cyrilzakka/clinical-trials huggingface dataset:
Hämeenlinna Metabolic Syndrome Research Program: Oxidized LDL and Arterial Elasticity in Metabolic Syndrome and Controls (HMS-01)

Mechanisms that link metabolic syndrome to atherosclerosis are incompletely understood. As a part of Hämeenlinna Metabolic Syndrome Research Program (HMS), 40 men with metabolic syndrome and their 40 physically active controls (age: 30 to 65 years) are compared in a cross-sectional study. Except routine laboratory parameters, arterial elasticity and levels of oxidized LDL are determined.

Study hypothesis: Levels of oxidized LDL and findings in arterial elasticity may differ between subjects with metabolic syndrome and controls explaining the elevated risk for cardiovascular diseases among patients with metabolic syndrome.

Accumulation of oxidized low-density lipoproteins in the intimae of arteries together with risk factors known to enhance atherosclerosis, damage the endothelium of the arterial wall. Dysfunction of the endothelium leads into loss of elasticity of the artery. Especially a reduction in the elasticity of small arteries has been found prominent in atherosclerosis and is believed to serve as a marker for early stages of atherosclerosis.

In this study, we investigate whether the levels of oxidized LDL and arterial elasticity differ between patients with metabolic syndrome and their physically active controls. Oxidized LDL is assessed by a two-site ELISA immunoassay (Mercodia, Uppsala, Sweden). The capacitive elasticity of large arteries (C1) and the reflective elasticity of small arteries (C2) are automatically assessed by the CR-2000 as a mean of five most similar pulse waves appearing during the measurement. C1 identifies the elastic properties of aorta and other large arteries, C2 the endothelial function of the microvascular circulation. Proper statistical methods are used to reveal possible differences and their significance between the patients and controls.

Eligibility Criteria:
Inclusion Criteria:

Group 1: Metabolic syndrome

* 40 Finnish men with metabolic syndrome (MetS) defined according to National Cholesterol Education Program (NCEP) Adult Treatment Panel III
* MetS diagnosed in routine health examination and laboratory tests
* Age: 30 to 65 years

Group 2: Control

* 40 age-matched men
* Exercise physically more than three times a week and more than 30 minutes per exercise on regular basis
* Never been studied or treated because of cardiovascular disease

Exclusion Criteria:

* Cholesterol-lowering medication
* ACE-inhibitor medication
* Angiotensin-receptor blocker medication
Polish Registry of Common Carotid Artery Access for TAVI

Transcatheter aortic valve implantation (TAVI) is valuable treatment option for patients, who are at the high risk of surgical aortic valve replacement (AVR). Majority of procedures are performed through femoral arteries, however in some this access cannot be applied. Common carotid artery is one of the alternative routes of delivering the device in those patients. Established registry aims at collecting the data prospectively to assess outcomes of TAVI through common carotid artery.

The study is a prospective multicenter evaluation of transcatheter aortic valve implantations through common carotid artery in Polish health centers.

Duration of this study is expected to be 6 years to ensure that all of the enrolled patients will complete at least 2 years of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Qualification for TAVI through common carotid artery by decision of the local Heart Team
* Patient provided written informed consent
A Monocenter, Cross-sectional Study to Compare Different Type of Cognitive Impairment in Multiple Sclerosis Patients and Cerebrospinal Fluid Biomarkers (Beta Amyloid, Total Tau Protein and Tau-phosphorylated Protein).

In multiple sclerosis (MS) sub cortical cognitive impairments are frequently reported. Nevertheless, cortical cognitive troubles, with hippocampic memory troubles have been described. Besides inflammatory damage, early cortical and degenerative damage are well known. In neurodegenerative diseases, three biomarkers of the cerebro spinal fluid (CSF), reflecting lesional mechanisms, are measured: the beta amyloid peptide, the tau total protein, and the phospho tau protein. Preliminary studies shown increased level of tau in MS. No study compare cognitive impairment and biomarkers of CSF.The aim of this study is to measure in the CSF of MS patients these three biomarkers (beta amyloid peptide, tau total and phosphotau) in order to establish correlations between a profile of biomarkers and a pattern of cognitive troubles, cortical or subcortical.The possibility to show, in MS patients with memory hippocampic troubles, a profile of biomarkers closed from the one encountered in AD, could argue in support of the degenerative hypothesis in MS and lead to discuss the interest of the use of AD treatment in MS.


