cyrilzakka/clinical-trials huggingface dataset:
Concomitant Administration of the Novavax Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Adults Aged ≥60 Years

Vaccination is a key strategy for preventing respiratory illnesses. Pneumococcal vaccination is recommended for all adults aged over 60 or 65 years (depending local guidelines) who have never received a pneumococcal vaccine or whose previous vaccination history is unknown. Given their wide application, co-administration of pneumococcal and Covid-19 vaccines may support broad population-wide coverage. However, it is unclear whether the co-administration of the Novavax (NVX) vaccine and a 20-valent pneumococcal conjugate vaccine (PCV20) results in lower immunogenicity than the administration of either alone.

The investigators will thus conduct a 4-four arm study with the following treatments: NVX plus placebo (NVX arm), PCV20 plus placebo group (PCV20 arm), NVX plus PCV20 (Combination arm), and placebo plus placebo group (Placebo arm). Vaccines and/or placebo will be administered as single doses, given as intramuscular injections on Day 1 (one in each shoulder). Subjects will be randomly assigned to one of the four arms.

The outcome will be the antibody levels after 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Age: 60 years or older
* Males and females
* Able and willing (in the investigator's opinion) to comply with all study requirements.
* Participants, who already received three Covid-19 vaccines, of which the third was a mRNA vaccine (BNT162b2 or mRNA-1273) and at least 16 weeks ago
* Only applicable for women: last menstrual bleeding more than one year ago

Exclusion Criteria:

* Use of immunosuppressants
* Congenital or acquired immunodeficiency (eg, history of HIV infection, hematological disease, current malignancy, or others)
* Chronic condition that may significantly interfere with the immune response in the opinion of the investigator
* History of Covid-19 within 16 weeks before study vaccination
* Previous pneumococcal vaccination
* Contraindication against any ingredient of the NVX or the PCV20 vaccine
Cytologic Analysis of Distention Media as a Screening Test for Endometrial Cancer

The purpose of this study is to learn fluid from sonohysterography can be used to diagnose endometrial cancer.

Participants will have a sonohysterography (SHG) performed. Fluid will be collected after instillation of 5mls of saline and again after an adequate SHG is performed. A pathologist will review this fluid to see is cancer cells are present.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed early-stage endometrial cancer

Exclusion Criteria:

* Recurrent or persistent endometrial cancer
* Evidence of distant metastases
Ghrelin With Anorexia Nervosa

The PICOWO research group in corporation with the University of Amsterdam (Artificial Intelligence) has developed a computer simulationmodel of eating disorders (Bosse, Delfos, Jonker \& Treur, 2003). In a running Phd project we want to add ghrelin to the model. The idea for this current research is to collect clinical information about the functioning and (patho)physiology of ghrelin in patients with AN, so we can extend the simulation.

Eating disorders are in need of new perspectives. A better understanding of the appetite in patients with eating disorders, especially Anorexia Nervosa, could be investigated by the levels of ghrelin in patients with and without tube feeding.

Eligibility Criteria:
Inclusion Criteria:

* Studypopulation: Patiënts: all female, non -age coupled.
* Subgroup patients without tube feeding, with tube feeding and a healthy matched control group.
* Control group: healty volunteers of the University of Maastricht.

Exclusion Criteria:

* Patients with a history of eating disorder different than AN or a psychiatric history.
* Control group: no history of eating disorders or other psychiatric disabilities. Normal physical examination, ecg, laboratorium (blood cells, liver, kidneys)
Early Vitrectomy for Macular Tractional Maculopathy

This study is designed to identify the effect of current vitreous surgery for symptomatic macular tractional maculopathy.

Characteristics of this study is as below

1. Multicenter, prospective clinical trial. (early surgical intervention vs.surgical intervention when full-thickness macular hole formation or deterioration of visual acuity occurs)
2. Non-randomized study (decision was made by patients after full explanation)
3. After 1 year follow up, functional change(visual acuity)and anatomical change would be evaluated

Degenerative myopia is relatively common disorder, especially in Korean, Japanese and Chinese.

Choroidal neovascularization is well-noted cause of VA deterioration, but nowadays, with improvement of diagnostic tools, such as OCT, VA deterioration from myopic tractional maculopathy is being concerned as well.

But till now, the necessity of early vitrectomy on MTM is controversial. By now some clinicians prefer conservative treatment, which means pars plana vitrectomy would be postponed till structural change such as macular hole formation is noticed. And the others prefer early vitrectomy, which means pars plana vitrectomy should be performed when the symptom begins.

