cyrilzakka/clinical-trials huggingface dataset:
68Ga-FAPI-RGD PET/CT Imaging in the Lung Cancer Patients

Based on the high expression of specific receptors on the surface of diseased tissues and neovascularization, noninvasive targeted molecular imaging can be used to visualize lesions in vitro by combining specific ligands labeled with short half-life isotopes. Lung cancer tissues express fibroblast activating protein FAP, and also have high expression of integrin αVβ3 receptor on the surface of blood vessels. In this study, a novel dual-target imaging agent 68Ga-FAPI-RGD was used for PET/CT imaging of lung cancer.

Conventional 18F-FDG PET/CT has important diagnostic value in cell metabolism level, early metastasis, judging malignant potential and prognosis of tumors. It has been routinely used for staging and restaging of most tumors, but there are still some tumors with low uptake of 18F-FDG PET/CT. Moreover, 18F-FDG cannot distinguish between tumors and inflammatory diseases, such as tuberculosis and granuloma. Receptor imaging with a single target also has some limitations in clinical application. For example, not all diseased cells express a large amount of single receptor on the surface, which greatly affects the judgment of the nature of the lesion. The dual-target molecular imaging based on FAP expressed in the lesion site and integrin αvβ3 receptor highly expressed on the surface of the lesion neovascularization will overcome the above limitations and make full use of the advantages of the dual-target molecular imaging, which will greatly assist the diagnosis of malignant tumors such as lung cancer. In this study, a novel dual-target imaging agent 68Ga-FAPI-RGD was used for PET/CT imaging of lung cancer, compared with conventional 18F-FDG, or single target imaging agent 68Ga-RGD or 68Ga-FAPI PET/CT imaging.

Eligibility Criteria:
Inclusion Criteria:

* patients with confirmed or suspected lung cancer;
* 68Ga-FAPI-RGD and 18F-FDG(or 68Ga-FAPI or 68Ga-RGD) PET/CT within 2 week;
* signed written consent.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Effects of Dual-Task Training in People With Multiple Sclerosis

The purpose of this study is to investigate the effects of dual task training on balance, gait, dual-task performance, cognitive function, fatigue and functional mobility in people with Multiple Sclerosis(MS).

Eligible participants will be randomized to dual-task group or control group. Dual-task group will receive 8 weeks of dual-task training twice a week and home exercise program. Control group will receive only home exercise program for 8 weeks. Each participant will be assessed before and after the 8 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Having a definitive diagnosis of MS according to the revised McDonald criteria
* Having Expanded Disability Status Scale score between 0-5.5
* No relapse in the last 30 days
* Having a Mini Mental Test score of 24 and above
* Being fluent in Turkish language
* No condition that prevents exercising

Exclusion Criteria:

* Being pregnant
* Presence of a neuro-musculoskeletal disease other than Multiple Sclerosis
* Having received physiotherapy for balance and gait disorders in the last 3 months
Alcohol & Exercise Study

The goal of this clinical trial is to learn if exercise can reduce alcohol craving in heavy social alcohol drinkers. The main questions this project aims to answer are 1) compared to a distraction activity (i.e., coloring), will mild-to-moderate intensity exercise (i.e., walking on a treadmill) reduce alcohol craving; 2) compared to a distraction, will mild-to-moderate intensity exercise reduce the amount of consumption of an alcohol-placebo beverage.

Upon arriving to the study, participants will complete baseline measures assessing for the inclusion and exclusion criteria, as well as baseline alcohol craving and subjective response measures. Participants will then be randomly assigned into the active treatment (exercise) or distraction (coloring) condition. After randomization, participants will consume a low-dose alcohol beverage (BAC=0.03g/dL; equivalent to approximately 1 standard alcohol beverage) within five minutes to induce active alcohol craving. 15 minutes post-beverage consumption, participants will complete the alcohol craving and subjective response measures. At 20 minutes post-beverage consumption, participants will begin their randomly assigned 20-minute activity (exercise or coloring). At approximately 12 minutes into the activity (32 minutes post beverage consumption) and immediately after the activity (44 minutes post beverage consumption), the participants will complete the alcohol craving and subjective response measures. Participants will then be given a tray of three 8oz. cups of water and 3 8oz. cups of an alcohol-placebo beverage and will be allowed to drink as much or as little of the beverages as they would like.

