cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate the Safety and Pharmacokinetics of Lebrikizumab in Healthy Chinese Participants

The main purpose of this study is to determine the tolerability and side effects related to lebrikizumab comparing with placebo given as a single dose administered under the skin to healthy Chinese participants. The study will also assess how fast lebrikizumab gets into the blood stream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of either Lebrikizumab or placebo.

For each participant, the total duration of the study will be approximately up to 21 weeks, including screening period.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be overtly healthy, as determined by medical evaluation.
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study.
* Participants must be native Chinese and born in China, where the participant's biological parents and all 4 of the participant's biological grandparents are of Chinese origin.
* Have a body mass index (BMI) within the range of 18.0 to 28.0 kilograms per square meter (kg/m²).
* Have venous access sufficient to allow for blood sampling.

Exclusion Criteria:

* Have known allergies to Lebrikizumab, related compounds, or any components of the formulation.
* Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational medicinal product; or of interfering with the interpretation of data.
* Have a history or presence of psychiatric disorders.
* Have a history or presence of multiple or severe drug allergies.
* Have significant allergies to monoclonal antibodies.
* Show evidence of active or latent TB, human immunodeficiency virus infection ,hepatitis B and C.
Assessment of Gingival Thickness Using Colored Periodontal Probe

the accuracy of different assessment methods of the gingival tissue thickness can be controversial affecting their correct classification and the techniques of gingival tissue management in case of mucogingival problems.

Aim: The aim of this study is to evaluate the accuracy of different assessment methods of measuring GT and to classify into the different gingival phenotypes.

The accuracy of different assessment methods of the gingival tissue thickness can be controversial affecting their correct classification and the techniques of gingival tissue management in case of mucogingival problems.

The aim of this study is to evaluate the accuracy of different assessment methods of measuring GT and to classify into the different gingival phenotypes.

Periodontally clinically healthy patients will be recruited from the Dental Clinic Complex (MIU) according to eligibility criteria. The gingival tissue thickness will be measured using probe-colored periodontal probes (CPP), standard periodontal probes (SPP) and transgingival sounding with an endodontic file (ISO #20), visual judgment using photographs will be done to the three assessment methods. All readings including GT (1ry outcome) as well as keratinized tissue width and probing depth will be carried out by three calibrated outcome assessors. Data collected will be tabulated and statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Systemically free patients (American Society of Anesthesiologists (ASA) I or II)
* Patients having a state of clinical periodontal health
* Patients aged from 18 to 65 years old
* Both genders
* Presence of anterior teeth in mandible and maxilla.
* Good oral hygiene

Exclusion Criteria:

* Carious teeth, teeth with crowns or veneers and non-carious cervical lesions
* Patients with healthy reduced periodontium.
* Smokers
* Pregnant and lactating females
* Patients taking drugs that affect the gingival tissues
Cardiovascular Diseases in the Silesian Region in Poland.

The Silesian Cardiovascular Database is an observational study of all patients hospitalized due to cardiovascular diseases. The date include information on the clinical characteristics, treatment modalities and prognosis in this population.

The data include information on all the applicable diagnostic and therapeutic procedures, prognosis and hospitalization costs. Likewise, data have been collected specialist care outpatient visits and primary health care patients were hospitalized.

The Silesian Cardiovascular Database is an prospective observational study patients who were hospitalized in the Silesian region in Poland due to cardiovascular diseases from 1st January 2006.

The aim of the study is to collect and analyze all epidemiological data, diagnostic and therapeutic procedures, in-hospital and long-term prognosis, hospitalization costs of these patients. Likewise, data have been collected specialist care outpatient visits and primary health care patients were hospitalized.

For the analysis were included patients hospitalized in the cardiology, cardiac surgery , diabetes, vascular surgery wards and who were hospitalized for cardiac diagnosis in the wards of internal medicine and intensive care.

The Silesian Cardiovascular Database was created based on the agreement between Silesian Centre for Heart Diseases in Zabrze and the Regional Department of National Health Fund in Katowice in order to conduct analyses and prepare scientific elaborations on the group of patients with circulatory system diseases. Data elaboration and preparation for analyses was conducted by the Science Department of Silesian Centre for Heart Diseases and the Department of Biostatistics of Medical University of Silesia.

Eligibility Criteria:
Inclusion Criteria:

* each hospitalisation in the departments of: cardiology, cardiac surgery, diabetology and vascular surgery,
* hospitalisation with cardiological diagnosis in the departments of internal medicine and intensive care.

Exclusion Criteria:

* hospitalisations of patients from beyond Silesia Province,
* patients at the age below18 years at the moment of admission to the hospital
Endoscopic Hand Suturing After Advanced Endoscopic Resections.

