cyrilzakka/clinical-trials huggingface dataset:
68Ga PSMA PET Imaging for the Treatment of Advanced Liver Cancer

This phase II trial tests whether 68-Gallium prostate specific membrane antigen (68Ga-PSMA) positron emission tomography (PET) imaging can improve the diagnosis and management of liver cancer that has spread to other parts of the body (advanced). PSMA is a protein that appears in large amounts on the surface of liver cancer cells. The radioactive chemical compound (68Ga-PSMA) has been designed to circulate through the body and attach itself to the PSMA protein on liver cancer cells. A PET scan is then used to detect the location of the tumor cells. 68Ga-PSMA PET may improve upon the diagnosis and management of liver cancer.

PRIMARY OBJECTIVES:

I. To test the performance of novel biomarkers derived from PSMA PET/computed tomography (CT) to measure response compared to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, in advanced hepatocellular carcinoma (HCC) patients treated with immunotherapy.

II. To identify precision imaging biomarkers that can predict response of HCC to novel immunotherapy.

OUTLINE:

Patients undergo 68GA PSMA PET/CT scans at baseline, and after 3, 6, 9, and 12 cycles of standard of care immunotherapy in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed-up every 6 months for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Patient with pathologically confirmed HCC not amenable to curative resection, transplantation or ablative therapies
* Have radiographically measurable disease by RECIST
* Eligible for atezolizumab/bevacizumab front line therapy
* Male or female with age greater than 18 years, with the capacity and willingness to provide written informed consent

Exclusion Criteria:

* Pregnant and/or breast-feeding patients. A negative pregnancy test within 48 hours of the PET scan
* Patients with higher than the weight/size limitations of PET/CT scanner
Developing an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy

The purpose of the proposed research is to test and validate a Risk Map decision-support system (DSS) for prostate cancer Magnetic Resonance Imaging (MRI) interpretation and identification of clinically significant tumor site(s).


Eligibility Criteria:
Inclusion Criteria:

* Patients with known or suspected prostate cancer who have been referred to the Department of Radiology at the University of Chicago Medical Center for a diagnostic MRI exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate.
* Written informed consent.

Exclusion Criteria:

* Patients incapable of giving informed written consent;
* Patients who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher;
* Patients with psychiatric disorders that affect their ability to consent for themselves will be excluded and not the entire population of patients with psychiatric disorders.
* Prisoners;
* Minor children (under the age of 18 years old).
Mobile-based Lifestyle Intervention in Women With Glucose Intolerance After Gestational Diabetes

Although lifestyle modification programs have been shown to be effective in preventing diabetes in older populations, interventions in women with recent gestational diabetes (GDM) clearly need to be adapted to address their unique barriers to behavior change in order to optimize adherence. The low participating rates in many studies using individual or group sessions, reflect how difficult it is to engage women in the first years postpartum. Since women with glucose intolerance (prediabetes) have the highest risk to develop type 2 diabetes (T2DM), we designed the MELINDA pilot study, a randomized controlled trial with 1 year of follow-up to evaluate the efficacy and feasibility of a telephone -and mobile (app) based lifestyle coaching intervention in women with glucose intolerance after a recent history of GDM to promote a healthy lifestyle.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 or older
* GDM based on the 2013 WHO criteria
* glucose intolerance (prediabetes based on the ADA criteria) based on the 75g OGTT 6-16 weeks after delivery

Exclusion Criteria:

* diabetes;
* current use of metformin;
* normal glucose tolerance (ADA criteria);
* health limitations or treatments which would restrict the participation in the intervention trial.
* Has no smartphone
Influence of Glucose on Metabolism and Clinical Symptoms of Patients With Parkinson's Disease

Many patients with Parkinson's Disease (PD) report an increased consumption of fast-acting sugars. This tendency to consume sweet, high-sugar foods occurs in some patients even before the onset of cardinal motor symptoms. Some recent studies have demonstrated that PD patients have an increased consumption of fast-acting carbohydrates compared to healthy controls. However, the reason for this change in eating behavior has not yet been adequately explained. It is discussed that the increased sugar intake leads to an increased dopamine release in the brain via an increase in insulin and thus to an improvement in clinical symptoms. This study investigates the influence of fast-acting carbohydrates on insulin and glucose blood levels as well as motor and non-motor symptoms in patients with PD using an oral glucose tolerance test and a placebo oral glucose tolerance test in a crossover design.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's Disease, stage Hoehn \& Yahr 1.5-3
* Ability to pause antiparkinsonian medication in the morning without relevant impairment
* Capacity to give consent (determined in doubt by two independent neurologists, MOCA ≥18) and written informed consent.
* Patients are between 50 and 80 years of age, with exceptions for a maximum of 5 additional patients enrolled per group
* For stratification into patients with and without sweet craving, a 3-day dietary protocol should be completed once by the patients
* Group I: increased hunger for sweets.
* Group II: no increased hunger for sweets.