Eligibility Criteria:
Inclusion Criteria:

* Heavy social alcohol drinkers (i.e., alcohol drinkers who consume 10-40 standard alcohol beverages per week and participate in 1-5 binge drinking episodes \[consume 4+/5+ drinks in a sitting for women/men, respectively\]) per week.

Exclusion Criteria:

* Meets DSM-5 diagnostic criteria for a current moderate or severe alcohol use disorder
* Meets DSM-5 diagnostic criteria for a current Moderate or Severe cannabis use disorder
* Endorses daily smoking of tobacco
* Endorses having a current DSM-5 psychiatric disorder
* Endorses having any medical conditions that may interfere with the exercise condition (e.g., knee-replacement, sprained ankle, etc.)
* Has a current level of physical activity that exceeds 20 minutes of moderate-to-vigorous physical activity per day
* Endorses illicit substance use (i.e., use of illicit substances x\&gt;2 times in the past year)
* Has self-reported allergies to pineapple juice, cranberry juice, orange juice, \&amp;/or tonic water
* Individuals not proficient in reading, writing, or speaking in English
* Women who are trying to conceive or who are pregnant
* Women who are currently breastfeeding
Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)

The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).

Study KTE-C19-102 enrolled participants with r/r MCL who have been treated with up to 5 prior regimens including a Bruton's tyrosine kinase inhibitor (BTKi) in Cohort 1 and Cohort 2. However, to fulfill FDA Postmarketing Requirement, Cohort 3 is added to the study. It will include participants with r/r MCL who have been treated with up to 5 prior regimens but have not received prior therapy with a BTKi.

The primary analysis in Cohort 1 and Cohort 2 is already completed. Data for Cohort 3 will be analyzed separately. Therefore, details for Cohort 3 were registered separately (NCT04880434) on ClinicalTrials.gov as this cohort will not be part of the main study analysis.

After the end of KTE-C19-102, subjects who received an infusion of anti-CD19 CAR T cells will complete the remainder of the 15-year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968

Eligibility Criteria:
Key Inclusion Criteria:

Up to 5 prior regimens for Mantle cell lymphoma. Prior therapy must have included:

* Anthracycline or bendamustine-containing chemotherapy and
* Anti-CD20 monoclonal antibody therapy and
* Ibrutinib or acalabrutinib

At least 1 measurable lesion

Platelet count ≥ 75,000/uL

Creatinine clearance (as estimated by Cockcroft Gault) \> or = to 60 mL/min

Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings

Baseline oxygen saturation \>92% on room air.

Key Exclusion Criteria:

* Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per standard serological and genetic testing
* History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with central nervous system (CNS) involvement
* Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Functional Restoration After Abdominal and Pelvic Laparoscopic Surgery: Effect of Perioperative Intravenous Lidocaine

This is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether perioperative intravenous lidocaine has an impact on the early post operative physical activity recovery of patients scheduled for laparoscopic colon surgery.

Twenty patients will receive thoracic epidural analgesia, twenty patients will receive intravenous lidocaine plus patient-controlled analgesia (PCA) and twenty patients will receive only PCA.

Hypothesis: patients receiving perioperative intravenous lidocaine, post operative recovery will be faster and decrease pain intensity, opioid consumption and side effects, length of hospital stay; probably as a result of a significant opioid sparing and attenuated inflammatory response.

This is a blinded randomised study of patients undergoing major laparoscopic abdominal and pelvic surgery. The first group of patients will receive thoracic epidural analgesia, the second group will receive perioperative intravenous lidocaine, the third group will PCA alone and the last group will receive spinal analgesia. Functional restoration assessed by self-administered quality of Life questionnaires (SF-36, CHAMPS, ICFS) and 2 and 6 min walking test will be assessed in the two groups at 3 and 8 weeks after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to undergo laparoscopic colonic resection

Exclusion Criteria:

* patients who have trouble to understand, read or communicate either in French or in English
* dementia
* patients suffering from severe physical disability (arthritis, neuromuscular dysfunction, stroke, paraplegia) or inability to walk or conduct daily activity
* patients suffering from severe cardiac or respiratory disease (status ASA IV)
* patients suffering from metastatic carcinoma
* patients who have a history of chemoradiation within the six months preceding surgery
* allergy to lidocaine
* morbid obesity
The Effect of the Nutraceutical "Hemofix" on the Coagulation System

