cyrilzakka/clinical-trials huggingface dataset:
Host Response to Infection by Direct Analysis of Leukocyte Single Cell-type Gene Expression/transcript Abundance, Direct LS-TA

Febrile illness is a common condition, particularly among young patients and it is crucial to have an early triage of patients according to various aetiologies to enable appropriate treatment. Most diagnostic tests are targeted towards the detection of pathogens while other assays are mostly related to serum proteins. Blood cells transcriptome has been explored to differentiate bacterial and viral infections.

Here, we propose to develop a rapid test using the host responses in terms of gene expressions of single-cell populations of peripheral leukocytes (monocytes and granulocytes) to differentiate three major categories of infections that are bacterial, viral, and tuberculosis.

The assay is called Direct leukocyte single cell-type transcript abundance (TA) assay (DIRECT LS-TA) as it can directly determine the gene expression of a specified single cell-type (e.g. monocytes and granulocytes) among various leukocyte cell populations directly in a peripheral blood sample. Such results signify the nature of host response and can be used to indicate the type of infection (viral, bacterial or active tuberculosis).

DIRECT LS-TA is a ratio-based biomarker (RBB) for blood gene expression analysis which can be performed in commonly available equipments (e.g. qPCR or digital PCR machines). Using the ratio of TA of prior defined numerator gene and denominator gene, this RBB can quantify gene expression of the specified constitutional single cell-type (e.g. monocytes and granulocytes) inside a cell-mixture sample of Whole blood.

DIRECT LS-TA was a method pioneered by the PI \[Tang 2017, https://patents.google.com/patent/US9589099B2/\]. And it has been developed for quantification of early B cell response after vaccination \[DOI: 10.3390/genes12070971\].

Recently, the method is used to develop host response biomarkers after infection to differentiate the type of pathogens (such as viral, bacterial or active tuberculosis). Numerator and denominator genes have been identified by using public gene expression datasets for monocytes and granulocytes. Diagnostic performance was good using these public data.

Therefore, these RBBs will be applied in these retrospective samples to evaluate and compare their diagnostic (triage) performance of febrile patients into different pathogen etiologies.

Eligibility Criteria:
Inclusion Criteria:

* Bacterial infection sample: positive isolation of organism in blood culture (Bacterial infection sample group)
* Clinical diagnosed active TB (Tuberculosis infection group)

Exclusion Criteria:

* End stage renal failure
* Pregnancy
* Infections for which long term antibiotic treatment is strongly recommended (including infective endocarditis, osteoarticular infections, cerebral or hepatic or lung abscesses, tuberculosis or nontuberculous mycobacterial infections)
Repeated Sweet Consumption and Subsequent Sweet Food Preferences and Intake

This study will assess the impact of repeated sweet versus non-sweet food consumption on subsequent sweet and non-sweet food preferences and intakes

Participants will be randomized to receive instructions to either increase or decrease sweet food consumption for 6 days, and impacts on food preferences and intakes will be assessed at baseline and after 1 week. Preferences for sweet and non-sweet foods will be assessed during two taste tests at each assessment time, where six different foods will be rated. Sweet and non-sweet food consumption will also be measured at two meals at each assessment time - breakfast and lunch. Identical buffet meals composed of sweet and non-sweet foods suitable for consumption at breakfast and lunch will be provided ad-libitum.

Eligibility Criteria:
Inclusion Criteria:

* No known food allergy
* No known taste or appetite allergies
* Non-smokers
* Do not habitually consume exclusively / almost exclusively a sweet or non-sweet diet
* Able to provide consent and complete all study measures

Race / ethnicity will not be requested.
The Application Value of Prostate Specific Membrane Antigen PET/CT in Biopsy Free of PSA Grey Area Prostate Cancer

The goal of this observational study is to establish an evaluation system for accurate identification of prostate cancer and clinical significant prostate cancer in patients in the PSA gray zone. The main questions it aims to answer are: proportion of men who could have avoided biopsy with positive PSMA-PET and no clinically significant cancer detected on biopsy.

