cyrilzakka/clinical-trials huggingface dataset:
Clinical Study for the Investigation and Validation of a Therapy Procedure for the Adjustment of Risk Factors in Patients With Coronary Heart Disease by Means of Digital Therapy Control

This study will test a controlled investigation of the efficacy and effectiveness of iATROS digital therapy management for risk factor adjustment in patients with coronary heart disease (CHD).

The purpose of this study is to determine the efficacy and effectiveness of iATROS digital therapy management for risk factor adjustment in patients with coronary heart disease compared to the medical standard of care.

In addition, data will be provided to investigate the functionality of the rule engine in the treatment of CHD patients and insights will be gained for the further development of this component of the iATROS platform for the digital and intelligent treatment of patients.

Furthermore, the use of digital everyday products (smartphones) in secondary prevention and therapy management of CHD patients will be considered.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* Patients diagnosed with ischemic heart disease according to ICD I20 to I25 who also have at least one of the following:

  1. inpatient stay with acute STEMI/NSTEMI or historic STEMI/NSTEMI; and/or
  2. Coronary stent implantation, angioplasty or bypass surgery that has taken place.
* Ownership and use of a smartphone that allows installation and use of "iATROS," where "use" requires having the physical and mental ability to use and apply the iATROS app.
* Insured with the cooperating insurances

Exclusion Criteria:

* No use of a smartphone
* Lack of the linguistic, physical and mental abilities necessary to use the iATROS app, or to use so-called "apps" on a smartphone or tablet in general.
* Absolute contraindications: Any disease associated with a reduced life expectancy of less than 2 years; Any disease/condition that limits participation in the program; Pregnant or breast feeding patients; Patients with advanced dementia
* Existing participation and enrollment in an iATROS health program.
* Participation in another clinical trial if participation results in complications with compliance, measures to be performed, bias of results, or status of treatment according to the current standard of care.
* Comorbidities or the presence of another physical condition that complicates the setting of the clinical target parameters sought in the study (i.e., if, due to the patient's individual situation, a different value would have to be issued as the target value for a clinical parameter to be classified as healthy).
French Post-Marketing Surveillance Survey

To assess the safety and effecacy of the Cypher stent ™ \& Cypher Select ™ in the normal use of medical practices, within the labeled indications.

Multi-center, retrospective and prospective French register. This register does not impose any constraint on the evaluated population, the procedure, or the required examinations. The local practice routines should be applied.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic ischemic heart disease due to de novo lesions (lesions \<30 mm vessel reference diameter of 2.25 mm to 5 mm), assessed visually, native coronary arteries.

Exclusion Criteria:

* Patients suffering from coronary heart disease.
* Patients for whom treatment antiplatelet and / or anticoagulant is against the state;
* Patients with injuries incompatible with the full inflation of a balloon angioplasty;
* Transplant patients ;
* Patients with known allergy to Sirolimus, the stainless steel 316L, to polymethacrylates or copolymers polyolefins;
Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (FluMist) and Measles, Mumps, Rubella, and Varicella Vaccines Administered Concurrently to Healthy Children

* To compare immune responses to measles, mumps, rubella, and varicella antigens following vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in children who receive an intranasal placebo mist concurrently with MMRIIÒ and VARIVAXÒ (Group 2 vs. Group 1).
* To compare immune responses to the three strains of influenza (H1N1, H3N2, and B) following a two dose regimen of FluMist in children who receive the initial FluMist dose concurrently with MMRIIÒ and VARIVAXÒ and in children who receive two doses of FluMist alone (Group 2 vs. Group 3).Secondary:
* To assess the safety and tolerability of concurrent administration of FluMist with MMRIIÒ and VARIVAXÒ.


Eligibility Criteria:
Inclusion Criteria:

* 12 to 15 months of age (not reached their 16th month birthday);
* In good health;
* Parent/guardian available by telephone or for home visits;
* Ability of the parent/guardian to understand and comply with the requirements of the protocol;
* Signed informed consent by parent/guardian; and
* Up to date with the primary series of recommended vaccines per standard clinic practice and local vaccine availability.