Hemofix is a herbal formula based on traditional Jewish and far eastern medicine created to assist in wound healing and bleeding arrest. It contains herbs such as Red Clover, Liquorice, Raspberry, Ginger and more. The present study will evaluate the formula on the coagulation system.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers and volunteers with a mild bleeding disorder

Exclusion Criteria:

* people with thrombophilic and cardiovascular complications,
* people who are treated with anti-coagulants,
* women taking birth control pills
* people with a history hypercoagulability
Quality of Life of Elderly Patients and Burnout Among Their Care Givers

Older people with multimorbidity are frequent users of health care services, and there is a relationship between the number of chronic conditions and health care costs. In addition, multimorbidity increases the risk of mortality and functional decline, and this negatively impacts health-related quality of life

. Furthermore, research tends to focus on individual organ systems, often ignoring the complexity of care for older people with multimorbidity. Moreover, patient QoL is a meaningful measure in the evaluation of health care services and patient-reported outcome Caregiving demands significantly reduce caregivers' opportunities to have a lifestyle in which leisure or time for themselves is available. According to different empirically supported theoretical frameworks that point to the importance for caregivers of experiencing pleasant events and receiving positive reinforcement in their daily lives in order to maintain a positive mood, not engaging in personally satisfying activities may result in more social withdrawal and depression, putting caregivers at risk of developing emotional disorders.

As the percentage of elderly cardiac population is growing and most of them have multimorbid conditions, we should find ways to improve their of life and to avoid their caregivers being burned out.

Asses quality of life of cardiac elderly patients with multimorbidity and to investigate the prevalence of burnout among their caregivers This study of multimorbidity among elderly cardiac patients attending Sohag university cardiac outpatient clinic and burnout among their care givers aims to:-

1. Study the effect of multimorbidity on health related quality of life of elderly cardiac patients.
2. Study determinants of health related quality of life among elderly cardiac patients with multimorbidity.
3. Study burnout prevalence among care givers

Eligibility Criteria:
Inclusion Criteria:

* elderly patients (60 years and over) \[2\] with multimorbid conditions and a cardiovascular disease is one of them .

caregivers of elderly patients included in the study.

Exclusion Criteria:

* patients and caregivers who will refuse to participate in this study and patients with disturbed conscious level and mentally disabled.
Randomized Controlled Trial Comparing Irrisept Versus Normal Saline for Wound Irrigation After Posterior Spine Surgery

To compare post-operative wound complications in patients randomized to normal saline versus Irrisept solution and any other adverse reactions from the solution.

Wound complications represent a significant risk factor in spinal surgery, particularly in complex multilevel procedures. Surgical site infections (SSI) are the most common health care-associated infection, accounting for 31% of all hospitalized patients with a health care-associated infection. The reported incidence of SSIs following spine surgery ranges from 0.2% to 18.8%. In one study, each episode of wound infection following spine procedure contributed to a mean increase in the cost of care by $4,067 compared to a non-complicated case. The bacteria can adhere to the implants and tissues to create biofilm made by polysaccharide matrix which makes it challenging to clear the infection. Different irrigation techniques and solutions have been utilized to help limit post-operative wound complications. No studies have compared Irrisept solution to normal saline to see if there is a difference in wound complications for posterior spine surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Presenting to the University of Missouri hospital system - including the University of Missouri Hospital and Missouri Orthopaedic Institute - with a need for isolated open posterior spine procedures using a posterior open approach.
* Failed conservative treatment - rest, anti-inflammatory medications, physical therapy
* \>18 years old and able to provide informed consent

Exclusion Criteria:

* Ongoing or suspected infection
* Revisions of failed back surgeries
* Documented allergy to CHG or CHG products
* Pregnancy - qualitative beta human chorionic gonadotropin (hCG) testing will be performed prior to enrollment
* Prisoners or wards of the state
* Unable to consent to research study
An Exploratory PET-study of Deposition, Disposition and Brain Uptake of [11C]Nicotine After Inhalation of 2 Nicotine Formulations Via the myBluTM E-cigarette in Smokers