Participants will: 1. undergo PSMA PET/CT and multiparametric MRI; and 2. undergo prostate biopsy

Researchers will compare the diagnostic performance of PSMA PET/CT and multiparametric MRI for prostate cancer and clinical significant prostate cancer to see if there are differences.

Prostate Specific Antigen (PSA) is a serine protease secreted by prostate epithelial cells, which is a tumor marker of prostate cancer. At present, PSA\<4 ng/ml is considered as the normal value, and PSA 4-10 ng/ml is considered as the gray value. PSA\>10 ng/ml should be highly suspected of prostate cancer. Prostate biopsy is still the gold standard for the diagnosis of prostate cancer. However, as an invasive procedure, it can cause many complications such as pain, bleeding, lower urinary tract symptoms and infection. There is a growing trend to reduce unnecessary prostate biopsies.

Prostate specific membrane antigen (PSMA) is a membrane-bound enzyme that is highly expressed in more than 90% of prostate cancer lesions and has become an important target for molecular imaging of prostate cancer. In recent years, radioactive nuclide 18F labeling targeting PSMA positron emission tomography/computed tomography (PET/CT) has shown important clinical application value in prostate cancer recurrence monitoring.

The goal of this observational study is to establish an evaluation system for accurate identification of prostate cancer and clinical significant prostate cancer in patients in the PSA gray zone.

Participants will: 1. undergo PSMA PET/CT and multiparametric MRI; and 2. undergo biopsy

Researchers will compare the diagnostic performance of PSMA PET/CT and multiparametric MRI for prostate cancer and clinical significant prostate cancer to see if there are differences.

Eligibility Criteria:
Inclusion Criteria:

* PSA (4-10 ng/mL)
* MRI and PSMA PET/CT were not contraindicated
* Did not receive prostate-related treatment
* There are no contraindications to biopsy

Exclusion Criteria:

* Coexisting with other malignancies
Opioid Free Anesthesia vs. Opioid Anesthesia Techniques.

A comparison of post-operative opioid use in Laparoscopic Colectomy patients receiving Opioid or Opioid-free Anesthesia.

The study population will be composed of 100 patients total, 50 opioid-free anesthesia laparoscopic colectomy patients and 50 opioid anesthesia laparoscopic colectomy patients at Tampa General Hospital. After consent is obtained patients will be electronically randomized using REDCap in a 1:1 ratio and assigned to a opioid anesthesia or opioid free anesthesia group. Patients will also consent to be asked survey questions preoperatively and be followed for 12 months postoperatively at specific intervals to evaluate pain, satisfaction, and opioid prescription use. This will be done through a data mining platform and service known as REDCap. REDCap is partnered with USF to allow for subject management, data collection and the distribution of surveys via mobile phone. All data collected by REDCap is stored on a HIPPA compliant server. Patients will receive automated push notifications to their mobile phones to fill out surveys regarding their pill usage, pain, and satisfaction for a year or until cessation of opioid use is confirmed. Confirmation of opioid cessation will be performed on a case by case basis by the principal investigator, Dr. Camporesi. In addition to the surveys performed, nausea and pain scores will be collected prospectively from observation in the PACU

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to TGH for laparoscopic colectomy under Dr. Sanchez's care
* Adults aged 18 and older

Exclusion Criteria:

* Patients who are pregnant
* Patients that are not registered within Tampa General Hospital Electronic Medical Records System
* Patients without smart phone capabilities
* Patients younger than 18 years
* Patients older than 80 years
* Patients who cannot speak or read English
SMART-IBD App Trial

The objective of this trial is to test whether a smartphone app, SMART-IBD, is effective in improving medication adherence and self-management skills in adolescents with IBD. The investigators will conduct a randomized control trial to compare a sample of 15 youth (ages 13-17) with IBD using an app that has educational content and medication reminders to 15 youth in an attention control group. The length of the intervention will include one month of baseline adherence data collection, one month of intervention, and one month of post-treatment adherence data collection.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis (collectively IBD)
* Prescribed at least one medication used to treat IBD, regardless of route of administration
* Access to internet or wi-fi or data plan and access to smartphone
* English fluency for patient and clinician

Exclusion Criteria:

* Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review
* Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review
Erlotinib Treatment Beyond Progression in EGFR Mutant NSCLC

The purpose of this study is to determine whether continuing erlotinib beyond disease progression in combination with chemotherapy is beneficial for NSCLC patients who have EGFR mutant disease or who have responded to EGFR TKI.