Exclusion Criteria:

* Previous known measles, mumps, rubella or varicella disease;
* Previous vaccination against measles, mumps, rubella or varicella disease;
* Hypersensitivity to egg or egg protein;
* Signs or symptoms of any immunosuppressive or immune deficiency disease or ongoing immunosuppressive therapy; or an immunosuppressed individual living in the same household;
* Acute febrile (\>100.0oF \[37.8°C\] oral) illness or clinically significant upper respiratory illness within the 72 hours prior to enrollment;
* Use of aspirin (acetylsalicylic acid) or aspirin-containing products in the month prior to enrollment, or expected use of aspirin while enrolled in this study;
* Administration of any intranasal medication within two weeks prior to enrollment or expected receipt during this study;
* Administration of any live virus vaccine within one month prior to enrollment through 30 days after Visit 3;
* Administration of any inactivated vaccine within two weeks prior to enrollment through 30 days after Visit 3;
* Participation in another investigational trial within one month prior to enrollment or expected enrollment in another investigational trial during this study;
* Receipt of any blood product within three months prior to vaccination or expected receipt within the study duration; and
* Any condition which, in the opinion of the investigator, would interfere with the interpretation or evaluation of the vaccines.
* History of two or more episodes of medically attended wheezing illness by parent/guardian report.
* History of medically attended wheezing illness or bronchodilator medication use within four weeks of enrollment by parent/guardian report.
The Acute Effect of Egg-Based High Protein Meal on Hypertensive Response to Exercise

The primary purpose of this study is to explore the effect of high versus normal egg-based protein meals on acute exercise-induced elevated blood pressure.

This study is designed to assess BP changes during and post- exercise after consumption of a test breakfast. The design consists of three visits. The first visit will assess each participants aerobic exercise capacity (VO2 max). Visit 2 and 3 will be clinical testing days where the subject will consume either the 13g or 30g protein breakfast in a randomized cross-over manner and perform the exercise intervention. BP changes will be monitored before and after breakfast consumption, during the exercise intervention,

Eligibility Criteria:
Inclusion Criteria:

* Pre-hypertensive (systolic, 120-139 mm Hg; diastolic, 80-89 mm Hg
* Age ≥ 21
* Body weight \<300 lb (136 kg)
* BMI between 20 and 34.9 kg/m2
* Fasting plasma glucose \<6.1 mmol/L,
* total cholesterol \<6.7 mmol/L
* LDL cholesterol \<4.1 mmol/L
* TG \<4.5 mmol/L
* No pre-existing or history of cardiovascular, renal or liver disease
* Not currently or previously (past 6 mo) consuming a weight-loss diet or other special/non-balanced diets
* No weight loss/gain (±4.5 kg) within the past 6 mo
* No physical impairments preventing properly exercise execution
* No caffeine intake the day of testing

Exclusion Criteria:

* Hypertensive
* Body weight ≥ 300 lb
* BMI \<20 or \>35 kg/m2
* Pregnant or planning pregnancy
* Unwilling to consume study foods and beverages
* Fasting plasma glucose ≥6.1 mmol/L
* Total cholesterol ≥6.7 mmol/L
* LDL cholesterol ≥4.1 mmol/L
* TG ≥4.5 mmol/L
* acute illness
* smoking
* diabetic
* pre-existing or history of cardiovascular, renal or liver disease
* currently or previously (past 6 mo) consuming a weight-loss diet or other special/non-balanced diets
* weight loss/gain (±4.5 kg) within the past 6 months
* physical impairments preventing properly exercise execution
* caffeine the day of testing
Electrophysiological Biomarkers in MTLE Patients.

The investigators plan to enroll individuals with medical temporal lobe epilepsy who are undergoing surgical workup with clinically implanted intracranial electrodes. The study intends to administer computerized memory tasks and stimulation during the intracranial Electroencephalography (EEG) monitoring period.

This is a nonrandomized interventional trial that will apply brain stimulation via clinically implanted intracranial electrodes to subjects with medial temporal lobe epilepsy with the purpose of identifying biomarkers related to the pre-ictal state; to perform an acute parameter search to determine the stimulation pattern that most effectively modifies these biomarkers and to identify changes in memory (free recall) during asynchronous distributed multi-electrode stimulation (ADMES).