Endoscopic hand-suturing (EHS) has emerged as a promising modality in gastrointestinal (GI) endoscopic procedures. The available reports regarding its effectiveness in clinical practice are limited due to the relatively recent expansion of this method. This study aims to describe the single-center experience of EHS and its outcomes.

Endoscopic hand-suturing (EHS) has emerged as a promising modality in gastrointestinal (GI) endoscopic procedures. The available reports regarding its effectiveness in clinical practice are limited due to the relatively recent expansion of this method. This study aims to describe the single-center experience of EHS and its outcomes. The retrospective single-center study included individuals that underwent advanced endoscopic procedures in upper and lower GI tract followed by EHS. Defined features (suturing time, suturing speed) and outcomes (postprocedural bleeding, abdominal pain) were assessed. Thirty-one patients were included in the analysis.

Eligibility Criteria:
Inclusion Criteria:

* all individuals who underwent advanced endoscopic procedures followed by EHS from March 2023 to June 2024.

Exclusion Criteria:

* none
Intra-ocular Pressure and Ventilation

Background: Positive pressure pneumoperitoneum (PP) may involve adverse pathophysiological changes, including increased intra-thoracic and ocular pressure, when combined with standard ventilation. High frequency jet ventilation (HFJV) was reported to reduce the adverse cardiovascular effects during laparoscopic cholecystectomy.

Aim: To study the effects of HFJV on intra-ocular pressure changes (reflecting intra-cranial pressure) during laparoscopic surgery under PP.

Patients and methods: The investigators studied 2 groups of patients electively scheduled for laparoscopic cholecystectomy. The study group included 10 patients that were ventilated by high frequency jet ventilation (HFJV). In the control group (16 patients) the investigators used the standard intermittent positive pressure ventilation (IPPV). Both groups were matched according to clinical and hemodynamic parameters. Intra-ocular pressure was measured by a senior ophthalmologist that was blinded to the ventilation technique. Laparoscopic surgery was done as usual, and the intra-peritoneal pressure was automatically set on 14 mmHg. Statistical significance was considered whenever P value was less than 0.05.

The investigators anticipate that the use of HFJV during laparoscopic operations under PP may prevent increased intra-ocular pressure that accompanies increased intra-abdominal pressure under conventional ventilation (IPPV).

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

* Ophthalmologic and severe Cardiopulmonary diseases
Memantine and Changes of Biological Markers and Brain PET Imaging in Alzheimer's Disease

In AD, tau protein is abnormally hyperphosphorylated. Significant changes of hyperphosphorylated tau levels in CSF are found in AD patients. It has been shown in vitro that memantine can reverse abnormal hyperphosphorylation of tau in hippocampal neurons of rats. A statistically significant reduction of CSF phosphorylated tau at a preliminary 1-year follow-up was observed, from median 126 (interquartile range 107-153) to 108 (88-133) ng/l (p = 0.018). No statistically significant differences of total tau or Aβ42 were found (Gunnarsson MD, 2007).

FDG-PET has the unique ability to estimate the local cerebral metabolic rate of glucose consumption, thus providing information on the distribution of neuronal death and synapse dysfunction in AD in vivo (Herholz K. 2003). Synaptic dysfunction and loss induce a reduction in neuronal energy demand that results in decreased glucose metabolism. Hypometabolism in AD is thought to reflect loss of synaptic activity and density (Herholz K. 2003; Mielke R, et al. 1998).

Another biological markers such as inflammatory factor and APOEε4 also play a part in the onset of AD (Glodzik-Sobanska L, 2007).

1. To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on biological markers of subjects with Alzheimer's disease.
2. To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on 18\[F\]-FDG-PET of brain in subjects with Alzheimer's disease.
3. To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on cognitive function in subjects with Alzheimer's disease.
4. To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on measures of behavior and activities of daily living of subjects with Alzheimer's disease.
5. To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on short term memory.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Clinical diagnosis of Alzheimer's disease which meet the DSM-IV criteria.
3. Subject has moderate to severe Alzheimer's disease as defined by a MMSE score 4 to 20 inclusive at screening.
4. Hachinski Ischemia Score \< 4 at screening.
5. Age ≥50 and ≤90 years.
6. Availability of a responsible and steady caregiver to ensure treatment compliance and provide information for assessments.

Exclusion Criteria:

1. Severe renal impairment.
2. History of seizures
3. Systolic blood pressure \>160 or \< 90 mmHg or diastolic blood pressure \> 95 or \< 60 mmHg at the time of screening.
4. Diagnosis of any concomitant life threatening illness.
Effects Of Darbepoetin On Vascular Repair Mechanisms In Kidney Disease The DARBEPC Study

Humans have cells in their blood stream called endothelial progenitor cells or EPCs. These are thought to be important in keeping blood vessels healthy. People with chronic kidney disease (CKD) have low numbers of these cells. People with cardiovascular (heart and blood vessel) disease also have low numbers. Patients with CKD have more cardiovascular disease then any other group.Erythropoietin is a hormone made by the kidneys. It is essential for making red blood cells and also activates EPCs. It is low in people with kidney disease.