Eligibility Criteria:
Inclusion Criteria:

* Groups 1 and 2 -patients MS - EDSS\<7

Group 3- patients with first clinical inflammatory symptom

Exclusion Criteria:

* Pregnant or not taking contraceptive
* Contraindication for lumbar puncture
* Contraindication for NMR
Reliability of the Swiss Emergency Triage Scale (SETS®) Used by Emergency Medical Service (EMS) Providers

The Swiss Emergency Triage Scale (SETS) in used for triage in emergency departments in Switzerland, France and Belgium. No validated triage scale is actually used by Emergency Medical Service (EMS) providers. The objective of this project is to evaluate the reliability and performance of triage by EMS providers with the SETS.

The Swiss Emergency Triage Scale (SETS) in used for triage in emergency departments in Switzerland, France and Belgium. No validated triage scale is actually used by EMS providers. The objective of this project is to evaluate the reliability and performance of triage by EMS providers with the SETS.

In order to perform this evaluation a cohort of 22 EMS providers will evaluate 28 standardized clinical scenarios using a computer simulator.

Eligibility Criteria:
Inclusion Criteria:

* All EMS providers employed by a private ambulance company in the State of Geneva, Switzerland

Exclusion Criteria:

* Not giving informed consent
A Study of the Safety and Tolerability of V419 in Healthy Infants at 2,4, 6 and 12 to 14 Months of Age (V419-003)

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 3 formulations of the HR5I vaccine (Haemophilus influenzae type b conjugate, recombinant hepatitis B surface antigen, diphtheria, tetanus, 5-component acellular pertussis, and inactivated poliovirus Types 1, 2, and 3). The primary hypothesis is that at least 1 of the 3 formulations of HR5I administered as a primary series at 2, 4, and 6 months of age will be acceptable (similar to targeted rates) with respect to Postdose 3 antibody responses to all antigens.

Participants will be randomized into 4 arms:

AR51 (12, 10): arm receiving vaccine formulation containing 12 mcg of polyribosylribitol phosphate (PRP) conjugated to tetanus toxoid (PRP-T) and 10 mcg of Hepatitis B surface antigen (HBsAg)

PR51 (3, 10): arm receiving vaccine formulation containing 3 mcg of polyribosylribitol phosphate conjugated to the outer membrane protein complex of Neisseria meningitides (PRP-OMPC) and 10 mcg of HBsAg

PR51 (6, 10): arm receiving vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg

PENTACEL™ + RECOMBIVAX HB™: open-label control group receiving PENTACEL™ (licensed vaccine for diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b) and RECOMBIVAX HB™ (licensed vaccine for hepatitis)

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants 2 months of age who have not received prior vaccinations for Haemophilus influenzae type b (Hib), hepatitis B, Diptheria/Pertussis/Tetanus (DPT), or Polio

Exclusion Criteria:

* HIV infection in participant (child/mother)
* Documented HBsAg seropositivity in the participant (child or mother)
* History of invasive Hib disease, hepatitis B, diphtheria, tetanus, pertussis, or poliovirus infection
* History of seizure disorder
* Underlying medical conditions such as inborn errors of metabolism, failure to thrive, or any major congenital abnormalities requiring surgery
* Prior or anticipated receipt of immune globulin, blood, or blood products
* Known hypersensitivity to any component of the investigational or marketed vaccines being administered in this protocol
* Any history or condition that would exclude the participant from receiving any vaccine administered under this protocol based on the contraindications that appear in the package circulars for each component of these vaccines
* Any condition that, in the opinion of the investigator, is not stable or may interfere with the evaluation of the study objectives
Assessing Tissue Remodeling in the Skin Using SFI (Skin Fluorescence Imaging)

The goal of the SFI is to provide non-invasive information about tissue remodeling occurring during melanocytic transition and atypia development in the skin