For the stratification into patients with and without increased hunger for sweets, participants are asked to answer the following questions:

1. Do you have sudden attacks of cravings for sweets?
2. Would you say that your consumption of sweet food has increased in recent years?
3. Would you describe your consumption of sugary food as increased or excessive?

If one of the questions is answered with yes, participants will be assigned to group I, if all questions are answered with no, participants will be assigned to group II.

Exclusion Criteria:

* Other significant neurological diseases primarily affecting the central nervous system (e.g., multiple sclerosis)
* Diagnosis of diabetes mellitus or prediabetes
* Use of medications that affect glucose metabolism, such as antidiabetics, glucocorticoids, ciclosporin, tacrolimus, sirolimus, beta-blockers, thiazide diuretics, beta-2 adrenoreceptor agonists, theophylline, Clozapine, olanzapine, paliperidone, quetiapine, risperidone, tricyclic antidepressants, mirtazapine, mianserin, carbamazepine, gabapentin, pregabalin, valproic acid, lithium, antiretroviral drugs, statins
* cardiac or brain pacemakers
Safety, Effectiveness, and Impact on Quality of Life on Long-Term Administration of OROS Hydromorphone Slow-Release in Patients With Chronic Low Back Pain

The purpose of this open-label, extension study is to characterize the safety, effectiveness, and impact on quality of life measures of long-term repeated dosing of OROS hydromorphone slow release (8, 16, 32 and 64 mg tablets) in patients with chronic low back pain.

This open label, extension study characterized the safety, effectiveness, and impact on quality of life of OROS hydromorphone slow release with long-term repeated dosing among patients with chronic low back pain, who previously completed short-term Study DO-127 with OROS hydromorphone slow release. Up to 150 patients were to be enrolled and evaluated. Patients were enrolled in this study immediately following Study DO-127. Patients continued their therapy with OROS hydromorphone slow release at the stable dose previously identified in the short-term study. The patient's initial prescribed dose of OROS hydromorphone slow release in Study DO-127X was the same as the last dose of OROS hydromorphone slow release in Study DO-127. Patients returned monthly for evaluations during this extension interval. Adjustments to dose were performed as needed, at the Investigator's discretion. The duration of this study was six months. Safety assessments included vital signs and physical examination at start, during and end of study. 8, 16, 32 and 64 mg tablets of OROS hydromorphone (dose will be at Investigators' discretion) slow release tablets were taken orally daily for the duration of the six month study

Eligibility Criteria:
Inclusion Criteria:

* Patients who have chronic low back pain who have successfully completed short-term Study DO-127 with OROS hydromorphone slow release
* Patients who require at least 8 mg of hydromorphone HCI (slow release) every 24 hours for the management of chronic low back pain
* Patients whose opioid requirements have been stable as demonstrated in short-term Study DO-127 with OROS hydromorphone slow release

Exclusion Criteria:

* Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists)
* Patients who are pregnant or breast-feeding
* Patients with any gastrointestinal disorder, including pre-existing severe GI narrowing (pathologic or iatrogenic) that may affect the absorption or transit of orally administered drugs
* Patients with significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, disorders of cognition, any clinically significant impaired renal or hepatic function, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture
* Patients who may be at risk for serious decreases in blood pressure upon taking an opioid analgesic
Synergizing Home Health Rehabilitation Therapy

The objective of this project is to pilot test an ADL (activities of daily living)-enhanced program as an adjuvant therapy to usual home health rehabilitation to improve patient outcomes. The project will compare the ADL-enhanced program plus usual care with usual care using an RCT design in home health patients.

Regaining the ability to take care of oneself after an illness or medical episode is critical for home health patients to maintain independent living at home. An ADL-enhanced program may augment the effect of home health rehabilitation therapy to support patients' self-care outcomes. Patients will be randomly assigned to two groups: one will receive the ADL-enhanced program with usual home health care, and the other will receive usual home health care. Researchers will compare outcomes in self-care activities and physical performance between the two groups to determine the effect of the ADL-enhanced program.