In this study, investigators try to verify the validity of early vitrectomy comparing conservative treatment.

Eligibility Criteria:
Inclusion Criteria:

* male or female with impending macular hole(identified with OCT)
* Age: over 20 years
* Symptom duration \< 6 Months
* Visual acuity on trial: more than 20/320 in ETDRS chart

Exclusion Criteria:

* Any vision disturbing disease other than impending macular hole
* Diabetic maculopathy or other retinal vascular disease
* Prior history of major trauma: If symptom begins after trauma
* Any evidence of atrophic change, scar or exudation on macula active intraocular inflammation
* History of intraocular surgery other than uncomplicated cataract extraction 3 months before
* Uncontrolled IOP \> 25mmHg
Determining Whether There is a Change in Time Taken to Return to Homeostatic Temperature With Repeated Exposure to a Cold Stressor

There has been previous research suggesting cold has an effect on pain relief, however there is limited knowledge on the relationship between exposure time of a cold stressor and how long it takes to return to homeostatic temperature and normal response to cold, in addition to whether location site affects this. The skin's thermal response to a cold stimulus is not fully understood. This provides precedent for potentially using cold stressors as a way to provide pain free injections.

5 participants will be exposed to a block of copper on the skin at -2°C for 30 seconds, and a thermal camera will be used to identify the amount of time it takes for the skin to return to its homeostatic temperature. The participant will then be left for 30 seconds before the experiment is repeated to identify if there is a change in the response to cold after the first exposure.

If increased sensitivity in the response to cold occurs, the experiment will be repeated by adding an additional 30 seconds between repeats to identify the minimum time required between exposures that doesn't result in increased sensitivity. This will occur until there are two consecutive times with no increased sensitivity.

This will occur on both the forehead and on the deltoid of the arm, two areas where injections are common.

The cold stressor will be block of copper metal which will be cooled to this temperature.

A thermal imaging camera is used to identify the 'normal' temperature of the skin on the forehead. A cooled block of copper is then placed onto the skin of the forehead at a temperature of -2°C for 30 seconds. A timer is then used to measure how long it takes for the skin on the forehead to return to its normal temperature. This is then repeated twice with a minute in between each measurement to identify if there is a change in the response to cold, where it takes more/less time to return to normal levels. If the time taken to return to normal changes, the participant will be given 30 minutes to rest, and then repeat the experiment with an additional minute between repeats. This will continue until there is no change in the amount of time it takes for the skin to return to normal on the forehead once exposed to the cold conditions to identify a sensitivity time due to a change in the response to cold. This will be tested on 5 patients.

This will also be tested on the outer deltoid, where injections usually occur in your arm.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed Consent
* Above 18 years old

Exclusion Criteria:

* Skin conditions or irregularities, or on medication that affects temperature regulation
Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold

SmartMatrix™ is a single layer dermal replacement scaffold for full thickness skin replacement. The scaffold consists of a porous matrix of cross-linked human fibrin plus alginate that has been designed and optimised to facilitate wound closure and healing through cellular ingress and rapid growth of new blood vessels.

This proof of concept study will involve patients with surgical wounds resulting from the excision of basal cell carcinoma (BCC) and squamous cell carcinoma SCC).


Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years of age
* Suspected or histologically proven BCC or SCC
* Suspected or histologically proven BCC or SCC ≥1cm ≤3cm in diameter on either leg
* Expected defect following surgery ≥3cm, ≤6cm in diameter
* Patient or authorised representative able to comprehend and sign the Informed Consent prior to enrolment in the study

Exclusion Criteria:

* Aged \<18 years of age
* Pregnant or lactating females
* Skin lesion \>4cm in diameter or size that will result in post-surgical defect \>6cm in diameter
* Lesion located over joint, i.e. ankle or knee
* Patient who are smokers
* Diabetic patients
* Patients diagnosed with peripheral vascular disease or venous stasis
* Patients receiving regular systemic steroids
* Patients who are immuno-compromised (either acquired or congenital)
* Patients with a known coagulopathy (either acquired or congenital) but not including patients on aspirin or other anti-platelet therapy
* Patients who have received radiotherapy treatment to the area about to be treated with Smart Matrix
* Concurrent participation in another experimental intervention or drug study
* Unwilling or unable to provide informed consent
3D Multi-Contrast Atherosclerosis Characterization of the Carotid Artery

This is a technical development study with the goal to develop 3D techniques for atherosclerosis plaque characterization. We hypothesize that 3D MRI is superior to 2D MRI in characterizing major plaque constituents that contribute to severe clinical events such as myocardial infarction or stroke. The major advantages of the 3D techniques to be developed will include high spatial resolution, reduced scan times, and optimized image contrast. The use of contrast injection is not needed with the new techniques, which is greatly beneficial for patients with advanced chronic kidney disease.This is not a funded clinical trial.