A Phase II randomised, multicenter study to assess the efficacy and safety of continuing erlotinib in addition to chemotherapy versus chemotherapy alone in patients who have EGFR mutant or EGFR TKI responsive NSCLC and have progressed on EGFR TKI.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed stage IIIB/IV NSCLC.
* Investigator confirmed progression according RECIST 1.1 during EGFR TKI treatment within 28 days of the randomization
* Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months
* Performance status: WHO 0-2
* Measurable disease according to RECIST 1.1
* Patients must be able to comply with study treatments
* Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study
* Neutrophils ≥ 1'000/μl, Platelets ≥ 100'000/μl, Alanine amino transferase ≤ 2.5 × Upper limit of normal (ULN) (\< 5 × ULN if liver metastases), Alkaline phosphatase ≤ 2.5 × ULN (\< 5 × ULN if liver metastases), Serum bilirubin ≤ 1.5 × ULN, Serum Creatinine ≤ 1.5 × ULN.
* Patient must be able to comply with the protocol

Exclusion Criteria:

* RECIST 1.1 defined disease progression for more than 28 days while on previous EGFR TKI treatment.
* Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
* Patient has history of hypersensitivity or intolerance to erlotinib or gefitinib.
* Patient has history of hypersensitivity or intolerance to chemotherapeutic agents used in the study.
* Patient with symptomatic central nervous system metastases
* Patient has known active hepatitis B or C, or HIV infection
* Pregnant or breastfeeding.
* Patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study
The Effect of Antiemetics on Bowel Preparation Before Colonoscopy

Polyethylene glycol (PEG) is one of the most common laxatives used in colonoscopy. However, 5 - 15% of patients can not complete the preparation due to its poor taste and large volume. So this study is aimed to explore the effect of antiemetics on abdominal discomforts associated with PEG.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years patients scheduled for colonoscopy

Exclusion Criteria:

* intestinal obstruction or hemorrhage;
* allergy to domperidone, sulpiride or PEG;
* pregnancy or breastfeeding;
* previous use of prokinetics within 1 month.
Evaluation of Stroke Patient Screening

Background and Rationale:

Traditionally, stroke rehabilitation studies have been performed in stroke patients beyond the first one to three months poststroke \[Stinear et al. 2013; Veerbeek et al. 2014\]. Acknowledging that early stroke rehabilitation should be initiated soon after stroke onset to optimize stroke outcomes, it is has been stressed that stroke rehabilitation trials should be initiated within the first month \[Stinear 2013\].

Early stroke rehabilitation trials face difficulties regarding patient recruitment with corresponding low enrollment rates \[AVERT 2015; Winters 2015\]. Explanations are for example priority given to (sub)acute medical interventions, highly dynamic situation at a stroke unit, and a more rapid change in patients' abilities when compared to patients in later stages poststroke. With the low enrollment rates (\~7%), the generalizability of study results is questionable.

Participant screening methods and procedures for research eligibility are part of the patient selection and recruitment process in clinical trials. However, no information is available regarding screening procedures and methods for these early initiated stroke rehabilitation trials, including reasons for not enrolling patients. This knowledge is essential to improve screening procedures and methods, in order to optimize patient enrollment and with that, increase the generalizability of study results.

Objective:

The objective of this project is to evaluate screening methods and procedures for stroke rehabilitation research.

Study Design:

Observational study

Objective:

The objective of this project is to evaluate screening methods and procedures for stroke rehabilitation research in the Department of Neurology, University Hospital Zurich.