As part of your regular medical care for correcting your low red blood cell count, you will be receiving a medication that acts like erythropoietin. It is called darbepoetin.

The purpose of this study is to see if darbepoetin treatment affects EPC numbers and function.

The majority of patients with kidney disease, an estimated 20 million adults in the U.S., will die of cardiovascular disease. Further, the risk for cardiovascular events is 2-3 fold higher than in the general population and increases with the severity of renal impairment \[1\]. Reasons for this accelerated atherosclerotic process are unclear. Recent evidence suggests that endothelial progenitor cells (EPC) are critical to maintaining vascular integrity \[2\]. Patient populations with low circulating EPCs, including patients with kidney disease, have excess vascular disease burden. The hematopoietic cytokine, erythropoietin, is a key regulator of EPCs and is reduced in patients with kidney disease \[3\]. Therefore, we hypothesize that supplementation with the erythropoietin analog, darbepoetin, enhances EPC function leading to improvement in vascular repair mechanisms in patients with chronic (CKD).

To begin to explore this hypothesis, we will pursue the following specific aims.

1. Determine the effects of darbepoetin on EPC number in patients with anemia related to CKD
2. Determine the effects of darbepoetin on EPC function in patients with anemia related to CKD
3. Determine the effects of darbepoetin on proangiogenic factors in patients with anemia related to CKD

These studies will expand our understanding and potentially guide therapy aimed at reducing the excess cardiovascular disease burden in high risk populations.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in University of Michigan's Nephrology Anemia Clinic
* 18 years old or older
* Have kidney disease but are not on dialysis

Exclusion Criteria:

* Not enrolled in University of Michigan's Nephrology Anemia Clinic
* Less than 18 years of age
* Hematocrit that is less than 28.5%
* Currently participating in a clinical trial with an intervention
* Planning to change their tobacco use habits during the study period
* Have had dose changes of certain medications for cholesterol or diabetes within one month of study enrollment
* Are currently receiving:

  * darbepoetin
  * erythopoietin
  * medications to lower your immune system
* Have had problems within the last 3 months with:

  * Bleeding
  * Heart attack or stroke
  * Heart or blood vessel procedures
* Are pregnant or lactating
The Effect of Rosuvastatin on Adenosine Metabolism

The aim of this study is to show whether rosuvastatin influences adenosine metabolism. Therefore we will determine whether rosuvasatin increases dipyridamole-induced vasodilation by increased adenosine receptor stimulation.


Eligibility Criteria:
Inclusion Criteria:

* age 18 - 50 years
* Signed informed consent

Exclusion Criteria:

* hypertension
* hypercholesterolemia
* diabetes Mellitus
* alanine aminotransferase \> 90 U/L
* creatinine Kinase \> 440 U/L
* cardiovascular disease
* GFR \< 80 ml/min
Cardiopulmonary Exercise Testing in Girls (8-18y) with Turner Sydrome.

The goal of this clinical trial is to have a beter insight in the exercise tolerance in girls with Turner Syndrome aged 8-18 years . The main question it aims to answer is:

Is there a difference in VO2 max comparing Turner syndrome girls with standard values? How do cardiovascular parameters change during exercise (heart rate, bloodpressure, ...)

Participants will perform a cyclo-ergometry in a standardised way.


Eligibility Criteria:
Inclusion Criteria:

* Turner syndrome girls aged 8-18 years old

Exclusion Criteria:

* Severe mental impairement making it impossible to perform an exercise test
Cost Effective Health Promotion for Older Adults

This project tests the cost-effectiveness of two promising evidence-based health promotion/ behavior change interventions. The first intervention is the COACH Program, a revised version of the Health Enhancement Program (HEP) that has been implemented to date with older adults at multiple Senior Centers across the country (Leveille et al, 1998). The second is the web-based RealAge program which is also being implemented for older adults at multiple sites nationally and internationally. The Coach program combines a web-based risk assessment with individualized counselling. In contrast, RealAge is a totally web-based program.

The specific hypotheses that we will test in the proposed cost-effectiveness study are shown below.

Primary Study Hypotheses:

COACH participants will experience significantly greater reductions in absenteeism, disability days, and healthcare use and cost at 6 and 12 months than RealAge participants. Participants in both the COACH and RealAge treatment groups will experience significantly greater reductions in absenteeism, disability days, and healthcare use and cost than control group participants at 6 and 12 months.