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Male or female, aged 18-65
3. Diagnosed with lesional or non-lesional mesial temporal (hippocampal) seizure onset confirmed on SEEG monitoring
4. Implanted with depth electrodes for localization of seizure onset with multiple hippocampal electrode arrays

Exclusion criteria:

1. Any patient who is unwilling or unable to provide consent
2. Women who are pregnant
3. Patients under 18 years
4. Incarcerated persons
Perioperative Salivary Alpha-amylase as a Predictor of Delirium After Lower Extremity Vascular Bypass Surgery

The aim of this study is to evaluate the role of salivary Alpha-amylase as a predictor biomarker of POD in elderly patients undergoing limb bypass surgery.

Delirium is a neuropsychiatric syndrome that is characterized by the sudden onset of altered awareness, decreased ability to maintain attention, and disorders of the mental process. The pathophysiology of Postoperative delirium (POD) is related to postoperative neuroinflammation.

Biomarkers not only indicate a certain pathological state, but also provide information about disease activity and progression. Although several biomarkers are reported to predict POD, biomarkers with high sensitivity and specificity are still lacking.

Biochemical parameters associated with complement cascade (C3a, C3, C5a) and inflammatory response (IL-17A, IL-33, E-selectin, MMP9) were involved in neurocognitive regulation.

Salivary alpha amylase (SAA) enzyme is one of the most important enzyme compositions in the saliva that accounts for 40% to 50% of the total salivary proteins, and most of it is secreted from the parotid gland. SAA is locally produced by the highly differentiated epithelial acinar cells of the exocrine salivary glands, mostly of the parotid glands and plays an important role in carbohydrate hydrolysis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status III.
* Undergoing lower extremity vascular surgery under general anesthesia.

Exclusion Criteria:

* Patients who used any medication that could affect salivary glands (such as antihypertensive, antidepressants or antipsychotic drugs).
* Inability to communicate.
* History of psychiatric diseases or previous stroke
* Previous history of pod.
* Those with smoking and drinking habits.
* Pregnant female.
Greater Omentum Binding to the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy

Background and aim: Distal pancreatectomy (DP) is often performed for primary benign or malignant lesions occurred in the body or tail of the pancreas. The occurrence of pancreatic fistula (PF) after DP remains high, ranging from 5% to 60%, despite in high-volume centers. Management of pancreatic stump to prevent PF has been a long-standing issue in pancreatic surgery. Our group has proposed greater omentum binding as a novel approach to secure pancreatic stump with the purpose of reducing PF. With respect to the previous preliminary data which demonstrated greater omentum binding of pancreatic stump significantly reduced the occurrence of PF based on a small prospective cohort, we therefore aimed to verify the safety and effectiveness of this novel approach in a large prospective randomized cohort.

Method: TJBDPS06 is a prospective, randomized controlled, parallel-group, superiority trial in a single high-volume pancreatic center. A total of 200 patients who will receive DP and fulfill the inclusion criteria will be randomly allocated to the greater omentum binding group or the group without this step in an enhanced recovery after surgery (ERAS) setting. The trial hypothesize that greater omentum binding of pancreatic stump could safely and effectively secure pancreatic stump following DP, therefore reducing the occurrence of PF. The primary outcome is PF within 90 days after DP. The secondary outcomes are overall morbidly, mortality, and major complications (Clavien-Dindo ≥III) within 90 days following DP. The duration of entire trial is presumably three years, including prearrangement, two-year inclusion period, and data analysis.

Discussion: The current trial will be the first in demonstrating safety and effectiveness of greater omentum binding of pancreatic stump following DP in a large high-volume pancreatic center. This approach will offer an inexpensive, technically easy, and secure coverage technique for the pancreatic stump in DP and may be particularly useful for patients with a soft pancreas which is a markedly risk factor of PF.


Eligibility Criteria:
Inclusion Criteria:

* All patients who undergo DP whether made by open or laparoscopic surgery;
* Patients age 18 to 75 years;
* Patients benefit from distal pancreatectomy according to NCCN guidelines;
* The subject understands the nature of this trial and willing to comply, and ability to provide written informed consent.

