cyrilzakka/clinical-trials huggingface dataset:
A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours

A Phase I/IIa First-in-human, Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD8853 in Participants with Selected Advanced/Metastatic Solid Tumours.

This study is evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AZD8853 in participants with advanced, unresectable or metastatic Non-Small Cell Lung Cancer (NSCLC), Microsatellite Stable Colorectal Cancer (MSS-CRC), Urothelial Carcinoma (UC).

This is a modular study, that includes a master protocol and Substudies.

Substudy 1 will be conducted in 3 parts - Part A: Dose escalation, Part B: Safety expansion and exploratory CD8+ T cell radiopharmaceutical tracer with PET imaging, and Part C: Efficacy expansion.

Eligibility Criteria:
\*Key Inclusion Criteria\*

All Substudies:

1. At least one measurable target lesions per RECIST 1.1.
2. Eastern Cooperative Group (ECOG) of 0-1.
3. Life expectancy of ≥ 12 weeks
4. Adequate organ and marrow function as defined in the protocol

Substudy 1:

1. Histologically or cytologically confirmed locally advanced, unresectable or metastatic NSCLC, MSS-CRC, or UC.
2. Documented progression from previous therapy
3. NSCLC:

3.a. At least 1 line of systemic therapy in the advanced / metastatic setting 3.b.Must have received anti-PD-1/anti-PD-L1 agent with or without chemotherapy 3.c. Part B and C: Documented no sensitizing EGFR mutations or ALK fusions/rearrangements

4. MSS-CRC: 4.a. At least 2 prior lines of systemic therapy in the advanced / metastatic setting, including specific therapies defined in the protocol

5. UC: 5.a. At least 1 prior line of systemic therapy in the advanced / metastatic setting, including either a platinum-containing regimen and/or an anti-PD-1 or anti-PD-L1 drug 6. Provision of archival tissue or unstained slides 7. Part B: Willing to provide mandatory biposies at screening and on study 8. Part B-CD8+ PET: At least 1 non-liver lesion suitable for PET imaging

\*Key Exclusion Criteria\*

All Substudies:

1. Unresolved toxicities ≥ Grade 2 per CTCAE 5.0 from prior therapy, with some exceptions defined in the protocol
2. Symptomatic CNS metastases or leptomeningeal disease
3. Active or ongoing infections, or uncontrolled intercurrent illness as defined in the protocol
4. Active or prior documented autoimmune or inflammatory disorder
5. Body weight loss of \> 10% within 30 days of screening visit
6. Type 2 diabetes requiring management by metformin, where metformin cannot be switched to another treatment at least 7 days prior to starting study treatment

Substudy 1:

1. Must not have had a toxicity from a checkpoint inhibitor that lead to permanent discontinuation of immunotherapy
2. Participants with brain metastases, unless treated, asymptomatic, stable, and not requiring treatment
Confocal Endomicroscopy of Pancreatic InVivo

Confocal laser endomicroscopy (CLE) is a novel and highly promising imaging method for that allows in vivo imaging of the mucosal layer at resolution of approximately 1 micron. Cellular and sub-cellular structures as well as capillaries and single red blood cells can be visualized. CLE is now well established as a highly accurate method for distinguishing neoplasia in the gastrointestinal tract lumen via endoscopy. A major new breakthrough is the development of sub-millimeter CLE probes that can be passed via an image guided needle (nCLE) into solid organs and cysts.

It is hypothesized that nCLE will help distinguish the benign, premalignant and malignant cystic lesions of pancreas by visualizing the cellular lining of the cysts, thereby, avoiding unnecessary surgery in patient with benign cysts and guiding to early and effective surgical removal of high risk neoplastic lesions.

A prototype minimal risk nCLE system has been developed that can be passed via standard endoscopic ultrasound needles into the pancreas but FDA clearance for in vivo use is not expected until late 2010. The investigators propose to evaluate this prototype nCLE system in vivo during endoscopic ultrasound (EUS), as an initial pilot study.