The goal of the SFI is to provide non-invasive information about tissue remodeling occurring during melanocytic transition and atypia development in the skin. SFI analyzes the topical staining of the skin surface using the ORL-1 dye to reveal the presence of remodeling in the skin, together with the visible feature characteristics. The system provides a biometric score corresponding to the dye staining, a structural score, and a composite SFI score to quantify the presence of tissue remodeling and the process of melanocytic transition in the skin.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with a pigmented skin lesion recommended for a skin biopsy.
2. A lesion that is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS.
3. At least 21 years old.
4. Written, signed, and dated informed consent
5. Scheduled for a primary excision/biopsy as part of the clinics SOC.

Exclusion Criteria:

1. Lesion is less than 1 centimeter from the eyes.
2. Lesion is on the palms of the hands or soles of the feet.
3. Mucosal lesion.
4. Ulcerated lesion.
5. Subject is pregnant or planning to become pregnant during the study period.
6. Patients who are mentally or physically unable to comply with all aspects of the study.
7. Any subject undergoing chemotherapy.
8. Any lesion that has been treated with local anesthesia such as lidocaine prior to enrollment that would confound study results.
Infection Watch Study

This study will reach out to patients who have undergone diagnostic testing for the following respiratory illnesses from January 1st, 2018 to July 9th, 2023: COVID-19, Influenza, Rhinovirus, and Respiratory Syncytial Virus. This study aims to develop a forecasting model to predict infection onset prior to symptom onset using wearable device data and known symptom onset and test dates.

DUHS patients who have diagnostic testing for Influenza, COVID-19, Respiratory syncytial virus, and Rhinovirus testing within the past 5 years will be initially screened for an email address. Participants will learn about this study via email with a link to complete the survey. A Study ID will be generated for all individuals with an email.

Participants will be asked to complete an e-consent via a REDCap survey. If participants have questions, they are provided with study contact information via e-mail. Participants will complete the survey which will have questions on prior symptoms and device ownership (anticipated time to complete: 5 minutes). If the participant owns one of the following wearable devices (Fitbit, Garmin, or Apple Watch), they will be sent to a redirect URL to login into their device account (for Fitbit or Garmin) or be provided with instructions to export their Healthkit data and dump their data into a unique Strongbox link (for Apple Watch). If participants choose to contribute their wearable device data to the study and the data obtained pass through data quality thresholds, they will receive compensation. There is no compensation for survey completion. The investigators will ask participants if they wish to be re-contacted for future studies related to this project.

The investigators will collect endpoint data values from the wearable. These data will be used to estimate daily activity amounts and intensity (i.e., exercise and walking), standing, sleep amounts, sleep quality, heart rate variability, SpO2, respiratory rate, and heart rate. All of the wearable device data will be identified using a Study ID.

The investigators will use statistical and machine learning models to develop personalized "baseline" models of health and detect anomalies that can help in identifying COVID-19 infection. The investigators will validate and test the sensitivity and specificity of our mode for detecting respiratory infection vs. no infection against symptom surveys and diagnostic testing as ground truth. The model testing and validation will be done separately for each brand of device and will be further modified according to the type of respiratory infection.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older

Exclusion Criteria:

* Less than 18 years of age
Study of BMS-275183 in Patients With Pretreated Locally Advanced or Metastatic NSCLC (Non Small Cell Lung Cancer)

BMS-275183 given orally twice weekly to patients pretreated for locally advanced or metastatic NSCLC will show anti-tumor activity in any of the 3 separate cohorts of the patients enrolled:

* Cohort I: Patients previously treated with one taxane containing regimen.
* Cohort II: Patients previously treated with a platinum based but non-taxane containing regimen.
* Cohort III: Patients previously treated with both a chemotherapy regimen and one EGFR-TKI (epidermal growth factor receptor-tyrosine kinase inhibitor) compound.

Patients in cohorts I and II should have not been treated with a prior EGFR-TKI compound. Prior treatment with a VEGFR (vascular endothelial growth factor receptor) inhibitor compound is allowed for all the patients provided that the VEGFR inhibitor is not also an EGFR inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, age \>= 18 years
* Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC who failed only one prior chemotherapy regimen.