This is a single-center, exploratory positron emission tomography (PET) study of deposition, disposition and brain uptake \[11C\]nicotine when given to smokers as two different formulations via mybluTM e-cigarette system.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index ≥18.0 and ≤ 30.0 kg/m2
* Habitual daily cigarette smoker
* Women have to be of non-child bearing potential

Exclusion Criteria:

* History of any clinically significant disease
* Relevant concomitant medication
* Any clinically significant condition
* Malignancy within the past 5 years
* Positif for HIV, hepatitis B or C
* Untreated hypertension
* Previous participation to a PET-study or other nuclide medical study
* Previous exposure to significant radiation
* Negative results of the modified Allen test on both arms at screening
* Alcohol or drug abuse
A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication

This study will evaluate how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication.

This is an 8-week, outpatient, multicenter, open-label, single-group, flexible-dose study.

Following a screening period of up to 21 days, eligible participants will take part in the study. In the 8-week treatment period, participants will be treated with SEP-363856 while continuing to take the full dose of their pre-switch antipsychotic. After the end of the treatment period, participants will be required to complete the follow-up visit, 7 days after the last dose of SEP-363856.

Eligibility Criteria:
Inclusion Criteria: This list is not all inclusive

* Participants meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a diagnosis of schizophrenia.
* Participants are judged to be clinically stable (ie, no evidence of an acute exacerbation of schizophrenia) by the Investigator for at least 8 weeks prior to Baseline.
* Participants must be judged by the Investigator to be an appropriate candidate for switching current antipsychotic medication due to safety or tolerability concerns and/or insufficient efficacy.
* Participants are taking an oral antipsychotic and the antipsychotic regimen has been stable for at least 6 weeks prior to Screening.

Exclusion Criteria:This list is not all inclusive

* Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than schizophrenia, that is the primary focus of treatment.
* Participants are at significant risk of harming self or others based on investigator's judgment.
* Participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the participant's ability to complete and/or participate in the study.
* Female participant who is pregnant or lactating.
* Participant tests positive for drugs of abuse at Screening.
The Effectiveness of High-flow Nasal Cannula After Extubation in Patients

Observe the current status of prolonged mechanical ventilation (PMV) patients using high-flow nasal cannula oxygen therapy (experimental group) or traditional oxygen therapy (control group) after extubation, and compare the differences in ventilator weaning rates between the two groups.

Record the ROX index (SpO2/FiO2/RR) at 2, 6, 12, and 24 hours after extubation in PMV patients and explore whether statistical methods can predict the weaning outcome within seven days.

Use statistical methods to analyze whether comorbidities in the PMV population affect ventilator weaning rates.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 20 years old and expected to undergo extubation.

Exclusion Criteria:

* Patients with tracheostomy who will use non-invasive or invasive ventilators immediately after extubation.
Smoking-Cessation and Stimulant Treatment (S-CAST)

The primary objective of this study is to evaluate the impact of substance-abuse treatment as usual plus smoking-cessation treatment (TAU+SCT), relative to substance-abuse treatment as usual (TAU), on drug-abuse outcomes. Specifically, this study will evaluate whether concurrent smoking-cessation treatment improves, worsens, or has no effect on stimulant-use outcomes in smokers who are in outpatient substance-abuse treatment for cocaine or methamphetamine dependence.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cocaine/methamphetamine dependence
* Smoked cigarettes for at least 3 months
* Currently smoking \> 6 cigarettes/day
* Have an interest in quitting smoking
* Enrolled in outpatient treatment at a participating site

Exclusion Criteria:

* Clinical diagnosis of current alcohol or sedative dependence, bipolar disorder; or a life-time diagnosis of anorexia nervosa or bulimia
* Seeking/receiving treatment for opiate-agonist replacement therapy
* Medical conditions that could compromise participant safety
* Taking medications with known/potential interactions with bupropion
* Hypersensitivity to bupropion, nicotine, or menthol
* Pregnant or breastfeeding
* Abnormal ECG
* Recent smoking cessation treatment
* Use of tobacco products other than cigarettes in the past week
* Likely to enter residential/inpatient treatment within 10 weeks
* Have all stimulant-positive urine drug screens during screening/baseline