Outcome:

Enrollment rates (defined as the number of patients enrolled per month of recruitment), reasons for non-enrollment, and estimated costs for screening for early stroke rehabilitation studies.

Study Design:

Observational study

Eligibility Criteria:
Inclusion Criteria:

* First-ever unilateral ischemic stroke \<48 hours, confirmed by MRI-DWI and/or CT
* Age 18 years or older
* Able to follow one-staged commands
* NIHSS arm score ≥1
* Informed consent after participants' information

Exclusion Criteria:

* Modified Rankin Scale score \>2 before stroke
* Neurological or other diseases affecting the upper limb(s) before stroke
* Intravenous line in the upper limb(s) which limits assessment
* Contra-indications on ethical grounds
* Expected or known non-compliance to participate in the observational study, severe drug or/and alcohol abuse
Acetaminophen and Impaired Musculoskeletal Adaptations to Exercise Training

The purpose of this study is to determine if taking the pain reliever acetaminophen (ACET) interferes with some of the benefits of weight lifting on muscles and bone density in older men.

The commonly used pain relievers acetaminophen and ibuprofen may impair musculoskeletal adaptations to progressive resistance exercise training by inhibiting exercise-induced muscle protein synthesis.

To test the hypothesis that acetaminophen and ibuprofen would diminish training-induced increases in fat-free mass, untrained men (n=26) aged ≥ 50 years participated in 16 weeks of high-intensity progressive resistance exercise training and bone-loading exercises and were randomly assigned to take ACET (1000 mg), ibuprofen (400 mg) or placebo 2 hours before each exercise session.

The primary outcome was the change in total body fat-free mass measured by dual-energy X-ray absorptiometry (DXA) at baseline and week 16. Our primary interest was in the comparison of the acetaminophen and placebo groups.

Eligibility Criteria:
Inclusion Criteria:

* average use of acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) \[including aspirin\] less than 3 days per month
* not currently engaged in moderate-to-vigorous weight-lifting exercise
* non-smoker
* willing to participate in a supervised exercise program for 9 months

Exclusion Criteria:

* relative or absolute contraindications to regular use of acetaminophen or NSAIDs including known allergy or intolerance to either drug,history of peptic ulcer or GI bleeding, anemia, asthma with bronchospasm induced by aspirin or other NSAIDS, moderate or severe renal impairment, known hepatobiliary disease
* contraindications to exercise testing and training including congestive heart failure class III or IV, uncontrolled hypertension and unstable cardiovascular disease
* thyroid dysfunction
* orthopedic problems that limit the ability to perform vigorous exercise or increase the likelihood of the use of pain medications
* drugs known to alter bone metabolism
* allergy to lidocaine
* diabetes mellitus requiring pharmacologic therapy
Assessment the Diagnostic Value of Pro-Neurotensin as a Serum Biomarker in MASLD

To assess the diagnostic significance of serum pro-NT in MASLD and ability to differentiate between early and advanced steatosis.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic adults were randomly recruited from relatives of patients in Tropical Medicine and Gastroenterology Outpatient Clinic or the Inpatient Section of the department. Participants were categorized as MASLD patients if their abdominal US examination showed the criteria of fatty liver as described later or Non-MASLD (Controls) if they did not show these criteria.

Exclusion Criteria:

* (i) Patients aged \<18 years or \>75 years. (ii) History of Alcohol consumption. (iii) A diagnosis of liver diseases other than MASLD, including viral hepatitis, drug-induced liver injury, clinically suspected cases of autoimmune liver disease, Wilson's diseases, primary biliary cholangitis.