Hypothesis: the confocal laser endomicroscopy imaging of the nCLE can differentiate between non-mucinous, mucinous non- malignant and malignant pancreatic cysts in vivo and has increased sensitivity compared to endoscopic ultrasound-fine needle aspiration (EUS-FNA) tissue sampling. In this pilot study the investigators will primarily evaluate technical feasibility and interobserver agreement.

1. In patients undergoing EUS for suspected pancreatic cysts, the investigators will evaluate the key nCLE image features of non mucinous, mucinous, and malignant pancreatic cystic neoplasms (PCN).
2. The investigators will estimate the initial image quality, feasibility, and interobserver agreement of nCLE
3. The investigators will establish the preliminary accuracy of nCLE to be used for planning a larger comparative trial

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing endoscopic ultrasound for evaluation of pancreatic cysts (including pseudocysts and suspected pancreatic cystic neoplasms) in the gastrointestinal (GI) lab at Mayo Clinic Jacksonville.

Exclusion Criteria:

* Unwilling/unable to consent;
* Solid pancreatic mass on computerized axial tomography/magnetic resonance (CT/MR);
* Allergy to Fluorescein;
* Pregnancy.
An Evaluation of Integration Success and Maintenance of Short Implants in Maxillas Needing Sinus Augmentation

This prospective randomized study will evaluate the integration success while supporting a prosthesis for short implants placed into maxillary sites having minimal bone height that would otherwise need sinus augmentation. The resources utilized during treatment will be assessed.

Study (null) hypothesis: the overall benefit of using short length implants to avoid sinus augmentation procedures will offset differences in the cumulative implant survival rates observed between treatment groups.

In this randomized study, patients needing restorations in the posterior maxilla will be randomly assigned to the short implant group (test) or the standard length and augmentation group (control). All implants will be placed using a two-stage approach with healing abutments placed at three months and temporary prosthesis at four months following implant and/ or sinus augmentation surgery. Time, materials, and efforts associated with treating test and control cases will be documented to allow an assessment of the costs incurred with each approach.

Eligibility Criteria:
Inclusion Criteria:

* patients of either sex and any race greater than 18 years of age
* patients with partial edentulism in the posterior maxilla requiring a unilateral implant-supported maxillary prosthesis
* patients with a residual alveolar floor of the sinus between 4 and 6 mm in height, as assessed on intraoral radiographs, and able to receive at least a 4mm wide implant
* patients must be physically able to tolerate conventional surgical and restorative procedures

Exclusion Criteria:

* patients with active infection or severe inflammation in the areas intended for implant placement
* patients with a \> 10 cigarettes per day smoking habit
* patients with uncontrolled diabetes or metabolic bone disease
* patient with a history of therapeutic radiation to the head
* patients who are known to be pregnant
* patients with para-functional habits with evidence of severe bruxing or clenching
* patients not able to commit to a 3 year follow-up program
Search for Biomarkers in Human Glaucoma: Lymphocytes Alterations and Rate of Progression

The aim of this study was to evaluate the lymphocyte phenotype in primary open- angle glaucoma (POAG) patients compared to healthy subjects of the same age, in order to confirm the importance of immune responses in glaucoma and the possible correlation to the severity of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of primary open-angle glaucoma
* age between 19 an 85 years old

Exclusion Criteria:

* age less than 19 or more than 85 yrs
* positive history for (a) neurodegenerative diseases, (b) autoimmune diseases, (c) cancer, (d) viral infection and (e) diabetes, (f)systemic inflammation
Nanofat Versus Platelet Poor Plasma Gel for Infraorbital Rejuvenation

this study was conducted for evaluation of the clinical efficacy, safety, and potential side effects of platelet poor plasma gel versus nonfat injection in infraorbital rejuvenation


Eligibility Criteria:
Inclusion Criteria:

* all patients with infraorbital dark circles

Exclusion Criteria:

* pregnancy
* breast feeding
* infectious disorders
Therapeutic Effects of Neurofeedback in Anorexia Nervosa

The purpose of this study is to determine whether neurofeedback training can significantly reduce the symptoms of anorexia nervosa (AN) with focus on changes in personality and psychological well-being. The primary aims of this study include:

1. To examine whether AN patients are able to control their alpha-activity through neurofeedback.
2. To examine the effects of neurofeedback on symptomatology and personality variables in AN patients.
3. To examine the long-term effects of neurofeedback in the treatment of AN.