Exclusion Criteria:

* Concomitant medication with a cytochrome P450 (CYP) 3A4 inhibitor or inducer
Validation of a Model for Predicting Anastomotic Leakage

This study will validate a machine learning model for predicting anastomotic leakage of esophagogastrostomy and esophagojejunostomy.

Anastomotic leakage is a fatal complication after total and proximal gastrectomy in gastric cancer patients. Identifying patients with high-risk of AL is important for guiding the surgeons' decision making, such as a more rigorous anastomotic operation， placing a jejunal feeding tube and dual-lumen flushable drainage catheter. We have developed a high-performance machine learning model based on 1660 gastric cancer patients, which showed good discrimination of anastomotic leakage. Hence, this multi-center prospective study will validiate the usability of the model for predicting anastomotic leakage in gastric cancer patients who receive total and proximal gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

1. Aged older than 18 years and younger than 85 years.
2. Primary gastric adenocarcinoma confirmed by preoperative pathology.
3. Expected curative resection via total or proximal gastrectomy.
4. American Society of Anesthesiologists (ASA) class I, II, or III.
5. Written informed consent.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Severe mental disorder or language communication disorder.
3. Other surgical procedures of gastrectomy is performed.
4. Interrupted of surgery for more than 30 minutes due to any cause.
5. Malignant tumors with other organs
The Effect of Experimental Knee Pain During Strengthening Exercises on Muscle Strength Gain

The purpose of this study is to evaluate the effects of experimental knee pain on the muscle strength gain after 8 weeks of strengthening exercises for the quadriceps. It is hypothesized that experimental knee pain will reduce the muscle strength gain following strengthening exercises in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* aged between 20 to 35 years
* healthy
* untrained (non-regular exercise participation \[i.e. \< 1 day/week\])

Exclusion Criteria:

* symptomatic musculoskeletal diseases
* history of traumatic injuries to muscles, tendons or joints of the lower extremity
* knee joint pain within a month prior to enrollment
A Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial Infarction

The objective is to obtain initial information regarding the safety and efficacy of the use of Filgrastim in the setting of acute myocardial infarction.

The secondary objectives are to obtain information regarding the mobilization of relevant stem cell progenitor cells by Filgrastim in this setting and to obtain further clinical information that may be helpful in the assessment of safety and efficacy of this drug as utilized.

It is a one center, randomized, placebo controlled, dose escalation, blinded study. It will be 2:1 randomization with 9 patients total.

Filgrastim 10 mcg/kg/day will be administered SQ for 5 days vs. placebo.

Primary endpoint is death /or myocardial rupture or change in left ventricular ejection fraction from baseline to 30 days.

9 pts. have already completed the first phase of the trial using Filgrastim 5 mcg/kg/day.


Eligibility Criteria:
Inclusion Criteria:

Acute Myocardial Infarction within 6 hours of symptoms

Exclusion Criteria:

-
Effect of Swedish Hand Massage on Pain in Patients Undergoing CABG Surgery

Coronary Artery Bypass Grafting (CABG) surgery is performed commonly today. Heart surgery performed on more than two million individuals every year leads patients experience severe postoperative pain for causes such as cutting of intercostal nerves along the incision line, pleural irritation caused by thoracic catheters etc. Hand massage, which is one of the non-pharmacological methods, is an effective procedure that can be applied independently by nurses for pain management. The objective of this randomized controlled study is to investigate the effect of hand massage applied to the patients with CABG surgery during the postoperative intensive care process, on pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent CABG surgery,
* Stated that they were in pain,
* 18 years old and older,
* Had not completed 48 hours after the surgical procedure,
* Accepted to participate in the study verbally and in writing after being informed about the study,
* Could understand the information given,
* Could read, write and speak Turkish,
* Did not have any physiological, psychological or mental problems that would prevent verbal communication,
* Did not have any limb, vascular problem, wound or catheter that would prevent the application of hand massage,
* were ASA classified as I and II,
* Had no previous hand massage experience,
* Did not participate in any other clinical studies during the same period,
* Did not develop any complications during and after the surgical procedure,
* Physiological parameters were within normal limits during the surgical procedure,
* Received the same type of treatment in the post-surgical period,
* Body mass index was within normal limits