Exclusion Criteria:

* Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs;
* History of abdominal disease or surgery which may results in obvious omentum adhesion;
* Synchronous malignancy in other organs;
* Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score \>4;
* Pregnant women.
Prevalence of Secondary Cardiac Damage in Rheumatic Fever Patients and Penicillin Secondary Prophylaxis

According to American Heart Association criteria, patients who have had Rheumatic Fever (RF) should be treated with antibiotic prophylaxis. Continuous prophylaxis is recommended in patients with well-documented histories of RF and in those with evidence of rheumatic heart disease.

There is a limited data regarding adherence of patients to treatment and efficacy of treatment.

In this study, patients with RF who are older than 21 years will be collected from a computerized database of 'Maccabi Healthcare Services', one of the biggest Israeli Health Funds. Patients will be assigned to the study after obtaining informed consent.

Previous adherence to antibiotic prophylaxis will be examined according to computerized database of drugs which were issued to the patient since RF diagnosis.

Past history of cardiac involvement, including past Echocardiograms, will be collected from computerized database. In addition, the current cardiac state will be assessed by an experienced cardiologist, including a full new Echocardiogram examination.


Eligibility Criteria:
Inclusion Criteria:

- Patients older than 21 years who were diagnosed with RF (before age 18 years) according to the computerized database.

Exclusion Criteria:

* patients with other rheumatic disease diagnosed before RF diagnosis
* patients with other cardiac disease diagnosed before RF diagnosis
* patients with neoplastic disease diagnosed before RF diagnosis
Metal Ion Concentrations After Total Knee Arthroplasty

The purpose of this study is to analyze the metal ion concentrations in the patients blood following robotic-assisted total knee arthroplasty (TKA) compared to conventional total knee arthroplasty using cutting guides.

This study focuses on comparing metal ion levels in 50 inpatient participants undergoing primary total knee arthroplasty (TKA) with either conventional cutting guides or robotic assistance. Baseline blood examinations for Cobalt, Chromium, Titanium, and Nickel will be performed before TKA implantation at preoperative visits and on the first day following the procedure. The investigation will encompass patients receiving both conventional and robotic-assisted primary TKA, framed within a prospective cohort study design. Baseline characteristics and additional follow-up information will be gathered.

Eligibility Criteria:
Inclusion Criteria:

* Adults undergoing conventional or robotic-assisted TKA
* Consent to the study

Exclusion Criteria:

* Patients who have undergone any previous arthroplasty procedures.
* Patients with metal implants, such as plates, nails, and screws, used in the repair of traumatic injuries.
* Patients below 110 pounds.
ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy

Based on the activation and regulation of immune system by cytokines, mRNA encoding cytokines has become one of the important directions of mRNA tumor drug development. This product (ABOD2011) is a new generation mRNA product for intratumoral injection.

The primary objective of this study is to assess the safety and tolerability, of ABOD2011 in patients with advanced solid tumors that progressed after standard systemic therapy.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years and older.
2. Understand and voluntarily sign the informed consent form (ICF).
3. Histopathologically confirmed recurrent or metastatic solid tumors.
4. Failure of prior systemic standard of care, or intolerance to severe toxicity, or lack of standard of care.
5. Presence of at least one measurable lesion as assessed by RECIST Version 1.1.
6. At least one superficial or deep lesion for intratumoral administration and biopsy.
7. Sufficient organ functions.
8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
9. Weight \> 30 kg.
10. Expected survival longer than 12 weeks.
11. Evidence of menopause in female patients, or for women of childbearing potential: negative for urine or blood pregnancy.