The aim of the present study is to investigate the impact of EEG frequency band biofeedback (neurofeedback) training on EEG topography and symptomatology of patients suffering from anorexia nervosa (AN).

There is evidence that alpha-neurofeedback leads to an increase in positive therapy outcome in clinical populations by changing long-lasting EEG frequency patterns. The use of an EEG-guided relaxation paradigm has been shown to be associated with well-being and improvements in pathology of psychiatric patients.

In the present study the effects of alpha-training on EEG activity, mood, personality, well-being, blood parameters, and heart frequency will be evaluated in a sample of anorectic girls (12-18 years).

The subjects are trained with at least 10 sessions alpha-neurofeedback, in order to enhance individual alpha frequency, with spectral resting EEG, EKG, blood samples, ERP-measures and psychometric measures assessed before and after training. Neurofeedback is conducted over a period of five weeks, with each participant receiving two training sessions per-week. Neurofeedback is administered using USBAmp-EEG system.

For better surveillance of training effects there are two non-treatment control groups. A patient group receiving conventional therapy programme of the Psychosomatic Division of the Pediatric Department at the University Hospital Graz and a healthy control group.

A twelve-week follow-up study is carried out in order to document long-term effects of alpha-neurofeedback training in AN patients.

Eligibility Criteria:
Inclusion Criteria:

* anorexia nervosa diagnosed by ICD-10

Exclusion Criteria:

* epilepsy or other brain organic diseases
Virtual Reality to Improve Patient Experience During Endoscopic Submucosal Resection

This study explores the feasibility of using Virtual Reality (VR) to manage pain and anxiety during Endoscopic Submucosal Dissection (ESD). ESD often requires sedation or analgesia, which can cause side effects like respiratory or cardiac suppression. VR, by immersing patients in a calming virtual environment, has shown potential in reducing pain and anxiety in medical settings. This study aims to evaluate its application in improving pain management and reducing sedation use during ESD.

This study utilizes a prospective randomized controlled trial (RCT) design to evaluate the feasibility of incorporating Virtual Reality (VR) as a method for pain management during Endoscopic Submucosal Dissection (ESD). Participants will be randomized into two groups: one receiving VR sedation with on-demand analgesia and sedation, and the other following standard sedation protocols. The primary endpoint is to assess the feasibility of integrating VR for pain management during ESD procedures.

Eligibility criteria ensure that participants are suitable for the study. Patients must be 18 years or older, scheduled for ESD, able to provide informed consent, and proficient in English. Those with contraindications for ESD, severe impairments affecting VR use, or conditions contraindicating VR are excluded. Endoscopists must be experienced in ESD, willing to participate, and fluent in English, with non-ESD practitioners or those unwilling to participate excluded.

The study aims to enroll 40 patients (20 per group) and involve five experienced endoscopists from the unit, all of whom will be consented. Secondary endpoints include the proportion of ESD procedures completed using VR, reductions in sedation and analgesia usage, differences in pain scores between the two groups, and satisfaction levels of both patients and endoscopists.

Follow-up will consist of immediate post-procedure feedback and questionnaires to gather insights on VR's impact. This trial will provide critical data on the potential for VR to enhance patient experience, optimize sedation use, and improve procedural outcomes during ESD, informing future research and clinical applications.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Able to consent.
* Fit to use virtual reality.
* Patients allocated to appropriate ESD lists.