The control group had no illness to cause any inflammation; no usage of alcohol, drug, or herbal substances; no history of previous liver diseases; and was negative for viral hepatitis serology tests and had completely normal liver US.
Cannabidiol for Bilateral Total Knee Arthroplasty

In light of the opioid epidemic and evidence suggesting that cannabis may be opioid-sparing, we are in a unique position to conduct a novel, high-impact study that would set the stage for future RCTs examining the effects of a nonintoxicating and nonaddictive cannabinoid in an orthopedic patient population. Epidiolex®, an oral cannabidiol (CBD) solution, is the first ever cannabis-derived medication to be approved by the Food \& Drug Administration. Our aim is to conduct a pilot study using a placebo oral solution, 400mg and 800mg Epidiolex® to gather data on its effects on patients undergoing bilateral total knee arthroplasty (BTKA). We will be estimating whether Epidiolex® is associated with minimal opioid use and adequate analgesia. We will also assess its tolerability, pharmacokinetics, and effects on inflammatory markers in the perioperative setting.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75
* Scheduled for same-day bilateral total knee replacements with participating surgeons
* American Society of Anesthesiologists (ASA) Physical Status 1 or 2

Exclusion Criteria:

* ASA 3 and higher
* Weight \< 40kg
* Planned use of general anesthesia
* Contraindication to major components of study protocol
* Cannabis or cannabinoid use within the past 3 months (recreational and/or medical)
* Use or ingestion of hemp seeds or hemp oil in any form within the past 30 days
* Chronic opioid use (\>3 months)
* Coumadin use
* Current use of SSRI or SNRIs
* History of substance abuse or dependence
* Active or history of major psychiatric illness
* Severe cardiovascular disorder
* Severe hepatic or renal insufficiency (transaminase levels above ULN)
* History of epilepsy
* Diagnosis of rheumatic disease, autoimmune disease, or immunodeficiency (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, etc.)
* Use of valproate or clobazam
* Known or suspected hypersensitivity, allergy, or contraindication to cannabinoids or any of the excipients in the study medications (i.e. sesame oil, sucralose, strawberry flavor)
* Active use of steroids - oral steroids upon admission
* Stress dose steroids
* Non-English speakers
* Planned discharge to home without caregiver(s)
Parent Management Training, Oregon

The purpose of the study is to examine the effects of Parent Management Training Oregon (PMTO) compared to treatment as usual (TAU) for parents with children aged 3 and 12 showing behavioral problems.

This project estimates the causal effect of Parent Management Training, Oregon (PMTO) in a Danish context. The study design is an RCT where PMTO is compared to Treatment As Usual (TAU). The target population is parents with children aged 3 and 12 showing behavioral problems. The primary outcome estimates changes in child behavior, and is measured three times: baseline, seven months follow-up, and 19 month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Families with children that are eligible for PMTO and at least one other type of family training program

Exclusion Criteria:

* The family does not want to participate
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)

This study will determine whether participants who receive V419 (PR5I) at 2, 4, and 11 to 12 months of age have an acceptable response to the vaccine. This study will also determine whether the immune response to V419 is similar to that of participants who received a licensed vaccine control. The primary hypothesis is that participants who receive PR5I at 2, 4, and 11 to 12 months have an acceptable response rate to all PR5I-contained antigens at one month after the Toddler dose of PR5I.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infant able to attend all study visits
* Parent(s)/legal representative are able to read, understand, and complete study questionnaires

Exclusion Criteria:

* History of congenital or acquired immunodeficiency
* Received or is expected to receive immunosuppressive agents or systemic immunomodulatory steroids
* History of leukemia, lymphoma, malignant melanoma, or myeloproliferative disorder
* Hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or concomitant study vaccines
* Has any chronic illness that could interfere with study conduct or completion
* Received any immune globulin, blood, or blood-derived products since birth
* Received a dose of hepatitis B vaccine prior to study entry
* Vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus vaccine, or combination thereof
* Fever within 24 hours prior to enrollment
* Received any non-study vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 14 days or more prior to enrolment
* Has a coagulation disorder
* Has developmental delay or neurological disorder
* Participant or his/her mother has a medical history of hepatitis B surface antigens (HBsAg) seropositivity
* History of Haemophilus influenzae type b, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus gastroenteritis, or invasive pneumococcal infection