Exclusion Criteria:

* Patients who have complications during or after surgical intervention,
* Intubated,
* Have any limb, vascular problem, wound or catheter that prevents hand massage,
* Under the effect of pharmacological or non-pharmacological interventions that will affect pain,
* Obese (body mass index (BMI≥30),
Combination Chemotherapy Given With Radiation Therapy or Radiation Therapy Alone in Treating Patients With Early-Stage Hodgkin's Disease

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus radiation therapy with radiation therapy alone in treating patients with early-stage Hodgkin's disease.

OBJECTIVES: I. Determine the recurrence rate and long term survival of patients with early stage Hodgkin's disease given vincristine/doxorubicin/prednisolone/ etoposide/cyclophosphamide/bleomycin (VAPEC-B) chemotherapy and involved field radiation vs mantle radiotherapy.

OUTLINE: This is a randomized multicenter study. Patients are randomized to receive either vincristine/doxorubicin/prednisolone/etoposide/cyclophosphamide/ bleomycin (VAPEC-B) chemotherapy and involved field radiotherapy or mantle radiotherapy only. Patients receiving VAPEC-B are given prednisolone daily on weeks 1-6, doxorubicin IV along with cyclophosphamide IV on week 1, doxorubicin IV and etoposide orally for 5 days on week 3, and vincristine and bleomycin IV on weeks 2 and 4. Involved field radiotherapy is commenced at week 6, within 14 to 21 days of the last chemotherapy treatment. Patients randomized to receive mantle radiotherapy only are given treatments daily for 4 weeks. Patients are followed every 3 months for the first two years, every 4 months for the third year, every 6 months for the fourth and fifth years and annually thereafter.

PROJECTED ACCRUAL: 400 patients will be accrued over 4-5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven stage IA or IIA Hodgkin's disease without mediastinal bulk Patients with Hodgkin's disease existing below diaphragm only are not eligible

PATIENT CHARACTERISTICS: Age: 16 to 75 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not HIV positive No prior malignancy other than basal cell carcinoma or cervical intraepithelial neoplasia

PRIOR CONCURRENT THERAPY: No prior treatment
Laryngeal Mask Airway (LMA) Insertion With Sevoflurane and Remifentanil

The purpose of this study was to determine the most suitable effect-site concentration of remifentanil for the LMA insertion during inhaled induction with 8% sevoflurane in adults.

For practical purposes, opioids with the ability to suppress upper airway reflexes have been used to facilitate insertion of the LMA during anaesthesia induction. To date, however, there have been no published reports addressing the use of remifentanil to facilitate LMA insertion during sevoflurane inhalation induction in adults. Therefore, the purpose of this study was to determine the most suitable effect-site concentration of remifentanil target-controlled infusion (TCI) for the LMA insertion during inhaled induction with 8% sevoflurane in adults.

Eligibility Criteria:
Inclusion Criteria:

- Adult patients, aged 18-60 with ASA physical status I or II, who were scheduled to minor elective surgery (\< 1 h) were considered for the study

Exclusion Criteria:

- Exclusion criteria were allergies to the study drugs, a history of gastric reflux, a history of drug abuse, obesity (body mass index \> 30 kg/m2) and suspected difficult airway
Prevention of Acute Kidney Injury - Molecular Mechanisms of Dietary Pre-conditioning in Human

The key objective of this pilot study is to assess the molecular mechanisms of renal pre-conditioning by a one-week low-calorie diet in humans.

The protective effect of the low-calorie diet and also of the protein-restriction in donor on transplant qualities and functions in receptor will also be investigated.

Analysis of transcriptome, lipidome, metabolome, epigenome, proteome und phosphoproteome through tissue samples as well as blood samples for comparison of low-calorie diet, protein-restriction and no-diet groups.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Competent patients
* Planned living kidney transplantation
* Provision of informed consent
* BMI ≥ 18,5 kg/m²

Exclusion Criteria:

* None