Exclusion Criteria:

* Patients who are unable to consent.
* Contraindication to use VR including, epilepsy and photosensitivity.
* Planned other interventional colonoscopy (EMR, Polypectomy, Stenting).
* Visually impaired.
* Pregnancy.
CALERIE (Washington University): Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy

This study is one of three CALERIE trials that test the hypothesis that a reduced calorie, nutritionally sound diet increases the length of life and prevents some age-related chronic diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are participating in the CALERIE trial represent a diversity of subject populations and interventional strategies.

Animal studies suggest that caloric restriction (CR), or consuming fewer calories, increases life span, and also protects against some aging-related disease processes such as artherosclerosis and type II diabetes. However, it appears that simply burning more calories through physical activity does not increase life span by itself. It is not known how CR affects humans, but based on this evidence it appears that the reduced total intake and metabolism of food is the main factor, rather than increased exercise alone.

To test this, volunteers will be placed on a program of either 20% caloric restriction or 20% increase of energy expenditure by exercise, or in a control group to be instructed in healthy living. All will be evaluated on a number of potential markers of aging, on body composition, and on risk factors for artherosclerosis and diabetes.

Participation in the study will last for 12 months. The Diet group will receive individual instruction from a registered dietician. The Exercise group will be given an individualized exercise program created by a personal trainer. The Healthy Lifestyle group will be given information on how to make healthier choices; both diet and activity will be discussed. All participants will be measured every two weeks, and will keep daily food and activity logs. All will be seen by a physician and will have lab tests done before beginning the study, at 1 month, and then 3 month intervals.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 to 60
* Women must be post-menopausal
* Normal weight to moderately overweight, (Body Mass Index \[BMI\] between 23 - 30)
* In good health, free of major chronic diseases or conditions
* Well motivated
* Reliable

Exclusion Criteria:

* Major chronic disease or condition that would interfere with exercise or caloric restriction (such as diabetes, coronary artery disease, significant obstructive airway disease, stroke, resting blood pressure over 170 mmHg systolic and/or 100 mmHg diastolic, history or evidence of malignancy, orthopedic or musculoskeletal problems)
* Hormone replacement therapy (DHEA, estrogen, thyroid, testosterone)
* Regular exercise twice or more per week
* Smoking
* Alcoholism
* Frequent travel
Beijing Protocol in Patients Receiving More Than 5/10 HLA-mismatched Allo-HSCT

The aim of the study is to evaluate the efficacy and safety of Beijing protocol in malignant haematologic disease patients receiving more than 5/10 HLA-mismatched allo-HSCT.

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative procedure for patients with hematological malignancies.Donor-recipient human leukocyte antigen (HLA) compatibility plays a key role in successful allo-HSCT as HLA-matching has a direct impact on the risk of GvHD, non-relapse mortality (NRM), and survival. Suitable, matched or haploidentical donors are not always available or accessible, even in the era of the international registries.Therefore, there is a need for new strategies that could negate the barrier of HLA-mismatching, allowing allo-HSCT from traditionally prohibitive highly mismatched donors.The aim of the study is to evaluate the efficacy and safety of Beijing protocol in malignant haematologic disease patients receiving more than 5/10 HLA-mismatched allo-HSCT.

Eligibility Criteria:
Inclusion Criteria:

* hematologic malignancy patients
* patients eligible for the transplantation of allogeneic hematopoietic stem cells;
* patients unavailable with HLA matched donor or related haploidentical donor
* voluntary participation in this study and signing the informed consent form.

Exclusion Criteria:

* Patients with the severe infections;
* Pregnant or lactating women
* Patients who are not eligible for hematopoietic stem cell transplantation;
* Patients who are enrolled in other clinical trials within 1 month;
* Patients who may not be able to complete the study for other reasons, or may be considered by the investigator not suitable to participate in the study;
* Patients unable to properly understand or refusing to accept the informed consent form.
Role of IV Calcium to Prevent Diltiazem-related Hypotension

The objective of this study is to examine the efficacy and safety of IV calcium pretreatment at varying doses prior to weight-adjusted IV Diltiazem on the incidence of Diltiazem-related hypotension in adult patients presenting to the Emergency Department due to Atrial Fibrillation with Rapid Ventricular Response. Specifically, we tested the hypothesis that patients with Atrial Fibrillation who receive IV calcium pretreatment prior to IV Diltiazem suffer less hypotension than those receiving Diltiazem monotherapy.