All participants will undergo the conventional MRI protocol and the new imaging protocol using our developed techniques. They may have either non-contrast scans or contrast-enhanced scans or both depending on the stage of development. The comparison results between the two protocols will be used to evaluate the performance of the new techniques and help optimization of specific technical aspects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers: male or female ≥ 18 years of age with a BMI\<30, with no history of cardiovascular disease
* Patients: Medically stable, male or female ≥ 18 years of age diagnosed with an atherosclerotic plaque in the carotid artery who have not undergone stenting of the carotid artery to be imaged.
* Ability to read and understand informed consent

Exclusion Criteria:

* Contraindications to MRI including mechanically, magnetically, or electrically activated implants, ferromagnetic implants and ferromagnetic foreign bodies, pregnancy.
* Inability to tolerate MRI secondary to an inability to lie supine or severe claustrophobia.
* Non-compliant with visit instructions, including inability to lie still, hold breath or follow procedure instructions
* Severe allergy to animal dander or animal-instigated asthma
* Specific to gadolinium-based contrast agents: Renal function test does not meet CSMC standard of care MRI contrast protocol requirements (GFR \<45ml/min) or previous allergic reaction to gadolinium-based contrast agents.\*
Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease

The overall goal of this study is to define the phenotype of Interstitial Lung Disease (ILD), and identify factors that predict radiologic progression in those with subclinical RA-ILD, in patients with rheumatoid arthritis (RA). The investigators hypothesize that there are common core elements (e.g. clinical features, genetic variants, and/or biologic markers) between other forms of ILD (e.g. idiopathic pulmonary fibrosis, IPF) and subclinical RA-ILD that places individuals at risk for the development of lung disease.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 45years old
2. Diagnosis of RA using the 2010 American College of Rheumatology (ACR) criteria

Exclusion Criteria:

1. Inability to give informed consent
2. Pregnant women
3. History of interstitial lung disease
4. Evidence of other causes of diffuse parenchymal lung disease such as infection, drug toxicity, other autoimmune processes, etc.
5. Subjects over the age of 90 years old or less than 45 years old
Simons Variation in Individuals Project, Functional Common Acquisition Protocol

The University of California, San Francisco (UCSF) Simons Variation in Individuals Project (Simons VIP) is currently recruiting healthy controls for a study aimed at better understanding autism spectrum disorder. The UCSF site of the Simons VIP is conducting functional and structural imaging, neuropsychological evaluation, genetic testing, and neurologic exams in healthy individuals to compare with findings in autism spectrum disorder.

To better understand autism spectrum disorders, the UCSF Simons VIP team is recruiting healthy controls to participate in a study involving brain imaging and psychological assessments and questionnaires. The study will involve phone interviews, cognitive testing and questionnaires, genetic testing, physical exam, photographs, non-invasive brain imaging sessions (MRI and MEG). The study can take up to 17 hours to complete, and there may be up to 5 study visits to UCSF and UC Berkeley.

Eligibility Criteria:
Inclusion Criteria:

* Healthy persons age 7 and older
* Must use English as primary language
* Must be able to lie still in MRI scanner for two hours
* Must be willing to travel to UCSF and UC Berkeley for up to 5 study visits.

Exclusion Criteria:

* Any metal implanted in the body
* Extensive dental work
* History of psychiatric of neurological illness
* History of drug or alcohol abuse
Reliability of Cardiac Output Monitoring Based on Uncalibrated Pulse Contour Analysis

The aim of our study was to evaluate the reliability of uncalibrated cardiac index monitoring based on arterial waveform analysis in patients undergoing off-pump coronary artery bypass grafting.

Using contemporary statistical method the cardiac index values obtained via uncalibrated pulse contour analysis with Pro AQT system will be compared with traditional transpulmonary thermodilution technique (Pulsion, Germany).