Eligibility Criteria:
Patients are eligible if they

* are 65 years of age over older
* are Medicare beneficiaries
* are referred for skilled rehabilitation services at the partnered home health agency
* have three or more comorbidities

Patients are ineligible if they have

* acute fractures with surgical or weight-bearing restrictions,
* elective joint replacement surgery
* lower-extremity amputation
* active treatment for cancer diagnosis
* ongoing dialysis treatment
* acute cardiac surgery,
* acute stroke or a major neurologic disorder limiting motor movements
* terminal stage of congestive heart failure
* a referral to hospice care
* severe cognitive deficits limiting verbal communication.
Austria Study - Analysis of Difference Between Active and Passive Fixation Leads

In this study the difference between screw in leads actively fixed in the septum and tined leads passively fixed in the apex concerning electrical parameters and implantation time will be evaluated. In addition the influence of the stimulation location by type of lead on QRS width, ejection fraction and NYHA class will be evaluated using and electrocardiogram and echocardiogram.


Eligibility Criteria:
Inclusion Criteria:

Age \< 18 years, indication for pacemaker implantation according to current guidelines, written consent of the patient

Exclusion Criteria:

Live expectancy \< 6 months, pregnancy or women without contraception in birth bearing age, inability or refusal to sign consent form, simultaneous participation in another clinical trial, contraindication for any procedure required during pacemaker implantation, patients who need other pacemaker systems including pacing leads than those required by the protocol, heart failure (LVEF \<35%, QRS-Width\>150ms), functional (rate dependent) bundle branch bloc
Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery

A randomized, controlled, double-blinded clinical trial evaluating the effect of the administration of a Maltodextrin solution on cardiac function in patients presenting for coronary artery bypass grafting surgery with a reduced left ventricular ejection fraction.

This randomized, double-blinded clinical trial will test the primary hypothesis that patients receiving preoperative maltodextrin will have an improved intraoperative left ventricular ejection fraction (LVEF), as measured by three-dimensional echocardiography, compared to patients who receive a placebo drink. Seventy patients will be recruited and randomized to each group in a 1:1 ratio.

The second hypothesis is that administering preoperative Maltodextrin to cardiac surgery patients enhances the quality of recovery, as measured by the Quality of Recovery-15 score. Each patient will undergo this questionnaire 48 hours after surgery.

The third hypothesis is that Maltodextrin improves cardiac function by its effect on myocardial glycogen content. This will be evaluated in two ways. First, a separate group of 20 patients will undergo the hyperinsulinemic-normoglycemic clamp (HNC) to have a high-insulin level during surgery with these patients randomized to Maltodextrin or placebo. In addition, 20 patients from the main study will undergo myocardial biopsies to assess the glycogen content in the Maltodextrin and the placebo groups.

Pre-defined subgroups:

* Need for vasopressors or inotropes during measures of cardiac function vs no need
* Male versus female
* Diabetic versus non-diabetic
* Sarcopenic versus non-sarcopenic
* Malnourished versus non-malnourished

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Presenting for coronary artery bypass grafting surgery
* Preoperative left ventricular ejection fraction \< 50%
* First case of the day (7:30am start time)

Exclusion Criteria:

* Dysphagia, gastroparesis
* Cannot tolerate oral intake
* Celiac disease
* Type 1 diabetes
Pharmacokinetics of Advantage Arrest

The study aim is to characterize the kinetics of silver and fluoride after topical application of silver diamine fluoride.

The purpose of this study is to characterize basic PK parameters (Cmax, t1/2, AUC, and total urinary recovery) to contribute to evidence for the safety of Advantage Arrest, consistent with Guidance for Industry--Exposure--Response Relationships (April 2003).

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older, minimum 20 teeth, healthy, not taking prescription or OTC medications

Exclusion Criteria:

* pregnant, weighed less than 50 kg, had oral mucositis or ulcerative lesions, known sensitivity to silver or fluoride
Axial Length and Central Corneal Thickness in Benign Intracranial Hypertension

Patients in for treatment of benign intracranial hypertension will undergo two tests that are not routinely performed for these patients: central corneal thickness and axial length of the eye. The data obtained from these measurements will be assessed to see if the correlate with aspects of vision loss including visual acuity, visual field status, optical coherence tomography (OCT) results, and fundus photographs.