Patients were randomly divided into one of three groups. We assessed the Systolic Blood Pressure and Heart Rate of participants before treatment and 5, 10, and 15 min after treatment among the patient groups. Successful rhythm control was defined as achieving an HR of \&lt;100 bpm, a reduction in HR by \&gt;20% compared to baseline, or the restoration of normal sinus rhythm (NSR). If adequate rhythm control was not achieved within 15 min of the initial treatment, we administered 0.35 mg/kg of IV diltiazem slowly over 2 minutes as a rescue treatment. The need for rescue treatment or any intervention for hypotension, as well as any adverse effects, were recorded in a prepared data form. Also, patient demographics (age and sex), new onset versus chronic AFib/AFL, relevant medical history, vital signs on admission (SBP and HR), complaints and symptoms on admission, and laboratory parameters were documented in a prepared data form.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years
* Patients with documented AFib/AFL (confirmed by ECG)
* Patients with a Heart Rate of ≥ 120 bpm, and a Systolic Blood Pressure of ≥ 90 mmHg

Exclusion Criteria:

* Patients under 18 years of age
* pregnant individuals
* Patients with hemodynamic instability requiring electrocardioversion
* Patients with a documented history of sick sinus syndrome, third-degree AV block, Wolff-Parkinson-White syndrome
* Patients with hypotension (SBP \&lt;90 mmHg)
* Patients with known or suspected hypercalcemia
* Patients with a confirmed allergy to diltiazem
* Patients with concurrent use of another Heart Rate control agent (such as beta-blockers, amiodarone, or digoxin) on the same admission
Analysis of Peripheral Serotonin Levels in a Control Cohort

The goal of this observational study is to measure serotonin levels in in a control cohort.

The main question aims to determine the mean serum serotonin level in a cohort of adult controls, based on age and sex.

This will allow for the establishment of reference values. We will also measure the different metabolites of tryptophan. These measurements will be performed on residual blood samples in the laboratory, after blood collection carried out as part of routine care. Thus, patients will not need to undergo an additional blood draw.

Serotonin (5-HT or 5-hydroxytryptamine) is a monoamine primarily recognized for its role as a neurotransmitter in the central nervous system (CNS). It is synthesized from tryptophan, which is also essential for the production of metabolites in the kynurenine and indole families.

However, serotonin's functions extend beyond the CNS: various peripheral tissues have the capacity to produce and/or utilize serotonin locally, forming systems referred to as "micro-serotonergic." Among serotonin's peripheral roles, it has been demonstrated to positively influence erythropoiesis and red blood cell survival, iron metabolism, skin pigmentation, as well as placental and embryonic development during pregnancy.

In humans, there is no established standard for blood serotonin levels. It is known that, aside from major events, an individual's serotonin levels remain stable throughout life, but it is likely that blood serotonin levels depend on age and sex.

We aim to establish a cohort of adult control patients, for whom we will measure serum serotonin and the different metabolites of tryptophan, to analyze whether serotonin varies according to sex and age, and to determine its average serum levels.

Preliminary data from the laboratory suggest a role for serotonin in iron metabolism. Therefore, as a secondary objective, we also intend to perform an iron status assessment in control patients to analyze whether there are variations in iron parameters based on serotonin levels.

This cohort could also serve as a comparison point for future studies of serum serotonin levels in pathological conditions or during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged ≥ 18 years
* Who have undergone a blood draw at CHSF during the recruitment period
* With hemoglobin, white blood cell, and platelet counts within the laboratory's normal ranges
* With a C-reactive protein (CRP) level \< 30 mg/L

Exclusion Criteria:

* Patients informed about the study who decline participation
* Patients with a current diagnosis or history of psychiatric disorders
* Patients on antidepressants or narcotics at the time of sampling