Eligibility Criteria:
Inclusion Criteria:

* elective off-pump coronary artery bypass grafting

Exclusion Criteria:

* age \< 18 and \> 80 years,
* preoperative ejection fraction \< 0.35,
* severe cardiac valve dysfunction or peripheral vascular disease,
* constant atrial fibrillation,
* simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.),
* transfer to cardiopulmonary bypass.
Clinical Trial of Continuing Treatment for Patients Who Have Participated on a Prior Protocol Investigating Tanespimycin

The primary purpose of this study is to provide treatment to patients who have participated on a prior protocol investigating Tanespimycin (KOS-953,17-AAG)


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Participated in and completed a previous Tanespimycin protocol without evidence of unacceptable toxicity and is deemed by the Investigator to be deriving benefit from the Tanespimycin drug as defined in the previous protocol
* All patients must rollover to this continuation protocol within 30 days of the last dose of Tanespimycin in the previous protocol, unless previously approved by the Medical Monitor
* All Adverse Events from the prior protocol, must have resolved to NCI CTCAE (v. 3.0) Grade \<= 2
* The following laboratory results, within 10 days of Tanespimycin administration:
* Hemoglobin \>= 8 g/dL
* Absolute neutrophils count \>= 1.0x 10\*9\* /L
* Platelet count \>= 50 x 10\*9\* /L
* Serum bilirubin \<= 2 x ULN
* AST \<= 2.5 ULN
* Serum creatinine \<= 2 x ULN
* ECOG performance status of 0, 1 or 2
* Signed informed consent

Exclusion Criteria:

* Pre-existing neuropathy of CTCAE Grade \>= 3 due to any cause
* Documented hypersensitivity reaction of CTCAE Grade \>= 3 to prior therapy containing Cremophor (for those patients receiving Tanespimycin Injection)
* Pregnant or breast-feeding women
* Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic), excluding Tanespimycin within 21 days prior to receipt of study medication
* Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient
Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus

The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* 18-78 years of age
* Taking stable twice daily (BID) dosing of metformin IR (at least 1500 mg) for at least 8 weeks
* A1C: 7-10%
* C-peptide: ≥ 0.8 ng/mL
* Body mass index (BMI): ≤45 kg/m\^2

Exclusion Criteria:

* Women of childbearing potential unable or unwilling to use acceptable birth control
* Women who are pregnant or breastfeeding
* Fasting plasma glucose (FPG) \>270 mg/dL
* Significant cardiovascular history
* Symptoms of poorly controlled diabetes
* History of diabetic ketoacidosis or hyperosmolar nonketotic coma
* Insulin therapy within one year of screening
* Cardiovascular even within the prior 6 months
* New York Heart Association Stage III/IV congestive heart failure and/or known left ventricular ejection fraction \<=40%
* Significant history of renal or hepatic disease
* History of a psychiatric disorder, alcohol or drug abuse within the previous year
* Treatment with potent CYP3A4 inhibitors or inducers
* Immunocompromised participants
* Active liver disease or clinically significant abnormal hepatic, renal , endocrine, metabolic, or hematological screening tests
Safety and Tolerability of GX-G6 in Healthy Male Subjects

This study is a single-center, double-blind, placebo-controlled, phase I study with healthy male subjects receiving ascending single s.c. doses of GX-G6

A screening examination will be performed within 28 days prior to dosing. Eligible subjects will return to the study center in the morning of Day -1 and will remain in-patient until discharge about 98 hours after dosing (after oral glucose tolerance test in the morning of Day 5) if there are no safety issues. The s.c. injection will be administered in the morning of Day 1. Ambulatory visits will take place on Days 7, 9 and 12. A follow-up visit will take place on Day 15 and a final visit on Day 28.

Eligibility Criteria:
Inclusion Criteria:

1. male subjects aged between 18-50 years (both inclusive)
2. healthy subjects as determined by medical history, physical examination including vital signs, ECG and clinical laboratory testing
3. subjects who are able and willing to give written informed consent
4. male subjects must be using 2 acceptable methods for contraception (one of these methods should be a barrier method e.g. spermicide and condom) from start of dosing and refrain from fathering a child in the 3 months following dosing.

Exclusion Criteria:

History of:

1. clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing), especially allergy to macrolide antibiotics;
2. any clinically significant pancreatic, hepatic, renal, gastrointestinal, cardiovascular, respiratory, hematological, central nervous system diseases or other significant diseases which might influence either the safety of the subject or the absorption, metabolism or excretion of the active agent under investigation;
3. diabetes mellitus and thyroid dysfunction or other endocrine disorders;
4. malignancy;
5. substance abuse or addiction (alcohol, drugs) in the past 3 years.

   Present Condition:
6. participation in a clinical investigation within the 30 days prior to the planned first drug administration or during this trial;
7. participation in this study at a previous dose level;