Patients with benign intracranial hypertension would be identified at diagnosis from the general ophthalmic and neurologic patient population in the Ochsner Health System. All would have a baseline eye examination with visual field and optical coherence tomography (OCT) testing, a standard step in managing any patient with this condition. Two measurements would be taken at minimal risk to the patient that they would not normally have done at the baseline exam: central corneal thickness and axial length. These procedures are routinely done on patients with glaucoma, corneal disease, and cataracts without a significant risk of injury. The theoretical risks with central corneal thickness and axial length measurements by A-scan ultrasonography are related to the small risk for transmission of infection or corneal abrasion due to a probe touching the cornea. These tests would be performed at no charge to the patient and would not significantly increase the time of the ocular examination. Patients would have neuro-imaging studies and lumbar puncture to confirm the diagnosis of benign intracranial hypertension as standard parts of the work up for the condition independent of the research study. The authors will statistically analyze the standard measures of visual field function and health of the nerve fiber layer by OCT to see if any or all of the proposed risk factors correlates with deterioration of visual function. Data would continue to be collected at follow up visits related to visual fields and OCT as would normally be performed on standard visits for this condition. The measurements of central corneal thickness and axial length would be performed solely at the time of enrollment in the study since these measurements do not change over time.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have benign intracranial hypertension.

Exclusion Criteria:

* None
Real-world Study on the Effectiveness and Safety of Control-IQ Technology in Teenagers with Type 1 Diabetes Engaging in Regular Physical Activity

We hypothesize that the use of the Control-IQ system positively influences glycemic control in teenagers with type 1 diabetes during physical activity. To test this hypothesis, we will evaluate the glucose profiles (based on CGM metrics) of adolescents engaging in different types, intensities, and durations of physical activity over a 14-day period, in real-life conditions. We will compare glucose control on exercise days with that on sedentary days.

As a secondary objective, we will investigate the influence of factors such as anthropometric characteristics, type and duration of exercise, the use of the exercise mode and other management strategies used for physical activity, on glycemic outcomes.

Regarding the safety, we will report any episodes of severe hypoglycemia or diabetic ketoacidosis (DKA).

This is an observational, open-label, non-randomized, real-world study. Each participant will be provided with a diary to record detailed information about physical activity sessions over a 14-day period, including type, intensity, and duration of exercise, and timing and composition of pre-exercise meals. Clear instructions on how to complete the diary will be provided.

CGM metrics will be analyzed throughout the 14-day observation period, including time in range, time in tight range, time above range, time below range, mean glucose level, and coefficient of variation. A daily comparison will be performed between metrics recorded on days of physical activity and sedentary days, assessing the entire day as well as daytime (07:00-23:00) and nighttime (23:00-07:00) periods.

The influence of factors such as anthropometrics, type of physical activity, the use of the exercise mode and other specific management strategies, type and duration of exercise, and pre-exercise meals on CGM metrics will be evaluated.

The frequency of severe hypoglycemia and DKA episodes, as defined by international guidelines, will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 diabetes according to International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines
* Duration of diabetes \> 12 months
* Age \< 20 years
* Pubertal development completed according to the Tanner stage
* Use of Control-IQ technology for at least 3 months
* Automatic mode use for at least 70% of the time during the 2 weeks preceding enrollment
* CGM use for at least 70% of the time during the 2 weeks preceding enrollment
* Regular physical activity (at least 2 sessions per week, each lasting at least 45 minutes)

Exclusion Criteria:

* Uncontrolled celiac disease or thyroid disease
* Presence of other chronic illnesses
* Psychiatric or neurological conditions, including eating disorders, that may interfere with the study
* Chronic use of medications (other than insulin) that may affect glucose control
* Chronic use of substances or drugs that could impact CGM accuracy
Open Label Study, Assessing the Effect of Diltiazem or Ketoconazole on the Pharmacokinetics of AZD9742 in Healthy Volunteers

The aim of this study is to examine the effect of coadministration of CYP3A4 inhibitors on the pharmacokinetics of AZD9742.


Eligibility Criteria:
Inclusion Criteria:

* non-childbearing potential, with suitable veins for cannulation or repeated venipuncture
* Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at screening.
* Male volunteers should be willing to use barrier contraception, ie, condoms, from the day of dosing until 3 months after dosing with the investigational product.

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
* History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product