotely and subjects will be asked to fill again the online questionnaire regarding their time of dosing preferences.

1. Primary Objective: To assess the efficacy of premeal dosing to post-meal dosing on parameters of glycemic control as obtained from continuous glucose monitoring.
2. Secondary Objective: To assess patient dosing preferences and the effect of premeal dosing vs. post-meal dosing on patient reported outcomes

Ref:

1. carelink.medtronic.eu
2. NutRatio.com.


Eligibility Criteria:
Inclusion Criteria:

Participants must be 18 years of age or older (inclusive).

Diagnosed with Type 1 Diabetes Mellitus (T1DM).

Already using the MiniMed 780G hybrid closed-loop system with Ultra Rapid Lispro Insulin (URLi) for at least 2 months prior to study enrollment.

Able and willing to provide informed consent electronically.

Willing and able to comply with the scheduled visits and other study procedures, including remote monitoring and completing questionnaires.

Exclusion Criteria:

Participants with a medical history of untreated active proliferative retinopathy.

Note: Subjects with non-proliferative retinopathy may be included. Subjects with treated proliferative retinopathy may be included based on the investigator's clinical judgment.

Severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or interfere with the interpretation of study results, as judged by the investigator.
Program on Surgical Control of Hyperlipidemias (POSCH)

To determine whether a profound reduction in serum cholesterol level, induced and maintained by partial ileal bypass, would prevent a second heart attack among men and women who had one myocardial infarction and whose blood cholesterol could not be reduced sufficiently by diet.

BACKGROUND:

The correlative evidence linking elevated cholesterol to increased risk of cardiovascular disease is incontrovertible. Animal studies have shown that significant reductions in disease in humans may be forthcoming if blood lipids are reduced from elevated levels. Beginning in the 1960s, some patients had undergone a surgical bypass procedure for hyperlipidemia. Patients were selected for surgery after dietary management had been carried out for three years. The average serum cholesterol concentrations decreased markedly and the decrease was sustained.

This grant-supported clinical trial attempted to determine the effect on cardiovascular morbidity and mortality of the partial ileal bypass in patients who had suffered a myocardial infarction within the previous 5 years and who had serum cholesterol over 220 mg deciliter (200 mg if LDL cholesterol was over l40 mg).

DESIGN NARRATIVE:

Randomized, non-blind, fixed sample study with a control group and an experimental group of equal size. The experimental group received a partial ileal bypass and diet therapy to reduce serum cholesterol and triglycerides. The control group was given conventional medical therapy exclusive of cholesterol-lowering drugs. The primary endpoint was death due to any cause. Secondary endpoints included death due to atherosclerosis and morbidity from recurrent myocardial infarction, unstable angina, cerebrovascular accident. Other secondary endpoints included coronary artery bypass surgery, percutaneous transluminal coronary angioplasty, cardiac transplantation, and peripheral vascular surgery.

Beginning in January 1993, long-term morbidity and mortality follow-up are continuing through December 1997 under grant support (R01HL49522). Follow-up includes tracking morbidity and mortality by an annual telephone survey and review of patient records, including death and autopsy results. In addition, mortality and morbidity will be correlated with lipid changes and existing arteriographic results. The long-term course of control patients treated with the AHA Phase II Diet counseling will be assessed and the long-term side effects of partial ileal bypass will be evaluated.

Eligibility Criteria:
Men and women, ages 30 to 64. Had one myocardial infarction. Had hyperlipoproteinemia.
Kinesiotaping and Rigid Taping in Sacroiliac Joint Dysfunction

Objective: To evaluate the effects of rigid-taping and kinesiotaping (lymphatic correction) on pain, joint mobility and disability in patients with sacroiliac joint dysfunction (SIJD).

Methods: A total of 84 patients with unilateral SJID were included in this randomized controlled study. Patients were divided into kinesiotaping (KT) (n=28), rigid-taping (RT) (n=28) and control (n=28) groups. Pain levels at rest and during movement with visual analog scale (VAS) (0-10 cm), Oswestry Disability Index (ODI), mobility and pain provocation tests were recorded on days 1 and 15.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 18-50 years
* patients who had subacute and chronic (lasting longer than 1 month), mechanical type low back and/or hip pain thought to be due to unilateral SIJD (spreading between 3 cm above and 10 cm below the posterior superior iliac spine, not extending above the 5th lumbar vertebra)
* patients who had at least 3 positive results out of 6 pain provocation tests for the sacroiliac joint.

Exclusion Criteria:

* the presence of known infectious, inflammatory, tumoral and advanced degenerative diseases that may cause low back pain, pain referred from abdominal or pelvic organs, history of spine or hip fracture/surgery,
* presence of nerve root involvement findings,
* presence of pregnancy, presence of inflammatory pathology in routine blood tests seen at the examination application
* presence of inflammatory or advanced degenerative changes in the sacroiliac joint in imaging methods,
* presence of findings suggesting bilateral sacroiliac joint dysfunction.
Continuous Glucose Monitoring System in Intensive Care Unit

To assess the accuracy, safety, and influence of sampling site of Real-time continuous glucose monitoring system (Medtronic Guardian).


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old
* Staying in intensive care units longer than 72 hours

Exclusion Criteria:

* Skin disease
* DIC
* Immune suppressed patients