Secondary Study Hypotheses:

COACH participants will experience significantly greater levels of adherence to health promotion Action Plans and greater reduction in weight, body mass index, blood pressure and depression and greater increase in vitality and quality of life than RealAge participants at 6 and 12 months. Participants in both the COACH and RealAge treatment arms will experience significantly better outcomes on these measures at 6 and 12 months than control group participants.


Eligibility Criteria:
Inclusion Criteria:

* Current employee of the University of Illinois at Chicago
* 40+ years of age

Exclusion Criteria:

* Those not currently employed by the University of Illinois at Chicago
* Those under the age of 40
MRI Perfusion Imaging at 3Tx Compared to Invasive FFR Measurements

Coronary artery disease (CAD) has a great significance concerning prevalence and mortality in the western world. It is usually diagnosed by catheterization and coronary arteries are visually assessed by the examiner. Thus having a great spectrum of interobserver differences, especially when it comes to intermediate lesions. The gold standard to assess the haemodynamic significance is the measurement of the myocardial fractional flow reserve (FFR). The FAME-study (Tonino, De Bruyne et al. 2009) was able o show that additional FFR- measurements in patients with intermediate lesions could significantly reduce stent implementation and consequently mortality. However this method is not used in daily routine and is available only in a fraction of catheter labs worldwide. Taking this into account decision finding especially in intermediate lesions remains difficult.

One major step to simplify the invasive approach concerning intermediate lesions would be to establish a non-invasive procedures which localizes the coronary vessel to intervene ahead catheterization.

Do to steady technical development cardiac MRI has become a powerful tool which is able to determine myocardial vitality, perfusion and function. In particular the new generation of 3 Tesla multi transmit MR with its higher field strength and better spatial resolution seems to be able to show first pass myocardial perfusion more precise. With this new technology prefixed to cardiac catheterization clinical relevant information can be made accessible and thus reduce the number of unnecessary implemented stents.


Eligibility Criteria:
Inclusion Criteria:

* intermediate lesion defined by myocardial fractional flow reserve measurement
* age \> 18 years

Exclusion Criteria:

* pregnancy
* contraindication with adenosin, contrast agents or MR-Scaning
* severe renal dysfunktion
* instable patient(e.g. acute myocardial infarction)
Clinical Investigation on the Outcome of Episealer Talus Post-operation for Treatment of Focal Osteochondral Defects

This is a retrospective, observational, single-arm, multi-centre, post-market clinical investigation designed to verify clinical performance and safety of Episealer Talus post-operation for treatment of focal osteochondral defects on the talus bone in the ankle. This retrospective investigation aims to collect data from patients with focal osteochondral defects treated with Episealer Talus, to provide insight on the potential benefit of Episealer Talus in the treatment of focal osteochondral defects.

The aim for the clinical investigation is to collect data from approximately 25 adult subjects who were treated for focal osteochondral defect with Episealer Talus implant in 6 clinics (Sweden and Germany) since January 2020, when the devices were CE-marked. The data collected for each subject will include demographics and data generated in relation to the surgery itself and the post-surgery phases including e.g. focal defect grade and position, collected through medical record review. Each subject will also be asked to complete a set of QoL questionnaires (SEFAS, FAOS and VAS).

This is a retrospective, observational, single-arm, multi-centre, post-market clinical investigation designed to verify clinical performance and safety of Episealer Talus post-operation for treatment of focal OCDs. The overall clinical investigation is based on the patient's reported outcome (PROs) from OCD patients previously treated with Episealer Talus implant after January 2020. In total approximately 25 adult subjects, male or female, from 6 clinics (Sweden and Germany) will be included in the investigation.

Subjects will be identified by the investigational site team through medical record review and/or site knowing the subjects from performing the implantation after January 2020. Following collection of the subject´s signed informed consent, subject demographics, health- and surgery-related data will be collected from the subjects' medical records. Therefore, only one visit is planned for each subject during the clinical investigation. The performance variables relate to quality of life, and all subjects will be asked to fill in three questionnaires (SEFAS, FAOS and VAS).

The overall duration of the investigation is estimated to be 4 months, including a 1 month recruitment period. Each subject is estimated to spend approximately 1-2 hour for completing the informed consent and completing the questionnaires. Subject´s participation in the clinical investigation will be terminated once the questionnaires have been completed and the site team considers all data collected for the subject.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Patients ≥ 18 years old at the time of index procedure
* Patients who previously received Episealer Talus implant after January 2020

Exclusion Criteria:

* "None"
Assessment of NAPS Performance.

To measure competencies in propofol sedation for endoscopic procedures (NAPS)through development, test and validation of a reliable assessment tool in a simulator setting.

Hypothesis: That the tool will demonstrate content and construct validity, ie. enable reliable measuring of necessary competencies of different levels in a reproducible way.


Eligibility Criteria:
Inclusion Criteria:

* eligible nurses, written informed consent.

Exclusion Criteria:

* Prior anesthesia or ICU experience