Exclusion Criteria:

1. Any systemic anti-tumor therapy, within 28 days prior to the first dose.
2. Radiotherapy within 14 days prior to first dose.
3. Use of immunosuppressants.
4. Major surgery within 28 days.
5. Inadequately controlled diseases.
6. Active autoimmune and inflammatory diseases.
7. Clinically symptomatic central nervous system tumors or metastases.
8. Toxicity of prior anti-tumor therapy is still NCI-CTCAE ≥ 2.
9. Other malignancies within the previous 5 years with the exception of cured basal cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the breast, and carcinoma in situ of the cervix.
10. Active infections.
11. Other conditions that may increase the risk associated with the study drug, or affect the study compliance, etc., which, in the opinion of the investigator, are not suitable for participation in the study.
Effectiveness of a Vitamin Mineral Supplement

The goal of the study is to evaluate the effectiveness of a new one-a-day Cooper complete vitamin supplement with or without a combined omega-3 fatty acid supplement on selected clinical risk factor measures. Participants taking the Cooper Complete one-a-day vitamin plus omega-3 fatty acid will have greater improvement in homocysteine, LDL cholesterol, and C-reactive protein than those taking the other supplements.

Participants will be randomized to 1 of 3 groups: vitamin with omega-3, vitamin w/o omega-3, or omega-3 alone. They will take the vitamin 12 weeks, after which time they will return for all laboratory tests. Persons who are currently taking a supplement must undergo a 2-week washout period before beginning the study. Participants taking the Cooper Complete one-a-day vitamin plus omega-3 fatty acid will have greater improvement in homocysteine, LDL cholesterol, and C-reactive protein than those taking the other supplements.

Eligibility Criteria:
Inclusion Criteria:

* 30-70 years of age, maintain current diet and exercise regimen, not currently taking vitamins or agree to stop for 6 weeks

Exclusion Criteria:

* BMI \<18.5 or \>34.9, recent blood donation, elevated blood pressure, cholesterol, or fasting blood glucose that requires medication, plans to move soon, or pregnant or plans to become pregnant
Dendritic Cell Vaccination in Patients With Advanced Melanoma

The purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells.

This is a single arm open label trial that will assess the safety and tolerability of mature dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with stage III and stage IV melanoma, followed by treatment with pembrolizumab (anti-PD-1 therapy).

Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production approximately 1 week prior to vaccine infusion. Each study subject will receive cyclophosphamide 300mg/m\^2 intravenously or by mouth 3 to 4 days prior to the vaccine dose, to deplete regulatory T cells. For each vaccine dose, all subjects will receive autologous dendritic cells pulsed with melanoma tumor-specific peptides. On Day 1, the subject will receive the primer vaccine dose; this will be followed by two booster vaccine doses at 6 weeks apart. Peripheral blood will be taken weekly to monitor the immune response to each peptide by tetramer assay. Re-staging will occur after the 3rd vaccine dose, along with tumor biopsy and second apheresis. Anti PD-1 therapy (standard of care) will commence 7-8 weeks after the subject's last dendritic cell vaccine.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed stage III and stage IV M1a/M1b/M1c melanoma. Measurable disease is not required for enrollment eligibility and patients with completely resected disease are permitted.
* Male or female patients age greater than or equal to 18 years
* ECOG (Eastern Cooperative Oncology Group) performance status 0-2
* Required initial laboratory values (performed within 14 days prior to eligibility confirmation by physician-investigator):

  * WBC (white blood cells) \>3,000/mm3
  * Hg (hemoglobin) greater than or equal to 9.0 gm/dl
  * Platelets \>75,000/mm3
  * Serum Bilirubin \< 2.0 mg/dl
  * Serum Creatinine \< 2.0 mg/dl
* Subjects of reproductive potential must agree to use a medically accepted birth control method during the trial and for at least two months following the trial.
* Provide written informed consent.

Exclusion Criteria:

* Prior treatment with more than one line of cytotoxic chemotherapy; prior treatment with one line of cytotoxic chemotherapy is permitted. Prior treatment with targeted therapy (such as ipilimumab, anti-PD1, or BRAF + MEK inhibitor combination) is permitted.
* Active untreated CNS (central nervous system) metastasis
* Active infection
* Prior malignancy (except non-melanoma skin cancer) within 3 years
* Pregnant or nursing (lactating) women
* Concurrent treatment with high-dose systemic corticosteroids; local (inhaled or topical) steroids are permitted
* Known allergy to eggs
* Prior history of uveitis or autoimmune inflammatory eye disease
* Known positivity for hepatitis B antibody, hepatitis C antibody, or HIV antibody